Dermatoethics: Contemporary Ethics and Professionalism in Dermatology

Dermatoethics Lionel Bercovitch • Clifford Perlis Editors Dermatoethics Contemporary Ethics and Professionalism in D...

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Dermatoethics

Lionel Bercovitch • Clifford Perlis Editors

Dermatoethics Contemporary Ethics and Professionalism in Dermatology

Editors Lionel Bercovitch, MD Departments of Dermatology Hasbro Children’s Hospital and Rhode Island Hospital Warren Alpert Medical School of Brown University Providence, RI, USA Clifford Perlis, MD, MBe Fox Chase Cancer Center Philadelphia, PA, USA

ISBN 978-1-4471-2190-9 e-ISBN 978-1-4471-2191-6 DOI 10.1007/978-1-4471-2191-6 Springer London Dordrecht Heidelberg New York British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Control Number: 2011940767 © Springer-Verlag London Limited 2012 Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publishers, or in the case of reprographic reproduction in accordance with the terms of licences issued by the Copyright Licensing Agency. Enquiries concerning reproduction outside those terms should be sent to the publishers. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore free for general use. Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)

To my parents, Solomon Bercovitch and Claire and Marcus Tessler from whom I acquired my values To my mentors and professional role models, Charles McDonald, MD, Bencel Schiff, MD, and Manly Rubin, MD, from whom I acquired my love of dermatology And to my family–Anne, Deb, Rob, Rhana, Ryden, Paul, Rains, and Carol, whose love and support have sustained me through this project and make every day a joy. —LB For my parents, Linda and Barry R. Perlis, whose patience and encouragement are limitless. For my teachers and colleagues, Charles McDonald, MD, Jonathon Merz, PhD, JD, and Stuart Lessin, MD who continue to inspire and support my academic endeavors. For the endless understanding of my wife, Emily, and love of my children, Elliot and Gabrielle. —CSP

Foreword

As a teacher of residents, a colleague of fellow academic dermatologists, and a past president of our national specialty society, I have witnessed a large array of ethical dilemmas. Controversy on how to teach the issues and guide our young people regarding their future choices has been discussed repeatedly in forums ranging from American Academy of Dermatology forums to Association of Professors of Dermatology panels. I have personally found the best method to raise consciousness in ethical decision-making to be real life situations, issues faced in everyday clinics, in business management, and in scholarly pursuits. Apparently Drs. Bercovitch, Perlis, and co-authors in the book Dermatoethics agree. In framing each of their over 40 chapters they elect to start with a series of scenarios which illustrate the problems encountered in each area, then review relevant AMA or AAD or guidelines, speak to the appropriate ethical principles, and end with a thorough discussion of ways each scenario might be resolved. This format makes the book a relatively easy read while tackling the most challenging of issues. In sum, there is no other book like it. Dermatoethics helps us prepare to face tough decisions. In prospectively considering these diverse situations we can be more critical consumers of the medical literature, models of transparency, and physicians who see the issues through the eyes of our patients. It is this perspective that should guide our actions, and Dermatoethics doesn’t let us deviate from this patient-centeredness. Bravo! Read, reflect and enjoy humanistic medicine at its best. Department of Dermatology University of Pennsylvania School of Medicine Philadelphia, PA

William D James, MD

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Preface

What would you do if a dermatopathology laboratory offered to pay 85% of the cost of an expensive electronic health record system for your practice? What if a patient asked you to accept an invitation to become a Facebook friend? What would you do if you saw a lesion you suspected might be melanoma on the back of a stranger getting dressed two lockers over at the gym? And, what would you do if one of your associates began to exhibit early signs of dementia? These are examples of the many contemporary ethical and professional dilemmas dermatologists and dermatology trainees might face in their day-to-day work. The solutions are more nuanced than they may appear to be at first glance. Fortunately, dermatologists do not need to be trained bioethicists, healthcare lawyers, or philosophers to analyze and deal with such dilemmas. Nor do they need to have a ready solution for every ethical dilemma encountered. Dermatologists do need to recognize when an ethical issue or dilemma arises, identify key issues, assess relevant ethical principles as well as legal and professional issues, seek advice and supplementary information when indicated, and attempt to resolve the issue in a sound and satisfying way. This approach is illustrated in Fig. 1. Behavioral ethicists emphasize the importance of honing one’s skills in ethical analysis to avoid self-deception. “When we fail to notice that a decision has an ethical ANALYZING A PROBLEM OR DECISION RECOGNIZE EXISTENCE OF AN ETHICAL DILEMMA OR PROBLEM BREAK DILEMMA DOWN TO ITS COMPONENT PARTS SEEK ADDITIONAL INFO INCLUDING PATIENT’S VIEWPOINT IDENTIFY RELEVANT LEGAL, PROFESSIONAL GUIDANCE SUBJECT THE DILEMMA TO CRITICAL ANALYSIS RESOLVED

NOT RESOLVED

JUSTIFY THE DECISION WITH SOUND ARGUMENTS

IRRESOLVABLE CONFLICT OR LAW UNCLEAR-MAY NEED COURT TO RESOLVE

Fig. 1 The approach to an ethical dilemma (Adapted from p. 8, Medical Ethics Today the BMA’s handbook of ethics and law. 2nd ed. BMJ Books. London, 2004) ix

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Preface

component, we are able to behave unethically while maintaining a positive selfimage,” write Max Bazerman and Ann Tenbrunsel in a recent New York Times article (April 21, 2011, p. A27). Furthermore, they add, “research shows that people consistently believe themselves to be more ethical than they are … (and) that people who have a vested self-interest, even the most honest of us, have difficulty being objective. Worse yet, they fail to recognize their lack of objectivity.” Since all physicians have vested self-interests, conflicts of interest are inherent in the practice of medicine. Accordingly, research suggests that even the most ethically aware physicians may not realize their own subjectivity. This concept of this book arose from a regular seminar entitled “Dermatoethics” in the Brown University dermatology residency, led by one of the editors (L.B.), that began in 2001. At that time, our faculty recognized the irony that educational offerings in ethics were abundant for medical students, but virtually non-existent for residents who for the first time actually have meaningful independent responsibility for patient care. Furthermore, each year the seminar identified new situations reflecting the everchanging medical environment. Electronic communication, social networking, healthcare reform, the changing reimbursement scene, consumerism and the business of medicine, cosmetic dermatology and medical spas, and advances in genetic technology, all give rise to new ethical concerns. These developments combined with the frailties of human nature, to which physicians are not exempt, underscore the need for ongoing teaching and dialogue on contemporary issues in ethics and professionalism for dermatology trainees and practitioners. From 2001 to 2010, 136 English-language articles on ethics in dermatology were published. By contrast, there were only 98 articles published over the prior 20 years. The American Academy of Dermatology offered four forums and discussion groups on ethics at its 2011 meeting. There has clearly been increasing interest in ethical issues in dermatology. It is our hope that this book will serve as a resource to stimulate discussion and teaching in ethics to dermatology trainees, as well as for practicing dermatologists in academia, public and military service, and the community. No work of this scope can be accomplished without the help and support of others. We wish to acknowledge the encouragement, foresight and patience of the publisher’s senior editor, Grant Weston, as well as the tireless work of our production editor, Rebecca McArdle, in keeping tabs on all the contributors, chapters, permissions, and figures. We are also grateful for the administrative support of Allison Marshall, Dawn Elder, and Kathy Zenszer. Our contributors good-humoredly and willingly allowed their work to be subjected to numerous edits and rewrites, and the final product in no small measure reflects their diligence and persistence. We thank Dr. Antonio P. Cruz for his assistance with technological challenges, usually with little notice. George Wakeman, Esq. provided insightful legal commentaries as helpful background to many of the chapters, as nearly all the chapters did not have authors with legal training. We would be remiss in failing to acknowledge the contributions of our former residents at Brown who were the experimental group for this project (N = 37) and the foresight of Charles McDonald, M.D., Professor and Chairman of Dermatology at Brown University, who encouraged the establishment of this seminar course. And lastly, to our spouses and children, who sacrificed many hours of quality time with us during the preparation of this book, we are grateful beyond words. Lionel Bercovitch, M.D. Clifford Perlis, M.D., MBe

What Do We Mean by Ethical? Clifford Warren Lober

Deﬁnition of Ethics Although we all use the term ethics (or ethical), there has been great difficulty and lack of clarity in defining this term. It is often used interchangeably with words such as “good”, “right”, “acceptable”, or “ideal”. Many texts define ethics in terms of “morals”, “moral life,” or “moral philosophy” [1, 2]. There is, however, an inherent paradox in defining ethical as “moral” or “good”. If, for example, one accepts the definition of ethical as “moral” and in turn looks up the definition of “moral”, one may find “morality” defined (among other descriptions) as “a system of rules, ethics” [3]. This circular definition both fails to clarify the meaning of either ethics or morals and, perhaps more importantly, provides absolutely no guidance for determining whether a given action is ethical or moral. If one searches for the definition of ethics in Black’s law dictionary, we are told to “see legal ethics” [4]. Legal ethics in turn is defined as “the standards of minimally acceptable conduct within the legal profession…” [5] We are again confronted with problems. Are ethical standards “minimally acceptable conduct”, or are they rather ideals toward which one should aspire? Furthermore, this definition again gives us no basis for determining whether a given action is ethical. The following definition of ethics is therefore proposed: ethics is a set of behavioral ideals derived from fundamental beliefs. These beliefs are either (1) arbitrarily accepted as true in and of themselves or (2) derived inductively or deductively from other fundamental beliefs. Let us examine this definition closely. Ethics represents behavioral ideals which describe behaviors and actions, not things. The moon or a tree, for example, is neither ethical nor unethical. Inherent in this definition is the fact that these behaviors have to be the intentional actions of people. A horse pulling a cart or the actions of a profoundly mentally impaired person are similarly neither ethical nor unethical. Ethics are not minimally acceptable behaviors, but rather ideals or goals to which we should strive. The Code of Medical Ethics of the American Academy of Dermatology, for example, clearly presents ideals to which we should strive since it “espouses a standard of behavior that is, in some cases, higher than that required by the law” [6]. Our ethical actions are based upon our fundamental beliefs. These beliefs are the basic bedrock, core, foundational beliefs that one holds, such as the belief in the existence of God to a religious person. They are beliefs, by which we mean values that are accepted as true or the “given” in a hypothetical situation. It is obviously critical that any definition of ethics address how we arrive at these beliefs. There are three ways one can arbitrarily accept beliefs to be inherently fundamentally true. They can be described as self-evident or innately obvious. The Declaration xi

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of Independence, for example, states that “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness.” [emphasis added] These truths were not scientifically proven or reasoned by deductive or inductive thinking, but were rather innately obvious to the framers of the Declaration and accepted as fundamentally true. Divine pronouncement is another way we arbitrarily accept beliefs to be fundamentally correct. God is perfect and therefore anything He says is accepted as absolute truth. Period. Statements made in religious texts attributed to God are clear examples of divine pronouncement. To those who believe that “God transcends all human reality and is without limit,” His word is absolute [7]. Finally, beliefs may be arbitrarily accepted as core values because they are sociobiologically necessary or adaptive. For example, I will probably not want to lie to you because you may never believe me again and I will not be able to trust statements made by you since you may now feel free to be dishonest with me. Therefore, it is not socially beneficial for me to lie to you. Fundamental beliefs may also be derived by either inductive or deductive reasoning. When using inductive reasoning, we generalize from a sample to a universal value or reasoning from specific instances to general propositions. For example, saving a particular patient’s life is ethically correct; therefore saving all patients’ lives is ethical. Alternatively, in deductive reasoning the conclusion is arrived at in a step-bystep manner and the conclusion necessarily follows as a logical consequence of the premises. For example, the death sentence is unethical. Lethal injection is a form of the death sentence. Therefore, lethal injection is unethical when used to carry out a death sentence.

Characteristics of Ethics Ethics facilitates the functioning of society. It is obvious how rejecting killing, stealing, or lying as unethical promotes an orderly society. As Odell stated, “Ethics is a social phenomenon. If we did not live in communities, ethics would lose its point. From the perspective of community, the goal of ethics is to make it possible for us to live together. …The production of harmonious co-existence is and must be the role of a system of ethics” [8]. Ethics are inherently subjective. If we alter our fundamental beliefs, our ethical values change. If we fundamentally believe that human life is sacred, the death penalty is obviously unethical. Alternatively, if we accept that society should seek “an eye for an eye,” the death penalty would be ethical. Ethics will differ in various societies. Many ancient cultures considered human sacrifice to the gods to be a high honor. Most contemporary Americans, conversely, would be horrified at the thought of sacrificing another human being for any reason. Ethics depends on the amount of detail one is given about a particular situation. If I tell you that I am going to rob a bank, you may find this action unethical. However, if I tell you that I plan to commit this robbery because my children are starving and that I have absolutely no other means of obtaining money to buy food other than robbing a bank, my action may become less ethically objectionable. Similarly, one may find it unethical to deny treating a patient who has a superficial basal cell carcinoma. However, if it is subsequently revealed that the same patient has metastatic pancreatic cancer and has a life expectancy of only a few months, allowing the skin cancer to go

What Do We Mean by Ethical?

What Do We Mean by Ethical?

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untreated may seem far less unethical. In fact, not treating the skin cancer may be the most ethical approach in this situation. Ethics is not the same as a code of laws. Laws are actions taken by elected or appointed groups of persons to govern society. It is not surprising, therefore, that each law may be viewed as ethical or unethical depending upon one’s beliefs. If, for example, you strictly oppose abortion you will find statutes permitting abortion to be highly unethical. Conversely, if you support abortion the same law may be ethical in your view. One should absolutely never state either that an action is ethical because it is legal or that a behavior is unethical because it is illegal. There will rarely be universal agreement on ethical values. This is merely a reflection that different individuals and societies will hold quite different fundamental beliefs. Ethical conflicts exist and are unavoidable. One may believe, for example, that it is ethically wrong to torture a person and simultaneously believe that human life is sacrosanct. If, hypothetically, a terrorist plants a bomb in a shopping center and the only way to learn the location of the bomb and save dozens of innocent lives is to torture the terrorist, the determination of whether or not to torture the terrorist presents a very obvious ethical conflict. Ethical conflicts are usually resolved by examining the relative strengths of the underlying fundamental beliefs upon which the ethical actions are founded. Ethics is often communicated using concepts such as good vs. bad, right vs. wrong, desirable vs. undesirable, or moral correctness. Although these terms may characterize ethics, they should not be used to define ethics for previously described reasons. Ethics changes with time due to changes in our fundamental beliefs. The American Medical Association’s 1847 Code of Ethics, for example, stated that “[i]t is derogatory to the dignity of the profession to resort to public advertisements or private cards or handbills, inviting the attention of individuals affected with particular diseases… These are the ordinary practices of empirics and are highly reprehensible in a regular physician” [9] [emphasis added]. This statement no longer appears in the AMA’s Code of Ethics.

Ethics Is Not Objectively Provable Many people are bothered by the fact that ethics is not objectively provable, in contrast to the temperature at which water boils or the distance to the moon. This objection, however, fades away when one considers that all knowledge, both scientific and ethical, is of necessity based upon assumptions. For centuries it was believed that the earth was both flat and the center of the solar system. People were burned alive at the stake for denying these very obvious “facts”. Many schools still teach that there are 180° in a triangle, despite our realization that this “fact” applies only in rare, theoretical instances where space-time is not curved by the existence of matter [10]. Dermatopathologists on a daily basis make diagnostic determinations using microscopes. Although none of us would seriously dispute the existence of optical distortion in all microscopic lenses, we routinely rely on these flawed instruments to make “objective”, diagnostic determinations. The key point is that just as our ethics are based upon fundamental assumptions, so-called “scientific” or “objective” statements are similarly made based upon assumptions or beliefs. As Brentano stated, “In a science it is not possible to prove every opinion which we set forth. For every proof rests upon certain presuppositions;

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if we prove these, it is upon the basis of still further presuppositions. But this process cannot go on forever. We cannot avoid this infinite regress by arguing in a circle, for then we simply explain the term in question by means of the same term, but in a disguised form. … Hence we must start with unproven principles, with immediate assumptions” [11]. It is similarly incorrect to discount the validity of ethical assumptions merely because they cannot be “scientifically” or “objectively” validated.

Where Does This Leave Us? Given the above definition of ethics and an understanding of the characteristics of ethics, we are in a far better position to consider individual situations and make ethical determinations. We know that our ethics are subjective, will reflect our fundamental beliefs, differ among various individuals, depend upon the amount of detail we are given, etc. We clearly understand that the fact an action is legal or illegal does not necessarily mean it is ethical. It is critical that in describing any behavior as ethical we address the fundamental underlying belief that we feel justifies that behavior and the reason we accept that underlying belief as true or correct. Finally, we recognize that neither ethical nor “scientific” beliefs are absolute.

Acknowledgment Presented in part on March 6, 2010 at the 68th Annual Meeting of the American Academy of Dermatology in Miami, Florida

References 1. Principles of biomedical ethics. 5th ed. In: Beauchamp TL, Childress JF, editors. Oxford: Oxford University Press; 2001. p. 1. 2. Historical dictionary of ethics. In: Gensler HJ, Sprugin EW, editors. Lanham, MD: The Scarecrow Press, Inc.; 2008. p. xi. 3. Black’s law dictionary. 7th ed. In: Garner BA, editor. St. Paul: West Group; 1999. p. 1025. 4. Id., p. 573. 5. Id., p. 904. 6. AAD Code of Medical Ethics for Dermatologists, 2010. http://www.aad.org/ Forms/Policies/Uploads/AR.pdf. Accessed 1 Mar 2010. 7. Reed ED. The genesis of ethics, on the authority of God as the origin of Christian ethics. Chapter One: the authority of God: God as author. Cleveland: The Pilgrim Press; 2000. p. 1. 8. Odell SJ. On consequentialist ethics. Australia: Thompson Wadsworth; 2004. p. 4. 9. Code of Ethics of the American Medical Association, 1847. http://www.ama-assn. org/ama/pub/about-ama/our-history/history-ama-ethics.shtml. Accessed 1 Mar 2010. 10. Gueron E. Adventures in curved spacetime. Sci Am. 2009;301:38–45. 11. Brentano F. The foundation and construction of ethics. Chapter 1: The extent to which principles of knowledge can be an object of investigation and controversy. New York: Humanities Press; 1973. p. 14.

What Do We Mean by Ethical?

Contents

Part I

Dermatologist as Clinician

1

“Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Lionel Bercovitch

2

“Give Me Enbrel™ or Give Me Death”: Confronting the Limits of Autonomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Lionel Bercovitch

3

Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age . . . . . . . . . 13 Lisa Pappas-Taffer and Alexander Miller

4

Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Kenneth E. Bloom and Lionel Bercovitch

5

“Who Speaks for the Child?” Consent, Assent, and Confidentiality in Pediatric Dermatology. . . . . . . . . . . . . . . . . . . . . . . 25 Kenneth E. Bloom and Lionel Bercovitch

6

Therapeutic Privilege: If, When, and How to Lie to Patients . . . . . . . . . . 33 Richard G. Fried and Clifford Perlis

7

Communicating with Patients About Adverse Medical Events: If, When, and How to Say “I’m Sorry”. . . . . . . . . . . . . . 37 Steven Shama, Lyn Duncan, and Lionel Bercovitch

8

The Computer Will See You Now: Ethics of Teledermatology . . . . . . . . . 45 Jennifer L. Weinberg, Rachel H. Gormley, and Carrie L. Kovarik

9

Hospital Consultations: Embracing Professionalism Even When It Hurts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Lauren E. Krug and Stephen E. Helms

10

The Extender Is In: Delegating Ethically—Ethical and Professional Issues Relating to Physician Extenders in Dermatology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Steven Rosenberg and Clifford Perlis

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Contents

Part II

Dermatologist as Professional

11

Professional Boundaries: Safeguarding the Physician–Patient Relationship . . . . . . . . . . . . . . . . . . . 61 Brandon H. Krupp

12

Taking Care of Uncle Bob’s Rash: Should One Treat Family Members? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Sandra Osswald

13

Peering into the Gift Horse: Is It Ethical to Accept Gifts from Patients?. . . . . . . . . . . . . . . . . . . . . . . . . 71 Lionel Bercovitch

14

The Dermatologist and Social Media: The Challenges of Friending and Tweeting . . . . . . . . . . . . . . . . . . . . . . . . . 77 Jennifer A. Sbicca and Stanton K. Wesson

15

Respecting Differences: Dermatology in a Diverse Society . . . . . . . . . . . . 83 Vimal Prajapati and Benjamin Barankin

16

Dermatologists Within, Beyond and Struggling with Borders: The Global Dermatologist . . . . . . . . . . . . . 91 Jennifer L. Weinberg

17

Feet of Clay: The Impaired Dermatologist . . . . . . . . . . . . . . . . . . . . . . . . . 97 Brandon H. Krupp

Part III

Dermatologist as Teacher and Trainee

18

The Mentor-Mentee Relationship: The Devil Is in the Details . . . . . . . . 109 Kimberly L. Merkel, John A. Cole, and Stanton K. Wesson

19

Tales from the Residency Interview Trail . . . . . . . . . . . . . . . . . . . . . . . . . 113 Jennifer A. Sbicca and Alfred T. Lane

20

Ethics Education for Residents: Growing Pains and Learning Crises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Irèn Kossintseva and Benjamin Barankin

21

Teaching Ethics in Clinic: Keeping You Smart and Honest. . . . . . . . . . . 125 Nely Z. Aldrich and Eliot N. Mostow

Part IV

Dermatologist as Businessperson

22

Boutiques, Botox®, and Basal Cells: Can Dermatology Set Its Priorities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Jeffrey J. Meffert and Maria Villegas

23

The Price Is Right: Office Dispensing and Product Pricing . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Tivon Sidorsky

Contents

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24

My Elixir, MD: Morphing a Medical Degree into a Skincare Brand . . . . . . . . . . . . . . . . . 143 Julie Cantor

25

Marketing the Physician: From Antitrust to Distrust . . . . . . . . . . . . . . . 147 Catherine L. Kowalewski and Jeffrey J. Meffert

26

What the Market Will Bear? Ethical and Professional Issues in Medical Fees . . . . . . . . . . . . . . . . . . . . 153 Carl Johnson and Lionel Bercovitch

27

Spa, MD: When Dermatology Meets Aromatherapy . . . . . . . . . . . . . . . . 157 Tivon Sidorsky and Lionel Bercovitch

28

Gatekeepers, Dermatologists, and Their Patients: Mixed Messages in Managed Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Lindsey A. Brodell, Robert T. Brodell, and Brendan Minogue

29

Ethical Adventures in 21st Century Dermatopathology . . . . . . . . . . . . . 169 Homer O. Wiland IV, Barry D. Kels, and Jane Grant-Kels

30

Defining the Gray Zone: Client Billing and Contractual Joint Ventures . . . . . . . . . . . . . . . . . . . . . 177 Homer O. Wiland IV, Barry D. Kels, and Jane Grant-Kels

31

No Strings Attached? Managing Conflicts of Interest in Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 Noah D. Shannon and Clifford Perlis

Part V

Dermatologist as Scholar

32

Respecting Human Subjects: Responsibilities of the Clinical Investigator . . . . . . . . . . . . . . . . . . . . . . . 193 Kenneth Katz and Samual Garner

33

Hope, Hype, and Genotype: Genetic Testing in Dermatological Diseases . . . . . . . . . . . . . . . . . . . . . . . 197 Natasha Shur

34

Desperate Measures for Desperate Patients: Translational Research in Epidermolysis Bullosa. . . . . . . . . . . . . . . . . . . 205 Alfred T. Lane

35

Reading Between the Lines: Can Peer Reviewers Be Expected to Detect Fraud? . . . . . . . . . . . . . . . . . 215 Jason D. Gillum, Jeffrey D. Bernhard, and Robert P. Dellavalle

36

Hiding Behind the Curtain: Anonomyous Versus Open Peer Review . . . . . . . . . . . . . . . . . . . . . . . . . . 221 Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

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Contents

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Ghost Busting in Dermatology Publications: Providing Byline Integrity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227 Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

38

Telling the Same Tale Twice: Déjà vu and the Shades of Grey in Self-Plagiarism . . . . . . . . . . . . . . . . . 233 Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

39

Cutting Edge or Cutting Corners? Innovative Care. . . . . . . . . . . . . . . . . 237 Jolion McGreevy and Clifford Perlis

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

Part I Dermatologist as Clinician

1

“Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues Lionel Bercovitch

Case Scenarios Case 1 (below). What would say if you saw this on your daughter’s best friend?

Case 2 (below). What would you do if you saw this lesion on the arm of a complete stranger in the health club locker room?

Fig. 1.2 Photo courtesy of Arthur Sober, M.D.

Fig. 1.1 Photo courtesy http://philip.greespun.com reproduced with permission

L. Bercovitch Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected] L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_1, © Springer-Verlag London Limited 2012

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Case 3 (below). What would you do if you saw this on the finger of the barista serving you coffee at Starbucks?

L. Bercovitch

Case 5 (below). Would you say something if you saw these lesions while a mother was changing her baby’s diaper at the beach? Would it be different if the mother were a family friend?

Fig. 1.3 Photo courtesy of Nathaniel Jellinek, M.D.

Case 4 (below). What would you do if you were standing next to this person at the subway station while waiting for a train?

Fig. 1.5

Discussion

Fig. 1.4

When is a dermatologist not a dermatologist? On vacation? At a family gathering? While exercising at the gym? At the theater or waiting for a subway? In reality, never. Dermatologists are skillful trained observers. Even without the “antenna raised”, they observe lesions and rashes on friends, relatives, and even complete strangers that in the context of an established doctor– patient relationship would demand attention and action, possibly urgently. But what should the dermatologist do when individual in question is not a patient and has not sought the doctor’s opinion? Should he or she offer an unsolicited diagnosis or advice? What if the consequences of inaction could be serious or even fatal for the “patient”?

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“Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues

Although offering an unsolicited medical opinion may be regarded as an act of beneficence, the physician does not have a strict moral obligation to do so [1]. On one end of the spectrum are conditions or actions that are well recognized as being harmful but that pose no immediate threat to the individual, such as obesity, smoking, excessive sun exposure or indoor tanning. On the other end are urgent, life-threatening emergencies such as an accident or cardiac arrest. In the former, the physician is not morally bound to offer his opinion or to take action while in the latter, the physician is professionally and morally bound to act. In the situations in between, in which the obligation of beneficence may exist, the physician may use his or her discretion in deciding how, when, or even whether to offer an unsolicited opinion [1]. The degree to which the physician is morally obligated to act is affected by the seriousness and urgency of the risk to the individual, the degree of certainty of the diagnosis, and the presumption that the stranger would want the physician’s opinion or intervention [1]. The more serious the consequences of inaction, the less certain the diagnosis needs to be before acting. The obligation to bring a diagnosis to someone’s attention also depends on how obvious it is to that individual that something is wrong. In addition, one cannot assume that the person either knows how to access medical care or that the condition is even treatable. Unless the problem is treatable, there should be no obligation to offer an unsolicited opinion [1]. Indeed, offering an unsolicited diagnosis for a condition that is untreatable or for which no beneficial intervention exists could conflict with the physician’s obligation of non-maleficence were the patient to suffer psychological distress or act in a self-destructive way. A latent diagnosis that may remain so before causing harm imposes greater moral obligation upon the dermatologist. The bystander physician should possess appropriate medical knowledge to render an opinion, but need not be a specialist in the field. A psychiatrist can suspect a melanoma [2] and a dermatologist can recognize exophthalmos as a sign of Graves’ disease or suspect a potential cardiac emergency. Even where there appears to be a professional obligation or duty to offer unsolicited advice, ordinary morality (such as “don’t invade someone’s privacy”) may clash with professional morality (the obligation to heal the sick and relieve suffering). One’s personal morals and ethics may conflict with one’s professional duty and ethics [3].

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Table 1.1 The bystander phenomenon 1 The bystander must notice that something is happening 2 Bystander recognizes it as an emergency or crisis demanding a response 3 Bystander attributes to self responsibility for acting 4 Bystander must decide on effective intervention 5 Bystander must decide how best to intervene Source: From Ratzan [3]

Ratzan [3] has described the “bystander phenomenon” as it applies to medical emergencies, summarized in Table 1.1. Even so, the likelihood of the “bystander” taking action may depend on the number of bystanders, so-called “diffusion of responsibility” [3], to which anyone who has been present at a cardiac arrest can attest. The bystander role can be ambiguous. How severe or urgent is the situation? Is there a threat of harm increasing with time and resulting from the bystander’s inaction? What are the bystander’s ethical obligations? A professional is no ordinary bystander by virtue of technical or medical expertise and professional duties. An ordinary bystander may be a Good Samaritan while a physician’s professional duty may create an obligation to stop and assist regardless of private morals. To what degree this applies to rashes and skin lesions is less clear than with a serious motor vehicle accident. Having any sort of relationship with the individual may make it easier and seemingly less intrusive to offer a diagnosis or opinion. It is easier to strike up a conversation with someone with whom one has even a passing acquaintance. In addition, if the physician knows the individual, it might even make it possible to have a closer look at the lesion or rash without seeming overly intrusive. As with any intervention, there are risks and benefits to be considered. These are summarized in Table 1.2. Intervention by the bystander physician can have unintended and unexpected consequences. For example, consider the following scenario. The physician notices a pigmented lesion on someone’s back at the beach and comments that it looks a bit worrisome and recommends that it be examined by a dermatologist. The person goes to his physician who remarks, “you’re lucky someone noticed that. It could have been very serious or even fatal if the diagnosis had been delayed a few more months”. On the other hand, consider a different scenario: The same person goes to the dermatologist who tells him the lesion is nothing to be worried about. Based on the initial impression of the doctor at the

6 Table 1.2 Benefits and risks of unsolicited opinions Benefits 1 Beneficence: physician-bystander has acted for the benefit of the recipient 2 May prevent serious consequences of untreated diagnosis by enabling timely intervention 3 Physician has fulfilled a professional duty Risks 1 Diagnosis may be incorrect. For pigmented lesions, there is a high probability of misdiagnosing malignant melanoma 2 Unnecessary, costly and potentially invasive investigations with potential morbidity. The risk is inversely proportional to the accuracy of the diagnosis 3 Anxiety and depression may result 4 Recipient may be stigmatized 5 Invasion of privacy Source: Adapted from Ratzan [3]

beach, the patient is not fully reassured and insists on having the lesion removed. The wound dehisces, becomes infected, and heals with unsightly keloid scar. The two scenarios illustrate some of the potential risks and benefits of unsolicited diagnosis.

Legal Issues* Ethical and moral issues need to be considered in light of legal considerations. Without obligation imposed by law, the dermatologist bystander has no legal duty to act regarding another person, as opposed to a moral obligation or professional duty. The law offers little guidance in this area. The mere act of intervention, however, creates a legal duty to act in a reasonable manner. The whole area of unsolicited diagnosis and opinion is a gray area legally because the physician’s legal duty to act is not created until there is a professional relationship. Once the physician intervenes, duty is created and obligations are imposed, the extent depending on the facts of the case. Exactly what those duties are in the case of an unsolicited diagnosis (as opposed to cardiopulmonary resuscitation or other urgent interventions) are unclear. However, generally a doctor-patient relationship does not exist until both parties agree to enter into one. Good Samaritan statutes have traditionally been associated with emergencies and differ significantly from state to state. In general, these laws immunize the physician from being used for acts of negligence but not “gross negligence” or willful, wanton, or reckless acts (which, parenthetically, would likely not be covered by malpractice insurance, either). It would be

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extremely rare, however, for a physician’s action in a Good Samaritan situation to rise to the level of gross negligence or involve intentional infliction of harm. Whether or not Good Samaritan laws would protect the dermatologist offering an unsolicited opinion is uncertain. Strictly speaking, “liability” requires a doctor– patient relationship, and offering unsolicited advice does not meet the legal definition of a doctor–patient relationship. Whether that is affected by the patient acting on such advice is a gray area.

Analysis of Case Scenarios We shall now consider the case scenarios presented at the beginning of a chapter. In case 1, the presence of a severe sunburn, while a well-known risk for skin cancer, does not pose an imminent danger to the son’s best friend. In addition to the embarrassment likely to be inflicted on the dermatologist’s daughter by offering her friend his unsolicited opinion or advice, it is likely that the sunburned recipient would not welcome it. Although the offer of advice may be an act of beneficence, the lack of immediate benefit as well as the invasion of privacy and social embarrassment created would not justify it. If the sunburned individual were one’s fiancée or niece, then perhaps it might be viewed as less intrusive and be more graciously accepted. Case 2 is somewhat more analogous to the situation of a serious accident in that a malignant melanoma is suspected. How certain the dermatologist is of the diagnosis might influence how comfortable he or she is about offering advice or a diagnosis. Having some relationship with the individual having the lesion might also make it less awkward. Although the risk of harm might not be imminent, that is impossible to gauge on a cursory look, and in any case, if the differential diagnosis includes malignant melanoma, the outcome might very well be fatal. The dermatologist has a professional duty to act that likely transcends his or her personal mortality. If one would be grateful for an early and fortuitous diagnosis of melanoma for oneself, then the risk of invading another’s privacy and causing possibly needless anxiety is justified. Case 3 is more problematic. As in case 2, the differential diagnoses include malignant melanoma. The same considerations as in case 2 should apply. However, it is much more difficult to diagnose visually and the diagnostic workup is potentially more invasive. If one is a regular customer at the local Starbucks and

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“Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues

has seen the barista frequently enough to strike up a conversation, it might be possible to offer unsolicited advice that is not perceived as being intrusive as it might otherwise be. However, the potential risks in this situation are greater. Case 4 involves a very obvious mutilating lesion. It is impossible to imagine that the individual involved is unaware of the lesion or the potential gravity of the situation. It is possible that the person might not have access to health care due to lack of resources, in which case diplomatically and sympathetically offered unsolicited advice might be graciously and even gratefully received, but it is very likely to be rejected or not acted upon, especially if there is significant underlying mental illness. The professional duty to intervene in this very serious situation is probably mitigated by the advanced and untreatable nature of the lesion and the fact that the affected individual almost certainly is or has been made aware of it. Case 5 involves an infant with multiple café au lait macules suggestive of NF-1 neurofibromatosis. The disease is genetic and not treatable. The main advantages of early diagnosis are timely surveillance for optic pathway gliomas, early intervention for cognitive or learning disabilities, and possibly genetic counseling for his parents prior to future pregnancies. However, one could reasonably assume that the infant’s pediatrician would sooner or later appreciate the significance of the café au lait macules and refer the child for evaluation. If the mother is someone familiar to the dermatologist, suggesting further evaluation might not be as likely to be perceived as intrusive or an invasion of privacy, but even in similar situations, good intentions can destroy relationships [4].

How to Offer Unsolicited Advice or Diagnosis [3] Offering unsolicited advice or diagnosis is fraught with difficulty. It should be done discretely, tactfully, and quietly in a private setting. The physician or dermatologist should identify one self as such, and not solicit the individual as a patient. One should never act or be perceived as being overly certain of the diagnosis. Refer the individual to his or her primary care physician or to the appropriate institution or specialist for follow-up. Reassure the stranger that your motives are not self-serving or financial, and that the diagnosis under such circumstances is by necessity imperfect and preliminary and is subject to error. Keep the encounter confidential afterward.

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Table 1.3 Conditions for offering unsolicited advice 1 Physician assesses probability of potentially serious disease to be high 2 Physician judges the diagnosis to be latent and to remain so prior to a serious problem developing 3 Physician possesses appropriate medical knowledge regarding condition 4 Physician is reasonably certain of diagnosis 5 Recipient would likely want to know diagnosis 6 Problem is potentially treatable Source: Adapted from Ratzan [3] and Mitchell [6]

Conclusion Virtually every dermatologist has seen something on a stranger or family member or friend that has aroused some concern, causing the physician to agonize over whether or not to say something. Table 1.3 summarizes the conditions under which offering an unsolicited opinion might be appropriate. Interestingly, lay individuals (although not a majority) are more likely than medical professionals to believe that unsolicited medical advice or intervention is appropriate, and a significant majority of physicians would not be inclined to intrude on a patient’s privacy to offer a diagnosis of suspected malignant melanoma [5]. Beneficence, non-maleficence, and respect for the individual’s privacy should guide the dermatologist, but in the end, one should also be guided by how one would want to be treated in the same situation. *Acknowledgments The author wishes to acknowledge the advice and counsel of George E. Wakeman, Jr., Boston, MA regarding the legal aspects of unsolicited medical advice. I am indebted to Manly Rubin, MD for case scenario 1.

References 1. Moseley R. Excuse me, but you have a melanoma on your neck! Unsolicited medical opinions. J Med Philos. 1985;10(2): 163–70. 2. Schildkrot B. Am I looking at a malignant melanoma? New York Times. April 1, 2008. 3. Ratzan RM. Unsolicited medical opinion. J Med Philos. 1985;10(2):147–62. 4. Marion RW. Genetic drift: the unsolvable puzzle. Am J Med Genet. 1996;62(4):327–9. 5. Zwitter M, Nilstun T, Knudsen LE, Zakotnik B, Klocker J, Bremberg S, et al. Professional and public attitudes towards unsolicited medical intervention. BMJ. 1999;318(7178):251–3. 6. Mitchell EW. The ethics of passer-by diagnosis. Lancet. 2008;371(9606):85–7.

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“Give Me Enbrel™ or Give Me Death”: Confronting the Limits of Autonomy Lionel Bercovitch

Case 1

Case 2

A 40-year-old man presents with plaque psoriasis limited to the hairline, elbows and knees. He is troubled by the cosmetic appearance but dislikes the greasy feel of topical medications as well as the need for regular application to control the disease. He also complains of right knee pain when he jogs. His father had severe psoriasis that limited his career in public relations. He has heard about etanercept (Enbrel™, Wyeth Amgen) and adalimumab (Humira™, Abbott) in media advertisements and wants a prescription for one of these biologics because of their published efficacy and infrequent administration. You discuss treatment options and quote from the Food and Drug Administration (FDA)-approved package insert that these biologic therapies are approved for “patients with moderately severe plaque psoriasis who are candidates for systemic treatment or phototherapy and when other systemic therapies are medically less appropriate” [1]. You explain that for this reason, you do not feel it is medically appropriate to prescribe either of these medications for him. The patient counters that your decision shows lack of respect for his autonomous medical decision-making and that it reflects a paternalistic style of doctoring not appropriate for the Internet era.

A 16-year-old male presents demanding that all his moles be removed. He is self-conscious and does not want to be seen by others without his shirt on. He has several clinically benign compound and dermal nevi on the face, neck, and back. Because several of these nevi are located on areas at risk for hypertrophic scarring and considering the lack of medical indication for removal, you express your reluctance to remove the moles. He insists that if you do not do it, he will find someone who will. His parents feel conflicted between considering their son’s wishes and psychological wellbeing and what they perceive to be common sense and your good medical judgment.

Case 3 A 50-year-old woman presents for consultation regarding wide excision of a biopsy confirmed radial growth phase 0.1 mm thick superficial spreading malignant melanoma of the calf. She has read about sentinel lymph node biopsy (SLNB) and staging workup on the Internet and is insistent on having SLNB, magnetic resonance imaging (MRI) and positron emission tomography (PET).

Unreasonable Demands for Care

L. Bercovitch Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

The literature on end-of-life care is replete with writings on unreasonable demands for medical intervention, usually referred to as futile care. In most ambulatory specialties, including dermatology, futile does not adequately describe clinically inappropriate demands. These are more aptly classified in Table 2.1.

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_2, © Springer-Verlag London Limited 2012

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10 Table 2.1 Unreasonable or inappropriate demands for care: When futile is not the right word NOT INDICATED: Outside practice guidelines or expert opinion CONTRAINDICATED: In addition to possible lack of indication, treatment carries risk of harm INAPPROPRIATE: Clinical judgment indicates that the treatment has little value or that the risks likely outweigh the benefits UNNECESSARY: Treatment offers little or no chance of benefit, or the condition is self-limited and benign without intervention Source: Adapted from Brett [8]

The concept that patients should actively participate in decisions regarding their medical care and that they should have as much information as possible to assist them in the process is central to patient autonomy. Indeed, there is a vast amount of information available in print and electronic media, much of it unfiltered and not subjected to expert peer review. Patients often assume the role of consumers of a commodity both in their expectations of the healthcare system and in their medical decision-making. The collision of an empowered patient with an a profusion of online health information can create the perfect storm of inappropriate demands for treatment or tests. In the past, physicians often assumed a more paternalistic role, presenting the patient with only the doctor’s recommended choice of intervention. Current practice recognizes that patients are in the best position to understand their needs and personal values and, equipped with information and knowledge of their options, to factor these into shared medical decisionmaking. Nevertheless, there is no absolute moral right to access any medical intervention that the patient desires. There is no moral basis to require health care providers to compromise professional integrity and standards to provide treatment or testing that they feel are medically unnecessary or potentially harmful or useless, just because a patient demands it. Also, third parties such as insurers and government entities may affect medical decision-making through their decisions whether or not to pay for the interventions. In addition to autonomy, other core ethical values, including beneficence, non-maleficence, and distributive justice- are involved in dealing with unreasonable demands for care. Physicians are morally obligated to act in a manner that benefits patients and avoids harm.

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Resources, both technological and financial, are finite. Healthcare providers have an obligation to utilize resources wisely and minimize waste in order to maximize society’s access to medical care. Physicians are expected to exercise good as well as independent medical judgment in patient care. If physicians routinely acted against their better judgment because of external demands, the public’s trust in the profession would erode. In addition, acceding to patient requests does not relieve physicians of medicolegal liability or allegations of criminal responsibility if adverse outcomes occur [2]. Professionals are not required to violate their professional standards or break the law at the behest of their clients. In this respect, there are dual loyalties. The mere fact that most treatments and tests require authorization of a licensed physician and that peer review organizations and jurisdictional licensing boards regulate medical practice attests to society’s expectations of physicians. The Council on Ethical and Judicial Affairs of the American Medical Association states “physicians are not obligated to deliver care that in their best professional judgment will not have a reasonable chance of benefitting their patients. Patients should not be given treatments simply because they demand them” [3].

Analysis of Cases In Case 1, the patient is demanding therapy that is not indicated (and is possibly contraindicated) (see Table 2.1). It would certainly be reasonable to tailor a topical regimen more compatible with the patient’s sensory preferences or to recommend alternative modalities for localized psoriasis such as the 310 nm excimer laser. He could (and probably should) be referred to a rheumatologist to evaluate his complaints of knee pain. Of course, the patient may then bring the same demand to the rheumatologist, who might feel that an oral non-steroidal anti-inflammatory agent would be the preferred treatment. In this case, the patient has localized psoriasis that can be managed by other modalities that are safer and less expensive than biologic therapies. While the high cost of biologic drugs might very well enter into the discussion and decision-making, the dermatologist should avoid creating the impression that bedside rationing is the basis for the decision. Treatment should be recommended based on appropriateness, treatment

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“Give Me Enbrel™ or Give Me Death”: Confronting the Limits of Autonomy

guidelines, and good clinical practice. Physicians have an obligation to allocate scarce resources appropriately and fairly, and therefore cost might enter into the decision, particularly when a third party is paying the cost, but the physician’s primary professional duty is to the wellbeing of the patient. Alternatively, the physician could decide that it is easier and less confrontational to honor the patient’s demands and prescribe etanercept or adalimumab. The problem with this course is that if the patient is harmed by a side effect of the treatment, the dermatologist would have little defense against having chosen a treatment for which there is a lack of indication both under practice guidelines and the FDA-approved manufacturer’s package insert. Although our legal system recognizes the patient’s right to self-determination, i.e. what can be done with one’s body, sound decision-making is the best defense against malpractice liability [4], p. 49]. The patient in Case 1, who has a chronic skin condition, may feel a need for some sort of control of the disease process and its treatment, as well as a need to have his preferences and autonomy validated by the dermatologist. If the dermatologist fails to recognize the patient’s role in medical decision making, address his demands and understand where they are coming from, the patient is likely to mistrust the physician, disregard his or her advice, and seek care elsewhere until he finds what he is looking for. By listening to the patient’s preferences, the patient’s concerns about his father’s disabling psoriasis can be elicited and validated, and the dermatologist can address the fact that therapy with a biologic agent does not affect the natural history of the skin disease. Paternalism occurs when beneficence and what the physician thinks is best for the patient takes priority over autonomy and the patient’s desires and values. It is what happens when medical decision-making is a one-way street rather than a shared process [4], p. 50, 5], pp. 176–93]. Although, as the patient points out, it is not acceptable in contemporary practice, it can be ethically justified when patients lack capacity to make informed decisions (although sharing decision-making with a health care proxy might be viewed as the appropriate course) or if the risk of harm outweighs any likely benefit or the patient’s demand falls outside of accepted standards of medical practice. In Case 1, the patient who wishes more control in medical decision-making accuses the dermatologist of being paternalistic despite the fact that the physician has

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made a good faith effort to validate the patient’s wishes and to propose an alternative, safer approach that is both clinically and economically appropriate, without precluding future consideration of biologic therapy if clinical circumstances warrant. If the patient continues to be unreasonable in his demand for care in this non-life threatening condition, the physician would be justified in advising the patient to seek care elsewhere. Case 2 is complicated by the fact that the patient has not reached the age of majority and legally lacks standing to give informed consent. Although physicians tend to respect the autonomy of adolescents as near adults, especially as they approach the age of majority (18 in the US and Canada), adolescents often live in the present with a limited grasp of the future, care about things out of proportion to their actual importance, may be disproportionately influenced by perceived peer impressions, and fail to recognize the long-term consequences of their decisions. Indeed, adolescence shares features of childhood and adulthood, and adolescents are risk-takers. Even if the adolescent had the legal standing to give informed consent, for example, as an “emancipated minor”, the physician is not obligated to suspend professional judgment to satisfy the patient’s demands. By validating the patient’s concerns in a nonjudgmental way, thoroughly detailing the risks and benefits of the surgical procedure, involving both the patient and parents (while focusing on the patient) in the decision, the petulant and demanding behavior of the teenaged patient can hopefully be channeled into constructive decisionmaking. In addition, the economic reality of lack of insurance coverage for an essentially cosmetic procedure might also temper the patient’s demands (or certainly affect how the parents feel). A satisfactory compromise might be to agree to excise one or two nevi to allow the patient, parents, and physician to assess the cosmetic outcome before proceeding with further procedures, recognizing that a good (or bad) result does not guarantee identical results in future procedures. Case 3 has many features in common with Case 1. The patient has read about SLNB, MRI, and PET scanning on the Internet and regards these as the current standard of care for malignant melanoma. Her expectation of the best and most up-to-date in therapeutic and staging procedures is undoubtedly influenced by the anxieties, fears, and uncertainties that accompany the diagnosis of a malignancy. In this case, the physician

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should validate and recognize the patient’s concerns and fears while at the same time reassuring her of the excellent prognosis of radial growth phase melanoma and the curability by wide excision alone. If the patient is obsessed with concerns about metastatic disease and wants these interventions for reassurance, then it is incumbent on the physician to explain the limitations of negative SLNB or medical imaging. The physician should also present current information on the role of SLNB as a staging procedure and present data that it has no effect on survival [6, 7], which in her case is likely to approach nearly 100% with or without it, as well as the potential morbidity of the procedure. If despite these explanations as well as an explanation regarding the lack of necessity for staging for such a thin melanoma as well as the very real risk of incidental findings whose workup may also have morbidity and unintended consequences, the patient is not persuaded of the lack of indication (if not contraindication) for these procedures, then the physician should suggest a second or multiple opinions before the patient proceeds.

Conclusion Medical decision-making should as much as possible be a shared process between the physician and patient. A successful physician-patient partnership is built on trust and is compromised by a paternalistic attitude on the part of the physician that fails to validate and recognize the patient’s requests (or demands) and understand the underlying basis for these. However, there are limits to autonomy. Physicians have professional standards and a duty to educate their patients and legal as well as contractual obligations to uphold. Furthermore, all resources

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have finite limits. Information is not knowledge. Knowledge without experience and clinical judgment is not wisdom. The skilled dermatologist must somehow temper unrealistic or unreasonable demands from patients armed with reams of information with that wisdom and reach a mutually acceptable decision that engenders trust and hopefulness. In a situation in which the inappropriateness of the request is not so clear-cut, the dermatologist has an obligation to weigh heavily the patient’s wishes and values in making a shared decision. Acknowledgment The author wishes to acknowledge the contribution of Case 1 by Thomas P. Long, M.D.

References 1. Abbott, Laboratories. Humira prescribing information 2010; http://www.humirapro.com/. 2. Archibold R. Doctor is charged in death of Jackson. New York Times. Feb 9 2010:A: 12. 3. Council, Affairs oEaJ. Opinion 2.035 futile care. In: Code of medical ethics of the American Medical Association: current opinions with annotations. 2006–2007 ed. Chicago: American Medical Association; 2006. 4. Jonsen A, Siegler M, Winslade W. Clinical ethics. 5th ed. New York: McGraw-Hill; 2002. 5. Beauchamp T, Childress J. Paternalism: conflicts between beneficence and autonomy. In: Principles of biomedical ethics. 5th ed. New York: Oxford University Press; 2001. 6. Stebbins WG, Garibyan L, Sober AJ. Sentinel lymph node biopsy and melanoma: 2010 update Part II. J Am Acad Dermatol. 2010;62(5):737–48; quiz 749–750. 7. Stebbins WG, Garibyan L, Sober AJ. Sentinel lymph node biopsy and melanoma: 2010 update Part I. J Am Acad Dermatol. 2010;62(5):723–34; quiz 735–726. 8. Brett A. Inappropriate requests for treatments and tests. In: Sugarman J, editor. 20 common problem: ethics in primary care. New York: McGraw-Hill; 2000. p. 3–11.

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Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age Lisa Pappas-Taffer and Alexander Miller

Practicing physicians, including dermatologists, can expect an average of ten specific drug requests per week from patients. Much of the increase in patient demand for prescriptions is fueled by direct-toconsumer drug advertising (DTCDA) in mass media [1] which has accelerated over the past 10–15 years to account for a significant portion of the amount spent on drug promotion. In fact, the rise in prescriptions for the drugs most heavily advertised to patients has far outstripped the rise in all other prescriptions during this period [1]. This chapter reviews the basic concepts of DTCDA, evaluates current data in the literature regarding its impact on the physician-patient relationship, highlights ethical issues that arise from DTCDA, and provides recommendations for responding to patients requesting prescriptions for medications they have seen advertised.

creams for fear of side-effects and my liver labs became too high on methotrexate. I simply do not have time for phototherapy given my work schedule. I saw this ad on TV for an injection for psoriasis. Will you please prescribe it for me? I want to start enjoying my life.” The patient shows the dermatologist an ad for an injectable psoriasis medication on her laptop computer. A young attractive woman is seen in the entryway of her house in a bikini top and shorts. Grabbing a towel and sandals, she smiles to herself as she catches a glimpse of her reflection in the mirror, before running outside to a jeep full of attractive, smiling peers. In the next scene, the jeep arrives at a sandy beach. As she confidently removes her cover-up and runs to the water with friends, the narrator states, “This medication may increase your risk of cancer.” With the sun setting over the water and the patient walking arm-in-arm with an attractive male, the narrator lists other side effects.

Case 1 Case 2 A new patient to the dermatologist states: “My psoriasis is ruining my life. I am 20-years-old and I have headto-toe psoriasis. I avoid going to social events and I’m ashamed of the flakes of skin I leave everywhere. My previous dermatologist would not give me steroid

L. Pappas-Taffer () Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected] A. Miller Department of Dermatology, University of California Irvine, Irvine, CA, USA

A 33-year-old female patient explains: “I saw this ad in a magazine for a natural medicine for genital warts. I have avoided becoming intimate with my new boyfriend because of my warts. I am also getting older and I want to have children. I am worried about medications causing birth defects, so I try to use only natural medications. Will you prescribe this new natural medicine for me?” The patient unfolds a glossy magazine advertisement featuring a young woman. The accompanying text states: “A drug that utilizes the therapeutic power of nature to rid genital warts for good.” The advertisement then refers the reader to the manufacturer’s website for further information.

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_3, © Springer-Verlag London Limited 2012

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Case 3 A 26-year-old woman thanks you for overbooking her into your schedule and explains, “The dark hair on the side of my face is driving me crazy! My mom and sisters all have the same thing. It isn’t normal. Let me show you this commercial for a cream that is supposed to help.” She opens her laptop computer to show you an advertisement where two young women are seen washing their hands at adjacent sinks in a restroom at work. One is an attractive confident woman, the other a timid younger woman. The confident woman looks over at her co-worker’s arms and states, “You have arm hair like a man! Why don’t you do something about that?” Another woman exits a stall as the confident coworker leaves the bathroom, opens her purse and shows the distraught hirsute woman a tube of cream and says, “You’re not alone.” At the end of the commercial a similar scenario unfolds, with a different female washing her hands. Next to her is the previously timid hirsute woman—now confident, well dressed, and with hairless arms. She looks over at her neighbor’s arms, smiles, hands her the tube of cream, and states, “You’re not alone”

Discussion Direct-to-consumer drug advertising (DTCDA) is defined as advertising directly to the consumer (or patient) through print or electronic media. These include newspaper, magazine, billboard, television, radio, and Internet advertisements [2]. There are three categories of DTCDA described by the FDA’s Division of Drug Marketing, Advertising, and Communications: (1) “help-seeking” advertisements, (2) “reminder” advertisements, and (3) “product claim” advertisements—of which only the latter two are regulated by the FDA. A “help-seeking” advertisement describes a disease or condition, but does not discuss specific treatments. For example, an advertisement that states that there are treatments for hair loss and encourages men to seek a doctor’s advice for more information qualifies as a “help-seeking” advertisement. A “reminder” advertisement mentions a specific drug by name, but does not mention its indications or efficacy. Reminder advertisements assume that the audience already knows the medication’s intended use. The FDA does not require

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these two types of advertisements to disclose risk information because the advertisements do not discuss benefits. The most common and most controversial DTCDA category and the major focus of this discussion, is the “product claim” advertisement, which mentions both the name of the medication and its FDA-approved indications. The FDA requires these advertisements to present balanced information about a medication’s risks and benefits [3]. The requirement for lengthy side effect disclosures historically precluded television and radio product claim advertisements. In 1997, the FDA loosened this requirement so that only the most important risk information needed to be mentioned, along with sources for accessing additional information. These “sources” could include toll-free telephone numbers, references to a magazine print ad or website address, or a statement like “ask a health care professional” [3]. As a result, the U.S. became one of only two countries (the other being New Zealand) to allow televised DTCDA [4]. In the ensuing decade, spending on broadcast DTCDA increased more than threefold [5], while generating considerable debate regarding DTCDA effects on patient care and the patient-physician relationship. FDA guidelines stipulate that printed advertisements must disclose each side effect, warning, precaution and contraindication from the approved product professional labeling. FDA-approved patient labeling that focuses on the most serious risks and less serious, but most frequently occurring, adverse reactions is also acceptable. The latter must include: contraindications, warnings, major precautions (including any that describe serious adverse events), and the 3–5 most common non-serious adverse reactions likely to affect the patient’s quality of life or compliance with drug therapy. Critics of DTCDA believe the practice compromises public health in several ways. First, it may threaten public health if it provides inaccurate, incomplete, or misleading information. Consumers could seek improper and even dangerous treatments. Additionally, there is the concern that, given its purpose to generate sales and profit, such advertising is inherently biased and promotes inappropriate prescribing. Even accurate and impartial advertising may also be harmful. Some fear that time spent discussing DTCDA during patient visits squanders already limited time for physician-patient encounters [6]. On the issue, the American College of Physicians states:

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Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age [DTCDA] consumes valuable time during the physicianpatient encounter fielding requests, clarifying misconceptions, and explaining other, sometimes more effective treatments… Time spent on this gets diverted from patient education to negotiation. Then depending on the patient’s insurance plan, negotiation on what is and is not covered. When a coveted drug is not part of a patient’s health plan’s formulary, patients may pressure physicians to make a case for medical necessity in hopes to get the prescription covered—another round of hassle and effort for the physicians. And when a physician withholds something a patient wants, patients often build mistrust in the physician. The result is a subtle but chronic adversarial element in the doctor-patient relationship that takes a substantial emotional toll on physicians. [7]

It is unclear whether prescription requests prompted by DTCDA are any more numerous or time consuming than prescription requests prompted by other sources (friends, family, or patient-support blogs). Other critics worry about promoting the belief that there is a “pill for every ill” [5]. This belief may obscure patients’ responsibilities to live a healthy lifestyle. Lastly, there is concern that DTCDA may exacerbate inequalities within the health care system. Studies reveal that physicians may be less willing to honor requests for medications from patients who are elderly, less educated, or racial minorities [8]. These arguments against DTCDA appeal to fundamental principles of medical ethics. Proponents of DTCDA argue that it provides a public service by educating patients. Specifically, such advertisements remove the stigma accompanying certain diseases (e.g. depression, erectile dysfunction, hair loss); empower patients to “take charge” of their health [9]; and encourage patient-initiated dialogue with physicians which increases the likelihood of appropriate care for “frequently under-diagnosed and under-treated conditions” [10]. Collectively, these arguments support patient autonomy. Proponents further claim that DTCDA “stimulate[s] competition, resulting in lower [drug] prices” [9] and encourages compliance with prescription drug treatment regimens, though no data is provided to support either claim [9]. Central to this debate is the inherent conflict between the fiduciary responsibility of a manufacturer to its shareholders and the industry’s stated mission to better public health [6]. These conflicting goals become especially relevant when DTCDA provides information regarding a medication’s risks. In one report, a panel of pharmacists judged that only 65% of DTCDA presented a fair and balanced discussion of risks and

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benefits [11]. Another report found that 91% of sampled televised advertisements recited risks nearly 50% faster than benefits [12]. In addition to highlighting the inherently biased nature of DTCDA, studies have begun to examine its public health impact. Current data support the claim that DTCDA increases consumer awareness and fosters patient-initiated communication with physicians. For example, the common catch phrase, “Ask your doctor about Drug X,” heard in DTCDA, may enhance communication between patients and physicians. Some argue, however, that it may imply to patients that their doctors cannot be trusted to provide necessary information without prompting [13]. For this reason, the American Medical Association (AMA) has advocated that the phrase “your physician may recommend other appropriate treatments” be incorporated in directto-consumer advertisements. In addition, many patients do not recognize the potential for bias in drug advertisements. The belief that DTCDA provides enough information to decide (without physician input) if a medications benefits outweigh its risks is inversely correlated with education level [14]. As with other forms of pharmaceutical advertising, DTCDA has been shown to affect physicians’ prescribing practices. A multi-site, randomized-controlled trial evaluated blinded physicians’ responses to three groups of standardized patients with major depression symptoms [15]. One group requested a highly advertised costly formulary medication (Paxil™); a second requested a prescription without specifying the medication, while the third group did not request a prescription at all. Results showed that patients who did not request prescriptions were much less likely to receive treatment compared with those who did (31% vs. 75%), and were significantly less likely to have a diagnosis of depression recorded in their medical charts (65% vs. 88%). Of those requesting the advertised drug by name, 27% received the drug (compared to 3% requesting an unspecified prescription drug), while 26% received a less expensive alternative, and 47% received no prescription at all. Thus, symptomatic patients who asked for any antidepressant were much more likely to receive adequate depression diagnosis and care than those that did not request a prescription. This study suggests that DTCDAprompted prescription requests may lead to improved diagnosis and treatment. The study also revealed that

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advertisement-specific prescription requests do increase the prescription volume for a particular drug, even when there may be potentially less expensive therapeutically equivalent options available.

Analysis of Case Scenarios In Case 1, a young woman presents with chronic, severe psoriasis for the first time. She has failed methotrexate and her hectic work schedule precludes phototherapy. She reports a significantly reduced quality of life, feelings of stigmatization, and lack of trust in her previous dermatologist. Did the advertisement for the injectable biologic drug enhance her autonomy? Autonomy refers to the right of competent informed individuals to make their own healthcare decisions without coercion or interference from others. Freedom from coercion, however, does not imply that the patient has all of the tools necessary to make an informed decision on his or her own. Advertisers motivate consumers to buy their products using many tactics, including appeals to emotions. As a result, direct-to-consumer advertisements can exploit the vulnerabilities of dermatologic patients with disfiguring or unsightly diseases. Although the advertisement in Case 1 verbally relayed accurate information—the non-verbal message was misleading. The joyful story line belied the potentially serious and even lethal side effects of the advertised medication. Specifically, the non-verbal message downplayed the risks while subtly suggesting a benefit unrelated to the effects of the drug itself, namely social intimacy. The advertisement failed to mention qualifying criteria for the medication, cost, or alternative therapies. Thus, the advertisement in Case 1 prompted enhanced awareness, but not necessarily autonomy. True autonomy requires balanced and sufficient information. Case 2 involves a magazine advertisement for a medication in which the information provided to the patient is misleading and inaccurate. The advertisement states that it is “all natural,” suggesting that it would therefore be less toxic than other wart medications. This is enticing to the patient because she states she would like to become pregnant soon. However, it would be important to note that the medication has not necessarily been evaluated in pregnant women, and that “all natural” doesn’t make it superior or less toxic (or teratogenic) than other genital wart therapies.

L. Pappas-Taffer and A. Miller

There are at least two inaccuracies in this advertisement. First, its comparative claim that this is the first natural wart product is incorrect (liquid nitrogen and podophyllin are also “natural”), as well as being in violation of AMA guidelines that prohibit claims of this type. Second, the statement that this medication “utilizes the therapeutic power of nature to rid genital warts for good” suggests that it will cure genital warts forever, which no genital wart treatment can claim. Such informational inaccuracies could not only result in unrealistic expectations, but also significant unintended negative consequences. For example, recurrence of genital warts in this patient following treatment could be misinterpreted by the patient as a new infection due to the infidelity of a longstanding partner. Therefore, it is important that physicians pay attention to DTCDA in order to prevent unrealistic expectations and misinterpretations. As in Case 1, inaccurate or biased information may be detrimental to informed patient decision-making. It is essential that the treating physician address these inaccuracies. Case 3 demonstrates an advertisement for a topical drug to prevent hair growth. Although one of the oftencited benefits of DTCDA is removing a condition’s stigma, it may actually do just the opposite. This advertisement achieves two related goals: it stigmatizes hypertrichosis, stressing its personal and social undesirability, and it provides a potential solution. This advertisement does not provide a public service by raising awareness of a “hidden” problem, it creates one. This phenomenon is called “medicalization.” This is a term that refers to the process by which a physiologic condition or behavior is labeled as a medical problem or illness for which the medical profession has treatment [16]. This process can be driven by new evidence or theories about conditions, by developments in social attitudes, by economic considerations, or by the development of potential therapy [16].

Conclusion Direct-to-consumer drug advertising has become increasingly prevalent in the U.S. The concept of DTCDA is not inherently unethical. In fact, many of the criticisms leveled against DTCDA could also be applied to advertising directed toward prescribers. To the extent that DTCDA enhances patient awareness and encourages patient-initiated communication with physicians, it

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Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age

promotes patient autonomy and appropriate care. However, pharmaceutical advertising, including DTCDA should not be viewed as educational material. If the intent were to educate, then the nature of advertisements would be strictly informational—not eye-catching seductive, or disingenuous. The goal of any advertisement is to engage and motivate patients to buy the product, and should be viewed as such. In most cases, such advertising falls short of fully informing patients. It remains the role of the physician to educate the patient regarding appropriate choice of medications.

References 1. Findlay S. Prescription drugs and mass media advertising. Washington, DC: National Institute of Health Care Management Research; 2000. http://www.nihcm.org/pdf/ DTCbrief.pdf. Accessed 5 Nov 2011. 2. Direct-to-consumer advertising in the United States. Source Watch 2008. http://www.sourcewatch.org/index.php?title= Direct-to-consumer_advertising_in_the_United_States . Accessed 5 Nov 2011. 3. Food and Drug Administration. Keeping watch over direct-toconsumer ads. http://www.fda.gov/ForConsumers/Consumer Updates/ucm107170.htm. Posted 10 May 2010. Accessed 5 Nov 2011. 4. Toop L, Mangin D. The impact of advertising prescription medicines directly to consumers in New Zealand: lessons for Australia. Aust Prescriber. 2006;29:30–2. 5. Connors AL. Big bad pharma: an ethical analysis of physician-directed and consumer-directed marketing tactics. Albany Law Rev. 2009;73:243–82. 6. Robinson AR, Hohmann KB, Rifkin JI, Topp D, Gilroy CM, Pickard JA, et al. Direct-to-consumer pharmaceutical advertising: physician and public opinion and potential effects on the physician-patient relationship. Arch Intern Med. 2004; 164:427–32.

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7. Statement of the American College of Physicians for the records of the public hearing on consider directed promotion of regulated medical products: Department of Health and Human Services, Food and Drug Administration; 2005. 8. Kaplan SH, Gandek B, Greenfield S, Rogers W, Ware JE. Patient and visit characteristics related to physicians’ participatory decision-making style. Results from the Medical Outcomes Study. Med Care. 1995;33:1176–87. 9. Lyles A. Direct marketing of pharmaceuticals to consumers. Annu Rev Public Health. 2002;23:73–91. 10. PhRMA guiding principles: direct to consumer advertisements about prescription medicines. http://www.phrma.org/ sites/default/files/631/phrmaguidingprinciplesdec08final. pdf. Posted Dec 2008. Accessed 5 Nov 2011. 11. Roth M. Patterns in direct-to-consumer prescription drug print advertising and their policy implications. J Public Policy Mark. 1996;15:63–75. 12. Kaphingst KA, DeJong W, Rudd RE, Daltroy LH. A content analysis of direct-to-consumer television prescription drug advertisements. J Health Commun. 2004;9:515–28. 13. Jagsi R. Conflicts of interest and the physician-patient relationship in the era of direct-to-patient advertising. J Clin Oncol. 2007;25:902–5. 14. Consumer reaction to DTC advertising of prescription medicines. Seventh annual survey. Prevention Magazine; 2003– 2004. Cited in: http://docs.google.com/viewer?a=v&q=cache: 7SfW2PauLksJ:www.fda.gov/ohrms/dockets/ac/08/ slides/2008-4362s1-03.ppt+Consumer+reaction+to+DTC+a dvertising+of+prescription+medicines.+Seventh+annual+su rvey.+Prevention+Magazine%3B&hl=en&gl=us&pid=bl&s rcid=ADGEESgaDEXO6NjffbTLvy3Cvke13DFVWRVbRBy4ebcKQjcud2iPrzsvS7m7WmNQB_694U4405Rv3TskDbwyQi8XPU3JVZV-ZfffvV8EBIUpGQ kZj0yML2eD29_bl_mrN2rpOoRuzeZ&sig=AHIEtbS3rqj_ CzTPD56UP9yVwguglunvIw. Accessed 5 Nov 2011. 15. Kravitz RL, Epstein RM, Feldman MD, Franz CE, Azari R, Wilkes MS, et al. Influence of patients’ requests for directto-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293:1995–2002. 16. Conrad P. Medicalization and social control. Annu Rev Sociol. 1992;18:20.

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Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication Kenneth E. Bloom and Lionel Bercovitch

Case 1 A 21-year-old woman presents to the university student health service dermatology clinic requesting isotretinoin for chronic scarring nodular acne. Despite reasonable trials of alternative therapies, her acne remains active. She states that she is not sexually active and wishes to choose abstinence as her method of contraception. During further discussion she confides that she is a lesbian and not sexually active with males. Her medical record shows she received emergency contraception treatment at the university health clinic within the past 6 months. The patient explains that she only vaguely remembers being drunk at a campus party and has no recollection of the events following.

Case 2 A 20-year-old woman with scarring nodular acne refractory to several months of topical and systemic therapies presents to discuss alternative treatments. She is anxious to start isotretinoin after learning about its potential to clear her acne. She is willing to participate in the pregnancy protection measures of

K.E. Bloom Dermatology Center for Children and Young Adults, PA, Eagan, MN, USA Department of Dermatology, University of Minnesota Medical School, Minneapolis, MN, USA L. Bercovitch (*) Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

the iPLEDGE program. Based on her religious beliefs, however, she opposes abortion and emergency contraception.

Case 3 A 16-year-old girl has been referred by her pediatrician to discuss the possibility of instituting treatment with isotretinoin. The patient is desperate to start isotretinoin because her acne is socially embarrassing to her and she is willing to comply with whatever the dermatologist recommends. She is felt to be a good candidate for treatment, but her mother, who is present in the room, refuses to allow her daughter to use hormonal contraception or to consider termination of pregnancy in the event of an unplanned pregnancy. Furthermore, the mother states that her daughter is not and has never been sexually active. She also refuses to allow the dermatologist to interview her daughter privately regarding these issues (even with a same sex chaperone present in the room).

Case 4 A 19-year-old woman presents to the dermatologist to discuss isotretinoin after failing aggressive topical and systemic therapies for severe acne. The dermatologist feels that she is a good candidate for isotretinoin. The dermatologist, however, is opposed to emergency contraception and abortion on moral and religious grounds. He therefore does not feel comfortable prescribing the medication for women of childbearing potential, but is comfortable prescribing the medication to women incapable of conceiving as well as men.

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_4, © Springer-Verlag London Limited 2012

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Discussion Introduced in the US in 1982, isotretinoin is a highly effective treatment for nodulocystic acne. A single 3–4 month course of isotretinoin 1–2 mg/kg/day can clear 60–95% of inflammatory lesions in patients with recalcitrant nodulocystic acne [1]. Unfortunately, however, the medication is also associated with several significant adverse effects including teratogenicity. Isotretinoin exposure during embryogenesis is associated with a risk of major birth malformations estimated to be up to 30% [2].The United States Food and Drug Administration (FDA) has classified isotretinoin as pregnancy category X, meaning that its teratogenicity outweighs its benefits to the pregnant patient. From the time the medication was released, the package insert contained warnings of possible congenital malformations resulting from in utero exposure to isotretinoin (“isotretinoin embryopathy”). As a result of pregnancies occurring despite these warnings and patient education, three increasingly restrictive and burdensome risk management programs were introduced, each with the stated goal of eradicating fetal exposure to this teratogen by either preventing women who were already pregnant from receiving isotretinoin or by ensuring that no women became pregnant while the medication was in their systems. These included the Roche Pregnancy Prevention Program (PPP) (1998– 2001), the Roche SMART (System to Manage Accutane Related Teratogenicity) program (2001–2005), and iPLEDGE (2005-present). Although each of the three risk management programs had the stated goal of eliminating in utero exposure to isotretinoin, it has become clear that while desirable, this goal is probably unattainable. Despite stringent regulations, there are continued reports of isotretinoin exposure to developing embryos in the US. One early study reported 900 pregnancies over a 10-year-period among the approximately 38–40% of reproductive-aged women who chose to enroll in the Boston University Accutane Survey [3]. The current program, iPLEDGE was introduced in 2005 in order to harmonize each manufacturer’s pregnancy risk management program. There were also concerns that the FDA would revoke approval of isotretinoin if in utero exposure were not reduced. The iPLEDGE program imposed such stringent and burdensome requirements on prescribers, patients, and pharmacies that it was initially not well received. It requires women

K.E. Bloom and L. Bercovitch

of childbearing potential to undergo thorough counseling about the teratogenic risks of isotretinoin, registration in a national database, and multiple (and ongoing) negative pregnancy tests (Table 4.1). Despite the desirable goal of reducing embryonic exposure to isotretinoin, the methods adopted have raised several ethical concerns and criticisms. Restrictions on patient autonomy, unequally applied regulations, confidentiality concerns, and the physician’s right of conscience are four of the ethical issues raised by isotretinoin risk management programs. iPLEDGE intentionally restricts patient reproductive autonomy. Women of childbearing potential must agree to practice abstinence or at least two forms of contraception if they could be sexually active. Additionally, patients must have two negative pregnancy tests prior to starting isotretinoin and undergo monthly pregnancy tests while receiving the medication. Imposing restrictions on a patient’s reproductive decisions, however, can be viewed as inappropriate interference with the patient’s autonomy. Doshi commented that isotretinoin manufacturers and the FDA are obligated to ensure women receive sufficient information to make informed reproductive decisions, but that mandating certain reproductive behavior may be difficult to justify [4]. On the other hand, regulatory agencies have a legitimate interest in preventing serious congenital malformations. Restricting autonomy to prevent harm to third parties, in this case, the developing embryo, is a compelling argument [5]. Just as some states mandate that motorcycle riders wear helmets and children wear car seats, iPLEDGE may be justified to reduce the societal burdens of birth defects. While the decision to use the medication should be between the physician and patient, a RMP such as iPLEDGE allows it to be used under conditions that minimize the risk of embryonic exposure to the drug. Imposing such a program, even though it disproportionately burdens women of child-bearing age with its requirements, allows the medication to remain available to all who need it, while minimizing adverse reproductive outcomes resulting from inadvertent in utero exposure. Although not a perfect and equitable solution, it provides the greatest societal benefit. A second ethical concern is that the iPLEDGE program unfairly limits access to isotretinoin in several ways. These regulations are unjust in that they impose significantly more restrictions on women of childbearing potential than other patients. Additionally, iPLEDGE requirements for literacy (to understand and follow the

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Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication

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Table 4.1 The essential components of the iPLEDGE program [13] • All patients who are to receive isotretinoin must be registered with the iPLEDGE system and receive a unique identifier number • Physicians and pharmacists must register with iPLEDGE in order to respectively prescribe or dispense isotretinoin • A provider can delegate other prescribers to prescribe isotretinoin to patients already registered in that provider’s name and can delegate office staff to do the requisite data entry necessary to activate a prescription • Each patient must sign a consent form (or in the case of females of childbearing age, multiple consent forms) in order to receive isotretinoin • Patients must be seen by the prescriber monthly and counseled at each visit not to donate blood while on isotretinoin and not to share their medication. Females of childbearing age must also complete a monthly online or telephone assessment of their understanding of the risks of pregnancy and to confirm to the provider that they are using two forms of contraception acceptable to the iPLEDGE program • Females of childbearing potential have a 30 day period after registration in which they must be using their two chosen forms of contraception before they can actually start isotretinoin. They must have two negative pregnancy tests prior to starting isotretinoin. • Females of childbearing potential have a 7 day window after the required monthly pregnancy test in which to fill their prescriptions. By contrast, men and women who are unable to get pregnant have a 30 day window • Contraception must be continued for a month following the last dose and a follow-up pregnancy test must be reported to iPLEDGE

program), practicing two forms of contraception, and access to a registered iPLEDGE prescriber may unjustly block poor, uneducated, and geographically remote individuals from benefiting from isotretinoin [6, 7]. Justice—as it relates to isotretinoin access—is an important ethical consideration. Fair and equal access is a reasonable goal. Different regulations for different populations are, however, justified when the regulatory variation depends on the population characteristics. For example, there is no reason to test men or postmenopausal women for pregnancy when they are physically incapable of becoming pregnant. Since the goal of iPLEDGE is to eliminate in utero exposure to isotretinoin, only those capable of becoming pregnant reasonably require such testing. Unequal access to the medication based on socioeconomic or geographic considerations is troubling, but not unique. Access to high quality health care in the US varies based on education, location, and socioeconomic status. In this way, potential inequalities associated with isotretinoin access simply reflect the same problems found with all other medications in the US. Another ethical concern is that isotretinoin is unfairly regulated relative to other teratogenic medications or even behaviors. It is reasonable to regulate isotretinoin since in utero exposure to the drug represents a significant problem and measures can reasonably be taken to reduce the likelihood of such exposure. In addition, use of thalidomide, a drug used in the treatment of Hansen’s disease, multiple myeloma, and

certain collagen vascular diseases has long been regulated in women of childbearing potential by a program upon which iPLEDGE was modeled. However, exposure to acitretin, another category-X retinoid, during pregnancy may not be as great a concern because the number of exposures is so small relative to those to isotretinoin and no program exists to regulate in utero exposure to this medication. Regulating access to alcohol and other teratogens by women of child-bearing potential may simply be impractical [7]. A third set of ethical concerns raised by the iPLEDGE program involves confidentiality. Recalcitrant nodulocystic acne frequently affects minors. Isotretinoin use by a minor requires parental consent. Discussions of sexual activity are invariably of a personal and sensitive nature. A candid conversation about sexual activity may be difficult to achieve with a parent present. Determining the right balance between parental participation, and consent, and an honest, confidential physician-patient relationship may be ethically challenging. The whole question of contraception for minor patients on isotretinoin is not some hypothetical concept. The most recent published data from the Centers for Disease Control (CDC)’s Youth Risk Behavior Surveillance System showed that 46% of high school students (as high as 72% in some sub-groups) had ever had sexual intercourse and that 6% of students had their first sexual intercourse before age 13 years [8]. Nationally, 53% of female high school seniors were sexually active at the time of the surveys.

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Another concern involves the physician’s “right of conscience.” This right, signed into US law by President Bush in 2008, permits physicians to refuse care based on their personal beliefs [9]. In the case of isotretinoin, some physicians may choose not to prescribe isotretinoin because of their beliefs about contraception or abortion. This right is well recognized so long as it does not deny a patient lifesaving care. The physician’s obligation to refer a patient to another provider willing to prescribe the drug is less well-defined.

Case Analysis Case 1 The iPLEDGE program requires that women of childbearing potential practice abstinence or use two forms of contraception. Regardless, all female patients of childbearing potential need to comply with the pregnancy testing and reporting requirements. While iPLEDGE modestly interferes with the patient’s autonomy by requiring monthly pregnancy tests and reporting in order to obtain a prescription, the dermatologist may further restrict this autonomy. If there is doubt about the motivation or ability of the patient to comply with two forms of contraception or to reliably abstain from unprotected sexual activity, the physician may refuse to prescribe isotretinoin. Patient autonomy does not confer unfettered access to treatments, nor does it obligate the physician to suspend good medical judgment.

Case 2 Case 2 presents a somewhat more complex dilemma. The patient is a candidate for isotretinoin and wishes to take the medication but is opposed on religious grounds to termination of pregnancy except to save the life of the mother. She is similarly opposed to emergency contraception. The patient has the right as an autonomous individual to refuse to do something either due to her own religious belief or personal values. In addition, one could argue that the principle of autonomy allows the patient to make her medical decisions based on information she has received regarding the risks, benefits, and costs of treatment. She has reached the age of consent and fully understands the risks to pregnancy while taking isotretinoin. There is

K.E. Bloom and L. Bercovitch

nothing in the iPLEDGE consent that requires her to proceed with emergency contraception in the event of unprotected intercourse or to termination of an unplanned pregnancy occurring while the patient is on isotretinoin. However, the prescribing physician might harbor misgivings about prescribing isotretinoin for her because of medicolegal concerns. In this situation, the dermatologist can do one of three things. He can consider offering a different therapeutic approach such as a combination of hormonal contraceptive or aldactone with a different antibiotic or one of the light-based therapies. The dermatologist may also suggest that the patient consult with another dermatologist if she still wishes to take isotretinoin but he or she is reluctant to prescribe it. Finally, the dermatologist could prescribe the medication after thorough counseling and documentation of the consent process. As previously mentioned, the patient’s right to autonomy does not trump the physician’s right to practice within professional guidelines or require the assumption of professional risks with which the physician is not comfortable, especially in circumstances where withholding a treatment would not pose immediate risk to the patient.

Case 3 Prescribing isotretinoin to a minor requires parental consent. This therefore introduces the parent to the discussion regarding contraception. While this does not prevent the adolescent from accessing confidential contraceptive counseling elsewhere, as is possible in all 50 states [10], it thrusts the parent into the process. Nevertheless, respecting and protecting the adolescent’s confidentiality is essential. The dermatologist should be able to confidentially and privately discuss the issue of the patient’s current and past sexual behavior as well as the pregnancy prevention measures of iPLEDGE. Although the physician can ask the parent to leave the examination room to allow for a private and confidential discussion, the parent is not obligated to do so. In addition, the patient might not feel comfortable discussing this with the dermatologist, knowing that the parent will then be able to deduce the need for contraception. It is imperative that the provider instills an environment of trust and that the issues and means of confidentiality are addressed. If the physician knows and trusts the patient and the patient pledges abstinence, then the dermatologist can

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Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication

proceed to prescribe isotretinoin within the requirements of the iPLEDGE program. Although not a requirement of iPLEDGE, the patient should be made aware of access to emergency contraception which does not require parental consent in any state and is available over-the counter [11], as well as elective termination of pregnancy, which requires parental consent in some but not all states [12]. However, if the physician feels uncomfortable prescribing isotretinoin in this situation, then the physician can refuse to do so at the time, offer alternative treatments, mention the availability of an alternative provider who may agree to treatment under these conditions, or ask the patient and her parents to think about the issues and consider further discussion at a followup visit.

Case 4 Case 4 is especially problematic as it pits the physician’s moral and religious beliefs against the patient’s autonomous right to control her reproductive decisions. If the patient has a demonstrated medical need for isotretinoin and is fully compliant with the iPLEDGE program’s requirements, does the dermatologist not have a professional obligation to inform her about the availability and use of emergency contraception as well as the option of termination of pregnancy despite the fact both conflict with his moral or religious beliefs? Does it not discriminate against females of childbearing potential if the dermatologist will only prescribe isotretinoin to males and to females who cannot conceive? One could argue that as long as the dermatologist is willing to refer the patient to another dermatologist, he is fulfilling his obligations to the patient. However, a dermatologist who cannot prescribe isotretinoin under these conditions might also feel that referral to a willing prescriber is equally immoral. Such a physician may be less likely to even mention isotretinoin as a viable option. In non life-threatening situations, a physician is not required to carry out medical interventions that are contrary to his or her moral or religious beliefs. Regardless, a physician is ethically bound to act in the best interests of the patient and ideally should facilitate transfer of care to another provider if he or she, for reasons of conscience cannot offer the patient the most appropriate and effective care for her disease.

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Conclusion A physician who prescribes isotretinoin to females capable of conceiving is morally obligated to fully inform the patient of risks, benefits, alternatives, and costs associated with isotretinoin therapy, the requirements of the iPLEDGE program, and the management of emergency contraception or unplanned pregnancy during treatment. Although the iPLEDGE program been criticized because it restricts women’s reproductive decision-making, one could argue that it does not do so as much as fully inform the patient of the risks of exposing the developing embryo to isotretinoin and impose measures to minimize this risk. The argument has also been made by some that the burdensome nature of the program can be justified because the risks of the medication during pregnancy are greatest to the fetus that has no autonomous way of mitigating its risks unlike the patient who can at least give informed consent and recognize symptoms of depression and other side effects. The iPLEDGE program, despite being significantly more complicated than its predecessors, has provided a standardized and consistent risk management program for pregnancy prevention for patients on isotretinoin. Although not perfect and while it has not completely prevented pregnancy during isotretinoin therapy, it is the best of the RMPs that have been available for this medication. The inconvenience and administrative burdens of the program are justified by iPLEDGE having played a key role in preserving availability of this valuable medication in the United States.

References 1. Ward A, Brogden RN, Heel RC, Speight TM, Avery GS. Isotretinoin. A review of its pharmacological properties and therapeutic efficacy in acne and other skin disorders. Drugs. 1984;28:6–37. 2. Schaefer C, Meister R, Weber-Schoendorfer C. Isotretinoin exposure and pregnancy outcome: an observational study of the Berlin Institute for clinical teratology and drug risk assessment in pregnancy. Arch Gynecol Obstet. 2010; 281:221–7. 3. Centers for Disease Control and Prevention. Accutaneexposed pregnancies—California, 1999. MMWR Morb Mortal Wkly Rep. 2000;49(2):28–31. 4. Doshi A. The cost of clear skin: balancing the social and safety costs of iPLEDGE with the efficacy of Accutane (isotretinoin). Seton Hall Law Rev. 2007;37:625–60.

24 5. Moskop JC, Smith ML, De Ville K. Ethical and legal aspects of teratogenic medications: the case of isotretinoin. J Clin Ethics. 1997;8:264–78. 6. Schonfeld TL, Amoura NJ, Kratochvil CJ. iPLEDGE allegiance to the pill: evaluation of year 1 of a birth defect prevention and monitoring system. J Law Med Ethics. 2009; 37:104–17. 7. Bonebrake R, Casey MJ, Huerter C, Ngo B, O’Brien R, Rendell M. Ethical challenges of pregnancy prevention programs. Cutis. 2008;81:494–500. 8. Centers for Disease Control and Prevention. National Youth Risk Behavior Surveillance-United States 2009. MMWR Morb Mortal Wkly Rep. 2010;54(SS5):1–148. 9. Stein R. Rule shields health workers who withhold care based on beliefs. December 19, 2008. http://www.washingtonpost.com/wp-dyn/content/article/2008/12/18/ AR2008121801556.html?sub=AR. Accessed 16 Jan 2011.

K.E. Bloom and L. Bercovitch 10. Women’s Health Partnership. Issue brief-parental consent for contraceptive access. http://www.gcappteens.org/pdf_ files/Confidential%20Access%20to%20Care.pdf. Accessed 1 Aug 2010. 11. Office of Population Studies Princeton University. The emergency contraception website: how to get emergency contraception. http://ec.princeton.edu/questions/ecconsent. html. Accessed 1 Aug 2010. 12. Planned Parenthood. Parental consent and notification laws. http://www.plannedparenthood.org/teen-talk/teen-pregnancy/parental-consent/parental-consent-notificationlaws-25268.htm. Accessed 1 Aug 2010. 13. Guide to the best practices for the iPLEDGE program. https://www.ipledgeprogram.com/Documents/Guide%20 to%20Best%20Practices%20-%20iPLEDGE%20Program. pdf. Accessed 16 Jan 2011.

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“Who Speaks for the Child?” Consent, Assent, and Conﬁdentiality in Pediatric Dermatology Kenneth E. Bloom and Lionel Bercovitch

Case Scenarios

Case 3a

Case 1 Parents bring in a 9–week-old infant requesting that an 8 mm congenital nevus be removed from his cheek. The lesion is benign in appearance and is of no immediate medical concern. His mother does not like the way that the lesion looks and fears that the child will be teased when he is older.

The boy from Case 1 is now 7 years old and presents with the same nevus that has grown proportionately to 1.5 cm. His mother asks that the lesion be removed. The boy does not have any concern about the lesion, has a healthy self-image and has experienced no teasing by his peers. He voices disagreement with his mother emphatically stating that he does not want the lesion removed.

Case 2

Case 3b

An 18-month-old girl presents with a 2 × 3 cm. superficial and deep infantile hemangioma on the left upper arm. The parents were led to believe that the lesion would disappear by age two, do not like its appearance, and would now like to have it removed. The parents brought in photographs which reveal that the lesion has not grown significantly for the past year, is stable and actually shows some signs of early involution with graying of the surface. The lesion is asymptomatic and not interfering with any vital functions.

Three months later, the same mother returns with her son who is now tearful and says that he has been bullied in school because of his appearance. He has changed his mind and would now like the nevus removed. The mother is also tearful and says that she cannot give consent at this time because she and her husband are having marital difficulties and that he has always been vehemently opposed to any surgery for his son’s lesion.

Case 3c K.E. Bloom Center for Dermatology for Children and Young Adults, Eagan, MN, USA Department of Dermatology, University of Minnesota Medical School, Minneapolis, MN, USA L. Bercovitch (*) Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

The same boy is now 13-years-old and is being seen for acne. His grandmother has accompanied him to the visit, and his parents are not available to sign or give telephone consent. The grandmother states that she brings the patient to all of his medical appointments, but she has no documentation of any authority to do so.

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Case 3d The same patient is now a 15-year-old young man and comes alone for a genital wart. He does not want his parents to know the purpose of the visit.

Discussion In this chapter and its illustrative case scenarios, we will explore some of the basic concepts and complexities of medical decision making in pediatric dermatology, especially when there are conflicting views among parent or responsible adult, child, and physician, and review the dynamics and ethical principles of handling such conflicts. For the sake of brevity and clarity, wherever the term parent is used in this chapter, it can be assumed to also refer to a responsible adult such as a legally appointed guardian.

Informed Permission In dealing with a competent adult patient, the process of obtaining informed consent for treatment is generally straightforward. One explains the proposed procedure, including its indications, nature, and potential risks. The physician ensures that the patient comprehends the discussion and that consent is voluntary. When appropriate, the patient signs a consent form and treatment can then be carried out. By contrast, in caring for pediatric patients, the medical provider will turn to one or both parents to make health care decisions for the child. Although by legal definition, children below the age of majority (except in certain situations) are not regarded as autonomous individuals, they are nonetheless deserving of respect, analogous to what is mandated for research subjects of all ages. As surrogate decision-makers, parents generally act in what they perceive to be the child’s and family unit’s best interests, consistent with their values and resources. In view of the difficulty in defining what is in the child’s best interests in many situations, Loretta Kopelman has suggested that a “standard of reasonableness” rather than that of “best interest” be applied [1]. The President’s Council on Bioethics has embraced this concept [2]. The American Academy of Pediatrics Committee on Bioethics prefers the term “informed permission” to be used in place of “informed consent” to describe the

K.E. Bloom and L. Bercovitch

process of pediatric decision-making, as the autonomous preferences of the patient (for example, as might be expressed in an advanced directive by an adult patient) do not form the basis of substituted judgment [3]. Parents have been granted wide latitude and legal authority to make healthcare decisions for their children as it is assumed that they uniquely know their children, want what is best for their children, can best judge what is best for the family unit as a whole, and are ultimately responsible for the well-being of their children. In addition, parental decision-making authority has historically been an integral part of the structure of the family in society. Absent a risk of serious harm or risk to the child’s well-being, the courts have respected the rights of parents to make these decisions [4]. A society’s cultural and religious views can influence this process strongly. Cultural or religious views on gender differences, on family, clan, or caste structure, and regarding autonomy can strongly influence the healthcare provider’s, parents’ and patient’s perspective on the consent process. Yousef et al. conducted surveys in Malaysia and Kashmir, India and found the Kashmir providers were accorded a larger role in medical decision-making. They were more likely to withhold information that they deemed potentially harmful from patients or, if requested by relatives, from women. However, they were less likely to agree that parents could refuse treatment on behalf of their children [5].

Assent Children are not legally considered autonomous individuals until they reach the age of majority. However, as children mature, their decision-making capacity matures, and their preferences are given more weight by healthcare providers and by their parents. The degree to which this is so depends on the gravity, complexity, and medical consequences of the decision, as well as a child’s emotional maturity and cognitive ability. The child or adolescent must be mature enough to process the information and to decide among alternatives in order to give meaningful assent. The concept of assent is grounded in the principle of “respect for persons” as stated in the Belmont Report and was intended to recognize and validate the child’s developing autonomy and decision-making capacity [6]. In the case of non-therapeutic research, a developmentally appropriate assent process is mandatory for children

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“Who Speaks for the Child?” Consent, Assent, and Confidentiality in Pediatric Dermatology

above age 8. However, in the usual clinical setting, there is no mandated formal process for minor assent. Nevertheless, the American Academy of Pediatrics Committee on Bioethics has recommended obtaining developmentally appropriate assent whenever possible, and that“to the greatest extent feasible”, parents and physicians should attempt to include children and adolescents in decision-making [3]. Ideally, whether in the clinical or research setting, the decision-making process should be an interactive collaborative one involving child, parent, and healthcare professional. The Committee on Bioethics also recommended that if medical care is going to be rendered despite the child’s objection, that the physician should disclose that fact and not deceive the child.

Minors’ Rights: Exemptions to Parental Consent Minors are not considered to have autonomous decision-making capacity and are considered to be a vulnerable population, and in most states, informed permission (or consent) of a parent or legal guardian is required to provide medical care. Indeed, no state grants decision-making ability to children under 12. However, there are exceptions that allow teenage minors the right to make autonomous medical decisions. All states allow teenage minors to obtain testing for HIV or sexually transmitted diseases, and almost all permit treatment of these conditions without parental consent. Some states permit parental notification even if consent is not required. Most states do not require parental consent for outpatient alcohol or drug counseling or other mental health services. In addition, most states do not require parental consent for the treatment of sexual abuse. A majority of (but not all) states explicitly allow minors to obtain contraceptive and family planning services, prenatal care, and delivery without parental consent or notification. However, only a few states explicitly allow minors to obtain abortion services on their own without parental notification or consent. Most states require at least parental notification or consent or both, unless a court allows an exemption [7]. There are three general exemptions from parental consent for treatment of minors-the emancipated minor , the mature minor, and emergency treatment. Generally, emancipated minors, as defined by law are 16 or over, living apart from their parents, and

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economically self-sufficient, or are in the military, married, pregnant, or already a parent [8]. Minors who are parents are also responsible for decisions regarding their own children’s medical care. The mature minor doctrine or statutes allow minors to petition a court to demonstrate that they are mature enough to consent to medical treatment. Only a small number of courts have such statutes enacted. In true serious or life-threatening emergencies, treatment can be provided to a minor without parental consent, as it is assumed that a reasonable parent would have consented to such treatment to avoid harm to the child.

Privacy and Conﬁdentiality for Minors Confidentiality refers to the protection (by law or otherwise) of disclosure of information to others without the individual’s consent. It is related to the concept of privacy (as it applies to medical information), in which individuals have the right to keep information about themselves or their health from being shared with others. In general, parents who consent to treatment of their minor children are entitled to information about the treatment. However, after the age of majority, such information cannot legally be disclosed without the written consent of the individual. In practice, however, as children mature and their autonomy develops, they are accorded more privacy as they develop a greater sense of self. Regardless of the law, most clinicians will accord adolescents a significant degree of confidentiality, except under certain circumstances. The boundaries of the zone of privacy around the adolescent are fluid and may change depending on the age and maturity of the patient and the situation. In treating the adolescent, the physician should define, where appropriate, what information can be shared, to whom, and under what circumstances. A parent or legal guardian can exercise the right to information about treatment, but sharing this information can, in some circumstances, disrupt the therapeutic relationship and undermine the trust between adolescent and physician. This is especially true in mental health treatment settings. Regardless, the physician has a professional obligation to protect the patient and others from harm, and in defining the limits of privacy and confidentiality to the adolescent, this should be made clear at the outset. Despite what may seem like a straightforward process, physicians often fail to appreciate ethical dilemmas inherent in obtaining informed consent A British study

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of 51 doctors (25 pediatricians and 26 other clinicians) showed that pediatricians were more likely to answer 10 ethical consent scenarios correctly (69 vs. 49%), although neither group fared well. In the same study 73% of pediatricians and 76% of others were unaware that a parent is unable to consent for a 20-year-old patient. This suggests that there is a need for better education regarding these issues [9].

Analysis of Case Scenarios In Case 1, an infant presents with a congenital facial nevus that is of no immediate medical concern. Removal would require a general anesthetic but is not technically complicated. The ultimate psychosocial impact of the lesion could be considerable depending on the exact location of the nevus on the face as well as its future growth. Parents dealing with a potentially disfiguring birthmark are driven to seek the best possible outcome for their child. They may project their anxieties and fears onto the child and hold strong opinions as to the need and urgency to proceed. This may be motivated by feelings of guilt or shame, or discomfort in how others might view the defect, or by a projected assumption of what the child would want. The U.S. Supreme Court has recognized that parents are to be trusted as having the knowledge, abilities and experience to make decisions in the best interest for their children [10]. The “Best Interests Standard” serves as a legal and moral guide relating to determining the threshold to intervene, to establish an ideal and to set some standard of reasonableness, but such standards are vague and left to interpretation [11]. The pediatric dermatologist must therefore reconcile the obligation to act in what he or she perceives to be in the best interests of the child with the obligation to respect the wishes of the parents. In advising a delay in treatment until the child is older, at least until general anesthesia is safest, the physician will need to “walk the tightrope” of seeming paternalistic, yet validating the parents’ concerns and anxieties. Case 2 is a familiar scenario to pediatric dermatologists caring for infantile hemangiomas. The natural history of hemangiomas is well documented. Involution is the rule, not the exception, with 50%, 70% and 90% having maximally involuted by 5, 7 and 9 years of age respectively [12, 13]. The cosmetic outcome might not

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be optimal and some surgical correction may be unavoidable. However, in most cases, early removal may result in a worse cosmetic outcome than that which would have resulted from spontaneous involution, and might even require further corrective procedures. Parents are naturally eager to see the lesions gone. They may be anxious and fearful about bleeding or what they perceive as disfigurement. Conspicuous hemangiomas attract attention and sometimes, negative comments or stares from strangers. Parents do not have the objectivity, experience, or patience of their physicians and might feel threatened and resent a course of “active non-intervention”. They may be receiving conflicting advice from friends, Internet sites, and their primary care provider. The challenge for the dermatologist is to guide the parents to the best course of action for the child while being cognizant of the “reasonable parent” standard. This might require showing photographs of other children whose hemangiomas have involuted. It might involve recommending a second opinion. It also involves educating parents about the evolution of the child’s body image, which usually is not developed until age three, as well as maintaining an open mind and willingness to act before the child starts school if the lesion is so conspicuous that it will be a source of embarrassment for the child. In Case 3a, the patient from Case 1 is now seven years of age and feels the need to participate and have his voice heard regarding medical decision-making. However, this “new voice” may express disagreement, as in this case, and should be taken into account in deciding how to proceed. This is especially important when procedures are thought to be neither medically necessary nor without risk. Under such circumstances, it is advisable to obtain the child’s assent before proceeding. In contrast, for medically necessary or urgent interventions, the minor patient’s assent is not crucial, but when possible, should be sought at a developmentally appropriate level. In this case, the parent should be encouraged to discuss the procedure with the patient in order to reach a consensus on how to proceed. Although parents are the legal decision-makers, most physicians would be uncomfortable about proceeding with a medically unnecessary procedure in an unwilling patient. Respect for this child’s limited autonomy would require that if he has the emotional maturity and mental capacity to participate in the decision, it should be respected [14]. In addition, respect for the future autonomy of the

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“Who Speaks for the Child?” Consent, Assent, and Confidentiality in Pediatric Dermatology

child suggests that proceeding with a medically unnecessary intervention that the child opposes removes the ability of the child to decide in the future whether or not to have it done [4]. If the assent of the child is not going to be considered for a given procedure, then one should not seek it as this would only add to a patient’s sense of vulnerability. And finally, the imposition of an elective and medically unnecessary procedure on an unwilling child who is old enough to voice dissent might be in itself harmful, being perceived by the child as a violent assault [4]. When this boy returns in Case 3b, his mother is now unwilling to give consent because of a difference of opinion between her and the boy’s father. Even though the child now desires such a procedure, he is still a minor. The treatment of this lesion is neither “emergent” in nature nor medically necessary. However, should an intervention be carried out when the parents disagree about giving consent? There are both legal and ethical dimensions to this question. There is no record of previous lawsuits against a provider rendering treatment under these circumstances. However, in the well-publicized case of Boldt v. Boldt in 2008, the Oregon Supreme Court was asked to rule on a lower court’s decision to compel a 12-year-old boy to undergo circumcision that the custodial father wished to have done against the wishes of the non-custodial mother, who argued that the child did not want to have the procedure done. Although ordinarily, custodial parents have the ultimate legal authority to make medical decisions for their children, the issue is less clearcut in the case of older minors undergoing elective or medically unnecessary procedures [4]. Although the courts upheld the legal right of parents to have their children who are too young to express their opinions circumcised without their assent, the right of this particular minor to dissent from being circumcised or converting to either parent’s religion was ultimately respected by the appellate court in 2009. It has been argued that elective irreversible procedures should not be performed unless there is agreement of both parents to grant informed permission [4]. No procedure or treatment is without risk, however small, and therefore, in the case of disagreement about an elective procedure such as this, a meeting should be held to address each parent’s concerns or wishes to try to reach a consensus. In the case of divorce or legal separation where there is not shared custody, then only the wishes of the custodial parent would be legally

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binding. Regardless, the child’s assent or dissent should be considered before proceeding. Case 3c focuses on who is able to consent for routine care of minors and whether a parent or legal guardian must accompany a minor to every visit. In order to see a patient and to bill and release information to third party payers, there are documents that must be signed by a “responsible party”. Competent adult patients are able to give such consent for themselves. Minors require the written consent of a parent or legal guardian. In addition, mentally impaired or otherwise vulnerable adults and wards of the state may require additional signatures of a guardian or someone delegated by a court to act in this capacity. According to the 2000 U.S. Census, only 72% of all households with children less than 18 years of age have two parents within the home [15]. In addition, 28% of children less than 5 years of age with working mothers were cared for by grandparents during the working hours [16]. Furthermore, 4% of children lived only with a non-parental adult such as a grandparent which overall translates into one-third of all children in the United States not living in a home with two parents able to give consent for medical treatment [17]. This phenomenon has led to a marked increase in the number of minors presenting to healthcare facilities and medical offices accompanied by adults other than parents. Such family members include older siblings, aunts, uncles, grandparents and stepparents. Unfortunately, none of these individuals is legally able to sign consent without specific written notice from a legally recognized “responsible party”. Foster parents are also not able to serve this function unless specifically authorized in writing by the state to do so. In addition, a parent without legal custody is also unable to consent for medical treatment. This would include an unmarried father, regardless of proof of paternity, and therefore without “legal” custody, who presents with his child. Documentation for signing rights could be supported by either court order or an affidavit such as a delegation of rights by proxy form [17] from an adult legally empowered to sign it. Treating the patient and billing insurance companies without written authorization by a “responsible party” are both illegal. In an emergency, such consent need not be obtained, but most dermatologic visits do not meet this definition. Yet, patients are often examined in offices and emergency rooms without such consent, although there is usually an attempt to at least

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obtain telephone consent. Motivation to do so may include: (a) Perception of the presenting complaint as being of an urgent nature. (b) Fear of litigation if a complication were to arise and the patient was not seen. (c) Potential loss of revenue. (d) Inconvenience to the patient’s family to reschedule. (e) Concern regarding delay of diagnosis and therapy. What would be the alternative to seeing the patient without written consent of a parent or guardian? In most cases, one can attempt to obtain a witnessed telephone consent, or ask that the patient reschedule when a parent or legal guardian would be available either in person or by telephone for consent. Alternatively, forms could be made available that allow the parent with legal custody to delegate responsibility to a proxy who is able and willing to act in this capacity or to allow an older minor patient (who otherwise would need consent) to come unescorted. Ideally, under these circumstances, the responsible party should be available by phone to discuss planned treatment, even if another family member has permission to accompany and sign for the patient. From a legal standpoint, the physician should determine and clearly document the reason for and necessity of seeing a patient without appropriate consent. In addition, the healthcare provider must be able to defend his or her position in the case of any charge of assault, battery or impropriety. The legal and ethical issues are tightly intertwined in such cases. [17]. The physician must balance the needs of the child for care with potential liability exposure when informed permission is given by proxy, if necessary delaying non-urgent care [17]. As a practical matter, dermatologists who treat children should have policies in place for dealing with such situations. Case 3d deals with situations in which adolescent patients are able to independently give consent for treatment, and the potential limits of confidentiality and billing under these circumstances. In virtually every North American jurisdiction, a patient, although still a minor, is legally allowed to obtain medical care and treatment for a sexually transmitted infection without parental consent or notification. Respecting the adolescent’s privacy and allowing him or her to consent for such treatment is driven more by concerns for

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public health than for adolescent autonomy. However, unless care is taken to safeguard the confidentiality of the encounter, including the billing, reminders for follow-up appointments, and notification of results, trust in the healthcare provider can be severely undermined and serve as a barrier to seek care [18]. In caring for minor patients, it is helpful to have written authorization stating exactly what information can be disclosed to parents or other guardians and under what circumstances. This would include who can and cannot be notified in matters relating to medical issues, test results, future appointments, or billing. The perception by adolescents that visits and testing results are not confidential could create a barrier for them to seek medical care [18]. Along with the right to consent, the mature or emancipated minor also assumes financial responsibility for any costs incurred for the visit or laboratory testing or medications. Even though the facility might have protocols in place to assure confidentiality, it is not uncommon for errors to occur especially when bills are inadvertently sent to the responsible party of record. A patient might opt not to use a parent’s insurance or billing address. A clinic may use a pseudonym and a separate account. Alternatively, the care and testing can be rendered through a state funded clinic and laboratory that does not bill the patient directly [10, 18, 19].

Conclusion Parents or other legally authorized representatives have the ultimate legal authority in making medical decisions for their children. In cases where there is disagreement between the parents and the physician, or between themselves, the physician should listen respectfully to the their concerns and try to reach a mutually satisfactory consensus. In cases where this is not possible, the physician has an ethical obligation to advocate for the best interests of the child, while at the same time recognizing parental legal authority. As children mature, they should be allowed to have a greater voice in medical decisions, a process known as assent. Especially in the case of elective medically unnecessary procedures, such assent or dissent, while not legally required or binding, should be given considerable weight. There are well-recognized exemptions from the need for parental consent for minors. Most dermatologists are most comfortable with the

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“Who Speaks for the Child?” Consent, Assent, and Confidentiality in Pediatric Dermatology

straightforward process of obtaining consent directly from a competent adult patient. However, all providers who treat minors must be aware of the ethical principles and laws that are relevant to the parent–child– physician triad as it relates to the consent process and confidentiality

References 1. Kopelman LM. The best interests standard as threshold, ideal, and standard of reasonableness. J Med Philos. 1997;22:271–89. 2. Kopelman LM. The best interests standard for incompetent or incapacitated persons of all ages. J Law Med Ethics. 2007;35:187–96. 3. Committee on Bioethics, American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics. 1995;95:314–7. 4. Diekema DS. Boldt v. boldt: a pediatric ethics perspective. J Clin Ethics. 2009;3:251–7. 5. Yousuf RM, Fauzi RM, How SH, Rasool AG, Rehana K. Awareness, knowledge and attitude towards informed consent among doctors in two different cultures in Asia: a crosssectional comparative study in Malaysia and Kashmir, India. Singapore Med J. 2007;48:559–65. 6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the Protection of Human Subjects of Research. Office of the Secretary, Department of Health, Education, and Welfare, Apr 18 1979.

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7. http://www.guttmacher.org/statecenter/spibs/spib_OAL. pdf. Accessed 4 Apr 2011. 8. Maradiegue A. Minors’ rights versus parental rights: review of legal issues in adolescent health care. J Midwifery Women Health. 2003;48:170–7. 9. Fisher-Jeffes L, Barton C, Finlay F. Clinicians’ knowledge of informed consent. J Med Ethics. 2007;33:181–4. 10. Sigman G, Silber TJ, English A, Gans Epner JE. Confidential health care for adolescents: position paper of the Society for Adolescent Medicine. J Adolesc Health. 1997;21:408–15. 11. Kopelman LM. Children and bioethics: uses and abuses of the best-interests standard. Clinicians’ knowledge of informed consent. J Med Philos. 1997;22:213–7. 12. Bower RE, Graham EA, Tonlinson KM. The natural history of the strawberry nevus. Arch Dermatol. 1960;82:667–80. 13. Bruckner AL, Frieden IL. Hemangiomas of infancy. J Am Acad Dermatol. 2003;48:477–93. 14. Davis D. Boldt v. Boldt. J Clin Ethics. 2009;20:241–3. 15. http://single-parenting.families.com/blog/single-parent-family-stats-from-the-2000-us-census. Accessed 2 Apr 2011. 16. http://seniorliving.about.com/od/grandparents/a/grandparents_da.htm. Accessed 2 Apr 2011. 17. McAbee GN, Committee on Medical Liability and Risk Management, American Academy of Pediatrics. Consent by proxy for nonurgent pediatric care. Pediatrics. 2010;126: 1022–31. 18. Ford C, English A, Sigman G. Confidential health care for adolescents: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2004;35:1–8. 19. Morreale MC, Kapphahn CJ, Elster AB, et al. Access to health care for adolescents and young adults: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2004;35:342–4.

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Therapeutic Privilege: If, When, and How to Lie to Patients Richard G. Fried and Clifford Perlis

Case 1 Mr. J presents to your office complaining of a 3 month history of insect infestation. He says that his apartment is filled with bugs that bite him day and night, leaving him with numerous itchy pink bumps over his arms, legs, and abdomen. The patient tells you he has brought along a sample of the insects in a plastic sandwich bag. Additionally, he asks you to perform a biopsy to “show all of the other doctors I am not crazy.” Mr. J’s wife and mother explain to you that they have seen his primary care physician, another dermatologist, and an entomologist who have all told the patient that they cannot find any evidence of insects biting him. His family is concerned that Mr. J is now having trouble sleeping, cannot focus at work, and often scratches himself until he bleeds.

Case 2 Mrs. N is a non-English speaking 88-year-old woman admitted to the hospital for an exacerbation of congestive heart failure. During this hospitalization, the attending hospitalist notices a line of purple nodules

R.G. Fried Yardley Dermatology Associates, Yardley, PA, USA e-mail: [email protected] C. Perlis (*) Fox Chase Cancer Center, Philadelphia, PA, USA e-mail: [email protected]

extending from the patient’s left elbow to her axilla. A dermatology consultant performs a biopsy of a lesion that reveals Merkel cell carcinoma. When the dermatologist returns to discuss the results, the patient’s oldest son offers to serve as a translator. The son interrupts the dermatologist to explain that he does not wish to tell his mother the diagnosis. He explains that in his culture, families often shield elderly relatives from potentially disturbing diagnoses. He further argues that telling his mother about this diagnosis would only upset her, “when there are no effective treatments for this anyway.”

Discussion Therapeutic privilege is the concept that a physician may sometimes deceive or lie to a patient for the patient’s own good. One example could include outright lying about a poor prognosis in an attempt to minimize a patient’s associated psychological stress. More subtle examples could include providing limited or incomplete information in order to steer a patient toward a preferred treatment. Therapeutic privilege may attempt to “preserve the patient’s hope, and psychological and moral integrity, as well as his self-image and dignity” [1]. Despite well-meaning intentions, the concept of therapeutic privilege conflicts with the contemporary ethical obligation to tell patients the truth. This core belief stems from both deontological and consequentialist arguments. Deontological arguments determine the morality of a behavior based on its correspondence to a duty or a rule. According to this tradition, “some acts, such as lying, are inherently and intrinsically

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immoral and therefore forbidden” [2]. Even when lying may better correspond with a patient’s previously expressed interests or possibly save a life, lying is always unethical. By contrast, consequentialist arguments evaluate the ethical propriety of an action based on its outcomes. For most cases, this approach also forbids lying. Patients cannot exercise autonomy without clear and honest information. Furthermore, if physicians routinely “filtered” or “shaped” the information presented to patients, then patients might no longer trust physicians [3]. Regular manipulation of information presented to patients could irreparably undermine the physician-patient relationship. In fact, these arguments against therapeutic privilege are legally supported by the obligation to obtain a patient’s informed consent. The 1972 US Court of Appeals for the District of Columbia Circuit decision in Canterbury v. Spence is frequently cited as establishing a standard for obtaining informed consent. Specifically, “the court held that physicians have a duty to disclose to patients all information regarding risks of treatment that is reasonable under the circumstances” [4]. Physicians are legally obligated to tell patients the truth so that they may make informed treatment decisions. While the American Academy of Dermatology Code of Ethics does not address therapeutic privilege, the American Medical Association (AMA) does comment upon it. Opinion 8.082 from the AMA states that “Withholding medical information from patients without their knowledge or consent is ethically unacceptable” [5]. The opinion further explains that physicians should be sensitive to how and when medical information is discussed, but that the decision to learn (or not learn) about medical information rests solely with the patient. Despite fundamental ethical principles demanding truth-telling, many counterarguments have been proposed. The first counterargument claims that the physician’s obligation to tell patients the truth is often balanced by an equally compelling obligation of beneficence. Doctors may be “caught between the necessity to inform the patient (principle of autonomy) and the desire to ensure the patient’s well-being by minimizing suffering (principle of beneficence)” [1]. Consider a patient whose daughter will be married in 2 weeks. The patient has a biopsy revealing a thick melanoma. The patient calls to request the biopsy results, but the

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physician lies and says the results are not back yet. The physician thinks the most beneficent thing to do for the patient is to lie, and tell the patient the results only after the upcoming wedding. Another counterargument views lying as a way to further—rather than inhibit—a patient’s autonomy. When a patient is distraught, it may further the principles of beneficence and autonomy to delay honest and complete disclosure until the patient has calmed down and has familial support available. Burdening a patient with the truth in a distressing setting may lead the patient to make decisions not in accordance with his or her own previously articulated values or own best interests. Accordingly, misleading patients may—at times—paradoxically actually further a patient’s autonomy. While the aforementioned arguments present some exceptional cases when it may permissible to subjugate truth-telling to other interests, the third counterargument claims such situations are actually commonplace. The concept of “a ‘right to truth’ entails unavoidable ambiguities” [1]. In the first place, evidence-based medical knowledge is itself dependent on probabilities and is constantly evolving. Additionally, the patient’s ability to comprehend medical information is limited. Studies reveal that patients retain only about 50% of medical information following a single interview [6]. Finally, communicating medical truths is itself a nuanced process. Timing, framing, and other delivery features invariably influence a patient’s comprehension and decision-making. Such influence is not inherently inappropriate. Rather, these considerations simply highlight the challenge to defining and mandating absolute truth-telling in a medical setting.

Case Analysis Case 1 While Mr. J seems to present a “textbook” case of delusions of parasitosis, the first step in his evaluation is necessarily a thorough history and physical exam. Ruling out an infestation or an organic cause for pruritus is essential. Assuming a thorough medical evaluation supports the diagnosis of delusions of parasitosis, what is the best way to care for this patient? By definition, delusions of parasitosis is characterized by the patient’s disconnect with reality. A delusion

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Therapeutic Privilege: When, If, and How to Lie to Patients

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is a fixed and false belief. In the case of delusions of parasitosis, patients believe (falsely) that they are infested with insects. Furthermore, “most patients reject any psychiatric help, expecting the dermatologist to solve their problems” [7]. The mainstays of treatment, however, are anti-psychotic medications. Effectively treating these patients may require encouraging patients to receive the psychiatric care that these patients often strongly oppose. The simplest approach for dermatologists or psychiatrists would be to lie to patients with delusions of parasitosis. The physician could tell the patient (and possibly accompanying family members) that a prescribed anti-psychotic medication will kill the infesting insects. Softer versions of misleading the patient could include encouragements like “this medication will help with your condition” and not mention that it is a psychoactive medication. Its easy to justify this approach as the only effective way to treat this patient. Furthermore, it is possible to inform the patient of the deception once the patient is improving while appropriately medicated. Risks associated with this approach include alienating the patient and failing to respect the patient’s autonomy. An online search or conversation with a pharmacist would quickly reveal the usual indications for the anti-psychotic medications. Upon this discovery, the patient is likely to be upset at the diagnosis of a delusional psychiatric disorder as well as the physician’s attempt at deception. Furthermore, the physician does not respect the patient’s rights as an autonomous individual by lying to the patient. An alternative approach may be to inform the patient that treatment with an anti-psychotic medication is a part of the treatment for this condition. It could be explained that: “Feeling infested by insects is a very uncomfortable and distressing sensation. An antipsychotic medication may help you feel better while we begin to treat your condition.” While the physician is not directly lying to patient, there is an element of deception. This implies that the anti-psychotic medication is only one component of other treatments for the condition, when, in fact, the medication is the main or only treatment. Despite this element of deception, this approach could also further the patient’s autonomy. One could argue that a delusional patient is unable to make rational, autonomous medical decisions. By treating the delusions with an anti-psychotic medication, the physician is able to restore the patient’s ability

to make rational and truly autonomous decisions. The medication may additionally, and not inconsequentially, resolve the patient’s initial presenting complaints and allow return to a normal life.

Case 2 Case 2 presents a different potential application for therapeutic privilege. Mrs. N’s son requests that the physician withhold the diagnosis of Merkel cell carcinoma from his 88-year-old mother. He argues that the diagnosis would serve no purpose other than to upset her. While withholding a diagnosis from a patient seems foreign to contemporary American bioethics, the practice is not unheard of in other cultures [8]. Often times, withholding distressing information from patients may not just be an option for the physician, but a positive obligation. Unfortunately, without clearly articulated patient preferences, its difficult to determine the appropriate management of medical information. Even when patients explicitly express preferences to learn (or not learn) about certain medical findings, the appropriate role of therapeutic privilege is cloudy. Sometimes, it may be unclear how to present completely unanticipated findings. Similarly, is it ethically appropriate to follow patients’ wishes when they are based on an inaccurate understanding of medical facts? Patients may, for example, associate cancer chemotherapy with hair loss, vomiting, and diarrhea. While such adverse effects are common to many types of chemotherapy, these symptoms are not universal for all types. Many chemotherapy regimens do not cause these same side effects. In such a situation, a patient could refuse all chemotherapy—and not want to discuss the matter—simply because he or she does not understand what chemotherapy would involve. In this case, determining the appropriate amount of information and method for disclosure is difficult. As a start, its important to involve an unrelated family member as the medical translator. This will ensure accurate and complete communication, and allow family members to act as relatives rather than as members of the medical team, and provide a source of unbiased insight into the patient’s culture and personal beliefs. It is important that the information provided to the patient reflects her own preferences rather than those of her son. In situations such as these, patients will often guide conversations to reveal how informed and

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involved they would like to be in medical decision making. In cooperation with the attending physician, the dermatologist—through the interpreter—could explain to the patient that she has a “serious medical condition with several treatment options. Would she like her doctors to explain all of the details to her or to her son?” The AMA opinion explains that physicians should “tailor disclosure to meet patients’ needs and expectations in light of their preferences” [5]. Patients may choose not to learn of certain information, but this decision must be their own. Family members cannot make decisions on a patient’s behalf without formal (or otherwise) delegation of this responsibility.

Conclusion Therapeutic privilege is the idea that it is sometimes permissible for physicians to lie to patients for the patients’ own good. Some argue that this is the most beneficent way to treat patients in certain situations, such as shielding them from news of an untreatable diagnosis. Others argue that therapeutic privilege may actually be an important way to further a patient’s autonomy if he or she is distraught and likely to make a decision inconsistent with personal beliefs. Finally, still others contend therapeutic privilege is unavoidable because all medical knowledge is based on probabilities, patients have a limited understanding of medical knowledge, and delivery and framing powerfully shape patient understanding. On the contrary,

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established contemporary medical ethics espouses a strong obligation for physicians to tell patients the truth. Deontological, consequentialist, and legal arguments support this practice. In most cases—as in those above—it is possible to reap the potential benefits of therapeutic privilege while still telling patients the truth in a sensitive and thoughtful manner.

References 1. Richard C, Lajeunesse Y, Lussier MT. Therapeutic privilege: between the ethics of lying and the practice of truth. J Med Ethics. 2010;36:353–7. 2. Brown C. Kant and therapeutic privilege. J Med Philos. 2008;33:321–36. 3. Berger JT. Ignorance is bliss? Ethical considerations in therapeutic nondisclosure. Cancer Invest. 2005;23:94–8. 4. Canterbury v. Spence United States Court Of Appeals For The District Of Columbia Circuit, 1972. 464 F.2d 772. http:// lawschool.courtroomview.com/acf_cases/9019-canterburyv-spence. Accessed 5 Nov 2011. 5. AMA Code of Ethics. Opinion 8.082 – Withholding Information from Patients. http://www.ama-assn.org/ama/ pub/physician-resources/medical-ethics/code-medical-ethics/ opinion8082.page. Posted 2006. Accessed 5 Nov 2011. 6. Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health literacy and cancer communication. CA Cancer J Clin. 2002;52:134–49. 7. Szepietowski JC, Salomon J, Hrehorow E, Pacan P, Zalewska A, Sysa-Jedrzejowska A. Delusional parasitosis in dermatological practice. J Eur Acad Dermatol Venereol. 2007;21: 462–5. 8. Takanami S. Cancer disclosure from recent disclosure from recent medical malpractice cases in Japan. Eubios J Asian Intl Bioeth. 2002;12:2–9.

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Communicating with Patients About Adverse Medical Events: If, When, and How to Say “I’m Sorry” Steven Shama, Lyn Duncan, and Lionel Bercovitch

Case 1 A dermatologist saw a young man for a 6 mm dark brown macule that had been present for about 4 months on his left forearm. The dermatologist performed a shave biopsy. The clinician’s differential diagnosis included melanoma. The patient was told to expect a call from the physician with the results. A new electronic medical record (EMR) system had been recently installed in the dermatologist’s office that used a laboratory interface to place pathology results directly into the patient’s electronic record. No hard copy of the pathology report was generated as was the routine in the past. Apparently, the physician failed to see the electronic pathology report that indicated a severely atypical melanocytic proliferation with the pathologist’s recommendation that this lesion be completely removed to rule out an invasive melanoma. Because the dermatologist never saw the pathology report, he never notified the patient. The patient assumed that no news from the physician’s office

S. Shama Joy Works Communications, Brookline, MA Private Practice and Department of Dermatology, Harvard Medical School (retired), Brookline and Boston, MA e-mail: [email protected] L. Duncan Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA e-mail: [email protected] L. Bercovitch (*) Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

meant that the report was normal. Six months later, the patient returned for a routine follow-up and mentioned that he had new nevi but there was a lump under his left arm. The dermatologist immediately became suspicious of a metastatic lesion and checked the record and noted for the first time that the lesion on the forearm that had been biopsied may have been a melanoma and had not been re-excised. Subsequent biopsy of the axillary lymph node revealed metastatic melanoma.

Case 2 A college student presented to the university student health service dermatologist for evaluation of recurring abscesses as well as an axillary boil which had been draining for several days. After obtaining a culture, the dermatologist prescribed trimethoprim/sulfamethoxazole for the infection, which he suspected to be due to methicillin resistant Staphylococcus aureus (MRSA). When the patient returned the following week, the dermatologist was surprised to notice that a sulfonamide allergy warning label was on the front of the chart but had been overlooked by the physician because it was covered by the encounter form. The patient, however, experienced no adverse reaction, and was doing well.

Discussion Virtually all dermatologists and other physicians, despite their training, expertise, and best efforts to provide high quality clinical care, will eventually encounter adverse medical events resulting from physician error or system failure. Inherent in any system that

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depends on care provided by humans, policies and processes devised by humans, and equipment designed, built, operated, or maintained by humans, is imperfection, the chance of failure and resulting unanticipated adverse outcomes. The foundation of the physicianpatient relationship is trust and patients both want and expect to be informed by their physicians about any harm they have experienced. Physicians have an ethical and professional responsibility to be truthful and candid with their patients and the principle of autonomy demands that patients be fully informed about their health care. Failure to communicate effectively can lead to patient dissatisfaction that can increase the possibility of malpractice litigation.

Adverse Medical Events An adverse medical event is defined by the Canadian Patient Safety Institute (CPSI) as “an event which results in unintended harm to the patient, and is related to the care and/or services provided to the patient rather than to the patient’s underlying medical condition” [1]. Such events can result from: • a disease that has become more symptomatic in a pattern that seems to be related to therapy • an anticipated predictable, but rare, negative event, e.g. a severe drug eruption • an unanticipated and unpredictable event • a systems failure • a physician/healthcare practitioner error In this chapter, we will focus on adverse events resulting from systems failure or practitioner error. System failures result “from a malfunction, or failure of policies, operational processes, or the supporting infrastructure for the provision of health care” [1] A medical error has been defined as “an omission or commission with potentially negative consequences for the patient which would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were negative consequences” [2]. However, medical error is not synonymous with negligence or fault, which are legal concepts. Indeed, most adverse events are not caused by negligence, but are inherent in the complex interaction of humans and systems in health care. Nevertheless, many errors result from ignoring safety steps (such as “time-outs”) or taking other shortcuts. Proof of negligence is not based on demonstrating deviation from

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perfection, but rather deviation from a standard of care reasonably expected from peers practicing in the same community at that time.

Disclosure The CPSI defines disclosure as “the process by which an adverse event is communicated to the patient by health care providers” [3]. The CPSI distinguishes between “initial disclosure”, which takes place as soon as reasonably possible after the adverse events, focusing on the facts as known and providing necessary clinical care, and “post-analysis disclosure” which is follow-up communication with the patient regarding the facts as known after further analysis of the adverse event [3]. The Canadian Medical Protective Association (CMPA) and American Society for Healthcare Risk Management, which have been leaders in the area of communicating with patients about harm, have provided comprehensive advice regarding disclosure of adverse events to patients. Their publications give detailed advice regarding the “disclosure road map” [4, 5]. Inherent in the disclosure process is attending to the patient’s immediate medical needs. Indeed, this should be the clinician’s priority. Stabilizing the patient, correcting equipment malfunction or other hazard, and remaining fully involved in the patient’s care are all essential. Informed discussion of further care, obtaining appropriate specialty consultations, and if necessary, transfer of care to a physician with greater or more appropriate expertise should then follow. Under no circumstances should patients perceive that they are being abandoned or that their health care providers are being disingenuous or uncaring. Furthermore, full documentation of the circumstances of the event should be made in the medical record and no alteration of the existing record should be made [6, 7].

When Is Disclosure Necessary? In the event of a “close call” in which the patient has not actually experienced an adverse event, the patient need not be informed, although many institutions require the reporting (as opposed to disclosure) of such events as a part of their quality improvement programs. If the patient has experienced an adverse event, whether or not harm has occurred, or there is a potential for

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Communicating with Patients About Adverse Medical Events: When, If, and How to Say “I’m Sorry”

future harm, some form of disclosure to the patient should occur. Most state and provincial regulatory bodies, whether or not there is specific legislative language, regard it as a professional and ethical obligation of healthcare providers and “apology laws” exist to protect such disclosures from being used against physicians during malpractice litigation.

Timing of Disclosure Disclosure should ideally occur as soon as reasonably possible after the adverse event is recognized. In addition, institutional policy or regulations and state laws may mandate reporting of adverse medical events or “close calls” via appropriate channels. The timing of the post-analysis disclosure obviously depends on when the analysis can be completed, but should be timely.

What Do Patients Want Disclosed? The CMPA recommends “the substitution test”: i.e. what you would want to know if you were the patient [4]. In one study nearly all (98%) of the patients would want their physicians to disclose to them all of the facts surrounding even minor errors [8]. The same authors believe that this disclosure may result in a reduced risk of punitive action. While fear of malpractice litigation remains an overriding concern for most practitioners, reduction of malpractice risk should be regarded as a secondary gain in revealing all facts. Doing what is right for patients should always be the primary reason for total disclosure. However, exactly what needs to be disclosed may be affected by state or provincial laws or institutional by-laws regarding the confidentiality of peer review proceedings.

What Do Our Professional Standards Dictate? The fifth edition of the Ethics Manual of the American College of Physicians (ACP) states: “physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being” [9]. In addition, the Joint Commission for Accreditation for Healthcare Organizations established the standard

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that requires practitioners in hospitals to notify patients and their families whenever there are unanticipated outcomes in their care [10].

What Does Risk Management Ask of the Medical Professional? General risk management principles would suggest that patients are entitled to know everything related to their care. Patients must know of variances in their care to make decisions for future care or actions, including seeking legitimate compensation for actual losses [5]. However, risk managers, while viewing disclosure of medical error more favorably than physicians, are more opposed than physicians to providing full apology [11]. Disclosure or reporting of medical error is crucial for quality improvement, improvement in patient safety, the education of physicians, and the public’s trust in the healthcare system [12]. It also seems clear that patients, professional ethics, and risk management principles all expect disclosure when adverse events take place. According to the ACP’s Ethics Manual, “errors do not necessarily constitute improper, negligent or unethical behavior but failures to disclose them may” [9].

The Process of Disclosure (adapted from (3)) As soon as the adverse event is recognized, the physician directly involved with the patient and the event should do the following: 1. Schedule a meeting as soon as reasonably possible after discovery of the adverse event and allow ample time for an unhurried interchange addressing the patient’s or family’s concerns and questions. 2. Schedule the meeting in a quiet, private setting without distractions and interruptions. 3. Provide the patient and risk management (institutional or malpractice insurance carrier) with an explanation of the facts as they are known at that time. 4. Take action to repair any injury that has taken place and to reduce the likelihood of further injury. 5. Assure the patient that steps have been taken to prevent this adverse event from occurring again. 6. Give appropriate emotional support to the patient and his or her family. All apologies should include an empathetic acknowledgement of the emotional or physical impact of the adverse event on the

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patient such as “I’m sorry for (or feel badly about) what has happened to you”. 7. Plan ahead how the disclosure will be made and how difficult questions will be answered. It is not necessary to know all the answers. Reassurance that “we will try to find out” should suffice, as long as it is followed up. 8. Exercise due caution in the wording of the disclosure. The CPSI’s disclosure guidelines specifically advise avoiding the word “error” in disclosure discussions, especially before all the facts are known [3]. Many adverse events or medical outcomes do not result from errors. In addition, a culture of blame has a chilling effect on disclosure and the reporting and the fostering of a culture of patient safety. 9. Acknowledge the adverse event and the physician’s role in it. If it is clear that the physician’s performance or an identifiable system failure has been responsible for the error, then the physician should be prepared to acknowledge this in the initial disclosure, with the qualification that further analysis might disclose other contributing factors. As noted above, both the CPSI and CMPA advise against using the word “error” during this discussion. In most jurisdictions “I’m sorry” is not considered an admission of negligence or fault and allows for a healing dialogue to ensue between physicians and patients Indeed, as of 2007, 34 states and most Canadian provinces had adopted “apology laws” that protected specific information conveyed in disclosures, most commonly “apologies or other expressions of regret” [13]. Apology is an important part of disclosure. It is an important step in healing, both in reducing the physician’s feelings of guilt or shame, as well as in opening the door for forgiveness by the patient [12, 14]. It should also be accompanied by a genuine expression of sympathy for the patient’s situation. If fault is clear, an apology should be a sincere one [15] Once the practitioner has decided to apologize, he should “make sure that the patient knows (you) really mean it.” It is not so much as what is said as what is heard by the patient. Is it an apology, or an admission that the physician is sorry for what has occurred but is not accepting any responsibility? As Lisa Belkin so eloquently stated in The New York Times, “A botched apology not only taints the act of apology but also the ability to accept an apology as well, (and) that is unforgivable” [16].

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10. Coordinate with risk management and, if appropriate, offer compensation. However, this should be undertaken with extreme caution and with consultation with the malpractice insurer and legal counsel. While in an ideal situation all of this action after the adverse event will go smoothly, physicians may be reluctant to embark on this process. A number of factors may lead to hesitation in completely revealing the truth, including the following: fear of creating patient anxiety and lack of trust in the physician; fear of experiencing personal guilt or having shameful feelings with colleagues or the community when they admit fault; general discomfort in disclosing anything negative having to do with patient outcomes; fear that the disclosure will generate a lawsuit. Finally, settlements may need to be publicly reported by the state’s licensing board or be reported to the National Practitioner Data Bank, depending on the amount and circumstances.

Is the Physician More Likely to Be Sued After Disclosure? The Veterans Administration Hospital experience addresses the question of whether full disclosure increases the likelihood of a lawsuit. Over a 6 year period, the Veterans Affairs Medical Center in Lexington, Kentucky found that with full disclosure, including a full apology and, in some instances, the offer of compensation there was no dramatic change in the volume of claims nor the size of claims paid, as compared to other VA Hospital centers that had not adopted full disclosure [17]. The institution actually realized a cost savings, in part because of reduced legal expenses. The University of Michigan Health System recently published similar experience with its disclosure-and-offer program, which led to a nearly two-third reduction in the number of lawsuits per month [18, 19]. Patients and families are more likely to initiate malpractice litigation if they sense that the physician or institution has been less than forthcoming or dishonest in their communication. In addition, finger-pointing or acknowledgement of responsibility before the facts are all known may also lead to litigation [4]. Physicians should be especially circumspect in discussing the care provided by other health care professionals, especially before all the facts are known. Unfounded disparaging comments can trigger a lawsuit.

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Communicating with Patients About Adverse Medical Events: When, If, and How to Say “I’m Sorry”

Are There Circumstances in Which Full Disclosure Might Not Be Appropriate? There is no reason to delay disclosure of information from patients who have been harmed or suffered adverse outcomes or from their families unless the patient’s well-being is being protected or early full disclosure is contraindicated [20].1 Fear of upsetting the patient is not acceptable grounds for non-disclosure. Disclosure of adverse events is an ethical and professional obligation in the eyes of most licensing bodies as well as often being institutional policy. If the patient does not have the capacity to absorb or fully comprehend the information, disclosure to a healthcare proxy or family member would be advisable [4]. Non-disclosure reasoning should stand the test of defending it in a public forum [21]. Since disclosure is a process, as facts become available the patient and family should be updated. Patients want a full disclosure; our professional ethical standards expect it and the legal system may hold us accountable. Ultimately it is the right thing to do.

Are There Special Circumstances That Might Affect How and When Disclosure Occurs? Patients who are minors, lack the capacity to understand, or are too sick to comprehend the communication of adverse events may require a health care proxy or family member to receive the information. Patients with a language barrier should receive disclosure with the aid of a qualified interpreter. There are instances in which multiple patients may be harmed by an adverse event (for example, a contaminated transfusion or defective medication or equipment, or a system failure). The CPSI recommends that each patient be informed individually to preserve confidentiality and that the disclosures should be timed to occur as close to simultaneously as possible [22].

What About the Caregiver? Adverse medical events and the process of disclosure can be extremely stressful for physicians. It is well1

For a discussion of the concept of therapeutic privilege, please refer to Chap. 6. (unless, of course, chapter numbers undergo revision)

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known that physicians have high expectations and standards and that at times society expects a standard of perfection in care that truly may not be humanly possible to always deliver. Human and systems error is inevitable. The whole process, particularly if it results in litigation often takes a serious emotional toll on the physician and his or her family. Accessing support from physician health programs, one’s own physician, or mental health professionals may be appropriate. Scott et al. have studied the “second victim” analogous to what happens to individuals who witness serious trauma experience [23]. After interviewing 31 “second victims”, they noted a common pattern of stages that followed the initial recognition of having committed an error causing significant harm to a patient [23]. These were (1) chaos and accident response, (2) intrusive reflections, (3) restoration of personal integrity, (4) enduring the inquisition, (5) obtaining emotional first aid, and (6) moving on [20]. Institutional administrators and department chairpersons should be especially sensitive to the emotional stresses caused by such events and be supportive, even to the extent of providing time off or temporarily relieving the physician of administrative or clinical obligations. Where possible, physicians should continue to advocate for the patient’s best interests and be encouraged to participate in any discussions regarding the question of compensation for the patient [24].

Analysis of Case 1 The adverse event in this case resulted from a lapse in communication and difficulty in transition to new technology. The system prior to adoption of the EMR involved a paper copy of the pathology report being faxed and/or mailed to the dermatologist who then acted on this report by notifying the patient and planning future therapy. The new system automatically directed the report into the electronic medical record without generating any hard copy. Without a system in place for assuring that pathology reports were always retrieved and signed off by the dermatologist, the report was overlooked and action recommended by the pathologist was not taken. When the patient returned to the office, the dermatologist at first was surprised by the clinical findings, then shocked and upset that he had not seen the report. This was followed by feelings of guilt and

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shame that he had not checked the medical record for the results. After discussing with the patient the chain of events as it was understood at that moment, expressing a heartfelt apology for the lack of communication and notification, and referring the patient to a melanoma center for further therapy, the dermatologist consulted with risk management. The goals at that point were to: 1. To ensure that the patient was treated appropriately, to repair any injury and to reduce any future harm to the patient. 2. To coordinate with risk management (institutional or malpractice carrier) and EMR software manufacturer to develop systems to prevent this adverse event from recurring. Before a complete transition from paper record to electronic medical record, failsafe redundant systems for checking reports should be implemented. This may include sending hard copy reports until the physician is confident that the electronic report checking system is fully functional after which hard copies can be routinely discarded. Redundant systems for laboratory report handling would likely have prevented this error from occurring. The practitioner, the patient and the laboratory should all be involved in report notification. The practitioner can keep a hard or electronic copy of a laboratory request and track that request until the final report comes back. The laboratory should have a mechanism for notifying the ordering physician of the status of incomplete tests and should also have a mechanism for verbal or electronic notification about potentially life-threatening diagnoses such as melanoma. With EMR, when a report is sent to the practitioner, an electronic sign-off indicator may be implemented to ensure that the report has been seen. Finally, the concept of “no news is good news” should be eliminated. Patients should be specifically asked to check for results of any laboratory tests not reported to them within an appropriate time interval. 3. To do any reporting required by institutional regulations or state and provincial statutes. 4. To maintain an open, honest, and caring relationship with the patient to the extent that is possible given the circumstances in this case. This might be impossible given the adverse outcome that has occurred and the nature of the adverse event (which even had it never happened might not have prevented metastasis). 5. To control the damaging effects of the emotional trauma to the physician. The nature of the adverse event, namely the development of a melanoma

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metastasis, is especially traumatic for the physician, who in addition to being involved in developing risk management strategies to prevent such events from recurring, must disclose the error to the patient, possibly deal with an internal institutional investigation, or even endure malpractice litigation. Measures to provide emotional support for the physician and facilitate recovery from the emotional trauma should not be overlooked.

Analysis of Case 2 This is an example of the adverse event not resulting in patient harm. Yet, the physician has an ethical and professional obligation to disclose the adverse event to the patient and the institution. First, the absence of a reaction despite the error suggests that the patient is not allergic to sulfonamides, which would be very important information for the patient to have, especially in the management of a recurrent MRSA infection. Second, the patient might not have been aware that it is not always obvious what medications fall into a class to which the patient is allergic. From the systems standpoint, there were multiple failures. First, the encounter form covered the allergy warning. Charts should have allergies noted in an area that is clearly visible during all visits. Second, the pharmacy was apparently unaware of the patient’s allergies (or might have assumed the student was another patient with the same name). Systems for recording medication allergies should be thoroughly analyzed and improved in order to prevent such errors from occurring in the future. Routinely asking the patient “do you have any allergies?” each time a prescription is written will also assist in preventing this type of error. The patient should then be notified of changes that occur as a result of this adverse event. Even if this had been a “near miss” because the error was detected in timely fashion by the physician or pharmacy and even if there is no absolute obligation to disclose every “near miss”, the patient in this case should be notified so that this can be prevented in the future to the extent that patient vigilance or education can contribute.

Conclusion The concept of complete disclosure to patients of adverse medical events and “near miss” events is a relatively recent concept in medical practice and risk

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Communicating with Patients About Adverse Medical Events: When, If, and How to Say “I’m Sorry”

management. The increasing use of chemotherapeutic medications, biologic immunomodulatory drugs, new information technology including electronic interfaces with laboratories, and the reliance on imperfect systems and infrastructure create the ideal circumstances for a “perfect storm” leading to adverse medical events. All dermatologists may one day face the need for disclosure following such an event, and should understand their ethical, legal, and professional obligations and should be prepared to utilize risk management and institutional resources to facilitate disclosure.

References 1. Canadian Medical Protective Association. Communicating with your patient about harm: disclosure of adverse events. http://www.cmpa-acpm.ca/cmpapd04/docs/resource_files/ ml_guides/disclosure/terminology/index-e.html. Accessed 18 Aug 2010. 2. Wu AW, Cavanaugh TA, McPhee SJ, Lo B, Micco GP. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12:770–5. 3. Canadian Patient Safety Institute. Canadian disclosure guidelines. http://www.patientsafetyinstitute.ca/English/ toolsResources/disclosure/Documents/CPSI_Canadian_ Disclosure_Guidelines_Nov2_2011_english.pdf. Posted 2 Nov, 2011. Accessed 21 Nov 2011. 4. Canadian Medical Protective Association. Communicating with your patients about harm: disclosure of adverse events. http://www.cmpa-acpm.ca/cmpapd04/docs/resource_files/ ml_guides/disclosure/pdf/com_disclosure_toolkit-e.pdf. Accessed 21 Aug 2010. 5. Monographs of the task force of the society for health care risk management disclosure of unanticipated events: the next step in better communication with patients, parts 1, 2, 3. Chicago: American Society for Health Care Risk Management of the American Hospital Association; 2003. 6. Canadian Medical Protective Association. Communicating with your patients about harm: the initial disclosure meeting. https://www.cmpa-acpm.ca/cmpapd04/docs/resource_ files/ml_guides/disclosure/first/index-e.html. Accessed 21 Aug 2010. 7. Canadian Medical Protective Association. Communicating with your patient about harm: first things first. https://www. cmpa-acpm.ca/cmpapd04/docs/resource_files/ml_guides/ disclosure/first/index-e.html. Accessed 21 Aug 2010.

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8. Witman AB, Park DM, Hardin SB. How do patients want physicians to handle mistakes? A survey of internal medicine patients in an academic setting. Arch Intern Med. 1996;156:2565–9. 9. Snyder L, Leffler C. Ethics manual: fifth edition. Ann Intern Med. 2005;142:560–82. 10. LeGros N, Pinkall JD. The new JCAHO patient safety standards and the disclosure of unanticipated outcomes. Joint Commission on Accreditation of Healthcare Organizations. J Health Law. 2002;35:189–210. 11. Loren DJ, Garbutt J, Dunagan WC, Bommarito KM, Ebers AG, Levinson W, et al. Risk managers, physicians, and disclosure of harmful medical errors. Jt Comm J Qual Patient Saf. 2010;36:101–8. 12. MacDonald N, Attaran A. Medical errors, apologies and apology laws. CMAJ. 2009;180:11–3. 13. Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients. N Engl J Med. 2007;356: 2713–9. 14. Lazare A. Apology in medical practice: an emerging clinical skill. JAMA. 2006;296:1401–4. 15. Wu AW. Handling hospital errors: is disclosure the best defense? Ann Intern Med. 1999;131:970–2. 16. Belkin L. Why is it so hard to apologize? The New York Times, 2 July 2010:Sect. MM9. 17. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999;131:963–7. 18. Kachalia A, Kaufman SR, Boothman R, Anderson S, Welch K, Saint S, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010;153:213–21. 19. Chen P. When doctors admit their mistakes. New York Times, 19 Aug 2010. 20. American Medical Association. Code of Medical Ethics: Opinion 8.082-With holding information from patients. 2008. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics/opinion8082.shtml . Accessed 21 Aug 2010. 21. Wu AW. Commentary: doctors are obliged to be honest with their patients. BMJ. 2001;322:1238–9. 22. Canadian Patient Safety Institute. Canadian disclosure guidelines. 2008. http://www.patientsafetyinstitute.ca/ English/toolsResources/disclosure/Documents/CPSI%20 -%20Canadian%20Disclosure%20Guidlines%20English. pdf. Accessed 21 Aug 2010. 23. Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care. 2009;18:325–30. 24. Pettker CM, Funai EF. Getting it right when things go wrong. JAMA. 2010;303:977–8.

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The Computer Will See You Now: Ethics of Teledermatology Jennifer L. Weinberg, Rachel H. Gormley, and Carrie L. Kovarik

Cases 1. A dermatologist receives an e-mail from a friend who is a nurse working in a prison health clinic in another state. The nurse friend has sent photographs of an inmate’s rash to the dermatologist’s personal e-mail account and requests help with the diagnosis. 2. You are a dermatologist participating in synchronous teledermatology (videoconferencing) in association with a pediatric HIV clinic. A mother accompanies her 4-year-old son who suffers from widespread flat warts. While she has an established relationship with the child’s pediatrician, she expresses concerns that she “does not know” this dermatologist and the dermatologist “does not know her child.” She also asks who may access this communication and review her child’s medical information. 3. You are the consulting dermatologist for multiple teledermatology clinics and save a large number of cases on your laptop computer. In addition to photos, there is linked information including names, addresses, diagnoses, and treatments. While travel-

J.L. Weinberg () University of Pennsylvania School of Medicine, Philadelphia, PA, USA e-mail: [email protected] R.H. Gormley • C.L. Kovarik Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA e-mail: [email protected]; [email protected]

ing to a professional conference, your laptop computer is stolen. While the computer is password protected, you are concerned that an unknown party could possibly access confidential patient data. 4. A dermatology resident volunteering in a community clinic receives permission from his patient to take photographs for his medical record. The patient’s case proves to be complex and the resident is uncertain about the correct diagnosis. He decides to send the images to his mentor who is not involved with the clinic for advice.

Background Telemedicine merges medical expertise and communication technology to allow for patient examination, monitoring, and management by a medical expert in a distant location. This technology facilitates delivery of high level specialty medical care to otherwise medically underserved regions. Telemedicine involves the electronic transfer of information which may be accomplished via several modalities. The two basic types currently in practice are [1] “synchronous” (also known as “real-time” or “live interactive”) and [2] “store-andforward” telemedicine. These two techniques both utilize historical and visual data but employ distinct manners of generating and presenting that information. Synchronous telemedicine most commonly takes the form of video conferencing in which patients, specialists and, sometimes the referring clinician, interact via a real time video link with dynamic visual images. The most commonly employed type of telemedicine,

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however, is store-and-forward, where digital images and patient data are captured, transferred, and stored. Store-and-forward technology allows transfer of patient history, physical examination findings, and digital images to a consulting physician who later evaluates the information and returns a diagnostic impression and recommendations. This method is useful in situations that do not necessitate immediate feedback. The asynchronous method does not involve a direct interaction between the patient and the consulting physician [1]. As technology expands, mobile telephones are increasingly being employed for the transfer of data in store-and-forward telemedicine. Telemedicine technology has many applications in health care. It has been used to provide specialty services such as dermatology, radiology, cardiology, pathology and obstetrics, as well as for telecolposcopy, neuropsychiatric and stroke evaluation, home care services and remote monitoring of various health conditions. As a primarily visual specialty, dermatology is especially well-suited to telemedicine. Teledermatology is the application of telemedicine to the specialty of dermatology and can serve as a means to provide support to local physicians and healthcare workers through expert consultation and discussion pertaining to diagnosis and management of patients with skin disease, facilitating broader access to dermatologic care with the benefit of geographic (and often temporal) flexibility for patients and physicians [2]. Additionally, teledermatology can provide educational and training support by offering local providers access to pertinent educational materials and resources. As a relatively new diagnostic tool, teledermatology continues to be the focus of active investigation. Accumulating data suggest teledermatology can be accurate, safe, cost-effective, and well-received by patients. When health care providers are trained to photograph skin lesions appropriately and record relevant clinical information, the teledermatology encounter produces diagnoses similar to those derived from live patient encounters [3]. In one study of store-and-forward, diagnostic agreement between face-to-face interactions and teledermatology consultations ranged from 81 to 89% and agreement on management decisions ranged from 90 to 96% [3]. Technological advancements, such as superior resolution digital cameras and more rapid data transmission may further improve diagnostic accuracy and clinical utility [4].

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Ethical Issues and Case Discussions While the technology and clinical use of teledermatology technologies advance, issues surrounding licensing, privacy, and ethical concerns remain to be clarified. Case 1 introduces an informal teledermatology request which raises several ethical and professionalism concerns. Because the consultation in the case is being submitted outside of a formal, established teledermatology program, no guidelines for the protection of clinical information, image quality, proper follow-up and data storage are available to shape the encounter. Further, given the nature of this informal consultation, the character of the clinical encounter and physicianpatient relationship is in question. As clarified by the American Medical Association’s (AMA) code of ethics, the critical therapeutic alliance between health care providers and patients leads to professional and ethical obligations for physicians, requiring them to place patients’ welfare above their own self-interest and giving them a prima facie obligation to support patient wellbeing [5]. Importantly, both physician and patient must voluntarily enter into this relationship to ensure the ethical and professional standing of such connections [6]. As such, the AMA states that electronic communications like e-mail should not be utilized to establish physician-patient relationships and that physicians should not respond to unsolicited e-mails [7]. In this situation, it is uncertain if the patient has been informed that his condition will be discussed with a distant consultant. It is also unclear who is assuming primary responsibility for the patient’s medical care—the local nurse or the consulting dermatologist. In such a situation, the dermatologist may lack a complete medical history and detailed information about the clinical problem. Without adequate information, clinical recommendations are at best speculative and at worst irresponsible. Additional ethical and professional concerns arise due to the fact that the dermatologist cannot assure adequate follow-up with the patient [4]. In situations similar to Case 1, the importance of the clinician-patient relationship must be remembered. To ensure an ethical interaction, all clinicians participating in the teledermatology consultation should respect the patient’s autonomy and strive to uphold the bioethical principles of beneficience and non-maleficience. Respecting the patient’s autonomy demands that professionals acknowledge the capacity of the patient as a rational individual to make informed,

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un-coerced decisions. As such, clinicians should engage in the process of shared decision making with an informed patient when participating in a teledermatology encounter. Professional standards and ethical responsibility require that the clinicians collect sufficient clinical information, facilitate adequate and secure communication with all parties involved, and establish appropriate follow-up with the patient. In Case 2, the teledermatology patient’s mother is concerned about the nature of the clinical encounter as well as the confidentiality and privacy of teleconsultation services. Similarly, Case 3 raises several issues of patient privacy and data security concerns related to teledermatology technology. Rapid data transfer and almost limitless storage capacity increase ethical concerns about protecting patient privacy. Patients have the right to control the use and distribution of information relating to their health. Confidentiality refers to the ways in which an individual’s information is protected from release by a clinician or researcher, while privacy refers to patients’ right to control access to themselves individually. The Health Insurance Portability and Accountability Act (HIPAA) sets forth standards for protecting the security of patient protected health information (PHI) [11]. With regards to electronic health care transactions such as those which occur with the use of teledermatology, HIPAA creates national standards and directs that digital health data remain private and secure. Dermatologists providing teledermatology services are covered entities under HIPAA. Teledermatology utilizes the transmission of patient medical information and therefore involves the possibility that health information may become accessible to unintended parties. When designing teledermatology systems, these standards must be kept in mind and integrated into the implementation of such programs. As illustrated in Case 2, patients (and guardians) may be concerned about violations of privacy when their health information is transmitted electronically. Additionally, patients may be concerned about breaches of privacy when technical staff is involved with supporting the transmission and organization of health information or when unfamiliar practitioners are integrated into their care. Similarly, many teledermatology programs employ an internet-based web server which may be owned and maintained by a private third party. With such teledermatology platforms, submitting sites and consulting dermatologists are able to securely log

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into the system to access patient information and provide feedback. Practitioners should clearly explain what teledermatology entails to patients (and guardians) and clarify in understandable terms the safeguards put in place to protect patient information and privacy. This information should be incorporated into the informed consent process. This model of teledermatology further raises issues of data ownership as well as the question of who has the right to access such medical records, issues which should continue to be addressed as teledermatology programs are implemented and expanded [8]. Additionally, as demonstrated in Case 3 the delivery of health care and storage of medical information on mobile devices such as mobile phones, personal digital assistants and laptop computers raises concerns around the protection of patients’ privacy and the violability of health care information. Ways to maintain the security and protected storage of patient medical information must be addressed when implementing teledermatology programs. In order to ensure that patient confidentiality and privacy are respected, information must be protected whenever transmitted, stored, or received in the course of teledermatology consultations [9]. Case 4 introduces the concept of informed consent in the context of a teledermatology consultation. Informed consent is an important ethical requirement in which a patient’s autonomy is maintained via his informed authorization of a medical intervention or participation in research. Informed consent, developed from guidelines such as the Belmont Report, requires that patients are given information regarding the proposed medical procedure and purposes including anticipated risks and benefits; alternative options; the ability to withdraw or ask questions at any time; and that the patient’s consent be voluntary [10]. Several concerns over the adequacy and appropriateness of individual informed consent obtained during telemedicine consultations may arise. While procedures and documentation standards are clear and established in most institutions for many different medical procedures, there is a lack of precedent and recognized standards of care in the setting of a teledermatology consultation [8]. Patients need to be informed of what a teledermatology consultation entails, who will have access to their health information, how that information will be transmitted and stored, and how this technology can facilitate their care. The principle of

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respecting patient autonomy demands that health care providers take reasonable actions to respect their patients’ right to make an informed decision regarding their clinical care, including in the context of teledermatology consultations. Related to the concept of informed consent, Case 4 presents a situation in which the dermatology resident breaches patient confidentiality. Confidentiality is breached in this case by the inappropriate disclosure of individual patient information to unauthorized persons outside of the patient’s official care team. In this case, the patient was not informed that his medical information would be shared with another party and therefore did not have the opportunity to consent to such actions. Unauthorized use of patient medical information may also occur in situations in which identifying images from a telemedicine case are utilized in a presentation or unauthorized individuals overhear video conferencing consultations [9].

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unintended parties. Careful attention must be paid to all stages of consultation—transmission, storage, and receiving of patient data. Core principles of bioethics, such as patient autonomy, non-maleficence and beneficence, should always be considered in order to optimize the outcome of the teledermatology encounter and minimize risks for all parties involved. For instance, informed consent for a teledermatology consultation requires that a patient be made aware that his or her medical history and clinical information will be discussed with a distant consultant, transmitted electronically, and stored. Patients must be made aware of risks to their privacy and consent to these risks, while at the same time clinicians must assure their patients that will do everything in their power to use safeguards to ensure data is protected. With careful consideration of these principles and implementation of appropriate protections, teledermatology promises to provide much-needed skin care services and expand access to dermatology services in an ethically sound manner.

Conclusion References Teledermatology has the potential to decrease health inequalities especially in resource-limited settings. This technology provides an effective means to increase access to specialty medical services and also has the potential to increase local providers’ knowledge, and therefore independence in practice, over time, as they are educated through the use of the consultation service and the feedback it provides. Not only is teledermatology a useful forum for distribution of educational materials to underserved areas, it also has the potential to contribute to continuing medical education for both local and international health care providers, promote scientific collaboration, and improve the cost-effectiveness and delivery of medical services. Despite the promise of such technology, several ethical issues may arise. As illustrated by the above cases studies, clinicians using teledermatology in practice must ensure that appropriate measures are in place to safeguard confidentiality. They must respect the changing nature of the physician-patient relationship when consultations are made at a distance, and carefully examine issues of patient autonomy, consent, and obligations of appropriate follow up. In implementing teledermatology systems, it becomes critical that high standards of privacy and data protection be implemented to ensure that health information does not become accessible to

1. American Academy of Dermatology Position Statements. Position statement on telemedicine. Updated 2004. http://www. aad.org/forms/policies/Uploads/PS/PS-Telemedicine%206-1507.pdf. Accessed 21 Feb 2010. 2. Norton SA, Burdick AE, Phillips CM, Berman B. Teledermatology and underserved populations. Arch Dermatol. 1997;133:197–200. 3. Pak H, Triplett CA, Lindquist JH, Grambow SC, Whited JD. Store-and-forward teledermatology results in similar clinical outcomes to conventional clinic-based care. J Telemed Telecare. 2007;13:26–30. 4. Grenier N, Bercovitch L, Long TP. Cyberdermatoethics II: a case-based approach to teledermatology ethics. Clin Dermatol. 2009;27:367–71. 5. American Medical Association. Code of medical ethics: E-10.015. The patient-physician relationship. Updated June 2001. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics.shtml. Accessed 6 Jan 2010. 6. Federation of the State Medical Boards of the United States, Inc. Model guidelines for the appropriate use of the internet in medical practice. Updated April 2002. http://www.fsmb. org/pdf/2002_grpol_Use_of_Internet.pdf. Accessed 6 Jan 2010. 7. Bovi AM, CEJA. Ethical guidelines for the use of electronic mail between patients and physicians. Am J Bioeth. 2003; 3:W43–7. 8. Demiris G, Oliver DP, Courtney KL. Ethical considerations for the utilization of telehealth technologies in home and hospice care by the nursing profession. Nurs Adm Q. 2006;30:56–66.

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9. Fleming D, Edison K, Pak H. Telehealth ethics. Telemed J E Health. 2009;15:797–803. 10. Fischer BA. A summary of important documents in the field of research ethics. Schizophr Bull. 2006;2:69–80.

49 11. U.S. Department of Health & Human Services, Office of the Secretary. Standards for privacy of individually identifiable health information; proposed rule. Fed Regist. 1999;64(212): 59917–60016.

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Hospital Consultations: Embracing Professionalism Even When It Hurts Lauren E. Krug and Stephen E. Helms

Introduction The American Medical Association met in Philadelphia in 1847 and revolutionized medicine in the United States by establishing standards for professional education, training, and conduct. The world’s first national code of medical ethics has remained the authoritative guide for practicing physicians since that time. The AMA’s Code of Medical Ethics is an ever evolving entity changing as the practice of medicine and healthcare delivery change [1]. The American Academy of Dermatology has developed The Code of Medical Ethics for Dermatologists in part from the Principles of Medical Ethics and Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association [2]. While these codes do not explicitly address hospital consultations, they do provide guidance for general patient interactions. Dermatological consultations are one aspect of such care. Consultations may be very important when one considers the concept of continuity of care which has been of ever increasing

importance with the growth of specialty care in the United States over the past 25 years. Dermatologists face moral, ethical, and even legal issues in determining whether or not to participate in hospital consultation services. Four cases will be presented to highlight the complex relationships that may exist between the dermatologist and hospitalized patients.

Case 1 An elderly 75-year-old man presented to the emergency room with a generalized blistering rash associated with fever, malaise, anorexia, and congestive heart failure requiring hospital admission. The patient had never been seen by a dermatologist. The primary care physician was unable to obtain an inpatient dermatology consultation as none of the ten local dermatologists were on the hospital staff.

Case 2 L.E. Krug Temple University School of Medicine, Philadelphia, PA, USA e-mail: [email protected] S.E. Helms (*) Department of Internal Medicine, Dermatology Section, Northeastern Ohio Universities College of Medicine, Rootstown, OH, USA Department of Dermatology, Case Western Reserve University School of Medicine, Cleveland, OH, USA e-mail: [email protected]

A 47-year-old man saw his dermatologist for a boil on his forearm of one week’s duration followed by multiple large, red, sore, blistering areas on his trunk and proximal extremities. He was found to have a methicillin-resistant staphylococcus aureus (MRSA) infection and was initially treated with sulfamethoxazoletrimethoprim and topical mupirocin ointment. Two days later, he became febrile with a generalized rash and was admitted to the only hospital within 30 miles under the care of his family physician. The patient’s dermatologist was consulted but refused to come to the

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hospital to see the patient, noting that he did not provide inpatient consultation services despite being a member of the hospital staff.

Case 3 A 61-year-old man was given sulfamethoxazoletrimethoprim for a methicillin-resistant staphylococcus aureus (MRSA) infection but failed to improve. He developed a fever and generalized morbilliform exanthem. Although his dermatologist provided consultation services at two of the six hospitals in this large metropolitan area. he did not have hospital privileges at the hospital to which this patient was admitted.

Case 4 A dermatologist was called to evaluate a lesion on the nose of an 84-year-old woman admitted to the hospital for worsening congestive heart failure. The referring physician requested that the patient be evaluated within 24 h, because discharge was planned for the next day.

Discussion Although the vast majority of dermatologists practice in an outpatient, non-institutional setting, dermatologic problems also frequently occur in inpatients, 36% being affected in one study [3]. Of these patients, 13.4% were admitted to the hospital for a disease process directly related to their cutaneous findings. Unfortunately, 77% of dermatologic issues had not been noted by the admitting team, including metastatic adenocarcinoma, drug eruptions, and non-melanoma skin cancers [4]. Another study revealed that the diagnosis and treatment was changed in more than 60% of cases when a dermatologist was consulted [5]. Clearly, dermatological expertise is very important in managing inpatient dermatological problems. Unfortunately, there appears to be a progressive decrease in the number of dermatologists providing inpatient services at many hospitals in the United States [6]. For example, 75% of dermatologists in Ohio reported performing hospital consultations during the 2007 calendar year but this number had declined to 60% by 2008 [7]. In addition, Medicare utilization data from 2005 showed that only 0.37% of all hospital consultations were performed by dermatologists [8]. A survey

L.E. Krug and S.E. Helms

of dermatologists practicing in Ohio disclosed that inconvenience was the most frequent reason given by physicians (52%) for not making themselves available for hospital consultations. They are unable to come to the hospital during the day while seeing patients at their offices and often, do not live near the hospital [7]. Respondents also reported that the consultations they received were frequently not truly emergent (24%) and could easily be handled in an outpatient setting after discharge. Other dermatologists reported not receiving requests for hospital consultations (9%). Some dermatologists stated that performing a single consultation might lead to an increased number of consultations since so few dermatologists in their area provide this service. Others said that, in their group practice, consultations were not in the “job description”. Beginning in 2010, Medicare eliminated procedure codes for billing of consultations, requiring that all comparable evaluation and management services be billed under the same code, thereby reducing compensation for all consultations. The lower levels of compensation for inpatient consultation are usually not adequate considering total time and effort put forth by the physician. Therefore, dermatologists do not do hospital consultations for purely economic motives. Hospitals that have dermatological hospitalists and academic centers that provide inpatient services relieve private practitioners of the need to offer consultations. However, in most communities, private practitioner dermatologists are called upon for advice in managing complicated inpatient dermatological problems. We believe many dermatologists refuse to do consultations without a careful analysis of their moral, ethical, and legal obligations. The terms “moral” and “ethical” are not interchangeable. Moral is a subjective term that permits societies and religions to label actions as “proper” or “right” in a humanitarian or philosophical sense. Professional ethics, on the other hand, are objective measurable standards of behavior based on accepted moral beliefs that are codified by organizations and governing bodies such as the American Medical Association’s Code of Medical Ethics.

Analysis of Case Scenarios The cases presented offer a variety of ethical, moral, and legal dilemmas. The focus of each is on the dermatologist-patient and dermatologist-referring physician relationship.

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In Case 1, the patient never established a relationship with a dermatologist. Dermatologists are under no legal or ethical obligation to serve such a patient. Specifically, the American Medical Association (AMA) has set forth ethical guidelines in the Principles of Medical Ethics which states, “a physician shall, … except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care” [9]. Although this patient had a serious medical condition that could benefit from dermatologic expertise, it was not an emergency requiring an immediate response. Collegiality, the desire to help a colleague who is not skilled at caring for a complicated dermatological disease, might motivate some dermatologists to accept this consultation. Calls for help from primary care practitioners are justifiable since their diagnostic accuracy in a hospital setting was found to be only 48% in one study [5]. Perhaps most importantly, the dermatologist may also feel a moral obligation to help this patient. The ten dermatologists in the area have one other ethical obligation not tied to seeing a specific patient. Section 10.05 of the AMA Code of Ethics states, “Physicians, as professionals and members of society, should work to assure access to adequate health care.” Thus, physicians have an obligation to set up a voluntary rotating “on-call” schedule to ensure that patients in their community receive appropriate dermatologic care in the hospital. This is not occurring if no dermatologists offer hospital consultation services. In Case 2, the patient has an established relationship with the dermatologist and appears to be having a serious reaction to a medicine prescribed by that physician. The moral and ethical considerations are clear. According to the AMA’s code of ethics 10.01(6) [10], The patient has the right to continuity of health care. The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicated, without giving the patient reasonable assistance and sufficient opportunity to make alternative arrangements for care.

Since the dermatologist served as the patient’s physician and prescribed the medication which is highly likely to be causing the patient’s rash, the dermatologist has an ethical obligation to provide medically indicated care to his patient or ensure that another dermatologist sees the patient in his absence. The dermatologist could potentially be accused of abandonment and could face disciplinary action or civil liability [11]. It is important

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to note that the majority of dermatologists choose to be on a nearby hospital staff because this allows them to access patient panels of insurance plans that require staff privileges for its providers. Hospitals commonly require staff members to perform consultations when called, at least on a rotating basis with other staff members in their specialty. Unless the dermatologist has a hospital staff category that does not provide consultative privileges, doing inpatient consultations is likely to be an obligation of medical staff privileges. In Case 3, the dermatologist would willingly have provided services if the patient were admitted to a hospital at which the doctor has privileges, but he is not on staff to provide services at the particular hospital to which his patient has been admitted. It would appear that the physician’s moral and ethical obligations are not the same in this case as in the previous two. Although the physician is very unlikely to be at risk of the charge of abandonment, it would be argued that the hospital is responsible for providing dermatological care and should strive to have a dermatologist on staff. In fact, the Joint Commission on Accreditation of Healthcare Organizations requires hospitals to ensure that specialists are available for consultation [12]. At the same time, physicians on a hospital staff are usually required to perform consultations in order to maintain hospital privileges. This may vary from hospital to hospital and is a function of institutional bylaws. The dermatologist could offer to see the patient if transferred to a hospital where that physician has privileges. Case 4: Many dermatologists are repeatedly faced with inpatient consultations that clearly could and should be seen after the patient is medically stable. Frequently, the patient or a family member mentions a growth or rash that has been present for weeks, months, or years for which treatment is desired “while in the hospital.” There is no urgency to see such a patient, since the dermatologic concern is neither acute nor related to the reason for admission to the hospital. Impending discharge does not justify an urgent consultation. These consults are less of a problem for a physician who “rounds” every day in the hospital than for the office-based dermatologist. Since the dermatologist is not refusing to see the patient, but merely requesting to see the patient at a later date in the office setting, there is no moral, ethical, or legal issue. Perhaps if fewer of these consultations were requested, more dermatologists would be willing to see in-patient consultations and feel more of an obligation to do so.

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Conclusion Successful practitioners are judged by their peers and patients by their affability, ability, and availability [13]. Unfortunately, many dermatologists choose to be unavailable for the provision of hospital consultations. This chapter presents the argument that it is ethically untenable for dermatologists to refuse to see all hospital consultations. Dermatologists have an obligation to care for: (1) established patients who are presently under their care when they are admitted to a hospital where they have privileges; and, (2) patients referred when they are “on call” as determined by hospital bylaws and or patients assigned by the chief of the appropriate service. The solution to providing needed dermatologic hospital consultations ultimately requires a system change that equitably shares the burden of performing this service among all dermatologists. It is hoped that the moral “calling” of the physician will motivate dermatologists to assist their colleagues in serving hospitalized patients when they are in need by devising an on-call schedule. Improving communication between consulting physicians and dermatologists may eliminate unnecessary, wasteful consultations by allowing some patients to be seen at the office soon after discharge. In addition, dermatological education needs to be improved in both the training of medical students and continuing medical education in dermatology for primary care physicians/house staff so that consultations for “unnecessary” inpatient dermatologic care can be avoided [14, 15]. Finally, dermatology residency programs should incorporate ethics courses that include such topics as “duty to treat” [16].

References 1. American Medical Association web site. American Medical Association code of medical ethics. Principles of medical ethics. www.ama-assn.org/ama/pub/physician-resources/medical/ ethics. Accessed 11 June 2010.

L.E. Krug and S.E. Helms 2. Code of Medical Ethics of the American Medical Association. 2008–2009. http://www.ama-assn.org/ama/pub/physicianresources/medical-ethics/code-medical-ethics.shtml . Accessed 27 June 2010. 3. Nahass GT, Meyer AJ, Campbell SF, Heaney RM. Prevalence of cutaneous findings in hospitalized medical patients. J Am Acad Dermatol. 1995;33:207–11. 4. Nahass GT. Inpatient dermatology consultation. Dermatol Clin. 2000;18:533–42. 5. Falanga V, Schachner LA, Rae V, Ceballos PI, Gonzalez A, Liang G, et al. Dermatologic consultations in the hospital setting. Arch Dermatol. 1994;130:1022–5. 6. Federman DG, Concato J, Kirsner RS. Comparison of dermatologic diagnoses by primary care practitioners and dermatologists. Arch Fam Med. 1999;8:170–2. 7. Helms AE, Helms SE, Brodell RT. Hospital consultations: time to address an unmet need? J Am Acad Dermatol. 2009;60:308–11. 8. Centers for Medicare and Medicaid Services. Medicare part B extract summary system report. http://www.cms.hhs.gov/ nonidentifiabledatafiles/03_partBextractsummarysystem. Asp#topofpage. Accessed 11 June 2010. 9. Centers for Medicare and Medicaid Services. Physician Fee Schedule. https://www.cms.gov/PFSlookup/02_PFSSearch. asp#TopOfPage. Accessed 28 June 2010. 10. American Medical Association. American Medical Association code of medical ethics. Principles of medical ethics. http:// www.ama-assn.org/ama/pub/category/2512.html. Accessed 11 June 2010. 11. Zibulewsky J. The Emergency Medical Treatment and Active Labor Act (EMTALA): what it is and what it means for physicians. Proc (Bayl Univ Med Cent). 2001;14: 339–46. 12. Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for hospitals: the official handbook. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 2005. 13. Valko GP. Open-access scheduling in practicing medicine in the 21st century. In: Nash DB, Skoufalos A, Hartman M, Horwitz H, editors. Practicing Medicine in the 21st Century. Tampa, FL: American College of Physician Executives; 2006. Ch.15 p. 244. 14. Davila M, Christenson LJ, Sontheimer RD. Epidemiology and outcomes of dermatology in-patient consultations in a Midwestern U.S. University hospital. Dermatology Online J. 2010;16:12. 15. Bauer J, Maroon M. Dermatology inpatient consultations: a retrospective study. J Am Acad Dermatol. 2010;62: 518–9. 16. Bercovitch L, Long TP. Dermatoethics: a curriculum in bioethics and professionalism for dermatology residents at Brown Medical School. J Am Acad Dermatol. 2007;56: 679–82.

The Extender Is In: Delegating Ethically—Ethical and Professional Issues Relating to Physician Extenders in Dermatology

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Steven Rosenberg and Clifford Perlis

Dermatologists traditionally delegate certain responsibilities to medical assistants and other staff members. More recently, many dermatologists have begun employing physician assistants (PA) and nurse practitioners (NP). Delegating to “dermatologist extenders” allows a dermatologist to be more efficient and accommodate more patients in a timely manner. Such benefits are especially relevant in the context of some data suggesting a relative dermatologist workforce shortage. If increased use of dermatology extenders results in substandard or inconsistent quality of care, then these potential benefits are replaced by real harm. Laws regulating PAs and NPs differ by state; ethical issues are, however, universal.

Case 1 A small dermatology group practice advertises to hire a physician extender. A recently graduated physician assistant applies for the job. He explains that he really enjoyed his two month dermatology rotation and cannot wait to join the group. In order to ensure sufficient cash flow to cover his generous salary, the practice has him seeing patients independently upon commencing employment. S. Rosenberg Palm Beach Dermatology, West Palm Beach, FL, USA Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA e-mail: [email protected] C. Perlis (*) Fox Chase Cancer Center, Philadelphia, PA, USA e-mail: [email protected]

Case 2 A solo dermatologist practices out of three small offices and has a long waiting list for new patients. A nurse practitioner with extensive dermatology experience has been hired to help see patients. She is assigned to work at one of the offices that would be vacant when the dermatologist is working elsewhere.

Case 3 A patient calls requesting to speak with Dr. Smith. The receptionist explains that Dr. Smith is actually Mr. Smith, the physician assistant. The patient becomes agitated and explains that she had been under the impression that Mr. Smith was actually a physician since he wears a white coat and saw her independently.

Discussion Recent studies document significant wait times for new patient dermatology appointments. While there is significant geographic variability, the mean wait time for patients with Medicare or private insurance was 37 days (50 days for Medicaid) [1]. Even patients with changing moles—perceived to be a much more urgent indication— experienced mean wait times of 38 days [2]. While it is difficult to precisely define appropriate wait times, at least one study revealed that dermatologists perceive wait times to see a dermatologist as too long [3]. Given the perception of prolonged wait times and the limited supply of new dermatologists, many practices now incorporate physician extenders. A 2007

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practice profile survey by the American Academy of dermatology revealed that 29.6% of responding dermatologists reported employing a PA or NP. Furthermore, 36.2% of respondents planned to hire a physician extender by 2010 [4]. Training for dermatology extenders varies considerably. Physician assistants (PAs) typically complete a 24–32-month-long training program following four years of college and some health care experience. Graduates of accredited programs may complete a national certifying exam, and must earn 100 h of CME every 2 years [5]. According to the Society of Dermatology Physician Assistants (SDPA), “most dermatology PAs are trained by their supervising dermatologist.” There are currently two dermatology PA residency programs in the US. The SDPA has over 1200 members [6]. Nurse practitioners receive graduate training, sometimes master’s degrees or doctorates, beyond their registered nurse preparation. Over 325 colleges and universities in the US train approximately 8,000 nurse practitioners annually [7]. Certification as a dermatology certified nurse practitioner requires a collaborative agreement with a board-certified dermatologist, a master’s degree in nursing, a minimum of 3,000 h of general dermatology practice with current practice in dermatology, and completion of a written examination [8]. Just as the training for nurse practitioners and physician assistants differs, so too do guidelines for scope of practice and supervision. The SDPA Position Paper on Physician Supervision stipulates the following: The physician is ultimately responsible for coordinating and managing the care of the patient … the physician must be available for consultation with the physician assistant at all times, either in person or through appropriate electronic means. [6]

By contrast, nurse practitioners are trained to practice independently unless otherwise governed by state regulation. Some states may require that nurse practitioners practice collaboratively with physicians. Generally, the dermatology nurse practitioner’s responsibility is to “evaluate the individual patient’s needs and provide the most appropriate care or referral as indicated [8].” The requirement for physician supervision and ultimate responsibility is notably absent from the Scope of Practice for the Nurse Practitioner in Dermatology standards. The American Academy of Dermatology (AAD) provides some guidance on the appropriate use of physician

extenders in its position statement titled The Practice of Dermatology: Protecting and Preserving Patient Safety and Quality Care. This document acknowledges that a team approach involving physician extenders is sometimes required. This position statement further recommends that all team members have adequate training, experience, and licensure for their activities, and that the physician also provide on-site supervision. It goes on to explain: “The optimum degree of dermatologic care is delivered when a dermatologist, as defined here, provides direct, on-site supervision to all non-dermatologist personnel” [9]. Furthermore, the position statement recommends that dermatologists perform initial evaluations for new problems. The statement reads: “When practicing in a dermatological setting, these licensed professionals should only perform delegated services after a patient receives an initial evaluation, diagnosis and treatment plan from a dermatologist” [9]. Accordingly, the AAD’s guidelines for physician extenders are both more explicit and stringent than those adopted by the Society for Dermatology Physician Assistants and Dermatology Nurses’ Association. The AAD guidelines reflect respect for basic bioethical principles including beneficence, non-maleficence, justice, and autonomy. Employing physician extenders furthers the principle of justice by facilitating timely expert dermatologic evaluation and care. Safeguards such as the requirement that the dermatologist provide the initial evaluation, diagnosis, and treatment plan, as well as subsequently provide on-site supervision support beneficence and non-maleficence. The patient’s primary care plan is determined by the individual most expert in the care of skin disease. Furthermore, respect for patient autonomy requires that patients be informed of the qualifications and role of all members of the treatment team, including the physician extenders. Survey data reveals, however, that few practices embrace the American Academy of Dermatology’s guidelines for employing physician extenders. Off-site supervision of physician extenders is common with 31% of surveyed respondents reporting off-site supervision 10% or more of the time [4]. Additionally, a majority of physicians allowed their physician extenders to see new patients (77%) or established patients with new problems (85%) [4]. Dermatologists’ lack of on-site supervision and willingness to allow extenders to evaluate new problems both contrast with the AAD’s position statement addressing physician extenders.

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The Extender Is In: Delegating Ethically

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Analysis of Case Scenarios

Case 2

Case 1

This case involves a scenario that is common in practices with multiple sites, often requiring the physician extender to work without a physician supervisor in close proximity. Not every physician extender will require the same degree of supervision. By design, physician assistants are trained for a more collaborative practice than are nurse practitioners. Regardless, the current AAD position statement addressing the topic recommends on-site supervision and that the physician evaluate all patients with significant new problems. Based on survey data, most dermatologists do not follow these recommendations. The most appropriate ethical approach is not obvious. Some problems—an additional wart on a patient who has previously been diagnosed with and treated for warts—would seem to be appropriately treated by a physician extender independently. On the other hand, what happens when the “new wart” is actually a keratoacanthoma or amelanotic melanoma that is misdiagnosed and inappropriately treated because it has not been evaluated by the supervising dermatologist? Despite clear evidence that most dermatologists do not follow the AAD recommendations, immediate on-site supervision seems to be a prudent approach to ensuring patient safety and appropriate physician extender support. None of the professional codes of the AAD, SDPA, or DNA provide clear guidelines for the appropriate scope of practice for dermatology physician extenders. The dermatologist assumes responsibility for the physician extender, but lacks clear guidelines for what constitutes appropriate supervision. The degree of supervision should depend on the extender’s previous training, experience, and the nature of his or her responsibilities within the practice. At least in theory, physician extenders could even interpret dermatopathology slides and perform Mohs surgery, as long as they are appropriately trained and supervised. Real time on-site supervision is essential to avoid potential pitfalls of seemingly simple procedures and clinical evaluations. For example, strong knowledge of anatomy, including nearby vessels and nerves, is critical for safely performing surgical procedures. Similarly, destruction of a presumed seborrheic keratosis that is actually a melanoma could be catastrophic. Respect for the principle of non-maleficence highlights the importance of carefully scrutinizing physician extender scope of practice.

Case 1 highlights the question of how a dermatology practice hiring a physician extender ensures that the new hire has adequate training, knowledge, and procedural skills to begin seeing patients independently. As the discussion above highlights, there are few residency-equivalent training opportunities currently available to physician extenders. Most physician extenders receive the majority of training “on the job.” Dermatologists face the difficult task of assuming the responsibility for the extender’s care and decisions, but have few objective, independent measures for assessing competence. Despite this challenge, ethical care requires supervising physicians appropriately assume this responsibility. Physicians are accountable for the care provided by themselves as well as their extenders. Satisfying the obligation to provide beneficent, high-quality care to patients therefore translates into a positive duty to assess, train, and continually reassess physician extenders. There are several reasonable steps to help ensure appropriate care. Close supervision early on in the relationship will both guarantee adequate learning opportunities for the extender as well as provide opportunities for continual assessment of the extender’s judgment and knowledge base. Supporting formal education opportunities, such as attendance at local and national dermatology conferences, can enhance training. In addition to providing opportunities for learning, periodic assessments are also essential. These will allow identifying knowledge gaps and opportunities for improvement. While the Society for Dermatology Physician Assistants and the Dermatology Nurses’ Association offer some guidance on dermatology physician extender education, the supervising dermatologist holds ultimate responsibility for appropriate training and experience. In Case 1, practice members have allowed economic factors to compromise their judgment on when the physician’s assistant should be allowed to see patients independently. The physicians have a duty to their patients to ensure that they have personally assessed that person’s skills and knowledge, have properly oriented the PA to the practice’s methods, and have made appropriate plans for supervision. Ensuring that the physician extender is adequately trained and sufficiently skilled to begin seeing patients should be considered part of the cost of hiring one.

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Case 3 Case 3 presents a common scenario in which patients often assume that physician extenders are physicians and may even address them as such. In addition to ensuring physician extenders are adequately trained and supervised, dermatologists need to also ensure that their patients are appropriately informed of extenders’ qualifications. Respect for autonomy as well as beneficence requires accurately informing patients who is delivering their medical care. In Florida, for example, this requirement is actually legislated. The TIME bill (Truth in Medical Education) requires providers to identify their degrees prior to patient visits [10]. In addition, if a patient addresses a PA or NP as doctor, it is the provider’s responsibility to advise the patient that they are not the doctor. The patients, however, rarely are aware that dermatology requires four years of post-graduate training after medical school. There is a difficult balance when one hopes that the patient has a level of confidence in the extender’s skills but still is not misled. The situation is somewhat more complex when the PA or NP has a doctorate. Should this type of physician extender be addressed as “doctor?” Clearly, addressing a physician extender with a PhD in economics as a doctor in a clinic setting would be misleading and inappropriate. The proper approach when a PA or NP has a clinical doctorate is less clear. All fundamental ethical principles require not only that physician extenders are appropriately trained to deliver care, but also that their patients are adequately informed of the caregivers’ training. In Case 3, it is the obligation of the practice to inform patients of this information when they schedule their appointments and when they check in. In addition, the extender’s title should be clearly marked on an identification badge or lab coat.

Conclusions An increasing number of physician extenders are joining dermatology practices. These providers may increase patient access and help optimize physician

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use of time. Their involvement in dermatology, however, raises important ethical concerns regarding education, supervision, and scope of practice. While the AAD provides some guidance on appropriate participation of physician extenders, survey data indicates these guidelines have been largely ignored. Dermatologists supervising physician extenders assume responsibility for the care provided. The importance of this responsibility cannot be understated. As the supervising physician, the dermatologist must ensure that care delivered by the physician extender adheres to basic principles of bioethics just as that delivered by the dermatologist him- or herself.

References 1. Resneck Jr J, Pletcher MJ, Lozano N. Medicare, Medicaid, and access to dermatologists: the effect of patient insurance on appointment access and wait times. J Am Acad Dermatol. 2004;50:85–92. 2. Tsang MW, Resneck Jr JS. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006;55:54–8. 3. Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer Jr AB, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001;137:1303–7. doi:1303. 4. Resneck Jr JS, Kimball AB. Who else is providing care in dermatology practices? Trends in the use of nonphysician clinicians. J Am Acad Dermatol. 2008;58:211–6. 5. www.aapa.org. Accessed 4 Oct 2010. 6. www.dermpa.org. Accessed 4 Oct 2010. 7. www.aanp.org. Accessed 4 Oct 2010. 8. www.dnanurse.org. Accessed 4 Oct 2010. 9. www.aad.org/forms/policies/Uploads/PS/PS%20-%20 Practice%20of%20Dermatology%20Protecting%20 and%20Preserving%20Patient%20Safety%20and%20 Quality%20Care.pdf. Accessed 26 Feb 2011. 10. http://www.acponline.org/about_acp/chapters/fl/ practicelaws_06.htm. Accessed 4 Oct 2010.

Part II Dermatologist as Professional

Professional Boundaries: Safeguarding the Physician–Patient Relationship

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Brandon H. Krupp

The most basic human boundary is between our skin and the rest of the universe. One might argue that the dermatologist, in his or her special focus on the body’s largest organ, is faced most clearly and obviously with boundary issues in every patient encounter. However, the concept of boundaries in medicine has come to include not just issues around touching skin, but also more subtle concepts involving the doctor–patient alliance, personal relationships in and out of the office, interactions with pharmaceutical company salespersons, expectations from patients, the handling of fees, the giving and receiving of gifts, and the supervision of employees, medical students, dermatology trainees [1–3]. As if this was not challenging enough, the definition of “boundary” and what constitutes a “boundary crossing” as opposed to a “boundary violation” is not always universally understood. Understanding boundaries is vitally important for the practicing dermatologist and an awareness of where to draw appropriate personal and professional boundaries has never been more critical.

Case 1 Dr. T is a single practicing dermatologist in a relatively small community that borders the one in which he grew up. He has been treating a young woman for severe eczema for many months. He noticed at her first visit that she was attractive and while caring for her, he has become aware that they have similar interests and she has a good sense of humor. With each visit, their interactions contain more social conversation and playfulness. He finds that the time taken after the consultation to “say goodbye” is growing. While his custom is to call his patients by their surnames, Dr. T has begun using the patient’s first name and has suggested that she call him by his first name, too. Recently, the treatment has begun to work and the patient is very pleased that her skin is clearing. She makes reference to “being able to wear that bikini again.” She says that she wants to send her mother to see him as well for a problem similar to the patient’s. At the end of their last session, she spontaneously gives him a hug and kiss on the cheek for “being such a great doctor”. Dr. T is considering asking her out for a date.

Case 2

B.H. Krupp Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

Dr. P has been treating Mr. W for severe psoriasis. The relationship is professional. Mr. W runs a successful asset management firm on Wall Street. Dr. P’s son graduated from college but has not been able to find a job due to the economic downturn. At his last office visit, Dr. P asks Mr. W if he would consider hiring Dr. P’s son or giving him a paid internship in his firm.

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Case 3 Dr. N is a dermatologic surgeon in a large metropolitan area who has treated Mrs. J for several basal cell carcinomas in the past. She returns for a follow-up examination and mentions that her mother was recently diagnosed with leukemia. In response, she has decided to train for a marathon to raise money for the Leukemia and Lymphoma Society. She asks if he would be interested in supporting her with a contribution.

Discussion Framing the Issue No system of moral decision-making lays out “rules” for every situation without exceptions [4]. Rather, our ethical principles are created to a large extent from what has been called our society’s “considered moral judgments.” That is, our shared beliefs about what is good or what ought to be done evolve over time and come from the interplay between our moral and philosophical reflection and real-world empiric facts [5]. Bioethics demonstrates the connection between moral values and medical decision-making [6]. The evolution of professional ethics in medicine has yielded a set of four principles central to the practice of medicine: patient autonomy, beneficence, non-maleficence and justice [4]. Physicians are expected, whenever possible, to apply these principles simultaneously, and to do so in a fair and balanced way with regard to resources and risks [4, 7]. Of course, sometimes a physician cannot respect all of these principles simultaneously. A physician must often decide between competing moral obligations and choose which obligation may outweigh another in a particular situation [4]. In the end, what a physician “ought” to do is guided by what he or she ought to do “all things considered.” [8] Professional boundaries have shifted over time. These are codified by licensing boards and professional societies, thereby affirming the ethical underpinnings of medical practice, Professional codes of ethics are constantly evolving to reflect current moral standards, the changing physician-patient relationship, and societal expectations. Such codes often focus on promoting virtuous behavior thought to be part of an organization’s mission and historical foundations,

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though they may also forbid behavior once deemed tolerable by society [9].

Boundaries The Oxford English Dictionary defines boundary as “a thing which serves to mark the limits of something; the limit itself, a dividing line” [10]. Unfortunately, in medicine, the lines defining socalled professional boundaries are not always bright. Most commonly, professional boundaries in the medical setting establish the limits of a fiduciary relationship in which the patient receives medical care (services) from the physician in return for financial remuneration (fees). These limits imply respect for the patient and his or her autonomy and welfare as well as some professional distance between the physician and the patient [2]. Boundaries in the doctor–patient relationship are an important component of the delivery of medical care in that they establish a safe atmosphere free from exploitation [11] and one which promotes respect for the patient [2]. Maintaining a professional atmosphere is essential for delivering optimal care [12]. Poor understanding of the existence and importance of such professional boundaries may lead to transgressions and violations [13]. A boundary crossing can be thought of as behavior that is a departure from one’s usual practice and which oversteps the line between professional and non-professional interaction. Boundary crossings are usually not hurtful to the patient, and while they are often early warning signs for more serious behavior, they can sometimes even facilitate treatment. A boundary violation is behavior that not only transgresses this line but also causes (or could cause) harm to the patient and which seriously disrupts the physician-patient alliance [2, 14]. Not every boundary crossing will lead to a boundary violation. Boundary violations may occur when physicians begin to focus on gratifying their own needs (consciously or unconsciously) rather than those of their patients [15]. In the physician-patient dyad, the physician is the one with the professional code and legal standards to follow; the responsibility for setting and maintaining clear, appropriate professional boundaries is his or hers [16].

11 Professional Boundaries: Safeguarding the Physician–Patient Relationship

Analysis of Cases Case 1 Personal relationships can be difficult to navigate at times. Physicians have the same desire for intimacy and companionship that anyone else has. It is difficult to consistently “turn off” one’s emotions or feelings for patients, whether they are negative or positive. It is not uncommon for physicians to experience attraction to a patient who may be physically appealing or charming or with whom the physician shares some interest. The prohibition against sexual contact with a patient is well-known and long-standing. Hippocrates recognized the problems inherent in a sexual relationship with patients, particularly an erosion of the trust patients must have in their physicians [17]. Physicians must be consistently aware that their education, knowledge base, and skill set as well as their socioeconomic standing in the community create an inherent power differential in the patient-physician relationship [18, 19]. In the case above, Dr. T appears initially to be professional and appropriate in his relationship with his patient. Noticing her attractiveness and sharing humorous moments are not in themselves boundary violations. In the right context, the use of humor, expressing warmth or empathy, exploring common interests, and even at times, self-disclosure might be seen as boundary crossings that actually enhance the treatment relationship and promote an atmosphere of safety [20, 21]. However, when Dr. T began to notice the “postconsultation lingering,” he should have recognized that he was leaving his own consistent, well-travelled professional path. When physicians find that they act in ways that are different from their usual, routine professional behavior, this is the time for self-scrutiny. An honest, straightforward look at the change in one’s behavior or feelings toward a patient, which may include consultation with a colleague, is critical to assess the motivation behind the behavior [21]. Often the concept of the “slippery slope” is invoked [11, 17]. The idea is that inappropriate sexual relationships with patients rarely happen in a single moment, but rather after a long time and with the incursion of more and more intimate boundary crossings. Holding hands, hugging, lingering at the end of a session all may be seen as precursors to more dramatic and inappropriate sexual behavior.

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The challenge of maintaining professional boundaries can be made more difficult by the behavior of some patients, especially those with significant character pathology [22] or who suffer from addictions [13]. Some patients, especially those under stress, may turn to the physician to satisfy needs not being otherwise met appropriately by friends or loved ones. Some patients may become openly seductive or flirtatious with the physician. Furthermore, in some settings, especially rural or underserved areas, physicians may find it difficult to avoid their work lives becoming intertwined with their personal lives [23]. Not everyone subscribes to the “slippery slope” argument. Many disagree with the idea that every boundary crossing, no matter how minor, inevitably leads to a serious boundary violation [21, 24]. Some argue that a focus on concepts of boundaries in the therapeutic encounter is more important than a fixed set of rules regarding what should be done or not be done in patient encounters [25]. All behavior is contextual and consideration of the context in which a particularly concerning behavior occurs is crucial in judging whether a specific behavior has risen to the level of a boundary violation [21]. Often the less than ideal action may appear innocuous or harmless at the outset, but when part of a pattern of behavior, it may lead to “long-term corrosive consequences.” [26]. In Dr. T’s case, his early behavior can be seen as less problematic than how he behaved well into the treatment relationship. He allowed her to call him by his first name, for example, which clearly disrupted the professional distance between them and can be seen as an attempt for him to gratify his own need for emotional and romantic closeness with a woman. His later behavior only served to reinforce this position, and moved them farther from the physician-patient relationship that would focus primarily on her medical needs. It is Dr. T’s responsibility to notice the change in their interactions and begin to set limits on the romantic and personal nature of their relationship, however difficult that might be. If he is unable to restore the purely professional relationship, he should straightforwardly share his concerns with his patient and arrange to transfer her care to another physician in a timely way. Would it be possible for Dr. T to have a relationship with this woman after she is no longer his patient? The answer is “maybe.” Psychiatrists have the strictest pro-

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hibition about seeing former patients in a romantic setting: “once a patient, always a patient.” While the nature of the treatment relationship may be unique in psychiatry, it is just as difficult to shift from a professional to a personal relationship in dermatology. Even without appealing to a “slippery slope” argument (that a pattern of increasingly sexualized boundary crossings will inexorably lead to frank sexual behavior) the problem may be that by the time enough “crossings” are noticed, the treatment relationship may have already been harmed. In addition, if a physician holds the belief that his or her relationship with any patient may be quickly changed in order to allow for something personal or romantic to develop, it will be infinitely more difficult to recognize and act upon early signals that inappropriate behavior may be ahead. By the end of the vignette in Case 1, Dr. T may have already lost his objectivity in subtle ways that could have affected his care of the patient in a fashion not readily apparent. Physicians must remain aware of the power differential inherent in the doctor–patient relationship in order to avoid exploiting patients for their own gratification.

Case 2 Physicians’ fiduciary duties obligate them to place patient interests and welfare above their own. The fiduciary relationship is the cornerstone of trust in the patient-physician relationship. Medical care and treatment delivery work best when patients believe physicians work exclusively to support patient health and wellbeing. Physicians promote the welfare of their patients and expect nothing in return other than their fees. In Case 2, when Dr. P asks that his patient, Mr. W, hire his son, Dr. P is changing his role from a patientcentered one that is exclusively focused on Mr. W’s welfare to one that may be perceived by Mr. W as quid pro quo. In this case, the patient may feel obliged to acquiesce to Dr. P’s request because of the good care he has already been given by Dr. P or he may believe that future care could be suddenly and negatively affected if he doesn’t hire Dr. P’s son. A further problem would present itself should Mr. W. agree to hire Dr. P’s son: Mr. W may believe he is to expected to ignore the usual assessment process for new employees. That is, the belief may exist in

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Mr. W’s mind that Dr. P’s son should be hired without the customary evaluation, the results of which might have lead to Mr. W’s rejecting Dr. P’s son for employment. However, if Mr. W agrees to Dr. P’s request, he has been put in an awkward position, one that may leave him feeling as if his relationship with his doctor has changed for the worse. This example might have seemed less problematic if Mr. W had volunteered to provide Dr. P’s son with a position in his firm. Without the solicitation of the physician on behalf of his son, the patient’s offer might seem to relieve the physician of any concern that he “manipulated” the patient or traded on the professional relationship the physician has with him. However, in the end, the analysis leads to the same place: exploiting the doctor–patient relationship for personal gain jeopardizes the patient’s trust in the physician.

Case 3 At first glance, this example may seem very different from that involving Mr. W and Dr. P since Mrs. J is not directly benefiting from Dr. N’s donation. The issue, however, is arguably the same as in the previous case. These requests complicate the physician-patient relationship. Physicians may be put in uncomfortable positions if they feel they have to explain why they choose not to donate to a specific charity. Or, physicians may even harbor resentment towards patients if they end up donating when they do not really want to. Is it ever appropriate to donate to a patient’s favorite charity or should physicians adopt policies to avoid all such donations? Such policies would be quite reasonable and if consistently and dispassionately enforced, could help relieve the physician of feeling personally challenged by each request. In addition, patients would be less likely to feel personally rejected or denied. However, one might argue that these two cases are dissimilar enough to permit different behavior on the part of the physician in each case. In Case 2, the potential boundary violation involves action that has a direct benefit to the physician because of the action or contributions on the part of the patient and the likelihood of negatively affecting the treatment relationship and perhaps the treatment. This seems clearly a boundary violation based upon dual agency. However, in Case 3, the fact that the patient is asking for a charitable donation

11 Professional Boundaries: Safeguarding the Physician–Patient Relationship

and would not directly benefit, seems less problematic. Furthermore, one might even argue that this boundary crossing is beneficial to Mrs. J: by making a small contribution to the charity, Dr. L would be seen as quite supportive of the patient’s altruism and that training for a marathon may yield short term improvements in Mrs. J’s compliance with an exercise regimen and long term improvements in her health. It is important for the physician to consider these kinds of situations ahead of time when possible and to formulate a coherent, reasonable and consistent way of responding. Physicians should adopt policies that focus on maximizing the welfare of patients. There is no single approach that will fit every possible situation. One physician may adopt a policy of never complying with requests from patients for anything outside of the treatment relationship, whether it is a request to hire a family member or contribute to a favorite charity. Another may take a stance that allows for personal contributions on his part to charities or other beneficiaries that do not directly benefit the patient. As long as such donations are given in a consistent way, there should be relatively little danger of treating some patients preferentially.

Conclusion Boundary issues in dermatologic practice are common and can involve a variety of aspects of the doctor–patient relationship. The key ethical principles at work in the clinical setting include patient autonomy, beneficence, non-maleficence and justice; they are held as central to the practice of medicine. Boundary crossings are common in medical practice, as are, unfortunately, boundary violations. In some cases, a boundary crossing may be the right and beneficent thing to do, all things considered. The greatest harm from boundary violations occurs if they are not addressed and are allowed to continue unchecked over time [15]. There is no “one size fits all” set of behavioral rules for the physician to follow. Physicians must constantly and critically examine their behaviors and motives to ensure that they continue to promote patient well being without respect to their own interests. Sensitively addressing boundary crossings, and effectively managing boundary violations when they occur is necessary to create the optimal therapeutic environment. Patients

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should not have any reason to doubt their physicians’ undivided and uncompromising commitment to the patient’s wellbeing.

References 1. Bercovitch L, Long TP. Ethics education for dermatology residents. Clin Dermatol. 2009;27:405–10. 2. Gabbard GO, Nadelson C. Professional boundaries in the physician-patient relationship. JAMA. 1995;273:1445–9. 3. Krupp BH. Ethical issues in forensic medicine in Rhode Island. Med Health R I. 2005;88:418–20. 4. Beauchamp TL. Childress. J.F. Principles of Biomedical Ethics. New York: Oxford University Press; 2001. 5. Rawls J. A Theory of Justice. Cambridge, MA: Belknap; 1971. 6. Bayer R, Fairchild AL. The genesis of public health ethics. Bioethics. 2004;18:473–92. 7. American Medical Association Code of Ethics. 8. Ross WD. The Right and the Good. Oxford: Clarendon; 1930. 9. Appelbaum PS. A theory of ethics for forensic psychiatry. J Am Acad Psychiatry Law. 1997;25:233–47. 10. Shorter Oxford English Dictionary. Oxford: Oxford University Press; 2007. 11. Strasburger LH, Jorgenson L, Sutherland P. The prevention of psychotherapist sexual misconduct: avoiding the slippery slope. Am J Psychother. 1992;46:544–55. 12. Gutheil TG, Gabbard GO. Misuses and misunderstandings of boundary theory in clinical and regulatory settings. Am J Psychiatry. 1998;155:409–14. 13. Farber NJ, Novack DH, Silverstein J, Davis EB, Weiner J, Boyer EG. Physicians’ experiences with patients who transgress boundaries. J Gen Intern Med. 2000;15:770–5. 14. Galletly CA. Crossing professional boundaries in medicine: the slippery slope to patient sexual exploitation. Med J Aust. 2004;181:380–3. 15. Simon RI. Therapist-patient sex: from boundary violations to sexual misconduct. Psychiatr Clin North Am. 1999;22:31–47. 16. Gutheil TG. Boundaries, blackmail, and double binds: a pattern observed in malpractice consultation. J Am Acad Psychiatry Law. 2005;33:476–81. 17. Gruenberg PB. Boundary violations. Ethics primer of the American Psychiatric Association. Washington, DC: American Psychiatric Association Ethics Committee; 2001. 18. Blackshaw SL, Miller JB. Boundaries in clinical psychiatry. Am J Psychiatry. 1994;151:293; author reply 5–6. 19. Brody H. The Healer’s Power. New Haven: Yale University Press; 1992. 20. Gabbard GO. Boundary Violations. In: Bloch S, Chodoff P, Green SA, editors. Psychiatric ethics. Oxford: Oxford University Press; 1999. p. 141–60. 21. Gabbard GO. Commentary: boundaries, culture, and psychotherapy. J Am Acad Psychiatry Law. 2001;29:284–6. 22. Gutheil TG. Borderline personality disorder, boundary violations, and patient-therapist sex: medicolegal pitfalls. Am J Psychiatry. 1989;146:597–602.

66 23. Miedema B, Easley J, Fortin P, Hamilton R, Tatemichi S. Crossing boundaries: family physicians’ struggles to protect their private lives. Can Fam Physician. 2009;55:286–7, e5. 24. Blatt SJ. Commentary: the therapeutic process and professional boundary guidelines. J Am Acad Psychiatry Law. 2001;29:290–3.

B.H. Krupp 25. Kroll J. Boundary violations: a culture-bound syndrome. J Am Acad Psychiatry Law. 2001;29:274–83. 26. Kim SY. The dilemma of hidden ethical dilemmas. Acad Psychiatry. 2004;28:168–9.

Taking Care of Uncle Bob’s Rash: Should One Treat Family Members?

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Sandra Osswald

Case Scenarios

Case 4

Case 1

Your mother says she has had bad back pain for a week. She has had back pain for many years off and on. She is very busy and says she has been under a lot of stress lately and can’t afford to take any days off from work. She is tired and is so thankful that she supported you through medical school. She says that she usually needs Percocet to help her get better and to sleep and wants you to write a prescription for her. What would you do?

Your sister’s 17-year-old daughter has acne and they are not satisfied with her current dermatologist’s care. Your sister is concerned and wants you to prescribe isotretinoin. What would you do?

Case 2 Your brother calls and says that his wife, your sisterin-law, has had a groin rash for the last month that will not away and he wants you to prescribe a cream for it. What would you do?

Case 3 Your 3-year-old son has had a fever, runny nose, congestion and now sore throat for 5 days. You and your spouse have not slept for 5 days and she would like you to prescribe him some antibiotics. What would you do?

S. Osswald Division of Dermatology and Cutaneous Surgery, School of Medicine, University of Texas Health Science Center San Antonio, San Antonio, TX, USA e-mail: [email protected]

Discussion Upon licensing, physicians are rewarded with the right to treat patients on their own. But, should they treat their family members? The American Medical Association Code of Medical Ethics Opinion 8.19Self-Treatment or Treatment of Immediate Family Members states, “Physicians generally should not treat themselves or members of their immediate families. Professional objectivity may be compromised when an immediate family member or the physician is the patient; the physician’s personal feelings may unduly influence his or her professional medical judgment, thereby interfering with the care being delivered [1].” Medicare’s list of those “immediate family members” includes spouses, parents, children, siblings, stepparents, stepchildren, stepbrothers, stepsisters, childrenin-law, siblings-in-law, grandparents, grandchildren, and spouses of grandparents or grandchildren [2]. Some states, such as Iowa, may also include anyone living with the physician [3].

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It is evident that there are physicians who have treated and continue to treat their family members. La Puma et al. [2] report data from a community hospital where 465 of 691 eligible members of the medical staff responded to questions regarding when physicians treat members of their own families. In this study, 99% reported requests from family members for medical advice, diagnosis or treatment. Those who were reported as making requests included spouses (reported by 65% of the respondents), children (59%), mothers (50%), siblings (44%), fathers (43%), nieces and nephews (41%), mothers-in-law (40%) and others (24%). When asked for advice, 57% of physicians reported “almost always” providing it. In addition, 80% had diagnosed medical illnesses, 72% had performed physical examinations, 15% had acted as a family member’s primary attending physician in the hospital, and 9% had operated on a family member. Procedures were most commonly performed on parents, spouses, children and parents-inlaws. Most procedures listed did not usually require general anesthesia; many were dermatologic. The dermatologic procedures performed included removal of basal-cell carcinomas, burn debridement, cryosurgery, excision, laceration repair and nail removal. Most respondents (262/465) also reported refusing a family member’s request for diagnosis and treatment. The most common reasons were that the “clinical problem was not within the physician’s area of expertise” and “examination and follow-up might be inadequate”. Other cited reasons for refusal included “relationship too close”, “unable to be objective”, “medically not indicated”, “patient needs own doctor”, “prefer not to be involved”, “unethical”, “legal concerns” and “family conflict”. Importantly, 33% reported they had observed another physician “inappropriately involved” in a family member’s care and 22% had given in to a specific request about which they felt uncomfortable. Reagan et al. [4] queried physicians in multiple specialties regarding how frequently physicians treat their relatives, their reasons, and their level of comfort. Of the 2,014 physicians, 1,292 (64%) questionnaires were analyzed. Their results suggest that most physicians don’t treat their family members often, and are less willing to treat them as the “level of complexity, seriousness, and potential for conflict with privacy increase.” However, all forms of care have been given to family members on occasion. The most common reason was for minor prescribing for colds, flu, allergies and oral antibiotics. There were many reasons for treatment. Most responses

S. Osswald

were for convenience, but honoring a request from a relative, saving the relative money, acute emergency and pressure from a relative were also given as responses. Of those against treating relatives, comments included lack of objectivity and role conflict. According to the study authors, those who did treat their relatives appeared to be aware of the dangers and were trying to help deliver the best care possible. Most of us could probably relate stories which we feel were positive, gratifying experiences demonstrating optimal patient care in treating family members and yet also stories of involvement which were regrettable, perhaps even harmful. It could be good to have a physician as a family member to help explain difficult or complicated information and to provide support. But, everyone should realize that there are risks involved when becoming involved in the treatment of your family member, particularly if you assume their primary care. Before you consider medical care of a family member, La Puma and Priest [5] suggest the following questions. Am I trained to meet my relative’s medical needs? Am I too close to probe my relative’s intimate history and physical being and to cope with bearing bad news if need be? Can I be objective enough to not give too much, too little, or inappropriate care? Is medical involvement likely to provoke or intensify intrafamilial conflicts? Will my relatives comply more readily with medical care delivered by an unrelated physician? Will I allow the physician to whom I refer my relative to attend him or her without interference? Finally, am I willing to be accountable to my peers and to the public for this care? These questions should serve you well as you encounter situations in which you are asked to treat a family member. You should review these questions as you consider the case scenarios that follow.

Analysis of Case Scenarios Case 1 is a case where you are asked to treat your teenage niece with isotretinoin for acne. You may feel that this treatment is within your scope of practice and something you treat commonly every day. However, consider that a loss of professional objectivity in this case may influence your judgment and the options you offer. Would you worry more about facial scarring in your niece and would that influence your decision to start isotretinoin? If you prescribe isotretinoin, do you think your niece would feel comfortable refusing

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Taking Care of Uncle Bob’s Rash: Should One Treat Family Members?

treatment? Douglas [6] writes, “Ethical tenets of autonomy and informed consent are likely to be easily compromised. Family members may feel as though they are offending the physician-relative if, for example, they refuse a particular recommendation.” It might be particularly difficult for a minor child to refuse. Douglas [6] writes further, “Any patient, even a family member, then has the right to ask questions, to refuse the physician’s recommendation and to understand the consequences of his or her choices. The informed consent dialogue might very likely be nonexistent or subpar if a physician were to treat a family member.” What about the risk of pregnancy involved in prescribing isotretinoin? Do you feel comfortable asking and discussing questions about your niece’s sexual activity and what forms of contraception/birth control she will use? Will she be able to discuss this as well as any feelings of depression with you? Is it possible she may fail to disclose her feelings for fear of her mother or others in the family finding out? Will your niece be more or less apt to take the medication and follow the program as recommended by you? What if she does not get better, is not satisfied, or develops a complication? Are you ready to deal with the possible strain in the personal relationship between you and your niece, not to mention between your sister, and perhaps more of the family? Just because you can treat, should you treat? Can you objectively deliver care in the best interest of your patient? Case 2 involves treating a family member in a sensitive area. You may know your sister-in-law very well, but are you able to probe into sensitive areas of the medical history and will you perform the complete examination and evaluation necessary to be able to render a diagnosis and recommend treatment? Do you think that she may withhold history regarding sexually transmitted diseases for fear of embarrassment? The AMA Opinion 8.19 statement warns that “Physicians may fail to probe sensitive areas when taking the medical history or may fail to perform intimate parts of the physical examination. Similarly, patients may feel uncomfortable disclosing sensitive information or undergoing an intimate examination when the physician is an immediate family member [1].” Consider that your sister-in-law may refuse a full examination and still wish for you to give her treatment. Will this intimate examination be omitted or limited in scope to avoid possible discomfort or conflict? Unless you are sure that you would be able to obtain the history and

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perform the examination, documentation and follow up required in this case, you should consider referral to another qualified physician. La Puma and Priest [5] write, “Previous intimacies and discarded fantasies are lively, determinedly personal subjects. Family members may not wish to share these sensitive matters with other family members. Patients, however, may wish to share such matters with a medical advisor and may wish to avoid having them become common family knowledge”. By being her physician, are you denying her the ability to disclose all? If she does disclose some confidential information, will you be able to maintain confidentiality throughout her course? Case 3 is a common scenario involving illness in a physician’s own child. There can be loss of objectivity when one may underestimate the seriousness of the child’s illness. Fromme et al. [7] state “Pediatricians estimated that physician-parents were more likely to wait inappropriately long before taking their children to be seen.” Or in some cases, “physicians gravitate straight to the worst condition on a differential diagnosis list when it comes to family [6].” This may lead to a delay in treatment or inappropriate risk. In this case, are you outside of your specialty? The AMA Opinion 8.19 states, “When treating themselves or immediate family members, physicians may be inclined to treat problems that are beyond their expertise or training [1].” Will you do the evaluation you believe a competent pediatrician would do to determine what therapy is best? Would your wife or child object or question your judgment and feel free to refuse care from you? Finally, will you document the medical record completely? Have you ever treated your child or perhaps a niece away at college, without writing a note? Consider making sure that you are trained to deliver the necessary care and then if so, perform the proper documentation so you are accountable to your patient and your peers. Case 4 also asks if you would treat a family member with a condition that may be outside your specialty. This case goes beyond the request for a controlled substance. Will you be able to objectively assess your mother’s risk for abuse, and the possibility of drug seeking behavior? Are you willing to take that role? The AMA Opinion 8.19 states, “Except in emergencies, it is not appropriate for physicians to write prescriptions for controlled substances for themselves or immediate family members (I, II, IV)” [1]. Medical licensing boards each have regulations regarding this. It follows that physicians should make sure they review

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the policies set by their state licensing boards. For instance, Price and McIntyre [8] write that in Rhode Island, “a physician may not prescribe for a non-therapeutic purpose and there needs to be an adequate medical record justifying the use of the medication…There needs to be documentation of the history, test results, drugs prescribed or administered.” And, if the prescribed medicine is a controlled substance, there are often more requirements. They add that Rhode Island requires “history and physical examinations, treatment plan and objectives, informed consent, periodic review of plan and treatment, consultations with experts, accurate and complete records, and compliance with State and Federal Laws [8].” Are you willing to provide this adequate documentation? If not, consider that if there is a review, that you might be disciplined. One must always be wary of the potential for abuse and the perception of abuse when prescribing controlled substances to family members and you must follow State and federal DEA laws. Remember that you are accountable to your peers and public and maintain a professional standard of care. Absent a true medical emergency, you should not be writing prescriptions for controlled substances for yourself or for your family members.

S. Osswald Table 12.1 Low-, medium, high-risk involvement by physicians in the care of a close friend or family member Low risk Helping to explain medical information, such as diagnoses Suggesting the patient should see a physician Answering questions about whether the patient should see the physician Answering questions about medications Providing education, such as how to take care of a sprained ankle Helping to navigate the health care system (for example, finding the right physician) Attending medical visits At medical visits, helping to ask the right questions and interpret medical jargon Medium risk Suggesting that the patient does not need to worry about a problem or see a physician Refilling a medication prescribed by the treating physician 1 time only Suggesting over-the-counter medications High risk Prescribing a medication not being prescribed by the treating physician Prescribing a controlled substancea or psychoactive medication Ordering tests Checking results Coordinating care Making decisions without involving the treating physician or patient Performing a procedure beyond first aid Reproduced from Fromme et al. [7], with permission of the publisher a

Inappropriate prescription of controlled substances to family members may result in license suspension and may violate state law

Conclusion Proper training, complete medical evaluation, documentation and sound judgment are required when treating family members. It certainly can be rewarding to help a loved one. But, be prepared to consider whether your role is best as physician or family member. Douglas [6] writes, “Although it may seem impossible to separate ourselves from the physicians we have become, at times it may be more helpful for us to be a good spouse, parent, child, sibling, grandparent, aunt, uncle, niece, nephew, cousin or in-law to the patient rather than a physician.” Fromme et al. [7] review several personal cases and provide a useful assessment of risk for physicians to consider before they get involved in the care of a family member. Table 12.1 is adapted from their paper and may help physicians assess their risk of involvement. The higher the risk, the more there is to consider and referral to a qualified physician may be best. Unfortunately, it is not known how being related to the patient truly affects the care delivered by physician. So, each physician will have to decide on a case by case basis.

References 1. The American Medical Association Code of Ethics, Ethics Opinion 8.19. 1993. http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/code-medical-ethics/ opinion819.shtml. Accessed 28 Feb 2010. 2. La Puma J, La Stocking CB, La Voie D, Darling CA. When physicians treat members of their own families. Practices in a community hospital. N Engl J Med. 1991;325:1290–4. 3. Freeman J. On the regulatory radar screen! Prescriptions for family and for management of pain. Iowa Med J Iowa Med Soc. 2007;97:10. 4. Reagan B, Reagan P, Sinclair A. Common sense and a thick hide. Arch Fam Med. 1994;3:599–604. 5. La Puma J, Priest ER. Is there a doctor in the house? An analysis of the practice of physicians’ treating their own families. JAMA. 1992;267:1810–2. 6. Douglas, S. The American Medical News. 2009. http://www. ama-assn.org/amednews/2009/04/13/prca0413.htm . Accessed 28 Feb 2010. 7. Fromme EK, Farber NJ, Babbott SF, Pickett ME, Beasley BW. What do you do when your loved one is ill? The line between physician and family member. Ann Intern Med. 2008;149:825–9. 8. Price M, McIntyre BW. Dangers of self-prescribing and prescribing for family members. Med Health R I. 2007;90:178–81.

Peering into the Gift Horse: Is It Ethical to Accept Gifts from Patients?

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Lionel Bercovitch

Although the giving of gifts by patients to their physicians has been a long-standing and common practice, it has received scant attention in the bioethics literature in comparison to gifts to physicians from industry, and only very recently has it received attention in professional codes of ethics [1–3]. In addition, a high profile case involving the dying Beatles singer George Harrison and his radiation oncologist also brought the issue to the forefront in the press [4]. This chapter will address the question of whether and under what circumstances it is ethical for physicians to accept gifts from patients.

Case Scenarios

children by his teenage daughter in return for treating her acne for free.

Case 3 A patient offers the dermatologist and her family free use of his beachfront condominium in Florida during school vacation week.

Case 4 A wealthy grateful patient wishes to donate $100,000 to the dermatologist’s research funds to help buy muchneeded cutting-edge gene sequencing equipment.

Case 1 A patient leaves his dermatologist a pair of tickets for box seats to watch the local major league baseball team play in the World Series. The tickets are scarce and have a face value of $250 each but are being “scalped” for several times that amount.

Case 2 A father who has no medical insurance offers the dermatologist several months of free babysitting for her L. Bercovitch Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

Discussion A gift is defined as “something given voluntarily without payment in return, or to show favor to someone, or to make a gesture of assistance; present” [5]. The giver selects the gift and the recipient, in this case the physician, who must then decide whether it is appropriate to accept the gift. Gifts can be offered for several reasons. Usually, there is no secondary gain. The donor bestows the gift out of a spirit of generosity or in gratitude. Some individuals do so as a matter of course. Sometimes gifts are given to acknowledge appreciation for what is perceived by the patient as an extraordinary effort by the physician. The most common scenario is the holiday gift in which individuals present gifts to everyone who

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has served them well in the prior year from the letter carrier to the dermatologist. Such gifts are gestures of goodwill and usually do not attempt to alter the patient– doctor relationship and in addition, nothing is expected in return except perhaps a note of thanks. The motives behind gift giving, however, can be subtle and complex. A patient who is “difficult” or non-compliant may give a gift out of feelings of guilt. A gift may be an attempt by the patient to gain special favor with the physician in the hope of getting preferential treatment in the future, for example in scheduling of tests or appointments. Sometimes, this practice is culturally rooted. Resentment can arise if the expected favored treatment does not materialize, and the physician may experience either an overt or subconscious feeling of obligation to provide the patient preferential treatment. Problems may also arise if other patients perceive that the gift giver is receiving special treatment. Sometimes, extravagant gifts are made to “level the playing field” in the physician–patient relationship and transform it into a more personal one, by creating in the recipient a feeling of obligation. An ethically problematic situation arises when gifts are given in an attempt to seduce the physician. Accepting large or intimate gifts or those accompanied by evidence of seductive behavior can be perceived as a boundary violation [6]. What should a physician do when given a gift by a patient? In ordinary social settings one is expected to graciously accept a gift and acknowledge thanks. However, the social relationship between health care professionals and their patients is defined by professional boundaries that carry a different set of rules and expectations. Physicians also have a fiduciary duty to their patients. They are expected to be altruistic and to place the interests of their patients ahead of any material gain to themselves. The Canadian Medical Association Code of Ethics states that “patients should not be exploited for personal advantage” [7]. Justice demands that all patients have equal access to health care and should not be able to “jump the queue” by virtue of a gift to the care giver. However, physicians are human. Even if one is conscious of the possible motivation of the gift giver and is aware of the possibility that accepting the gift could create an obligation to reciprocate by providing preferential treatment, it may be difficult to subconsciously avoid such an ethical lapse.

L. Bercovitch

Acceptance of a gift is often in the patient’s best interest, since rejection of the gift may imply rejection of the patient. There should be little ethical concern in accepting a modest token of the patient’s gratitude or esteem, and acknowledging it with a warm thank-you. Rejecting such a gift can cause hurt feelings and damage the doctor–patient relationship. However, when are gifts no longer considered small? What about monetary gifts? A particularly troublesome situation is one in which the patient either gifts or bequeaths a large sum of money to the physician. If the patient announces it in advance, the patient should be encouraged to donate the money to a charity that is independent of the physician. If the gift or bequest is received after the patient’s death, it should be declined, particularly if it exceeds the family’s means, creates the impression of impropriety, or is likely to create family conflict [1]. Problems can arise if family members contest the will, and in at least two Canadian cases, acceptance of such a bequest led to formal discipline of a physician [8]. It is generally felt that monetary gifts for the physician’s personal use are ethically problematic and that such gifts should be designated to a charitable fund, non-profit institution, or foundation. Institutions and physicians commonly solicit donations from patients. The solicitation of patients by their physicians in the context of providing medical care can erode the trust which forms the basis of the physician– patient relationship [9, 10]. Regardless, such donations should not result in expectation of preferential treatment by the institution (although in reality, large donations and trusteeship often do). Gifts can also have a cultural basis. Prior to the breakup of the Soviet Union, it was common practice for Soviet physicians to supplement their meager government salaries with tips, gifts, and preferential access to consumer goods and services. There is extensive literature on “informal payments” (both solicited and voluntary) to health care providers in several Eastern European countries, Turkey, and Greece to ensure access to better medical facilities and surgeons and physicians, and this pervasive practice is viewed as a corrupting influence in ensuring equitable universal access to health care. Takayama describes the seasonal Japanese gift-giving traditions of oseibo and ochujen in which gifts are given to family, friends, and those who have helped or provided service to them in the prior year [11]. He also describes the custom of orei in which

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Peering into the Gift Horse: Is It Ethical to Accept Gifts from Patients?

patients or family leave a cash gift in a plain envelope prior to a surgical procedure [11]. Although this custom has not gained popularity in the US, it would run counter to contemporary North American medical ethical standards. Takayama raises the possibility that refusing gifts which are given as part of cultural tradition can be seen as an insensitive affront by the giver, but he suggests accepting only those which are appropriate and declining those gifts which are in conflict with the recipient’s ethical framework. Although not strictly gift giving, the bartering of services with patients can be problematic. If the physician is dissatisfied with the services provided by the patient in exchange for medical care or if an injury occurs while providing such services, the doctor– patient relationship can be seriously harmed [12]. Similarly, entering into business arrangements with patients is fraught with risk and can be viewed as a potential boundary violation [12, 13]. The four cases presented at the beginning of the chapter illustrate quite different ethical dilemmas. There are no hard and fast rules for dealing with these situations, and sometimes the physician has to make a decision without much time to ponder all the ethical ramifications and consequences of accepting or declining the gift. The physician is foremost bound to consider the patient’s interests in deciding how to deal with the gift and then to consider all the other ethical ramifications. It is also important to consider how best to express one’s decision and gratitude in a way that will not offend the patient, particularly if the gift cannot be accepted. Pragmatic decisions have to be made based on the situation, the patient, and the nature and value of the gift, not on abstract ethical and moral principles.

Analysis of Case Scenarios Case 1 illustrates a dilemma for the dermatologist, particularly if he or she is an avid baseball fan. This is an expensive gift and one which is a scarce commodity and in high demand. Ethical considerations aside, it is one which few baseball-loving physicians could bring themselves to decline. The physician should certainly be aware of the possible underlying motivation for the gift and should also have the insight to understand what ethical problems accepting this gift could create. Will having accepted this gift compromise the physician’s

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sense of oneself as an ethical professional? Will it affect clinical judgment in the future? How would it be viewed by the dermatologist’s colleagues? Graciously offering to pay for the tickets (or in the event this is refused, to make a donation to a favorite charity of the donor) while thanking the donor would create the impression of professionalism. If one were not going to use the tickets, they could be donated to a charity. Case 2 is a “prescription for disaster”. While not strictly a gift, bartering has much in common with gift giving. While accepting the offer may allow the physician to treat a patient in financial need while maintaining the family’s pride, problems are bound to arise if the babysitting patient is unreliable, she is unavailable when needed, resents her parent offering her services for free when she could have a paying babysitting job, or if something harmful occurs to the physician’s children while under the care of the babysitter. Similarly, the patient’s acne might not do well, and the family might not be happy with the dermatological care. Or, the patient might ultimately require isotretinoin therapy which might require substantial out of pocket expense for medication and laboratory testing that the dermatologist cannot barter. In addition, in a group practice in which expenses and income are divided among partners, bartering deprives the partners of income while leaving them to share the burden of the overhead. In this situation, it might be better to make arrangements to treat the patient for an agreed upon amount the patient’s family can afford. Case 3 is an example of an extravagant gift. While this patient is wealthy and the gift might not pose an economic hardship, gifts of this magnitude, particularly involving the use of something personal such as a home do potentially involve a boundary crossing (defined as “a departure from the usual professional relationship that does no harm” as opposed to a boundary violation, “a deviation which either exploits or harms the patient”) [14]. In addition to any ethical qualms, the dermatologist and his family might feel particularly uncomfortable about the possibility of something in the vacation home breaking during their stay, or may feel undue pressure to leave the home in more pristine condition than they found it. Regardless of the temptation to accept this magnanimous gift, it would be preferable to pay market value to rent it or better yet, to politely decline and rent through customary channels if planning travel away for school vacation. The ethical dilemma can be compounded if the

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donor’s family invites the doctor’s family to stay with them in the condominium over school vacation, particularly if they are not already social friends. Case 4 is a challenging one. It would certainly be inappropriate for the dermatologist to accept a gift of $100,000 for personal use. Brendel et al. [14] have considered a similar case in the psychiatric setting. The situation in Case 4 is much less nuanced and complex than Brendel’s hypothetical case. The gift will enhance the dermatologist’s research and enhance her professional reputation. It will also free up some research funds for other purposes. Does the gift come with “strings attached” or the expectations of preferential care? Did the dermatologist solicit the gift on behalf of the institution? Was this done in the setting of a clinical encounter? If so, did this in any way affect the physician–patient relationship or was it made under the duress of care for a particularly serious melanoma or cutaneous lymphoma, for example? If approached directly by the development office of the institution, did this is any way compromise the patient’s confidentiality? Does the donor possess the decision-making capacity to make such a gift? Decisions and strategies regarding such gifts should be made with thoughtful consultation among development officers, the physician, department chairman, and institutional administration [1, 10].

Conclusion Although there are no written rules that determine a specific value which makes accepting a gift inappropriate or when physicians should or should not accept a gift, sensible guidelines have been offered by several authors [9, 15, 16] and by the AMA Council on Ethical and Judicial Affairs [1, 3]. The sensible rules of thumb offered by Lyckholm [9] are: • Never accept personal cash gifts • Never accept intimate or extravagant gifts • Never let a gift dictate or influence treatment Brendel et al. [14] also recommend consulting with colleagues or an ethics committee if there is concern that accepting the gift might run counter to professional norms in one’s locale. Gaufberg [17] has offered excellent advice on strategies for rejecting a gift from a patient or setting limits on future gifts, which is quoted and summarized below (Table 13.1). In the end, a gift that does not pass the “sniff test”, i.e. one which would make the physician uncomfortable

L. Bercovitch Table 13.1 Strategies for rejecting a gift from a patient [17] 1. Appeal to general principles; “I appreciate your thoughtfulness but I have a general rule about not accepting gifts. The best gift for me is knowing that you are satisfied with the care provided” 2. Appeal to professional/ethical standards: “I have appreciated your generosity…but I can’t continue to accept such expensive gifs. It’s an ethical issue. I don’t want these gifts to influence me, and I don’t want my other patients to feel obligated to give me gifts” 3. Accept a gift on behalf of the entire care team 4. Suggest a donation to charity in lieu of a cash gift 5. Reassure the patient if needed, especially in cases where the patient’s culture mandates gift giving in return for medical care, that he will receive the same high standard of care whether or not he brings a gift

if one’s colleagues or other patients knew about it, or which makes one intuitively uncomfortable should be graciously declined [18].

References 1. Council on Ethical and Judiciual Affairs. Code of medical ethics of the American Medical Association. 2006–2007 ed. Chicago: American Medical Association; 2006. 2. British Medical Association. Medical ethics today. The BMA’s handbook on ethics and law. 2nd ed. London: BMJ Books; 2004. 3. Council on Ethical and Judicial Affairs of the American Medical Association. CEJA Report 4-A-03 gifts from patients to physicians. 2003. http://www.ama-assn.org/ ama1/pub/upload/mm/369/4a03.pdf. Accessed Jan 3 2010. 4. Glaberson W. Harrison estate settles suit over guitar autographed by dying Beatle. New York Times. 17 Jan 2004: Sect. 1. 5. Flexner S, editor. The Random House dictionary of the English language. 2nd ed. New York: Random House; 1987. 6. Farber NJ, Novack DH, O’Brien MK. Love, boundaries, and the patient-physician relationship. Arch Intern Med. 1997;157:2291–4. 7. Canadian Medical Association. CMA code of ethics. 2004. http://policybase.cma.ca/PolicyPDF/PD04-06.pdf. Accessed Jan 3 2010. 8. Cohen L. Patients bearing gifts can pose problems. CMAJ. 1987;136:408–9. 9. Lyckholm LJ. Should physicians accept gifts from patients? JAMA. 1998;280:1944–6. 10. Council on Ethical and Judicial Affairs of the American Medical Association. CEJA Report 7-A-04 Physician participation in soliciting gifts from patients. 2004. http://www. ama-assn.org/ama1/pub/upload/mm/369/7a04.pdf . Accessed 31 Jan 2010.

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Peering into the Gift Horse: Is It Ethical to Accept Gifts from Patients?

11. Takayama JI. Giving and receiving gifts: one perspective. West J Med. 2001;75:138–9. 12. Gabbard GO, Nadelson C. Professional boundaries in the physician-patient relationship. JAMA. 1995;273:1445–9. 13. Nadelson C, Notman MT. Boundaries in the doctor-patient relationship. Theor Med Bioeth. 2002;23:191–201. 14. Brendel DH, Chu J, Radden J, Leeper H, Pope HG, Samson J, et al. The price of a gift: an approach to receiving gifts from patients in psychiatric practice. Harv Rev Psychiatry. 2007;15(2):43–51.

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15. Weijer C. Point-counterpoint: should physicians accept gifts from their patients? No: gifts debase the true value of care. West J Med. 2001;175:77. 16. Anderek W. Point-counterpoint: should physicians accept gifts from their patients? Yes: if they are given out of beneficence or appreciation. West J Med. 2001;175:76. 17. Gaufberg E. Should physicians accept gifts from patients? Am Fam Physician. 2007;76(3):437–8. 18. AMA Council on Ethical and Judicial Affairs. Gifts from patients to physicians 2003.

The Dermatologist and Social Media: The Challenges of Friending and Tweeting

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Jennifer A. Sbicca and Stanton K. Wesson

Case 1 Venu Kirtane is a busy dermatologist in a large practice. Last month, Dr. Kirtane treated Mr. Blue, a 35 year old man, for mild psoriasis. This was Venu’s first time meeting Mr. Blue, and their brief encounter was a pleasant standard of care encounter to manage and treat Mr. Blue’s psoriasis. A month later, Mr. Blue asks Venu Kirtane to be his Facebook friend. Should Dr. Kirtane ‘friend’ one of his patients? Facebook is a Web 2.0 application (see Table 14.1) that started in 2004 as a website for college students and by 2011 has more than 500 million users of all ages [1]. Web 2.0 applications are websites in which users generate the content. Facebook, YouTube, weblogs (blogs), LinkedIn, Twitter, and StudentDoctor. net are a few examples. On Facebook profiles, people share photographs, thoughts, interests, and day-to-day activities. In the health care system, there is no limit to who uses Facebook, as patients, families, physicians, medical students, and hospitals are all on Facebook. Some patients with rare diseases use Facebook to network with those who have been similarly diagnosed, such as the Epidermolysis Bullosa Facebook page [2]. Some physicians have ‘Fan Pages’ about themselves with information about the kind of medicine they practice, public health messages, and newly available treatments [3, 4]. A new job description at some large hospitals is Social Media Manager, a person whose

J.A. Sbicca • S.K. Wesson () Division of Dermatology, University of Florida College of Medicine, Gainesville, FL, USA e-mail: [email protected]; [email protected]

role is to manage the hospital’s social media presence, use social media to communicate with patients, and teach physicians how to use social media [5]. In 2011, 719 hospitals used Facebook as part of their public marketing campaigns [6]. Thompson et al. found that Facebook use is prevalent among student doctors, as 44.5% of medical students and residents at the University of Florida have a Facebook profile [7]. Physicians who are new to Facebook often intend to use it to connect with family and friends. Likewise, many medical students and residents created their Facebook pages during high school or college as a way to connect with family and friends. When patients find their physician on Facebook, and when medical students and residents start seeing patients, is it professionally and ethically appropriate to ‘friend’ patients? If Dr. Kirtane accepts Mr. Blue as a friend on Facebook, it does not mean they are really friends and there is no expectation to make plans together or start emailing. ‘Friending’ Mr. Blue is like making a passing acquaintance. Dr. Kirtane may never directly interact with Mr. Blue online again, but they would be part of the same online network and be able to view each other’s Facebook profiles. If Dr. Kirtane is comfortable with patients viewing his Facebook profile and potentially interacting with his Facebook friends, he needs make sure his Facebook presence is the professional image he wishes to project. Professionalism is generally defined as behavior appropriate to the standard established by a given profession. Chief information officer of Children’s Hospital Boston has stated it is “probably not” appropriate for a patient to see “comments that my high school friends are talking about from 30 years ago” [8]. Content appropriate for friends and family may not be appropriate for patients.

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Table 14.1 Common Web 2.0 Jargon Web 2.0 websites

Facebook profile

Facebook page Being a ‘Fan’ Friend or friending

Facebook Wall

Tagging photos on Facebook

Untagging photos on Facebook

Twitter

On a Web 2.0 website, the user generates content and interacts with other users. Web 2.0 websites are defined in contrast to classic non-interactive websites where users passively view information displayed for them. Examples of Web 2.0 websites are: YouTube, weblogs (blogs), HealthGrades, Twitter, Yelp, and Studentdoctor.net A Facebook profile is a website people create about themselves that displays basic information about them including their name, gender, date of birth, hometown, relationship status, favorite books, high school attended, college attended, etc. A profile is also called a Facebook account Facebook pages allow persons or organizations to create a website on Facebook. Usually pages are created by businesses, institutions, musicians, physicians, foundations, etc. Users can become a fan of Facebook pages (not profiles) as a way to share information about that business or organization with their friends Most people on Facebook only allow those that they have accepted as ‘friends’ to view their profile. When users ‘friend’ someone, that means this friend is able to look at their profile, their photos, and write on their wall - and vice versa. Ex: Kim ‘friended’ John on Facebook. Users can set specific privacy settings for friends, so that certain content visible only to select friends The Wall is a public message board on which friends can write public comments on each other’s profiles. Users can restrict who can view their wall or post to their wall. Users are able to delete any messages posted to their wall Users can upload photos to Facebook and ‘tag’ their friends in these photos. When a photograph is tagged, it is linked to a user’s name and Facebook profile. Users can set specific privacy settings for photos, for example, making certain photos visible only to select friends If users do not like the picture someone has ‘tagged’ of them, they can ‘untag’ the photo. This means that their name and their profile are no longer linked to that photograph. That photograph will no longer appear when someone is looking at the user’s profile Twitter is a separate website that is not part of Facebook. However, like Facebook, it is a Web 2.0 website in which the user generates the content. Users write something quick and short (restricted to 140 characters) about what they are doing or thinking about. This is displayed on their Twitter page. The act of writing on Twitter is called ‘tweeting’

An alternative to address this is to have a separate Facebook page for his practice which allows patients to access it, although patients may voluntarily surrender some privacy in doing so. If Dr. Kirtane wants to keep his Facebook profile private and separate from his professional life, we suggest he create a Facebook page and a Facebook profile. Crotty and Mostaghimi agree, and in their 2011 article published in Annals of Internal Medicine suggest this same approach. They call creating separate public and private online personas a “dual-citizenship” approach to being a part of online social networking [9]. The Facebook page would be Dr. Kirtane’s professional presence online to connect with patients, co-workers, and physicians in a professional setting. On his Facebook page, he can share information with fans about his practice, answer basic questions, or provide dermatologic information. His Facebook profile would be a platform for self-expression, where he can

post photographs from vacations and perform social activities like connect online with members of the local camera club. We recommend that his private Facebook profile be professional so he does not inadvertently create a negative reputation and so he can safeguard private information. What if Mr. Blue was Miss Blue, a single woman who flirts with Dr. Kirtane in the office? Then, perhaps, Venu might want to consider the implications this would have on the doctor-patient relationship. Accepting Miss Blue’s friendship might make Miss Blue think that Venu is interested in a romantic relationship. In this case, being a Facebook friend of Miss. Blue might make the nature of the doctor-patient relationship ambiguous. What if Mr. Blue is 10 years old? Because he is a minor, his parents might think the interaction is inappropriate. Or, their friendship could be encouraged by parents who think Venu is a good role model for their son.

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Although Facebook friending of patients does not break any cardinal or unspoken rule of the doctor-patient relationship, some experts recommend against it [8]. The 2010 AMA Policy of Professionalism in the Use of Social Media states, “If physicians interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just, as they would in any other context” [10]. As long as Mr. Blue’s autonomy and privacy as a patient is maintained, it is ethically and legally acceptable for Dr. Kirtane to friend Mr. Blue. If Venu chooses to interact with patients on the Internet, he needs to consider the potential for Health Insurance Portability and Accountability Act (HIPAA) violations. For example, if Venu wrote on Mr. Blue’s wall, “Great seeing you today at the office! Let me know if you if you have any additional questions about your psoriasis” this well intentioned comment would be a HIPAA violation, as Dr. Kirtane publicly stated that Mr. Blue is a patient and disclosed Venu’s protected health information (PHI) by saying he has psoriasis. In addition, if Mr. Blue were to privately message Dr. Kirtane in order to discuss some aspect of his protected health information (PHI), it probably would be in the doctor’s best interest to ask Mr. Blue to come into the for further discussion instead of replying through Facebook. However, this is a gray zone, and an example of the way social media and the internet are transforming the way physicians and patients communicate. Many physician offices refill prescriptions by requests received over the phone and by email, and so it is a logical extension to accept a request by Facebook. Likewise, physicians speak to their patients over the phone, some communicate with patients by e-mail, and there are likely some that already communicate with patients on Facebook. Experts recommend communicating with patients regarding their PHI by work email [8]. Although Facebook is not an ideal place to discuss PHI, its speed and convenience appeals to many patients. We recommend that if physicians would like to communicate with patients online, they should strive to use an appropriately secured work email, but as long as patients are aware their PHI has a higher risk of being inadvertently disclosed, physicians and patients may choose to communicate using Facebook. Surgeons at the Henry Ford Hospital use Twitter to publically update interested parties about a patient’s progress in the operating room [11]. Such

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synergy of technology and rapid dissemination of information could be a promising tool for communicating with family and friends during a lengthy Mohs surgery. There are some ethical and legal hurdles, however, and HIPAA violations are a major concern. Full consent of the patient who will be tweeted about must be obtained. Twitter is public, and readers often know which hospital is tweeting. Therefore, the public could know the time, date, and location of the surgery. Depending on the content of the tweets, the public may also learn the gender and age of the patient, thus discovering the identity of the patient. Additionally, communication barriers may develop between the surgeon and the patient’s family. The family members reading the tweets may not understand what the doctor is writing, or worse, may misinterpret a benign tweet as a turn for the worse during surgery. What if an adverse event occurred during the surgery? Would the family be satisfied learning about it immediately online, where the empathy of the physician cannot be fully conveyed and the family’s questions cannot be answered? HIPAA violations and patient preferences must be considered when attempting to use social networking sites so that non-maleficence is respected. In most situations, friending a patient on Facebook is a benign action that depends on the comfort level of the physician and the patient. As long as physicians maintain a professional online demeanor and protect patient privacy, physicians can enjoy browsing their patients’ Facebook profiles and, if they choose, communicating with patients online.

Case 2 On a busy Wednesday afternoon at Imaginary University’s dermatology clinic, Julie Veniti, a PGY-2 dermatology resident, is assigned to see Angela White, an adolescent with cystic acne. Julie walks into the patient exam room to find Angela and her mother, Sarah White. Julie introduces herself, and then begins her history and physical examination of Angela. After Julie finishes the examination, Sarah asks Angela to leave the room for a moment. As Angela shuts the door, Sarah turns to Julie and says, “I think it would be best for us if we could see another doctor here at the clinic.”

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Julie clears her throat and says, “I’m sure I can find someone else to see your daughter. In the meantime, is there anything I can do to help solve the problem?” “Well, it’s just that I don’t want you setting a bad example for my daughter…you know…with all that drinking and carrying on that you do…” Embarrassed and wondering what Angela’s mother is referring to, Julie apologizes for any inconvenience and leaves the room. Wondering what Mrs. White was describing, Julie considers the possibility of some unrecalled online content. That night, Julie Veniti goes home and searches the Internet and her Facebook profile for any offending material. Julie searches for her name in Google and finds only professional information about her achievements during medical school. Julie’s Facebook profile is professional and most of the 586 photos of Julie Veniti are suitable for patients to view. Forgotten among some of the oldest photos of her on Facebook are 20 pictures from a spring break trip Julie took during her first year of medical school. That spring break, she and some of her medical school classmates went to Cabo San Lucas, Mexico, to enjoy the beach and local nightlife. This was so long ago that Julie had forgotten these photos were on Facebook. Julie’s friends ‘tagged’ Julie in some pictures at a bar, and in one of the photos, Julie is hugging a pole and pretending to lick it. When Julie sees these photos, she groans, knowing that this must be what Angela’s mother was referring to. Julie Veniti checks her Facebook settings and confirms that access to her pictures and to her profile is set for the highest levels of privacy, which means that only those who she allows, her friends, can see her profile or photos of her. A host of questions flood Julie’s mind. How did Mrs. White, whom she does not know, and whom does not have access to her Facebook account, see these pictures? What if her friend does not agree take down the photos? What kind of disciplinary action could she face for these photos? Back story: Julie Veniti is a Facebook friend of her younger cousin. Julie’s younger cousin is a close friend of Angela White. The two friends were on Julie’s cousin’s Facebook account looking at pictures of Julie, and they told Angela’s mother that they think it is “cool” that doctors drink and go to strip clubs because they saw Julie doing that.

It is a long-standing tradition for students, including medical students, to spend a night drinking as a way to

celebrate key milestones in their education. On these nights, students may become uninhibited, use profanity, and “cut loose” with their friends in other professionally questionable ways. Just because this behavior occurs in a non-professional setting and context does not make the behavior professionally acceptable. And because no medical student would dream of handing over racy photographs to patients or faculty members, these private, unprofessional activities are rarely a public issue. However, with the advent of Facebook and other similar websites, when medical students celebrate the New Year, on New Year’s Day their friends are posting Facebook photos of them celebrating and tweeting about with whom they might have shared a New Year’s Eve kiss. Behavior that was once forgotten the next morning now has new life on the Internet. In medical education, much attention has recently been given to teaching professionalism. According to the Accreditation Council for Graduate Medical Education (ACGME), professionalism is one of the six general competencies that residents must learn before graduating from residency [12]. Professionalism standards will also apply to Julie after she graduates from her residency program, as the American Medical Association (AMA) lists professionalism as one of the “standards of conduct that define the essentials of honorable behavior for the physician” [13]. Facebook blurs the lines between medical students’ professional lives and private lives, sometimes leading to an unintended extension of one’s private persona into the public sphere. In 2008, Thompson et al. found that, “some [medical student and resident Facebook] accounts displayed potentially unprofessional material” [7]. In 2009, Chretien et al. found that “60% [of US medical schools] reported incidents of students posting unprofessional online content” [14]. Thirty-eight percent of medical schools believe their professionalism policies cover online content, yet “most of these (82%) reported that the policies do not explicitly mention Internet use” [14]. There are certainly degrees of unprofessionalism and there are many examples of unprofessional online content in the medical education literature that are far worse than Julie’s photograph. Some of the most egregious unprofessional conduct by medical students and residents includes: identifying patients in blogs, showing nudity, expressing blatant racism, and depicting medical students or residents using illicit drugs [7, 14]. By comparison, one questionable photo out of over 500

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The Dermatologist and Social Media: The Challenges of Friending and Tweeting

professional photos that shows a resident pretending to lick a pole is arguably not a major concern. Julie is not directly harming patients and her actions did not occur while she was engaged in medical education or in the treatment or care for patients. Relaxing on the beach, snorkeling, and drinking margaritas at bars are acceptable, age-appropriate behavior for a medical student in her early twenties who is enjoying a break from the rigors of medical school. However, Julie is a medical resident and not a college student and what was inappropriate about this situation is that the professional distance between Julie and her patient was not maintained. Privacy settings on Facebook can help maintain this distance, but are not absolute. Student doctors and physicians need to be aware that online content may negatively affect their reputation and can undermine the public trust of physicians. A Harvard internist who wrote about the intersection of his Facebook profile and his patients noted that, “physicians, after all, are members of real-life communities and might be observed in public behaving in ways that are discordant with their professional personas. During medical training, the importance of maintaining professional distance—however much one desires to have a close, meaningful relationship with one’s patients—is taught by educators and reinforced by the use of beepers and paging services meant to shield physicians from their patients” [15]. In addition to teaching the principles of professionalism, the University of Florida College of Medicine counsels students to set their Facebook accounts to the highest security levels [16]. However, only 37.5% of University of Florida medical students and residents made their Facebook profile private [7]. While it is prudent to recommend strict privacy settings, Julie found that strict privacy settings did not prevent her patient from seeing unprofessional pictures of her. Even though Facebook maintains that their members’ Web sites are strictly private, in reality, the most private Facebook account is only as private as e-mail [17]. As with e-mail, an individual on another person’s private Facebook account can save a copy of the private material and send it to another individual or share their computer screen with others. Actions or photographs posted to the internet can stay there forever. This is the lesson we can learn from Julie’s experience. In the era of the Internet, it is both vitally important and increasingly challenging to maintain a professional persona online without revealing embarrassing or pri-

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vate information. Privacy settings on websites such as Facebook can help create this safeguard, but these settings are not complete. A good rule of thumb is: Only share things on the Internet that you would be willing to share with your fiancé(e)’s grandmother, no matter how ‘private’ you think the website is. To medical students, residents, and other professionals who endeavor to maintain a professional persona, Facebook should be perceived as a public web site, not a private forum. When Facebook is perceived as private, medical students and residents are more likely to compromise their professional personas [7, 14]. The consequences could be more than one upset patient, as deans, residency directors, and future employers can also access online content. Residency programs or employers may decide not to hire an applicant if they find unprofessional content online. Julie Veniti wondered what sort of disciplinary action she might face. Chretien et al. found that the most common form of disciplinary action taken against a medical student for unprofessional online content was an informal warning [14]. Other reported actions were formal disciplinary meetings, no action, student dismissal, temporary suspension, and remedial projects [14]. In the business world, job applicants have been rejected because a prospective employer discovered their unprofessional online content [18]. The same could easily happen to medical students applying to residency programs or physicians applying for jobs. In order to assist medical students and residents in managing their online activities, university centers need to encourage students to monitor their digital footprint for unprofessional content. We suggest the following: 1. Performing Google searches of one’s name is an easy way to quickly identify any potentially unprofessional content online, but one may be powerless to remove content or links from Google. One can pay websites such as http://www.reputation.com to help remove personal information from public databases. 2. Medical student and resident Facebook profiles should be professional. Posting unprofessional content, even if it is to a private web site, is strongly discouraged because it is likely to create a negative reputation for the individual, the institution, and erodes public trust of the medical profession. Assume that everything you post is public and stays online forever.

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3. Rather than simply “untagging” unprofessional photos, ask Facebook to remove them. Others do not have the right to post pictures of you online without your expressed approval. Facebook’s policy states that, “You will not post content or take any action on Facebook that infringes or violates someone else’s rights” [19] and that “We can remove any content or information you post on Facebook if we believe that it violates this Statement” [19]. Therefore, if Julie’s friend refuses to take down the photo of her, Julie can contact Facebook and ask them to remove the photo directly. The Internet has created the opportunity for rapid communication between physicians and millions of people. The professional distance traditionally kept between physicians and patients has grown smaller. The ease with which seemingly ‘private’ information can be spread to an unintended audience may create the appearance or reality of unprofessional images of medical students and residents. In order to ensure that inadvertent disclosure does not occur, medical schools and residency programs can educate students about what is considered professional and unprofessional online content and how to manage their online persona. Physicians and student doctors should anticipate the possibility of unintended consequences when creating an online persona and need to aggressively manage their online persona in order to ensure that a positive image is maintained.

References 1. Facebook Statistics. Facebook. 2010. http://www.facebook. com/press/info.php?statistics. Accessed 30 Jan 2011. 2. EB World- Epidermolysis Bullosa Awareness Facebook Page. http://www.facebook.com/pages/Tampa-FL/EpidermolysisBullosa/102773016506. Accessed 30 Jan 2011. 3. Dolan PL. How Facebook fan pages can connect with patients. American Medical News. 2010. http://www.amaassn.org/amednews/2010/03/15/bica0315.htm. Accessed 30,Jan 2011. 4. Mize L. A healthy medium: the art of balancing social media and health care. The Post at UF Health Science Center. April 2010:12–3.

J.A. Sbicca and S.K. Wesson 5. Cook B. Hospitals’ new specialist: social media manager. American Medical News. 2010. http://www.ama-assn.org/ amednews/2010/11/08/bisa1108.htm. Accessed 30 Jan 2011. 6. Bennett Ed. Hospital Social Network List. 2010. http://ebennett.org/hsnl/. Accessed 30 Jan 2011. 7. Thompson LA, Dawson K, Ferdig R, et al. The intersection of online social networking with medical professionalism. J Gen Intern Med. 2008;23:954–7. 8. Conaboy C. For doctors, social media a tricky case. The Boston Globe online. 2011. http://www.boston.com/ lifestyle/health/articles/2011/04/20/for_doctors_social_ media_a_tricky_case/?s_campaign=8315. Accessed 28 Apr 2011. 9. Mostaghimi A, Crotty BH. Professionalism in the digital age. Ann Intern Med. 2011;154:560–2. 10. American Medical Association. AMA Policy: Professionalism in the Use of Social Media. 2010. http://www.ama-assn.org/ ama/pub/meeting/professionalism-social-media.shtml . Accessed 30 Jan 2011. 11. Surgeons send ‘tweets’ from operating room. CNN online. 2009. http://edition.cnn.com/2009/TECH/02/17/twitter. surgery/index.html. Accessed 30 Jan 2011. 12. ACGME Outcome Project. AGME. 1999. http://www. acgme.org/outcome/comp/compMin.asp. Accessed 30 Jan 2011. 13. AMA Code of Medical Ethics, Principles of Medical Ethics. American Medical Association. 2001. http://www.ama-assn. org/ama/pub/physician-resources/medical-ethics/codemedical-ethics/principles-medical-ethics.shtml. Accessed 10 Jan 2009. 14. Chretien KC, Greysen SR, Chretien JP, et al. Online posting of unprofessional content by medical students. JAMA. 2009;302:1309–15. 15. Jain SH. Practicing medicine in the age of Facebook. N Engl J Med. 2009;361:649–51. 16. Allen W, Cheong J. “Facebook and Professionalism”. Presented at the University of Florida meeting of the Medical Education Journal Club. 2009. 17. Privacy Policy. Facebook, Inc. 2010. http://www.facebook. com/terms.php#/policy.php. Accessed 27 Apr 2009. 18. More Employers Screening Candidates via Social Networking Sites. CareerBuilder.com. 2009. http://www. careerbuilder.com/Article/CB-1337-Getting-Hired-MoreEmployers-Screening-Candidates-via-Social-Networking-S ites/?cbsid=84fc14a6f1594e8cb671ca975066c8fb318327127-J4-5&ns_siteid=ns_us_g_hr_social_networks_ ca_&ArticleID=1337&cbRecursionCnt=2. Accessed 31 Jan 2010. 19. Statement of Rights and Responsibilities. Facebook, Inc. 2010. http://www.facebook.com/terms.php?ref=pf. Accessed 31 Jan 2011.

Respecting Differences: Dermatology in a Diverse Society

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Vimal Prajapati and Benjamin Barankin

In most of the Western world, we find ourselves living in an increasingly multicultural society. As a result, encounters between ethnically, racially, culturally, and religiously diverse patients and healthcare providers have become commonplace in all areas of medicine, dermatology being no exception. This chapter will explore the ethical and professional issues that can arise from the practice of dermatology in today’s diverse society and also will address the ethical and professional obligations of the dermatologist in these sensitive, difficult to handle, and often tension-provoking situations.

Case Scenarios Case 1 A dermatologist is consulted in the emergency department to assess a Muslim woman with a painful skin rash involving the anogenital region. The patient refuses to be examined by the dermatologist because he is male, and neither her family nor friends are with her.

V. Prajapati Division of Dermatology and Cutaneous Sciences, Department of Medicine, University of Alberta, Edmonton, AB, Canada e-mail: [email protected] B. Barankin Toronto Dermatology Centre, Toronto, ON, Canada e-mail: [email protected]

Case 2 A patient with limited knowledge of the English language presents to a dermatologist’s clinic with a severe generalized rash of unknown etiology. The dermatologist would like to perform a skin biopsy. However, neither the patient nor the accompanying individual are able to fully comprehend the dermatologist’s explanation of the procedure or the consent form.

Case 3 A new patient presents to a dermatology clinic and notes that the dermatologist is dark-skinned and presumes from his name that he is Muslim. The patient then refuses to be seen stating that he does not wish to be treated by a “foreign doctor”.

Case 4 An on-call Jewish dermatologist is consulted to assess a medically-unstable elderly gentleman in the emergency department with a severe generalized rash. On physical examination, the dermatologist notes a swastika tattoo on the arm and wonders if he is obligated to treat someone he perceives to be anti-Semitic.

Case 5 A 30-year-old woman with adult-onset acne affecting the sides of her face and chin presents to a dermatology

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clinic requesting a birth control pill so she can “kill two birds with one stone” – her acne has been unresponsive to previous therapies and she is in need of a contraceptive method due to irregular menses. The dermatologist is Catholic and does not wish to prescribe the requested treatment due to moral/religious beliefs about artificial contraception.

Discussion Ethnic and racial disparities in healthcare have been well documented in both the United States and Canada [1–4]. These disparities have been shown to persist even when social determinants of health are accounted for. The possible reasons are multiple, including linguistic barriers, cultural differences leading to different degrees of trust in the patient-physician relationship, and bias and prejudice in both patients and physicians, all of which can interfere with providing optimal healthcare. Cultural and linguistic barriers are a major cause of ethnic and racial disparities in healthcare. Patients’ cultural backgrounds can impact their beliefs about the etiology and meaning of disease, willingness to seek and expectations of medical care, and adherence to physician recommendations [5–9]. An increased preference for traditional, complementary and alternative medicine therapies by certain ethnic and racial groups may also interfere with the utilization and efficacy of conventional medical treatment. Language barriers in healthcare can prevent patients from communicating with their healthcare providers regarding their symptoms and concerns, make informed consent impossible to obtain, prevent accurate diagnosis, make it difficult for patients to follow instructions and comply with treatment, and prevent patients and physicians from engaging in participatory decision making. Trust is another fundamental component of the patient-physician relationship and decreased levels of trust can be associated with negative outcomes, such as reduced patient satisfaction, poor adherence to medical advice and treatment regimens, lack of continuity of care, poorer outcomes, unwillingness to participate in research, and increased reliance on non-medical sources of information or alternative medical treatments. A higher prevalence of distrust of physicians has been observed among patients belonging to certain minority groups [10–15]; a notable example is the African-American population. Based on past events,

V. Prajapati and B. Barankin

such as medical experimentation on slaves and the Tuskegee Syphilis Study, many African-Americans are less inclined to pursue certain types of care or participate in research [16]. Increased distrust in medicine by other minorities, such as Hispanics, has also been reported [10]. Historical and contemporary conflicts between certain races or religions can substantially heighten distrust as well. Bias and prejudice on the part of the healthcare provider also contributes to the disparate treatment of minority populations [17, 18]. These attitudes and behaviors can be conscious or subconscious. When physicians inappropriately rely upon patient characteristics, such as ethnicity or race, in the setting of clinical uncertainty – for example, by making judgments about certain groups of people based on historical or personal experiences and applying these generalizations to all individuals belonging to that group – individualized health care is compromised. Physicians may be more likely to bring such judgments into the patient-physician encounter when faced with complex patient presentations, communication difficulties, time constraints, or unfamiliarity due to infrequent interactions with certain minority groups [18]. Regardless, medically relevant racial variations in disease presentation and treatment response should not be ignored. Bias and prejudice in healthcare providers leads to poor rapport with patients; misinterpretation of symptoms; inaccurate assumptions regarding patient socioeconomic status or intelligence, ability to adhere to diagnostic and treatment recommendations, or likelihood of patients to engage in high-risk behaviors. All of these can adversely affect healthcare outcomes. What are the precise ethical and professional obligations of the physician when providing care for ethnically, racially, culturally, and religiously diverse patients? According to the Canadian Medical Association (CMA) Code of Ethics, physicians “[must not] discriminate against any patient on such grounds as…national or ethnic origin,…race, [or] religion” [19]. Likewise, Principle I of the American Medical Association (AMA) Principles of Medical Ethics requires that physicians “provide competent medical care, with compassion and respect for human dignity and rights” [20]. The AMA Code of Medical Ethics also states that “physicians who offer their service to the public may not decline to accept patients because of race, color, religion, national origin,…or any other

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basis that would constitute invidious discrimination” [20] and the AMA Council on Ethical and Judicial Affairs (CEJA) adds that “the general obligation to provide care should not be contingent on the characteristics of individuals” [22]. Thus, codes of medical ethics and professionalism, as well as human rights and anti-discrimination laws, prohibit patient discrimination on the basis of ethnicity, race, or religion. Cultural competence is an emerging field that has garnered great interest in recent years as a strategy to help reduce ethnic and racial healthcare disparities. Several different conceptual models have been published in the literature. Essentially, a culturally competent healthcare system has four core requirements which help ensure provision of patient-centered care in cross-cultural situations. These are: knowledge about racial variations in disease epidemiology and therapeutic outcomes, integration of the unique cultural and religious beliefs and practices of patients into healthcare decisions, effective communication with appropriate use of language assistance services in language-discordant encounters, and avoidance of healthcare provider bias and prejudice on the basis of patient ethnicity or race [23]. There is strong evidence that cultural competence improves healthcare provider knowledge, attitudes, and skills; patient satisfaction; and exchange of information between patients and physicians [24, 25]. Future research must focus on the impact of cultural competence on patient adherence and health outcomes, as only seven studies have investigated this relationship, three showing a beneficial effect [25]. However, due to the expectation to provide care for patients from varied ethnic and racial backgrounds, cultural competence has become an absolute requirement for health care providers in today’s diverse society. In fact, the federal Office of Minority Health has developed national standards for delivering culturally and linguistically appropriate services (CLAS) in the United States [26] to which physicians can refer to ensure the provision of culturally competent care. The importance of cultural competence is also recognized by the American Board of Dermatology (ABD) and the Royal College of Physicians and Surgeons of Canada (RCPSC), which are the governing bodies for dermatology education and certification in the United States and Canada, respectively. Both the ABD and RCPSC identify cultural competence as one of the core requirements of dermatology

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training and practice. The ABD states that residents are expected to “provide care that is sensitive to each patient’s… cultural, economic, and social circumstances” and must “demonstrate respect for the dignity of patients and colleagues as persons including their culture” [27]. Likewise, the RCPSC maintains that “residents must demonstrate the requisite knowledge, skills, and attitudes for effective patientcentered care and service to a diverse population” and that the “graduate must be able to address issues of… culture, ethnicity, and ethics in a professional manner” [28]. It is evident that culture and religion can significantly influence the patient’s decision-making process, but what about physicians? Are physicians’ recommendations influenced by their own culture and religion? Can physicians refuse to provide medical services to which they have moral objections based on their culture or religion? What are the ethical and professional responsibilities of the physician toward the patient in these circumstances? Several studies have demonstrated that physicians’ religious beliefs can influence their practice of medicine [29, 30]. The most overt and controversial example that often garners significant media attention is physician refusal to provide a medical intervention due to moral objections based on religion. In these situations, there is ongoing debate about whether or not physicians are justified in allowing their own religious commitments to supersede their commitment to serve patients. There are also differences in opinion regarding the obligation of the physician to disclose the reason for the objection to the patient and the requirement to refer patients to another physician who will provide the intervention in question. Some believe that physicians have an ethical and professional obligation to ensure patient access to any legal medical intervention that is required or requested in the appropriate clinical setting. Others argue that physicians have the right to refuse counselling, referral, and services for medical interventions to which they have moral objections based on religion. The latter respects the notion of conscience, which represents an individual’s “commitment to morality” and the “activity of judging [whether previous or future actions] violates that commitment” [31]. On the issue of physician conscience, the AMA CEJA states that “physicians should not be required to violate or revoke strongly held beliefs by virtue of

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entering the medical profession” [22]. Consequently, except in emergency situations, a physician may be justified in refusing to provide a medical intervention “that is accepted widely by the medical community but incompatible with his or her religious, moral, or personal beliefs” [22]. However, as this would undermine Principles VIII and IX of the AMA Principles of Medical Ethics (which requires physicians “to regard [their] responsibility to the patient as paramount” and “support access to medical care to all [patients]”), the AMA CEJA advises that “the physician’s conscientious objection must be counter-balanced with obligations that will respect patient autonomy and ability to access medical services” [20, 32]. For this reason, if a physician refuses to provide a certain medical intervention to a patient due to moral objections based on religion, it is recommended that the physician explain the reason for the objection and facilitate referral to other physicians or healthcare facilities where the intervention can be accessed [22, 32]. Any additional discussion on the subject of the intervention that the physician chooses to become involved in – e.g., benefits and risks of the intervention– should be based on medical evidence only. The AMA CEJA reminds physicians not to “dissuade patients from pursuing a [medical intervention]” on the basis of their own religious, moral, or personal beliefs, and, according to the CMA Code of Ethics, physicians must always inform patients when “[such beliefs] may influence the recommendation or practice of any medical [intervention] that the patient needs or wants” [20, 22]. What does the law say about physician conscience? In recent years, many jurisdictions have passed laws to protect physicians who refuse to participate in medical services that are contrary to their religious beliefs. These “conscience clause” laws have sparked much debate among healthcare professionals, lawmakers, and ethicists, as well as in the media. All physicians should inquire about the specific legal concessions granted in their jurisdictions on the subject of physician conscience.

Analysis of Case Scenarios Different ethical and professional issues are brought to light by the case scenarios presented at the beginning of this chapter. We shall now consider these scenarios.

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Case 1 illustrates a situation in which the cultural and religious beliefs of a patient threaten the provision of needed medical attention. In this scenario, the patient’s refusal to be examined by an opposite-gender physician precludes the dermatologist from accurately diagnosing and managing the patient’s disease. Although this represents one of the most frustrating situations for any physician, the dermatologist in this case is ethically and professionally obligated to respect the patient’s autonomy and free choice of physician [33]. However, in providing culturally competent care, it is imperative that the dermatologist spend time discussing with the patient (in a non-judgmental manner) the reason(s) for refusing to be examined and which circumstances may permit the required examination. In this case, the intimate nature of the proposed examination challenges the Islamic concept of cross-gender modesty, which requires Muslim females to conceal their zeenah (charms, beauty, or ornaments) or awrah (areas of the body that should not be publicly exposed – i.e., genital region) in the presence of any male who is not their husband or close family member [34, 35]. Often cross-gender patient-physician encounters are permitted in emergency situations or when alternatives are not possible, but a patient’s family member or samegender medical staff should be present during the interaction [36, 37]. In this scenario, it may be permissible for the dermatologist to examine the patient in the presence of a relative or female medical staff. If the patient still refuses and is adamant about being examined by a same-gender physician only, it would be reasonable for the male dermatologist to accommodate the request by asking a female colleague to see the patient [37]. A final option would be for a female non-dermatologist physician to assess the patient and describe the findings to the dermatologist. Of course, if the patient in this scenario was critically ill or unconscious, this would preclude her free choice of physician. Case 2 is an example of a situation where language barriers compromise patient autonomy and physician beneficence. Virtually every dermatologist has come across this type of scenario. In language-discordant encounters, the preferred action is to procure a professional medical interpreter. Physicians and their support staffs should have knowledge about available interpreter services in their areas of practice. Other reasonable options for the dermatologist would include use of an untrained ad hoc interpreter (e.g., staff member) or referral to a colleague who speaks the same language as the

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patient. Frequently, patients’ family members or accompanying individuals are asked to interpret. Although this practice is often discouraged, it would be acceptable if it is the patient’s preference (despite being offered the above options), if the aforementioned options are not available (e.g., in a rural setting), or if only simple explanations and decisions have to be made (e.g., as in uncomplicated routine follow-up). The health literacy of patients can also be improved by supplying translated medical documents (e.g., information sheets for common diagnoses and treatments as well as consent forms). It is worth mentioning here that the professional and legal requirements for physicians to provide qualified interpreters in language-discordant encounters (as opposed to those whose inability to communicate is caused by deafness) is a gray area. Although both the AMA and CMA codes of ethics as well as the law emphasize the importance of ensuring effective communication with limited English proficiency (LEP) patients, neither explicitly comments on which language assistance services physicians are obliged to provide and neither mandates the use of interpreter services in all situations. Regardless, physicians should take note that successful lawsuits have been filed against those failing to provide qualified interpreters to patients in certain situations [38]. As a result, physicians must take legal considerations into account when deciding how to facilitate effective communication with LEP patients. Consequently, the use of professional medical interpreters is recommended whenever possible as this reduces the risk of misinterpretation and liability; unfortunately, in the private clinic setting (as is often the case in dermatology), this may be difficult and expensive to obtain as opposed to a larger hospital setting where such services may be readily available. Case 3 deals with the difficult scenario of handling prejudiced patients. These situations require the utmost professionalism to resolve. In this particular case, the patient refuses to interact with the dermatologist on the basis of prejudice towards Muslims or foreign-born physicians in general. There may be several reasons for the prejudice: the patient might be racist in his attitudes and beliefs; the patient might question the skills of the dermatologist due to false notions regarding the quality of physicians who are “foreign”-appearing or “foreign”-trained; or the patient’s feelings may stem from the xenophobia (or “islamophobia”) that has developed in some Western nations after the September 11, 2001 al-Qaeda terrorist attacks upon the United

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States. Unfortunately, how the dermatologist in Case 3 and other physicians should handle prejudiced patients is not specifically addressed by the AMA and CMA codes of ethics, and published medical literature on this topic is scant. Certain guiding principles can provide assistance on how best to proceed. For one, by virtue of having entered the medical field, the physician should recall that he or she is required to “respect human dignity and rights”, “respect the law”, and “uphold the standards of professionalism” [20]. The dermatologist in Case 3 should therefore remain calm and courteous at all times, and must avoid any discriminatory behavior towards the patient. Although separating what is professional from what is personal can be difficult, the dermatologist must refrain from making harsh comments in retaliation to unjust remarks made by the patient. The dermatologist can comment in an unemotional way that he finds the patient’s remarks to be offensive and that the clinic or hospital does not tolerate discrimination towards any staff member [39, 40]. Other dermatologists may prefer to remain quiet. Ultimately, the physician’s personality will dictate how he or she decides to respond. In any case, confrontation should be avoided. Secondly, healthcare providers in these scenarios must bear in mind that a patient’s free choice of physician has to be respected, even if the choice is based on characteristics of the physician, such as ethnicity and race. However, physicians ought not to walk away from such situations without trying to educate prejudiced patients. The dermatologist in Case 3 could attempt to set right any misconceptions held by the prejudiced patient, for example, by discussing his credentials and explaining his professional commitment to provide equitable, effective, and safe healthcare to all patients. Additionally, the dermatologist can direct the patient’s attention to the waiting room to demonstrate that he treats a diverse group of people. If mistaken beliefs are corrected and trust is gained in the process, it might be possible for a patient-physician relationship to be established. If such attempts prove futile, it would be appropriate to refer the patient to another physician likely to be acceptable to the patient. Proper documentation is required in all cases. Case 4 explores the issue of whether or not physicians are justified in choosing whom to serve due to moral beliefs based on religion. In this scenario, the on-call dermatologist is consulted to assess a patient with a racist tattoo, particularly offensive to the

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physician’s ethnic group and religion. As a result, the physician does not wish to enter into a therapeutic relationship with the patient who holds views that might be hostile or prejudicial toward the physician. Although the discussion to this point has focused on the importance of respecting patients’ free choice of physicians, physicians also have a right of free choice when deciding whom to serve, but there are several limitations. First, physicians cannot refuse to provide treatment for patients in emergency situations. This is similar to patients having to forgo free choice of physicians when in need of urgent care. Second, ethical, professional, and legal considerations prohibit physicians from declining to accept patients on the basis of characteristics such as ethnicity, race, or religion, as this would constitute discrimination. In fact, the AMA CEJA comments that such practice would be “unprofessional and possibly even illegal” [22]. Thirdly, physicians cannot refuse to provide care for patients if there is a pre-existing contractual agreement in place, such as being on-call. According to the AMA CEJA, “the on-call physician temporarily forfeits his or her privilege in deciding whom to serve” [22]. On the other hand, physicians would be justified in declining to care for and treat patients if treatment requests are beyond their training, invalid, or incompatible with their religious, moral, or personal beliefs. With respect to the latter, the AMA CEJA points out that the “reasons for refusal [should] not be directed at the potential patient, or characteristics of the individual [such as ethnicity, race, or religion], but rather at the treatment requested by the individual” [22]. On these grounds, it is apparent that the on-call dermatologist in Case 4 is obligated to accept the care of provide treatment for the acutely ill patient. But, what if the same dermatologist (without any pre-existing oncall requirements) was asked by a patient to treat keloid scars developing at the site of a swastika tattoo? In this instance, the dermatologist should still provide the required therapeutic intervention to the patient as there is a clear clinical indication and the treatment itself is not morally controversial. One can liken this situation to managing abscesses due to injection drug use, alcohol withdrawal seizures, and acute exacerbations of chronic obstructive pulmonary disease – despite disapproving of the patients’ “bad habits” which caused the disease, there is still an obligation to provide treatment. However, since the encounter is not an emergency and there are no on-call requirements, it might be justifiable

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for the dermatologist to refer the patient colleague if he or she cannot tolerate interacting with him. Case 5 deals with the issue of physician conscience. In this encounter, the patient asks for a treatment to which the physician has moral objections based on personal religious beliefs. Given that the particular therapy requested (oral contraception) is a very effective choice for the likely diagnosis (hormonal acne and irregular menses secondary to a hyperandrogenic state), it would be most advisable for the dermatologist to disclose the reason for the objection to the patient and refer the patient to another colleague who does not have moral qualms about providing the treatment. A patient should not be denied the best available treatment for a medical condition based on the personal values of the physician he or she happens to be referred to. In addition, providing less effective therapies in such circumstances can reduce patients’ trust in physicians. However, it should be kept in mind that the dermatologist may be legally justified in refusing to discuss, provide, and refer patients for contraception in such a scenario, depending on “conscience clauses” in the jurisdiction where he or she practices.

Conclusion In today’s diverse society, providing effective, equitable, and safe healthcare to all members of the population requires physicians and other health care professionals to be culturally competent. For dermatologists, this means that in addition to having knowledge about the inherent racial variations in the structure and function of skin, hair, and nails that produce differences in disease epidemiology and therapeutic outcomes, there must also be an effort to eliminate cultural and linguistic barriers and avoid discrimination based on ethnicity, race, and religion. These principles are crucial for strengthening patient trust in the healthcare system and for reducing healthcare disparities, an issue that warrants further investigation in dermatology.

References 1. Agency for Healthcare Research and Quality. National healthcare disparities report. Rockville: U.S. Department of Health and Human Services; 2004.

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2. Betancourt JR, King RK. Unequal treatment: the Institute of Medicine report and its public health implications. Public Health Rep. 2003;118:287–92. 3. Institute of Medicine. Unequal treatment: confronting racial and ethnic disparities in healthcare. Washington: National Academic Press; 2003. 4. Health Canada. Certain circumstances – issues in equity and responsiveness in access to health care in Canada. http:// www.hc-sc.gc.ca/hcs-sss/pubs/acces/2001-certain-equitacces/index-eng.php. Accessed 15 Apr 2010. 5. Betancourt JR, Green AR, Carrillo JE, et al. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003;118:293–302. 6. Kundhal KK, Kundhal PS. Cultural diversity: an evolving challenge to physician-patient communication. JAMA. 2003;289:94. 7. Carrillo JE, Green AR, Betancourt JR. Cross-cultural primary care: a patient-based approach. Ann Intern Med. 1999;130:829–34. 8. Einbinder LC, Schulman KA. The effect of race on the referral process for invasive cardiac procedures. Med Care Res Rev. 2000;57 Suppl 1:162–77. 9. Horner RE, Oddone E, Matcher DB. Theories explaining racial differences in the utilization of diagnostic and therapeutic procedures for cerebrovascular disease. Milbank Q. 1995;73:443–62. 10. Armstrong K, Ravenell KL, McMurphy S, et al. Racial/ethnic differences in physician distrust in the United States. Am J Public Health. 2007;97:1283–9. 11. Boulware LE, Cooper LA, Ratner LE, et al. Race and trust in the health care system. Public Health Rep. 2003;118:358–65. 12. Doescher MP, Saver BG, Franks P, et al. Racial and ethnic disparities in perceptions of physician style and trust. Arch Fam Med. 2000;9:1156–63. 13. Corbie-Smith G, Thomas SB, St George DM. Distrust, race, and research. Arch Intern Med. 2002;162:2458–63. 14. LaVeist TA, Nickerson KJ, Bowie JV. Attitudes about racism, medical mistrust, and satisfaction with care among African American and white cardiac patients. Med Care Res Rev. 2000;57 Suppl 1:146–61. 15. Corbie-Smith G, Thomas SB, Williams MV, et al. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med. 1999;14:537–46. 16. Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997; 87:1773–8. 17. Schulman KA, Berlin JA, Harless W, et al. The effect of race and sex on physicians’ recommendations for cardiac catheterization. N Engl J Med. 1999;340:618–26. 18. van Ryn M, Burke J. The effect of patient race and socioeconomic status on physicians’ perceptions of patients. Soc Sci Med. 2000;50:813–28. 19. Canadian Medical Association. CMA Code of Ethics. 2004 [cited April 15, 2010]. http://policybase.cma.ca/PolicyPDF/ PD04-06.pdf. 20. American Medical Association Code of Medical Ethics. Principles of Medical Ethics. 2001. [cited April 15, 2010]. http:// www.ama-assn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics/principles-medical-ethics.shtml.

89 21. American Medical Association Code of Medical Ethics. Opinion 9.12 – Patient-Physician Relationship: Respect for Law and Human Rights. 2008. [cited April 15, 2010]. http:// www.ama-assn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics/opinion912.shtml. 22. Council on Ethics and Judicial Affairs of the American Medical Association. CEJA report 4-A-00 potential patients: ethical considerations. 2000 [cited April 15, 2010]. http:// www.ama-assn.org/ama1/pub/upload/mm/369/ceja_4a00. pdf. 23. Lavizzo-Mourey R, Mackenzie E. Cultural competence: an essential hybrid for delivering high quality care in the 1990’s and beyond. Trans Am Clin Climatol Assoc. 1996;107: 226–38. 24. Beach MC, Price EG, Gary TL, et al. Cultural competence: a systematic review of health care provider educational interventions. Med Care. 2005;43:356–73. 25. Lie DA, Lee-Rey E, Gomez A et al. Does cultural competency training of healthy professionals improve patient outcomes? A systematic review and proposed algorithm for future research. J Gen Int Med. 2011;26:317–25. 26. The Office of Minority Health. National standards for culturally and linguistically appropriate health care: final report. Washington: U.S. Department of Health and Human Services; 2001. 27. The American Board of Dermatology, Inc. ABMS/ACGME core competencies in Dermatology. http://www.abderm.org/ residency/definition.html. Accessed 6 Sept 2010. 28. Royal College of Physicians and Surgeons of Canada. Objectives of training in Dermatology. 2009 [cited September 6, 2010]. http://rcpsc.medical.org/residency/certification/ objectives/derm_e.pdf. 29. Curlin FA, Lantos JD, Roach CJ, et al. Religious characteristics of U.S. physicians: a national survey. J Gen Intern Med. 2005;20:629–34. 30. Catlin EA, Cadge W, Ecklund EH, et al. The spiritual and religious identities, beliefs, and practices of academic pediatricians in the United States. Acad Med. 2008;83:1146–52. 31. Sulmasy DP. What is conscience and why is respect for it important? Theor Med Bioeth. 2008;29:135–49. 32. Council on Ethics and Judicial Affairs of the American Medical Association. CEJA report 6-A-07 physician objection to treatment and individual patient discrimination. 2007 [cited April 15, 2010]. http://www.ama-assn.org/ama1/pub/ upload/mm/369/ceja_6a07.pdf. 33. American Medical Association Code of Medical Ethics. Opinion 9.06 – free choice. 1977 [cited June 15, 2010]. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics/opinion906.shtml. 34. Sechzer JA. Islam and woman: where tradition meets modernity. History and interpretations of Islamic women’s status. Sex Roles. 2004;51:263–72. 35. McLean M, Al Ahbabi S, Al Ameri M, et al. Muslim women and medical students in the clinical encounter. Med Educ. 2010;44:306–15. 36. Hammoud MM, White CB, Fetters MD. Opening cultural doors: providing culturally sensitive healthcare to Arab American and American Muslim patients. Am J Obstet Gynecol. 2005;193:1307–11.

90 37. Aldeen AZ. The muslim ethical tradition and emergent medical care: an uneasy fit. Acad Emerg Med. 2007;14:277–8. 38. American Medical News. Making sure your patients know what you’re saying. 2009 [cited June 22, 2010]. http://www. ama-assn.org/amednews/2009/04/20/prsa0420.htm.

V. Prajapati and B. Barankin 39. American Medical News. How to handle a prejudiced patient. 2008 [cited June 22, 2010]. http://www.ama-assn. org/amednews/2008/03/03/prca0303.htm. 40. Easmon C. Ethical dilemma: dealing with racist patients. Commentary: isolate the problem. BMJ. 1999;318:1130.

Dermatologists Within, Beyond and Struggling with Borders: The Global Dermatologist

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Jennifer L. Weinberg

Cases Case 1 On her first day of a 3-week trip to work in a rural area of India, a visiting dermatology resident arrives to find a room packed with patients waiting to be seen for skin complaints. She cannot speak Hindi and therefore searches for someone to interpret. Unfortunately, the clinic is very busy and understaffed with no dedicated translators. She feels she cannot see the patients without someone to translate so a nurse from the obstetrics clinic is pulled to help her. During the course of seeing patients, she requires a lot of assistance in navigating the local medical system, One of the medical officers spends an entire day orienting her to the functioning of the clinic and the available resources. The local staff becomes frustrated and feels that she is taking up time and resources that they should be dedicating to treating their patients.

Case 2 A dermatologist travels to Bolivia with a team of volunteer physicians to work in a clinic set up by a nongovernmental organization in the region. She sees a patient with untreated psoriasis and prescribes some topical steroids that she has brought with her on her

trip, instructing the patient via her limited Spanish to return to the clinic in 3–4 weeks. The patient returns in a month and the dermatologist notes that the psoriasis is unchanged and there is also now what appears to be a contact dermatitis in the same area. Upon questioning the patient using a nurse interpreter, the dermatologist learns that the patient did not trust the prescribed steroids and instead went to her local traditional healer who gave her an herbal poultice to apply to the area and a traditional Bolivian folk remedy to take by mouth. The nurse comments that this is a common and acceptable practice in the region and notes that the patient will not have access to topical steroids once the dermatologist leaves in a few weeks anyway. The dermatologist is frustrated and angry with the patient and the nurse.

Case 3 A visiting dermatology resident is seeing patients in a village clinic in Honduras. He diagnoses a large basal cell carcinoma on a patient’s cheek. Even though close supervision is not available to him in the village clinic and the defect could probably be adequately closed without tissue transfer, he is excited by the opportunity to repair the wound with a large flap, since he has not yet had the opportunity to do one in his residency.

Case 4 J.L. Weinberg University of Pennsylvania School of Medicine, Philadelphia, PA, USA e-mail: [email protected]

An 18-year-old female is seen at a health clinic in Cambodia by a visiting dermatologist. She has extensive nodulocystic facial acne. Although there are some

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_16, © Springer-Verlag London Limited 2012

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difficulties in communicating due to the language difference, the local practitioner explains that the patient’s acne has not responded to previous therapy with topical treatments and systemic antibiotics. The Ministry of Health has recently placed isotretinoin on the national formulary. The dermatologist is considering starting the patient on isotretinoin but is concerned with the difficulty of communicating with the patient, potential for poor follow-up with the patient especially once the dermatologist has left Cambodia, and lack of regular access to laboratory monitoring.

Case 5 A dermatologist is volunteering in a community clinic in a rural area of Namibia for 6 weeks. He sees a patient who presents with weight loss as well as an expanding reddish-purple nodular growth on his lower right leg. The dermatologist diagnoses the lesion as Kaposi’s sarcoma and suspects that this patient has an undiagnosed HIV infection. There are no resources available in the community for laboratory diagnosis of HIV, nor would this patient be able to access antiretroviral medications or chemotherapy.

Discussion Dermatologists are confronted with news and images of international issues on a daily basis, leading to increased awareness of global health challenges. The ubiquity of these stories and global nature of modern society emphasize the reality that international conditions are closer than they may have previously appeared [1, 2]. Health is acknowledged as crucial to the development and sustainability of nations throughout the world [3]. In recent years, there has been growing awareness of global health issues and interest in participating in international health experiences in developing nations [4]. In addition, there is a growing need for dermatologists and dermatology trainees to have an understanding of the international dimensions of the burden of skin disease. The specialty of dermatology has actively embraced global health issues. The burden of skin disease globally is immense and the resources to meet such need are inadequate. The 2001 World Health Organization report on the global burden of disease indicated that skin diseases were

J.L. Weinberg

associated with annual mortality rates of 20,000 in Sub-Saharan Africa, a burden comparable to mortality rates attributed to meningitis, hepatitis B, obstructed labor, and rheumatic heart disease in the same region [5]. Despite the immense prevalence of skin disease, scarce resources, a lack of knowledgeable providers and challenging social, political and economic factors combine to create conditions in which many patients lack access to quality skin care [6–8]. With around 90% of cutaneous conditions in developing countries managed by providers with no formal dermatologic training, treatment failure rates of over 80% are common [5, 9]. Dermatologists have the potential to impact the health of many through service in the international community. They may encounter limited resources and infrastructure or political instability. They might also encounter greater focus on health care at the population level than that of the individual [10]. These dynamics shape unique ethical dilemmas which health care professionals are frequently poorly prepared to dissect and resolve, as seen in the five case vignettes.

Ethical Issues and Case Analysis As in Case 1, dermatologists often travel abroad for short periods of time, with limited knowledge of the local language, culture, practices or common illnesses and lacking skills and goals compatible with the needs of the host community. The case demonstrates how local healthcare workers, who are already overburdened, are often required to orient and assist visitors, draining limited time and energy and distracting from patient care. As this dermatology resident strives to benefit the community, she risks violating the principles of non-maleficence (“do no harm”) and justice. Because her lack of knowledge of the local culture and medical system, dealing with her needs strains the already overburdened healthcare resources of the community. This creates ethical conflicts and distracts from patient care. The potential dangers inherent in such situations have led to the suggestion that those engaging in international collaborations and research should uphold the principle of non-maleficence by ensuring that “existing disparities are not more deeply entrenched by inappropriate deflection of local human or material resources away from the healthcare system in the host country” [11, p. 826]. Visiting dermatologists have an ethical responsibility to critically evaluate their roles in

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a host community and assess whether their activities are causing unintended harm by diverting resources away from local needs. In caring for underserved populations, healthcare workers must remain acutely aware of their own biases, agendas and actions. Case 2 illustrates an example of how visiting clinicians and local patients may share different worldviews, thus complicating the doctorpatient relationship and the provision of ethical and safe care. In the case, the patient and dermatologist have differing understandings of the clinical condition and appropriate treatment, and lack sufficient communication. The clinician is accustomed to treating patients who approach health care with a Western perspective and expectations. On the other hand, the patient conceptualizes her health in a different manner, rooted in her cultural understandings. For example, in her worldview illness may result from angered spirits or imbalanced energy instead of from pathogens. Additionally, the patient lacks long-term access to pharmaceuticals such as topical steroids. In such a situation, it may be unethical and unjust to impose one’s own worldview and values upon the local population. The dermatologist in Case 2 must remain sensitive of her own presumptions and biases, and strive to treat the patient in a culturally-sensitive non-paternalistic manner. The temptation to rush in and utilize one’s wealth and power to rescue those in less resource-rich nations or less privileged positions may be great if one does not reflect on and question the true motivation and impact of one’s actions. The disparities created by social, cultural and political conditions and the mismatch between provider and patient values, may also give rise to a power imbalance between health professionals from the developed world and the patients in resource-poor settings whom they are trying to help. This mismatch can lead to misunderstandings and risks for both patients and visiting dermatologists, and the resulting inequality contributes to patients’ vulnerability to exploitation from visiting clinicians and researchers [2]. As in Case 3, residents and students working abroad may find themselves in a situation where they are expected to or have the opportunity to fulfill a role for which they are inadequately prepared or insufficiently supervised. A common misperception exists that underserved and impoverished populations will benefit from any medical care, irrespective of quality or experience level of the provider [4]. Contributing to this potentially dangerous situation,

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local health workers may not understand the level of skill of visiting trainees or the level of responsibility they are to assume, allowing or even encouraging visitors to work unsupervised or in capacities beyond their level of training. Compounding the issue, educational benefits gleaned abroad are frequently transferred to patients in the developed world as trainees return to practice in their home country. In this situation, the burden of harm from inexperienced trainees practicing their skills is placed upon indigent populations in developing nations, while most of the benefit is ultimately realized by patients in the developed world. In Case 4, cultural and language limitations, a lack of resources and available technology, and an inability to ensure consistent, long-term follow-up contribute to the complexity of the international experience. Even using a translator, there can be challenges in communication. For example, inadequately informed consent and deficient patient understanding of crucial components of care, such as the need for reliable contraception and follow-up while taking isotretinoin, can still occur. Dermatologists have a primary moral and professional obligation in all settings to maintain the trust underlying the doctor-patient relationship. In order to develop this trust, the patient must be able to depend on the clinician’s ability to assist her in making informed choices in her best interest. While the concept of informed consent is well established in developed nations and its provision called for by international ethical codes such as the Declaration of Helsinki and the Nuremberg Code, its interpretation and role may not be as clear in various international settings and different cultures [12]. When the local culture and customs of the host region are ignored in the process of procuring informed consent in developing nations, the completeness and voluntary nature of such consent may be questionable. Many factors contribute to the divide between the philosophical ideal of individual informed consent and the reality of the concept in foreign contexts. In areas where potential participants may lack formal education and literacy and are living in poverty and stressful life conditions, the concept of informed consent as conceptualized in the West may not exist in the indigenous population. Additionally, technical language utilized in informed consent documents does not exist in many languages, and the local socio-cultural conceptual frameworks around disease and healing may be incongruent with Western norms, presenting concepts

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foreign to many patients [13]. In situations such as Case 4, it may be difficult for potential participants to gain a valid understanding of the goals, risks and structure of the intervention or research, concepts which are fundamental to one’s ability to provide truly informed consent. Basic communication is crucial in all doctorpatient relationships, influencing the quality and safety of care, and may be compromised by inadequate cultural competency or an inability to directly communicate with the patient. In many resource-limited settings, advances in diagnostics, therapeutics, and technology come face-to-face with the reality of fiscal constraints, cultural barriers, and sociopolitical obstacles. Case 5 presents the paradox of having the knowledge to diagnose a life-threatening condition while lacking the resources to confirm the diagnosis, and provide proper treatment and followup care. The dermatologist in the case is able to rely on his clinical skills to recognize that this patient likely has HIV/AIDS but health inequities shape the resources available for the patient’s care. In such a situation, he must struggle with several ethical conflicts. One is the obligation to inform the patient of his suspected HIV infection in a setting in which treatment is not available. Another is the moral responsibility to inform the patient of his infection and encourage methods to prevent further transmission. On a broader scale, the case brings up the ethical issue of whether health care providers should focus their efforts on individual clinical encounters or expend efforts towards addressing underlying health inequities. Contributing to efforts to help the millions around the world living in extreme poverty and in the midst of treatable but untreated diseases addresses the core meaning of professionalism: a physician must be dedicated to caring for the patient while maintaining his own integrity and respecting human dignity and rights [14]. Physicians and physicians-intraining must combine technical and cognitive capabilities with an ethical duty to serve. As Farmer (2001) expressed, “excellence without equity” stands as a fundamental challenge to the profession [15].

Conclusion Although large numbers of clinicians and clinicians-intraining are engaged in international medical volunteerism in developing nations, the health care community has only recently begun a discussion about the ethical

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dilemmas and consequences arising within and as a result of this work. Health care workers wanting to serve abroad must be willing and able to cope with instability, unpredictability, diverse sociopolitical and cultural circumstances and complex challenges inherent in international work. Those who engage in global health experiences should undergo both adequate technical as well as cultural and language training before going abroad, including discussion of potential ethical challenges. This can include engaging in ethical analysis and providing chances for workers to discuss these dilemmas, developing ethical guidelines to assist workers in the field, forming mentoring relationships in which clinicians can discuss issues which arise in their work and learn from more experienced colleagues, and emphasizing discussion of moral and ethical issues between all stakeholders, both local community members and international aid workers [10]. Equally important as advance preparation are opportunities for clinicians and trainees to debrief upon returning home. Training in cultural competency can also enhance one’s understanding of proper professional and ethical conduct in diverse settings. Ethical dilemmas in global health are often complex and can significantly impact international health experiences. When engaging in global health experiences it is important to work within the established health care system and to help build capacity in order to create sustainable change that is sensitive to national and local priorities and policies. Educating dermatologists and dermatologists-in-training about bioethics and professionalism can enhance their awareness and understanding of ethical, socioeconomic, cultural and political factors which shape patients’ access to and utilization of skin care[14]. The global health arena presents both a challenge and an opportunity for dermatologists to clarify their professional and ethical standards.

References 1. Haq C, Rothenberg D, Gierde C, et al. New world views: preparing physicians in training for global health work. Fam Med. 2000;32:566–72. 2. Pinto A, Upshur R. Global health ethics for students. Dev World Bioeth. 2009;9:1–10. 3. Ruger JP. Health and development. Lancet. 2003;362:678. 4. Shah S, Wu T. The medical student global health experience: professionalism and ethical implications. J Med Ethics. 2008;34:375–8.

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5. Morrone A. Poverty, health and development in dermatology. Int J Dermatol. 2007;46 Suppl 2:1–9. 6. Charles M, Boyle B. Excess and access: the continuing controversy regarding HIV and health care in Africa. AIDS Read. 2002;12:288–92. 7. International Foundation for Dermatology (IFD) about IFD: who needs our help? http://www.ifd.org/about2.html. Accessed 14 Jan 2010. 8. Schmid-Grendelmeir P, Doe P, Pakenham-Walsh N. Teledermatology in sub-Saharan Africa. Curr Probl Dermatol. 2003;32:233–46. 9. Figueroa JI, Fuller LC, Abraha A, et al. The prevalence of skin disease among schoolchildren in rural Ethiopia: a preliminary assessment of dermatologic needs. Pediatr Dermatol. 1996;13:378–81. 10. Hunt M. Ethics beyond borders: how health professionals experience ethics in humanitarian assistance and development work. Dev World Bioeth. 2008;8:59–69.

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11. Benatar SR, Singer PA. A new look at international research ethics. BMJ. 2000;321:824–6. 12. Barry M. Ethical considerations of human investigation in developing countries: the AIDS dilemma. N Engl J Med. 1988;319:1083–6. 13. Buchanan D, Sifunda D, Naldoo N, James S, Reddy P. Assuring adequate protections in international health research: a principled justification and practical recommendations for the role of community oversight. Public Health Ethics. 2008;1:246–57. 14. O’Neil E. The “ethical imperative” of global health service. Virtual Mentor. 2006;8:846–50. 15. Farmer PE. The major infectious diseases in the world—to treat or not to treat? N Engl J Med. 2001;345:208–10.

Feet of Clay: The Impaired Dermatologist

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Brandon H. Krupp

Case Scenarios

Case 2

Case 1

Dr. Y is a senior Mohs surgeon on the academic service at a teaching hospital. He is considered a giant in his field, known for a variety of surgical innovations developed at that center over the years. He is personable and enjoys almost universal respect and affection from his colleagues and the program staff. In the last year, he has become noticeably stooped in his posture and slower in his gait. He seems more forgetful lately and has made mistakes in the names of some of the staff. He has developed a rhythmic 4–5 Hz tremor in his right hand. On a few occasions he has dropped an instrument during a procedure. Whenever anyone brings up the subject of retirement, he is quick to laugh and say that he will “probably go during clinic rounds one day.”

Dr. L is a senior partner in a large practice associated with an academic center and a professor of dermatology at the local medical school. Though not currently chair of the department, he has served in that role in the past. At a recent Christmas celebration for the department, he was observed to drink heavily throughout the evening. As the evening wore on, he became louder, more belligerent and began to slur his words. He was somewhat incoherent when he tried to provide a toast to the assembled group. Later, he drove himself home in his car. No one at the event confronted him or attempted to keep him from getting into his car at the end of the evening. A few days later, one of his partners tried to broach the evening’s events with Dr. L, saying that he was concerned about him. Dr. L became angry and defensive. He could not remember all the details of his behavior at the dinner, but was aware that he had “probably had a little too much” and “may have said some inopportune things.” He insisted he had just “had a good time like everyone else.” Nevertheless, he reluctantly agreed to apologize to some of his colleagues. When approached by Dr. L, they each quickly “let him off the hook,” laughing with him and dismissing his behavior as just “blowing off some steam.”

B.H. Krupp Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

Case 3 Dr. Q is a dermatologist in a private multispecialty group practice. He is considered an excellent clinician and is noted for being quick and efficient in his patient encounters and technically gifted during procedures. He is a “workhorse” as well and brings a great deal of revenue into the practice. He is generally curt and officious with patients and staff. He is also a perfectionist and can be quite impatient with staff members who do not respond quickly to his demands. He routinely shouts at staff members and has thrown both instruments and charts to emphasize his unhappiness. There is a fairly high rate of turnover among the support staff in the practice. His partners (an internist, a rheumatologist and an allergist) prefer to avoid him whenever possible and are reluctant to confront him, even when asked to do so by the staff.

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_17, © Springer-Verlag London Limited 2012

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Introduction For centuries, physicians have held a lofty, responsible and even sacred place in our world. Respected and venerated, they are expected to care for others in society in a compassionate and skillful way. Most of us have as much trust in our physicians as we have in anyone and we invite them into the most sacred part of our experience. Especially at times where one’s health concerns are literally a matter of life and death, one’s doctor can be the most powerful figure in one’s life. We have a need to see our doctors as unfailingly competent, sane, ethical and above reproach. Unfortunately, the idealized figure of the physician is a powerful one, coming not just from patients, families and society (e.g., accrediting agencies, regulators, insurance companies) but also from physicians themselves [1]. These expectations, arguably part of the fabric of medicine are internalized early on as physicians develop their professional identities and almost certainly contribute to burnout, substance abuse and dependence, and bad behavior. The practice of medicine involves stressful and demanding work, often over long hours, and frequently performed with the knowledge that one’s actions may have potentially life-changing consequences [2]. This is in addition to having to cope with the usual stressors of life outside of medicine that everyone experiences. Furthermore, medicine’s managed care environment, dwindling resources, diminished compensation, and litigious practice climate, coupled with increasing limits on physician autonomy have led to increased stress, decreased professional satisfaction and in some, disruptive behavior [3–6]. In addition, doctors are vulnerable to the same diseases, imperfections and flaws as everyone else. External demands and pressures combined with internalized high expectations have made today’s physicians especially susceptible to burnout, depression, anxiety, fatigue, cardiovascular disease, substance abuse and dependence, disability, fractured interpersonal relationships and suicide [1, 6–9].

Discussion Professionalism Few would argue with the assertion that medicine is a profession, although defining “a profession” can be rather challenging. Three features common to the

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notion of professionalism are extensive and lengthy specialized education, training that involves a significant intellectual and scholarly component, and providing a necessary and valuable contribution to society [10]. Professions often have a process of self-regulation through licensing or certification, and they commonly have organizations made up of members of the profession. There is also generally speaking a sense of autonomy in the work of the professional. While not absolute, this autonomy is important in understanding the role a professional has in society. Physicians, for example, are expected to exercise their independent clinical judgment on a regular basis, though this is expected to be done within certain, often specific, professional guidelines [10, 11]. There are some who argue that a profession has a normative feature as part of its inherent design. That is, members of a profession should be expected to behave in certain ways because they are members of that profession. Pirsig [12] has described three normative principles, including, that services should be given to those who need them, that the services should be designed in the public interest, and the profession itself should be the sole arbiter of the way in which the first two principles are accomplished. Struggling with the notion of professionalism in medicine and working to paint a picture of the virtuous and ethical physician, focused on the compassionate, just and prudent healing of patients is necessary in order to address the problem of impaired physicians. This is because a significant feature of professionalism is the idea of self-regulation. Members of a profession are given autonomy and have unique expertise. In return, they are expected to behave morally and ethically in the interests of the patient and to police their own with regard to incompetent or unethical behavior. Professional status may confer some privileges upon physicians, but this should not be seen as limitless freedom. Autonomy and collegial respect, as important as they are to the professional image of the physician, cannot come at the expense of the patient [13]. Physicians must have the humility to be honest with themselves and society about their own fallibility and the limits inherent in the art of practicing medicine [14]. A strong professional self-concept must come with the courage to consistently and consciously act in the patient’s interest in the most virtuous and principled way possible and to expect one’s colleagues to do the same. Intellectual honesty, beneficence and prudence call for not only making clinical decisions in situations

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of stress and uncertainty, but also in understanding the limits of medicine and knowing when a fellow physician’s behavior has become so impaired or compromised that he or she is no longer acting from a trust covenant in the interests of the patient. The self-policing nature of the medical profession requires that all physicians are honest with themselves and their colleagues when the behavior of a physician has become so self-interested or exploitative that it is harmful or potentially harmful to a patient. Professional self-regulation of physicians is far from perfect. Physicians find it hard to ask for help or assistance for their own health problems or don’t come to the attention of treatment providers for a variety of reasons [1, 13, 15]. Furthermore, the help they need may be hindered by the presence of a significant psychiatric illness or significant character pathology [9, 16–18]. While physicians have been very good at accepting their own advice about cigarette smoking and its risks over the last few decades (demonstrating a drop in mortality due to cardiovascular illness) [9, 19, 20] they have shown less acumen when it comes to managing stress, depression and substance abuse. Historically, licensing boards had made the assumption that oversight of physicians had been given by the government to the medical profession itself, with the evaluation of physicians and their behavior being the sole purview of state medical specialty societies. However, because medical societies have increasingly devoted their limited resources to broader political and patient advocacy agendas, their role in the enforcement and discipline of unacceptable physician behavior has become much more limited [3]. This led to the delegation of authority to medical licensing boards that have been primarily made up of physicians, although in recent years, there has been increased representation by non-physician members [21]. While one might assume that physicians on the board might be sympathetic to the plight of their colleagues who suffer from mental illness or addiction, the truth is that these physicians’ feelings about their colleagues who suffer from these disorders are reflected in the general attitude of the profession toward such problems. Physicians tend to be uncomfortable talking with patients about psychiatric disorders, mood issues or suicidal ideation so their inability to talk about it among themselves or to notice when a colleague is suffering from depression or may be suicidal is not surprising [1].

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The Scope of the Problem Physicians have an incidence of substance abuse that varies in the literature, but consistently is reported at between 10% and 15% [16, 22]. The prevalence reported in the literature varies substantially but can reach as high as 14%. Getting precise figures for the problem is difficult for a number of reasons. Physicians are concerned that their behavior could lead to disciplinary action and so are secretive about their use. Additionally, physicians may seek treatment in a secluded or private area so as to escape the attention of their colleagues or patients. Third, many physicians are simply not identified as having a problem and so are not referred to treatment [15]. A number of studies have confirmed the higher rate of physician suicide when compared to that of the general population as well as the association between depression and taking one’s life [1, 9, 23, 24]. When cause of death of physicians is looked at, suicide represents a higher proportion than one would expect. Women physicians in particular, appeared to be vulnerable to suicide [25, 26]. Specific data for the risk or incidence of suicidal ideation or behavior in dermatologists are not available, but there is no reason to suspect that dermatologists are at higher risk than their colleagues in other specialties. Issues involving substance use and mental illness can begin early in a physician’s career. Consensus panels have found that beginning as early as medical school and residency, physicians have a deplorable lack of attention to treatment for mental illness [27]. “Problem residents” exist across all programs and specialties and have the potential of threatening the functioning of a training program and can have a negative impact on the professional development of other trainees [28–30].

Intervention It wasn’t until the middle of the twentieth century that alcohol and drug addicted doctors were thought to need not just discipline, but also rehabilitation programs, and that such programs ought to be created by the individual state medical boards that licensed the physicians [18]. Relatively recently, in 1973, the AMA acknowledged as a matter of policy that physicians had an ethical duty to be aware of those colleagues whose impairment may make it impossible to “practice medicine adequately” [31]. According to the AMA’s second Principle of Medical Ethics, physicians are

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ethically obligated to report an impaired physician or one who may be “deficient in character or competence” [11]. Physicians’ concerns for colleagues led to the “impaired physician movement,” which has evolved over the last four or five decades into the widespread creation of Physicians’ Health Programs (PHPs) in all 50 states. PHPs can be a confidential resource for physicians to self-refer or for colleagues to refer one about whom they have concern. Every state has some version of a PHP and the Federation of State Physician Health Programs supports their educational and interventional activities. The Federation has a dual mission: to reach out to, treat and rehabilitate physicians who are ill and to ensure that this is done in a manner consistent with safeguarding the public [32]. This movement, which began with a focus on the assessment and treatment of physicians with primarily substance abuse problems, has relatively recently expanded to include diagnosing and treating mental illnesses such as depression, bipolar disorder and anxiety as well as addressing problem behavior. The FSPHP has also worked hard to educate physicians, hospitals and licensing boards that illness and impairment are not synonymous terms. These two concepts exist on a continuum, with illness generally occurring before impairment (often years before). This concept is important to address the tendency by some medical boards to treat all physicians who are ill as if they are also automatically impaired. It is important not to “reflexively” discipline a physician in need of treatment when there is no evidence of impairment [33]. The goal of treatment is to prevent impairment when possible, thus allowing the physician to practice and simultaneously protecting the public. Early intervention by a PHP can give physicians an opportunity to prevent the worsening of their addiction or psychiatric illness, often at a time before their difficulties become public and they suffer losses in clinical privileges, strained family relationships, discipline by a medical board and financial hardship [34]. Intervention can prevent suicide [35]. In many states, a physician reporting another physician is legally protected from civil suit [18].

may be impaired. PHPs use such assessment to identify illness and plan for its treatment. Protecting the public is the guiding value that justifies and necessitates a fitness for duty evaluation of a physician [36–38]. The assessment provides the basis of a comprehensive treatment and recovery plan that can be overseen and facilitated by the PHP. In this way, the physician gets support and does not have to be the “doctor” responsible for his or her own care. However, it has been suggested that one problem with assessing physicians has been a paucity of practice guidelines designed to address the unique clinical and other issues at work in the assessment of doctors [37]. Assessments vary as does the expertise of the evaluators [37, 39, 40]. Often there is little empirical data upon which to base conclusions drawn from the evaluation, and these conclusions may not necessarily flow from the little data that is present [39, 40]. A new American Psychiatric Association (APA) guideline addressing psychiatric fitness-for duty evaluations of physicians is thought to be a helpful contribution to the process [41], although there are limits to practice guidelines in general [37]. Often, they represent collective opinion of experts in the field, rather than being empirically based. There are also problems with universal implementation. Wettstein has noted that even with new guidelines, it is unclear what is actually done in a fitness-for-duty evaluation and it is unclear how well those reading the evaluation can judge its quality [37]. Some may even see physicians evaluating physicians as the “guild” protecting its own [13, 42]. The choice of evaluator is also critical. Those who evaluate physicians must have experience and expertise in the assessment and treatment of physicians and be objective enough and composed enough to remain focused on the evaluation in the face of what could be significant resistance and (often narcissistic) character pathology [36, 37]. A variety of tests could be useful in assessment in monitoring of physicians, though there are no clear guidelines or recommendations for these [37]. These may include psychological or neuropsychological instruments, real world skill assessments, symptom validating tests, and laboratory tests [37, 43, 44].

Assessing the Physician

Returning to Work

It is important to perform an appropriate and comprehensive assessment of physicians who are ill and who

Physicians who return to work after a period away for treatment or as a result of discipline encounter

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some unique issues involving treatment, licensure and employment, and often also face legal issues. This is where the PHP can play a significant or even pivotal role. The recovery plan, usually outlined in a recovery contract with the physician can address ongoing treatment issues, avoiding substance use, and monitoring compliance as well as ensuring steps to protect licensure. Most programs require written contracts, commonly covering a 5-year period and detailing mandatory supervision and treatment, including random urine drug screens, 12-step meeting (e.g. Alcoholics Anonymous and Narcotics Anonymous) attendance, group and individual psychotherapy and compliance with psychiatric and other medication when necessary [32, 34]. Programs must have a top-down focus on physician health and wellbeing. If hospital and medical group leadership values programs to enhance physician wellbeing, it is more likely that the current culture will change [6].

Analysis of Case Scenarios Case 1 raises a number of issues. It is not an uncommon phenomenon for a physician to witness a fellow physician behaving badly. Addressing impaired behavior in colleagues is challenging. Denial, rationalization and resistance are common in persons addicted to alcohol or drugs. In this case there were a number of opportunities for colleagues to confront Dr. L as the evening wore on. Though it seems obvious that someone should have acted to help Dr. L, one could imagine that as he became more impaired, his colleagues might have believed that confronting Dr. L would be increasingly difficult and publicly embarrassing for everyone. It is easy to see the disincentives for anyone considering intervening with Dr. L. It would take a bold individual to risk facing almost certain resistance to insist that Dr. L curtail his alcohol use, remove himself from the party or relinquish his car keys. There are difficulties in physicians confronting their colleagues about inappropriate behavior. It is difficult to report a colleague who may also be a friend. There may be concern that reporting someone or addressing it directly will inevitably lead to the fellow physician losing his job or license. Physicians may be worried that public awareness of a physician in trouble may diminish the reputation of medicine in general. There is also the understandable feeling for many that “there

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but for the grace of God go I.” There is a natural human tendency to minimize the import of certain negative behavior if one exhibits that behavior oneself. Other physicians who may participate in the “fun” of drinking or substance use may not feel that the behavior is wrong. It is much more likely that someone will abuse substances if readily available or if there is someone with whom to do so [13, 18]. However, the reluctance to refer an addicted or impaired colleague must be trumped in the end by the moral obligation we all have to ensure the well-being of patients. The use of alcohol and drugs (and the recovery from their use) can not only directly affect the physician’s cognition and performance, but the “addict behavior” of lying, secrecy and extraordinary concern for procuring and using the addictive substance can have a variety of negative impacts on his “sober” behavior as well. While the impaired colleague might argue (quite possibly truthfully) that he has “never been intoxicated” or otherwise impaired while treating a patient, the threat to patient well-being is obvious. It is unlikely that the physician’s patients will consistently get the full attention and focus necessary to ensure that he or she is indeed promoting their health and well-being. It is impossible to expect patients to protect themselves in these circumstances; it is unlikely that the patients of an addict will even be aware of the addiction of their physician, much less be able to address it. This is a collegial responsibility. Of course, the impaired physician has a primary ethical obligation to address his or her addiction, including voluntarily seeking treatment and possibly suspending practice for a time to promote patient safety. Unfortunately, the nature of addiction makes it difficult, though not impossible to examine oneself frankly and honestly and ask for help. This case is particularly challenging because it was the senior partner who behaved badly. Addressing bad behavior that is clearly the result of drinking too much alcohol in a fellow physician who is a direct supervisor or in a position of authority is dramatically more difficult. One may revere the impaired physician and find it hard to accept that he might be addicted or in need of treatment. The risk of punitive action on the part of the supervisor toward the intervening subordinate will also make many reluctant to confront the bad behavior. Further, there will be a strong unspoken tendency to want to minimize the event and allow the supervisor to save face. In this case example, even when Dr. L was persuaded to apologize to his staff for his behavior at

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the party, they were very quick to downplay the import of his actions and “let him off the hook.” This is part of the classic pattern of “enabling” that contributes to reinforcing inappropriate behavior and making it less likely that the addicted physician will see a need for treatment. In addition, it is worth noting that one might expect that persons in powerful positions would command the best care. The evidence shows that frequently the opposite is true. The so-called “VIP” patient more often than not gets worse care, in part because of the reluctance of those providing treatment to do the customary and appropriate thing for fear that it may be painful, difficult or not well received, but also because the behavior of some “VIPs” leads treatment staff to withdraw and avoid them [45]. Case 2 highlights the challenge presented to all physicians as they age: to notice when their skills have diminished to the extent that they can no longer perform consistently and safely. The Hippocratic Oath asserts that physicians should not perform actions that they are not properly trained and skilled to perform, an admonition that both the American Medical Association (AMA) and American Academy of Dermatology codes have incorporated as well [46]. Nevertheless, it is difficult for each of us to judge our own competence. Taking a keen, dispassionate look at one’s own behaviors and skills, especially if such observation may lead to limitation or cessation of practice, is extraordinarily difficult. It might be easier to notice the diminution of technical performance in a colleague, but it could be as difficult to openly and directly address it with him as to confront oneself with this reality. The confrontation is made more difficult when the colleague is likeable, has contributed a great deal to the profession and does not want to stop practicing medicine. The American physician population is aging. The American Medical Association has noted in 2006 that more than 18% of physician population was over the age of 65 [47]. While continuing to work as one becomes more senior contributes to the pool of experience, an increased knowledge base, and more resources for teaching and education, there exists the potential in this group for burnout and cognitive and physical decline [48]. There is some evidence that older physicians have a greater risk of being brought to the attention of licensing board than younger physicians. Studies have demonstrated that the longer one has been in practice, the more likely the risk of disciplinary

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action by a board, especially those in practice more than 20 years [49–51] It is not clear whether this represents a greater overall (time) exposure to the possibility of complaints and disciplinary involvement, the deterioration of the physicians’ knowledge or skills, an as yet unknown aspect of physician performance associated with age or some combination of these factors. There is a dearth of studies addressing function and performance of aging physicians when compared to the literature on those who are addicted or psychiatrically ill [52]. Limited studies have tended to focus on the cognitive impairments found in aging doctors [53]. Aging is accompanied by neurodegenerative changes in the brain and associated somatosensory and functional decline [54]. One systematic examination by Pesiah and Wilhelm of 41 aging physicians (over 60 years of age) who were presented to the New South Wales (Australia) Medical Board’s Health Committee because of “potential impairment” during the period of January 2000-January 2006 found cognitive impairment in nearly 54% of those referred (albeit a select population), with 12% demonstrating frank dementing illness. A number of neuropsychological deficits were demonstrated, including decreased auditory memory and learning abilities, poor encoding and retention in memory of novel information after a short delay, slowed information processing, problems with planning and cognitive flexibility, difficulty dealing with complex or unusual problems and a tendency to be rigid and concrete in one’s thinking. Nearly half (48.6%) of these doctors were subjects of “low level patient complaints” or poor performance in the 10 years prior to presentation to the committee. Researchers found a great deal of “work until you drop” thinking and a significant amount of denial of the impact the illness had on the physician’s career [52]. More attention to this population of physicians is needed. Given the lack of clear data and specific guidelines to know exactly when clinical performance is no longer up to par, physicians should be aware of the behavior of their colleagues who are aging. Recognizing the risk of subtle impairment does not mean that undue scrutiny is warranted, but rather physicians can be open to addressing concerns in a collegial way. A good place to start would be to make a referral to the local PHP. In this way, the process does not begin with discipline and the focus can be on getting the proper assessment before deciding if and

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how to proceed toward treatment or modifying ones practice. Additionally, the more sensitized younger physicians are to this issue, the more likely it will be that they may notice changes in their own performance as they age and be able to either ask for an evaluative assessment or recognize in a more timely way when they are no longer able to practice medicine with the same proficiency. Case 3 presents a common though vexing example of a physician who appears not to have a clear mental illness (depression, bipolar illness or the like) but has the kind of behavior that is destructive, demeaning to the work environment and, in the end, unacceptable. The so-called “disruptive physician” presents unique challenges to the model that deals with substance abuse and mental illness, all thought to be straightforward in their diagnosis and treatment. Physicians with impaired behavior are not necessarily disruptive, but frequently the two conditions coexist [55]. Physicians may use a variety of poor coping strategies, including temper tantrums, “taking it out on” subordinates or blowing up at colleagues [2]. The concept of the “disruptive physician” is relatively new. One could argue that prior to the development of this concept, physicians were thought to be so thoroughly “right” all the time that they would never be challenged. Nurses, colleagues and patients were all supposed to just “tolerate” rather than confront a badly behaving physician with the details of his or her unprofessional and inappropriate behavior. In the example above, Dr. Q. appears to be a very difficult physician with whom to work. He has a long history of disruptive behavior that centers on having his needs met and being quite intolerant of others’ mistakes. His demands can be quite dramatic and appeared to center around his need to have things his way and not to have his work day disrupted in any fashion. Dr. Q. feels quite free to express his unhappiness, especially toward people, with abusive language and threatening behavior. It would appear that he has very little insight into the inappropriateness of his behavior. However, Dr. Q. is known as a “workhorse”, one who sees a lot of patients and as a result brings a great deal of money into the practice. His office staff will be very reluctant to address his behavior with anyone. His colleagues may be reluctant as well, because of his monetary value to the practice. Inappropriate behavior begins early. Much as the presentation of psychiatric illness can begin in medical

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school, there is a significant amount of evidence that medical students who engage in problem behavior become residents who engage in problem behavior. Likewise, those physicians who have trouble managing their behavior or interacting with colleagues and staff while in training become the physicians who are disruptive once they begin their practice [56, 57]. Further, those students who are unable to identify their own weaknesses in the first half of medical school were more likely to be seen as unprofessional during the last two clinical years of training [58]. Because of the significant role of the physician in the healthcare workplace, how one handles stress can have a significant impact on the healthcare team, and ultimately on patient care and safety [2, 55]. Disruptive or impaired behavior limits the good delivery of care: it weakens communication and reduces collaboration among colleagues and staff [2, 6]. Intimidation of staff, especially subordinates, can decrease the likelihood that they will want to share any information with the physician, much less information that may be central to the physician’s management of the patient’s illness. In the end patient safety suffers [2]. The physician has an ethical obligation to address such behavior, ideally in oneself, but also in colleagues to ensure that the promotion of patient health in a professional and respectful working environment is paramount. In addition, from a consequentialist perspective, improving the interpersonal and professional behavior of the physician leads to a better work environment for all and better patient outcomes and satisfaction. It is no longer optional to address the problem physician. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), has recognized the significant and deleterious effect such problematic physicians have on the healthcare environment and the delivery of medical care. They reviewed sentinel events (defined as “unexpected occurrence(s) involving death or serious physical or psychological injury, or the risk thereof”) [59] in 2009 and found that disruptive and intimidating behavior by physicians leads to medical errors and preventable negative outcomes, while at the same time, diminishing patient satisfaction and increasing staff turnover. These data confirmed the importance of their 2001 mandate that all hospitals have policies that define inappropriate or disruptive physician behavior as well a system in place whereby all persons who come in contact with such physicians have the ability to report such behavior and to be sure

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that their concerns will be taken seriously by the hospital leadership [2, 60, 61]. The AMA has also addressed disruptive physician behavior in its Code of Medical Ethics [11]. No one wants to confront a powerful physician, especially those who have little power themselves within the system or who may be beholden to the physician for their livelihood. Yet, it is the rank and file healthcare worker who often has the best and most first-hand knowledge of the behavior of the disruptive physician. While it is of course possible that specious complaints may be made against physicians in which their behavior may be incorrectly interpreted as being disruptive or abusive, the Joint Commission requires that such complaints, whether initiated by a member of the medical staff or the housekeeping staff, be taken seriously and investigated and addressed in a confidential manner.

Conclusion Physicians suffer from the same shortcomings that their patients do. Despite society’s lofty expectations, all have feet of clay. No human is perfect, and all physicians are vulnerable to physical and mental illness or addiction. The practice of medicine demands commitment and expertise and can be consuming and exhausting. Yet physicians need not wear the mantle of perfection to do their jobs, nor must they live and work in the kind of silent isolation that prevents them from asking for help when needed or keeps them from taking the most basic steps to ensure that issues of mental illness, substance abuse and burnout are addressed in a timely way before the physician so disrupts his life and practice that he, the patient and the medical enterprise suffers unnecessarily. Physicians have an ethical obligation through a “covenant of trust” with their patients to use their knowledge, skill and expertise in a fair and balanced way and with the goal of healing their patients and preventing their exploitation. Impairment due to addiction, aging or by narcissistic and provocative behavior threatens to erode that trust and can lead to patient harm. Inappropriate or impaired physician behavior must be addressed by colleagues and should remain focused on the assessment and treatment of illness in the physician whenever possible. The Physician’s Heath movement provides a non-punitive,

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treatment and recovery-based alternative that can both help physicians and protect the public. Nietzsche admonished the physician to “heal thyself” but physicians cannot heal themselves. They can instead accept that (to paraphrase Abraham Lincoln) “a physician who treats himself has a fool for a patient” and learn to recognize when treatment and support from others are the required prescription.

References 1. Miller NM, McGowen RK. The painful truth: physicians are not invincible. South Med J. 2000;93:966–73. 2. Lowen JT. Disruptive docs. Minn Med. 2011;94:16–8. 3. Wall BW. Commentary: the clinical implications of doctors’ evaluating doctors. J Am Acad Psychiatry Law. 2005;33:89–91. 4. Pfefferling JH. Managing the unmanagable: the disruptive physician. Fam Pract Manag. 1997;4:77–92. 5. Murray A, Montgomery JE, Chang H, Rogers WH, Inui T, Safran DG. Doctor discontent. A comparison of physician satisfaction in different delivery system settings, 1986 and 1997. J Gen Intern Med. 2001;16:452–9. 6. Dunn PM, Arnetz BB, Christensen JF, Homer L. Meeting the imperative to improve physician well-being: assessment of an innovative program. J Gen Intern Med. 2007;22:1544–52. 7. Williams ES, Konrad TR, Scheckler WE, Pathman DE, Linzer M, McMurray JE, et al. Understanding physicians’ intentions to withdraw from practice: the role of job satisfaction, job stress, mental and physical health. Health Care Manage Rev. 2001;26:7–19. 8. Rollman BL, Mead LA, Wang NY, Klag MJ. Medical specialty and the incidence of divorce. N Engl J Med. 1997;336:800–3. 9. Center C, Davis M, Detre T, Ford DE, Hansbrough W, Hendin H, et al. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003;289:3161–6. 10. Bayles M. Professional ethics. Belmont: Wadsworth; 1981. 11. Code of Medical Ethics: current opinions with annotations. In: AMA CoEaJA, editor. Chicago, IL; 2004. 12. MacIver RM. The social significance of professional ethics. In: Pirsig ME, editor. Cases and materials on professional responsibility. St. Paul, MN: West; 1965. 13. May W. Professional ethics: setting, terrain and teacher. In: Callahan D, Bok S, editors. Ethics teaching in higher education. New York: Plenum; 1980. 14. Gorovitz S. Doctor’s dilemmas: moral conflict and medical care. New York: Macmillan; 1982. 15. Boisaubin EV, Levine RE. Identifying and assisting the impaired physician. Am J Med Sci. 2001;322:31–6. 16. Skipper GE. Treating the chemically dependent health professional. J Addict Dis. 1997;16:67–73. 17. Stoudemire A, Rhoades JM. When the doctor needs a doctor: special considerations for the physician-patient. Ann Intern Med. 1983;98:654–9. 18. Baldisseri MR. Impaired healthcare professional. Crit Care Med. 2007;35:S106–16.

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19. Current trends smoking-related mortality decline among physicians - Rhode Island. Morbidity and mortality weekly report: centers for disease control and prevention; 1990. p. 656–8. 20. Nelson DE, Giovino GA, Emont SL, Brackbill R, Cameron LL, Peddicord J, et al. Trends in cigarette smoking among US physicians and nurses. JAMA. 1994;271:1273–5. 21. Fox DM. Commentary: impaired physicians and the new politics of accountability. Acad Med. 2009;84:692–4. 22. Bohigian GM, Croughan JL, Sanders K. Substance abuse and dependence in physicians: an overview of the effects of alcohol and drug abuse. Mo Med. 1994;91:233–9. 23. Holmes VF, Rich CL. Suicide among physicians. In: Blumental S, Kupfer D, editors. Suicide over the life cycle: risk factors, assessment, and treatment of suicidal patients. Washington, DC: American Psychiatric Press, Inc; 1990. p. 599–615. 24. Silverman M. Physicians and suicide. In: Goldman LS, Myers M, Dickstein LJ, editors. The handbook of physician health: essential guide to understanding the health care needs of physicians. Chicago: American Medical Association; 2000. 25. Lindeman S, Laara E, Hakko H, Lonnqvist J. A systematic review on gender-specific suicide mortality in medical doctors. Br J Psychiatry. 1996;168:274–9. 26. Hawton K, Clements A, Sakarovitch C, Simkin S, Deeks JJ. Suicide in doctors: a study of risk according to gender, seniority and specialty in medical practitioners in England and Wales, 1979–1995. J Epidemiol Community Health. 2001;55:296–300. 27. Hampton T. Experts address risk of physician suicide. JAMA. 2005;294:1189–91. 28. Yao DC, Wright SM. The challenge of problem residents. J Gen Intern Med. 2001;16:486–92. 29. Steinert Y, Levitt C. Working with the “problem” resident: guidelines for definition and intervention. Fam Med. 1993;25:627–32. 30. Gordon MJ. A prerogatives-based model for assessing and managing the resident in difficulty. Fam Med. 1993;25:637–45. 31. The sick physician. Impairment by psychiatric disorders, including alcoholism and drug dependence. JAMA. 1973; 223:684–7. 32. Federation of State Physician Health Programs. 33. Public Policy Statement: physician illness vs. impairment: Federation of State Physician Health Programs. 34. Bohigian GM, Bondurant R, Croughan J. The impaired and disruptive physician: the Missouri Physicians’ Health Program–an update (1995–2002). J Addict Dis. 2005;24:13–23. 35. Rakatansky H. Physician suicide. N Engl J Med. 2005;353:1184–5. 36. Nye GS. Psychiatric evaluation for diversion program candidates. Fed Bull. 1996;83:95–101. 37. Wettstein RM. Commentary: quality improvement and psychiatric fitness-for-duty evaluations of physicians. J Am Acad Psychiatry Law. 2005;33:92–4. 38. Wall BW, Appelbaum KL. Disabled doctors: the insurance industry seeks a second opinion. J Am Acad Psychiatry Law. 1998;26:7–19.

105 39. Nicholson RA, Norwood S. The quality of forensic psychological assessments, reports, and testimony: acknowledging the gap between promise and practice. Law Hum Behav. 2000;24:9–44. 40. Skeem JL, Golding SL, Cohn NB, Berge G. Logic and reliability of evaluations of competence to stand trial. Law Hum Behav. 1998;22:519–47. 41. Anfang SA, Faulkner LR, Fromson JA, Gendel MH. The American Psychiatric Association’s resource document on guidelines for psychiatric fitness-for-duty evaluations of physicians. J Am Acad Psychiatry Law. 2005;33:85–8. 42. Brodsky CM. Psychiatric aspects of fitness for duty. Occup Med. 1996;11:719–26. 43. Jansen M, Bell LB, Sucher MA, et al. Detection of alcohol use in monitored aftercare programs: a national survey of state physician health programs. J Med Licens Discipl. 2004;90:8–13. 44. Skipper GE, Weinmann W, Wurst FM. Ethylglucuronide (ETG): a new marker to detect alcohol use in recovering physicians. J Med Licens Discipl. 2004;90:14–7. 45. Weintraub W. “The Vip Syndrome”: a clinical study in hospital psychiatry. J Nerv Ment Dis. 1964;138:181–93. 46. Meffert JJ. “I swear!” Physician oaths and their current relevance. Clin Dermatol. 2009;27:411–5. 47. Physician Characteristics. In: Smart DR, editor. Physician characteristics and distribution in the US. Washington, DC: American Medical Association; 2006. 48. LoboPrabhu SM, Molinari VA, Hamilton JD, Lomax JW. The aging physician with cognitive impairment: approaches to oversight, prevention, and remediation. Am J Geriatr Psychiatry. 2009;17:445–54. 49. Weycker DA, Jensen GA. Medical malpractice among physicians: who will be sued and who will pay? Health Care Manag Sci. 2000;3:269–77. 50. Kohatsu ND, Gould D, Ross LK, Fox PJ. Characteristics associated with physician discipline: a case-control study. Arch Intern Med. 2004;164:653–8. 51. Morrison J, Wickersham P. Physicians disciplined by a state medical board. JAMA. 1998;279:1889–93. 52. Pesiah C, Wilhelm K. Physician don’t heal thyself: a descriptive study of impaired older doctors. Int Psychogeriatr. 2007;19:974–84. 53. Eva KW. The aging physician: changes in cognitive processing and their impact on medical practice. Acad Med. 2002;77:S1–6. 54. Pesiah C, Wilhelm K. The impaired aging doctor. Intern Med J. 2002;32:457–9. 55. Brown SD, Goske MJ, Johnson CM. Beyond substance abuse: stress, burnout, and depression as causes of physician impairment and disruptive behavior. J Am Coll Radiol. 2009;6:479–85. 56. Papadakis MA, Hodgson CS, Teherani A, Kohatsu ND. Unprofessional behavior in medical school is associated with subsequent disciplinary action by a state medical board. Acad Med. 2004;79:244–9. 57. Papadakis MA, Teherani A, Banach MA, Knettler TR, Rattner SL, Stern DT, et al. Disciplinary action by medical boards and prior behavior in medical school. N Engl J Med. 2005;353:2673–82.

106 58. Stern DT, Frohna AZ, Gruppen LD. The prediction of professional behaviour. Med Educ. 2005;39:75–82. 59. Joint Commission Sentinel Event Alert: behaviors that undermine and issue of safety: Joint Commission on Accreditation of Healthcare Organizations. www.jointcommission.org/sentinel_event_alert_issue_40_behaviors_that_ undermine_a_culture_of_safety/. Accessed 13 Jun 2011. 60. Youssi MD. JCAHO standards help address disruptive physician behavior. Physician Exec. 2002;28:12–3. 61. Leadership in healthcare organizations: A guide to Joint Commission healthcare standards: Governance Institute.

B.H. Krupp http://docs.google.com/viewer?a=v&q=cache:y1IPRWvW_ WwJ:www.jointcommission.org/assets/1/18/WP_ Leadership_Standards.pdf+Leadership+in+healthcare+orga nizations:+A+guide+to+Joint+Commission+healthcare+s tandards:+Governance+Institute.&hl=en&gl=us&pid=bl &srcid=ADGEESgeSb1oqBNrKnznqMdZWPLVp2JjsW vep1QP_XI2w21QuCRFuhBgELRWxlIB9eMVyDz1atu4 5l1Uwzo6cooFdxsbE0vmh-FjIh1KXymPy_ HjNEJaLIE0g-m1ywDITrT6SLzqMoDk&sig=AHIEtbQh Zxkm_UbG6qwTMTTfHiWWOI01Aw. Accessed 13 June 2011.

Part III Dermatologist as Teacher and Trainee

The Mentor-Mentee Relationship: The Devil Is in the Details

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Kimberly L. Merkel, John A. Cole, and Stanton K. Wesson

Introduction The concept of a mentor-mentee relationship can be traced back throughout history. Be it Socrates’ instruction of Plato, Plato’s tutelage of Aristotle, or countless other relationships since, the efficacy of a seasoned leader cultivating the skills of a younger follower is well established. Today, this model can be detected in many disciplines, including science. Its significance is demonstrated in one study where over half of 92 Nobel laureates had worked under the mentorship of a previous Nobel laureate [1]. These interactions, particularly within medicine, possess a set of principles, some more well-defined than others, that dictate proper behavior between individuals within the confines of these relationships. Unfortunately, these rules are at times subjective, creating possible problems or ethical and professional dilemmas. Consider the following.

Case 1 Kaylee Fort has recently moved to a new city to begin her dermatology training at a program in the Midwest. Within a few months of starting residency, she begins to form good relationships with her co-residents and attending physicians alike. Given her interest in academics and clinical research, Kaylee soon finds a mentor in Dr. Jack Smith, the chairman of the department.

K.L. Merkel • J.A. Cole • S.K. Wesson (*) Division of Dermatology and Cutaneous Surgery, University of Florida College of Medicine, Gainesville, FL, USA e-mail: [email protected]

Although Dr. Smith has several ongoing projects with residents and medical students, he is particularly drawn to Kaylee’s outgoing personality and work ethic. Over the first 18 months of her residency, Kaylee manages to publish three articles. Soon, it is brought to the attention of another faculty member that Kaylee and Dr. Smith are spending significant amounts of time together, both during and after work. When confronted by the other departmental faculty about the relationship, Dr. Smith argues that nothing inappropriate is occurring. Mentoring relationships are important for career development. Studies show that those involved in mentorships have higher incomes, more promotions, and better career satisfaction compared with their counterparts [2]. Mentoring can be broken down into two basic types: formal and informal. Informal mentoring is analogous to apprenticeships of old where most trades were learned by observation and teaching from someone who had experience in that field. These typically develop spontaneously, last several years, and often have a more interpersonal connection between the participants. In the formal setting, mentoring relationships are assigned, which may result in a different dynamic than one that develops naturally. They are typically more contractual and of shorter duration than informal relationships [2]. However, given the obvious benefits of mentoring, formal systems have still been developed despite their limitations. Although some authors have praised the dynamic of the informal mentorship, robust studies comparing the outcomes of formal versus informal mentoring are lacking [2]. The case above demonstrates an informal relationship, which is common in small residencies typical of dermatology. The benefits of this relationship type

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usually stem from mutual attraction arising from similar interests, or from personality chemistry that is hard to mimic in the formal setting. Given that these two attributes are at the core of attraction between two people in any relationship, one could understand how Kaylee and Dr. Smith could have developed a deeper relationship beyond the scope of the initial connection. In fact, a survey by Jackson, et al., found that chemistry was emphasized as an integral part of a successful mentor-mentee relationship [3]. Despite the benefits of the interpersonal connection of an informal mentorship, possible pitfalls can exist. Although ethical boundaries are not always welldefined, certain behaviors are generally viewed as inappropriate, including sexual or financial exploitation. However, crossing obvious boundaries is not required to cause potential harm. Resentment by other residents could develop if the perception of favoritism exists. This could result in disrupted relationships between co-residents, potentially damaging camaraderie within a program. If other faculty members perceive the relationship unfavorably, it can cause them to question the integrity of and lose respect for the chairman. Furthermore, a conflict of interest between mentoring and supervisory roles is possible Mentoring is a complex relationship with proven benefits despite its imperfections. The example above shows a flourishing relationship founded on a common interest. This growth is part of a progression of the mentor-mentee relationship through several phases that often ends with a lasting friendship.

Case 2 Gideon Reid is a PGY-4 resident, with 6 months left in his residency. Since starting training, he has excelled in every aspect of dermatology, developing a keen interest in academic medicine. He has published numerous papers with his mentor, Dr. Emily Garcia, regarding cutaneous T-cell lymphoma (CTCL), a passion both of them share. Over the course of his residency he has expressed strong interest in remaining in academia. He was instrumental in starting a CTCL specialty clinic and is actively involved in medical student education. Last month, he approached Dr. Garcia and informed her that he has decided to join the large aesthetic dermatology group in a nearby

K.L. Merkel et al.

city. Since that time, Dr. Garcia has been more distant and there have been awkward interactions between the two of them in clinic. Gideon is worried, as the practice is asking for a reference letter from the program director. Within a mentorship, mentees evolve through several stages to reach their personal and professional goals. According to Kram, four distinct phases exist [4]. The first, initiation, varies depending on whether the relationship is formal or informal, as discussed above. Cultivation, the second stage, involves the bulk of relationship-building between the mentor and mentee. Next, the termination or separation stage, involves the dissolution of the mentoring hierarchy. Lastly, depending on the successful completion of the aforementioned steps, a redefinition phase occurs, and may result in a long-lasting friendship or peer status. In the above example, Dr. Reid is approaching the end of his residency, a common time for the termination stage to occur. This stage is usually preceded by an increase in self-confidence, autonomy, and realization of professional goals [5]. Termination can either be planned or unplanned, functional or dysfunctional, although these are not mutually exclusive. Regardless of how termination occurs, intense emotions can be evoked given the complexity and closeness that some mentoring relationships possess [1]. Ideally, the termination is planned, with the mentee attaining a level of maturity and independent thinking necessary for self-sufficiency. This is the ultimate goal of the mentor-mentee relationship. A dysfunctional relationship can occur if the mentee is too dependent or fails to progress towards autonomy. In addition, a mentor can hinder progress by being overprotective and not allowing the mentee to take risks. It can also occur if the mentor becomes jealous or unhappy with decisions made by the mentee or if the mentor is trying to make the mentee a copy of himself. In the case above, a termination becomes dysfunctional when a disconnect develops between goals of the mentor and those of the mentee. Given the complexity and closeness of a mentor-mentee relationship, it is natural to let emotions and disappointment occur as demonstrated in Case 2. However, a good mentor is non-judgmental and constructive, regardless of the ultimate choices made by the mentee. Some disappointment may be normal, but it is important not to let it negatively impact the relationship.

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Case 3 Michelle McCook is a medical student interested in going into dermatology residency. For the past year, she has been working with Dr. David Morgan, a junior faculty member within the dermatology department. He provides advice and guidance on how to increase her chances for matching into dermatology. He has many ongoing projects, hoping to advance his career in academic dermatology. She has helped him complete two projects, and is currently assisting with him on two others. Between her third-year clerkships and the extra time spent on her projects, her grades slip. Michelle approaches Dr. Morgan visibly upset about her grades, and expresses feeling overwhelmed. After providing words of encouragement, he presents another research project that he wants her to lead. Although the mentee is the obvious beneficiary of a mentoring relationship, the mentor also reaps reward. In addition to practical benefits such as assistance with research or other projects, the relationship often fulfills a genuine interest in helping others. This altruistic attitude is ideal, but some research suggests that mentors are more likely to participate in mentorships if they anticipate more rewards for themselves [6]. Qualities of a good mentor include those attributes that help develop the mentee and foster independence. For example, mentors should be readily available, offer challenges, and provide constructive criticism to their mentees. In addition, mentees learn indirectly through observation of their mentors’ behaviors, attitudes, and interactions with patients and colleagues. The mentor can also influence how a mentee deals with conflict by how he himself responds to frustration, stress, or anxiety. It is important for mentors to avoid promoting their own agendas, attempting to fashion clones of themselves, or abusing mentees as free labor. Periodic assessment of the relationship allows both parties to reevaluate their goals and make changes as needed. This requires direct and honest communication between the mentor and mentee. Mentoring is not a passive process, and an active role enhances the benefits to both. As the leader, it is the mentor’s responsibility to be vigilant for problems that the mentee may face and help guide the mentee through them. For example, mentees that become overly dependent on their mentors may not fully develop the selfconfidence necessary to be independent. Furthermore,

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personal or professional stresses may begin to impact a specific mentor-mentee relationship or its products. In the above case, Dr. Morgan fails to realize, or acknowledge, that Michelle is seeking guidance, and instead of being a source of comfort, ends up adding to her distress. This failure of open communication, either from Dr. Morgan’s lack of perception or disregard for Michelle’s concerns, weakens the relationship. In addition to not being constructive, Dr. Morgan’s actions are potentially destructive to Michelle’s other personal or professional aspirations. If Michelle’s focus on these projects negatively effects her grades or board scores, she may have difficulty matching into dermatology. Given that that was one of the goals of the relationship, Dr. Morgan fails as a good mentor by potentially hindering her chances of achieving her goal.

Conclusion Mentoring is an important and complex interaction that can benefit students and doctors at all career stages. Studies have shown that 90–95% of medical students rate mentoring as important or very important [7]. Students can find mentors informally via their interactions with preceptors, attending physicians, or residents; however, this can be hindered by limited personal contact with potential mentors. Because of the proven benefit of mentorship in professional development, many schools have implemented formal mentoring programs. As previously discussed, these have their limitations. Furthermore, research suggests that leaders in academic settings often undervalue mentoring, as it is not considered essential for tenure or promotion [8]. Considering the positive effects on personal and career development, mentoring should be encouraged. Institutions can help by offering mentoring workshops and providing more recognition for good mentors. Mentoring can and should be mutually beneficial and its success is dependent on the successful navigation through its stages and open communication between participants. Through the guidance and support of the mentor, a mentee evolves into a more self-reliant individual. The mentoring relationship, like any other, is not without potential problems, and a better understanding of the process and self-awareness of ones own strengths and weaknesses may mitigate potential obstacles to success.

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References 1. Chong S. Mentoring: Are we doing it right? Ann Acad Med Singapore. 2009;38:643–6. 2. Ragins BR, Cotton JL. Mentor functions and outcomes: a comparison of men and women in formal and informal mentoring relationships. J Appl Psychol. 1999;84:529–50. 3. Jackson VA et al. Having the right chemistry: a qualitative study of mentoring in academic medicine. Acad Med. 2003;78:328–34. 4. Kram KE. Phases of the mentor relationship. Acad Manage J. 1983;26:608–25.

K.L. Merkel et al. 5. Ragins BR, Scandura TA. The way we were: gender and the termination of mentoring relationships. J Appl Psychol. 1997;82:945–53. 6. Oian JD, Caroll SJ, Giannantonio CM. What do protégés look for in a mentor: results from three experimental studies. J Vocat Behav. 1988;33:15–37. 7. Rose GL, Rukstalis MR, Schuckit MA. Informal mentoring between faculty and medical students. Acad Med. 2005;80:344–8. 8. Straus SE, Chatur F, Taylor M. Issues in the mentor-mentee relationship in academic medicine: a qualitative study. Acad Med. 2009;84:135–9.

Tales from the Residency Interview Trail

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Jennifer A. Sbicca and Alfred T. Lane

Case 1 Audrey Mott has interviewed at five dermatology residency programs including her home program, Average American University (AAU). She felt honored to interview at Top American University’s (TAU) program and felt a connection with the program, the residents, and the faculty members she met there, but is worried that because it is such a highly regarded program her chances of matching there are slim. Audrey also feels that she would be very happy to match to her home program at AAU. The program director of AAU calls her and says, “Audrey, we have known you for many years and have always thought very highly of you. We think you would be a perfect fit for our program. We want to let you know that you are ranked to match.” She is thrilled and thanks him for letting her know her rank. She tells him how much she loves the program as well. However, she doesn’t tell him any information about how she intends to rank programs to which she has applied. Internally, she worries that remaining in a top position on AAU’s rank list is contingent upon her also agreeing to rank them highly. The program director at AAU then says to her, “Audrey, as we only have limited spots to offer we

J.A. Sbicca Division of Dermatology, University of Florida College of Medicine, Gainesville, FL, USA A.T. Lane (*) Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA e-mail: [email protected]

need to know if you are serious about this program. How will you rank our program?” This program director has put Audrey in a compromising position. It is unclear why he wants to know how Audrey plans on ranking his program. However, a common assumption is that if her answer is not reciprocal to the program’s expressed interest, it could negatively affect her ranking at this program. Although not directly stated, it seems implied that the program director is asking Audrey to make a ‘quid pro quo’ agreement to rank AAU’s program highly. So how should Audrey respond? Should she be honest with AAU’s program director or lie about her preference to gain advantage? What is her most ethical course of action? This tactic is a well-known problem among applicants to dermatology programs. In 2009, “31% of dermatology applicants felt pressured to reveal to programs how they ranked them before match day” [1]. What is an applicant to do when presented with this situation? If Audrey tells the program director that she liked TAU’s program more, then he might not rank her. If he doesn’t rank her, then she is at serious risk of not matching to any dermatology program. However, if she lies and tells the program director at AAU that she will rank AAU’s program highest and instead ranks TAU higher, one of two things could happen. If TAU ranks her highly too, then she matches at TAU and her ethical conscience is comforted knowing that another applicant will be happy to take her spot at AAU. If she matches at AAU, then she will be happy there and AAU will never know that she ranked TAU higher. It appears that lying to AAU’s program director ensures Audrey her best possible outcome.

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J.A. Sbicca and A.T. Lane Applicant A is honest

All other applicants are honest

Applicant A is dishonest

All get intermediate A’s best choice; choice all other applicants’ worse choice

All other applicants A’s worst choice; All get intermediate are dishonest all other applicants choice get good choice

Fig. 19.1 Punnett square, reproduced from (2) with permission

If the program director behaves rationally, he should not be influenced by Audrey’s rank list. Regardless of how Audrey ranks his program, he will get the best residents that have ranked his program who have not matched to their highest choices. If, as in this case, he allows his perception of the applicants’ preferences to influence how he ranks them in the match, then the candor of the applicants will very much influence the outcome of their respective matches. This is illustrated in Fig. 19.1 and discussion and paragraph below, which are reproduced with permission from, which is reproduced from a study of the Urology match that appeared in the Journal of Urology in 2000 (see Table 19.1). “A resident applicant’s best outcome is to inform program directors that (she) will rank the program number 1 (assuming this claim to be false) when all other applicants inform the program director honestly that they will not rank that program highly. If each resident applicant (A and all others) appreciates this outcome, then each resident applicant has an incentive to inform dishonestly the program director that they will rank that program number 1. However, all achieve an intermediate outcome. If resident applicant A chooses to respond honestly where he/she will rank the program (not a top rank order selection) and all other applicants similarly answer honestly, then all resident applicants achieve an intermediate outcome, too. However, if resident applicant A chooses to answer honestly and all other applicants choose to answer dishonestly that they will rank the program number 1, then resident applicant A appears uninterested in the program and achieves the worst possible outcome, since the program director perceives all other applicants to be more interested in the program compared to applicant A. Thus, resident applicants perceive incentive to be dishonest to avoid their worst case scenario, knowing that dishonesty yields either their best case scenario or at worst, an intermediate” [2].

This moral dilemma occurs for all medical students applying for medical residencies, but it is especially a problem in the more competitive specialties. In competitive specialties, the more common negative outcome is not matching at all, while in less competitive specialties, it is not matching to one’s preferred program or locale. The risks of not matching in dermatology are real. In 2009, 30% of U.S. allopathic and osteopathic seniors applying for dermatology residency failed to match to any dermatology program, compared with the overall 8% unsuccessful match rate of U.S. allopathic and osteopathic seniors applying to all other residencies [3]. As most dermatology applicants understand the risks and benefits of lying or being honest, some may elect to ‘play the game’ in order to serve their self-interest. And who can blame them? We have shown how those who elect to be honest are potentially at a real disadvantage. Medical students obtain residencies in most specialties utilizing the National Resident Matching Program (NRMP). In 1981, dermatology programs began to use the match to replace the traditional and somewhat disorganized way in which applicants previously obtained positions and program directors obtained residents to fill positions. The NRMP instructs programs and applicants to create a numerically ranked list of the other. A computer algorithm then matches applicants with programs, assuring both their highest available placement ranks. Almost all dermatology residency programs (excluding military programs) fill residency positions using the NRMP. The major rule of the NRMP is, “both applicants and programs may express their interest in each other; however, they shall not solicit verbal or written statements implying a commitment” [4]. The program director at AAU violated this policy when he asked Audrey how she planned to rank AAU. NRMP policy states specifically that, “it is a breach of the applicable Match Participation Agreement for a program to request applicants to reveal ranking preferences” [4]. The NRMP specifically permits program directors and applicants to “express interest” in each other (4). However, residency program directors are in a position of power, and sharing rank order is essentially ‘giving’ extremely valuable knowledge to a candidate. It is well known that the act of giving something to another person, no matter how small, often makes the giver feel entitled to something in return [5]. Because the gift in this case is so valuable, we can postulate that candidates might feel pressured to ‘give’ the program

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Tales from the Residency Interview Trail

Table 19.1 National Hiring Standards Area of inquiry Legal Name To inquire if the applicant’s work records are under another name

Martial/parental status

Married or single status only after hiring for insurance and tax purposes Number and ages of dependents and age of spouse after hiring for insurance and tax purposes

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Illegal To ask if a woman is a Miss, Mrs., or Ms. To ask the applicant to give maiden name or any previous names s/he has useda To ask marital status before hiring To ask the number and age of children, who cares for them and if applicant plans to have more children

Legislation Title VII of Civil Rights Act of 1964 as amended by the Equal Opportunity Act of 1972 Title VII and IX of the Education Amendments of 1972 Title VII Title IX

a

Curiously, this question, along with applicant’s age and participation in the couples match are on the ERAS application received by residency programs Adapted from Ref. [8]

director information regarding the program’s rank order on their lists. Revealing rank order to candidates, even obliquely, however indirectly and vice versa, creates undue pressure for applicants. In the scenario above, Audrey Mott’s most professional and most ethical course is to tell the program director at AAU something such as, “Thank you for letting me know that I am ranked to match at your program. You know that I have always felt at home at your program too and that I would be thrilled to match here, but asking me to reveal my rank list is against NRMP policy and so I cannot answer your question.” Then, she has the option of reporting his behavior to the NRMP in hopes that this would change his behavior in the future. Perhaps this is a way to remain on his rank list and maintain her integrity. Perhaps she makes this decision because she understands that the clean Punnett square above is not completely reliable. Studies have found that while some applicants are not honest with program directors, some program directors are not honest with applicants [2, 6, 7]. As program director behavior is a mix of both honest and dishonest behavior, the above Punnett square cannot be accurately used to gain advantage. Realistically, however, this response is not feasible for Audrey. This response could anger the program director and ensure that Audrey is now definitely not on his rank list. One could argue that the risks of not matching are too great for Audrey to reasonably attempt this option; she should do everything possible to secure for herself the best possible chance of matching at every program at which she interviewed. Another ethically acceptable course of action is for Audrey to be honest with AAU’s program director about her rank list. She could say something like,

‘Thank you for letting me know that I am ranked to match at your program. I have always felt at home at AAU and would love to match here, but I liked TAU’s program more and therefore plan on ranking them highest. Please know that your program is ranked very highly by me – in the next highest spot – and that I would be very, very happy at AAU as well.’ Then she would hope for the best, taking solace in the fact that she, at least, has acted with integrity. However, this option is not truly reality-based either. The risks are too great for Audrey or any dermatology candidate to choose this response. If she told the program director at AAU that she liked TAU’s program better, she might not match to any institution’s dermatology program. What we see is that in this scenario the most ethically satisfying options are potentially risky for Audrey Mott. The NRMP can help avoid creating such ethical conflicts by issuing restrictions regarding contact between applicants and programs after interviewing and by expressly prohibiting participating programs from revealing ranking information to candidates before the match rank lists are due. An oversight committee or NRMP officer with the power and the will to sanction those who violate this policy would help to deter this type of ethically questionable conduct.

Case 2 Wilma Claiborne is a fourth year medical student applying for a dermatology residency. Today she is interviewing at Large Midwestern University (LMU), a program she is very excited about because it has happy residents, renowned faculty, and a fantastic

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reputation. LMU is a top choice for Wilma and her husband William, as they plan to start a family during residency and her parents, who live nearby, will help with child care. During her interview at LMU, the program director asks her, among other things, “Wilma, are you married?” Wilma tells the program director, “Yes, I am happily married to William Claiborne, and my husband has already secured a job opportunity in the area. This helps to make LMU our top choice.” The program director then says, “Our program does not allow our residents to become pregnant during residency and it’s assumed that our female residents will be on birth control. Do you plan on having children during residency?” Is it permissible for the program director to ask Wilma questions regarding her marital status or intent to have children? The program director has made it clear to Wilma that he does not want any residents to become pregnant or have children during residency. It is assumed that if Wilma wants to match at LMU, she needs to assure the program director that she does not plan on having children during residency. Is there something she can say which will allow her to remain both truthful and in serious consideration at this program? In a study of the urology residency match, 91% of male and 100% of female applicants recalled being asked their marital status, 53% of male and 67% of female applicants recalled being asked if they had children, and 25% of male and 62% of female applicants were queried regarding their plans to have children in the near future [2]. Sbicca et al. reported that some dermatology residents and applicants were also asked about marriage or children during dermatology residency interviews [1]. Even though this program director is asking Wilma these questions in order to filter out residency applicants who might take parental leave during training, it cannot be assumed that all program directors are motivated by self-interest. Some program directors may have benign intentions in asking applicants questions about their marital and dependent status during the natural course of the interview conversation. Some may ask these questions in order to attract an applicant by describing child care services at the hospital or by offering to help the family relocate. Or, some program directors may have a preference for married applicants, believing that they make happier, more stable residents.

J.A. Sbicca and A.T. Lane

Regardless of their intentions, it seems that some program directors have forgotten that federal laws regarding hiring of personnel also apply to the hiring of residents. Applicants are not asked to provide information regarding their marital status on Electronic Residency Application Service (ERAS). Although it is easy to let the interview conversation become personal, program directors should be aware of the federal statutes regarding hiring. Program directors are potentially liable if discriminatory hiring decisions are made. Federal law dictates what program directors can and cannot ask residency applicants (Table 19.1). To ask a candidate even a seemingly benign question like, ‘Are you are married?’ before hiring is actually a violation of his or her civil rights. There is a fine line between directly asking an applicant if they are married and asking indirectly. For example, what if a program director were to say to an applicant, “If you are married, how can we help you move to our program and help your spouse with the move?” Is this within the boundaries of what is legal? It is emphatically not. Program directors cannot pose a leading question like this until the resident has matched at the institution. However, if an applicant of his or her own accord reveals marital status to the interviewer, the program is not legally liable for having obtained that information. However, the hiring decision should not be made on the basis of that information (although, it might be hard to prove). LMU’s program director violated federal law when he asked Wilma if she was married. Wilma may have known that this was an inappropriate question, but she chose to answer honestly. Wilma must successfully navigate this question in order to continue a good interview, as refusing to answer could create a negative impression, or at the least, be awkward for her. She could be politely diplomatic, allowing an inexperienced interviewer a chance to retreat without embarrassment. One way to do this is to smile pleasantly and ask the interviewer if the question is pertinent to the interview or ask if this is really part of the requirements for the position. However, this strategy might be viewed as threatening, especially as the interviewer is most likely aware that a ‘no-pregnancy’ policy in the dermatology department is ethically and legally inappropriate. In addition, because dermatology residency is so competitive, most likely there are men and women who are willing

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to abide by this incredible stipulation in order to successfully match. Our recommended course of action is for Wilma to answer him honestly but remain non-committal, ‘One day we plan to start a family, and we have considered doing so during residency, but we have not made a firm decision about this.’ If she matches to LMU, there is no way her program director could physically prevent her from having children, yet perceived social pressure from faculty members and other residents may be strong enough to deter her. If she does become pregnant and decides to continue the pregnancy, she may encounter a program that is negative and unsupportive of this decision. Perhaps it is best for Wilma and William Claiborne to consider a different dermatology program that is more open to families and has reasonable child care available. Acknowledgements We thank Lisa Martin, B.A. (Stanford University School of Medicine, Palo Alto, CA) for providing information about national industry hiring standards.

References 1. Sbicca JA, Gorell ES, Kanzler MH, Lane AT. The integrity of the dermatology National Resident Matching Program: results of a national study. J Am Acad Dermatol. 2010; 63(4):594–601.

117 2. Teichman JMH, Anderson KD, Dorough MM, et al. The urology residency matching program in practice. J Urol. 2000;163:1878–87. Reproduction with permission from the publisher. 3. National Resident Matching Program. Charting outcomes in the match. Characteristics of applicants who matched to their preferred specialty in the 2009 main residency match, 3rd edn. 2009. http://www.nrmp.org/data/chartingoutcomes2009v3.pdf. Accessed 26 Jan 2011. 4. Match Participation Agreement for Applicants and Programs for the 2009 Main Residency Match. 2008. http://www. nrmp.org/res_match/about-res/ensuring. Accessed 23 Oct 2011. 5. Abbasi K, Smith R. No more free lunches. BMJ. 2003;326: 1155–6. 6. Anderson KD, Jacobs DM, Blue AV. Is match ethics an oxymoron? Am J Surg. 1999;177:237–9. 7. Miller JB, Schaad DC, Crittenden RA, Oriol NE, MacLaren C. Communication between programs and applicants during residency selection: effects of the match on medical students’ professional development. Acad Med. 2003;78: 403–11. 8. Legal/illegal interview questions. Office of Human Resources Management. University of Albany. http://hr. albany.edu/content/legalqtn.asp. Accessed 26 Jan 2011.

Ethics Education for Residents: Growing Pains and Learning Crises

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Irèn Kossintseva and Benjamin Barankin

Case Scenarios

inquires how many such procedures the resident has performed, the attending dermatologist is evasive.

Case 1 A resident sees a patient in consultation in the hospital. Upon introduction, he says “My name is Dr. X and I will be taking care of you.” During further interactions he does not clarify his role in the hierarchy of medical care.

Case 2 A resident is asked to perform a procedure he has never done before. The patient is medically unsophisticated and unlikely to know what to expect as an acceptable outcome of this procedure or what questions to ask. For the sake of saving time, the resident is asked to evaluate the patient and perform the procedure completely unsupervised.

Case 3 A resident is performing a specific surgical repair for the first time, but is not sure if he is obliged to inform the patient of his inexperience. When the patient

I. Kossintseva (*) Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada e-mail: [email protected] B. Barankin Toronto Dermatology Centre, Toronto, ON, Canada

Case 4 A resident encounters a patient with a large basal cell carcinoma of the cheek that could be repaired with a rhombic flap after removal. Alternatively, the wound could be repaired by a simpler layered closure after wide undermining. This resident is anxious to learn the more complex repair and fails to mention the simpler approach to the patient.

Discussion Who Is “the Doctor”? Patients have the right to know who is caring for them. Many patients do not understand the medical training hierarchy and how training is conducted in a teaching facility, creating an obligation for informational disclosure by trainees and their supervisors. One should not presume that because the patient is aware of being in a teaching facility, that the patient fully understands all that this implies. The patient may not be prepared to encounter and differentiate medical learners, or actively participate in the learning process. One study showed that 80% of patients felt that it was important to know their physician’s level of training, yet only slightly more than half (58%) reported knowing it [1]. This can be a significant cause of distress, anxiety and even anger when faced with multiple providers at different levels of training. Even when

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patients know the titles of medical personnel taking care of them, the actual meaning of the titles is frequently misunderstood. In fact, the survey of Santen et al. showed that only 43% of patients understood that residents are always supervised when caring for patients, while 30% thought that attending physicians require supervision by a resident [1].

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medical learners, which include balancing the tension between the demand to deliver optimal care while acquiring knowledge and learning new skills [2]. These goals are frequently in conflict, creating issues of pride, embarrassment or peer pressure and encroach on the duties of beneficence and non-maleficence [2, pg. 39].

Implicit Consent to Care by Medical Learners Personal Identity In addition to patients’ confusion regarding the medical hierarchy, intentional omission of one’s title and thus misrepresentation of one’s personal identity occurs frequently in teaching settings. This misrepresentation often arises from convenience, practicality, and perceived benefit to the academic agenda. Thus, sometimes trainees will either passively or intentionally misrepresent themselves in order to gain the patient’s trust. Occasionally, attending physicians will introduce their residents as their equal colleagues, perhaps with the same intent of gaining the patient’s trust and averting questions about the trainees’ purpose at the bedside. This approach, an example of paternalistic beneficence [2, pg. 174], is based on the paradoxical notion that physicians can cultivate trust through deception. Trust is the basis for successful patient-physician relationships and is achieved through honesty and open communication. Misrepresenting one’s professional identity undermines the patient’s autonomy, interfering with the ability to make informed decisions.

Discomfort of Inexperience A combination of knowledge gaps and inexperience may cause residents to experience discomfort and selfdoubt in treating patients. Distinct from this, however, is an ethically-driven discomfort that happens when residents feel manipulated or are forced to perform certain procedures beyond their skill level. This occurs when the residents are aware: • of their limitations and inexperience in interventions they are asked to perform • that this could harm the patient • that this likely would not happen in the case of a more sophisticated patient The resident might accept this lack of supervision as routine and carry out the procedure, despite misgivings [2]. This may stem from the pressures put on

Some argue that patients admitted to teaching hospitals are aware that physicians in training are providing direct patient care, including performing invasive procedures [2, pg. 19]. In reality, many patients who present to teaching facilities do not realize they will be cared for by physicians-in-training, and furthermore frankly dislike being subject to the hands of learners. In fact, [1] while 62% of patients surveyed at a teaching facility reported being comfortable with receiving care from physicians in training, 22% of the patients preferred not to be treated in a teaching setting.

Withholding Disclosure of First-Time Procedures Several ethical principles require physicians in training to disclose when it is their first time performing a medical intervention [2]: • the Kantian principle of truth telling • respect for autonomy • the fiduciary obligation of the physician to act in the best interests of the patient • the moral obligation of the educator to train residents in safe medical practices On the other hand, intentional nondisclosure of first-time procedures is sometimes justified by three counter-arguments [2, pg. 19]. First is on the basis of implied consent – by virtue of being a patient in a teaching facility. However, as noted above, a significant number of patients in teaching facilities would prefer not to be cared for by trainees. Second is on the basis of social utility – the idea that patients would refuse a novice performing a procedure, thus jeopardizing the training of future skilled physicians. Although the principle of utility is an essential extension of beneficence it has been criticized for allowing society’s interests to override individual interests and rights [3, pg. 261]. Third is on the basis of therapeutic privilege –where divulgence of this information could lead to undue

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Ethics Education for Residents: Growing Pains and Learning Crises

psychological distress and anxiety for the patient [3, pg. 150]. However, in 1986, the US Supreme Court attacked the notion of therapeutic privilege stating “it is the very nature of informed consent provisions that they may produce anxiety in the patient and influence her in her choice. This is in fact their reason for existence [3, pg. 151].” When residents invoke therapeutic privilege in performing first-time procedures, they undermine informed consent.

What Constitutes Informed Consent? Informed consent consists of at least three critical components. First, the patient must have decision making capacity. Second, it must be voluntary and free from coercion or manipulation. Third, valid consent requires full disclosure of all relevant information that a reasonable person would require to make a decision. Omitting information regarding the inexperience of the operator constitutes a form of deception and is not only morally questionable but also potentially legally hazardous. In the intimidating environment of the health care facility, patients can feel inhibited and apprehensive and are less likely to ask clarifying questions [2, pg. 20], thus creating a duty for the physician to ensure that truly informed consent is obtained.

Who Obtains Informed Consent When the Operator Is Inexperienced? The responsibility for obtaining proper informed consent ethically and legally falls on the person performing the procedure. Thus, if a resident is doing a procedure, it is that individual’s responsibility to ensure that the patient understands the material risks, benefits, and alternatives of the proposed intervention. Although this could be done by other members of the medical team, it is ultimately the responsibility of the supervising physician to ensure it has been obtained [2, pg. 23].

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act of managing information that alters the patient’s understanding of a situation, motivating him to do what the agent of influence intends. Informational manipulation is not compatible with autonomous decision making.

Clinical Teaching and Medical Ethics Medicine as a profession could not continue to exist without educating future generations of physicians. Young physicians must have an opportunity to develop and refine their skills. Nevertheless, many patients may be reluctant to put themselves in the hands of an inexperienced physician or medical student. Patients assume that physicians will be their advocates, and do not expect their own needs to be subordinated to those of learners [2, pg. 21]. Thus, teaching hospitals would struggle to fulfill their academic obligations if novices were not permitted access to patients. Even a moderate number of patients refusing resident involvement in patient care would threaten medical learning, underscoring the inherent tension between priorities of patient care and medical education [2, pg. 20].

Medicolegal Consequences of Omitting Lack of Experience Liability may result from omission of the trainee’s status or lack of experience, particularly should complications or a poorer than expected outcome occur. Knowingly manipulating information such as the operator’s inexperience in order to secure the consent of the patient could be material to a plaintiff’s case [2, pg. 22]. In fact, 72% of patients would be upset to find out in retrospect that they were a subject of a first-timer [4]. Additionally, failure to relate relevant information can be legally viewed as negligence. Furthermore, the emotional impact of an after-the-fact revelation may outweigh that generated by full disclosure before the procedure.

Forms of Inﬂuence in Decision Making How recommendations are communicated can profoundly influence patients’ decisions. The three primary forms of influence include coercion, persuasion and manipulation. In healthcare, a key form of influence is informational manipulation, a deliberate

Will Patients Consent to a First-Time Procedure? Comfort with novices is dependent on the intervention in question. For example, less than half of patients appear to be comfortable with a resident’s

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first-time suturing, less than a third with intubation, and very few with a lumbar puncture [5]. The likelihood of consent is greater in younger patients, in poorer socio-economic groups, where greater time is allotted to form rapport with the patients, and for procedures where anticipated discomfort is low or the novice has already performed the procedure at least once [6]. The elective and cosmetic nature of most dermatologic procedures may allow for more time for patients to deliberate and lead to a higher rate of refusal of consent for allowing trainees to perform procedures [7].

Case Analysis In Case 1, the resident correctly introduces himself as a doctor, and goes on to inform the patient that he will be taking care of him. Both statements are true, especially in a busy teaching hospital where the majority of the “footwork” is done by residents. However, the resident fails to explain to the patient that he is a resident, and therefore not the physician ultimately responsible for the patients’ medical care. However, this introduction is intentionally misleading and paternalistic. This approach is unethical, because it misrepresents the resident’s role on the medical team. Patients cannot make autonomous decisions without full and truthful information. There is an implied duty to clearly explain the roles of individual health care team members to patients. Not infrequently, as in Case 2, situations arise in which a resident is asked to perform a procedure for the first time that he or she may not feel comfortable performing independently. In such instances, open and honest communication with the supervising physician is the key. The trainee has an ethical obligation to disclose to his supervisor that he has never performed the procedure and to request support. At the very least, the trainee should disclose to the patient that the procedure will be supervised by a more senior member of the team who will be present throughout the procedure. The trainee in this situation has a duty to the patient to perform the procedure under supervision and in a manner that does not place the patient in undue jeopardy. The trainee should never jeopardize a patient’s safety and well-being in the interests of learning and acquiring clinical experience. As in case 3, patients often want to know if it is a learner’s first time, especially because of a common

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presumption that complications may be higher when a novice is performing a procedure. However, the fact that a learner is performing a procedure is not nearly as important as the need to explain the extent of supervision, active guidance and direction that the learner receives from an experienced staff physician, including intervening or taking over if necessary. Further, the supervising physician should explicitly address whether the learner’s inexperience puts the patient at risk, and how he intends to protect the patient from that possible risk [2, pg. 23]. More specifically, an elegant and ethical approach that experienced attending physicians undertake while fully supervising first-time procedures, is to explain to the patient that the resident and the attending are doing the procedure together, that the attending is supervising, and that the procedure is being done exactly as it would if the attending were doing it alone. The attending physician should know each resident’s skill level. If the resident appears to be faltering or getting into trouble, he should silently take over until the situation is under control and continue giving the resident tips, but not in a way that would give the patient any cause for alarm. Patients do not relinquish the clinical judgment and experience of the attending physician by consenting to have a resident perform the procedure. In case 4, the patient is being directed toward having a more complex and potentially riskier repair than indicated in order to provide the resident the opportunity to gain experience with flaps. This is an example of persuasion through informational manipulation, in which the way the information is presented influences the patient’s decision-making. In this instance, the resident placing his educational needs ahead of the patient’s best interests, is in violation of his fiduciary duty.

Conclusion There is an inherent tension between providing patients with the best possible care while ensuring that trainees receive adequate clinical and procedural experience. Patient refusal for a procedure is real and poses a threat to adequate medical training. However, the resident has a moral obligation to be truthful, avoid coercion or manipulation, and to respect the patient’s autonomy. Patients are more likely to participate in medical training if they are assured that there is adequate

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supervision and oversight present and that their own risks are minimized by the sound judgment and experience of more senior physicians. However, a resident should be emotionally prepared to accept a patient’s refusal or request to have someone more senior involved. Ultimately, a resident who behaves ethically, demonstrating to the patient that he is his advocate, disclosing truthfully the extent and limits of his experience, along with reassurance that supervision is always at hand, should win the patient’s confidence.

Epilogue While writing this chapter, the resident co-author (I.K.) was keen on applying some of the ethical principles discussed above to clinical practice. There was a perfect opportunity during an off-service rotation in bone marrow transplant medicine, as the service requires frequent bone marrow biopsies (BMBx). One case is worth mentioning. A patient required a BMBx, and during the consent process the resident co-author fully discussed not only the risks and benefits, but also the degree of experience that the resident had (six successful, independent BMBx) and the extensive supervision present during the procedure either from a fellow or an attending physician. The biggest concern with a medical learner doing a BMBx is longer procedural time, potentially multiple attempts to acquire a proper bone marrow sample, and pain—for which the patient receives intravenous analgesia and sedation in addition to local anaesthesia. After much deliberation, the patient refused to allow the procedure to be performed by a resident and requested that the attending perform it. The resident informed the attending physician of this stipulation and the attending agreed, but asked the

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resident to prepare the patient prior to the actual biopsy. On the morning of the procedure, the resident premedicated, sterilized and locally anaesthetized the patient, but when the attending hematologist entered the room, he insisted that the resident “just do it”. Perhaps the attending felt that he was doing the resident a favor. The resident felt pressured, went ahead and quickly and successfully acquired the BMBx sample from the patient. The patient experienced no pain during or after the procedure, and in fact afterwards expressed his thanks for such a comfortable experience. However, the resident felt morally conflicted about having done the procedure. In the end, it seemed to be much more difficult to abide by sound ethical principles, even with the best of intentions.

References 1. Santen SA, Hemphill RR, Prough EE, Perlowski AA. Do patients understand their physician’s level of training? a survey of emergency department patients. Acad Med. 2004;79: 139–43. 2. Kushner TK, Thomasma DC. Ward Ethics: dilemmas for medical students and doctors in training. Cambridge, New York: Cambridge University Press; 2001. 3. Beauchamp TL, Childress JF. Principles of biomedical ethics. 4th ed. New York: Oxford University Press; 1994. 4. Williams CT, Frost N. Ethical considerations surrounding first time procedures: a study and analysis of patient attitudes toward spinal taps by students. Kennedy Inst Ethics J. 1992;2:217–31. 5. Santen SA, Hemphill RR, McDonald MF, Jo CO. Patients’ willingness to allow residents to learn to practice medical procedures. Acad Med. 2004;79:144–7. 6. Santen SA, Hemphill RR, Spanier CM, Fletcher ND. ‘Sorry, it’s my first time!’ Will patients consent to medical students learning procedures? Med Educ. 2005;39:365–9. 7. Ubel PA, Silver-Isenstadt A. Are patients willing to participate in medical education? J Clin Ethics. 2000;11:230–5.

Teaching Ethics in Clinic: Keeping You Smart and Honest

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Nely Z. Aldrich and Eliot N. Mostow

In the midst of a busy clinic with patients coming and going, harried residents and attending dermatologists trying to remain on schedule while teaching therapeutics, procedures, and differential diagnosis, it is small wonder that teaching and modeling ethics and professionalism “take a back seat”. Yet it is in the clinic, especially in the private practice setting, where the ethical and professional challenges most germane to the dermatologist are encountered in a very direct and personal way. And it is at this stage of their careers that medical students and residents gain the most from training in ethics. It is the role of the seasoned dermatologist acting as teacher and mentor to seize the opportunity to initiate dialogue about the ethical aspects of the clinical situations whenever appropriate. No textbook or hypothetical scenario can educate as well as an actual ethical dilemma encountered directly and solved by the trainee.

asymptomatic skin tag that he wants removed. The patient requests that the dermatologist bill the charges for the procedure to his insurance plan.

Case 2 A very popular pharmaceutical representative brings lunch to the office. The topical antifungal sold by this company has been shown to have similar but not superior efficacy than competing brands in a trusted independent therapeutics newsletter.

Case 3 A teenager with significantly disfiguring acne is seen. The mother says that the family has no insurance for office visits or medications and cannot afford the outof-pocket expenses.

Case Scenarios Case 1

Case 4

An attending dermatologist sees a patient with a medical student for follow-up of his psoriasis. Toward the end of the encounter, the patient states he also has an

An attending dermatologist wants to prescribe oral isotretinoin for a young female patient’s acne. The patient, aged 15, has hair dyed fuchsia, darkly painted nails, tattoos on each ankle, a nose ring, pierced tongue, and a very short skirt. When the issue of contraception is raised, the parents say they are morally opposed to oral contraceptives and premarital sex and are certain their teen is not sexually active.

N.Z. Aldrrich • E.N. Mostow () Section of Dermatology, Northeastern Ohio Universities Colleges of Medicine, Akron, OH, USA e-mail: [email protected]; [email protected]

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Discussion At the end of training, residents are expected to be competent in the six general competencies as defined by the Accreditation Committee for Graduate Medical Education (ACGME), one of which, professionalism, includes professional behavior and ethical principles. Despite this, the wealth of opportunities to teach ethics and professionalism during dermatology training is vastly underutilized. Indeed, in dermatology, these opportunities abound in the clinical setting, and much of this teaching can take place effectively outside the examination room door. The ad hoc teaching encounter in the clinic hallway can be brief but it is the perfect setting to discuss patient-centered ethical issues efficiently, effectively, and in timely fashion [1, 2]. The relationship between the clinical teacher and trainee is a symbiotic one. Students learn from their preceptors, and in the process of teaching and being challenged, teachers learn from their trainees. Not only should the residents and students receive feedback on their differential diagnoses and biopsy technique, but also on their professional interactions and their ethical judgment. It is in this setting that feedback, dialogue, and role modeling will have the most impact on the ethical and professional development of the next generation of dermatologists and other physicians. Ethical issues encountered in a private practice setting are especially compelling when compared to those experienced in academic outpatient settings. In a private practice: • physicians’ decisions can directly affect their compensation. In academic or other salaried settings, choosing to discount or not charge for services provided to indigent patients will likely not as directly impact the physician’s paycheck. • oversight of physicians in private practice is often limited in comparison with colleagues in large groups or academic practices. For example, in the former case, the physician decides whether or not to accept lunches sponsored by a pharmaceutical or device manufacturer, in contrast to enforced adherence to institutional policy in the latter instance. • freedom from oversight is accompanied by the assumption of full responsibility for decisions and

N.Z. Aldrich and E.N. Mostow

their consequences. There are no convenient ways to shift responsibility to “institutional policy” or institutional “indigent care programs”. Ethical concerns in the private practice setting are particularly relevant to dermatology. Data show that about 32% of allopathic and 50% of osteopathic dermatologists are in solo private practice and 8% practice in an academic setting [3, 4]. The rest are in single specialty or multispecialty group practices, with details of their institutional affiliations more difficult to determine. Interestingly, the percentage of dermatologists in solo practice seems to be declining in the younger cohorts [3]. Most dermatologic procedures are conducted exclusively in an office setting. Even some laboratory testing can be done in an office setting. The dermatologist can determine the appropriate fee and discount it for an indigent patient. In contrast, procedures done by surgical specialists in a facility setting might also generate facility fees, pre-operative testing charges, as well as anesthesiologist and pathologist professional fees which are not set or controlled by the surgeon. In the dermatology private practice setting, many visits are for cosmetic issues, creating a unique group of ethical concerns. Most practices, especially in primary care specialties, have few or no cosmetic procedures. The four cases presented at the beginning of the chapter show ethical dilemmas that are common place in any clinician’s practice. These are not rare conditions only seen in a tertiary academic center. Confronting them in the clinic or private office keeps the teacher “smart and honest”. The dilemma created by the patient’s demand in Case 1 relates to honesty, integrity, and the physician’s contractual or legal obligation to adhere to the insurer’s regulations. This could also lead into a discussion of health care costs. One way for the preceptor to model ethical behavior and professional integrity might be to say, “It’s not legal for me to bill something to your insurance that’s not medically necessary. I know you’d like them to pay, but I have a moral and contractual obligation to follow their rules. I’m happy to take care of it for you, but you would be responsible for the cost. Is that something you’d want done?” A discussion of this scenario after the patient leaves might include the physician’s moral and ethical obligations to the patient, to the insurer, and to society, as well as when,

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Teaching Ethics in Clinic: Keeping You Smart and Honest

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if ever, it is appropriate to lie for a patient, and how to deal with an insistent or angry patient in a similar situation. Case 2 illustrates a typical encounter with a pharmaceutical sales representative. One of the reasons this pharmaceutical representative is popular is her gregarious personality, combined with appropriate respect for the practice’s need to conduct patient care, excellent knowledge of the company’s products, and frequent lunches and bagels. The dilemma here is that the particular antifungal product being promoted is no more effective than at least four generic prescription topical antifungal creams and at least one that is available over-the-counter. The pharmaceutical representative then leaves a stack of “rebate cards” that instantly reduce the out of pocket cost to the patient to the lowest tier co-payment. Behaviors to model or discuss with the trainee, time permitting, might be respect and courtesy toward pharmaceutical representatives doing their job, cost-effectiveness of the topical medication, how to conduct a constructive dialogue with pharmaceutical sales representatives, the appropriateness of rebate cards, and issues related to the costs to patients, insurers, and the healthcare system as a whole. This is an ideal opportunity to discuss the broader issues of generic prescribing and how to decide when or if minor differences such as side-effect profile or bioavailability of branded products might justify their significantly higher cost. Case 3 brings up many issues relating to the care of indigent patients. It is a time to model altruistic professional behavior. It might be an ideal time for the trainee to learn systems based practice, one of the basic competencies, in the process of learning about resources for those who are indigent, such as use of samples, industry-sponsored programs supplying free medications to the indigent, free community clinics and hospital supported free care. It might lead to a discussion of volunteerism in medicine. Even the notion of not charging someone or charging a reduced fee carries ethical and sometimes legal implications, depending on whether the patient has some insurance (perhaps a plan with a very high deductible in case of catastrophic illness, but the family cannot reasonably afford to pay the deductible for office visits). Case 4 illustrates the common private practice issues of “first impressions” and addressing parental

desires. The iPLEDGE program for isotretinoin requires two effective forms of contraception for females taking the medication [5]. In this case, the dermatologist sees a teenager with hair dyed in a fuchsia color, dark painted nails, a provocative “tanktop” that exposes cleavage and a short skirt with eyecatching tattoos on both ankles, and makes assumptions regarding the patient’s sexual activity and likely compliance with iPLEDGE contraception requirements. There are many potential issues illustrated by this case to discuss with the trainee, including the potential for someone’s appearance to color one’s impression of their politics, morals or other behavior and thus impact one’s treatment choices. Other issues for discussion include addressing parental desires regarding treatment, as well as the informed consent process in regard to teratogenic drugs. In the case of isotretinoin, many of the treatment guidelines are mandated by the iPLEDGE program, which in this case allows the dermatologist to shift some responsibility for his or her policies to these requirements that are explicitly stated in the patient information booklet [5]. More germane to the teaching of dermatoethics, however, is discussion that might ensue related to the physician’s biases about their patients in general as well as their lifestyles and habits, and how such stereotyping might affect the medical care they deliver and clinical outcomes. Insight into one’s personal beliefs and biases are necessary to understand ethical issues and how they should be addressed.

Conclusion By discussing ethical dilemmas in the clinic and private practice setting, physicians not only educate others, but confront their own moral beliefs and ethical behaviors Being forced to verbalize their thought processes on such matters, rather than the rote following of patterns that have become ingrained, can help dermatologists better understand their ethical and professional obligations. The creation of a dialogue between the attending dermatologist and trainee can teach both new viewpoints and insights. The modeling of care that is in the best interests of the patient, delivered in a thoughtful and professional manner, and with respect for patient, family, and staff

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will not only enhance the practice environment but also pay great dividends in the ethical and professional development of the next generation of dermatologists.

References 1. Molodysky E. Clinical teacher training - maximising the ‘ad hoc’ teaching encounter. Aust Fam Physician. 2007;36: 1044–6.

N.Z. Aldrich and E.N. Mostow 2. Aldrich NZ, Mostow EN. Incorporating teaching dermatoethics in a busy outpatient clinic. J Am Acad Dermatol. In press, 2011, 3. Jacobson CC, Resneck JS, Kimball AB. Generational differences in practice patterns of dermatologists in the United States: implications for workforce planning. Arch Dermatol. 2004;140:1477–82. 4. Yoo JY, Lee H, Kimball AB. Practice patterns among osteopathic dermatologists in the United States. J Am Acad Dermatol. 2007;56:524–5. 5. IPLEDGE: Committed to pregnancy prevention. Public Home Page. 2007. http://www.ipledgeprogram.com. Accessed 19,Dec 2010.

Part IV Dermatologist as Businessperson

Boutiques, Botox®, and Basal Cells: Can Dermatology Set Its Priorities?

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Jeffrey J. Meffert and Maria Villegas

Case Scenarios

A patient with health insurance is seen by his family physician who is concerned about an unusually large and irregularly pigmented mole on his back. He is unaware that he had anything of concern there but is certain it was not there 5 years ago. New patient appointments with dermatologists who accept the patient’s insurance are 4–6 weeks in the future. Appointments with the same dermatologists for botulinum toxin injection are available less than a week and some even offer a Friday afternoon walk-in clinic for this. What are the obligations of the referring family physician? The patient? The dermatologist?

and inject different types of fillers. He also blocked off time from his clinic so he could learn to perform tumescent liposuction from an experienced dermatologist, receiving hands-on training. By the end of 3 years, because of the expansion of cash-pay cosmetic procedures in his schedule, he was not accepting any new patients. By the end of 5 years he had transferred the care of all his regular dermatology patients to other local dermatologists and the university health care system and had a practice “limited to cosmetic procedures”. In this practice, he performs botulinum toxin injections, filler placement, laser hair and leg vein removal, and outpatient liposuction, with patients paying by cash or credit card before treatment. His outcomes are good and patient satisfaction is high.

Case 2

Case 3

Dr. Jones did well in medical school and in his dermatology residency, passing his certification exam with ease. When he started his practice, he accepted patients with any dermatological complaints including some challenging patients who had medically complex skin disorders. Because his training program was not especially strong in cosmetic procedural training, over the next 3 years he attended a number of seminars to learn how to use several laser systems

Dr. Clark is known to participate as a speaker at “Dermatology for Primary Care” conferences. At a local dermatologic society meeting, Dr. Clark is taken aside by one of his colleagues and berated for encouraging substandard dermatologic care by primary care physicians. He feels these patients should instead be referred immediately to a dermatologist. Is that a valid concern?

Case 1

Discussion J.J Meffert (*) • M. Villegas Division of Dermatology and Cutaneous Surgery, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA e-mail: [email protected]; [email protected]

Both the American Medical Association (AMA) and American Academy of Dermatology (AAD) codes of medical ethics specifically state that one may not refuse to see patients because of race, religion, sexual

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orientation or specific disease states [1, 2]. In addition, the AAD code specifically states “The dermatologist may choose whom he or she will serve”. If one does not want to care for complex dermatological conditions such as immunobullous and collagen vascular diseases, one is not obliged to do so. If one prefers to spend the day injecting botulinum toxin (BTX), that is one’s prerogative. There is nothing inherently unethical or illegal about restricting one’s practice to cash-payment cosmetic procedures. A problem arises when no one else is willing to see the complex medical dermatologic cases and everyone prefers to only do cosmetic and procedural dermatology. Furthermore, our professional societies and political action committees advocate for primary access for patients because “no one knows skin like we know skin” [3]. Similarly, these groups engage in turf battles with other specialties for the unique right to utilize lasers, inject fillers, and administer BTX. There simply aren’t enough dermatologists to handle all of the medical, surgical, and cosmetic dermatology needs of the patient population. And yet, in its brochures, the AAD recommends that everyone have a professional skin examination annually. The fact that it is usually easier and faster to get an appointment for BTX than for a changing mole is concerning. The typical wait for a dermatology appointment varies widely with geographic location and generally is about 3–4 weeks [4]. A recent study looked at appointment availability in relation to cosmetic procedures and came to some troubling conclusions. The waiting time for a BTX appointment also varied widely with geographic location (6–32.5 days) but had a relatively short median wait of 8 days. The median wait for a “changing mole” was 26 days, essentially the same as any other appointment for a new patient [4]. As prevention, early diagnosis, and effective treatment of melanoma remain among the primary published goals of the AAD, a three-fold longer wait for a patient who may have a melanoma is morally and medically difficult to justify. It is likely true that if the referring family spoke personally to the dermatologist, describing the lesion and expressing his concern, efforts would be made to see the patient sooner. The problem with viewing this as a solution for this problem is that it usually requires expending precious clinic time for the primary care physician to contact the specialist, which frequently turns into a round of “telephone tag”. Although declar-

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ing every pigmented skin lesion a “rule out melanoma” might result in the anxious patient seeing the specialist a little bit sooner, it will eventually backfire with the dermatologists likely to dismiss the primary care physician’s concerns as overreaction or, at worst, disingenuous. Another option would be for the anxious patient to seek care outside his insurance network on a cash-pay basis. However, this may not help as studies showed the wait for non-cosmetic procedure evaluations was about the same for both insured and cash-paying patients [4]. The most direct solution for the problem of inadequate appointments for non-cosmetic dermatology would be to either teach dermatology to primary care physicians or to increase the availability of general dermatology appointments. Addressing the latter first, the yearly number of graduating dermatologists has changed little in the last two decades although the dermatologic needs of a growing and aging population have risen steadily [5]. In addition, perhaps because of the change in the age and gender of the dermatology work force, more dermatologists work part time and dermatologists devote a greater proportion of their practices to procedural and cosmetic dermatology. Surveys have shown that the percentage of time dermatologists report doing cosmetic dermatology (however that may be defined) is 10%. While this appears low, it does represent the loss of hundreds of thousands of potential medical dermatology appointments. Furthermore, 29% of dermatologists in practice do primarily surgical and cosmetic procedures [5]. A simplistic approach to solving the “too few appointments” dilemma is for dermatologists to eschew devoting precious patient slots to purely cosmetic procedures until they are caught up with the demand or there are more dermatologists available in the work force. However, many “medical” skin disorders have some cosmetic impact and several studies have shown psychosocial damage and diminished quality of life from chronic skin conditions [6]. In addition, medical and cosmetic concerns often overlap or co-exist. While some critics of boutique cosmetic practices feel they further divide the “haves” from the “have-nots” in our society, it is hard to argue that patients willing and able to pay for prompt and expert cosmetic care should be denied it [7]. There is also the possibility that the opportunity for a cosmetic practice might reduce physician burnout and keep some experienced physicians

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Boutiques, Botox®, and Basal Cells: Can Dermatology Set Its Priorities?

who were considering an early retirement in the workforce longer. The need for additional medical dermatology manpower is one of the factors driving the increase in the number of practices utilizing physician extenders (PE) for basic dermatology evaluations and treatments. Despite the increased availability of “dermatology” appointments, there are many obvious and significant limitations to depending upon PEs [8]. Specific, formal specialty level dermatology training is rare among PEs in the work force. There are only two dermatology physician assistant (PA) programs in the country and only one for nurse practitioners. While dermatology is integral to every Physician Assistant program, most of the dermatological skills the “Derm PA” employs are learned through on-the-job training and experience. It is ironic that one of the most contentious issues on the 2010 AAD ballot was whether graduates of osteopathic rather than allopathic residencies should be granted full fellowship in the AAD and whether they can properly call themselves “dermatologists”. One of the arguments opposing this change in status is that many osteopathic residencies have bordered on 3 year long private apprenticeships and that one cannot possibly learn all that what one needs to know with on-the-job training alone. No practice puts its PE on a three-year, 100% directly supervised probation period, not to mention a threeyear integrated academic and clinical traineeship. Each state has its own regulations about how many PEs a physician can supervise and how close supervision or records review must be. Implicitly acknowledging that PE’s are providing specialty level care, the American Academy of Dermatology has stated that “whenever possible” that a dermatologist should be physically on site and available to those PEs practicing dermatology in his name [9]. It is up to the individual physician to determine how much direct supervision, records review and restriction of scope of care each PE is subjected to. Even more contentious is the issue of training primary care physicians, who currently provide more than two-thirds of the non-malignancy-related dermatology care in this country [10], to be better “dermatologists”. Medical schools recognize some of these deficiencies, and primary care residencies have identified basic dermatology skills they expect their trainees to acquire [11, 12]. The American Board of Family Practice has specific guidelines about how

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much formal dermatology exposure a Family Practice residency is required to provide. The problem arises in prioritizing precious training time, especially in light of newer trainee manpower and work hour standards. The training emphasis is on inpatient and ambulatory family medicine skills. The result is that time devoted to specialty clinics such as dermatology is sacrificed, resulting in the newly minted primary care physicians being poorly prepared to handle the range and volume of dermatologic complaints they will see in practice. Trying to improve these skills is the goal of postgraduate dermatology continuing education for primary care physicians. For decades, courses in “Dermatology for Primary Care Physicians” have been among the more popular continuing medical education (CME) offerings. While some primary care physicians have the experience and training to provide this training, clinically experienced dermatologists who can connect with the needs of the audience are often the most sought after speakers. In a world in which there are enough dermatology appointments to satisfy everyone’s needs, one might argue that any act that encourages the care of skin disease patients by less experienced, less trained, or less efficient providers is ethically wrong. That, however, is not the world in which we live. Indeed, the number of available dermatology appointments for basic medical dermatologists may actually be declining as the workforce remains relatively static, more dermatologists are doing primarily cosmetic work, and more dermatologists are working part-time or retiring early. In the Hippocratic Oath, new physicians are exhorted to teach others their craft. There is nothing ethically wrong with doing all one can to ensure that patients with unmet dermatologic needs get the best care realistically possible, whether it is provided by the dermatologist, primary care physician, or a PE. Dermatology fellowship-like training programs for primary care physicians are controversial. These differ from combined residencies such as Internal Medicine and Dermatology or Pediatrics and Dermatology in which the graduate meets the requirements for certification in two specialties. Rather, these are programs, usually of limited length such as a year or less, in which the board certified or board eligible FP concentrates on dermatology in order to become a dermatologist surrogate either in the community or in a family practice training program. In 2010, there are only two such programs in the United States, one

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managed by a family practice physician and the other by a dermatologist. Together, these have not graduated even a half dozen physicians and they do not yet have recognition by the AAFP or the ABFP as accepted fellowships, in contrast to geriatrics or sports medicine. On the other hand, the United Kingdom recognized years ago that there would never be sufficient dermatologic manpower in that country and developed the “Special Interest” program in dermatology for their generalists. There are currently over 4,000 graduates providing dermatologic care as a bridge between the generalist in the clinic and the residency trained consultant dermatologist who is often hospital-based. Patient satisfaction with how it has increased access is generally favorable and outcomes data so far are encouraging [13]. Perhaps dermatology “fellowships” focusing on basic medical dermatology have a future in the United States as well. We do not require that only those dermatologists who have done cosmetic and surgical fellowships be allowed to do cosmetic procedures (although there is a movement to develop some specialty certification in procedural dermatology); by the same token, perhaps we should not insist that only certified specialists provide any sort of dermatologic care. A potential problem in training primary care physicians is that they too might be seduced by the prospect of shifting from “nuts and bolts” acne, psoriasis, and eczema to the more lucrative cosmetic procedures that are already impacting the number of available appointments with board certified dermatologists. This is a realistic concern. Unlike the FP sports medicine fellow who cannot easily start to perform total hip replacements, an FP dermatology fellow can always buy a laser or a filler kit. This concern has not been borne out in the UK experience but in the more entrepreneurial US medical environment, such a shift could negate any advantages of putting hybrid primary care physicians into the work force. An additional unintended consequence is that this might also reduce the number of physicians available for providing primary care by diverting them to more lucrative dermatology practice.

Analysis of Case Scenarios In case 1, there is an apparent incongruity when this patient will have to look at a possible melanoma of his own forehead four times longer than the surrounding

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wrinkles before accessing dermatological care. Our personal discomfort with this scenario alerts us to possible ethical concerns. How does the dermatologist decide how to deal with this patient if he actually showed up in the office for his botulinum toxin and also has a suspicious looking pigmented lesion on the forehead. How many dermatologists would proceed to inject BTX through a possible lentigo maligna melanoma, telling the patient to schedule a follow up appointment at a later date, so the suspicious lesion may be properly evaluated and biopsied? We would like to think that few, if any, would do such a thing but that is essentially the result of the current system of telephone triage when patients call for appointments. All clinicians should periodically observe how the phones in their offices are being answered. It is good business to ensure that every telephone encounter is effective and courteous. Dermatologists may discover, however, that the decision when to evaluate a patient with a changing mole is made by a receptionist working off a template that says the next new medical appointment is a month away and the next available initial cosmetic visit is next week. The primary care doctor who personally expresses concern about a suspicious lesion will usually get an expedited appointment time but telephone contact between two busy doctors may prove difficult to arrange. Responsibility for the care of this problem rests with a primary care physician until arrangements have been made for specialty consultation. The fact that the current system delays this hand-off is unfortunate but irrelevant should the patient come to misadventure before a referral or consultation is completed. In communities where specialty access is limited, primary care physicians may wish to provide some basic specialty care in their practices. This requires proper training to ensure this care is as competent as possible. In case 2, there is nothing unethical about what Dr. Jones has done. In contrast to many dermatologists who offer cosmetic procedures with little or no training, Dr. Jones sought out extra experience and mentoring so that he could practice safely and effectively. He has responsibly handled turning over the care of his medical and surgical dermatology patients to colleagues. Long term, the specialty should look to increasing the number of trainees so that we can afford to lose a few to well run cosmetic practices while working to ensure that “cognitive dermatology”, those aspects of dermatology that require a well-trained and

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Boutiques, Botox®, and Basal Cells: Can Dermatology Set Its Priorities?

experienced clinician, are appropriately compensated. Ultimately, even if there is near unanimous consensus throughout the community of practicing dermatologists that the care of cutaneous malignancies should take precedence over elective cosmetic procedures, there is little will as a specialty to define these expectations, much less enforce them. Significant systemic changes will be slow and difficult to enact. Training more dermatologists takes time, faculty, and money, all of which tend to be in short supply. There certainly are more than enough qualified applicants to fill several extra residency programs but government policy and Medicare funding that supports the majority of training positions in the United States, regards training of primary care physicians as a higher priority, and is due to be radically cut over the next few years in an effort to reduce Medicare expenditures. Turning to the pharmaceutical and medical device industry for this extra funding is tempting but there will always be a quid pro quo expected beyond just expanding the supply of dermatologists. The fastest and most effective systemic change would be for the dermatologic community to develop a sense of obligation to devote more appointment slots to general dermatology even if affects the “bottom line”. Case 3 is more problematic because arguments on both sides of the issue have merit. Dermatologists do provide better dermatological care than non-dermatologists. It is equally true that there are not, nor will there be in the foreseeable future enough specialist appointments to meet society’s needs for dermatologic care. Primary care physicians frequently provide dermatologic care because they must, and it is our obligation to ensure that our patients receive the best care possible even if it runs counter to self-interest. A family physician cannot be considered equivalent to a dermatologist nor, for that matter, is a PE working in a dermatologist’s office. To be an independent consultant for complex dermatologic disease requires comprehensive specialty training. On the other hand, primary care physicians and PEs can be taught enough to serve the less complex patients or to safely inject BTX. Our emphasis should be as educators improving dermatological competence and care rather than as competitors trying to carve out procedural exclusivity. A recent French study found that patients who waited until their primary care doctors referred them to the dermatologist had more advanced melanomas than

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those who were self-referred [14]. Patient anxiety over early lesions may partly explain this but one of the other conclusions of the study is that we are duty bound to teach primary care physicians how to better recognize malignancies and know when to refer for specialty care. Unless and until we are willing and able to see all dermatology patients ourselves, we must be supportive of our colleagues trying to do more themselves and do it more effectively. There is nothing unethical about teaching fellow professionals, dermatologists, primary care physicians, PEs, and any others involved in patient care, to better serve our patients in need.

Conclusion The public perception, now confirmed in the scientific literature, that it is easier and faster to get an appointment for cosmetic botulinum toxin injection than one to evaluate a possible melanoma poses a challenge to the specialty of dermatology. Addressing this disparity will require significant changes in the attitudes and priorities of many dermatologists; additionally, changes in the financing of graduate medical education may also be required. The demand for dermatological advice and treatment far outstrips specialist availability and will do so indefinitely. Primary care physicians and physician extenders will continue to deliver dermatologic care. Dermatologists are duty-bound to ensure that those providing this care are as well trained as possible.

References 1. American Medical Association. AMA Code of Medical Ethics, opinion 10.05– potential patients. Adapted November 2007. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics/opinion1005.shtml . Accessed 14 Mar 2010. 2. American Academy of Dermatology and AAD Association. Administrative Regulation, AAD Code of Medical Ethics for Dermatologists, last revised 4 November, 2006. http:// www.aad.org/Forms/Policies/Uploads/AR/AR%20 CODE%20OF%20MEDICAL%20ETHICS%20FOR%20 DERMATOLOGISTS.pdf. Accessed 25 Feb 2010. 3. American Academy of Dermatology and AAD Association. Position statement on access to specialty care and direct access to dermatological care. Approved March 21, 1997, 2006. h t t p : / / w w w. a a d . o rg / Fo r m s / P o l i c i e s / U p l o a d s / P S / PS-Access%20to%20Specialty%20Care%20and%20 Direct%20Access%20to%20Dermatologic%20Care%20 6-15-06.pdf. Accessed 14 Mar 2010.

136 4. Resneck Jr JS, Lipton S, Pletcher MJ. Short wait times for patients seeking cosmetic botulinum toxin appointments with dermatologists. J Am Acad Dermatol. 2007;57:985–9. 5. Kimball AB, Resneck Jr JS. The US dermatology workforce: a specialty remains in shortage. J Am Acad Dermatol. 2008;59:741–5. 6. Hong J, Koo B, Koo J. The psychosocial and occupational impact of chronic skin disease. Dermatol Ther. 2008;21:54–9. 7. Brennan MP, Troyen A. Concierge care and the future of general internal medicine. J Gen Intern Med. 2005;20:1190. 8. Resneck Jr JS, Kimball AB. Who else is providing care in dermatology practices? Trends in the use of nonphysian clinicians. J Am Acad Dermatol. 2008;58:211–6. 9. American Academy of Dermatology and AAD Association. Position statement on the use of non-physician office personnel. Last amended 23 July 2005. http://www.aad.org/ Forms/Policies/Uploads/PS/PS-Use%20of%20NonPhysician%20Office%20Personnel%206-15-07.pdf . Accessed 25 Feb 2010.

J.J. Meffert and M. Villegas 10. Distribution of U.S. office visits for skin complaints (excluding neoplasms) by specialty provider: dermatology, primary care physicans, 2000–2009. IMS Health, IMS National Disease and Therapeutic Index, 4Q, 2001–2009. 11. Hansra NK, OSullivan P, Chen CL, Berger TG. Medical school dermatology curriculum: are we adequately preparing primary care physicians? J Am Acad Dermatol. 2009;61:36–8. 12. Awadalla F, Rosenbaum DA, Camacho F, Fleischer Jr AB, Feldman SR. Dermatologic disease in family medicine. Fam Med. 2008;40:507–11. 13. Salisbury C, Noble A, Horrocks S, Crosby Z, Harrison V, Coast J, et al. Evaluation of a general practitioner with special interest service for dermatology: randomized controlled trial. BMJ. 2005;331:1441–6. 14. Durbec F, Vitry F, Granel-Brocard F, Lipsker D, Aubin F, Hedelin G, et al. The role of circumstances of diagnosis and access to dermatological care in early diagnosis of cutaneous melanoma. Arch Dermatol. 2010;146:240–6.

The Price Is Right: Ofﬁce Dispensing and Product Pricing

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Tivon Sidorsky

Case Scenario Case 1 Dr. Medbizi has worked as a general dermatologist at Dermethica Practitioners, a small suburban dermatology group practice, for 2 years since completing his residency training. Although the practice has remained financially stable, the group would like to increase profitability. Dr. Medbizi has spoken to a number of his colleagues working in other practices, and many of them note that their practices profit substantially from selling skin care products. In fact, after researching this concept further, Dr. Medbizi finds that approximately 40–70% of all dermatology practices dispense products from their offices [1–3]. Many of the articles suggest that office dispensing not only generates profit for the medical practice, but also benefits patients in several ways. Should Dr. Medbizi recommend that Dermethica begin selling skin products from the office?

Case 2 Dr. Medbizi and Dermethica decide to dispense products out of the office, and this dispensing business makes a significant contribution to the practice’s profitability. While Dr. Medbizi is pleased with the financial success of Dermethica’s office dispensing, he T. Sidorsky Department of Dermatology, University of California, San Francisco, CA, USA e-mail: [email protected]

begins to question the methods they use to price their products; Dermethica had simply followed the advice of suppliers and added a 100% mark-up to the purchase price for all products. Dr. Medbizi wonders: What are the factors determining the different prices that various stakeholders pay for a product? Additionally, would it be ethical for Dermethica to use the same pricing strategy employed by most retail firms? Dr. Medbizi refers back to the American Academy of Dermatology (AAD) position statement (Table 23.1) [1] and notes the last item, which claims that it would be unethical to charge patients an “excessive” mark-up rate on products sold in the office. Two major questions emerge: Is the current rate over the purchase cost to Dermethica an “excessive” mark-up to patients? If so, how should Dermethica determine what to charge for each product?

Ofﬁce Dispensing in Dermatolgy While dermatologists have been dispensing products from their offices for decades, the practice has only more recently attracted greater attention and scrutiny. In 1998, it was estimated that approximately 40–70% of dermatologists practiced office dispensing, and that number has likely increased over the last decade [1–3]. A 1998 California Dermatology Society survey revealed that 83% of 297 physicians felt that office dispensing of nonprescription products was ethical [3, 4]. Because most states prohibit office dispensing of prescription medications, the vast majority of practices dispense only over-the-counter products in the office. The items most commonly sold include cleansers,

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Table 23.1 American Academy of Dermatology Position Statement on Dispensing

Opponents

•

The fundamental arguments against office dispensing are that it: 1. Compromises the physician-patient relationship and coerces (even if subconsciously) patients to purchase in-house products through the physician’s unavoidable conflict of interest; 2. Is unlikely to offer products sufficiently different from more readily available products to warrant either the ethical drawbacks or the price mark-ups commonly charged; The American Academy of Dermatology (AAD) has also issued a position statement on the topic of office dispensing (Table 23.1). The overriding theme is that office dispensing is ethical only when done in such a way that it is clearly in the patient’s best interests.

•

•

1. 2.

3.

4.

5. 6. 7. 8.

Dermatologists should not dispense or supply drugs, remedies or appliances unless it is manifestly in the best interest of their patients. Dermatologists who dispense in office should do so in a manner with the best interest of their patient as their highest priority, as it is in all other aspects of dermatologic practice. It is ethical to dispense, by sale, prescription or nonprescription drugs, to patients in a dermatologist’s office except in the following circumstances: When the dermatologist places his/her own financial interests above the welfare of his/her patients. When creating an atmosphere which is coercive to patients such that they feel compelled to purchase drugs from the dermatologist. When dispensing drugs under a dermatologist’s private label without clearly listing the ingredients, including generic names of the drugs. When dispensing to patients drugs which are easily available at proprietary pharmacies without advising patients of this availability. When representing drugs as being a special formula not elsewhere available, when this is not the case. When selling health-related products whose claims of benefit lack validity. When refusing to give refills of drugs except when they are purchased from the dermatologist. When charging patients at an excessive mark-up rate.

Approved by the Board of Directors October 12, 1998; amended by the Board of Directors September 26, 1999 [1]

moisturizers, anti-aging products, sunscreens, and acne treatments [3, 5].

General Arguments for and Against Ofﬁce Dispensing Proponents The most common arguments provided by proponents of office dispensing are that such a practice: 1. Offers patients convenience; 2. Improves treatment compliance; 3. Supplies high quality products at a justifiable price; 4. Provides patients with access to professional knowledge about the products

Case Analysis Case 1 Deciding whether or not to enter the office dispensing market presents a number of ethical challenges. Ultimately, Dr. Medbizi must decide whether he feels confident that dispensing medical products at Dermethica Practitioners will provide an overall net benefit to patients without compromising ethical standards. On the one hand, if he does indeed believe that office dispensing could offer his patients significant value, it may be possible to mitigate some of the potential ethical concerns raised by opponents through the use of disclaimers, acknowledging conflicts of interest, and comprehensively informing patients of their options. On the other hand, this would not allay opponents’ concerns about coercing patients, redefining the dermatologist as a business person. Lastly, the degree to which Dr. Medbizi believes office dispensing will benefit Dermethica’s patients will depend on the unique demographics of the patient population, and the environment in which the practice is located. One could imagine, for instance, how the extreme ends of the spectrum for certain variables such as pharmacy availability, product variety and availability within pharmacies, and patients’ willingness to pay for certain conveniences could affect the potential value office dispensing offers to patients. Dr. Medbizi should have a strong understanding for how these variables

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affect Dermethica’s clientele before making a recommendation for or against office dispensing to his colleagues.

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Financial Relationships in the Pharmaceutical Supply Chain Unique Supply Chain Features in Dermatology Ofﬁce Dispensing

Product Pricing in Ofﬁce Dispensing Primary Considerations It may seem that determining the appropriate price for a product should be quite straightforward: Mark up the product over the price paid to the supplier to maximize profits. Total profits from product sales are equal to the profit margin on the product (the price charged to consumers less the price paid to suppliers) multiplied by the quantity of product sold. By understanding the demand curve (the relationship between price and quantity demanded) and the price elasticity of demand (the percentage change in quantity demanded for a product resulting from a 1% change in price for a product) for a product, firms can estimate how different price points affect the quantity of product sold. Should the price simply be set based on the optimal balance between margin and quantity to achieve maximal total profits? It may be argued, however, that healthcare providers should not function merely as profit-maximizing entities. Unlike traditional retail stores, health care providers exist principally to promote patient health—rather than maximize profit. Accordingly, product sales should further the goal of patient health ahead of that of maximizing profit. The AAD statement on office dispensing underscores this point: “Dermatologists should not dispense or supply drugs, remedies or appliances unless it is manifestly in the best interest of their patients.” Rather than simply maximizing profit, physicians dispensing products must consider the physician’s moral and fiduciary responsibility toward the patient. There are a number of forces beyond the healthcare provider’s control that influence the price charged to the consumer: raw materials expenses, manufacturing costs, transportation charges, and similar considerations. Indeed, the supply chain cost, as well as that for the physician to dispense the product, determine the minimal price; any lower pricing would not be economically viable for the manufacturer, distributor, or physician. With this dynamic in mind, it is then possible to discuss an ethically-based pricing model for providers.

The dermatology office is a unique retail environment. First, the products sold in dermatology offices are generally non-prescription. As such, the supply chain dynamics may differ from relationships influencing the price of prescription products. Most end-users pay for office dispensed products out-of-pocket—health plans and pharmacy benefits managers play much less of a role, if any. There are a number of smaller manufacturers and distributors that are relatively prominent players in supplying office dispensing practices, and many specialize in manufacturing and distributing dermatologic products [3]. Second, compared to prescription pricing, there is considerably less governmental regulation of over-thecounter (OTC) products. Systematic cost control is not a central issue for OTC products, as the vast majority of health care expenditures related to medication are attributable to prescription medications [4]. Lastly, while many of the products sold in offices are exactly the same as those available elsewhere in the retail market, many are “customized”, created and labeled as a provider’s own product line. Of note, the Food and Drug Administration (FDA) requires premarketing approval for all products that they classify as “drugs” or “high-risk devices” based on safety and efficacy data, but they do not regulate cosmetic products; such items need not be filed with the FDA and do not require premarketing approval [5]. Customized products may be very similar or even identical to mass market products with respect to their active ingredients, and may be classified as either a drug or cosmetic. However, there is considerably less transparency or accessible information for consumers to compare such products head to head on quality and cost. Thus, the determination of value for these products is highly anecdotal, and the exact market forces supporting the price structure are much more opaque. The result of this murkiness is that consumers face highly variable prices in office dispensing, while providers may or may not be charging “excessively” high premiums. While, the AAD position statement on office dispensing states that it is unethical to charge an “excessive” mark-up rate on

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products sold in the office, the definition of “excessive” is unspecified, and determining what is “excessive” from an ethical standpoint is unclear.

An Approach to Product Pricing for Ofﬁce Dispensing in Dermatology One possible approach to determining an “ethical,” or at least non-excessive, mark-up for the product would be to determine its Economic Value to the Customer (EVC). That is, what is this product worth to patients to have it available from a dermatologist’s office. If a dermatologist purchases a product directly from a manufacturer, then the patient pays a price reflecting the manufacturer’s wholesale price plus the margin collected by the dermatologist. However, the manufacturer might use a distributor, who then sells the product to the dermatologist. The exact price that is available to the dermatologist again depends on the ability to negotiate discounts from various players. In general, small practices have very little negotiating power, and even larger multi-member practices may have difficulty negotiating a significant discount. Thus, in some cases the patient may face the added margin costs of a distributor along with those of the manufacturer and office dispenser. Manufacturers often suggest that dermatologists sell products at a 100% mark-up on the wholesale price. Again, because the manufacturer and distributor must profit from sales to the dermatologist, the patient likely faces a price that is at least 200% (and typically approaches 300–600%) greater than the cost of production [6]. It may initially seem unreasonable that a patient should face mark-ups over 300%. A few key questions must be addressed when considering the eventual price a dermatologist charges: 1. Is the product available elsewhere in the mass market? 2. If so, what is the market retail price? 3. Does the option to purchase this product directly from the dermatologist “add value” to the product? 4. If so, how much is this “added value” worth? 5. If the specific product is not available elsewhere, does a similar “reference” product exist in the mass market? 6. If so, what is the market retail price of the “reference” product? 7. If the “reference” product is deemed to be of lesser quality than the product offered by the dermatolo-

T. Sidorsky

gist, how much is the “added value” of the dermatologist’s product worth? 8. If the products are of equal quality, does the option to purchase this product directly from the dermatologist “add value” to the product above the value of the “reference” product? 9. If so, how much is this “added value” worth? 10. With questions 1–9 in mind, what is the product’s Economic Value to the Customer (EVC) where • EVC = the fair price of the product • EVC = Reference Value + Added Value • Reference Value = the price of the similar “reference” product available in the mass market. • Added Value = the justifiable additional price (monetary worth) of the product above that of the “reference” product. Calculating the reference value is simple—it is the retail price of the reference product charged in the mass market. Conversely, calculating the added value is slightly more complex, and unfortunately, often quite subjective. Some components of added value are easier to define. Such a value component might include the cost of a separate trip to the retail store, including both the cost of transportation and the opportunity cost of taking the time to make the trip. However, determining other components of added value such as the marginal superior quality of the product, the added quality control, fewer adverse reactions, the sense of security bestowed on the patient, or the simple convenience of purchasing in the office despite nearly negligible transportation and opportunity costs of buying in the mass market, may be much more difficult. Ultimately, it could be argued that in order for a dermatologist to avoid charging an “excessive” markup rate to patients they must consider all of these variables thoroughly in order to eventually arrive at an ethical price point for their office dispensed product. Thus, if dispensing dermatologists cannot clearly describe and justify the calculation of their added value, they should probably not sell the product, or should at least rethink the pricing of the product.

Case Analysis Case 2 Dr. Medbizi can do little about the supply chain markups built into the price he ultimately faces from Dermethica’s suppliers. However, he does have control

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over the final mark-up he presents to his patients. Dr. Medbizi needs to realize that the flatly applied 100% mark-up suggested by suppliers is not necessarily an ethical approach for Dermethica’s office product pricing. This industry standard is largely a marketing tactic to entice dermatologists to pursue product dispensing, and in the face of substantial profit potential, many dermatologists blindly apply this mark-up without considering an ethical justification. Given the unique ethical considerations of selling healthcare products, such a methodology fails to consider both the product’s value to patients and the product’s value compared to references in the market. Dermethica needs to profit from product sales to justify the business venture, but this margin must be ethically valid on the basis of its added value to patients. Dr. Medbizi could set out to apply the pricing methodology described above, starting, for example, with Dermethica’s acne treatment product. Suppose Dermethica pays $10 per container of this product. And suppose Dr. Medbizi calculates the average price of reference products in the mass market to be $12. He could then attempt to monetize the addedvalue of Dermethica’s product. In this case, assume Dermethica’s product formulation carries a slightly higher concentration of active ingredients than products available in the mass market. If, for instance, Dr. Medbizi has data demonstrating that this increased potency requires only 15 applications versus an average of 20 applications of the same product volume of reference product to achieve similar clinical results, he could likely justify a 25% markup ($3) over the average reference product price. Let’s also assume Dr. Medbizi believes that because Dermethica’s product formulation contains fewer allergenic inactive substances, patients will experience up to 5% fewer allergic reactions than those resulting from the reference products. While this seems like it may add value to the product, he may have trouble assigning a monetary value to this potential benefit. Not all allergic reactions result in economic cost to patients, and he has not yet collected enough data to support this claim. Lastly, if Dermethica patients have relatively easy access to a nearby pharmacy, it would be difficult for Dr. Medbizi to justify increasing the price of their product on the basis of saving patients travel expenses. Through this analysis, Dr. Medbizi could reasonably justify a 25% mark-up over the reference product price of $12 based on the added value afforded by

greater potency, and should re-price Dermethica’s acne treatment product at $15. Note that this new price is only a 50% (compared to the previous supplier-recommended 100%) mark-up over the cost of the product to Dermethica. Lastly, dermatologists must keep in mind that beyond the cost of purchasing a medical product, there may be many additional direct costs and opportunity costs incurred from an office dispensing business. It is tempting to justify adjusting product mark-ups to cover these costs of doing business. However, it should be realized that such a mark-up does not bring additional value to the patient, and thus should not be charged. Taking this into account, it is both economically and ethically advisable to be sure that the justifiable markup charged to patients on the basis of added-value alone produces a net profit above all office dispensing business costs.

Conclusions Product pricing is a critical consideration for providers who choose to dispense medical products. Financial relationships within the product supply chain largely dictate the eventual price an end-user faces. While there are certainly differences between the supply chain dynamics for prescription and non-prescription products, some general concepts apply to both industries. Margins must be collected by manufacturers, wholesale distributors and retailers in order for products to be available on the market. These margins largely determine the price a consumer pays for the product. However, the degree to which each supply chain player influences the final product price through their margin contribution is central to a discussion of ethical pricing methodology. For prescription products, there tends to be a greater degree of regulation than there is for nonprescription products. Non-prescription products may also be much more difficult for consumers to compare systematically. There is much greater product variability and less transparency. For non-medical retail products, supply chain dynamics and pricing strategies are somewhat similar to those for medical products. From an ethical standpoint, however, it often seems less palatable to accept a pricing strategy that is fundamentally most concerned with maximizing profits when the product is intended to improve health. From a retailer’s perspective, the

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most appropriate price strategy is simply the one that produces the greatest profits for the firm. However, informational asymmetries between physicians and patients, lack of transparency related to product value, the physician-patient relationship, a physician’s fiduciary responsibility to the patient, and the physician’s duty of non-maleficence raise ethical issues related to applying a similar pricing methodology for products dispensed in the office. Patients must be able to trust that their physicians are always acting in the patients’ best interests. It is the physician’s professional obligation to ensure that this trust necessarily extends to all aspects of physician-patient transactions, including the recommendation and sale of healthcare products. This sales dynamic is uniquely different from commodity retail sales in that the product price should represent the physician’s consideration and endorsement of the product’s value to the patient, not merely the price that most benefits the physician’s bottom line. It is not fundamentally unethical for a physician to profit from products sold in their office, but the margin they build

T. Sidorsky

into the final price must be justified by adding value through features of the product itself or the service of selling it at the point of care.

References 1. American Academy of Dermatology and AAD. Association position statement on dispensing. http://www.aad.org/Forms/ Policies/ps.aspx. Posted 26 Sep 1999. Accessed 23 Oct 2011. 2. Follow the pill: understanding the U.S. pharmaceutical supply chain. http://www.kff.org/rxdrugs/7296.cfm. Posted 14 Mar 2005. Accessed 21 Mar 2011. 3. Farris PK. Office dispensing: a responsible approach. Semin Cutan Med Surg. 2000;19:195–200. 4. National Center for Policy Analysis. Patient power: over-thecounter drugs. http://www.ncpa.org/pub/ba524. Posted 22 Aug 2005. Accessed 23 Oct 2011. 5. Morganroth P, Wilmot AC, Miller C. JAAD online. Overthe-counter scar products for postsurgical patients: disparities between online advertised benefits and evidence regarding efficacy. J Am Acad Dermatol. 2009;61:e31–47. 6. Draelos ZD. The dermatology dispensing debate. Skin Therapy Lett. 2007;12:1–3.

My Elixir, MD: Morphing a Medical Degree into a Skincare Brand

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Julie Cantor

Consumers are willing to pay top dollar for perfect, ageless skin. In recent years, perhaps drawn by an implicit promise of staying forever young, they have paid billions upon billions of dollars for skincare products [1]. Some dermatologists have jumped into this lucrative market and developed their own skincare lines. According to a recent New York Times article, over the past decade, “nearly two dozen dermatologist skin-care brands have appeared in stores” [2]. Young dermatologists may even aspire to create an eponymous product line, given the pseudo-celebrity status of doctors who do just that [3]. When, if ever, is it ethical for dermatologists to develop and sell a product line? Although the academic literature discusses the ethics of selling skincare products in a medical office [4], few articles address the problems that arise when dermatologists sell their own product lines. This chapter explores those issues.

Case Scenarios Case 1 Two dermatologists develop an “anti-aging” skincare line with safe ingredients that are found in other skincare products. The product includes certain antioxidants that may have beneficial effects [5]. They trademark and use the name, Physician’s Own, and J. Cantor UCLA School of Law, Los Angeles, CA, USA e-mail: [email protected]

sell their products in their medical office, online, and in high-end department stores. They extol the product line’s virtues in infomercials, and they are careful to follow the legal distinctions between pharmaceuticals and cosmeceuticals, keeping their product firmly in the camp of the latter [6]. Their product line has not been evaluated by randomized, double-blinded, and placebo-controlled trials because, they say, it would be “too expensive” to do so. Their advertising campaign relies on testimonials and their own “clinical study” of non-blinded physician assessments of patient photos at 0, 4, and 8 weeks to support claims that the products “improve the appearance of agerelated skin changes.”

Case 2 Two dermatologists develop a cosmeceutical skincare line. They design and execute three randomized, double-blinded, and placebo-controlled trials and publish the marginally positive results in peer-reviewed journals. They sell the products to their patients and the public. They also make it plain that the creams are not a panacea and are not a medicine. But, they say, “We like this product, and you might too.”

Discussion: General Principles The Council of Medical Specialty Societies published a consensus statement that discusses the “core values and principles” of medical ethics that specialists should follow [7]. That statement begins with the premise that “[t]he practice of medicine is rooted in a covenant of

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trust among patients, physicians and society” and, as a corollary to that idea, physicians should treat patients with “honesty, compassion, dignity and respect for individual autonomy.” Further, it argues, physicians “have a responsibility” to maintain moral integrity and intellectual honesty, and they also have a responsibility to educate patients about health issues. Although the statement does not discuss what physicians receive in return for adhering to these principles, there are clear practical and tangible rewards for practicing medicine—among them, recession-proof job security, public admiration along a continuum from respect to reverence, and a reliably strong salary. In addition, it seems fair to posit that physicians have an obligation to be true to science, to translate complex medical research findings for their patients, and to refrain from taking advantage of trusting patients who are not inclined to research or dispute physicians’ recommendations. Also, in the interest of informed consent, physicians have an obligation to present relevant and accurate information to their patients and to offer treatment recommendations. At base, these guiding ethics are those of respect, service, and honesty, and they follow what are currently considered to be core tenets of medical ethics—beneficence, nonmaleficence, autonomy, and justice [8].

Case Analysis The cases present two contrasting approaches—and surely, there are others—to developing and marketing a physician product line. The first case includes a number of ethical red flags. Notably, the product line is devoid of evidence-based support. The single observational study suffers from implicit biases: it lacked controls, and the physicians who evaluated the patients had an interest, financial and otherwise, in the efficacy of the products. In truth, the product may or may not work. The rationale for the lack of controlled testing— cost—is suspect. Even if the creation of a placebo version of the product was truly too expensive, the study design could have called for application of the product on only half of the face with the other half serving as a control. Alternatively, an inexpensive moisturizer without the active ingredients of the product could have been used as a control. Further, randomization and blinding may be time-consuming, but they are not necessarily prohibitively expensive.

J. Cantor

In addition, the brand name aims to associate the product with the medical profession and the positive associations that flow from it. The white-coat endorsement is a marketing tool; if the aura of medicine did nothing, there would be no reason to invoke it. Any physician endorsement of a product, through the product’s name or otherwise, necessarily basks in the reflected glory of the public’s trust in doctors and the medical profession. And, arguably, the invocation of medicine implies that the product works. Although puffery may be legally acceptable in ads for cosmetics, for physicians, it is unseemly. Patients need unvarnished scientific truths to inform their decisions. Further, the lack of evidence in support of the products is not necessarily clear to patients and the public. A physician-created or –endorsed brand that does not actually do what it professes runs afoul of principles like intellectual honesty and beneficence. Physicians who create products that lack scientific support seem to be sullying the trust that the public has in the profession. They cheapen the profession. While physicians should be compensated for their work, and entrepreneurs should be rewarded for their innovations, the physician-entrepreneurs who associate themselves with products that have no data behind them are doing little more than hawking wares like the snake-oil salesmen and quacks of yesteryear. Would the medical community and the public approve of a surgeon who created a system of wound care that had no data to support its use and then sold it à la carte to her own post-operative patients, other doctors, or the public at large? Further, patients may begin to question whether other physicians’ decisions are truly in their best interest—or the physician’s own. Some people see through the ruse, and doctors lose their credibility. Others are not so insightful or sophisticated. At base, the principle is a simple one: do not make unsubstantiated claims. Ethics requires doctors to be more than just salespeople with an M.D. Their behavior must be worthy of the public’s trust. These concerns emerge in stark relief when the products are prohibitively expensive and the physician stands to rake in huge profits. The second case illustrates the better approach to product development and marketing. Those dermatologists followed a scientific approach to testing, published their results in peer-reviewed journals, and disclosed the shortcomings of their product. Those checkpoints serve as markers of intellectual honesty. Indeed, the physicians are upfront about

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My Elixir, MD: Morphing a Medical Degree into a Skincare Brand

the evidence that exists to support the product’s efficacy, and they focus their sales pitch on preference, not performance. That said, selling products—regardless of their efficacy—is fraught with ethical perils, and both cases illustrate an inherent conflict of interest. The conflict exists even when the science is strong. Assuming that they do not donate their profits to research or philanthropic causes, when these dermatologists sell their products, the physicians make money. It is only natural that their recommendations about products that fill the same market niche as their own may be less likely to be neutral. As an article about ethics in dermatology suggested, “Financial incentives are dangerous. We have learned painfully that physicians respond to them. In a fee-for-service system they may order too many tests and procedures; in a capitated system they may order too few. When physicians have a stake in a laboratory, they send their patients there for studies, and when they have a financial interest in a hospital, they admit their patients there” [9]. Those perils may be magnified when the product at issue is elective. Although it is true that physicians’ treatment recommendations may be inherently conflicted—surgeons get paid to operate, for example, so perhaps they are more likely to recommend surgery—malpractice concerns may serve as a check on self-dealing. Few surgeons would want to be brought to task for recommending treatment that is unnecessary or not the standard of care but lines their own pockets. One solution to the conflict here, assuming that the science behind a product is strong, is not to engage in the behavior. Don’t sell products. That rule applies to other professions and fiduciaries. Because of the inherent biases, self-dealing is generally frowned upon and often banned for those who act as fiduciaries with a duty to act in another’s best interests—judges and trustees among them. A less restrictive solution is to disclose the conflict. For physicians who choose to sell their own elixir, they should disclose the financial conflict. As an editorial in the Archives of Dermatology recently stated, “All dermatologists should be expected to make known any financial ties they have to products or procedures that they are promoting, advertising, or marketing to their patients. Failure to disclose this information is a blatant conflict of interest and makes valid informed consent on the part of the patient impossible” [10]. If their product is a for-profit line, they should also disclose that fact.

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In addition, patients should be told that it may just be the act of consistently following a skincare regimen that has an effect, not the act of consistently following a particular skincare regimen. And although caveat emptor is a useful motto for the buying public, that warning is diluted by the physician endorsement of a product. The public implicitly trusts physicians, and dermatologists who derive even a modest income from a product line are capitalizing on that trust. The honest and scientific approach to product development—not to sell products at all, and if you do, to make sure they work—may not be popular. The sales pitch is tempered, and the requirements are stringent. But dermatologists have another option. Create “Elixir”—not “Elixir, MD”—and sell it outside of the medical environment. Great products need no MD endorsement; the market will find them. If that idea is cringe-worthy, then another gut-check is the “residency application” litmus test: If the product line is not something that you would be proud to write in your residency application (“I hope to create an expensive skin care line with no proven benefits and sell it under my name, with the M.D., out of my office to patients who are not sophisticated enough to know the difference between randomized controlled trial data and a case study….”), then ethics likely precludes it. The FDA may allow these products to be created and marketed by physicians, but just because a dermatologist can do something doesn’t mean that he or she should do something.

Conclusion Dermatologist Zoe Diana Draelos described her experience at a recent dermatology meeting where lecturers extolled the virtues of various expensive devices without disclosing their conflicts of interest. After the lectures, she learned that one speaker was a stockholder of the manufacturer and was praising a soon-to-beoutdated device, and another speaker “actually owned the company that made the device” [11]. Dr. Draelos argues for transparency and honesty, and she suggests that this kind of information might save dermatologists “from making the wrong expensive purchase” of equipment. That standard of honest and full disclosure, one that physicians want for themselves, should apply to dermatologists who sell wares to patients and the public.

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The pull of profits is nothing new to physicians. But it cannot be a primary motivation. Science and patients should come first. As Sir William Osler once said to students of medicine, if you “seek your own interests, make of a high and sacred calling a sordid business, regard your fellow creatures as so many tools of trade, and, if your heart’s desire is for riches, they may be yours; but you will have bartered away the birthright of a noble heritage, traduced the physician’s welldeserved title of the Friend of Man, and falsified the best traditions of an ancient and honourable Guild” [12]. Put plainly, as one physician told the New York Times over a decade ago, “Doctors are given certain privileges and respect in our society because their primary motivation is patient well-being, and if you misuse those privileges to increase profits, it’s unethical” [13]. Indeed, it is.

References 1. NPD reports U.S. prestige beauty industry posts declines across the board in 2009. http://www.npd.com/press/ releases/press_100323.html. Accessed 5 Jun 2010. 2. Singer N. Skin deep: a word from our sponsor. New York Times. 25 Jan 2007.

J. Cantor 3. Williams A. Up close: a dermatologist to the stars calls on them to heal Haiti. New York Times. 26 May 2010. 4. Castandeo-Tardan MP, Baumann L. Ethics of selling skin care. Clin Dermatol. 2009;27:355–8. 5. Junkins-Hopkins JM. Antioxidants and their chemopreventive properties in dermatology. J Am Acad Dermatol. 2010;62:663–5. 6. Newburger AE. Cosmeceuticals: myths and misconceptions. Clin Dermatol. 2009;27:446–52. 7. Sams WM. Consensus statement on the ethic of medicine. J Am Acad Dermatol. 2000;42:124–6. 8. Beauchamp TL, Childress JF. Principles of biomedical ethics. 6th ed. New York: Oxford University Press; 2008. 9. Kassirer JP, Angell M. The high price of product endorsement. N Engl J Med. 1997;337:700. 10. Newburger AE, Caplan AL. Taking ethics seriously in cosmetic dermatology. Arch Dermatol. 2006;142:1641–2. 11. Draelos ZD. Disclosure: a modest proposal. Clin Dermatol. 2009;27:336–8. 12. Osler W. Aequanimitas: with other addresses to medical students, nurses and practitioners of medicine. 2nd ed. Philadelphia: Blakiston’s 1910. http://books.google.com/books/reader?id=32 YPAAAAYAAJ&printsec=frontcover&output=reader&pg= GBS.PA42. Accessed 1 Nov 2011. p. 42. 13. Hayt E. Vanity goes to the doctor; today’s dermatologists are remaking themselves as beauty gurus and even opening spas. New York Times. 14 Nov 1999.

Marketing the Physician: From Antitrust to Distrust

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Catherine L. Kowalewski and Jeffrey J. Meffert

Case Scenarios Case 1 A pediatric dermatologist, who specializes in the treatment of vascular anomalies, takes a position as an employee of a large hospital-based group practice. One evening, he views a television advertisement, sponsored by the hospital, that describes the group practice as having the best and most experienced doctors in the state.

Case 2 In a direct-to-consumer advertisement of her newly opened practice, a dermatologist states that she was formerly a professor in a prestigious medical school dermatology department. She fails to disclose that her contract was prematurely terminated due to disruptive behavior and questionable ethical and financial behavior.

Case 3 A middle-aged woman would like to have cosmetic procedures including botulinum toxin injections and

C.L. Kowalewski • J.J. Meffert (*) Division of Dermatology and Cutaneous Surgery, University of Texas Health Science Center at San Antonio, San Antonio TX, USA e-mail: [email protected]; [email protected]

facial hair removal. Many of her friends have had esthetic procedures with excellent results. She is too embarrassed to ask her friends for a referral and, instead, finds several advertisements, accompanied by patient testimonials that promise amazing results with no risk or down time. She chooses a cosmetic spa for facial hair removal and develops significant scarring and dyschromia following the procedure.

Discussion These three cases present ethical dilemmas related to the commercialization of medicine. When the American Medical Association (AMA) produced its first code of ethics in 1847, it stated specifically that physician advertising was “derogatory to the profession” when promising cures, directed at specific diseases or patients, promising free medicine or advice to the poor, or flaunting success [1]. Physicians were subsequently proscribed from advertising and self-promotion due to their professionalism and codes of ethics. In 1975, the Federal Trade Commission (FTC) brought suit against the AMA stating that by prohibiting advertising, it was guilty of restraint of trade. The FTC felt that doctors were creating a monopoly and charging inflated fees. Removing the prohibition against advertising was intended to control costs by subjecting the practice of medicine to market forces [2]. By the 1980s, the AMA reluctantly lifted its rules regarding physician advertising and the era of physician marketing then began. In addition, government regulators now also viewed medical practice as a business or trade in addition to being a “profession”. Physician self-promotion,

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historically considered unethical and unprofessional, not only became tolerated but routine [3]. Many physicians now feel that advertising is necessary to maintain a prosperous practice. The AMA currently recommends (described under Opinion 5.02) [4] limiting advertising to avoid aggressive advertisement, creation of unrealistic expectations, deceptive statements and untruths. The commercial content may include “the educational background of the physician, the basis on which fees are determined, available credit or methods of payment and non-deceptive information” [4]. The AMA does not enforce those recommendations. However, the AMA recommendations have been adopted by many professional societies and state licensing boards. Individual societies have ethics committees that could discipline their own members. Repeated or egregious violations of advertising standards could lead to sanctions by state licensing boards. Generally a complaint leads to investigation, informal admonishment, and correction of the offending advertisement. Some have suggested that the medical profession has entered a commerce-driven era that views an individual more as a consumer with specific needs or desires to be satisfied than as a patient with physical and emotional needs to be met [2]. As a professional, the physician has traditionally frowned on the use of self-promotion in an attempt to protect the general public from unscrupulous practitioners and to nurture physician-patient relationships based on trust. We are at risk of sacrificing professionalism for entrepreneurial medicine in which the patient’s needs may become secondary to the profit motive [5]. Physicians are engaged in a tug of war between ethical advertising and economic self-interest. The advertising extremes range from those of the traditional ‘quiet professional’ to the flagrant and opportunistic solicitation of patients for lucrative but medically unnecessary interventions. Truthful advertising is supported by many organizations, but is there adequate oversight and regulation of physician marketing? How is the vulnerable patient protected from being harmed by practitioners who misrepresent themselves? With the institution of the FTC deregulation of advertising, physicians must search for an ethical middle ground in which fair and honest advertisements can improve the business of the practice without resorting to unprofessional hucksterism. What may be legal may not necessarily be ethical.

C.L. Kowalewski and J.J. Meffert

How does advertising help or hurt a physician? Rizzo and Zeckhauser examined the effect of advertising on the ability of new physicians entering practice to generate earnings or secure market share [6]. This study found that younger, less experienced physicians received a lower return on investment from advertising than did their older, more experienced counterparts. Also, specialists enjoyed higher returns on advertising dollars than generalists [6]. Folland found that the least experienced physicians do the majority of advertising [7]. He conjectured that older physicians advertise less, perhaps as a result of having trained or practiced in the era antedating the lifting of restrictions on physician advertising. Interestingly, the group that advertises least, U.S. trained male physicians, enjoys the highest return on the advertising dollar [6].

Analysis of Case Scenarios Case 1: Unsubstantiated Advertising This case describes a hospital promoting its employed physicians as the best and most experienced in the state. Is the subjective phrase ‘the best’ supported by objective data or does it take criteria such as listings in “best doctors” directories, out of context? Does an employer have the right to advertise its physician employees without the latter reviewing and approving the content? If it is not specifically prohibited in the physicians’ contracts, they certainly may. This type of publicity is intended to increase the visibility and prestige of the organization. Gershon and Buerstatte expressed the opinion that while it is acceptable to promote the organization, the message must be accurate and truthful [8]. Prospective patients rely on the integrity of the institution and its professional staff [3]. The use of unsubstantiated, broad claims of being “the best” affects the integrity of the hospital and, by association, the doctors who work there. Motivated by the increasing competition among health care facilities, the hospital is trying to distinguish itself from others in order to gain competitive advantage, even though its ads do not necessarily mention competitors by name. By suggesting this group of doctors is the best, does the hospital create unrealistic expectations? Does the claim increase demand for treatment in that facility, because doesn’t everyone want to have the ‘best doctors’? Institutions and physicians have an ethical obli-

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gation to qualify any claims of superiority. Tomycz best summarizes claims of superiority when he writes, “There is simply no single variable with which one can measure physicians in order to determine who is the best for a particular patient” [9], although hospitals regularly use magazine rankings such as U.S. News and World Report’s for this purpose. It would appear that in this case, the claims of superiority are not in accordance with AMA guidelines, as the claim of ‘best’ cannot be substantiated. In fact, under the AMA 1976 Judicial Council ruling on advertising and solicitation, it is noted that there should be no advertising to imply that a physician is superior to other physicians in the same specialty or to suggest ‘unjustified expectations of favorable results’ [1]. Some regional publications and commercial publishing ventures have “Best Doctor” programs in which physicians are apparently nominated by their peers. Unless one is in collusion with other physicians to trade nominations (or nominates oneself), being selected is considered a form of peer respect. Along with the recognition will usually come the offer to advertise one’s practice in the same magazine issue that features the “Best Doctors”. With this offer comes another to purchase an attractive plaque for the reception area, announcing to all present that they will be seeing a “best doctor”. There is no ethical problem with being recognized by one’s peers in a popularity contest. Knowing that term “best” in this particular context has nothing to do with competency, clinical outcomes, or the ability to practice safe and cost-effective medicine makes its use in practice advertisement much more problematic.

Case 2: Deceptive Advertising This case involves the use of deceptive or at the very least, disingenuous advertising by the dermatologist who, in order to promote her practice, assumes the aura of a prestigious institution with which she was once affiliated. Omitting the details of early contract termination due to poor performance or financial misadventure constitutes marketing of a product (physician) under false pretenses and is not ethical [10]. The practice causes consumers (patients) to make poorly informed choices that put them at risk of emotional, financial and physical harm. The AMA disapproves of this kind of advertising because it contains ‘incorrect

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or incomplete facts, or representations or implications that are likely to cause the average person to misunderstand or be deceived’ [4]. In the past, advertising was strongly discouraged, in part, to make patient safety a priority, and as a result, physicians were sought out based on their reputations. Patients also might also select a physician based on participation in their health insurance network, practice location, and gender of physician. Unfortunately, there are some who will be unduly influenced by puffery and visual appeal in advertisements. Less educated patients may not know what questions they need to ask beyond what is stated in an attractive advertisement. Tomycz writes, “It will be unfortunate if the public begins to associate the quality of a doctor with the quality of his or her advertisement” [8].

Case 3: Patient Autonomy versus Paternalism This case describes a person experiencing harm from a cosmetic procedure. In her quest for cosmetic treatment, she searches the local “yellow pages” and notes that there is no shortage of medical advertising for elective cosmetic procedures such as liposuction, facial and body plastic surgery, laser hair removal, botulinum toxin and dermal fillers. In this particular circumstance, the advertisement implied that there was no associated risk or “down time”. A well-informed consumer would realize that such guarantees are impossible. In addition, testimonials in advertisements are often suspect as there is no way to ascertain whether it is a genuine endorsement by an actual patient who received no consideration in return for the endorsement. Although a recommendation from one of her friends might have been based on anecdotal experience, at least the patient could trust the source more than she could a laudatory testimonial from a patient who may not actually exist. Based on the 1980s revision of AMA Principles of Medical Ethics, the distribution of information, including fees, is ethical. In a competitive market in which providers advertise fees and discounts, price rather than the credentials and experience of the physician may lure patients. The true training and expertise of the practitioner, the safety of the environment, documented outcomes, and other information crucial to informed decision-making are downplayed (or even omitted) relative to the emphasis on price. The case

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discussed represents a poorly informed patient who, based on advertising promising no “down-time” and no risk, chose to have her cosmetic services performed in a spa setting. Although the Food and Drug Administration strictly regulates what pharmaceutical manufacturers can state in advertising and promotion of prescription drugs based on evidence of efficacy in clinical trials, no such oversight exists for puffery and practitioners’ claims of procedural expertise, experience, or outcomes. We expect consumers to be aware that advertising claims might overstate the condition and value of a house for sale. We might expect autonomous patients to be able to make medical decisions with the same caution and due diligence they would use in purchasing a car or computer. However, seeking medical care is usually not a simple consumer decision. Even the act of searching for information about a procedure or practitioner may be affected by the work of website managers who use a variety of tools to steer an inquiring patient towards a particular practice or treatment. One example of this would include a search for options in “fat reduction” listing liposuction websites in the first “page” of listings. Another would be a search for “liposuction” having a web-ad for a particular health spa appear as a link above any factual sites that discuss the indications and risks of the procedure. O’Neill argues that respect for autonomy is more important than simple autonomy. Informed consent respects autonomy by informing competent patients without attempts at coercion or deception thereby allowing them to best exercise their autonomy in medical decisionmaking [12]. However, the playing field in rational medical decision-making is not level. Less affluent and less educated patients may be more easily swayed by colorful advertisements promising bargain-priced care. The manner in which medical information is presented can have a profound effect on patients’ decisions.

Conclusion History is rife with tales of miracle healers, instant cures and quackery. These practitioners took advantage of desperate and uneducated persons by the unethical use of advertising. Ironically, despite dramatic advances in medical science and therapeutics, and despite a better-informed public, these practices continue to flourish as they did in centuries past.

C.L. Kowalewski and J.J. Meffert

The ethical physician practicing in a competitive environment is faced with many questions. Am I a professional or an entrepreneur? Should I advertise or not? How can I provide information without solicitation? Is the information factual, substantiated and complete? What are my motives in self-promotion? How will my peers view me? Is there evidence to suggest return on investment with advertising? Do I want to engage in a costly escalating battle of bigger, glossier ads with my competitors? Can I be successful with new technologies and treatments if I do not promote them? How informed do I expect the patient to be and what are my responsibilities to ensure their expectations match reality rather than advertised ideals? Am I being both honest and fair in my dealings with my colleagues as well as my patients? How do I best deal with patients who have seen or are planning to see other practitioners whose advertisements seem too good to be true? Although addressed to a limited extent by professional codes of ethics, individual physicians can best answer these questions after careful introspection regarding their priorities, motives, and values. Advertising and self-promotion are a fact of life in American medicine and especially in specialties dealing with esthetic medicine and surgery such as dermatology. The FTC has partially succeeded in its goal of making medicine subject to the forces of the marketplace. Yet advertising and marketing add another layer of overhead to be ultimately passed on to the consumer or insurer, and in the process, competition has not succeeded in reining in healthcare costs. In the process, medicine has become less collegial, and antitrust has bred patient distrust. Patients are more informed, but they are not necessarily better informed. The advent of billboards, glossy lifestyle magazine ads, infomercials, and 30-second broadcast spots has not enhanced physician-patient communication. The media are rife with ads for rejuvenating nostrums and unproven hair growth and anti-aging products. In sum, it is as it was 100 years ago, “caveat emptor”.

References 1. AMA Judicial Council. Statement of the Judicial Council RE: advertising and solicitation. JAMA. 1976;235:2328. 2. Dyer AR. Ethics, advertising and the definition of a profession. J Med Ethics. 1985;11:72–8.

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3. Richman BW, McCullogh LB, Jones JW. Ethics of institutional marketing: role of physicians. J Vasc Surg. 2003;38: 409–10. 4. American Medical Association Code of Medical Ethics. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics.shtml. Accessed 5 Dec 2010. 5. Hanlon CR. The ethics of entrepreneurial medicine. J Am Coll Surg. 2000;190:458–65. 6. Rizzo JA, Zeckhauser RJ. Advertising and entry: the case of physician services. J Political Economy. 1990;98:476–500. 7. Folland ST. Advertising by physicians. Behavior and attitudes. Med Care. 1987;25:311–26.

151 8. Gershon HJ, Buerstatte GE. The E in marketing: ethics in the age of misbehavior. J Healthc Manag. 2003;48: 292–4. 9. Tomycz ND. A profession selling out: lamenting the paradigm shift in physician advertising. J Med Ethics. 2006; 32:26–8. 10. Latham SR. Ethics in the marketing of medical services. Mt Sinai J Med. 2004;71:243–50. 11. Oneill O. Autonomy and trust in bioethics. Cambridge: Cambridge University Press; 2002. 12. Siegler M. The progression of medicine: from physician paternalism to patient autonomy to bureaucratic parsimony. Arch Intern Med. 1985;145:713–5.

What the Market Will Bear? Ethical and Professional Issues in Medical Fees

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Carl Johnson and Lionel Bercovitch

Every profession is both a business and a calling. Professionals provide valued services, incur overhead in providing those services, and require compensation. Physicians, like other professionals, have traditionally maintained the right to self-regulate. With the universal penetration of third-party payers and managed care in the US over the last 30–40 years, physicians no longer set their own fees. With new paradigms have come new rules, new economic realities, and new moral and ethical challenges.

Case 2 Dr. Smith, a dermatologist in a large group practice, routinely bills $150 for an expanded problem focused (level 3) follow-up visit. The highest reimbursement for this service that he receives from any of the contracted insurers is $62. Patients who are uninsured or who have insurance that his practice does not accept are expected to pay the full $150 fee. Dr. Smith instinctively senses that this is a hardship for many of his patients. However, he cannot change his group’s fee schedule, and does not feel comfortable discussing money with his patients.

Case 1 A patient with severe psoriasis has preferred provider organization (PPO) insurance requiring a $60 copayment for specialist visits. The patient begins narrowband UVB phototherapy, but soon discovers that the $60 copayment applies to each phototherapy session. He asks the dermatologist to waive the copayment because the three treatments weekly would pose an economic hardship.

C. Johnson Division of Dermatology, University of South Carolina School of Medicine, Columbia, SC, USA e-mail: [email protected] L. Bercovitch (*) Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

Case 3 An experienced solo practitioner dermatologist with an outstanding reputation in the medical community participates in the region’s largest insurance plan. The plan has announced that it will begin instituting “pay for performance” (P4P) measures including economic tiering. To his surprise, he discovers that he is in the lowest of three tiers, requiring his patients to pay a $40 copayment in contrast to the first tier dermatologists, whose patients pay a $10 copayment. He is unable to determine the methodology used to stratify physicians into tiers. His reputation is based on what he perceives to be the quality of care and the attention that he gives his patients, yet he feels that he has been unfairly labeled by the insurer as a low-tier (and presumably low-quality) physician based on unspecified measures.

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Discussion Since at least the time of Hammurabi, 4,000 years ago, patients have paid physicians directly for healthcare. Until the nineteenth-century in England, medical fees were voluntary honoraria (what Thomas Percival called “pecuniary acknowledgements”) [1]. The British model regarded medicine as a “public calling.” Physicians could not sue to collect fees for medical care [1]. In the United States, by contrast, colonial Massachusetts courts ruled in 1766 that medical services had “as fixed a price as goods sold by shopkeepers” [1] and physicians maintained the right to collect their fees. “Sliding scale” fees based on the ability of the patient to pay were the standard in the US throughout the first half of the twentieth-century [1]. Even courts recognized the graduated fee to be the customary and reasonable practice [1]. This changed, however, in the mid-twentieth-century. The justifications for sliding scale fees gradually disappeared. Free clinics and charity hospitals proliferated to provide medical care for those otherwise unable to afford it. Additionally, new considerations drove a shift toward a standardized fee schedule. Medicare and private third party payors drove the development of standardized fee schedules. While such schedules limited excessive charges, they also had the unintended consequence of limiting discounts. By 1980, even the American Medical Association (AMA) code of ethics abandoned the recommendation that physicians’ fees reflect the ability of the patient to pay. The development of “usual, customary, and reasonable” (UCR) fee schedules and the ability to “balance bill” drove fees even higher. Hospital and physician fees continued to rise, sometimes to several times the amount that insurers paid. It was estimated in 2002–2004 that specialists charged 2–2.5 times what insurers actually reimbursed, compared to the pre-managed care era when 25–50% markups over actual insurance reimbursement were standard [1]. List price mark-ups for surgical and invasive procedures are the highest while those for cognitive services are the lowest. In the last decade, hospital list prices have increased 2–3 times as fast as resource based costs [1]. What has developed is a perverse (or rather, reverse) sliding scale in which those who can least afford it, the uninsured, are charged the most [2]. Indeed, this is counter to the principle of justice, in which healthcare resources are not distributed according to status or wealth but based on the greatest medical

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need [3], as well as being inconsistent with the altruistic tradition (as opposed to strict moral obligation) of medicine to provide care without respect to financial means. Although the tax-exempt status of non-profit hospitals requires them to provide care to the community, even if uncompensated, and provides for sliding-scale fees based on income, physicians are not bound by similar regulations. In practical terms, most medical practices do not possess the infrastructure to determine financial need or to fairly administer a sliding fee scale. Offering sliding-scale fees to uninsured patients or to those with economic hardship can be regarded as consistent with what many regard as the moral obligation of medicine as a healing profession. By virtue of its monopoly as providers of lifesaving medical care and the esteem that society holds for the profession, as well as the role that society plays in subsidizing and facilitating the training of physicians, physicians have a reciprocal societal obligation to provide care for those who cannot afford it, which transcends laws and ethical codes of conduct that do not mandate it.

Analysis of Cases Case 1 represents a scenario that is becoming increasingly common over the last 5 years. As double-digit annual premium inflation has placed healthcare insurance beyond what many employers and employees can afford, one way to limit premium increases has been to have the insured shoulder more of a burden through rising annual deductibles and copayments (commonly as high as $40–$60 per visit in 2011). This trend is euphemistically known as “consumer-directed healthcare” in which patients share a substantial burden of their health care costs with the insurer. The high copayments sometimes create a financial hardship for many patients, creating challenges for the provider. Physicians are often uncomfortable discussing fees with their patients, reluctant to be misunderstood as avaricious or mercenary. Patients are often equally uncomfortable discussing fees with their physicians, fearful of offending them. In fact, healthcare is one of the few areas of commerce in which prices are not routinely posted or discussed in advance of transactions. The physician may completely miss cues that out-ofpocket cost is an issue for the patient.

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What the Market Will Bear? Ethical and Professional Issues in Medical Fees

In this scenario, the patient did not realize in advance that the insurer would treat phototherapy sessions like office visits, and so was “blindsided” when informed that a $60 copayment was required for each treatment. The patient brought her financial plight to the dermatologist’s attention. In many cases, financial hardship would have presented incognito as missed treatments, a request for less frequent treatments, non-compliance, or by the patient discontinuing treatment altogether. Although neither the AMA nor American Academy of Dermatology codes of conduct address this issue, dermatologists should have in place a mechanism for waiving a portion or all of a patient’s out-of-pocket expenses in cases of financial hardship, including having copayment waiver forms that can be placed in the patient’s chart. Ideally, as a matter of office policy, physicians should have a mechanism for adjusting their fees for those who cannot afford out of pocket charges for medically essential services. Alternatively, the physician may assist the patient in obtaining the services at another facility in the community such as a hospital, as long as these services are available in a timely fashion and the need is not urgent. One physician diffuses embarrassment caused by financial hardship by routinely asking his patients in a tactful and matter of fact way if insurance coverage will be an issue for them; this deflects the discussion away from the patient and physician to an impersonal third party [4]. Another area of concern in writing off or discounting out-of-pocket costs is that routinely waiving copayments or coinsurance can be viewed, especially by Medicare, as an illegal discount offered to obtain market share or to entice patients. Such discounts could be considered Medicare fraud. In cases such as this, in which the practice is applied selectively to those in financial need, and is acknowledged by a paper trail, this practice would likely withstand any legal scrutiny. Case 2 illustrates the perverse or reverse sliding scale that exists for the uninsured. Although the clinic cannot legally maintain different fee schedules for the uninsured and the insured, or for different insurers, the unintended consequences of “rack rates” greatly exceeding the discounted insurance allowable charges are that the uninsured, often those least able to pay, are billed the highest fees. Although the dermatologist might be unaware of what his medical group charges for each procedure, each physician has a professional duty (now codified as a “general competency”) to be cognizant of practice within the healthcare system

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(“systems-based practice”); one of those skills is learning the costs of medications and procedures so that patients are not unduly burdened. In addition, by noting unusually high patient out-of-pocket balances on the encounter form or electronic record, the physician can sympathetically and tactfully inquire if the balances are creating a financial burden and act accordingly. By broaching the subject in an empathetic and timely manner, the dermatologist can relieve much of the tension created by this burden. Case 3 illustrates another twenty first-century example of cost control in the health care system, so called “pay for performance”, or P4P. A full discussion of this phenomenon is beyond the scope of his chapter, but it is an offshoot of outcomes-based medicine, which purports to link reimbursement to quality of care (for which outcomes are a proxy). The impetus behind this movement has come from large purchasers of healthcare, such as large corporations, but has been adapted in some form by many commercial insurance plans as well as government plans such as Medicare, as the means to stimulate and reward a performance based culture. Reining in health care costs has been seen as essential both to preserving corporate returns on investment for shareholders as well as maintaining the competitiveness of American industry in the global marketplace. This has coincided with the perfect storm of the public’s, government’s, and regulators’ concerns for quality and patient safety to create mechanisms for incentivizing “quality” healthcare by rewarding quality measures rather than only the type or quantity of services provided. There are two basic mechanisms for P4P. The first is economic tiering in which physicians are stratified into tiers, most often three, and ranked according to proprietary measures of quality, cost effectiveness, or costs to the system [5]. The other is the so-called “threshold” system in which physicians are rewarded for a certain threshold number of their patients achieving a specific quality measure, for example a full skin examination on all melanoma patients or beta-blocker use post-myocardial infarction [5]. The problem with the first approach is that economic tiering often is not a transparent process, and the quality measures may not accurately reflect physician technical skill, diagnostic acumen, thoroughness, empathy, or communication skills, which are often more meaningful measures of “quality” of healthcare. In the second type, incentives are often linked to those measurements

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that can be “mined” from data fields in electronic records. Unlike internal medicine and primary care, most other specialties have not yet defined quality measures to be used in P4P [5]. For example, can a documented “full skin exam” be a proxy for a skillful and thorough skin exam which employs dermoscopy for suspect lesions and photographs and drawings for comparison? In addition, unless these outcome measures are reliably corrected for acuity level and patient compliance, physicians would refuse to care for complex or non-compliant patients [5]. While it may be a desirable societal goal to maximize the quality of healthcare by rewarding good outcomes in order to get the best return on the healthcare dollar, the sheer complexity of this task as well as the difficulty of obtaining evidence-based scientific data for many quality measures, as well as difficulty quantifying what makes a provider-patient relationship good, can have the unintended consequences of driving physicians to game the system by spending so much time documenting measurable outcomes, that encounters become more rushed and impersonal. The dermatologist in Case 3 might not be able to successfully appeal his tier, especially if his ranking is heavily influenced by the cost of caring for a few patients with severe psoriasis who are on biologic medications, or by his not using an electronic health record. A pillar of the dermatologic community can be stigmatized despite being a “dermatologist’s dermatologist”.

Conclusion It took 4,000 years for sliding scale fees to give way to fee schedules. It has taken less than 10 years for the managed care revolution of the late twentieth-century

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to spawn offshoots such as P4P and consumer-driven healthcare. As with advancing technology, the anticipated ethical and professional challenges and their solutions often lag behind changes in reimbursement methodology. The physician’s professional and moral obligations continue to be buffeted by the shifting tides of the sea change in healthcare financing and the economy in general. One of the greatest challenges facing physicians in the twenty first-century will be for medicine to remain a noble calling and a caring profession, and in particular for dermatology to maintain its traditional medical and surgical roots in the face of institutionalized financial controls.

References 1. Hall MA, Schneider CE. Learning from the legal history of billing for medical fees. J Gen Intern Med. 2008;23(8): 1257–60. 2. Tompkins CP, Altman SH, Eilat E. The precarious pricing system for hospital services. Health Aff (Millwood). 2006; 25(1):45–56. 3. Beauchamps T, Childress J. Principles of biomedical ethics. 6th ed. New York: Oxford University Press; 2008. 4. Hall MA, Schneider CE. Professional obligations when patients pay out of pocket. J Fam Pract. 2009;58(11):E1–4. 5. Cognetti DM, Reiter D. The implications of “pay-forperformance” reimbursement for Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2006;134(6): 1036–42.

Spa, MD: When Dermatology Meets Aromatherapy

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Tivon Sidorsky and Lionel Bercovitch

Case Scenarios

One day Dr. Medbizi receives a phone call from the Vice-President (VP) of Development at Cutispas Inc., a dermatology-focused medical spa (commonly known as a medi-spa) company with over 50 branches located throughout the U.S. The VP asks Dr. Medbizi if he would consider being the medical director of a new Cutispas branch opening nearby. The VP explains that as the medical director, Dr. Medbizi would not necessarily be required to administer any services personally, but would be responsible for the oversight of other providers, including physicians, nurse practitioners, physician assistants, electrologists, mesotherapists, chiropractors, and massage therapists, among others. Are there any legal or ethical issues related to the corporate organizational structure and medical directorship of medi-spas that Dr. Medbizi should consider in making his decision?

disappointed, but knows he will have little difficulty finding someone else eager to take the position. Noting that Dr. Medbizi’s dermatology practice, Dermethica, currently offers little in the way of cosmetic services except botulinum toxin injections and that the nearest dermatology clinic offering comprehensive cosmetic services is over 25 miles away, the Cutispas VP asks Dr. Medbizi and the other dermatologists at Dermethica if they would be willing to recommend Cutispas to patients seeking cosmetic consultation. He also asks whether Dermethica would be willing to display Cutispas flyers in the Dermethica waiting room. In return for these referrals, the VP states that he may be willing pay Dermethica a percentage of the revenue generated from referred patients, or possibly form a legal partnership between Cutispas and Dermethica to facilitate more formal profit-sharing opportunities. Is it ethical and legal for Dermethica to refer patients to Cutispas if Dermethica stands to benefit financially? Would the legal and ethical considerations be different if they did not form a financial relationship?

Case 2

Case 3

While Dr. Medbizi is honored to be offered the job with Cutispas, he ultimately declines. The Cutispsas VP is

Many of Dr. Medbizi’s patients have shown considerable interest in cosmetic treatments that would be conveniently offered by Cutispas, but are currently unavailable at Dermethica. He realizes that his patients will inevitably ask about Cutispas regardless of whether he proactively recommends the medi-spa or not. As such, he asks to see one of the Cutispas flyers that the VP had hoped to display in Dermethica’s waiting room. Reviewing the flyer, he finds himself confused by some of the language. For instance, one caption states “All of our providers are

Case 1

T. Sidorsky Department of Dermatology, University of California, San Francisco, CA, USA e-mail: [email protected] L. Bercovitch(*) Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, RI, USA e-mail: [email protected]

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board certified”, another reads “Consult with physicians nationally recognized and certified by the American Board of Aesthetic Mesotherapy regarding treatments to reduce cellulite”, and another “We offer premier quality custom formula anti-acne and anti-aging products highly recommended by dermatologists”. Are there any ethical concerns with Cutispas’ flyers?

Discussion Medical Spas Medi-spas traditionally integrate the luxury and allure of day spas and beauty salons, with cosmetically focused, noninvasive medical procedures. The most commonly offered cosmetic medical procedures are generally dermatologic in nature, including laser hair removal, nonablative vascular laser procedures, microdermabrasion, and botulinum toxin (Botox™) and dermal filler injections [1]. Such a combination of services allows patients the opportunity to simultaneously obtain standard cosmetic treatments offered by nonphysician estheticians (i.e. waxing), cosmetic procedures requiring a medical license (i.e. filler and botulinum toxin injections), and non-cosmetic day spa services such as those provided by chiropractors or masseuses. The profit drivers common to many medispa business models include: • Office dispensing of non-prescription cosmeceutical and cosmetic products; • Out-of-pocket payment for all services; • High margin services that can be provided by lower cost providers (i.e. non-physician providers); • Premium pricing on the basis of: – The desirable environment in which the services are being delivered; – Providing a sense of legitimacy and security through physician sponsorship or physician delivery of various cosmetic services; – Offering “one-stop-shopping”. In 2008, the U.S. medi-spa market exceeded $2 billion, and it has continued to grow [2]. As such, it is not surprising that medi-spas are not only owned by corporations, but also by a wide variety of health-related professionals ranging from physicians (e.g., plastic surgeons, dermatologists, family physicians, and obstetricians/ gynecologists), to non-physicians (e.g., chiropractors, electrologists, naturopaths, and nurse practitioners) [1].

T. Sidorsky and L. Bercovitch

Legal and Ethical Considerations Legal Considerations State regulations differ regarding various medi-spa operational practices. The most significant and controversial legal operational questions addressed by policy makers include [1]: 1. Who should be allowed to supervise and provide specific services offered at medi-spas? Because so many medical cosmetic procedures offered at medi-spas are highly lucrative, the question of who should be allowed to provide these services is hotly debated. To be clear, the services in question are those such as botulinum toxin or filler injections, which can only be provided by a licensed medical practitioner. While it is legal for anyone owning a medical license to perform these procedures—just as it is theoretically legal for a dermatologist to perform an amniocentesis—many would argue that only physicians with substantial cosmetic procedural training are equipped to provide these services. It can be argued that the technical skills needed to perform botulinum toxin injections can be easily learned. Thus, physicians such as obstetricians and family doctors, who may perform more technically challenging procedures, or nurse practitioners, who are permitted to independently administer high risk pharmaceuticals, argue that they should be allowed to provide procedures as seemingly benign as injecting botulinum toxin [1]. On the other hand, opponents assert that while the requisite technical training may be brief and straightforward, other critical skills such as evaluating patient suitability, optimizing the prevention and management of complications, and providing continuity of care, cannot be learned without more extensive targeted training [1]. Those who maintain this position also generally concede that while it would be permissible for most physicians and non-physicians such as nurse practitioners or physician assistants to perform the technical administration of botulinum toxin or filler injections, they should do so only under the strict supervision of a physician with extensive cosmetic training such as a dermatologist or plastic surgeon [1]. The legal standards regarding medi-spas are not uniform throughout the country. In 2006, Florida passed the Safe Supervision Bill requiring all medispas be supervised by either a dermatologist or plastic

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surgeon [2]. The Commonwealth of Massachusetts has drafted legislation, not yet enacted, that will require medi-spas offering “level II [example: nonablative lasers] and level III [example: botulinum toxin injection] procedures” to be supervised by onsite physicians (required for level III), nurses level II only or electrologists who are adequately trained to perform the procedures [1, 3]. 2. How should office dispensing of cosmeceutical and cosmetic products be regulated? The legal and ethical issues related to the regulation of office cosmeceutical and cosmetic product dispensing has been written about extensively. It is beyond the scope of this chapter to comprehensively review the published debate of this topic further than what is addressed in the “Office Dispensing in Dermatology” section in Chap. 23. 3. How should relevant referral practices and “corporate practice of medicine” regulations be addressed? Laws related to physician self-referral practices and “corporate practice of medicine” prohibitions are also quite relevant to the regulation of medispas. The Physician Self-Referral Law, or Stark Law, prohibits physician referrals for certain designated health services (DHS) that are eligible for reimbursement by Medicare or Medicaid to anyone (including immediate family members) with whom the referring physician has a financial relationship [4]. Referrals and shared profits within legal physician partnerships or group practices where physicians own shared responsibility of medical decision making is permissible. The DHS umbrella for selfreferral restrictions is broad, and includes most federally reimbursed health-related services. With respect to medi-spas, on the one hand, the majority of services typically offered are not federally reimbursed, and thus are not subject to Stark Law regulation. On the other hand, some states such as California, have instituted Stark law style prohibitions for non-federally funded services as well [5]. In addition, states such as California, New York and Texas, among others, uphold relatively strict “corporate practice of medicine doctrine” laws designed to limit corporate lay entities from influencing the judgment of the physicians they employ. For example, in some states it would be illegal for a medi-spa owned by a lay entity, which offers medical services such as botulinum toxin injections (requiring a medical license to provide), to hire a physician as the medical director.

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Under this ownership and operating structure, the physician’s judgment would be considered potentially vulnerable to corporate influence, and the physician thus would not ultimately maintain full ownership of the medical decision-making.

Ethical Considerations Although only a few states have passed legislation directly addressing the corporate practice of medicine doctrine [6], the underlying ethical principle supporting these laws warrants consideration; it does seem that the ethical corporate practice of medicine is possible, but only when the corporation’s incentives and the patient’s best interests are aligned. Further, while many medi-spas are owned by physicians, mid-level providers, or non-physician health professionals (as opposed to lay entities) the same ethical consideration applies. All entrepreneurs are vulnerable to mishandling potential conflicts between self-interest as owners and a fiduciary responsibility to patients. Because medi-spas often offer many services and products that are not seemingly “medical”, but rather purely cosmetic, medispa owners and managers may view their business as primarily just a business, not a medical practice. By doing so, physician medi-spa owners might operate within a similar ethical framework as they would, for instance, if they owned a beauty salon. This would be fine if they did not (a) offer any services that carried significant health risks to patients, or (b) sell non-evidence-based services and products while touting their medical efficacy. For many medi-spas that offer risk-laden services such as laser therapy, botulinum toxin injection, and filler injections, or claim treatments such as cellulite removal cream to be effective, this is not the case. As discussed below, many medi-spa executives, regardless of their professional licensure, use business strategies that are primarily motivated by the bottom line, but may cross over the ethical line. For example, by employing physician medical directors or practitioners, medi-spas may impart an aura of medical legitimacy to an array of non-evidence-based cosmetic services such as cellulite treatment. The same ethical concern pertains to office dispensing of nonprescription products. Many of the services and products commonly offered at medi-spas have not been proven effective [1]. Although a medi-spa may be able to legally navigate the labeling and marketing of its

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products, such strategies are often quite misleading to the public. Furthermore, although many providers at medi-spas are credentialed by a variety of certifying boards, many of these are not recognized by the American Board of Medical Specialties [1]. Most patients (and many physicians who may be referring patients to medi-spas) may not be fully aware of which specialties are recognized by the American Board of Medical Specialties. Practitioners credentialed by these unrecognized cosmetic boards are not necessarily guilty of manifestly false advertising, but again, given the confusion surrounding the lack of national medical recognition of these certifying groups, there is certainly a significant risk that patients are at least being indirectly misled. For instance, even if a provider is board certified by, for instance, the American Board of Aesthetic Mesotherapy, many patients are unlikely to realize that this is not a specialty recognized by the American Board of Medical Specialties. That said, it is important to point out that “Cosmetic Dermatology” and “Mohs Surgery” are also both specialties unrecognized by the American Board of Medical Specialties. The difference, however, is that unlike treatments such as mesotherapy, these specialties may still legitimately claim to operate primarily on evidence-based platforms. The ethics of certification semantics is even more complicated. For example, while it may be true that a medi-spa employs physicians who are “board certified” to provide various services, without clarifying context, such a statement intentionally obfuscates the nature of both the provider’s training and the service being offered. A “board certified physician” generally refers to physicians who have both medical or osteopathic degree and board certification in a specialty recognized by the American Board of Medical Specialties. But the devil is in the details, as even physicians who truly meet these criteria are still only considered to be adequately trained to practice within the scope of their specialties. Indeed, a board certified oncologist is likely to be as adequately trained to administer botulinum toxin as a board certified dermatologist is to prescribe chemotherapy.

Case Analysis Case 1 Some states have passed legislation specific to the ownership and management of medi-spas, but even among these states there is wide regulatory variation.

T. Sidorsky and L. Bercovitch

Within states proscribing the corporate practice of medicine, it would be illegal for physicians to serve as paid medical directors for medi-spas owned by a lay entity that offers services requiring a medical license to administer. As such, if Dr. Medbizi practiced in such a state, it would be illegal for him to accept the job as Cutispas’ medical director. Another legal consideration is the level of physician oversight a state requires for midlevel providers to administer certain services. It may not be enough for Cutispas to simply hire board certified dermatologists as medical directors if they are not available for onsite supervision. Even if Dr. Medbizi faced no state-specific legal prohibitions, he must still consider the ethical obligations of serving as Cutispas’ medical director. By accepting the position, he would assume responsibility for ensuring the quality and safety of client care. He would also be responsible for ensuring proper training, oversight, credentialing, and licensing of all providers at the medi-spa. As a related issue, Dr. Medbizi must also consider the potential risk that his credentials could be intentionally misappropriated by Cutispas, or unconsciously misinterpreted by patients to convey physician validation of all services provided by Cutispas. Although as a local medical director, Dr. Medbizi may have little control over Cutispas’ corporate marketing, he would bear ultimate ethical responsibility for the truthfulness of the medi-spa’s advertising. Dermatologists and plastic surgeons have the most cosmetic training among health professionals, and thus are the most qualified to supervise the provision of such services within the medi-spa setting. Yet considering how difficult this might be even for a board certified dermatologist like Dr. Medbizi, it is hard to imagine that a physician or midlevel provider with minimal or no formal training or experience with aesthetic skin care services would be able to meet these ethical challenges. For many providers growing weary of dealing with dwindling reimbursements and bureaucratic demands from third party payers, the high margin out-of-pocket model of medi-spas becomes very attractive. Unfortunately, the economic temptations of entering this market may blur the ethical line for providers in determining the difference between good business and good medicine. In general, all medical practices are businesses, and there is nothing wrong with entrepreneurship in medicine as long as the ethical balance between the bottom line and the Hippocratic Oath is maintained. It seems that this balance is clearly sacrificed when a medical professional attempts to

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provide, let alone attempts to supervise others to provide services in which they are not trained in the pursuit of profit.

Case 2 From a legal standpoint, the answer to this scenario again depends on the state regulations under which Dermethica and Cutispas operate. Although the Stark Law itself does not apply to the services typically offered at medi-spas, as they are not federally reimbursed, many states uphold similar prohibitions for these services even when paid for out-of-pocket. In other states, it would be legally permissible to arrange a financial referral arrangement provided the financial conflict of interest is fully disclosed. It may initially seem that Dermethica could avoid violating state self-referral and fee-splitting restrictions by accepting Cutispas’ offer to form a legal partnership. However, recall that such partnerships are only exempt when the ownership of the business is shared between physicians. Legal considerations aside, the same ethical responsibility as described in Case 1 for Dr. Medbizi if he were to serve as Cutispas’ medical director applies to Dermethica here. Implicit in physicians’ referrals is that they recommend services with the best interests of their patients in mind. Ethically speaking, referrals are endorsements, and serve as extensions of a physician’s care when they are not able to directly provide a service. It would be irresponsible for Dermethica to either refer patients to Cutispas, or permit Cutispas to advertise on their premises, without performing due diligence to ensure the safety, quality, and efficacy of the cosmetic services offered at the medi-spa.

Case 3 Although not blatantly false, the statements in Cutispas’ flyer are at best lacking important clarifying context, and at worst misleading customers with respect to the certification of the Cutispas’ practitioners and the efficacy of the services and products they provide. While the flyer itself may not directly violate marketing law, it does seem to cross an ethical boundary. Cutispas’ nuanced verbiage exploits the public’s misunderstanding of physician specialty board certification to sell their services and products under false pretenses.

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Assume the most reassuring scenario where Cutispas was in fact owned or medically directed by a board certified dermatologist or plastic surgeon. Does this necessarily mean that this individual would actively oversee cosmetic services, let alone providing them directly to patients? Does this mean that this individual is ever actually physically present at the medi-spa? Does this mean that all of the services and products offered at Cutispas are as safe and efficacious as those you would receive in the medical setting of a dermatologist’s or plastic surgeon’s clinic? What if the supervising physician was board certified in an unrelated medical specialty, lacked training in cosmetic medicine, worked off-site, and endorsed cosmetic products without supporting evidence? In the case of medi-spas, where relevant legal restrictions are scarce and variable, this type of exploitation is unfortunately fairly common.

Conclusion Medi-spas are a rapidly growing industry within the U.S. and worldwide. Despite the apparent appeal of medi-spas to patients, there are mounting, interrelated legal and ethical concerns stemming from the relative lack of industry regulation. The majority of states have not passed legislation related to the ownership and operation of medi-spas, and those states that have begun broaching the issue face opposition from some stakeholders. Indeed, the current economic opportunities within the medi-spa market have sparked considerable competition and turf battles for the right to own and operate medispas. Dermatologists stand at the center of this ongoing debate. Even dermatologists with no interest in involving themselves with medi-spas in any capacity will be forced to at least understand both the nature of these businesses. Given the variable and often murky legal regulation of medi-spas, dermatologists interested in participating in the medi-spa market should thoroughly investigate relevant laws and regulations for the jurisdiction in which they practice. It is certainly not intrinsically unethical for dermatologists to practice in, manage or own a medi-spa. However, it is critical that dermatologists not only recognize the many ethical hurdles related to this industry, but also overcome them in a manner that ultimately has the patient’s best interests in mind.

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References 1. Bercovitch L. Mainstream medicine meets the medi-spa. American Medical Association Virtual Mentor. 2009;11: 361–7. 2. Schlessinger J. Spa dermatology: past, present, and future. Dermatol Clin. 2008;26:403–11. 3. Report of the medical spa task force established by chapter 81 of the acts of 2006. http://www.massacademyofdermatology.org/Files/DRAFT%201%201%20.0.pdf. Accessed 19 Mar 2011.

T. Sidorsky and L. Bercovitch 4. Center for Medicare and Medicaid Services: section on self-referral. https://www.cms.gov/PhysicianSelfReferral. Accessed 19 Mar 2011. 5. California Business & Professions Code section 650: http:// law.onecle.com/california/business/651.html. Accessed 19 Mar 2011. 6. Corporate Practice of Medicine Doctrine 50 States Survey Summary. http://www.pdfdocspace.com/docs/33699/corporate-practice-of-medicine-50-state-summarypdf.html Accessed 19 Mar 2011.

Gatekeepers, Dermatologists, and Their Patients: Mixed Messages in Managed Care

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Lindsey A. Brodell, Robert T. Brodell, and Brendan Minogue

Skin diseases represent one of fifteen areas of medicine in which prevalence and health care costs increased most rapidly between 1987 and 2000 in the United States [1]. The estimated cost of skin disease in the United States in 2004 was approximately $96 billion, including health services, skin products, surgical treatments, and lost productivity [1]. As the cost of treating skin disease has increased, it has become critical to develop cost-saving measures so that health care can be affordable for the average American health care consumer and for the insurers that directly pay for dermatological treatment. The promise of managed care organizations is to “combine health care insurance with the delivery of a broad range of integrated health services for a population of plan enrollees, financing the services prospectively from a predicted, limited budget” [2]. They are charged with insuring the health care of their subscribers, managing the complex roles of all members of the health care delivery system, and, in some cases, gener-

L.A. Brodell Division of Dermatology, Washington University School of Medicine, St. Louis, MO, USA R.T. Brodell (*) Northeastern Ohio Universities College of Medicine, Rootstown, OH, USA Case Western Reserve University School of Medicine, Cleveland, OH, USA University of Rochester School of Medicine and Dentistry, Rochester, NY, USA e-mail: [email protected] B. Minogue Department of Religion and Philosophy, Youngstown State University, Youngstown, OH, USA

ating a return on investment for shareholders. In a perfect world, managed care organizations would balance the quality and quantity of medical services with cost to produce a maximally efficient health care system. In this chapter, we will focus on managed care organizations (MCOs) that utilize the gatekeeper model, including health maintenance organizations (HMOs) and independent practice associations (IPAs) that contract with HMOs, and evolving accountable care organizations (ACOs). The gatekeeper is a primary care physician who controls access to specialty care, laboratory services, and radiology services, and is used by some managed care systems to insure that only “necessary” care is provided to a group of insured patients. Because of the competing concerns among various stakeholders, including specialists, primary care providers, hospitals, insurers, pharmacies, employers, and patients, it is inevitable that ethical concerns will arise with the gatekeeper system in place. In this chapter, we will explore the ethical implications of the gatekeeper system in the field of dermatology. Three clinical cases are presented to demonstrate the ethical challenges of managed care in dermatology.

Case 1 A 65-year-old woman with health insurance that permits direct access to specialists consulted a dermatologist because of a 1.5 cm ulcerated lesion of the thigh that demonstrated a pearly border with overlying telangiectasia. The clinical diagnosis of basal cell carcinoma was made and a small biopsy was taken which subsequently confirmed the diagnosis of nodular basal

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_28, © Springer-Verlag London Limited 2012

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cell carcinoma. A single stage of Mohs micrographic surgery was used to remove this lesion, and the defect was closed primarily after undermining the edges of the wound. An excellent cosmetic result was achieved. Total cost to the health care system was $1100.

Case 2 A 65-year-old woman participating in a closed panel HMO with a gatekeeper model presented to her primary care physician with a 1.5 cm ulcerated lesion on her thigh demonstrating pearly borders with overlying telangiectasia. The clinical diagnosis of basal cell carcinoma was made, and a small biopsy performed by the primary care physician confirmed the diagnosis of nodular basal cell carcinoma. The patient was referred to a dermatologist for excision of this lesion. The excision was performed, and the defect was closed primarily. Histopathology demonstrated the lesion was completely excised. An excellent cosmetic result was achieved. Total cost to the health care system was $550.

Case 3 A 65-year-old woman participating in a closed panel HMO with a gatekeeper model presented to her primary care physician with a 1.5 cm ulcerated lesion on her thigh demonstrating pearly borders with overlying telangiectasia. The clinical diagnosis of basal cell carcinoma was made and confirmed by biopsy. The primary care physician chose to treat the lesion with imiquimod cream daily for 6 weeks. At follow-up, the lesion was ulcerated and purulent, and she was treated with doxycycline and silver impregnated dressings. Three weeks later, the lesion remained ulcerated and the patient was referred to a dermatologist at which time it measured 3 cm in diameter. The lesion was widely excised and closed with a small skin graft. Total cost to the health care system was $2600.

Discussion The Gatekeeper System Today, some managed care plans, including many HMOs, utilize primary care physicians (or contracted

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pharmacy benefit and imaging utilization managers) as gatekeepers, in an attempt to coordinate care and control costs by decreasing the utilization of unnecessary services [3]. These gatekeepers control access to specialists, laboratory studies, and advanced imaging by permitting insurance payment only for services they approve. The insurer also employs case managers to oversee and to adjudicate disputes regarding access to resources according to the insurer’s medical policies. This model reveals a shift in the delegation of medical care in the United States. For example, in 1965, only 40% of the American population had a primary care physician whom they saw regularly, 15% saw a specialist as their regular doctor, and 45% had no regular physician [4]. In gatekeeper systems, all patients have primary care physicians, and specialty care services are not covered (i.e. not paid by the insurance plan) unless the patient receives a direct referral from the patient’s primary care physician. The primary care physician gatekeeper is often paid a per-member-per-month (PMPM) management fee (capitation) for the time and overhead involved in the gatekeeper function in addition to a capitated monthly fee for primary care services. Around the time of its peak market penetration in 1996, capitated plans accounted for 25% of office-based visit payments in the United States [5] although in some markets it was significantly higher. Primary care physicians in such a system are usually part of a pool or panel whose utilization of specialty care and other services relative to a budgeted amount or performance of comparable panels determines their year-end bonus or return of retention or “withhold” funds [6, 7]. In addition to financial incentives to restrict utilization, primary care physicians may be “deselected” from managed care plans or penalized financially if their pattern of utilization of specialty care and other healthcare resources is deemed to make them outliers [8]. The gatekeeper system becomes ethically problematic when the gatekeeper is reimbursed under a system that incentivizes withholding evidence-based necessary care or financially penalizes those who are statistical outliers in their referral patterns. A Gallup Poll revealed that 12% of American physicians in direct patient care from 60 randomly selected communities in 2004–2005 reported that financial incentives favored reducing care for individual patients [9]. In this same poll, capitated and noncapitated managed care accounted for 16% and 30% of

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practice revenues, respectively during 2000–2001 and declined slightly in 2004–2005 [9]. Dermatologists and their patients may be disproportionately impacted by a gatekeeper system relative to other specialists because primary care physicians often feel comfortable taking care of skin conditions. However, many primary care practitioners have not mastered the necessary dermatologic diagnostic and therapeutic skills [6]. It can be argued that dermatologists provide the most efficient services and highest quality of care for patients with skin disease at the lowest cost [10, 11]. In fact, studies of referral patterns suggest that some primary care physicians have great difficulty managing a wide range of skin problems [11]. For instance, melanoma is diagnosed at an early stage more efficiently by dermatologists than by primary care physicians [12]. Increasing morbidity, mortality, and costs to the health care system may result when gatekeepers replace dermatologists as screeners for melanoma. In addition, since skin diseases are outwardly apparent, patients with skin problems may be uniquely capable of appropriately determining when they need to see a dermatologist. In view of these facts, managed care plans have been unpopular with many dermatologists. Some argue that it would be unethical to participate in a system in which patients receive sub-optimal care. On the other hand, some managed care proponents have argued that “adequate” care is as acceptable as “optimal” care when the clinical outcomes are comparable, but the differences in cost are significant. As dermatologists and other physicians become increasingly regulated, scrutinized, and even micromanaged, criticism of managed care has grown even more strident. Despite this, no one can imagine practicing in 2011 without some degree of oversight or adherence to evidence-based clinical guidelines.

Analysis of Case Scenarios Case 1 demonstrates the worst aspects of a fee–forservice system. A Mohs surgeon with little incentive to control costs chooses an expensive procedure that has no demonstrable benefit over a clinically appropriate, less expensive procedure (elliptical excision). If the choice of treatment is motivated by financial self-interest, it is a breach of ethics. In an ideal situation, a sophisticated and knowledgeable gatekeeper physician would

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have recognized that a technically simpler, less expensive procedure was adequate to treat this lesion and more cost-effective. Alternatively, repeated overutilization or inappropriate utilization of Mohs surgery would come to the attention of the primary care physician or the local HMO’s administration so that this pattern of overutilization of services could be addressed. In Case 2, the gatekeeper managed care system worked effectively. The primary care physician made the correct diagnosis, confirmed it, and referred the patient to an appropriate specialist who chose an appropriate and cost-effective treatment. A minimum number of office visits was required, and treatment resulted in a satisfactory clinical outcome for the patient. Case 3 is somewhat more problematic. The clinical diagnosis is not in doubt and indeed was confirmed by biopsy. The gatekeeper chose to manage the problem with a topical medication, possibly in the mistaken belief that this would be an inexpensive approach to avoid an unnecessary specialty referral. The gatekeeper may have simply been uninformed regarding the appropriate indications for imiquimod therapy of basal cell carcinoma and the proper management of this neoplasm. Ultimately, the gatekeeper’s errors in judgment increased the cost of the patient’s medical encounter and resulted in inconvenience and unnecessary surgical trauma for the patient. These cases illustrate some of the potential ethical issues arising in a gatekeeper system. First is the primacy of patient autonomy. Each patient has the right to make an independent decision based on receipt of all relevant medical information. When a physician motivated by financial self-interest fails to inform a patient that a simpler, less expensive, and equally effective procedure is available, patient autonomy cannot be exercised. Secondly, according to the AMA’s Principles of Medical Ethics, “A physician shall, while caring for a patient, regard responsibility to the patient as paramount” [13]. In other words, the physician must put the needs of the patient before his or her own. Clearly, the Mohs surgeon must carefully choose when micrographic surgery is truly indicated and not use it indiscriminately. Similarly, a gatekeeper physician who limits medically necessary specialty referrals out of self-interest is breaching his fiduciary responsibility to the patient. In fact, patients assume that their primary care physician is advocating primarily for their needs and is not being influenced by the insurer or by the

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amount of “withhold” returned at year-end in clinical decision-making. Patient-centered ethics is an important component of high quality health care for both the gatekeeper primary care physician and the dermatologist. It is also an essential element of the physician-patient relationship. If patients believe that their physicians place other interests above their interests, trust is broken, and the professional integrity of the physician is compromised. Some physicians find the managed care gatekeeper to be ethically abhorrent. They argue that physicians should never deny their patients “the best possible care.” They cite anecdotes of patients having to beg their primary care gatekeepers for a needed referral. On the other hand, some Mohs surgeons rationalize that the great majority of basal cell carcinomas should be treated by the Mohs technique because it offers the best tissue conservation and the highest cure rate. This is certainly a flawed argument. An expensive procedure for certain low-risk tumors cannot be justified by a marginal increase in cure rate. Of course, physicians are not ethically bound to participate in managed care plans because “except in emergencies, [they are] free to choose whom to serve, with whom to associate, and the environment in which to provide medical care” [13]. However, if all dermatologists refused to participate, none of the patients in these plans would benefit from the care of dermatologists. Moreover, anti-trust concerns would be raised if dermatologists acted in unison. Some physicians believe that when resources are truly limited, they have two fundamental duties: to attend to the needs of their individual patient and to accept some measure of responsibility for the health care system as a whole [14]. Just as dermatologists must place the interests of their patients ahead of their economic self-interest in a fee-for-service system, they must willingly concede some control to the gatekeeper if the primary care physician is to serve an effective role as the “captain of the health care team.” The American Medical Association tacitly recognized a physician’s responsibility to the health care system in their code of ethics that was amended in June 2001 to read “A physician shall support access to medical care for all people” [13]. It would be ethically problematic for physicians to participate in any health care system that denies many patients access to health care and squanders limited health care resources. An efficient, effective gatekeeper system which protects the interests of patients while

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insuring appropriate use of limited financial resources is one method of caring for patients according to the Hippocratic Principle that we shall focus all measures within our abilities for the benefit of the sick [15]. The dermatologist has an ethical duty to provide the least expensive medically appropriate care capable of achieving the therapeutic goal, which in the case of basal cell carcinoma is a cure with acceptable cosmetic outcome. In practical terms, the views of the gatekeeper and the dermatologist are perfectly aligned on this point. Provision of care based on this principle is good for the patient and good for society. Of course, transparency is critical. The patient should be clearly informed when decisions are made based in whole or in part on non-medical considerations such as cost savings for an insurance company. In addition, the physician has an ethical obligation to advocate for the patient when gatekeepers restrict necessary care because the patient’s needs do not fall within the insurance plan’s treatment guidelines. The dermatologist should help a patient who is denied a referral to a Mohs surgeon for a 2 cm diameter morpheaform basal cell carcinoma at the melolabial fold. Ethically speaking, to appeal the decision of a gatekeeper or health insurer, it is important for the gatekeeper physician and the dermatologist to focus their clinical decisions on the provision of high-quality, cost-effective care for their patients while insulating themselves from parochial interests based on purely financial incentives.

Conclusion The passage of the Patient Protection and Affordable Care Act of 2010, will likely solidify the position of managed care in our society as the health care system struggles to care for 30–40 million previously uninsured Americans despite limited resources. While managed care to this point has failed to deliver a system that controls escalating health care costs, it is clear that payers, providers, and policy makers have accepted that unfettered access to “fee for service” practice leads to overutilization and overcapacity [16]. Every indication is that HMOs with physician gatekeepers will be a key element of the system [17]. The evolving health care system should be transparent to patients and to physicians who must make decisions about health care in an increasingly complex health care system [13].

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Many dermatologists will continue to work in systems controlled by gatekeepers. Those who do not may still be required to assume some risk in managing skin care. This might be done by developing specialty networks which can “carve out” management of skin care from a larger plan [18]. More likely is the arrival of ACOs in the near future. ACOs will require a high degree of integration, cooperation, and collegiality among physicians within a healthcare organization such as an HMO or IPA to reduce duplication, medical errors, avoidable complications, and unnecessary care in order to meet the fiscal goals of the ACO. These goals will essentially be based on a twenty firstcentury model of global capitation [19]. Although dermatologists may be required to act as stewards of limited resources in such a system, they should recognize the primacy of their obligation to always act in the best interests of their patients.

6. 7.

8. 9. 10.

11.

12.

13. 14.

References 1. Bickers DR, Lim HW, Margolis D, et al. The burden of skin diseases: 2004 a joint project of the American academy of dermatology association and the society for investigative dermatology. J Am Acad Dermatol. 2006;55:490–500. 2. Buchanan A. Managed care: rationing without justice, but not unjustly. J Health Polit Policy Law. 1998;23:617–34. 3. Kongstvedt PR. Chapter 29: authorization systems. Gaithersburg: Aspen Publication; 1996. 4. Bodenheimer T, Lo B, Casalino L. Primary care physicians should be coordinators, not gatekeepers. JAMA. 1999;281:2045–9. 5. Zuveckas SH, Cohen J. How prevalent is capitation in private and public health insurance plans. Abstr Book Assoc

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16.

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18. 19.

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Health Serv Res Meet. 1999; 16:73. http://gateway.nlm.nih. gov/MeetingAbstracts/ma?f=102194437.html Eisenberg JM. The internist as gatekeeper. Preparing the general internist for a new role. Ann Intern Med. 1985;102:537–43. Kongstvedt PR. Chapter 9: compensation of primary care physicians in open panel plans. Gathersburg: Aspen Publication; 1996. Liner R. Physician deselection: the dynamics of a new threat to the physician-patient relationship. Am J Law Med. 1997;23:511. Fang H, Rizzo JA. The changing effect of managed care on physician financial incentives. Am J Manag Care. 2008;14:653–60. Federman DG, Kirsner RS. The abilities of primary care physicians in dermatology: implications for quality of care. Am J Manag Care. 1997;3:1487–92. Feldman SR, Fleischer Jr AB, Chen JG. The gatekeeper model is inefficient for the delivery of dermatologic services. J Am Acad Dermatol. 1999;40:426–32. Gerbert B, Maurer T, Berger T, et al. Primary care physicians as gatekeepers in managed care. Primary care physicians’ and dermatologists’ skills at secondary prevention of skin cancer. Arch Dermatol. 1996;132:1030–8. Affairs CoEaJ. Code of Medical Ethics of the American Medical Association; 2008–2009. Minogue B. The two fundamental duties of the physician. Acad Med. 2000;75:431–42. Fairfield G, Hunter DJ, Mechanic D, Dubos R, Rosleff F. Managed care: implications of managed care for health systems, clinicians and patients. BMJ. 1997;314:1895. Gosden T, Forland F, Kristiansen IS, Sutton M, Leese B, Giuffrida A, Sergison M, Pedersen L. Capitation, salary, feefor-service and mixed systems of payment: effects on the behaviour of primary care physicians. In: Cochrane Rev. Fang H, Liu H, Rizzo JA. Has the use of physician gatekeepers declined among HMOs? Evidence from the United States. Int J Health Care Finance Econ. 2009;9:183–95. Hall TS. Bargaining with Hippocrates: managed care and the doctor-patient relationship. S C Law Rev. 2003;54:689–740. Diamond F. Accountable care organizations give capitation a surprise encore. Manag Care. 2009;18:14–5. 21–4.

Ethical Adventures in 21st Century Dermatopathology

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Homer O. Wiland IV, Barry D. Kels, and Jane Grant-Kels

Introduction The field of dermatopathology is confronted with a wide variety of ethical issues that range from day-today practical practice matters to sometimes questionable business tactics. The purpose of this chapter is to familiarize the reader with pertinent ethical dilemmas in modern day dermatopathology and to address the differing points of view pertaining to each issue. Additionally, the ethical obligations of the dermatologist and dermatopathologist in each scenario will be defined according to established ethical guidelines including the American Academy of Dermatology’s (AAD) and the American Medical Association’s (AMA) Codes of Ethics.

Case 1 A newly established private practice dermatologist decides that she would like to begin interpreting skin biopsies on a part-time basis. She develops an in-office histology laboratory and hires lab personnel to process

H.O. Wiland IV Department of Pathology, Cleveland Clinic Foundation, Cleveland, OH, USA B.D. Kels Division of Ophthalmology, Department of Surgery, University of Connecticut Health Center, Farmington, CT, USA J. Grant-Kels (*) Department of Dermatology, University of Connecticut Health Center, Farmington, CT, USA e-mail: [email protected]

specimens. Subsequently, she interprets all biopsies performed on the patients she sees in her clinical practice.

Discussion This case example is central to the practice of many clinical dermatologists in modern medicine. It poses more of an ethical debate than it does a legal debate. There are no laws that restrict a licensed physician from practicing medicine as he or she sees fit. Limits on physicians may come from hospital regulations, but these generally do not affect outpatient services. Also, limitations may be placed by a state medical board, but usually only after a complaint is lodged. Finally, the threat of malpractice may limit actions of dermatologists, but the financial benefits of signing out their own dermatopathology cases may counterbalance the fear of malpractice. The knowledge base to interpret dermatopathology is gained by completing a 3-year dermatology residency or a 4-year pathology residency. In both cases, this can be followed by specialized dermatopathology training and ultimately board certification in dermatopathology [1, 2]. A number of ethical issues surround the practice of clinicians trained in dermatopathology interpreting specimens from the very same patients that they care for in clinic. In general, the bulk of this ethical debate focuses on dermatologists who have not pursued fellowship training in dermatopathology, and this topic will be discussed first. Most of the ethical debate regarding whether dermatologists without dermatopathology fellowship training should perform pathology services for their

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patients centers on the adequacy of their training in this area. Those who are in favor of this practice emphasize that approximately one-quarter of the board examination in dermatology is devoted to dermatopathology, and that a significant amount of residency training in dermatology is devoted to dermatopathology [1, 2]. In fact, studies have found that dermatology residents spend more time training in dermatopathology in 3 years of residency than pathology residents do in 4 years of training in combined anatomic/clinical pathology [3]. Further, studies have shown that as a group, general pathologists have a low diagnostic error rate in interpreting skin biopsies [4]. Thus, it can be argued that if pathologists without subspecialty training in dermatopathology are entitled to sign out skin biopsies and can do so successfully, clinical dermatologists should be entitled as well in that they may be even better suited for this job. Proponents of this practice also argue that clinical dermatologists care for patients and are fully aware of the patient’s clinical situation. Thus, they have a unique advantage when studying a patient’s histopathology in that they can correlate clinical and pathologic findings to arrive at a final diagnosis. The paucity of clinical information that is often supplied to the dermatopathologist on requisitions highlights this advantage [5]. In addition, some diagnoses in dermatology, such as acrocordons, are routinely made on a clinical basis and biopsies may only serve to fulfill medicolegal obligations [1, 2, 6]. Finally, dermatologists always have the capability of requesting consults on “difficult” cases by a trusted board-certified dermatopathologist. Some argue that this practice is analogous to a general pathologist referring to a dermatopathologist, or a general practitioner referring to a subspecialist. In essence, this may create an efficient triage environment in which the bulk of straightforward cases are handled by a dermatologist, reserving the most difficult ones for a dermatopathologist [6]. It should be further noted that the American Academy of Dermatology has issued a “Position Statement on Pathology Billing” supporting the right of dermatologists, based on their training, to interpret skin biopsy specimens and be paid fairly for such work [7]. Opponents of this practice readily admit that some dermatologists have the capability to perform dermatopathology services for their patients. However, much of the argument that opponents propose gets its credence from some of the basic principles of ethics—beneficience

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and non-maleficence. Namely, pathology services provided by fellowship-trained dermatopathologists, as opposed to clinical dermatologists without fellowship training in dermatopathology, may be of higher quality and result in less patient harm. For instance, even though the board examination in dermatopathology is, by itself, an arbitrary measure of knowledge, a board certified dermatopathologist, in general, is likely to be more skilled at dermatopathology than a clinical dermatologist [1, 2]. This skill results from additional training devoted to dermatopathology, continuing medical education in dermatopathology, and the day-to-day practice of dermatopathology [2]. While clinical dermatologists have every legal right to sign out pathology specimens for their patients and the ability to accurately interpret the majority of these cases, the clinical dermatologists might not be acting in the best interests of patients. Opponents also claim that in a field such as dermatopathology where subtle histolopathologic findings may prove of great importance, the so-called “easy” cases some dermatologists state should be triaged and handled solely by them may turn out to be the most difficult cases of all [2]. Also, there is the opinion that while correlation with clinical findings may often help to hasten the process of arriving at a pathologic diagnosis, such correlation may also induce a prejudice to have the microscopic findings agree with the clinical findings, a practice which on occasion may prove harmful to the patient [1, 2]. Another similar ethical debate focuses on whether a clinical dermatologist with fellowship training in dermatopathology should perform pathology services for one’s own clinic patients. In this case, it can be assumed that the quality of pathology service provided by the dermatologist is equivalent to that of any dermatopathology referral lab. However, the ethical debate in this scenario centers on additional financial remuneration that results when slides are read by any clinician. Studies have shown that when physicians have a financial incentive to utilize a service, overutilization of such a service may occur [8]. Therefore, if a dermatologist also acts as a dermatopathologist for one’s own patients, these patients may be subjected to excessive numbers of unnecessary biopsies. The ethics of this situation are solely dependant upon the motives of individual clinical dermatologists who choose to practice as dermatopathologists. If the motivation behind this practice is primarily to generate increased profit and performing unnecessary biopsies is a means to accomplish this, then this activity is

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unethical. The AMA Code of Ethics makes it clear that physicians should not place their own financial interests above patient welfare, and this would be violated by medically unnecessary biopsies [9]. However, one must also consider the practical benefits to patient care that are generated by a dermatologist acting as a dermatopathologist. This practice eliminates the need for specimens to be shipped to another location and this may be associated with a significant decrease in turnaround time for results. Also, this practice obviates any potentially confusing reports, as the dermatologist authors the reports. These benefits can lead one to argue that this method of practice can save the medical system both time and money in addition to enhancing patient care. Overall, when considering the ethics of a dermatologist reading his or her own slides, quality of pathology service must be the first consideration. Just as dermatologists are ethically obligated to refer to outside pathology labs based on quality of service over any other factor, they must first consider the quality of their own pathology service compared to other options available, especially if one is not board-certified in dermatopathology. This would include an honest assessment of one’s preparedness to appreciate and recognize subtle histopathologic findings in addition to features that are more common.

Case 2 A dermatopathologist renders a diagnosis of actinic keratosis and adds in the report that the lesion is incompletely excised and that “re-excision is required.” The referring dermatologist is pleased to learn that squamous cell carcinoma is not present, but personally believes that the patient is a good candidate for topical chemotherapy and that re-excision is not necessary.

Discussion Reports generated by dermatopathologists follow a typical surgical pathology report format. This format includes sections for demographic data, patient history, gross description, microscopic description, microscopic diagnosis and, if needed, additional comments and addendum reports. The dermatopathology report is essentially a guide to clinicians that helps facilitate a

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patient’s diagnosis, prognosis, and treatment plan [10]. With this overall goal in mind, dermatopathologists sometimes include suggested treatment options in pathology reports. Established guidelines for the surgical pathology report mention treatment recommendations from pathologists as an “optional” component that may be included in the “comments” section of the report [10]. For example, a dermatopathologist may want to mention a need for the dermatologist to perform a wider excision for treatment of a cutaneous neoplasm. A close analogy to this situation involves diagnostic radiologists recommending evidence-based treatments or additional imaging procedures in their reports. According to the American College of Radiology, radiologists should mention the need for additional studies “when appropriate” [11]. The lack of strict regulation on whether a pathologist should report treatment recommendations or a subsequent course of action for the clinician to follow can lead one to conclude that this practice is dependant on the pathologist’s best judgment. It appears that clinicians have mixed attitudes about this practice. Those who favor pathologists recommending a clinical course of action may do so because it facilitates the care of an unfamiliar diagnosis or minimizes the risk that inattention to detail will compromise patient care. A survey distributed by Canadian radiologists to clinicians supports this view. In this study, it was found that greater than 50% of general practitioners wanted radiology reports to include recommendations for additional workup of a diagnosis. However, only about one-third of internists and surgeons valued such input [12]. When applied to pathology, this suggests that generalists may have more of a positive attitude than specialists do regarding the practice of pathologists suggesting a plan of action. General practitioners, by virtue of their broad practice scope, are less likely to possess expertise in managing a given diagnosis than specialists in their field of training [13]. Clinicians may not be in favor of treatment recommendations from pathologists for a number of reasons. Some clinicians believe it is their responsibility alone to formulate a treatment plan based on all facts of a case, a process that requires clinical-pathologic correlation [13]. In addition, any additional recommendations that accompany a diagnosis may compel a clinician to comply with such a plan for medicolegal reasons, despite any disagreement the clinician may have with

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the plan [12]. For example, if a dermatopathologist were to report that “re-excision is required” for a cutaneous neoplasm, the referring dermatologist may feel compelled to comply with this recommendation despite believing that topical chemotherapy or another approach might work best for the patient. Pathologists, in general, are obligated to provide clinical colleagues with information that can guide a patient’s diagnosis, treatment, and prognosis. The information presented must be carefully weighed with reasonable options presented when appropriate. In some cases it might be preferable to state “additional treatment is recommended” as opposed to “re-excision is required”. Thus, the clinician is alerted to the importance of taking action without direct pressure for a specific course of treatment.

Case 3 A patient files a malpractice suit against his dermatologist and the associated dermatopathologist for failure to diagnose melanoma. His attorney claims that both the dermatologist and dermatopathologist failed to consider the patient’s previous pathology records from an outside institution that could have facilitated the diagnosis of melanoma at an earlier, more treatable stage. A dermatopathologist is hired by the patient’s attorney to serve as an expert witness. Extra compensation is promised to this dermatopathologist for a successful outcome at trial.

Discussion Historically, the field of dermatology has been considered a relatively “low-risk” specialty of medicine in regard to medical malpractice. However, it has been noted that in recent years malpractice rates for dermatologists have significantly increased [14, 15]. Part of this may be due to poor market conditions for malpractice insurers, who have been burdened with the task of paying out increasing sums for physicians in general. It is also suggested, however, that a changing scope of practice in dermatology may be responsible for increased rates of malpractice suits filed against dermatologists. Specifically, dermatologists have increasingly engaged themselves in the practice of cosmetic procedures and surgical treatments. In particular,

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the management of malignant cutaneous neoplasms generates more malpractice claims than any other service a dermatologist performs [16]. As dermatopathologists often work very closely with dermatologists in management of cutaneous neoplasms, dermatopathologists are often called upon to serve as expert medical witnesses in malpractice cases. In addition, dermatopathologists are often called upon as expert witnesses to testify regarding other dermatopathologists for “failure to diagnose” a malignancy. This, especially, is becoming more frequent in cases involving the diagnosis of malignant melanoma. Physicians, as a group, have a number of ethical obligations with regard to medical testimony. First, physicians should serve as medical expert witnesses when needed, as they are obligated to assist in the administration of justice. This may include assessing medical information, interpreting and explaining medical uncertainty, medical research, and customary practice, and exerting an opinion as to whether standards of medical care have been met in a case [17]. Expert witnesses should accurately disclose their background and experience in the area in which they are testifying. Also, expert witnesses have a duty to be adequately prepared for trial and to testify honestly in a manner that accurately reflects current scientific thought. Finally, medical testimony should not be influenced by financial considerations. For instance, a physician should never arrange to receive extra compensation for a successful outcome in a trial [18]. Although the ethical obligations of any physician who serves as an expert medical witness appear well defined, it is not uncommon for witnesses to act unethically. The most common motivating factor behind such behavior is some form of financial incentive. By virtue of today’s legal system, attorneys are motivated to attract expert medical witnesses who will be “cooperative” in helping develop an argument, and such witnesses can be rewarded “handsome fees” for doing so [17, 19]. Such compensation may entice an expert witness to misrepresent his or her background or alter medical testimony in such a manner that he or she misquotes standard medical journals or texts, deliberately omits important facts, or provides false statements [20]. This behavior can have significant impact on the outcome of a malpractice trial as decisions by judges and jury members are based upon expert witness testimony [17]. Expert witness testimony is recognized by the American Academy of Dermatology as constituting

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Table 29.1 Responsibilities of the Expert Witness Prior to testimony

During testimony

• Become familiar with all data relevant to the particular matter at issue, excluding no relevant information for the purpose of creating a view that favors either party to a dispute; • Review previous and current concepts related to standards of dermatologic practice standards applicable to the matter at issue; • Decide whether his or her opinions, if any, will contribute in a meaningful, positive, and unbiased way to adjudication of the case impartially. • Testify honestly, fully, and impartially concerning his or her qualifications as an expert. • Offer expert testimony that is objective, truthful and accurate, based solely on medical knowledge of the matter at issue and never on the litigation posture of plaintiff(s) or defendant(s). • Offer an assessment of the matter at issue in the context of generally accepted standards of practice, neither condemning performance that clearly falls within generally accepted standards of practice nor endorsing or condoning performance that clearly falls outside accepted standards of practice. • Honestly, and fully, describe where and how his or her opinions may differ from common practice, never representing his or her own views as the only correct ones if they differ from those held by other qualified dermatologists.

one of “the most frequent complaints that the Ethics Committee has received in recent years…” [21]. In an attempt to discourage such unethical testimony by expert witnesses, increasing numbers of state and professional medical societies have developed codes of conduct for the expert witness [17]. The American Academy of Dermatology has developed a position statement on expert witnesses that delineates appropriate qualifications for expert witnesses and responsibilities regarding trial preparation and testimony delivery. Table 29.1 lists these responsibilities as outlined in the position statement [22]. Many of these organizations argue that this testimony is a form of practice of medicine and as such should be subject to peer review [17, 23]. Some societies have even developed disciplinary actions for noncompliance with their established guidelines [17]. In summary, it is essential for dermatopathologists, when called upon to testify, to adhere to the ethical guidelines provided by the American Academy of Dermatology and the AMA. Such testimony can have substantial impact on the views of the jury and judge, and any attempts to provide unfair expert testimony can damage not only the personal reputation of the witness but also result in sanctions from medical societies and even legal consequences [17].

Case 4 A dermatologist has been referring all of his patients’ biopsies to the same local dermatopathologist for many years, as he has come to trust the dermatopathologist

for accurate, timely results. However, he has noticed that some of his patients’ managed care plans have started to develop lists of approved pathology labs for skin biopsy interpretation. He notices that the dermatopathologist to which he has always referred is not on these lists as all approved labs are out-of-state commercial labs. Some of the patients’ plans refuse to cover any pathology fees unless one of these approved labs is utilized.

Discussion Dermatologists are often faced with ethical dilemmas when they decide where to send their patients’ biopsy specimens. There may be many options for dermatopathology service, including local hospitals, academic medical centers, private dermatopathology labs and national commercial dermatopathology labs. Also, as addressed previously, some clinicians may choose to perform their own pathology services. Regardless of which option is chosen, dermatologists are ethically obligated to refer to a laboratory that they feel offers the best quality of service and accuracy when compared to all options available. Other factors such as cost may be taken into account, but these must remain secondary to quality [24]. Currently, actions being taken by insurance organizations may be making it more difficult for dermatologists and other clinicians to adhere to this ethical standard. Some insurers request that associated clinicians refer all pathology services to a specific laboratory determined by the insurance organization. This may create an ethical dilemma if a clinician has already developed a trusting

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relationship with a certain lab, and he or she is being asked to begin referring to a new and unfamiliar lab. Insurance organizations may argue that this practice is a means of reducing healthcare costs. Large national laboratories, or commercial labs, are often the laboratories designated by insurance as they perform pathology services at reduced rates for services when compared to other labs. Often, this results from arrangements in which these labs accept capitated annual payments for patients’ laboratory services in exchange for a large volume of referrals from managed care organizations. Additionally, insurers may favor this system of payment because of administrative convenience and simplified paperwork [25, 26]. Overall, they argue that these labs can provide quality service and that quality can be maintained while costs are reduced. Some may feel that this practice by insurance organizations is inherently unethical in that cost is the primary consideration. In addition, it is certainly an unethical practice if quality of service and accuracy is jeopardized. Quality of pathology service may be measured by several factors including accuracy, speed, and availability of laboratory pathologists to discuss difficult cases. Although accuracy of diagnosis is dependent upon skill level of the interpreting pathologist, it is also highly dependent upon the working environment for the pathologist. The amount of time given to review individual cases, the ability to order special stains and deeper sections when needed, and the opportunity to request second opinions all factor into the accuracy of a final pathologic diagnosis [27]. There are many reasons for why the accuracy of diagnoses at “mandated” labs might not be comparable to accuracy at other dermatopathology labs. First, it must be considered that some capitation agreements may result in dermatologists being mandated to refer to labs in which employed pathologists are not board-certified in dermatopathology and who do not have sufficient experience in dermatopathology [26]. This can logically result in an increased diagnostic error rate. Next, commercial labs, in comparison to other available labs, usually require a larger volume of cases signed out per day and may not provide dermatopathologists with colleagues with whom they can review difficult cases around a multiheaded microscope. Finally, mandated referrals and capitation arrangements eliminate the need for involved labs to compete. The absence of competition can create an environment in which

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standards fall and inaccurate diagnoses become more frequent [26]. Studies do in fact demonstrate that when third party payers mandate skin biopsy referrals to labs that are not known by a dermatologist, a significant error rate results and overall quality of service decreases [28]. Further, there is evidence that initial attempts to limit costs of dermatopathology services by referring to the cheapest available lab may result in hidden increased costs at a later time. For example, the increased rate of diagnostic errors linked to low-cost labs may lead to costly surgery for benign lesions or the additional cost of treating a malignancy diagnosed too late [29]. By dictating a lab to which a dermatologist must refer, managed care organizations may also be jeopardizing turn around time and quality of communication to which a dermatologist is accustomed. Studies have demonstrated that results from managed careauthorized labs are significantly delayed when compared to results from other dermatopathology labs [30]. Possible reasons for this may include greater shipping distances or reduced standards of quality at commercial labs which, as previously mentioned, may feel little need to compete when referrals are mandated. In terms of communication, our case example provides an excellent illustration of how mandated referrals can negatively impact quality of service. Dermatopathologists serve as valuable consultants to dermatologists and are integral in the management of all patients, and thus it is essential that all dermatologists have a strong working relationship with a chosen dermatopathologist to ensure quality of care [25]. This is much more difficult to achieve if dermatologists are mandated to refer to anonymous consultants, and clinical errors may result from reading reports written in styles that are different from those to which a dermatologist is accustomed. It is beneficial for dermatologists to have the ability to utilize their professional judgment in deciding which dermatopathology lab is trusted most and can best serve their patients. This is especially true considering that dermatologists may be held medicolegally liable for referrals. Some states still enforce the joint and several liability statute which states that physicians may be held fully accountable for monetary damages in a malpractice case even if they were only found to be one percent responsible. As clinical dermatologists engage in direct patient contact, unlike some dermatopathologists, patients are often inclined to place most

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blame on dermatologists for unexpected medical results and name them in malpractice claims. In fact, studies of malpractice claims against dermatologists regarding melanoma, the diagnosis which yields the greatest awards in dermatology malpractice, have shown that the top two reasons for patient awards are delay in diagnosis and mistaken diagnosis. Both of these reasons often stem from errors on the part of the dermatopathologist [31, 32]. The American Academy of Dermatology has developed a “Position Statement on Physician Choice of Consultation for Interpretation of Skin Biopsy Specimens”. Essentially, it is determined that the right of a dermatologist to choose a dermatopathologist is an extension of the right of patient access to care and choice of physician [33]. Insurance organizations, by virtue of lacking a true working relationship with laboratories, are not as well-suited in determining the quality of a laboratory as a dermatologist. Thus, it is imperative that dermatologists have some control over where they refer in order for sound, ethical decisions to be made in terms of laboratory utilization. Simply adhering to the mandates of insurance organizations creates an open window of opportunity for a breach of ethics and may contribute to poor patient care. Finally, it should be considered that mandated dermatopathology lab referrals, in general, can result in a shift of referrals away from academic institutions and toward commercial labs. This would deprive dermatology and pathology residents as well as dermatopathology fellows of valuable teaching material. Third-party payers must recognize that academic dermatopathology labs are indispensable to society and must receive a significant volume of referrals so that generations of dermatologists and pathologists to come will be competent and well-prepared for practice.

Conclusion The day-to-day practice of dermatopathology has been known to present challenging ethical scenarios to dermatopathologists and dermatologists alike. Both parties should be familiar with relevant ethical guidelines so as to enhance clinical decision making and facilitate high-quality patient care. Additionally, the practice of modern day dermatopathology is not limited to the local dermatopathologist. Rather, the commercial dermatopathology laboratory has enabled competition

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for skin specimens to occur on a national level. Dermatologists must approach any potential pathology provider with careful scrutiny as to the quality of service provided and should be entitled to refer based on their best professional judgment.

References 1. Ackerman AB. Dermatologist ¹ dermatopathologist: no place in a profession for pretenders. J Am Acad Dermatol. 2005;53:698–9. 2. Grant-Kels JM. The whys and wherefores of who reads dermatopathology slides. J Am Acad Dermatol. 2005;53: 703–4. 3. Singh S et al. The extent of dermatopathology education: a comparison of pathology and dermatology. J Am Acad Dermatol. 2005;5:694–7. 4. Trotter MJ, Brueck AK. Interpretation of skin biopsies by general pathologists: diagnostic discrepancy rate measured by blinded review. Arch Pathol Lab Med. 2003;127: 1489–92. 5. Waller JM, Zedek DC. How informative are dermatopathology requisition forms completed by dermatologists? A review of the clinical information provided for 100 consecutive melanocytic lesions. J Am Acad Dermatol. 2010;62: 257–61. 6. Moy R. The reason that dermatologists should not send all their slides to dermatopathologists is a scope of practice argument, not an ethical argument. J Am Acad Dermatol. 2005;5:700. 7. American Academy of Dermatology. Position statement on pathology billing. 2007. http://www.aad.org/Forms/Policies/ ps.aspx. Accessed 13 June 2011. 8. US Health and Human Services Department Office of the Inspector General Office of Analysis and Inspections. Financial arrangements between physicians and health care businesses: report to congress; May 1989. p.3. http://oig. hhs.gov/oei/reports/oai-12-88-01410.pdf. Accessed 13 June 2011. 9. American Medical Association. Opinion 8.03. Conflicts of interest: guidelines. In: AMA code of medical ethics. Chicago: American Medical Association; 1994. 10. Goldsmith JD. Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med. 2008;132:1608–16. 11. Berlin L. Malpractice issues in radiology: relying on the radiologist. Am J Radiol. 2002;179:43–6. 12. Lafortune M, Breton G, Baudouin JL. The radiological report: what is useful for the referring physician? Can Assoc Radiol J. 1998;39:140–3. 13. Titus K. Clinicians talk shop – here’s what they want. CAP Today. Sept, 2003. http://www.cap.org/apps/cap.portal?_ nfpb=true&_pageLabel=reference. Accessed 11 Jan 2010. 14. Dermatology World. What dermatologists should consider when choosing malpractice insurance. 2005. http://12.107.100.40/pm/compliance/management/_doc/ MedicalLiability_Primer_%20What_dermatologists%20 should%20consider.pdf. Accessed 13 June 2011.

176 15. Resneck JS. Trends in malpractice premiums for dermatologists: results of a national survey. Arch Dermatol. 2006;142: 337–40. 16. Dermatology World. Changes in specialty and legal environment lead to increases in malpractice rates for dermatology. 2004. http://12.107.100.40/pm/compliance/management/_ doc/MedicalLiability_Changes%20in%20specialty%20 a n d % 2 0 l eg a l % 2 0 e nv i r o n m e n t % 2 0 l e a d % 2 0 t o % 2 0 increases%20in%20malpractice%20rates%20for%20dermatology.pdf. Accessed 13 June 2011. 17. Feld AD, Carey WD. Expert witness malfeasance: how should specialty societies respond? Am J Gastroenterol. 2005;100:991–5. 18. American Medical Association. Opinion 9.07. Medical testimony. In: AMA code of medical ethics. Chicago: American Medical Association; 1994. 19. Berlin L. The miasmatic expert witness. AJR Am J Roentgenol. 2003;181:29–35. 20. Reardon TR. AMA report on expert witness testimony. http:// truthinjustice.org/amareport.htm. Accessed 12 Jan 2010. 21. Greenberg RD. The American academy of dermatology ethics committee: how it works and what you need to know. Clin Dermatol. 2009;27:331–5. 22. American Academy of Dermatology. Position statement on expert witnesses. 22 Nov 2003. http://www.aad.org/Forms/ Policies/ps.aspx. Accessed 13 June 2011. 23. Austin RM, McCoy DR. The confused pathology expert: the ongoing challenge of monitoring physician expert witness testimony. Diagn Cytopathol. 2007;35:749–55.

H.O. Wiland IV et al. 24. American Medical Association. Opinion 8.09. Laboratory services. In: AMA code of medical ethics. Chicago: American Medical Association; 1994. 25. Brodell RT. The effort to decapitate American dermatopathology. J Am Acad Dermatol. 1995;32:299. 26. LeBoit PE, Cockerell CJ. The effort to decapitate American dermatopathology through laboratory capitation: an urgent and dire warning to dermatologists and dermatopathologists. J Am Acad Dermatol. 1994;31:98–100. 27. Grant-Kels JM, Kels BD. Dermatology lab referrals: cash cow or ethical trap? Virtual Mentor. 2006;8:499–502. 28. Penneys NS. Quality assessment of skin biopsy specimens referred to anonymous consultants. Arch Dermatol. 1996;132:1053–6. 29. Olhoffer IH et al. Histopathologic misdiagnoses and their clinical consequences. Arch Dermatol. 2002;138:1381–3. 30. Penneys NS. Log-in/log-out time: a quality factor for a reference laboratory – prolonged times. J Am Acad Dermatol. 1997; 36:995–8. 31. Ratushny V, Allen HB. The effect of medical malpractice on dermatology and related specialties. J Med Sci Res. 2007;1:15–20. 32. Crowson AN. Medicolegal aspects of neoplastic dermatology. Mod Pathol. 2006;19:S148–54. 33. American Academy of Dermatology. Position statement on physician choice of consultant for interpretation of skin biopsy specimens. 2007. http://www.aad.org/Forms/Policies/ ps.aspx. Accessed 13 June 2011.

Deﬁning the Gray Zone: Client Billing and Contractual Joint Ventures

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Homer O. Wiland IV, Barry D. Kels, and Jane Grant-Kels

Case Scenarios Case 1 Dr. C is a clinical dermatologist who sends 2,000 specimens per year to an out-of-state laboratory rather than to a nearby university hospital. He pays the dermatopathology lab $30 per specimen for slide processing and interpretation. Dr. C receives, however, on average $100 per slide from third party payers for the pathology component from each biopsy. Patients in this practice are not informed that Dr. C does not directly process and interpret their slides. They are unaware of the arrangement he has with the out of state laboratory.

Case 2 Friendly Derm Services (FDS) approaches several local dermatologists offering reduced rates for its slide processing and interpretation in exchange for referral of all of the dermatologist’s specimens. FDS tells the dermatologists they will profit from the difference between

H.O. Wiland IV Department of Pathology, Cleveland Clinic Foundation, Cleveland, OH, USA B.D. Kels Division of Ophthalmology, Department of Surgery, University of Connecticut Health Center, Farmington, CT, USA J. Grant-Kels (*) Department of Dermatology, University of Connecticut Health Center,Farmington, CT, USA e-mail: [email protected]

the discounted pathology fees and reimbursements by insurers. FDS, however, supports this arrangement because of the opportunity to earn money from consistent and increased volume.

Case 3 Innovative Dermatology Ventures (IDV) is a private practice of seven dermatologists. They purchase laboratory space, equipment, and personnel from a private pathology group. This laboratory consists of a single room in which only the group’s specimens are processed and interpreted. There are many other similar rooms in the same building in which the pathology providers work for other referring practices. IDV pays an annual set fee to have this lab maintained and to have all of its specimens interpreted. Subsequently, they bill patients’ third party payers, including Medicare and Medicaid, a fee that includes both technical and professional components of dermatopathology service. This arrangement generates a significant profit for IDV.

Case 4 Instead of purchasing a laboratory from a private pathology group, IDV decides to hire a full-time dermatopathologist to interpret their specimens on-site. An outside laboratory continues to process and bill the technical component for all specimens. The dermatopathologist is paid a fixed salary, and the group generates a significant profit by billing for the technical and professional pathology services.

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Discussion In anatomic pathology, and dermatopathology specifically, billing for services takes into account two separate components: a technical component (CPT code modifier “TC”) and a professional component (CPT code modifier “-26”) [1]. The technical component of the overall fee takes into consideration laboratory supplies, facility rent, and technician work time. The professional component reflects the time and effort as well as professional overhead of the pathologist interpreting the specimen [1]. These components, billed separately or combined as a global pathology fee, may then be passed along to patients and insurers. Direct billing is the most commonly used system in the U.S. The dermatopathology laboratory that processes and interprets the specimen directly bills the patient or insurer [2]. Client (or account) billing is an alternative approach which has generated significant controversy. In this system, the referring clinician pays the dermatopathology laboratory a fixed amount for both the technical and professional fees, and then the clinician bills the patient or insurer [3]. Much of the ethical controversy regarding this billing system revolves around the participating physicians’ motives. Legal issues also directly impact the practice of clientbased billing.

The Ethical Case Against Client Billing Professionalism requires physicians to act in their patients’ best interests, placing their fiduciary duty to patients ahead of their own self interests. The American Medical Association (AMA) Code of Ethics includes several opinions on billing practices as they pertain to the cases above: Opinion 6.09: “When it is not possible for the laboratory bill to be sent directly to the patient, the referring physician’s bill to the patient should indicate the actual charges for laboratory services…” [4] Opinion 6.10: “No physician should bill or be paid for a service which is not performed; mere referral does not constitute a professional service for which a professional charge should be made or for which a fee may be ethically paid or received…A physician should not charge a markup, commission, or profit on the services rendered by others.” [5] Opinion 8.09: “…A physician may make an acquisition charge or processing charge. The patient should be notified of any such charge in advance.” [6]

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While Dr. C’s client billing practice is not necessarily unethical in itself, there are a number of his actions that may be unethical or even illegal. First, no attempt was made on the part of the dermatologist to disclose to patients the actual fee charged by the dermatopathology lab. Second, this case involves the clinical dermatologist directly profiting from ordering a laboratory test. The dermatologist knowingly billed insurers significantly higher fees than paid to the laboratory. Aside from a possible processing fee incurred by the dermatologist, the difference between the insurance payment and the laboratory fee represents substantial income for the dermatologist, especially when multiplied by the scores of biopsies performed weekly in a routine dermatology practice. In an attempt to prohibit this practice, some advocate permitting only dermatopathology laboratories to bill patients and insurers for pathology interpretation services. The theory is that this billing method prevents clinicians from marking up pathology services or receiving kickbacks. Medicare has required direct billing for laboratory services since 1984 under the Deficit Reduction Act (DEFRA) [7]. Since then, a number of private insurance companies and 16 states, most recently Connecticut, have adopted similar legislation [8]. Direct billing proponents emphasize harmful consequences of allowing clinicians the opportunity to mark up laboratory costs. If physicians profit from laboratory services, excessive utilization may occur. Some data supports this conclusion. In 1988, prior to Stark law enactment, the Health and Human Services Office of the Inspector General conducted a study revealing that “Patients of referring physicians who own or invest in independent clinical laboratories received 45% more clinical laboratory services than all Medicare patients in general, regardless of place of service [9].” This increased utilization was estimated to cost Medicare 28 million dollars in 1987 [9]. Likewise, in another study published by the Center for Health Policy Studies, nondirect billing states were associated with higher rates of laboratory test utilization, as clinicians in these states ordered 28% more tests. Additionally, laboratory charges to insurance companies were 41% higher in non-direct billing states (ie. states the permit client billing) [10]. When physicians profit from ordering laboratory services, the fees per service and total number of services ordered were higher. This utilization pattern not only raises health care costs, but may also compromise patient care. When the additional studies are unnecessary, then patients are

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Defining the Gray Zone: Client Billing and Contractual Joint Ventures

exposed to unjustified risk and discomfort [3, 11, 12]. Patient care may also suffer if clinical dermatologists are subtly motivated to refer to the least expensive available lab, regardless of quality [11, 12]. Emphasizing cost—without first considering measures of laboratory quality—clearly compromises a patient’s interest. Some also argue that client billing practices additionally threaten patient care by limiting the resources dermatopathology laboratories can muster to provide quality care. More narrow profit margins may discourage laboratories from providing deeper sections, performing additional stains, or requesting outside consultations.

The Ethical Case for Client Billing Proponents of client billing argue that it is not only ethical, but also beneficial to patients. They claim that client billing can decrease health care expenses, ensure consistent quality slide interpretation, and simplify patient billing procedures. One survey comparing what dermatologists charge for pathology services versus what dermatopathologists charge, demonstrated that dermatologists who client bill charge an estimated 80% of what dermatopathologists charge for services [13, 14]. This study concluded that permitting dermatologists to client bill actually ends up saving patients and insurers money. Even with some degree of markup over what the dermatopathology lab charges the dermatologists, this client billing practice may still save money [14, 15]. A dermatopathology laboratory’s discount for guaranteeing volume may exceed the dermatologist’s subsequent mark up. One explanation for this condition is the decreased cost and financial risk faced by a laboratory when a dermatologist directly bills insurers. Client billing not only eliminates the cost of laboratories directly sending out bills, but it also eliminates the risk that they would take of not getting paid since they are guaranteed timely payment from the dermatologist. With client billing, it is the dermatologist who assumes the risk of not receiving payment for laboratory services [13]. The dermatologist, however, already has mechanisms in place to directly bill the patient and the marginal cost of billing for an additional service (slide processing and interpretation) is minimal. Eliminating the need for the laboratory to research patient demographics or prepare and mail out bills, client billing may save significant time and money and in so doing create a more efficient system [13]. Some data, at least,

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support the claim that client billing leads to lower charges than direct billing [13–15]. Another argument in favor of client billing focuses on dermatologist choice for obtaining pathology services. When a dermatopathology lab direct bills for services, this lab must have a contract with the specific insurance plan. Insurers may choose to contract with some labs, but not others. In this way, where a patient’s specimen is sent depends on the third party payer’s contractual agreements, rather than the clinical dermatologist’s preferences. Client billing permits a dermatologist to select the laboratory for pathology services. Ideally, this selection is based on laboratory and dermatopathologist quality. All specimens could be sent to a single lab that the dermatologist had come to trust [13, 14]. However, under the practice of direct billing, such a trustworthy lab may not be recognized by every patient’s insurance plan, and the dermatologist is left to decide whether to refer innetwork to a possibly lower-quality lab or to the trusted lab at an increased cost to the patient. Finally, some claim that client billing offers increased convenience and efficiency when compared to direct billing. One comprehensive bill is more convenient and understandable than multiple bills from multiple sources. Increased convenience, possibly lower costs, and improved quality are all claimed to support client billing.

Additional Considerations Most dermatologists can choose among many dermatopathologists. These may include local hospitals, academic medical centers, local private laboratories, and large national laboratories. In an effort to attract increased referral volume, some laboratories may offer clinicians discounted rates [16]. In regard to clinicians considering the cost of laboratory services, the AMA Code of Ethics offers the following opinions: Opinion 8.03: “Under no circumstances may physicians place their own financial interests above the welfare of their patients.” [17] Opinion 8.09: “Medical considerations, not cost, must be paramount when the physician chooses a laboratory. The physician who disregards quality as the primary criterion or who chooses a laboratory solely because it provides low-cost laboratory services on which the patient is charged a profit, is not acting in the best interests of the patient. However, if reliable, quality laboratory services are available at lower cost, the patient should have the benefit of the savings…” [6]

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Taking these recommendations into account, the primary obligation of the dermatologist is to search for a laboratory that will offer the highest quality of service. Quality considerations may include factors such as accuracy, speed, and the availability of the dermatopathologist to discuss difficult cases [16]. Valuing cost over quality harms patients and is unethical. It would be ethical and even encouraged, however, if a lab could provide equal or superior quality services at a reduced cost, and the dermatologist passed the savings along to the patient. Thus, in Case 1, if the distant lab has a proven track record of accuracy, speed, and availability, then there is nothing unethical about the dermatologist’s decision to refer to it. In addition to considering clinical dermatologists’ ethical obligations, dermatopathologists also assume important ethical obligations. As already mentioned, labs may be tempted to offer clinicians, as opposed to insurers, discounts based on referral volume. In essence, this can be viewed as a form of competition for specimens with other labs. The AMA code of ethics addresses competition in medicine by giving the following opinion: Opinion 6.11: “Competition between and among physicians and other health care practitioners on the basis of competitive factors such as quality of services, skill, experience, miscellaneous conveniences offered to patients, credit terms, fees charged, etc., is not only ethical but is encouraged…” [18]

Therefore, if one views the practice of pathology labs working for a discount solely as a means of competition, this practice appears to be consistent with AMA ethics guidelines. Such a practice may become ethically suspect, however, if the clinical dermatologist uses these discounts to essentially profit from simply referring specimens to a certain lab. In this manner, the practice may constitute fee-splitting [12]. The AMA Code of ethics offers opinions on feesplitting: Opinion 6.02: “Payment by or to a physician solely for the referral of a patient is fee-splitting and is unethical.” [19] Opinion 6.03: “…clinics, laboratories, hospitals, or other health care facilities that compensate physicians for referral of patients are engaged in fee-splitting, which is unethical.” [20]

Fee splitting practices are explicitly proscribed by the AMA ethics code as well as several legal statutes.

H.O. Wiland IV et al.

Legal Issues Federal legislation prohibits dermatologists from client billing for Medicare and Medicaid patients. Several states as well as some private health insurers also ban client billing [7, 8]. Other states, while not requiring direct billing, adopted anti-markup legislation, that either forbids clinical dermatologists from marking up the cost of slide processing or requires disclosure of any markups that do occur [12]. Even in states lacking anti-markup legislation or requiring direct billing, client billing may still violate other statutes. If a clinician secures personal profit from client billing for pathology services, this may constitute fee-splitting. Some states have fee-splitting prohibitions, and efforts to circumvent such legislation may result in the loss of one’s medical license [12]. Other legislation for both parties to be aware of includes federal anti-kickback laws, self-referral laws, and the Medicare “Usual Claims” statute. The federal “Anti-Kickback Statute” states: (1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program…shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both [21].

In an attempt to facilitate any “innocuous” or potentially beneficial commercial arrangements that would otherwise violate the statute, a number of “safe harbors” have been created to provide immunity to these arrangements. Even if there is a potential violation of the anti-kickback statute and the case does not fall within the realm of a safe harbor, it is subject to review based on facts and circumstances before any charges are filed [22]. Still, a dermatologist who receives any remuneration in return for referring Medicare or Medicaid patients to a specific laboratory is at risk of violating the federal “Anti-Kickback Statute.” This may include a dermatologist being charged prices less than fair market value for pathology services for privately-insured patients in return for continued referral of Medicare patients [12]. Pathology providers also fall subject to this legislation, and guilt on their part

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requires that there is proof of “knowing” of an impending kickback and “willful” illegal remuneration [3]. Physician self-referral involves a physician referring patients to a medical facility in which the physician or immediate family members have a financial interest [3]. The federal Stark laws are specifically designed to prevent physicians from “self-referring” Medicare or Medicaid patients to certain designated health services, including pathology laboratories. The Medicare “Usual Charge” Statute may be violated if a pathology provider bills Medicare or Medicaid for charges that are “substantially in excess of such [provider’s] usual charge.” As it has been determined by the Office of the Inspector General (OIG), this means charging for more than 120% of the cost of an item or service. This statute is very vulnerable to violation if a laboratory allows certain referring clinicians to client bill, as volume discounts to such clinicians often result in prices that are 50% or even less of what such laboratories charge Medicare. Any provider that violates this statute risks being excluded from the Medicare program [12].

Contractual Joint Ventures Contractual joint ventures (CJV’s), which take on several forms including the so-called “pod” or “condo” labs and vertically integrated group practices, are unique laboratory arrangements set up by clinicians, including dermatologists. A pod lab can be described as: (“…an entity that leases space in a medical building, subdivides it into separate cubicles or ‘pods,’ equips each space with microscopes and other laboratory equipment, and leases out these limited labs to a physician group. The entity hires a histotechnologist to perform the technical component and arranges for a pathologist to perform the professional component. The entity charges the physician group a management fee that covers the space, equipment, and histotechnologist. The group practice compensates the pathologists on a per slide basis (a purchased test) or with a set fee. In this latter scenario, the pathologist reassigns his or her billing rights to the group practice. The group practice then bills for the professional component provided by the pathologist and the technical component provided by the histotechnologist.”) [3]

Vertically-integrated group practice is a model by which typically a group of dermatologists hires its own dermatopathologist. This dermatopathologist will perform the professional component for pathology

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services. These groups may choose to build their own “in-house” laboratory and bill for the technical component or, most often, contract with an outside laboratory to perform the technical component. Table 30.1 compares the different models of contractual joint venture. In either arrangement, a dermatologist or dermatology group obtains the ability to directly bill for a larger proportion of its patients, including those under Medicare and Medicaid, assuming these plans do not already mandate pathology services be performed by a specific laboratory. This ability is derived from exceptions to Medicare Reassignment rules. While these rules generally do not allow any physician not performing a service to be compensated by Medicare for that service, there are exceptions in which group employees (pathologists in the vertically-oriented group) or independent contractor physicians (pathologists in the pod lab model) may assign Medicare benefits to a specific medical group [22]. Thus, if clinicians who set up a CJV bill for reimbursement which is greater than what they pay contracted pathologists, they have potential to profit from these pathology services [11]. Both of these business models potentially violate the spirit and possibly the letter of the applicable laws, such as the Federal Anti-Kickback Statute and Stark law, as well as professional ethics, as they provide further models by which clinicians, such as dermatologists, can directly profit from services provided by pathologists interpreting their biopsy specimens. The Stark law is designed specifically to prevent physician self-referral. Yet, there are a number of exceptions to this law, including an “in-office ancillary services exception” for pathology services. To clarify and summarize this exception, a physician may refer pathology cases to a contracted pathologist (which could be a group member or an independent contractor) provided that pathology services are performed on-site at the referring physician’s practice or at an off-site, centralized building owned and operated exclusively by the referring physician’s practice [22, 23]. Under federal anti-kickback legislation, amounts paid to pathologists who are either group employees or independent contractors are safeharbored [22]. However, clinicians who wish to utilize these business arrangements to secure extra profit from pathology services may not be fully complying with these laws. Both the in-office ancillary services exception of Stark law and the safe harbors of anti-kickback legislation require clinicians to compensate contracted

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Table 30.1 Contractual joint venture models Pathologist’s role Pathologist reimbursement Lab location

Lab reimbursement

Pod labs • Independent contractor • Clinician pays a per slide or set fee • Off site-among other similar labs contracted to other practices •

Clinician pays all inclusive management fee to pathology provider

pathologists in a manner that reflects fair market value and does not reflect volume of referrals [22]. Finally, with respect to the legal implications of CJV’s, recent legislation passed by the Center for Medicare/Medicaid Services (CMS) includes an antimarkup restriction, which has made existence of profitable “pod labs” much more difficult to achieve for clinicians. This restriction makes it illegal for any clinician to mark up a professional component performed by a contracted pathologist, with two exceptions in which a clinician is defined as “sharing” a practice with a pathologist. The first exception involves a scenario in which the pathologist performs at least 75% of his or her professional services through the referring clinician’s practice. The second exception involves a scenario in which the pathologist is an owner, employee, or independent contractor of the referring clinician’s practice, and the pathologist performs professional services in the same medical office space in which the referring clinician cares for patients [25].

Case Resolution Case 1 This case clearly illustrates a dermatologist who is client billing for pathology services. Taken together, the ethical arguments for and against client billing do not restrict it in all circumstances. In this case, the dermatologist would have been acting in accordance with the AMA Code of Ethics if he had the laboratory directly bill the patient or insurance company. He would have also been acting ethically if, while engaging in client billing, he itemized the laboratory’s exact fee and his “processing or handling fee”, and abstained from marking up the cost beyond these fees alone. A violation of ethics is encountered only when a clinician

Vertically integrated practice • Group employee • Salaried Two type Practice owned • On site • Clinician bills for technical component

Contracted lab • Off site • Contracted lab bills for technical component

takes advantage of client billing to secure personal profit, as demonstrated in this case, or fails to act in the patient’s best interest by not selecting the highest quality laboratory to interpret the patient’s biopsies.

Case 2 This case describes a dermatopathology lab providing a dermatologist with a volume discount. The practice of dermatopathology labs working for volume discounts can be considered ethical so long as the lab is aware that the referring dermatologist will not charge a markup for profit, or if the lab will bill insurers directly for all patients. It is apparent in this case that the lab was fully aware that it was allowing the dermatologist to secure a profit through client billing for pathology services. Thus, the behavior demonstrated in this case, both by the lab and the dermatologist, is unethical. Laboratories have a strong incentive to ensure that their business arrangements with dermatologists do not constitute fee-splitting, as this may result in illegal behavior in addition to a breach of ethics [12]. Overall, it is recommended that laboratories not charge clinicians deeply discounted prices (prices below fair market value or below the cost to the lab to provide the service) for pathology services, as this may constitute a “kickback” for clinicians [12].

Case 3 This case describes the operation of a contractual joint venture known as a “pod lab”. Ethically, this case differs little from case 1 in that the dermatologists are profiting directly from work done by pathologists interpreting the dermatologists’ biopsy specimens. Also, this case illustrates a potential violation of the

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anti-markup restriction recently passed by the CMS. It is unlikely that the pathology group provides 75% of its services to the dermatology practice in this case and the lab is not located in the same medical office space in which the dermatologists care for patients. Therefore, the arrangement would not qualify as a “safe harbor” practice. If the dermatologists mark up the price of pathology services when they bill Medicare or Medicaid patients, they are acting illegally.

Case 4 This case describes the operation of a type of contractual joint venture referred to as vertically-integrated group practice. This type of dermatology practice can be considered beneficial to patient care in many ways due to the convenience of having a full-time dermatopathologist on-site. These benefits may include decreased specimen turn-around time, increased availability of the dermatopathologist for discussion of difficult cases, and increased availability of a dermatopathologist for intra-operative consultation in procedures such as Mohs micrographic surgery. In this type of practice, while the group bills patients or third party payers for the professional component of pathology services, the dermatopathologist must be compensated fairly to avoid violating the Stark Law and anti-kickback legislation. Since the dermatopathologist is employed full-time in this case, the CMS anti-markup legislation does not apply.

Conclusions It is apparent that dermatologists and dermatopathologists alike face both ethical and legal challenges. While client billing is illegal in several states and situations, it is still practiced by many physicians today. Though not inherently unethical, client billing may facilitate unethical behavior on the part of clinicians, such as choosing laboratories based solely on low cost or by facilitating fee splitting. This concept also holds true for evolving business models including pod labs and vertically oriented group practices. It is beneficial for dermatologists and dermatopathologists to appreciate the arguments presented for each side of these issues and, regardless of their decision whether to engage in these practices, to adhere to the highest ethical and professional standards. These ethical standards not

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only act as a means by which physicians may be judged by their peers and state medical licensing authorities [22], but more importantly serve as guidelines designed to maintain the highest levels of professionalism and quality in patient care.

References 1. American Medical Association. Current procedural terminology. 2010 Standard ed. Chicago: American Medical Association Press; 2009. 2. College of American Pathologists. Direct billing of pathology services. Advocacy issue brief. http://www.cap.org/ apps/docs/advocacy/advocacy_issues/Direct_Billing_ Pathology_Services_08.pdf. Accessed 16 June 2011. 3. American Society for Clinical Pathology. Self-referral, markups, fee-splitting, and related practices. The American Society for Clinical Pathology Policy Statement. Policy Number 04-03. 2009. http://www.ascp.org/pdf/Advocacy/SelfReferral-Policy-Statement-09.aspx. Accessed 16 June 2011. 4. American Medical Association. Opinion 6.09. Laboratory bill. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www.ama-assn.org/ama/ pub/physician-resources/medical-ethics/code-medical -ethics.page. Accessed 16 June 2011. 5. American Medical Association. Opinion 6.10. Services provided by multiple physicians. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics.page. Accessed 16 June 2011. 6. American Medical Association. Opinion 8.09. Laboratory services. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www.ama-assn. org/ama/pub/physician-resources/medical-ethics/codemedical-ethics.page. Accessed 16 June 2011. 7. Description of the current medicare payment system and its historic roots. In: Wolman DM, Kalfoglou AL, LeRoy L, editors. Medicare lab payment policy: now and in the future. Washington: National Academy Press; 2000. p. 75–99. http:// www.nap.edu/openbook.php?record_id=9997&page=75. Accessed 16 June 2011. 8. College of American Pathologists. Connecticut passes direct billing legislation protecting patients from markups. Statline: Federal and State News Briefs. 2009; 25(13). http://www. cap.org. Accessed 14 June 2011. 9. US Health and Human Services Department Office of the Inspector General Office of Analysis and Inspections. Financial arrangements between physicians and health care businesses: report to congress; May 1989. p. 3. http://oig. hhs.gov/oei/reports/oai-12-88-01410.pdf. Accessed 16 June 2011. 10. American Society for Clinical Pathology. Fee-splitting, markups, and related practices. The American Society for Clinical Pathology Policy Statement Policy Number 04-03; 2004. http:// www.ascp.org/PDF/FeeSplittingMarkupsandRelatedPractices. aspx. Accessed 16 June 2011. 11. Armstrong D. How some doctors turn a $79 profit from a $30 test. The Wall Street Journal. 30 Sept. 2005: p. A1.

184 12. Wood JP. Anatomic pathology in today’s volatile marketplace: beating back the challenges. Phoenix: College of American Pathologists; 2004. http://www.cap.org/apps/ docs/annual_meeting/presentations/2004/monday/ PM105_Volatile_Marketplace_Part_2.pdf. Accessed 16 June 2011. 13. Kumar M, Taylor S, Camacho FT, Tart D, Feldman SR. Who really benefits when dermatologists bill patients for pathology services. Skin Aging. 2007;15:64–9. http://skinandaging.com/article/7746. Accessed 16 June 2011. 14. Feldman SR. Chief medical editor’s message: should patients be prohibited from paying dermatologists for pathologist’s services? Skin Aging. 2007;15:8. http://skinandaging.com/article/7735. Accessed 16 June 2011. 15. Schneider ME. Revised pathology billing rules limit markup. Skin and Allergy News. 2009. http://www.entrepreneur. com/tradejournals/article/198472170.html. Accessed 16 June 2011. 16. Grant-Kels JM, Kels BD. Dermatology lab referrals: cash cow or ethical trap? Virtual Mentor. 2006;8:499–502. 17. American Medical Association. Opinion 8.03. Conflicts of interest: guidelines. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www. ama-assn.org/ama/pub/physician-resources/medical-ethics/ code-medical-ethics.page. Accessed 16 June 2011. 18. American Medical Association. Opinion 6.11. Competition. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page. Accessed 16 June 2011.

H.O. Wiland IV et al. 19. American Medical Association. Opinion 6.02. Fee splitting. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http://www.ama-assn.org/ama/ pub/physician-resources/medical-ethics/code-medical-ethics.page. Accessed 16 June 2011. 20. American Medical Association. Opinion 6.03. Fee splitting: referrals to health care facilities. In: AMA Code of Medical Ethics. Chicago: American Medical Association; 1994. http:// www.ama-assn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics.page. Accessed 16 June 2011. 21. 42 USC 1320a-7b. 22. Wood JP. How to compete when everyone seems to be cheating. In: American Society for Clinical Pathology Companion Meeting, 2007 United States and Canadian Academy of Pathology Annual Meeting, San Diego, 25 Mar 2007. http://www.pathologyportal.org/96th/pdf/companion21h02. pdf. Accessed 16 June 2011. 23. College of American Pathologists. Annual meeting preview: the CAP response to contractual joint ventures. Statline: Federal and State News Briefs. 15 Sept 2004. http://www. cap.org. Accessed 14 June 2011. 24. Wood JP. New CMS anti-markup rules. Las Vegas: American Pathology Foundation; 2009. http://www.uscap.org/ site~/98th/pdf/companion23h02.pdf. Accessed 16 June 2011. 25. US Department of Health and Human Services. Special advisory bulletin: contractual joint ventures. Office of the Inspector General; April 2003. p.2. http://oig.hhs.gov/fraud/ docs/alertsandbulletins/042303SABJointVentures.pdf . Accessed 16 June 2011.

No Strings Attached? Managing Conﬂicts of Interest in Medicine

31

Noah D. Shannon and Clifford Perlis

Conflicts of interest are widespread in dermatology, arising whenever medically relevant decisions are potentially inappropriately influenced by other factors. Financial conflicts of interest may range from ownership of a treatment facility or medical device company to simply receiving gifts from a pharmaceutical company. While financial conflicts of interest tend to receive the most attention by regulators and ethicists, conflicts involving religion, friendships, prestige, or other non-financial interests may also prove relevant. Conflicts of interest are not inherently harmful. They do, however, highlight the potential for inappropriate influence. Accordingly, conflicts of interest should be identified and appropriately managed. This chapter will review the concept of conflict of interest with a focus on ethical considerations, common manifestations, and potential remedies.

Case Scenarios Case 1 Dr. MacDonald been asked to appoint a panel of experts to create guidelines for treating psoriasis. While these guidelines are intended to be evidence-

based, it is acknowledged that some areas will need to rely on expert consensus due to incomplete scientific evidence. Some leading experts receive or have received in the past industry support for enrolling patients in clinical trials, participating on scientific advisory boards, and lecturing about specific treatments. The amount of support as well as the number of contributing companies varies widely among participants. What should Dr. MacDonald consider when selecting expert participants?

Case 2 Dr. Alexander has worked closely with a biotechnology startup company to develop a new treatment for cutaneous T-cell lymphoma (CTCL) and is a joint patent-holder on the underlying technology for this new treatment. She is also one of only 15 specialists who have extensive experience treating CTCL. The company has recently received regulatory approval to conduct a clinical trial on the new treatment and is planning to utilize Dr. Alexander as an expert advisor and consultant for the trial. What issues may this raise and how should they be addressed?

Case 3 N.D. Shannon N.D. Shannon Associates, New York, NY, USA C. Perlis (*) Fox Chase Cancer Center, Philadelphia, PA, USA e-mail: [email protected]

Dr. Zyme regularly conducts lectures supported by a pharmaceutical manufacturer. She also treats several patients with the company’s products. Does she have a conflict of interest, and if so, how could it be resolved?

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_31, © Springer-Verlag London Limited 2012

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Case 4

Ethical Considerations

Dr. Pasquale sits on his hospital’s pharmacy and therapeutics committee. The committee is currently evaluating treatments for atopic dermatitis. Dr. Pasquale’s brother works for a pharmaceutical company selling a newly FDA-approved medication for this condition. Does Dr. Pasquale have a conflict of interest? If so, how should he proceed?

In assessing conflicts of interest from an ethical perspective, it is helpful to define the primary ethical obligations of physicians. The first principle in the AMA’s Code of Medical Ethics is, “A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights [5].” The Code continues, stating, “Under no circumstances may physicians place their own financial interests above the welfare of their patients. The primary objective of the medical profession is to render service to humanity; reward or financial gain is a subordinate consideration… If a conflict develops between the physician’s financial interest and the physician’s responsibilities to the patient, the conflict must be resolved to the patient’s benefit [5].” While the AMA’s Code focuses on financial conflicts of interest, its message is clear; medical decision-making must be focused on patient welfare above any personal factors. While the primary ethical concern related to conflicts of interest is compromised or biased decisionmaking, conflicts of interest create another potential risk; negative perception. In medicine, apparent conflicts of interest have the potential to erode trust between physicians and their patients as well as their colleagues, whether or not the conflict of interest has an impact on decision-making. For example, if a patient is aware of a financial relationship between his or her physician and a pharmaceutical company, the patient may perceive that the physician’s selection of prescription drugs may be biased. Trust is known to be a key element of an effective physician-patient relationship. Studies have also demonstrated that it is positively correlated with better medical outcomes [6]. The trust of medical colleagues is also important and should be seriously considered within this paradigm. Financial interests are the focus of both the headlines and scholarship in the area of conflicts of interest, but non-financial conflicts of interest must also be seriously considered. Both the Council of Medical Specialties Societies’ (CMSS) Code for Interactions with Companies and the American Academy of Dermatology’s Conflict of Interest Management Procedure for Clinical Practice Guidelines explicitly recognize the importance of non-financial, uncompensated conflicts of interest [7, 8]. Factors driving these non-financial conflicts of interest can range from personal friendships or antipathies to religious beliefs to

Discussion The Institute of Medicine of the National Academies defines a conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest [1].” In medicine, the primary interests include “promoting and protecting the integrity of research, the welfare of patients, and the quality of medical education.” Secondary interests “include not only financial gain but also the desire for professional advancement, recognition for personal achievement, and favors to friends and family or to students and colleagues [1].” A conflict of interest is a condition rather than an action or behavior. Accordingly, a conflict of interest may exist even if no improper act or decision results from it [2]. This is possibly the greatest area of confusion related to conflicts of interest; one can have a conflict of interest even if one’s decision-making is not in the least bit impacted by it. This confusion has a great deal to do with the stigma related to conflicts of interest. Importantly, even when they do not impact decisionmaking, they may impact how certain decisions are perceived [3]. To use an analogy, having a conflict of interest is in some ways like having your king “in check” during a game of chess. In chess, being “in check” does not mean that you will lose the game, but that you have an issue that must be addressed. More often than not, the king can move out of check if the situation is handled properly [4]. Similarly, rather than considering a conflict of interest as something that impugns one’s professional judgment, it should be viewed as a common, sometimes unavoidable, situation that must be managed with careful consideration.

31 No Strings Attached? Managing Conflicts of Interest in Medicine

personal ambition. Like financial conflicts of interest, the underlying concern is that a secondary interest (in this case, certain personal factors) carries the risk of inappropriately impacting decisions related to one’s primary interest (patient welfare, medical research, or medical education). While this type of conflict of interest is often difficult to identify and quantify, it nevertheless deserves careful consideration and management [9]. A major challenge in assessing conflicts of interest relates to determining whether or not they are “significant.” That is, what is the likelihood that the conflict of interest may influence or appear to influence professional judgment? For financial conflicts of interest, significance is typically tied to certain dollar thresholds. The US Department of Health and Human Services, in its research grant conflict of interest guidance, defines a “Significant Financial Interest” as “anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights)” valued at over $10,000 annually, or representing more than a 5% ownership interest in a private company [10]. This financial threshold for significance appears to have been adopted in the conflict of interest policies of several health care institutions, including the Mayo Clinic [5] and Harvard Medical School [5]. The question then arises, “Why do $10,000 and 5% equity constitute a significant interest?” It would seem logical that the amount should vary based on the income of the individual in question. Further, certain studies suggest that even small gifts or forms of remuneration given to medical professionals may have the potential to impact medical decision-making [11]. The answer is likely that, while imprecise, a dollar value standard must be set to trigger extra scrutiny and consideration for conflicts of interest. Accordingly, certain academic medical institutions and hospitals have adopted the government’s standard as a guideline.

Common Conﬂicts of Interest The majority of financial conflicts of interest in medicine result from relationships between the medical profession and the healthcare industry, and in particu-

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lar the pharmaceutical and medical device industries. According to a national physician survey conducted in 2007, 94% of physicians have some type of relationship with the pharmaceutical industry, whether it involves receiving free food (83%), drug samples (78%), or consulting payments (28%) [12]. Industry may provide physicians a wide array of financial inducements, including: • Consulting fees and honoraria, • Meals, • Payment for travel expenses, • Equity interests, • Royalty income, and • Compensation for service as an officer or director [13] While physicians generally deny that these financial relationships impact their own decision-making, they largely believe that similar financial relationships impact the judgment of their peers [14]. Moreover, social science research suggests that financial inducements, including gift-giving, do in fact influence behavior, whether or not the recipient recognizes the phenomenon [15]. More specifically, there is evidence that attending industry-sponsored events and receiving industry funding are associated with increased prescription rates for the sponsor’s medication [16]. There is also evidence that clinical trials sponsored by pharmaceutical companies are more likely to have outcomes favoring the sponsor than studies with other sponsors [17, 18]. This phenomenon, however, may have more to do with trial design than financial conflicts of interest among clinical investigators [19]. The pharmaceutical and medical device industries have recognized that financial and gift-giving relationships with physicians have the potential to negatively impact their reputations and have therefore engaged in self-regulation. In each case, the industry’s trade association (PhRMA in the case of pharmaceuticals and AdvaMed in the case of medical devices) has developed codes of ethics focused in large part on addressing conflicts of interest [5, 20]. Each code of ethics prohibits member companies from providing non-educational gifts or recreation to physicians. While these provisions can go a long way toward limiting certain highly criticized industry practices, it remains unclear if they fully address concerns related to other practices, such as paid consultancies and provision of meals in connection with promotional presentations [21].

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Remedies According to the Institute of Medicine (IOM) of the National Academies, the purpose of conflict of interest policies and other remedies “…is to protect the integrity of professional judgment and to preserve the public trust rather than try to remediate problems with bias or mistrust after they occur [1].” The federal government has also taken a position on remedying of conflicts, requiring that “recipients of Public Health Service and National Science Foundation funding identify and manage potential financial conflicts of interest when funds from those two Agencies are involved [22].” There are two general approaches for addressing conflicts of interest: 1. Eliminating conflicts of interest, and 2. Managing conflicts of interest. Each has its own benefits and shortcomings. Many conflicts of interest can be eliminated by having the party with the conflict of interest divest external interests or refuse (or in some cases, reduce) compensation related to external interests. They can also be eliminated by proscribing involvement in the activity in question by anyone with a conflict of interest [13]. The CMSS Code, for example, prohibits key society leaders from having direct financial relationships with companies during their time of service [7]. It is important to note, however, that in some cases patient care is best served when conflicts of interest are managed rather than eliminated outright. For example, barring the world’s foremost expert on melanoma from participating on FDA panels because she has received grant funding from the pharmaceutical industry may limit important, medically relevant dialogue and guidance. In this type of case, other approaches should be considered. Late Supreme Court Justice Louis Brandeis is known for stating that “sunlight is the best disinfectant,” meaning openness and transparency are an effective prophylactic or antidote for corruption. Disclosure has become a common approach for managing conflicts of interest. Publication authorship guidelines used by biomedical research journals require disclosure of pertinent financial relationships [23]. In 2010, as part of the Patient Protection and Affordable Care Act, the Federal Government enacted the Physician Payment Sunshine Provision, which will require forprofit healthcare industry participants to publicly dis-

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close their financial relationships with healthcare professionals [5]. Guidelines enacted by academic medical centers, hospitals, and the American Academy of Dermatology regularly require disclosure of outside financial relationships in certain settings. Disclosure both encourages self-regulation and provides interested parties with information on potential conflicts of interest. In theory, this transparency allows interested parties to critically evaluate information provided by individuals with conflicts of interest. It is unclear, however, if these third parties know how to best use the information. For example, a non-expert is likely unable to discern whether a medical publication contains biased assessments or if a prescription was influenced inappropriately [15]. In addition, colleagues are not trained in how to assess information presented by a physician with a conflict of interest. Further, there is evidence that disclosure can sometimes “increase rather than decrease trust, especially if the person with the conflict of interest is the one who issues the disclosure [24].” In addition to disclosure, several other approaches exist for managing conflicts of interest. Some of these may include incorporating additional independent oversight of activities where conflicts of interest may be present, adopting policies to diffuse and dilute conflicts by engaging multiple (rather than single) funding sources, and utilizing conflict of interest committees to implement additional steps to minimize the impact of conflicts of interest. Each of these steps requires a formal process with clear guidelines.

Analysis of Case Scenarios Case 1 Clinical practice guidelines ideally rely exclusively on high-quality empirical research. In reality, such comprehensive data are rarely available and these guidelines may draw instead upon lower quality data and even expert opinion. The potential for inappropriate influence coupled with the importance of clinical practice guidelines highlight the need for the American Academy of Dermatology’s Conflict of Interest Management Procedure for Development of Clinical Guidelines. These guidelines state: “disclosed information for all contributors considers both the nature of the inter-

31 No Strings Attached? Managing Conflicts of Interest in Medicine

est, the relevancy to the guideline topic, and the potential impact. There is no set monetary threshold or de facto disqualifying interest, as all interests have the potential to lead to undue influence [8].” Some considerations could include the extent of the relationship to industry, availability of alternative experts without similar conflicts, and practicality of managing the conflict through disclosure or limiting contributions to certain parts of the discussion. While this section of the guidelines offers little direction to Dr. MacDonald, the guidelines provide more practical suggestions elsewhere. They require that at least 51% of working group members have no relevant financial conflicts of interest. Furthermore, the working group chair and medical writer may not have any relevant financial conflicts of interest. Additionally, all member conflicts of interest must be published with the draft discussion and final version of the clinical practice guidelines.

Case 2 This case illustrates a clear financial conflict of interest. Dr. Alexander has a potentially significant financial stake in the outcome of this research. She may also have a non-financial conflict of interest; the esteem and professional recognition related to successful research and drug development. While Dr. Alexander may be an expert in cutaneous T-cell lymphoma, it is important to assess the possibility of enlisting other experts without similar conflicts of interest. If there is a compelling circumstance for enlisting Dr. Alexander as a local site principal investigator, then several safeguards should be adopted to assist in managing her conflicts. Disclosure to potential study participants, co-investigators, local institutional review board (IRB), and other interested parties is a start. Strict compliance with a human subjects research protection program is essential. The program should include, but not be limited to, regular (IRB) review, periodic assessment by an independent data safety monitoring committee, and ongoing audits. Furthermore, Dr. Alexander’s financial conflict of interest must be managed in such a way that the trial’s success or failure does not impact her compensation from her commercial involvement. That is, Dr. Alexander’s compensation from the company should be fixed and cash rather than equity or

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some other method influenced by the trial’s performance. Disclosure, IRBs, and data safety monitoring committees are necessary, although not always sufficient for monitoring direct financial conflicts of interest of investigators.

Case 3 This case presents a very common situation. Physicians experienced with certain medications are well qualified to teach others about using such medications. These physicians regularly receive financial compensation for the time and effort involved in developing and delivering these educational presentations. As with other conflicts of interest, the magnitude and nature of the conflicts dictate the appropriate management. Physicians with expertise in a given area who receive modest compensation for lectures from many different pharmaceutical companies require less scrutiny than similar experts receiving significant income from a single company. It is also important—as with the previous case—that clinical decisions do not directly influence financial compensation. That is, physicians writing a certain number of prescriptions should not be rewarded with lucrative lecturing opportunities. Perhaps even more important than the actual impact of the conflict of interest is its perception by other physicians, patients, and the public. Accordingly, disclosure and judicious selection of financial arrangements are important.

Case 4 Case 4 highlights the significance of non-financial conflicts of interest. While Dr. Pasquale’s judgment may not be impacted by his brother’s working for a potential supplier to his hospital, it is important that this conflict of interest is recognized and addressed. An appropriate resolution for this particular situation would involve Dr. Pasquale disclosing the situation to the committee. A formal committee process could then determine the necessary response. The disclosure itself may resolve the issue, but additional steps, including recusal from decisions related to atopic dermatitis and other disease states served by his brother’s company might be appropriate.

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Conclusion Although no hard and fast rules exist, certain principles regarding conflicts of interest should be kept in mind: 1. Primary consideration must be one’s obligations to patients, research subjects, and the medical profession. 2. Conflicts of interest which cannot be avoided should be disclosed and managed, preferably through formal institutional processes. 3. Even if a conflict of interest has no impact on one’s professional judgment, it may impact how one’s decisions are perceived. Ultimately, certain conflicts of interest cannot be completely avoided. All conflicts of interest, however, can be managed. It is the obligation of medical professionals to identify, and as appropriate, address any conflict of interest that has the potential to inappropriately bias their professional judgment.

References 1. Lo B, Field M. Conflict of interest in medical, research, education and practice. Washington: National Academies Press; 2009. 2. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573–6. 3. Watson PY, Khandelwal AK, Musial JL, Buckley JD. Resident and faculty perceptions of conflict of interest in medical education. J Gen Intern Med. 2005;20:357–9. 4. Bertok J. Managing conflicts of interest in the public service. Paper presented at: Organisation for Economic Co-Operation and Development; March 11, 2004, Washington, DC; 2004. 5. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics/principles-medicalethics.shtml. Accessed 28 Sept 2010. 6. Keating NL, Green DC, Kao AC, Gazmararian JA, Wu VY, Cleary PD. How are patients’ specific ambulatory care experiences related to trust, satisfaction, and considering changing physicians? J Gen Intern Med. 2002;17:29–39. 7. Code for interactions with companies http://www.cmss.org/ codeforinteractions.aspx Accessed 28 Sept 010 8. Policy summary: conflict of interest management procedures for clinical practice guidelines. http://www.aad.org/ research/guidelines/_doc/COIPolicySummary.pdf . Accessed 22 May 2010.

N.D. Shannon and C. Perlis 9. Levinsky NG. Nonfinancial conflicts of interest in research. N Engl J Med. 2002;347:759–61. 10. 42 CFR Part 50 Subpart F. http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm. Accessed 28 Sept 2010. 11. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth. 2003;3:39–46. 12. Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D. A national survey of physician-industry relationships. N Engl J Med. 2007;356:1742–50. 13. Protecting patients, preserving integrity, advancing health: accelerating the implementation of COI policies in human subjects research. Paper presented at: Association of American Medical Colleges; 2008. 14. Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001; 110:551–7. 15. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290:252–5. 16. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373–80. 17. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454–65. 18. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167–70. 19. Nieto A, Mazon A, Pamies R, et al. Adverse effects of inhaled corticosteroids in funded and nonfunded studies. Arch Intern Med. 2007;167:2047–53. 20. AdvaMed code of ethics. http://www.advamed.org/memberportal/Shared/ContentMgt/Templates/OpenDetail.aspx?NR MODE=Published&NRNODEGUID=%7B9234A42C8E7F-41E6-9DF4-A2E1D0E57F15%7D&NRORIGINAL URL=%2fMemberPortal%2fAbout%2fcode%2f&NRCAC HEHINT=NoModifyGuest#AdvaMed%20Code%20of%20 Ethics. Accessed 28 Sept 2010. 21. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429–33. 22. 2995 NIH Financial conflict of Interest Workgroup Report. http://grants.nih.gov/Grants/policy/regulatoryburden/conflictofinterest.htm. Accessed 28 Sept 2010. 23. ICJME uniform requirements for manuscripts submitted to biomedical journals: ethical considerations in the conduct and reporting of research. http://www.icmje.org/ ethical_4conflicts.html. Accessed 28 Sept 2010. 24. Cain DM, Loewenstein G, Moore DA. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Leg Stud. 2005;34:1–25.

Part V Dermatologist as Scholar

Respecting Human Subjects: Responsibilities of the Clinical Investigator

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Kenneth Katz and Samual Garner

Introduction The most accessible human organ, skin has played a historically significant role in human experimentation. From syphilis to psoriasis, research related to dermatology has contributed greatly to the prevention and treatment of diseases. Unfortunately, abuses have also occurred, including, in the twentieth century, the following: • Sulfonamide experiments in Nazi concentration camps, in which inmates were intentionally wounded, and the wounds inoculated with bacteria, in order to then test the effectiveness of sulfonamide and other compounds in treating infections [1]. • The Tuskegee Syphilis Study, conducted by the U.S. Public Health Service from 1932 to 1972. In that study, researchers prevented 399 poor AfricanAmerican men in rural Macon County, Alabama from being treated for syphilis, even after penicillin became available, in order to study long-term effects of the disease [2]. Research conducted by dermatologist Dr. Albert Kligman of the University of Pennsylvania on prison inmates during the 1950s and 1960s has also stirred controversy [3, 4]. In those experiments, for which prisoners were paid, researchers tested the effects of dioxin (the active compound in Agent Orange) and other substances, including cosmetics. In light of that history,

dermatologists, like all physicians, should be sensitive to the requirements of conducting ethical clinical research. The goal of clinical research is to produce generalizable biomedical knowledge to improve human health and well-being [5]. Research is critical to advancing dermatologists’ ability to care for their patients [5]. Understanding and applying ethical principles integral to good research, in turn, is essential if the rights and welfare of those who volunteer to participate in research are to be respected and if the science itself is to yield rigorous, valid results. To be both ethical and scientifically valuable, clinical research involving human participants must effectively answer important scientific questions. Clinical research that does not meet that standard does not make meaningful contributions to biomedical knowledge, squanders scarce resources, and subjects research participants to unnecessary risk. Once researchers identify a question of scientific value, they should consider how best to maintain the rigor and relevance of the science, while balancing risks and benefits to trial participants and society. To illustrate the ethical significance of clinical trial design, this chapter will present two vignettes of proposed studies, provide an overview of the basics of clinical research ethics, and then, on the basis of that overview, identify important issues in clinical research ethics raised by the vignettes.

Case Vignettes K. Katz (*) Graduate School of Public Health, San Diego State University, San Diego, CA, USA e-mail: [email protected]

Another Look at an Effective Therapy for Psoriasis

S. Garner Kevric/IMC, Office of Biotechnology Activities, National Institutes of Health, Bethesda, MD

A treatment for psoriasis was approved by the FDA many years ago and is recognized by dermatologists as

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effective, but its effectiveness had never been measured using a recently introduced psoriasis severity scale. A randomized, double-blind, placebo-controlled trial of that treatment for psoriasis is proposed, using the new psoriasis severity scale to measure the treatment’s effectiveness compared with placebo. The investigators then propose to informally compare results of the trial to results from other psoriasis trials in order to determine how effective the treatment is relative to other psoriasis treatments.

Comparison of Two FDA-Approved Therapies for Psoriasis A comparison of the effectiveness of two FDAapproved treatments in a double-blind randomized controlled trial is proposed. Participants will be assigned to receive either treatment A or treatment B. The trial will be funded by the manufacturer of Treatment A, which will control the data and will decide whether or not to publish or otherwise disseminate results of the trial.

The Ethics of Clinical Research Over the past century, abuses of research study subjects such as those described above in the chapter introduction led to heightened scrutiny of the design and conduct of biomedical research. That scrutiny, in turn, has led to the formulation of ethical principles that should undergird research and to the codification of those principles in regulations stipulating the requirements for ethically sound human subjects research, as follows: • The Nuremburg Code [6] was developed in 1947 by Dr. Leo Alexander and the American judges at the “Doctor’s Trial” of the International Military Tribunal in response to the abhorrent medical experiments of Nazi physicians. The Nuremberg Code was the first major international code of research ethics and is the most prominent articulation of the necessity for the voluntary and informed consent of research participants. The Nuremburg Code also included provisions for the right to withdraw from research, requirements that risks and benefits of the research to subjects be considered, and mandates for rigorous preclinical data before undertaking human experimentation.

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• The Declaration of Helsinki [7], adopted in 1964 by the World Medical Association, is likely the most influential international code of research ethics. It has undergone six revisions, with the most recent in 2008, and has expanded from 11 to 32 paragraphs. The Declaration contains much of the same content as the Nuremberg code, although it expands the discussion of research participants’ right to control what happens to their bodies (self-determination), as well as additional provisions on clinical trial design (e.g., how to choose a control), access to the investigational intervention after the trial has stopped (post-trial access), and the requirement for independent ethical review of research protocols. • The Belmont Report [8] was published in 1979 by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, in response to the Tuskegee Syphilis Study. The Belmont Report is the ethical foundation of the US “Common Rule” regulations for the protection of human subjects. The Report articulates three principles: respect for persons, which includes both respect for the autonomy of research participants and that additional protections are afforded to those with diminished autonomy; beneficence, or promoting the well-being of others, which can be broken into two components: (1) do not harm and (2) maximize possible benefits and minimize possible harms; and justice, meant as the need to balance research benefits and burdens. It also articulates other important concepts, including the distinction between treatment and research. • The International Ethical Guidelines for Biomedical Research Involving Human Subjects [5], which first appeared in 1982, was a product of the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization. Catalyzed by the research abuses of the 1970s, the guidelines include the same three basic principles as the Belmont Report and expand upon the provisions in the Declaration of Helsinki by addressing special issues of conducting research in developing countries. • The International Conference on Harmonisation (ICH) of Good Clinical Practice Guidelines (GCP) [9], a product of an international regulatory harmonization initiative between the European Union, Japan and the United States, were finalized in 1996. Designed for investigators intending to submit clinical trial data to regulatory agencies,

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such as the FDA, the Guidelines include provisions on Institutional Review Boards (IRBs), investigator qualifications, medical care for trial participants, protocol compliance, responsibilities of trial sponsors, reporting of safety issues, and aspects of trial design such as blinding and randomization. Seeking to answer the question, “What makes clinical research ethical?,” Emanuel and colleagues distilled the content of these codes, as well as several others, into seven principles, as follows [10]: 1. Value: Does the trial evaluate a diagnostic or therapeutic intervention that could lead to improvements in health or well-being? 2. Scientific Validity: Will the design and accompanying analytic methods effectively answer the scientific questions, or are there alternative designs that might better suit the scientific and ethical needs of the trial? 3. Fair Participant Selection: Have the research participants been chosen for their applicability to the purposes of the trial and have participants been selected so as not to place undue burden on certain communities? 4. Favorable Risk-Benefit Ratio: Will the benefits to individual participants or the value of the knowledge to society outweigh the risks of conducting the study? 5. Independent Ethics Review: Has the study been reviewed and approved by an Institutional Review Board (IRB) or equivalent review body? 6. Informed Consent: Do the participants understand the major concepts of a clinical trial and their rights as research participants? 7. Respect for the Rights and Welfare of ResearchParticipants: Are participants treated with respect throughout the course of the trial? For example, is confidentiality maintained? Are participants permitted to withdraw if they change their minds about participating in the trial? Are participants kept informed about new information related to the trial? Is the welfare of participants monitored during the trial? Are participants informed of the results of the research after the study concludes?

Analysis of Vignettes The first vignette describes a trial that compares a treatment that is known to be effective against a placebo, with the trial’s results to be informally compared

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with results of other studies to ascertain the treatment’s effectiveness relative to other treatments. That trial raises the questions of value and validity. In terms of value, might results of the proposed comparison contribute to improvements in health and well-being? It seems unlikely. After all, the treatment is already known to be effective. In terms of validity, does the design answer the question at hand? The trial will answer the question of whether the treatment is more effective than placebo. But the answer to that question is already known and, as discussed, that fact undermines the value of the trial. As for the question of how the treatment compares with other treatments, answering that question would require a trial that directly compares all treatments. Therefore, the proposed trial raises serious ethical questions on the basis of value and validity. Particularly when research resources— participants, investigators, and funding—are scarce, the proposed trial might not be ethical to conduct. The second vignette describes a trial that compares two effective treatments for psoriasis. It will be funded by the manufacturer of one of those treatments, and that manufacturer will control the data from the trial and will decide whether or not to publish the data. That the manufacturer might—or might not—publish the trial results raises ethical questions about value and the respect for the rights and welfare of research participants. Regarding value, even important research that would likely improve health and well-being lacks value if it is not disseminated. As Emanuel et al. write: “Only if society will gain knowledge, which requires sharing results, whether positive or negative, can exposing human subjects to risk in clinical research be justified [10].” Regarding respect for the participants, that the results might not be published or otherwise disseminated indicates a lack of respect for participants, who have a right to be informed of the results of the research. On those two grounds, then, the trial raises serious ethical concerns.

Conclusion Clinical research plays a significant role in modern medicine, including helping clinicians make important treatment decisions. Clinical research must adhere to rigorous ethical standards to justify the risk to which research subjects are exposed. Researchers must always take the utmost care in conducting scientifically valuable, ethically rigorous research that respects

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the rights and welfare of those who volunteer to advance the cause of medical science.

References 1. Annas GJ, Grodin MA. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. New York: Oxford University Press; 1992. 2. Jones JH. The Tuskegee syphilis experiment. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. Oxford/New York: Oxford University Press; 2008. p. 86–96. 3. Hornblum AM. Acres of skin: human experiments at Holmesburg Prison: a story of abuse and exploitation in the name of medical science. New York: Routledge; 1998. 4. Stanley JR. Ethical accusations: the loss of common sense. Arch Dermatol. 2000;136:268–9. 5. Council for International Organizations of Medical Sciences, World Health Organization. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS; 2002.

K. Katz and S. Garner 6. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–182. Washington, DC: U.S. Government Printing Office; 1949. http://ohsr.od.nih.gov/guidelines/nuremberg. html. Accessed 9 Sept 10. 7. World Medical Association. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects; 2008. http://www.wma.net/ en/30publications/10policies/b3/17c.pdf. Accessed 9 Sept 10. 8. United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Bethesda, Washington: The Commission;: for sale by the Supt. of Docs., U.S. Govt. Print. Off; 1978. 9. ICH harmonised tripartite guideline: guideline for good clinical practice E6(R1). In: International Conference on Harmonisation; 1996. http://www.ich.org/LOB/media/ MEDIA482.pdf. Accessed 9 sept 10. 10. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701–11.

Hope, Hype, and Genotype: Genetic Testing in Dermatological Diseases

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Natasha Shur

Case 1

Case 2

The referral form to the dermatologist in clinic for 5-year-old Stephanie, who sat nervously on her mother’s lap, said “brown spots on the lips.” After carefully examining Stephanie, the dermatologist noted dark brown mucocutaneous macules around the girl’s mouth and a few on her fingers. He also noted two light brown spots on her mother’s lips. “Any family history of cancer?” the dermatologist asked. “I had breast cancer 5 years ago, but I am alright now. My mom had some polyps in her colon, but I don’t remember the type,” the mom answered. Aha, thought the dermatologist, Peutz–Jeghers Syndrome, associated with gastrointestinal polyposis, mucocutaneous pigmentation, and increased cancer risk. Anxious to confirm his clinical suspicion, he ordered genetic testing. A month later, the child’s results returned with a mutation in the STK11 gene consistent with Peutz–Jeghers Syndrome. The dermatologist immediately asked his nurse to arrange a follow-up appointment, and then proceeded with his busy clinic. Soon, he was interrupted by his secretary. “Stephanie’s mom keeps calling, and she sounds quite distraught. She’s just received a $2,000 bill for the testing, and the insurance company won’t cover it.”

The mother saw her baby after delivery and screamed. The baby had everted eyelids, pinched arms and legs, and a shiny membrane that encased his entire body. In the next moments, urgent transfer to the neonatal intensive care took place. The dermatology consultant suspected lamellar ichthyosis (LI) or nonbullous congenital ichthyosiform erythroderma. The baby was transferred to an incubator, covered in sterile emollient, and provided with hydration and good nutrition. In the next few days, genetic testing for mutations associated with lamellar ichthyosis was ordered. A week later, the baby developed sepsis and remained in critical condition, at which point “do not resuscitate orders” were discussed. In the interim, genetic testing returned revealing two mutations in the TGM1 genes consistent with the diagnosis of LI, which is usually inherited as an autosomal recessive condition with one mutant allele transmitted by each parent. Ultimately, the baby survived the infection and slowly shed the collodion membrane, which was replaced with brown scale in some areas and normal skin in other areas. At follow-up, the mother and father asked for parental testing. “We do not want to go through this ordeal again” they said. When the test results returned, they appeared confounding; the mother was a carrier, but the father was not. The dermatologist stared at the results before her. How would she explain the results to these parents?

N. Shur Division of Genetics, Genetic Counseling Center, Department of Pediatrics, Warren Alpert Medical School of Brown University, Providence, RI 02903 e-mail: [email protected]

Case 3 “Do you think that a couple of brown spots on my skin are going to be an issue for me?” a 23-year-old naval officer asked the dermatologist. The dermatologist

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paused. The patient was in great physical shape, without any significant past medical history. She had just completed an arduous officer training program in Newport, Rhode Island. At graduation, she had enjoyed a crowning achievement: since she outranked the drill instructors from boot camp, they now had to salute her. She was scheduled to leave on her first navy cruise in a month. When she returned, she planned to get married. It was her fiancé’s sister, a medical student practicing her ophthalmology examination, who first noticed Lisch nodules (pigmented hamartomas of the iris). On physical examination that day, the dermatologist noted axillary and inguinal freckling and a few café au lait spots. The patient did not have any neurofibromas. Family history revealed that the patient’s mother had some similar spots. The officer met the diagnostic criteria for neurofibromatosis type 1 (NF-1), which only required the presence of two major features (in this case, Lisch nodules, and axillary and inguinal freckling). Genetic testing was available, but were there any benefits to testing? Could the diagnosis or test results jeopardize this patient’s military career?

Case 4 “I saw an ad for a test that can tell if I might get melanoma,” the patient mentioned at her follow-up appointment for psoriasis. “What do you think?” The dermatologist paused. Undoubtedly, the patient had heard about a test for “a melanoma gene” through direct-to-consumer marketing. In this test, previous studies of families with multiple members affected have shown that those who carry mutations in the tumor suppressor gene, cyclin dependent kinase 2A(CDKN2A) have a lifetime risk (i.e., penetrance) of melanoma that is very high, ranging from 58% in Europe to 91% in Australia by age 80 years. However, the risk of melanoma in carriers without a family history is probably less than 30% [1]. The American Academy of Dermatology issued a statement against the use of CDKN2A testing in the general population. A normal test result could falsely reassure consumers that they could not get cancer; while an abnormal result would only reinforce the need for regular skin screening, exams, and skin protection. On the other hand, the question for this particular patient was not entirely straightforward. Studies had shown that patients who had been told that they had mutations

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for CDKN2A were more adherent to sun-screening regimens. While the dermatologist had discouraged the patient from going to tanning beds, the patient had gone anyway with a great deal of improvement in her psoriasis. If the test came back positive for a mutation, the patient might adhere to safer health practices.

Discussion Dermatogenetics is a burgeoning field due to recent advances in the understanding of the molecular basis of many skin and hair diseases. Knowledge has increased regarding numerous genetic conditions that have manifestations in the skin: from blistering disorders such as epidermolysis bullosa syndromes, keratinizing disorders such as the ichthyoses, neurocutaneous disorders such as neurofibromatosis type I, to cancerassociated syndromes such as basal cell nevus syndrome and familial atypical mole-melanoma syndrome. More recently, an explosion of clinically available genetic tests has created new options for physicians, genetic counselors, and patients. The future will inevitably bring even more testing options, with hundreds of tests already available, and in the first two months of 2010 alone, 28 new clinical tests posted [2]. Based on information regarding genotype, personalized genomic medicine promises to provide an individualized risk assessment and custom-tailored preventive and therapeutic treatments. For example, in pharmacogenetics, patients about to receive warfarin can find out whether their genotype suggests rapid, intermediate, or slow metabolism and, hence, physicians can modify doses accordingly. Specifically, single nucleotide variants in certain genes, such as the CYP2D6 gene, help predict an individual’s rate of drug metabolism (such as propranolol, an important new treatment for infantile hemangiomas) [3]. The Pharmacogenetics Research Network of the National Institute of General Medical Sciences catalogues every newly discovered pharmacogenetic gene and application, and the list increases steadily [4]. Genetic tests potentially offer patients many additional benefits, including increased diagnostic ability; more accurate information for prenatal counseling and family members; and, as aforementioned, knowledge that may guide treatment.

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Hope, Hype, and Genotype: Genetic Testing in Dermatological Diseases

Yet, rapidly expanding genetic information brings a multitude of challenges. Tests often carry a prohibitive price tag as well as additional concerns such as inappropriate selection of patients for testing; the burden of time to explain, order, and interpret testing; detailed and difficult pre-test and post-test counseling; unexpected or unintended consequences of test results; increased premiums for life and medical insurance or risk of denial; and potential employment discrimination. In addition, fear of stigmatization or psychological distress to patients as a result of genetic testing offers a strong reason to pause before sending patients to the laboratory. Even when genetic testing is clearly beneficial, the complexity of ethical, social, and legal issues may pose an insurmountable barrier for physicians and patients to pursue testing. Is there a simple approach that allows the clinician to select appropriate and useful genetic tests for the right patients? One suggested strategy has been to categorize the priority of genetic tests based on determination of both clinical validity (the accuracy with which a test predicts a particular clinical outcome) and the availability of effective treatment [5]. Tests with high clinical validity for a disorder with available effective treatment are considered justified, while those tests with low clinical validity and lack of effective treatment are medically unjustified. Tests that have high clinical validity but lack of effective treatment are more controversial, such as in the case of genetic testing for Huntington disease or neurofibromatosis: at the minimum, careful non-directive counseling allows the informed and competent patient to decide whether to get tested. Likewise, tests with limited clinical validity but effective intervention should involve extensive risk versus benefit analysis. A dermatological example of a test with questionable clinical validity but possible intervention is a new genetic test that identifies patients particularly susceptible to frequent genital herpes outbreaks through presence or absence of specific mutations in the mannose-binding lectin (MBL) gene, which has an important role in immune response. Potentially, patients who test positive for a mutation, and thus decreased immune response, would be prescribed antiviral prophylaxis. However, the clinical validity remains uncertain: it is easy to imagine a scenario in which a patient tests negative, does not receive preventive treatment, and still experiences recurrent outbreaks. A common way to distinguish between genetic tests has been to categorize them by their intended purposes.

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Carrier testing provides information about a couple’s risk of having a child with a genetic condition such as cystic fibrosis or sickle cell disease, and may be offered either to ethnic groups with an increased risk for a disease or increasingly to the general population. Prenatal testing detects changes in the fetus’s genes or chromosomes before birth. Diagnostic testing, as implied, diagnoses a specific genetic or chromosomal condition, suspected on the basis of phenotype, for example NF-1 in the infant with multiple café-au-lait macules. Predictive testing detects gene mutations associated with disorders that appear after birth, often later in life, and can be used to inform patients about risks and preventive options. The classic example of predictive testing is for the BRCA genes, associated with 40–80% cumulative lifetime risk of breast cancer and 40–65% risk of ovarian cancer. Patients with an increased risk are offered testing, and those found to have a mutation receive counseling regarding screening, pharmacological, and surgical interventions that may significantly reduce that risk. Presymptomatic testing can determine whether a person will develop a genetic disorder before signs or symptoms appear, such as hemochromatosis (an iron overload disorder), for which phlebotomy may be recommended, or pseudoxanthoma elasticum, for which effective intervention is not curently available.

Analysis of Case Scenarios For a dermatologist, the most frequently considered tests are diagnostic or predictive. Once those results return, carrier testing of the parents becomes an option. The question of when predictive testing is appropriate is raised in Case 1, the story of a 5-year-old child with Peutz-Jeghers syndrome (PJS). In PJS, gastrointestinal polyps can result in chronic bleeding and anemia and cause recurrent obstruction and intussusception requiring repeated laparotomies and bowel resections. Screening at the age of 8 is recommended for increased risk for malignancies, particularly colorectal. Since the mucocutaneous hyperpigmentation may fade in puberty and adulthood, the diagnosis may be missed later in life [6]. All of these factors weigh towards aggressively making the diagnosis in order to guide medical screening. Thus, there is a temptation to do early genetic testing on a 5-year-old who appears to meet clinical criteria for the diagnosis.

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On the other hand, universal consensus mandates against the routine use of predictive testing in children [7]. The American Academy of Pediatrics bioethics committee firmly states that unless there is an anticipated benefit to the child, pediatricians should decline requests from parents or guardians to obtain predictive genetic testing. Testing in childhood inappropriately eliminates the possibility of future autonomous choice by the person and risks stigmatization. A hypothetical extreme example would be a parent who knows that one child has the gene for Huntington disease, while the other did not have it: if the parent only has enough money for college for one of the children, would not most parents choose the “healthy” child? Or, could an affected child be treated like fragile china by anxious parents? On the other hand, knowing the molecular basis for disease in a child may have advantages as novel treatments become available. For example, in the case of Duchenne Muscular Dystrophy, exon-skipping therapy may hold some promise, and only patients with known and specific gene deletions are eligible to participate in trials [8]. What if a patient does not get tested based on the argument that a treatment is not available, but by the time a breakthrough happens, the patient no longer has insurance? A case can be made that predictive testing allows families to have molecular tools in their arsenal for the moment when novel treatments or cures become suddenly available. Rapid advances in understanding the genetic mechanisms of disease offer hope that genetic information will become increasingly useful and clinically applicable. The argument is that information is power; if not today, then tomorrow. On the other hand, many adults decline pre-symptomatic testing, because they may not want to lead their lives knowing about imminent danger. The conclusion is that it is unethical to presume that children would want or will benefit from such testing. Along these lines, in cancers that tend to occur in adulthood, children are not routinely offered testing, such as in the case of BRCA testing before the age of 18. The same holds true for Lynch syndrome (previously termed hereditary non-polyposis colon cancer), an autosomal dominant condition with a high predisposition for colon cancer, but in which the cancer generally does not occur before age 20. On the subject of childhood testing, professionals have shown a great deal of ambivalence about whether and when to test high-risk children for genetic mutations [8]. Uniform consensus to test only exists when results directly influence a child’s medical management,

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according to policy statements and surveys of geneticists [9]. For example, in familial adenomatous polyposis (FAP), an autosomal dominant condition caused by mutations in a gene called adenomatous polyposis coli (APC), patients have multiple polyps in the large intestine that have a strikingly high potential to become cancerous. Without intervention, most affected individuals can be expected to have colorectal cancer before age 40, and many cases have been reported as early as the age of ten. Because of the early onset of polyps and significant risk of cancer in children with APC mutations, in offspring of patients with FAP, yearly colonoscopy is recommended after age 10. A positive genetic test for a known familial mutation confirms the need for colonoscopies and colon resection, while a negative genetic test result spares the child unnecessary and invasive procedures. For these reasons, children are routinely tested for familial APC mutations. A more nuanced example is presymptomatic testing for pseudoxanthoma elasticum (PXE) in children. Once the diagnosis has been made in a sibling, it is possible to test other siblings for mutations in ABCC6, the causative gene. However, there exists no effective treatment. There is a real risk of stigmatization, even unintentional, from unaffected siblings or by the parents, and of difficulty in obtaining life insurance or bearing increased premiums in a non-group health insurance policy. However, concerned parents might argue that knowing the diagnosis in the pre-symptomatic phase allows for career and life planning for the affected child and timely institution of preventive measures such as avoiding contact sports and wearing protective eyewear in sports. Ethicists agree that the decision to offer genetic testing to a child remains complex, requiring some knowledge of the concept of assent – incorporating the views and desires of the child-patient in the decision-making process [10]. To obtain assent, pediatricians and parents must explain genetic testing to the extent possible, answer questions at a level commensurate with the child’s development, and listen carefully to the child’s opinions. Respect for autonomy and best interests of the child enter into decisions regarding genetic testing. These intense psychosocial considerations may make it difficult for the clinician to broach the topic of genetic testing in pediatric patients. Fortunately, a simple rule for selecting children that may benefit the most from cancer testing, which may be extrapolated to other genetic tests, has been proposed and supported by the literature and professional organizations, such as the

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American College of Medical Genetics: genetic testing should be permitted at an age no earlier than the age of first possible onset of cancer [11]. Using such a dictum maximizes the benefits and minimizes the risks to children. Thus, for FAP, the age to test is around ten. In the case of PJS, as previously mentioned, screening is recommended as early as age eight. Therefore, in Case 1, testing a 5-year-old patient would be deemed too young. Instead, an optimal strategy revolves around discussing the clinical diagnosis at the initial visit and over multiple follow-up appointments. If one of the parents appears classically affected, testing that parent first may be more ethical and practical. Once the adult’s test is positive for a disease-causing mutation, the child’s test becomes simpler and less expensive, since rather than sequencing the entire gene, the test can simply target for the known familial mutation(s). However, if neither parent appears affected, then testing the child first, rather than screening both parents, is more direct and cost-effective. Discussions regarding cost of testing and insurance preauthorization, a laborious process that often requires multiple phone calls and letters of medical necessity, play a key role. Informing patients about the potential financial toll may influence both their decisions to test and timing. Sometimes, patients plan on switching insurance plans; other times, patients may want to do the testing after they have already met their yearly deductible. Another area of focus for pre-test counseling revolves around the limitations of genetic testing. Explaining that genetic test results are not always conclusive helps prepare patients for possible uncertainty. Many genetic tests return with variants of unknown significance, a change in the DNA that is usually not present in the normal population but has not definitively been proven to cause disease. These variants make counseling regarding management difficult: patients need to know that in some cases results that return may not be understood for several more years, until additional cases get reported and catalogued. Finally, it is important to emphasize that a negative test does not necessarily rule out disease (unless a patient is tested for a known familial mutation), since genetic testing is not perfect. In many disorders, such as PXE or NF-1, the mutation detection rate is not 100%. Phenotypes such as multiple café-au-lait macules and axillary freckling may be associated with more than one gene (NF-1 and Spred-1). Referral to a geneticist for further counseling may help alleviate the burden of addressing many difficult issues.

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On the surface, the decision to pursue diagnostic testing appears more straightforward than predictive testing. Clinicians may justify it based on the desire to know as much information as possible in efforts to guide their decision-making. In Case 2, for example, a baby with a collodion membrane faces a life-threatening infection, and certainly a precise diagnosis helps in evaluating prognosis, considering the future of retinoids, and genetic counseling of the parents. In this case, the clinical validity of testing is high, but the results do not necessarily affect treatment. After all, babies born with a collodion membrane, regardless of type, receive the same neonatal management: a moist environment in an isolette, hygienic handling to prevent infection, antibiotics and prompt treatment for infections, and petrolatum-based ointments. Thus, the clinical utility of testing at this stage remains debatable. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group is an independent panel established in 2005 to develop a systematic process for evidence-based assessment of genetic tests and other applications of genomic technology [12]. Its key objectives include outlining a transparent, publicly accountable process to select genetic testing, and to provide clear links between the scientific evidence and subsequently developed recommendation statements. Until these clear guidelines make their way into dermatology and other clinics, and professional specialty societies issue clear-cut consensus statements, physicians remain in the precarious position of making difficult decisions regarding genetic testing on an ad hoc basis. Explaining to patients the ambiguities involved in these decisions, as well as the complexity of interpreting results, helps alleviate a part of the burden from the physician and sets the stage for a physician-patient partnership. Sometimes genetic testing, while originally ordered for diagnosis, plays a more central role in family and prenatal counseling rather than in medical management. For example, in Case 2, genetic testing revealed mutations in TGM1, which account for 90% or more of lamellar ichthyosis and in the clinical vignette, led to carrier testing of the parents. Genetic testing of carriers raises a set of different issues including potentially unintended or confounding results, which should be mentioned to parents before carrier testing is done. Since the mother in Case 2 carries a mutation, while the father does not, non-paternity could be a possible explanation. While for most autosomal recessive disorders, parents are considered obligate carriers, certain

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exceptions have been reported in some genetic skin disorders: post-zygotic mutation in the embryo or germline mosaicism may explain the results [13]. Raising all of these distinct possibilities may exacerbate stress in the mix of already vulnerable family dynamics. In addition, carriers may experience feelings of guilt or blame. The most ethical way to mitigate these issues is to provide extensive pre-test counseling. Genetic testing can also impact extended family: siblings of carriers of autosomal recessive diseases have a 2/3 chance of being carriers. Physicians cannot divulge genetic test results to relatives, but they can encourage their patients to do so. While in diseases with low carrier incidence like LI such discussions, albeit standard, may bear less practical importance, in more common diseases, such as cystic fibrosis and sickle cell anemia, or in disorders associated with cancer risk, these discussions are paramount. Genetic testing for adult patients raises similar ethical issues and once again involves considering clinical validity and utility. In Case 3, an officer with a clinical diagnosis of NF-1 neurofibromatosis, wonders about the impact of the diagnosis as she learns about her disease, and the dermatologist must explain to her the clinical diagnosis and molecular testing. Years ago, most clinical geneticists did not order testing for NF-1, since the results did not change medical management or prognosis, and because it was thought that the only causative gene was neurofibromin. A positive mutation would not provide additional information, and a negative test did not rule out the condition. However, recently it has been discovered that changes in a different gene called Spred-1 can result in a similar picture to NF-1 but with a more benign course with a lack of neurofibromas and less risk of malignancy [14]. However, in Case 3, our patient had Lisch nodules, which have not yet been reported in patients with Spred-1 mutations [15]. Ultimately, whether or not to test depends on questions of clinical validity, utility, and individual risk versus benefit. In the case of NF-1 neurofibromatosis, clinical validity is high, since a mutation can be detected in 90–95% of cases meeting clinical criteria (sensitivity, specificity, and positive predictive value all factor into calculating clinical validity). However, the clinical utility may be low. In Case 3, the navy officer is generally healthy, and management would simply include blood pressure screening, ophthalmological follow-up and prompt attention to any new lumps or bumps, regardless of her genetic test results. The ben-

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efit of the testing may increase if she desires prenatal diagnosis for future pregnancies (which would only be available to her if her mutation has been tested and known). She has a 50% recurrence risk with each pregnancy, and an affected child could be more severely affected, due to variable expression among individuals even in the same family. Addressing the impact of test results on management, prenatal counseling, and potential employment empowers the patient to make an informed decision. Recently, researchers sought to evaluate the impact of laws like the recently passed Genetic Information Non-Discrimination Act (GINA) of 2008 on the utilization of genetic testing. The authors concluded that patients’ and clinicians’ fear of genetic discrimination greatly exceeds reality, at least for health insurance, with the greatest deterrence to testing being the out-ofpocket cost. They also found that fear of discrimination plays virtually no role in testing decisions in pediatric or prenatal situations, but it did more significantly for adult-onset genetic conditions [16]. Thus, existing laws have not greatly reduced the fear of discrimination, but ironically, there may be so little actual discrimination that it may not be possible to initiate good test cases. GINA does prohibit discrimination in group health coverage and employment based on genetic information. However, many limitations exist, including that non-discrimination protections do not extend to nongroup health insurance, life insurance, disability insurance, and long-term care insurance. In addition, GINA’s employment provisions generally do not apply to employers with fewer than 15 employees [17]. Ironically, this law does not apply to people in the military, an important fact to address with the naval officer in Case 3. Many patients, when confronted with these issues, choose to forego immediate testing but possibly consider it for the future. The rapid expansion of genetic testing has led to commercial enterprises that use direct-to-consumer (DTC) advertising to market genetic tests thereby bypassing clinical oversight by health professionals [18]. The industry is estimated at around 3 billion dollars per year [19]. On the positive side, these DTCs can improve education, access, and privacy of testing (bypassing insurance company access to the information). Conversely, consumers may misinterpret testing, get inappropriately or incorrectly tested, and most importantly, lack access to adequate pre-test and post-test counseling. In 2003, the Food and Drug

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Table 33.1 Benefits and Risks of Genetic Testing Testing Carrier

Predictive

Benefits • Large programs may successfully decrease incidence of diseases • Increased public awareness • Family planning (options include preimplantation and prenatal diagnosis) • Screening or follow-up may change • Interventions may decrease risk • In families with known mutations, those individuals who do not carry mutations avoid unnecessary tests • May empower patients to make life-altering and personal decisions regarding medical care

Diagnostic • • • Direct-to- • Consumer • •

Helps provide more information regarding similar cases May direct therapeutic approaches Improves family member and prenatal counseling Raises awareness of genetic testing Bypasses paying through insurance Commercialization may drive down costs

Administration (FDA) held a public meeting to review data on the impact of DTC marketing of prescription drugs and found that advertisements increased consumers’ awareness about diseases, but failed to accurately convey risk information [18]. In May, 2010, Walgreen’s Pharmacy postponed plans to sell a DTC saliva collection system for personal genetic testing (Pathway Genomics Insight Saliva Collection Kit) after the FDA sent letters to the manufacturer and other DTC genetic testing laboratories warning that these tests require FDA approval [19]. In Case 4, a patient inquires about a test for CDKN2A, a test that is clinically indicated in patients who meet diagnostic criteria for familial malignant melanoma. One argument for screening is that when testing is positive for a CDKN2A mutation, the patient would likely become more adherent to sun-protecting measures and close surveillance of pigmented lesions [20]. In addition, screening for pancreatic cancer, for which patients with CDKN2A mutations are at higher risk, might be considered. However, if the test returns as negative, the patient may harbor a false sense of security bordering on a feeling of immunity, even though 98% of sporadic malignant melanomas are thought to occur in individuals without CDKN2A mutations [21]. Rather than offer testing for CDKN2A as a population screen, a more ethical approach includes addressing issues of concern regarding increased skin cancer risk (such as tanning booths). Studies indicate that patients who received physician advice on healthy behaviors, like quitting smoking, eating less fat, or getting more exercise

Risks • Questions regarding paternity may arise • Carries may experience feelings of guilt • Insurance often excludes carrier screening • Variants of unknown significance • Risk of stigma • Difficult to guarantee against health insurance and job discrimination • Pediatric patients may erroneously be tested at ages before medical management changes • Patients may receive high bills • As above • If the test returns as negative for a mutation, there could be false reassurance against the disease • Inappropriate use of testing • Inadequate pre-test and post-test counseling • Increased unnecessary spending on medical care

prior to reading intervention materials on the same topic have been shown to be more likely to remember the materials, promote them to others, and perceive the materials as applying to them specifically [22]. When the question of DTC genetic tests arises—from those for melanoma to those for cardiac risk factors—patient interest in knowing risk at the minimum ignites opportunity to shifts focus from expensive tests to universal preventive strategies. A consumer could pay between several hundred and several thousand dollars for a DTC test, since most are not covered by insurance.

Conclusion Genetic testing does not equate to optimal medical care. The hope remains that results may influence positively medical management or treatment. The hype is that genetic testing offers some sort of panacea, a fast route to critical information. Instead, universal preventive campaigns and good clinical judgment remain unshaken paradigms to improving patient lives. Since genetic testing is only one part of a multidisciplinary approach, the majority of decisions need not proceed in haste. Time devoted to considering the ethical, financial, and practical implications may lead to more prudent and directed use of genetic testing. By carefully selecting patients, providing good counseling, and considering practical issues such as costs and timing, the benefits of genetic testing can exceed the risks (Table 33.1).

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References 1. Begg CB, Orlow I, Hummer AJ, et al. Lifetime risk of melanoma in CDKN2A mutation carriers in a population-based sample. J Natl Cancer Inst. 2005;97:1507–15. 2. New genetic tests. www.genetests.org. Accessed 1 Mar 2010. 3. de Leon J, Susce MT, Murray-Carmichael E. The AmpliChip CYP450 genotyping test: integrating a new clinical tool. Mol Diagn Ther. 2006;10:135–51. 4. Pharmacogenetics research network. http://www.nigms.nih. gov/Initiatives/PGRN. Accessed 12 Aug 2010. 5. Burke W, Pinsky LE, Press NA. Categorizing genetic tests to identify their ethical, legal, and social implications. Am J Med Genet C Semin Med Genet. 2001;106:233–40. 6. Peutz-Jegers syndrome. http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=gene&part=pjs. Accessed 13 Aug 2010. 7. Committee on Bioethics. Ethical issues with genetic testing in pediatrics. Pediatrics. 2001;10:1451–5. 8. Exon skipping therapy for Duchenne muscular dystrophy. h t t p : / / w w w. p a r e n t p r o j e c t m d . o rg / s i t e / D o c S e r ve r / March_31009_Aartsma-Rus_PPasia_exon_skip_for_pdf. pdf?docID=6581. Accessed 10 Aug 2010. 9. Arribas-Ayllon M, Sarangi S, Clarke A. Professional ambivalence: accounts of ethical practice in childhood genetic testing. J Genet Couns. 2009;1:173–84. 10. Borry P, Goffin T, Nys H, et al. Attitudes regarding predictive genetic testing in minors: a survey of European clinical geneticists. Am J Med Genet C Semin Med Genet. 2008; 148:78–83. 11. Kodish ED. Testing children for cancer genes: the rule of earliest onset. J Pediatr. 1999;135:390–5.

N. Shur 12. Teutsch SM, Bradley LA, Palomaki GE, et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Initiative: methods of the EGAPP Working Group. Genet Med. 2009;11:3–14. 13. Bernards A, Gusella JF. The importance of genetic mosaicism in human disease. N Engl J Med. 1994;331:1447–9. 14. Kissil JL, Blakeley JO, Ferner RE, et al. What’s new in neurofibromatosis? proceedings from the 2009 NF conference: new frontiers. Am J Med Genet A. 2010;152A:269–83. 15. Messiaen L, Yao S, Brems H. Clinical and mutational spectrum of neurofibromatosis type 1-like syndrome. JAMA. 2009;302:2111–8. 16. Hall MA, Rich SS. Patients’ fear of genetic discrimination by health insurers: the impact of legal protections. Genet Med. 2000;2:214–21. 17. GINA. http://www.genome.gov/Pages/PolicyEthics/ GeneticDiscrimination/GINAInfoDoc.pdf.Accessed 13 Aug 2010. 18. Rogowsk W, Grosse SD, Khoury MJ. Challenges of translating genetic tests into clinical and public health practice. Nat Rev Genet. 2009;1:489–95. 19. Food and Drug Administration. Direct-to-consumer promotion: public meeting. http://www.genome.gov/12010659. Accessed 13 Aug 2010. 20. Aspinwall LG, Leaf SL, Dola ER, Kohlmann W. CDKN2A/ p16 genetic test reporting improves early detection intentions and practices in high-risk melanoma families. Cancer Epidemiol Biomarkers Prev. 2008;1:1510. 21. Somoano B, Niendorf KB, Tsao H. Hereditary cancer syndromes of the skin. Clin Dermatol. 2005;23:85–106. 22. Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? evidence for a priming effect. Arch Fam Med. 2000;9:426–33.

Desperate Measures for Desperate Patients: Translational Research in Epidermolysis Bullosa

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Alfred T. Lane

Abbreviations EB IRB FDA IND RAC ELBW

Epidermolysis bullosa Institutional Review Board Food & Drug Administration Investigational New Drug Recombinant DNA Advisory Committee Extremely low-birth-weight

Case Report Soon after Jennifer was born her parents realized there was something terribly wrong with her skin when she developed large blisters on her hands, arms and legs. She was urgently transferred to a medical center where several skin biopsies confirmed the diagnosis of recessive dystrophic epidermolysis bullosa. The family read everything they could find about the disease and about the lifelong suffering in Jennifer’s future. The parents are overwhelmed with how caring for Jennifer has interfered with the life they hoped to live. Each parent wondered at times if Jennifer might be better off dead than alive. Jennifer’s family learned about a research study that may benefit Jennifer but it has a 30% risk of death. The research doctor is pressuring the family to enter the study. The family pediatrician is skeptical that the study

will offer Jennifer benefit. Jennifer’s parents clearly do not understand the difference between research and treatment and they do not know where to turn.

Introduction Major advances in understanding the biology and classification of epidermolysis bullosa (EB) have occurred over the past 20 years [1]. The advances in knowledge of the basic biology of these diseases are now allowing for development of potential therapies that have benefits that exceed advances in wound care alone. New options for therapy are focused on cell-based therapies, protein replacement therapy and gene therapy [2]. Each therapy offers risks and benefits for patients with a previously untreatable disease. The focus of this report is to summarize the ethical dilemmas that current options create and to establish guidelines that may benefit the research participant, the parents of the research participant, the research physicians, and the practitioners who care for these patients. The process of applying new therapies for EB is fraught with moral obstacles, ethical quandaries and questions of distributive justice.

Epidermolysis Bullosa

A.T. Lane Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, USA e-mail: [email protected]

EB is a term used to describe a group of genetic skin diseases where the attachment between skin cells is abnormally weak in the epidermis or epidermal-dermal junction [3]. Children with the most severe forms may die an extremely painful death soon after birth or in infancy because routine handling strips off large areas

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_34, © Springer-Verlag London Limited 2012

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of skin. Parents and physicians may need to make early decisions about limiting medical support and focusing on comfort care [4]. In addition, the infants who survive the severe forms will develop recurrent wound infections of damaged skin, have associated inadequate nutrition because of mouth sores or erosions within the esophagus, and may eventually die from squamous cell carcinoma associated with chronic wounds [5]. In the severe form of these diseases, infants and children endure relentless pain from chronic wounds that never heal before they die.

Research Oversight Clinical research on children and adults requires several levels of oversight involving local, state, and federal regulatory requirements. On the local level, the Institutional Review Board (IRB) focuses on protecting the rights and welfare of human research participants. The IRB has formal processes to evaluate, monitor and exercise oversight on research efforts. The IRB has responsibility to educate investigators and research staff about their ethical responsibility to protect research participants, as described in the Stanford University Research Protection Program website [6]. A portion of the authority of the IRB is guided by the Code of Federal Regulations under Title 45 [7]. Additional requirements exist if research involves a drug as defined by the Food & Drug Administration (FDA). “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The Investigational New Drug (IND) is the means through which the sponsor technically obtains this exemption from the FDA [8].” The process of IND development can be very intricate involving detailed evaluation by the FDA. The complex details of IND processes are not the focus of this manuscript, but instead I would like to explore the recent advances in therapy for EB and how these advances relate to the human research subject with EB. The required level of oversight scrutiny will be based on the specific investigative research activities. Use of bone marrow transplantation requires only IRB approval at the local institution, as it does not involve

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use of an investigational drug or FDA oversight. In this circumstance, an IRB at one institution may approve a plan, where the IRB at a different institution might have additional requirements prior to approval of a research protocol or might even totally deny approval. The local IRB is able to stipulate the age of the research subjects as well as require other specific details in the study. Protein therapy is considered a drug and therefore requires an FDA-approved IND before submission for IRB approval. The process of gene transfer requires recombinant DNA and in trials using recombinant DNA additional review is required by the Recombinant DNA Advisory Committee (RAC) prior to application to the FDA for an IND. “The NIH established the Recombinant DNA Advisory Committee (RAC) on October 7, 1974 in response to public concerns regarding the safety of manipulating genetic material through the use of recombinant DNA techniques…. The RAC is a federal advisory committee that is responsible for the NIH system of oversight of recombinant DNA research…. A major responsibility of the RAC at present is to review human gene transfer research on behalf of the NIH [9].” Additional institutional biosafety approvals may be necessary based on the manufacturing process of the protein, drug, or cells and the processes used. If adults with the disease are available for inclusion, FDA guidelines usually require initial trials to be performed in adults who can freely consent rather than in children who require the proxy consent of their parents or guardians. Novel therapies for EB may have many known and unknown risks. Because of the high level of risks, the FDA is very clear that trials must first be done in consenting adults.

The Research Physician The research physician has much greater knowledge about the patient and his or her disease than the patient has knowledge about the potential complications of the research procedure. The research physician may already have directed care of the individual patient and established his or her knowledge and authority in the patient’s care. These factors give the research physician enormous power over ill patients and their families in research studies. It is important that the patient’s consent represents the best interest of the patient and not obedience to the physician’s authority [10]. After

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Desperate Measures for Desperate Patients: Translational Research in Epidermolysis Bullosa

individuals enroll in a research trial, they are considered research subjects and not patients in order to emphasize the fact that a research subject might not derive benefit from the research trial. These research subjects and their families must trust that the physician is responsible and truly concerned for their well-being. Because the patient is ill and may face risks in the trial, the patient will be affected by the research in a way that the physician is not affected. The research physician may have the twin desire to help the individual patient and also future patients. The research physician has invested a great deal of time and effort in the success of the research project. The research physician may also gain self-satisfaction, institutional recognition, public fame, future funding and possible personal financial gain if the trial is successful. This difference in the power of the physician and the goals of the subject can lead to a conflict of interest, which may or may not be recognized by the research physician and the research subject. The purpose of biomedical research is to improve the condition of humankind. The biomedical researcher has a thirst for new knowledge as well as a desire to relieve affliction. The practice of such medical research is directed and controlled by detailed scientific, ethical and financial guidelines and policies. Section 2.07 of the American Medical Association Code of Medical Ethics states that: “A physician may participate in clinical investigation only to the extent that those activities are a part of a systematic program competently designed, under accepted standards of scientific research, to produce data which are scientifically valid and significant [11].” Clinical investigation can be considered therapeutic or non-therapeutic research. Therapeutic research is defined as research which could result in direct benefit to the participant, while non-therapeutic research produces knowledge of general importance without any direct benefit to the participant [12]. A Phase 1 trial is a study designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness and safety [13]. The Phase 1 trial may offer no therapeutic benefit to the research subject, but even in a phase 1 trial, research subjects with cancer may receive psychological benefit from the regular physician contact. They may also feel empowered to exercise their choice in a situation that is not in their control, and at the same time they may be able to help future patients [14].

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Ethical Research Protection of the rights of research subjects has evolved during the past century. The Belmont Report written in 1979 is the foundation of modern American principles regarding research involving human subjects and current research practice [15]. It is derived from the previous standards and was intended to correct unacceptable variations that occurred over time. The Belmont Report established three basic principles that are outlined in Table 36.1. The Belmont Report recognized different rights for children. “Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions [15].” In a clinical trial, the parents act as proxy for the child and informed consent is obtained from the parent [12]. It is ethically permissible to allow higher risks in children when the trial is therapeutic research [12]. In addition, the more acute or critical is the child’s illness, the more likely are the parents to consent to trial entry [12].

Respect for Persons The principle of Respect for Persons “incorporates two ethical convictions: first, that individuals should be treated as autonomous agents; and second, that persons with diminished autonomy are entitled to increased protection [15].” An autonomous person can decide what he or she wants to do and act accordingly. Parents who act as proxy for chronically and terminally ill children are prepared to take greater risks in treatment trials than in non-treatment trials because they highly value curing their child’s illness [16]. Parents who volunteer their children for clinical research might be socially disadvantaged or emotionally vulnerable, which may psychologically predispose them to volunteering [17]. The patient with EB has severe pain and suffering, possibly impelling the parent or patient to request that the treating physician at least try something more than what is currently being done. The patient may be feel driven to participate in the research because of a personal expectation that he will receive

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study benefits and not experience any adverse consequences [18, 19]. Parents of children with life-threatening conditions may be more likely to enter a trial with hope for a miracle cure. This is particularly true of parents of oncology patients who may feel that they have no choice but to participate in a cancer treatment [16]. The health care team may have a different perception of the patient’s illness than either the patient or his family. Previous studies evaluating extremely lowbirth-weight (ELBW) infants documented that doctors and nurses rated the health–related quality of life lower than did parents of normal infants and ELBW survivors and adolescents who were normal birth weight or ELBW survivors [20]. If the physician perceives the research subject’s distress to be greater than does the research subject, would the research physician even consider riskier therapies? Could doctors who consider the research subject to have a lower quality of life be willing to take higher risks than if they thought the subject had a higher quality of life? If parents or guardians are making the decision for a critically ill child, can they be objective or are they so psychologically trapped in the daily care for the child as to be unable to gain perspective and process information and subsequently make an informed choice? If the parents of a child consider their child’s condition worse than death, would they subject their child to greater risk than others might consider appropriate?

Beneﬁcence Infants with severe forms of EB suffer relentless pain each day. Genetically corrected keratinocyte grafts, stem cell therapy, and protein therapy have the potential to not only repair cutaneous wounds but also mucosal abnormalities and thereby eliminate or reduce the constant pain that these produce. The Belmont report states that we have an obligation to ensure that “persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. In addition, beneficence has a twofold commitment of doing no harm while maximizing possible benefits and minimizing possible harm [15].” The research subject or the parents as proxy will therefore need to weigh the potential benefit to both the research subject and to others with EB against the known and unknown risks, including possible death [15].

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The process of entering into a potentially therapeutic trial for EB will cause pain and discomfort for the subject. The process of ex vivo gene transfer first requires genetic confirmation of the specific defect (blood drawing), skin biopsies to culture keratinocytes prior to insertion of the correct gene into the cultured cells, grafting of corrected cells to small areas, and constant monitoring and biopsies of the grafted areas into the future. The FDA requires the Phase 1 trial to show success with lower doses initially and requires the initial grafted area to be limited. If the initial grafts appear to be effective and non-problematic, it may then be possible to perform grafts over larger areas. The one previously reported gene transfer onto a subject with junctional epidermolysis bullosa documented absence of migration outside of the areas of grafting [21]. If grafts begin to displace non-blistered diseased skin, removal of the gene transfer treated skin adjacent to specialized surfaces such as cornea or mucous membranes is envisioned. Development of immunological reactions to the newly made protein expressed in their gene transfer treated skin may also be manageable with minimal harm. In such a condition, the research subject would probably develop blisters under the grafts and eventually push off the entire graft resulting in a wound like the pre-grafted ulcer. It is likewise expected that development of skin cancers in the grafts would be an extremely remote but real possibility [22, 23]. Because of the visibility of the grafted areas, changes can be observed and biopsied, with graft excision as needed. Depending on the success of initial studies, gene transfer-based methods to treat the mucous membrane surfaces and the cornea of the eye may be developed. Protein replacement therapy may also be an option for patients with RDEB [24]. Associated with this therapy may be the need for repeated injections or infusions due to the turnover of type VII collagen, and the risks of immunological rejection of the type VII collagen by induction of hypersensitivity or autoimmunity [24]. Cell based therapies using fibroblasts are also being considered. Fibroblasts which over express type VII collagen can be injected directly into skin and restore the basement membrane structure [25]. Allogeneic fibroblasts from relatives without RDEB, injected into the dermis of subjects with RDEB, appear to increase the recipients’ own deposition of mutant type-VII collagen formation, produced by

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Desperate Measures for Desperate Patients: Translational Research in Epidermolysis Bullosa

their own cells, and increase the numbers of rudimentary anchoring fibrils [26]. Currently, efforts are underway to use bone marrowderived cells to treat RDEB. Initial reports documented that wild type congenic bone marrow cells produced type VII collagen and anchoring fibrils in a lethal mouse model of RDEB [27]. A similar study using congenic embryonic bone marrow cells documented differentiation toward fibroblastic phenotypes as well as type VII collagen deposition [28]. Trials in children have begun, resulting in the death of two of the research subjects and possible benefit to others [29]. Other methods, such as reduced intensity-conditioning, are being developed to try to reduce the morbidity and mortality associated with the intense myeloablative conditioning routinely needed for bone marrow transplantation [2, 30, 31]. Future studies using autologous induced pluripotent stem (iPS) cells may not require myeloablative conditioning.

Justice In the U.S., families enrolled in a research trial will still have to pay for various hospital expenses, wound dressings, medication and physician time and effort for the health care costs associated with treatment of their condition, but not the time and effort of the research physicians that are related to the clinical trial. They may also have to pay travel expenses and housing expenses for the time spent at the research site, if those funds are not available for the investigators to share with the research subjects. Since subjects could come from all over the U.S., and possibly other countries, those costs could be considerable. Insurance companies might pay for some of the expenses related to hospitalization for highly experimental procedures in oncology clinical trials where the research subject has little hope. However, they might not pay for the experimental drugs. A similar model could conceivably be developed for EB. Patients with EB as well as their parents or caregivers are overwhelmed by the pain that these children and adults suffer. These families also socialize in communities of other families with children with EB. These families are often willing to take extra risk if there is hope to help the other families’ children. The parents have a huge instinctual drive to maximize the quality of life of their affected children. Normally, a deep-seated sense of compassion will lead parents of

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healthy children to make great sacrifices of time, of money and of their other personal projects in order to raise their children and provide them with more than merely the necessities of life. When a child is ill with such a severe disease as EB, a deeply felt parental sense of duty to sacrifice for the child appears all the stronger. Research communities can respond to the principle of distributive justice in several other ways. Charitable donations can be used to partially offset the expenses for the families. Low cost housing may be arranged. We expect insurance payment for routine hospital care or for surgeries that may be required if complications of grafting occur. Generally, research funds pay for the cost of the grafts. We and others continue to actively solicit foundation and research support for the entire care of these children. Eventual approval of the initial research treatment as a drug by the FDA could allow for insurance coverage of more of the cost. Treatment of other forms of EB and genetic skin diseases may be advanced based upon the knowledge gained in EB gene transfer or stem cell trials. According to Martha Nussbaum, “Distributive justice requires that the allocation of income, wealth, and power in society be evaluated in light of its effects on persons whose basic material needs are unmet [32].” Studies on EB have focused millions of dollars of research money on this very painful but unique skin condition. Why should we as a society fund such focused research through federal grants? Why should we as research physicians spend so much of our time and expertise on this rare disease when other diseases affect far larger numbers of persons? There are several reasons for such research. The severity of the agony of these children makes an absolute moral claim on us; we must dedicate resources to meet the needs of these children for pain relief in the most effective way possible. As well, the research techniques and information gained in these studies may be applicable to many other diseases; there are often unintended benefits and unimagined discoveries that come from basic research of this type. Development of a successful gene therapy, protein therapy, or stem cell program for these children may help clear the path for additional successful research focused on related or even totally unrelated problems. The term “basic” research is often used for these types of studies where information gained may focus on unique biological functions. Finally, there is a multiplier effect, for the techniques and methods that

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are developed to answer biologic questions about EB will be published and shared by others in the research community, and may ignite connections in fields both near and far. In other words, even basic research can contribute to the Common Good. We are faced with the difficult situation of caring for children with EB. Martha Nussbaum states, “If one believes that the misfortunes of others are serious, and that they have not brought misfortune on themselves, and, in addition, that they are themselves important parts of one’s own scheme of ends and goals, then the conjunction of these beliefs is very likely to lead to action addressing the suffering [33].” The factors that drive the research dermatologist’s life include the deepseated belief that we as a community of scientists studying skin diseases can make a difference in the lives of our patients. We have the desire to act to address the monumental suffering of these patients. Children with EB have inalienable human rights, including the right to medical care, which precludes decisions based merely upon fiscal constraints. We are not in a lifeboat situation where we must choose between saving A or B. Rather, we are in a large and well-resourced society that chooses to constrain funds in one area in order to spend them in another. We as researchers have a responsibility to conduct our research in a planned and organized way such that the questions that we ask and our research plan will give valuable answers. The second principle in the Nuremberg Code states, “The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature [34].” Moving forward in research on such a severe disease requires us to make correct scientific decisions. When faced with a difficult and almost impossible situation, I often share with patients and their families that life has pain and suffering, but misery is optional. Misery may come from the feeling of hopelessness or loneliness. All human suffering makes an absolute claim on the resources, talents and attention of all human communities, including the academic, scientific community. How do we, as researchers, know that what we are doing now is correct? William Spohn clarifies this when he states, “General moral principles can help determine what the right action would be; they cannot determine exactly what the appropriate action is here and now [35].” The severity of the pain and suffering of the children with EB cries out for us to help. Success

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in basic research may translate into significant benefit for a population that is suffering severely. Success in one area may translate to success in many more areas of therapy for severe genetic diseases.

Guidelines for EB Research The severity of RDEB demands careful consideration of Respect for Persons, Beneficence and Justice in approaching a patient or parents of a patient with RDEB for a research trial. Consideration needs to include the Principle of Proportionate Care which Jonsen defines as follows “This principle states that a medical treatment is ethically mandatory to the extent that it is likely to confer greater benefits than burdens upon the patients [36].” This is especially true for research on children where the parents must act as proxy and the true burden the child feels is often not obvious to the parents or research team. Greater caution must be taken because of the power and selfinterests of the research physician [10], the potential vulnerability and sense of hopelessness of the parents [17], as well as the potential for the research physician to perceive the child’s condition as worse than the child or the child’s family may consider it [20]. In evaluating the child’s life, a parent may consider the pain and suffering that the child is experiencing to be worse than death [37]. In such a situation, the parents may consider death a benefit and take much higher risks in order to achieve an effective therapy. In order to develop ethical practices in this severe disease as well as other severe diseases, I suggest the following guiding principles. 1. The research physician should not be the primary physician responsible for the care of the research subject. In a research trial with considerable risks, the patient with EB should be a research subject for one team and receive medical care from another team. We have a pediatric dermatologist who cares for our EB patients and continues the routine care even when the patient becomes a subject in a research trial where another pediatric dermatologist is monitoring the research protocol. This separation allows the patient options for choice during the research process. This gives the research subjects and their families’ additional avenues of communication. It may be easier for the research subject to tell the caretaking team that he would like

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to withdraw from the research process. It could be more awkward or difficult to tell the research team of one’s desire to withdraw from the trial, as the research subject is aware that the research team has invested much time and effort related to the study. This separation may also allow the research subject to more effectively understand what portion of their care is research and what is non-research related patient care. 2. A member of the ethics community, removed from the research process, should be available to communicate with the research subject. This ethics individual should be knowledgeable about the research but not benefit from the success of the research process by being a coauthor or co-investigator. The ethics advocate should be reimbursed for his or her time and effort. This ethics individual can support the autonomy of the research subject or the family of the research subject. This individual can intervene in the research process as an advocate for the research subject. This personal relationship gives the research subject an additional avenue to express concern or a desire to withdraw from the research effort. 3. The research team, the research subject, and the public must realize that there is a fine line between developing false hope of benefit and sharing information about the potential research success. Many orphan diseases have developed support groups to help fund preliminary research. Each donor and family affected is personally interested in the success of the research effort and how it may help immediately. The pace of success in translating basic research into clinical benefit can be extremely slow and cumbersome. The individual affected with the disease should not be exposed to false hope through claims made in the public press by the research physicians. An open public forum is ClinicalTrials.gov that has been an effective method to document IRB approved research studies and to keep the public informed of available clinical trials. The research investigator must maintain effective communication with the orphan drug community while at the same time preventing false hope. 4. The informed consent document needs to be as complete as possible detailing all the details of the study. The risks and potential benefits of the study must be clearly described in a language that is easily understood. The consent should be shared

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with the research subject, ethics advocate, as well as the patient care team well in advance of the time the research subject enters the trial. The research subject should have adequate time to grasp the detailed information in the consent form. Children between the ages of 7 and 17 years of age should have an opportunity to understand, sign or refuse to sign an age appropriate assent. 5. An additional safeguard for subjects in a clinical research trial where risk to the research subjects is unusually high is the creation of a Data Monitoring Committee (DMC) which is also called a Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC) [38]. Because of the complexity of EB care a DMC should be considered. The responsibility of the DMC includes gathering data related to anticipated and unanticipated problems and adverse events. Assessment of the data may require action by the DMC that could include pausing or stopping the trial. The IRB, NIH or FDA has an option to require a DSMB to be formed to monitor the trial. The potential for effective therapy for EB appears to be rapidly improving because of the fruits of current EB research. Balancing the risks and the benefits of each new therapy will continue to be a dilemma into the future, because of the severity of this disease and the potential risks of each new advance. Accurate information and counseling are necessary for Jennifer’s parents so that they can make an accurate decision to enroll or reject Jennifer’s involvement in a risky research trial. Jennifer’s pediatrician has no stake in the research and may offer a more objective view to the family. This case emphasizes that the parent must act as the surrogate for the child. Mature adults can make the decision to enter a risky trial when they have or have not an expectation of possible benefit. Adults can decide for themselves. The parents of such a severely affected child not only see the pain and suffering that the child experiences, but they also feel the disruption in their own goals and plans. They may truly have misery. Other families may have much greater community and family support leading to less misery. Application of the five guiding principles above into the research process may help the family and research team make a decision today that they will not regret tomorrow.

212 Acknowledgments This study was supported by National Institutes of Health (NIAMS) grant R01 AR055914 to AT Lane as well as the Epidermolysis Bullosa Medical Research Foundation. The author appreciates the administrative assistance of Emily Gorell, M.S.

References 1. Fine JD, Eady RA, Bauer EA, et al. The classification of inherited epidermolysis bullosa (EB): report of the Third International Consensus Meeting on Diagnosis and Classification of EB. J Am Acad Dermatol. 2008;5:931–50. 2. Tamai K, Kaneda Y, Uitto J. Molecular therapies for heritable blistering diseases. Trends Mol Med. 2009;15:285–92. 3. Fine JD, Bauer EA, McGuire J, Moshell A. Epidermolysis bullosa: clinical, epidemiologic, and laboratory advances, and the findings of the national epidermolysis bullosa registry. Baltimore: Johns Hopkins University Press; 1999. 4. Yan EG, Paris JJ, Ahluwalia J, Lane AT, Bruckner AL. Treatment decision-making for patients with the Herlitz subtype of junctional epidermolysis bullosa. J Perinatol. 2007;2:307–11. 5. Fine JD, Johnson LB, Weiner M, Li KP, Suchindran C. Epidermolysis bullosa and the risk of life-threatening cancers: the National EB Registry experience, 1986–2006. J Am Acad Dermatol. 2009;60:203–11. 6. Stanford University Human Research Protection Program (HRPP). http://humansubjects.stanford.edu/hrpp/Chapter1. html. Accessed 21 Jan 2010. 7. Protection of human subjects – Title 45, code of federal regulations, Part 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.107. Accessed 21 Jan 2010. 8. U.S. Food and Drug Administration – Types of applications. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ ApprovalApplications/default.htm. Accessed 21 Jan 2010. 9. Office of biotechnology activities – About Recombinant DNA Advisory Committee (RAC). http://oba.od.nih.gov/ rdna_rac/rac_about.html. Accessed 21 Jan 2010. 10. Cassell EJ. Consent or obedience? power and authority in medicine. N Engl J Med. 2005;352:328–30. 11. American Medical Association. Council on Ethical and Judicial Affairs. Southern Illinois University at Carbondale. School of Medicine, Southern Illinois University at Carbondale. School of Law. Code of medical ethics, current opinions with annotations: including the principles of medical ethics, fundamental elements of the patient-physician relationship and rules of the Council on Ethical and Judicial Affairs. Chicago: American Medical Association; 2006.p. 399. 12. Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004;364:803–11. 13. U.S. Food and Drug Administration – Drug Development and Review Definitions. http://www.fda.gov/Drugs /DevelopmentApprovalProcess/HowDrugsareDevelopedand A p p r ove d / A p p r ova l A p p l i c a t i o n s / I nve s t i g a t i o n a l NewDrugINDApplication/ucm176522.htm. Accessed 21 Jan2010.

A.T. Lane 14. Agrawal M, Emanuel EJ. Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA. 2003; 290:1075–82. 15. National Institutes of Health – Office of Human Subjects Research: The Belmont Report. http://ohsr.od.nih.gov/ guidelines/belmont.html. Accessed 21 Jan 2010. 16. Caldwell PH, Butow PN, Craig JC. Parents’ attitudes to children’s participation in randomized controlled trials. J Pediatr. 2003;142:554–9. 17. Harth SC, Johnstone RR, Thong YH. The psychological profile of parents who volunteer their children for clinical research: a controlled study. J Med Ethics. 1992;18:86–93. 18. Appelbaum PS, Lidz CW, Klitzman R. Voluntariness of consent to research: a conceptual model. Hastings Cent Rep. 2009;3:30–9. 19. Davidson AJ, O’Brien M. Ethics and medical research in children. Paediatr Anaesth. 2009;19:994–1004. 20. Saigal S, Stoskopf BL, Feeny D, et al. Differences in preferences for neonatal outcomes among health care professionals, parents, and adolescents. JAMA. 1999;281(21):1991–7. 21. Mavilio F, Pellegrini G, Ferrari S, et al. Correction of junctional epidermolysis bullosa by transplantation of genetically modified epidermal stem cells. Nat Med. 2006;12:1397–402. 22. Hacein-Bey-Abina S, Von Kalle C, Schmidt M, et al. LMO2associated clonal T cell proliferation in two patients after gene therapy for SCID-X1. Science. 2003;302:415–9. 23. Hacein-Bey-Abina S, Garrigue A, Wang GP, et al. Insertional oncogenesis in 4 patients after retrovirus-mediated gene therapy of SCID-X1. J Clin Invest. 2008;11:3132–42. 24. Remington J, Wang X, Hou Y, et al. Injection of recombinant human type VII collagen corrects the disease phenotype in a murine model of dystrophic epidermolysis bullosa. Mol Ther. 2009;1:26–33. 25. Ortiz-Urda S, Lin Q, Green CL, Keene DR, Marinkovich MP, Khavari PA. Injection of genetically engineered fibroblasts corrects regenerated human epidermolysis bullosa skin tissue. J Clin Invest. 2003;11:251–5. 26. Wong T, Gammon L, Liu L, et al. Potential of fibroblast cell therapy for recessive dystrophic epidermolysis bullosa. J Invest Dermatol. 2008;12:2179–89. 27. Tolar J, Ishida-Yamamoto A, Riddle M, et al. Amelioration of epidermolysis bullosa by transfer of wild-type bone marrow cells. Blood. 2009;11:1167–74. 28. Chino T, Tamai K, Yamazaki T, et al. Bone marrow cell transfer into fetal circulation can ameliorate genetic skin diseases by providing fibroblasts to the skin and inducing immune tolerance. Am J Pathol. 2008;173:803–14. 29. Wagner JE, Ishida-Yamamoto A, McGrath JA, et al. Bone marrow transplantation for recessive dystrophic epidermolysis bullosa. N Engl J Med. 2010;36:629–39. 30. Satwani P, Cooper N, Rao K, Veys P, Amrolia P. Reduced intensity conditioning and allogeneic stem cell transplantation in childhood malignant and nonmalignant diseases. Bone Marrow Transplant. 2008;4:173–82. 31. van de Ven C, Collins D, Bradley MB, Morris E, Cairo MS. The potential of umbilical cord blood multipotent stem cells for nonhematopoietic tissue and cell regeneration. Exp Hematol. 2007;35:1753–65. 32. National Conference of Catholic Bishops. Economic justice for all. Washington: United States Catholic Conference, Inc.; 1997. 33. Nussbaum MC. Upheavals of thought: the intelligence of emotions. Cambridge: Cambridge University Press; 2001.

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34. National Institutes of Health – Office of Human Subjects Research: Nuremberg Code, Directives for Human Experimentation. http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed 21 Jan 2010. 35. Spohn WC. Go and do likewise: Jesus and ethics. New York: Continuum; 1999. 36. R-Jonsen A, Siegler M, Winslade WJ. Clinical ethics: A pratical approach to ethical decisions in clinical medicine. 6th ed. New York: Mc-Graw Hill; 2006.

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37. Patrick DL, Starks HE, Cain KC, Uhlmann RF, Pearlman RA. Measuring preferences for health states worse than death. Med Decis Making. 1994;14:9–18. 38. U.S. Food and Drug Administration – The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors. http://www.fda.gov/ RegulatoryInformation/Guidances/ucm127069.htm . Accessed 21 Jan 2010.

Reading Between the Lines: Can Peer Reviewers Be Expected to Detect Fraud?

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Jason D. Gillum, Jeffrey D. Bernhard, and Robert P. Dellavalle

Scientific publishing depends upon the peer review process. Peer review certifies the legitimacy of scientific papers, and helps journal editors identify papers worthy of publication. This chapter discusses the peer review process for detecting and reporting fraud in scientific publication.

Case Scenarios Case 1 Dr. F is a prominent dermatologist and researcher who regularly commits scientific fraud, including falsification of experiments and fabrication of data. Dr. F is clever enough to make his results appear legitimate, so his work has never raised the suspicion of peer reviewers.

No peer reviewer or editor to date has ever asked to see Dr. F’s data.

Case 1a Dr. F sends the Journal of Prestigious Dermatology Research an article he wrote based on “data” from an experiment that was never actually conducted. The fraudulent article is sent to Dr. J for peer review. Dr. J becomes highly suspicious that Dr. F is committing fraud because the experimental methods did not make sense. In spite of his concern, Dr. J does not report his suspicion. The article is published, and is cited many times.

Case 1b J.D. Gillum Indiana University School of Medicine, Indianapolis, IN, USA J.D. Bernhard University of Massachusetts Medical School, Worcester, MA, USA R.P. Dellavalle (*) Department of Veterans’ Affairs, Dermatology Service, Eastern Colorado Health Care System, Denver, CO, USA

Dr. F submits another fraudulent paper to the Journal of Prestigious Dermatology Research. Dr. W is the peer reviewer. Dr. W suspects fraud, based on the number of errors and inconsistencies in the paper. She promptly reports this suspected fraud to the journal editor. The journal editor does not want to become embroiled in a fraud investigation, so he rejects the article for publication, citing “editorial priorities”, and takes no further action.

Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA

Case 1c

Department of Dermatology, University of Colorado Denver, School of Medicine, Aurora, CO, USA e-mail: [email protected]

Dr. F is undeterred by his rejection at the Journal of Prestigious Dermatology Research, and sends the same paper as in Case 1b to the Journal of Cutting-Edge

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_35, © Springer-Verlag London Limited 2012

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Dermatology Research. The reviewer at the Journal of Cutting-Edge Dermatology Research suspects fraud, and reports this to the editor. The editor gathers evidence of the suspected fraud, and e-mails Dr. F, asking to talk to him about his data. Dr. F ignores the editor’s efforts. The editor then reports the suspicion of fraud to Dr. F’s home institution and to Dr. F’s Department Chair. The institution inquires into the matter and then launches an investigation in cooperation with the United States government’s Office for Research Integrity. The end result is that Dr. F loses his eligibility for NIH funding, is prosecuted by the federal government, and is ultimately convicted of research fraud.

Case 2 Dr. U submits a paper to a journal. The peer reviewer, Dr. E, a competitor of Dr. U at another institution, thinks that Dr. U’s data are too good to be true. Dr. E tells the editor of the journal, but the editor is not interested in pursuing the matter. Dr. E therefore makes a confidential report to an appropriate official at Dr. U’s university. Although the fraud allegations are soon dismissed upon a brief inquiry by the university, and no report is filed with the federal government, the university’s inquiry process badly disrupts Dr. U’s research: his lab temporarily stops work, causing a great waste of grant money and a loss of data. Dr. E is now anxious about the possible repercussions of his mistake. Dr. E worries that although his report was confidential, and that the law protects him from certain kinds of overt retaliation, Dr. U may eventually figure out who filed the report. He is especially worried because the members of his grant review committee are personal friends and co-authors of Dr. U, and have expressed anger at what happened to Dr. U. He is also worried about professional ostracism and the threat of a lawsuit if Dr. U finds out. Because of his bad experience, Dr. E never again reports suspected fraud.

Discussion Fraud is a relatively common and destructive behavior in the scientific world [1, 2]. The temptation toward scientific fraud is strong: if successful, fraudulent publication could be a ticket to rapid career advancement, money, and fame [1]. However, the damage

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caused by scientific fraud is enormous and farreaching; it can destroy scientific reputations and also damage the reputations of journals, editors, research institutions, and even entire fields of science [1]. When applied translationally, fraudulent science can harm patients and financially damage companies, and grant-issuing agencies. Because of its potentially devastating effects, combating fraud is a priority for the scientific community [2, 3]. The peer review process plays a key role in scientific publication; it serves as a stamp of legitimacy for scientific work. But to what extent can peer reviewers police scientific papers for fraud? Peer review helps only modestly in identifying fraud, for a number of reasons discussed below [4]. While the peer review process is widely used, peer review practices differ from journal to journal [5, 6]. Even assuming that the peer review process may have some potential for detecting fraud, the position of peer reviewers is not optimal for detecting or reporting scientific fraud [3, 4]. First, the peer review system is characterized by a lack of time and resources. In general, peer reviewers are researchers who are busy and generally receive no remuneration for the time they spend in reviewing submissions. Therefore, reviewers may fail to notice carefully disguised fraud [4]. Second, even if fraud is suspected, the peer reviewer must report it to someone. The two most logical candidates for reporting are (1) the editorial staff of the journal, and (2) the appropriate official at the author’s institution [1, 7]. A number of scientific publishing organizations, including the Council of Science Editors (CSE) and the Committee on Publication Ethics (COPE) are generally in agreement that the reviewer should first report concerns to the editor of the journal. According to COPE and CSE, once the reviewer has reported his or her suspicions, the journal’s editorial staff should assume responsibility in assisting any investigation, including gathering evidence, and reporting to universities or government agencies [7, 8]. A system in which peer reviewers report fraud to journal editors, however, cannot control fraud in the long term. First, a journal cannot impose real sanctions on fraudulent authors; the only real recourse a journal has against fraudulent papers is to reject them [4]. This measure is of limited long-run efficacy against fraud, as miscreant authors can simply choose other journals. Second, even if they had disciplinary power, journals are unlikely to be able to conclusively establish fraud

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because they lack the investigative capabilities and resources: first, they may or may not be able to access the raw data for many of their submissions, and second, they are not funded to process the data to conclusively establish fraud [3, 4, 9]. Potential fraud may also be reported to a Research Integrity Officer (RIO), or similar official at the offending author’s home institution [10]. A credible allegation of fraud by a peer reviewer does not always result in appropriate investigation by the researcher’s institution. Furthermore, there is no guarantee that the reviewer will escape direct or indirect retaliation as a result of the complaint [10, 11]. The fact that the peer reviewer is not a true witness to the potential fraud certainly does not help the credibility of his or her reports (and therefore the chances of an inquiry), and also does not help the inquiry’s chances of progressing to a full investigation. Furthermore, a clever scientific fraud may be more likely to be able to deflect the institution’s suspicions at the inquiry stage [12]. In order to better understand this problem, a discussion of the relevant procedures is helpful. According to regulations and other materials promulgated by the federal Office of Research Integrity, suspected fraud is looked into by universities and other institutions by a two-step process: the first step is called an “inquiry”, and the second step is called an “investigation [10, 11]. A “credible and specific” allegation of fraud by a peer reviewer may be sufficient to trigger the “inquiry” phase of the process. During the course of the inquiry, the university’s goal is to gather information on the suspected fraud, while minimizing disruption. The suspected researcher can continue to conduct research and use his or her grant funds, but records and evidence of possible misconduct, including lab notes and equipment may be taken and sequestered by the home institution [11]. If the inquiry shows that the complainant’s allegation “has substance”, then a broader procedure called an “investigation” is warranted. During an investigation, a report may be made to the Office of Research Integrity, and all of the accused scientist’s research activity and federal Public Health Service funding will be suspended [10, 11]. The initiation of an inquiry not only inconveniences the accused investigator, but also impugns his or her integrity. In short, regardless of whether the inquiry is ever successful in substantiating the reviewer’s suspicions, the complaining reviewer may have to live with any possible consequences, including retaliation [13].

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Reputations may be justly or unjustly destroyed in the process. In spite of the federal government’s efforts to establish safeguards for complainants of scientific fraud, these safeguards are not complete. First, the complainant’s identity is generally confidential; the ORI’s regulations specify that the name of the complainant must be kept confidential unless and until the complainant is called as a witness in an ORI proceeding [14, 15]. Second, the home institution of anyone, including a peer reviewer, who makes a good-faith allegation of misconduct (meaning that a reasonable person in the peer reviewer’s position could believe that misconduct had occurred) has a legal duty to protect the “reputation and position” of that person [10, 16]. Actual or suspected retaliatory acts may be reported to the institution’s RIO [7]. Although these rules may protect a complaining peer reviewer from certain obvious retaliatory actions by his or her home institution, there may be other consequences, which could include inconvenience and discomfort during the investigation process, as well as professional ostracism or refusal to collaborate by colleagues, negative peer reviews, or rarely, reductions in grant money [8, 11, 17, 18]. The case studies presented at the beginning of this chapter illustrate the facts discussed here. An ethical analysis of the case studies follows. While state tort and contract laws may often echo the ethical principles discussed here, the analysis below is strictly an ethical analysis. In cases 1a and 1b Dr. F successfully hides his fraud. As discussed above, the peer review process cannot reliably detect fraud. The main ethical values involved in this case, as well as the other case studies include the prevention of societal, institutional, and individual harm from fraud, and the keeping of promises between the reviewers and the journals. While peer reviewers cannot efficiently police for fraud, a peer reviewer can prevent harm from obvious frauds that come across his or her desk, and should therefore take appropriate steps to prevent this harm. The reviewer is obligated to disclose any conflicts of interest, including professional and personal, before undertaking the review, and also agrees to diligently review the manuscript and communicate opinions and recommendations to the editor and authors in timely fashion. By fulfilling his or her ethical responsibilities to the journal, the reviewer is also helping to prevent harm from fraud at the societal level.

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In Case 1a, Dr. J has not fulfilled his obligation to communicate honestly with the editor. The editors based their decision at least in part on the peer reviewer’s opinion and could not reasonably have been expected to detect the fraud. With regard to the second ethical obligation, that of preventing harm, the peer review process has a limited capacity to detect fraud and to prevent harm resulting from fraud. The process is only as strong as its weakest link, which in this case was the reviewer. In Case 1b, the peer reviewer reports a suspected fraud to a journal editor, but the editor chooses not to proceed with reporting the fraud. Like the reviewer, the editor has also promised the journal to ensure high quality publication; the editor fulfills this obligation to the journal by rejecting the article. But he runs afoul of the ethical principle of preventing harm by not reporting the reviewer’s suspicions. In so doing, the editor deprives the institution and the NIH of a chance to prevent further harm from the fraud. The editor therefore should have reported the reviewer’s suspicions. In Case 1c, the peer review process is successful at stopping a fraud. Although the peer review process cannot efficiently detect fraud, peer review can stop some cases of fraud. If peer reviewers, editors, institutional officials, and government cooperate in reporting and processing suspected fraud cases, they can minimize harm, and bring perpetrators to justice. Case 2 illustrates the importance of safeguards and protective measures for peer reviewers, and helps explain why some people may hesitate to report fraud. In this case, a reviewer suffers unpleasant consequences from reporting. Without sufficient legal safeguards in place to protect peer reviewers from unnecessary losses of anonymity or retaliation, peer reviewers may underreport, and the peer review system may not perform to its full ethical and societal potential.

Conclusion In short, peer review suffers from serious shortcomings both in detecting fraud, and in reaching satisfactory results when it uncovers possible frauds. Specifically, reviewers and journals lack the time and the resources to actively police papers for fraud. In some cases, a peer reviewer may be able to a detect fraud, but these may represent only a portion of the total number of frauds in science. Furthermore, even if

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fraud is suspected by the reviewer, the mechanisms presently available to reviewers for combating the possible fraud are profoundly limited: first, the journal can reject the article and hope that no other journals will try to publish it, or second, the reviewer could embark on the risky and possibly fruitless path of reporting the possible fraud to the author’s institution. Because of the present insufficiency of peer review as a fraud-sensing mechanism, it is useful to think about alternative methods of fraud reporting and detection. At the level of the journals, fraud is usually dealt with after publication through retraction of fraudulent articles by the journals, while suspected fraud or inaccuracy is dealt with through practices such as a published “expression of concern” [19]. A mechanism for detecting fraud prior to publication is preferable. Two alternatives for pre-publication detection of fraud come to mind. First, some authors have discussed the possibility that journals or government agencies could establish electronic data repositories to audit their submissions; other authors have suggested the idea of implementing random data audits in scientific research [1, 21]. This alternative could be expensive, however, and some have argued that an audit system could undermine the independence of science [20]. Another alternative is the possibility of a publication system in which “noisy rejections” are possible – what is meant here is that journals could make a paper’s history of prior rejections (and reviewers’ suspicions) known to subsequent journals that receive the paper as a submission. Although no such system presently exists, one might imagine a system in which a group of journals or institutions maintain an electronic database of information on whether other journals had concerns about individual submissions. Subsequent reviewers would be able to search the database, not only for information on whether a submission had been reviewed and rejected, but also for indications of concern about the integrity of the work. If designed appropriately, such a system could be a relatively inexpensive deterrent to fraudulent submissions [13]. At the level of institutions, authors have discussed a system in which universities can audit their researchers before fraud is reported or suspected. In conjunction with an institutional audit system, some commentators suggest that data-retention systems be put in place by the universities, in order to facilitate future audits of papers [21]. Another institutional mechanism of fraud control discussed in the literature would involve making

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the principal investigator accountable for the actions of all his or her subordinates [22]. Many journals already ask the senior author(s) to accept responsibility for the integrity of the data. At the governmental level, the United States government has already implemented a number of fraud-control mechanisms [8, 11]. The most common one involves “debarment”, which means preventing a researcher from receiving federal funds for a period of time [11, 23]. Researchers who commit fraud can also be held criminally liable for their actions, although this practice is rare at present [23]. Researchers can be held civilly liable for misappropriated grant money as well [24]. In an era of increasingly specialized and narrow fields of knowledge combined with increasingly complex, if not arcane, statistical techniques, several other issues arise. (1) Should a statistical consultant review all papers with more than a basic statistical analysis? If so, at what point in the editorial process? (2) Can we expect peer reviewers, not to mention editors, to be sufficiently well versed in a given subject to be able to understand the work and detect fraud if it is present? (3) How can the quality and reliability of peer reviewers be assessed? (4) What should an editor do when an extremely accomplished and senior expert or a member of the editorial board writes a one word review: “accept” or “reject”, and a more junior person writes an insightful two page review and comes to the opposite conclusion? When should an additional reviewer be enlisted, and what effect would that have on the ultimate impact of the paper, priority claims, and the like? (5) Why isn’t instruction in the peer review process, and a sense of obligation to participate in it, taught in medical schools and graduate programs? Finally, can scientific integrity be taught by example or instruction? In summary, peer review remains vital for insuring the scientific integrity of the literature. The process of detecting scientific fraud continues to evolve, using peer review whenever possible, but never depending solely upon it.

References 1. Triggle CR, Triggle DJ. What is the future of peer review? Why is there fraud in science? Is plagiarism out of control? Why do scientists do bad things? Is it all a case of: “all that is necessary for the triumph of evil is that good men do nothing”? Vasc Health Risk Manag. 2007;3:39–53.

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2. Titus SL, Wells JA, Rhoades LJ. Repairing research integrity. Nature. 2008;453:980–2. 3. Marris E. Should journals police scientific fraud? Nature. 2006;439:520–1. 4. Anonymous. Editorial: can peer review police fraud? Nat Neurosci. 2006;9:149. 5. Anonymous. Editorial: striving for excellence in peer review. Nat Neurosci. 2009;12:1. 6. Arms WY. What are the alternatives to peer review? Quality control in scholarly publishing on the web. J Electron Pub. 2002;8(1):72–87. 7. Committee on Publication Ethics Flowchart for dealing with suspected fraud. http://publicationethics.org/flowcharts. Accessed 16 Jun 2010. 8. Council of Science Editors website. http://www.councilscienceeditors.org/editorial_policies/whitepaper/3-3_ reporting.cfm. Accessed 16 Jun 2010. 9. Grouse LD. Dealing with alleged fraud in medical research. JAMA. 1982;248:1637–8. 10. Office of Research Integrity Requirements for Institutional Policies and Procedures. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 11. Office of Research Integrity Regulation 42C.F.R. § 93. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 12. Extension of argument from reference 4. 13. Own analysis. 14. Office of Research Integrity Regulation 42C.F.R. § 93.108. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 15. Office of Research Integrity Regulations. 42C.F.R. §§ 93.512 and 93.513. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 16. Office of Research Integrity Regulations. 42C.F.R. § 93.300. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 17. Merz B. Many address task of preventing research fraud. JAMA. 1988;260(14):2011–2. 18. Office of Research Integrity Regulations. 42C.F.R. § 93.310. http://ori.dhhs.gov/. Accessed 16 Jun 2010. 19. Bombardier et al. Expression of concern: “comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis”. N Engl J Med. 2005; 353:2813–4. 20. Anderson A. Plagiarism charge casts shadow on peer review. Nature. 1989;340:173. 21. Hilgartner S. Research fraud, misconduct, and the IRB. IRB. 1990;12:1–4. 22. Altman L, Melcher L. Fraud in science. Br Med J (Clin Res Ed). 1983;286:2003–6. 23. Basu P. Focus on fraud: where are they now? Nat Med. 2006;12:492–3. 24. Program Fraud Civil Remedies Act. 31 U.S.C. §§ 3801– 3812. http://uscode.house.gov/search/criteria.shtml . Accessed 22 Feb 2011.

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Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

Case Scenarios

Case 2

Case 1

Dr. Lee is asked by BioMed Central (BMC) Dermatology to review a manuscript examining Gingko biloba extract and markers of DNA damage in skin cell lines following UV irradiation. Dr. Lee dedicates the greater portion of an afternoon to rigorously critiquing the manuscript, and is made aware that this journal offers reviewers the option to take credit by signing their reviews, which he elects to do. A few months later, he approaches the study’s lead author, Dr. Williams, at a conference and offers to collaborate on an unrelated project. Dr. Lee is puzzled when Dr. Williams very coldly rejects the offer without any explanation for his disinterest in this collegial proposal. Thinking back to a few criticisms in his review, Dr. Lee cannot help but wonder if Dr. Williams’ antipathy toward collaboration stems from his having taken offense from Dr. Lee’s review.

Dr. Jones, a junior investigator at XYZ University is asked to review a manuscript on the role of YFGmutations in pediatric mastocytosis. The invitation comes from a journal with an editorial policy of open peer review. Dr. Jones is currently on the verge of submitting his credentials for a faculty position in the Department of Cutaneous Biology at Shangrila University whose chairman incidentally is the author of this manuscript. Given the circumstances of open review, Dr. Jones declines the journal’s invitation out of concern that any criticism of the manuscript could adversely affect his future prospects at Shangrila University.

A.L. Suárez Department of Dermatology, School of Medicine, Denver VA Medical Center, University of Colorado Denver, Aurora, CO, USA J.D. Bernhard University of Massachusetts Medical School, Worcester, MA, USA R.P. Dellavalle (*) Department of Dermatology, School of Medicine, Denver VA Medical Center, University of Colorado Denver, Aurora, CO, USA Department of Epidemiology, Colorado School of Public Health,Aurora, CO, USA Department of Veterans Affairs, Dermatology Service, Eastern Colorado Health Care System, Denver, CO, USA e-mail: [email protected]

Discussion Peer review has been a major component of the decision-making process of editors and professional societies since World War II [1, 2]. It has been central, along with the editors’ judgment, in determining whether a manuscript merits publication. Akin to an appraisal system, peer review takes into account expert views and opinions regarding the work in question. In an effort to elevate the quality of a journal or academic meeting, peer review encompasses the academic community’s best efforts to objectively assess an individual’s work. One’s publication history is a very important component in the evaluation of one’s performance as a

L. Bercovitch and C. Perlis (eds.), Dermatoethics, DOI 10.1007/978-1-4471-2191-6_36, © Springer-Verlag London Limited 2012

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scholar, with both publication quantity and quality factoring into the evaluation of candidates for faculty appointments, academic promotion, and research funding [3]. Publication, therefore, benchmarks success as a scientist. Many therefore argue that “the organization of science consists of an exchange of social recognition for information” [4]. Peer reviews can be influenced by knowledge of the authors’ identities as well as anonymity of the referee. Peer review functions in its purest form when a work is selected solely for its scientific merit. Subjectivity, whether conscious or unintentional, dilutes intellectual validity. Is peer review improved by blinding? Table 38.1 defines the various types of blinding in peer review. In a single-blind review the reviewer’s name is hidden from the author, while in a double-blind review both author and reviewers’ identities are hidden from one another. In contrast, open peer review occurs when there is no blinding and the author’s and reviewer’s names are known to each other. Post-publication review refers to the practice wherein any reader has the opportunity to become a reviewer, further refining the assessment of an already published works’ scientific value. Here we provide an overview of the arguments for and against these refinements in working towards improved and more ethically sound methods of peer review.

Author Anonymity Just as a celebrity’s face can render a certain brand of sunscreen more attractive to consumers, creating a purchasing bias, knowledge of a work’s author and affiliation lends itself to bias in peer review. Furthermore, when a field is comprised of only a small number of people, certain individuals can tend to dominate the review process of papers, potentially leading to bias and delays in publication of papers from others. Recently the topic of public debate, these tensions are palpable within the stem cell research community [5, 6]. De-identifying the authors and their respective institutions provides a mechanism for removing certain unconscious or conscious biases, allowing the reviewer to focus solely on the content of the manuscript itself. Biomedical journals and professional societies do not exclusively use single-blind peer review. For example, The Society of Investigative Dermatology (SID)

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Annual Scientific Session reviewers are not privy to author identities on abstracts that are submitted via their online electronic submission management system (Manuscript Central) [7]. Author anonymity in peer review is the current practice of the American Journal of Epidemiology [8], American Sociological Review [9], Journal of Adolescent Health [10] and several other health and social sciences journals [11]. Skeptics of double-blind review question the guarantee of author anonymity, suggesting that it is often easy to guess the author of a manuscript [12]. Authors new to a field may have few references to their prior work within the paper under review [13], while scientists who frequently refer to their own work may also be easy to identify [14]. In one study, reviewers were able to identify at least one of the authors on about 40% of masked papers [15]. Perhaps the authors were recognizable because they were well-known [16]. Editors at the Public Library of Science have abandoned double-blind peer review on account of the ready detection of masked authors [17]. Furthermore, it is not entirely unreasonable for reviewers to want to know authors’ names, as a literature search of the authors’ related publications can help reviewers evaluate the methodology’s rigor, as well as the significance and contribution of the work to the current literature. Blinded reviewers should attempt to conduct a fair and unbiased analysis of a manuscript and should consider communicating to editors any strongly suspected author identity that would influence their critique. The current peer review system is criticized for being time consuming, and imposing excessive delay on publication. The time frame from date of submission to date of acceptance, while generally decreasing with the aid of electronic manuscript management systems, can still exceed 6 months [18]. Skeptics of blinding are concerned that the cumbersome and time-intensive process of removing author identity from a manuscript adds excess cost and may protract the already lengthy decision-making process. Several groups have investigated the effects of masking author identity on the quality of peer review, and these studies demonstrate marginal to no improvement in review quality [15, 19– 21]. Arguably, because manuscripts of well-known authors are more difficult to mask, and those manuscripts may be more likely to benefit from masking, the inability to mask reviewers to the identity of wellknown authors may have contributed to the lack of effect [15]. Taken together, these studies demonstrate

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the challenge of masking well-known authors, and suggest that peer review is not significantly improved by masking. However, reviewers have an ethical responsibility to conduct a fair and unbiased analysis of a manuscript. Should a reviewer suspect author identity in a blinded peer review, he or she must communicate this suspicion to the editors, given its potential to influence the quality of the critique.

Reviewer Anonymity In the case of single-blinded review, journals disclose authors’ names and institutions to reviewers, but keep reviewer’s names from authors [22]. Described as “a perfect example of privilege and power (that of the reviewer over the author’s manuscript) being dislocated from accountability” [23], single-blinded review does not treat authors and reviewers equally. With the average review taking about five hours to complete, the typical referee, because of time constraints, agrees to about eight and declines around two invitations to review a year [11, 18]. The current system offers referees little credit for the time and energy they invest in review. Importantly, reviewers could be using this time instead on their own scholarly activity, as up to 90% of reviewers are themselves authors [11, 18]. Some journals, such as BMJ and Biomed Central (BMC) Dermatology offer reviewers the option to sign their reviews. While signed reviews tend to be more polite [24], signed reviews are not significantly less critical [25]. On the contrary, reviewers who sign their names to reviews more frequently provide constructive and higher quality reviews [24–26]. Interestingly, lack of formal recognition was not as important a factor as lack of time in reviewers’ decisions to take on or decline doing a review [27]. Arguments in favor of reviewer anonymity include concerns that in an open system, junior reviewers might be hesitant to honestly critique the work of senior colleagues, which would lend itself to increased acceptance rates and bias the literature towards overrepresentation of more senior authors [28]. However, authors and editors do not perceive a difference in review quality between open and anonymous reviewers [19, 20, 24, 29], and one study suggests better quality with open review [25]. Furthermore, open review proponents posit that it diminishes editors’ ability to “hide behind the spuriously heightened authority of

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anonymous reviewers” [26], suggesting that an open review forces editors to take ownership of their reviewer selection and interpretation of reviewer comments [26].

Post-publication Criticism The criticism of a public work does not stop with prepublication peer review, but rather continues after publication in journal clubs, research forums, and society meetings. Because the advancement of science and medicine depend on knowledge born of valid and compelling research, scientific and medical communities have an ethical obligation to uphold standards of objective peer review. With the growth of electronic publishing technology, a new variant of open review is possible in which any reader can comment on and critique a published manuscript. This includes readers numerically rating manuscripts following publication [2]. The British Medical Journal’s “rapid responses” allows readers to post electronic letters to the editor that can be viewed online alongside the original article [30]. Some journals, such as BMC Dermatology [31], make the peer review record public and allow readers online access to original drafts, reviewer comments, and author responses. JournalReview.org is an Internet resource that archives post-publication reviews. Taking into account comments from a wider cohort of individuals, post-publication review is a dynamic and ongoing process that can significantly improve the review process. The value system of researchers and educators includes the tenets of collaboration and free exchange of knowledge [32]. Sophisticated Internet resources and technological advances have cultivated these values over the last decade into an entire innovative movement of open education [33–37]. Open access scientific publications, and other readily available online information resources, portend tremendous benefit in producing and refining high quality reviews. It is, however, difficult to evaluate the quality, accuracy, and relevance of what is posted in online forums [38]. With online open access to reviews, drafts, and repositories of reader feedback, there is no single final form but rather a series of distinct versions. This raises the question: “what happens when versions change so rapidly or proliferate so quickly that there is no time to review everything?” [37].

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Analysis of Cases The case studies presented at the beginning of this chapter serve to facilitate the reader’s consideration of the above discussion points. An analysis of the case studies, including potential solutions, follows. Case 1 illustrates how knowledge of a manuscript’s author can influence the outcome of a review. Dr. Jones was presumably invited to review the manuscript because of his credentials and reputation in this particular field of study. However, because he knew the author’s identity, he instead chose to avoid repercussions resulting from providing a negative review, and therefore declined to review the manuscript. Alternatively, Dr. Jones might have chosen to write a more favorable critique, with the hopes that a gleaming review might bolster his chances of being offered a faculty position at Shangrila University. In Case 1, Dr. Jones may very well have been the best man for reviewing the manuscript, and had he not felt careerrelated pressure to decline, the manuscript may have undergone a more rigorous review, with heavier criticism. Case 1, therefore, raises the concern related to how open peer review can be biased, if reviewers are concerned their careers will be adversely affected by their reviews. How then could Dr. Jones’ dilemma, in Case 1, of feeling pressured to decline the review invitation have been avoided? This situation could have been avoided had the review been initiated in a double blind fashion, eliminating any question of how Dr. Jones’ review might impact his career, and subsequently allowing for a more objective review of the manuscript. Likewise, in Case 2, Dr. Williams’ refusal to collaborate with Dr. Lee could reflect a personal grudge with Dr. Lee’s review. Case 2 illustrates a potential negative consequence of open peer review, as the open exchange of ideas and materials was halted due to a potential grudge with a harsh review. The Publishing Research Consortium’s (PRC) international assessment of attitudes towards peer review illustrates the commitment of academics to peer review, with the belief that it facilitates scientific communication and improves the quality of research publications [11]. The value of the current system apparently offsets areas of dissatisfaction that include: (a) reviewer bias as a result of knowing author identity, (b) unequal valuation of reviewer versus author anonymity, (c) resource expense for

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authors, reviewers, editors, and journals, and (d) inhibition of free communication. In Case 2 Dr. Lee spent a great deal of time critiquing the manuscript, so what is wrong with him wanting recognition for his work? Should he then be punished later on with “burned bridges” to collaboration? Electronic submission management systems offer an opportunity to accommodate refinements in peer review. Following a double-blind review, reviewers could be offered the option of unmasking their reviews after the unmasking of author identity [7]. In Case 2, this approach may have helped delay some of the animosity felt by Dr. Williams, perhaps long enough to allow some ongoing collaboration with Dr. Lee. Additionally, journals could also post exceptional reviews on their websites, providing referees with public credit for their hard work. Exceptional reader postpublication reviews could also be highlighted. While giving Dr. Lee his due credit, this option, however, would not avoid the subsequent personal conflict between Dr. Lee and Dr. Williams. A new algorithm of peer review, proposed by computational biologist Stefano Allesina, suggests a system for maximizing the efficiency of peer review wherein journals bid on manuscripts, rather than authors choosing a journal for submission. Incorporating authors, reviewers, manuscripts and journals, this “agent-based” model of interactions produces a novel system with great potential for expediting peer review, targeting appropriate manuscripts to appropriate journals, and ensuring optimal quality and rigor of published manuscripts [39]. Still in the preliminary phases of development, it will be exciting to see if this algorithm can be adapted to mainstream publishing. In conclusion, the current system of single-blinded peer review presents the following pitfalls: (a) reviewer bias as a result of knowing author identity, (b) unequal valuation of reviewer versus author anonymity, (c) resource expense for authors, reviewers, editors, and journals, and (d) inhibition of free communication. Case 1 and Case 2 illustrate these issues, and highlight the need for refinements in the peer review process. From an ethical perspective, we maintain that a system of double blinding would eliminate many of these issues, and are optimistic that new computational algorithms will facilitate incorporating a more ethical and fair system of peer review. Funding: None.

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References 1. Kronick DA. Peer review in 18th-century scientific journalism. JAMA. 1990;263:1321–2. 2. Rennie D. Editorial peer review: its development and rationale. In: Godlee F, Jefferson T, editors. Peer review in health sciences. London: BMJ Books; 2003. http://resources.bmj. com/bmj/pdfs/rennie.pdf Accessed 6 Nov 2011 3. Schachman HK. From “publish or perish” to “patent and prosper”. J Biol Chem. 2006;281:6889–903. 4. Hagstrom W. The scientific community. Carbondale: Southern Illinois University Press; 1965. 5. Kemp E, Smith A, Buckingham M, et al. Open letter to senior editors of peer-review journals publishing in the field of stem cell biology. Euro Stem Cell. 2009;305:221–4. 6. Ghosh P. Stem cell research ‘biased’. BBC Today. Vol England: British Broadcasting Corporation; 2010:4 minutes 45 seconds. 7. Dellavalle RP. Cultivating peer review. J Am Acad Dermatol. 2006;55:1113–5. 8. Instructions to authors, American Journal of Epidemiology. http://www.oxfordjournals.org/our_journals/aje/for_ authors/general.html. Accessed 11 Mar 2010. 9. Instructions to authors, American Sociological Review. http://www2.asanet.org/journals/asr/submission.html . Accessed 11 Mar 2010. 10. Instructions to authors, Journal of Adolescent Health. http:// www.elsevier.com/wps/find/journaldescription.cws_ home/505765/authorinstructions. Accessed 11 Mar 2010. 11. Ware M. Peer review in scholarly journals: perspective of the scholarly community – an international study. Bristol: Publishing Research Consortium; 2008. p. 32. Available on Google Scholar http://scholar.google.com/scholar?q=Peer+review+in+scholarl y+journals:+perspective+of+the+scholarly+community+– +an+international+study.&hl=en&as_sdt=0&as_vis=1& oi=scholart. Accessed 6 Nov 2011. 12. Lock S. A difficult balance: editorial peer review in medicine. Philadelphia: ISI Press; 1986. p. 122–3. 13. Naqvi KR. Double-blind review: the paw print is a giveaway. Nature. 2008;452:28. 14. Stigler S. More about the lion and its claw. Nature. 1988; 333:592. 15. Cho MK, Justice AC, Winker MA, et al. Masking author identity in peer review: what factors influence masking success? PEER Investigators. JAMA. 1998;280:243–5. 16. O’Hara B. Double-blind review: let diversity reign. Nature. 2008;452:28. 17. Editorial: Working double-blind. Nature. 2008;451:605–6. 18. Ware M, Consulting MW. Peer review: benefits, perceptions and alternatives. London: The Publishers Association; 2008. 19. Godlee F, Gale CR, Martyn CN. Effect on the quality of peer review of blinding reviewers and asking them to sign their reports: a randomized controlled trial. JAMA. 1998;280:237–40. 20. van Rooyen S, Godlee F, Evans S, Smith R, Black N. Effect of blinding and unmasking on the quality of peer review: a randomized trial. JAMA. 1998;280:234–7.

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21. Justice AC, Cho MK, Winker MA, Berlin JA, Rennie D. Does masking author identity improve peer review quality? A randomized controlled trial. PEER Investigators. JAMA. 1998;280:240–2. 22. Davidoff F. Masking, blinding, and peer review: the blind leading the blinded. Ann Intern Med. 1998;128:66–8. 23. Rennie D. Freedom and responsibility in medical publication: setting the balance right. JAMA. 1998;280:300–2. 24. McNutt RA, Evans AT, Fletcher RH, Fletcher SW. The effects of blinding on the quality of peer review. A randomized trial. JAMA. 1990;263:1371–6. 25. Walsh E, Rooney M, Appleby L, Wilkinson G. Open peer review: a randomised controlled trial. Br J Psychiatry. 2000;176:47–51. 26. Godlee F. Making reviewers visible: openness, accountability, and credit. JAMA. 2002;287:2762–5. 27. Tite L, Schroter S. Why do peer reviewers decline to review? A survey. J Epidemiol Community Health. 2007;61:9–12. 28. Fabiato A. Anonymity of reviewers. Cardiovasc Res. 1994;28:1134–9; discussion 1140–1145. 29. Jefferson T, Rudin M, Brodney Folse S, Davidoff F. Editorial peer review for improving the quality of reports of biomedical studies. Cochrane Database Syst Rev. 2008:39. 30. Allen R. Bravo, brave BMJ, for the rapid response section. BMJ. 2002;325:223. 31. BioMed Central. Dermatology publication and peer review process. http://www.biomedcentral.com/bmcdermatol/ifora/ %23peerreview. Accessed 13 Mar 2010. 32. Baraniuk R. Challenges and opportunities for the open educaiton movement: a Connexions case study. In: Iiyoshi T, Kumar MSV, editors. Opening up education – the collective advancement of education through open technology, open content, and open knowledge. Cambridge: MIT Press; 2008. 33. Baraniuk RG, and Cervenka K. Connexions White Paper: Building Communities and Sharing Knowledge. Houston, TX: Rice University; 2002. 34. Burrus C. Connexions: An open educational resources for the 21st century. Educ Technol. 2007;47:19–22. 35. Atkins DE, Brown JS, Hammond AL. A review of the open educational resources (OER) movement: achievments, challenges, and new opportunities. Report to The William and Flora Hewlett Foundation; 2007. 36. Organisation for Economic Co-operation and Development. Giving knowledge for free: the emergence of open educational resources. http://www.213.253.134.43/oecd/pdfs/ browseit/9607041E.pdf. Accessed 13 Mar 2010. 37. Kelty C, Burrus C, Barniuk R. Peer review anew: three principles and a case study in postpublication quality assurance. Proc IEEE. 2008;96:1000–11. 38. Harnad S, Brody T, Vallieres F, et al. The access/impact problem and the green and gold roads to open access. Serials Rev. 2004;30:310–4. 39. Allesina S. Acclerating the pace of discovery by changing the peer review algorithm. CoRR. Chicago: University of Chicago; 2009. p. 9.

Ghost Busting in Dermatology Publications: Providing Byline Integrity

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Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

Case Scenarios Case 1 Dr. X is a recent dermatology residency graduate who is intently focused on establishing his clinical research career in novel psoriasis therapeutics. A pharmaceutical company approaches him with an offer to help write up his experiences with prescribing their new company product: a cream for decreasing psoriatic plaque severity. Delighted at the prospect of collaboration, Dr. X analyzes his evolving database of psoriasis patients, drafts a manuscript outline based on preliminary findings, and solicits feedback from the company liaison. Within the next few months the company forwards him a polished manuscript under the email

A.L. Suárez Department of Dermatology, Denver VA Medical Center, School of Medicine, University of Colorado Denver, Aurora, CO, USA J.D. Bernhard University of Massachusetts Medical School, Worcester, MA, USA R.P. Dellavalle(*) Department of Dermatology, Denver VA Medical Center, School of Medicine, University of Colorado Denver, Aurora, CO, USA Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA Department of Veterans Affairs, Dermatology Service, Eastern Colorado Health Care System, Denver, CO, USA e-mail: [email protected]

subject heading “Ready to go!” However, the data suggesting the company cream had no effect on plaque burden was not included, and none of the company contact names were included in the author byline.

Case 2 A pharmaceutical company has several new topical and oral products, which they tout as “top of the line” for reducing plaque psoriasis severity. The company has sponsored several randomized controlled trials of these medications, and while these data indicate modest improvement in patient-reported pain and itching, these agents have no effect on the number or size of psoriasis plaques. In an effort to promote these agents, the company creates a journal supplement to feature those study results that depict their products’ favorable effects on psoriatic plaque-associated itch. This journal supplement is not peer reviewed, and does not include the study results that show no difference in plaque size or number.

Discussion The International Committee of Medical Journal Editors (ICMJE) defines authorship credit as “based on (1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published. Authors should meet criteria 1, 2, and 3 [1].” Guest (honorary or gift) authorship encompasses those individuals that do not meet criteria for

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authorship. Ghost authorship, in contrast, is failure to designate an individual as an author who has made a substantial contribution to the research or writing of a manuscript [2, 3]. Case 1 is an example of ghost authorship, in that the pharmaceutical company employees involved in Dr. X’s database review and production of the final manuscript did not appear as authors on the manuscript. Taken to extremes, ghost authorship often involves pharmaceutical companies managing and controlling several crucial steps in the research, including paying for, designing, and writing up studies or reviews, then pursuing a guest author “opinion leader” to be credited while the company goes unacknowledged. This practice, deemed “ghost management,” is such an important marketing and publication strategy that pharmaceutical companies utilize an entire cottage industry, medical education and communications companies (MECCs), which specialize in producing, placing, and tracking journal articles [4]. In the late 1990s Merck & Co. promoted articles describing sponsored studies of the painkiller Vioxx (rofecoxib) [5], and Wyeth promoted articles describing sponsored studies of the hormone replacement therapy Prempro (conjugated estrogens and medroxyprogesterone) [6]. These sponsored articles failed to acknowledge the hired medical writers that produced them. Recently, the company took matters a step further and paid Elsevier to produce a journal that merely contained reprinted or summarized articles. Under the guise of a “peer reviewed journal,” this publication primarily featured data in favor of Merck products without disclosure of company sponsorship [7].

Ghosts in the Literature It has been suggested that, during critical marketing periods, up to 40% of specific drug-focused articles are ghostwritten [8]. Pharmaceutical companies sponsor and perform a significant chunk of medical research, and their involvement is strongly associated with the publication of positive pro-industry results [9]. JAMA editors conducted a survey in which corresponding authors of 900 papers published in six medical journals were asked if any ghost authors or honorary authors were on the published papers [10]. Of the 630 replies, honorary authors were reported for 31% of original research reports, 24% of reviews, and 22% of editorials [10]. Ghosts were more prevalent in research articles

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(12%) vs. reviews (6%) and editorials (5%), and no significant differences were found between journals requiring author contribution disclosures compared to those that do not [10]. In a study of 179 evaluated trials in dermatology published between October 2000 and 2003, 57% were funded by industry sources, and, consistent with the general medical literature, industryfunded and employee-author studies in dermatology were more likely to report positive findings [11]. Physicians and medical researchers rely heavily on medical journals to provide evidence for treatments, validate claims, and substantiate research methods. Bias introduced by ghost-managed articles thus threatens the integrity and reliability of these invaluable decision making tools. As in Cases 1 and 2, the omission of negative results from an industry-sponsored trial can bias the reader’s view of the product. From an ethical standpoint, Sismondo argues that this practice is “a step in the intervention into medical practice [12].” Industry ghostwriting hides conflicts of interest [13]. Failure to disclose author contributions and conflicts of interests masks a graver ethical problem: the manipulation of research for marketing purposes [14].

Motivating Factors in Ghost Management Publications and grants propel scientific careers. Today’s academic investigator is faced with significant competition for research funding [15–17]. One’s publication history is a testimony to a researcher’s independence as a researcher, thus publication quantity and quality are significant determinants in the delegation of research dollars [18]. Furthermore, publications are a very important component of tenure decisions involving biomedical faculty [19]. Academics focus on the prominence or “impact factor” of the journal as well, and may consider it better to publish one paper in a high quality journal than multiple papers in lesser journals. Google Scholar and the ISI Web of Science are online tools utilized by tenure committees and employers for objectively quantifying the quality of a candidate’s work. Invitation to participate in ghost-managed work to be published in high-profile journals thus has its appeal, despite its potential ethical shortcomings. Editorial conflicts of interests or commercial influences can shape a journal’s content [20]. Despite their role in scientific advancement, biomedical journals must manage financial constraints and commercial

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demands to ensure their viability. Many high-profile peer reviewed journals rely heavily on the sale of reprints which are often used for direct marketing, exhibitions/seminars and sales support campaigns, as well as tools for mailing new product information [21]. Companies might spend as much as one million dollars on reprints for distribution to physicians, generating substantial revenue for the journal and obvious conflicts of interest for editors [22–24]. Additionally, journals may obtain substantial revenue from the sale of advertisements. This represents another important source of financial conflict [25]. An integral factor in this conflict is that drug companies can refuse to continue advertising in journals that publish data that reflect negatively on their products. For example, after the Annals of Internal Medicine published a critical examination of the accuracy of advertisements for drugs in ten leading medical journals, Annals lost an estimated $1–1.5 million in advertising revenue [26]. Industry sponsored research is cited more often than what might be expected [8]. While the marketing motives of pharmaceutical companies and their agents are the driving force of ghost practices, these parties are not solely to blame. Equally at fault are the “investigators” who accept “authorship” invitations and the journal editors that accept the works for publication. Several medical journals and drug makers have modified their policies on publication in response to a Congressional report, issued by Senator Charles E. Grassley of Iowa, which urged medical journals, medical schools, and the National Institutes of Health (NIH) to adopt protocols and policy for eliminating ghostwritten work [27]. Additionally, NIH is already considering new policies to increase financial disclosures from individuals seeking grants [27]. Determining authorship is difficult, particularly as the average number of authors increases in proportion to a trial’s size and complexity [28]. Designations are largely based on subjective judgment that a person has made substantial intellectual contribution. In addition to ICMJE criteria for authorship, the Journal of the American Academy of Dermatology (JAAD) expects that the contributions of medical writers not meeting the ICMJE standards, as well as the funding for such writers, appear in the acknowledgments. JAAD, and Journal of Investigative Dermatology (JID) maintain that disclosure of medical writers’ funding assists readers in determining any potential bias in the publication [29, 30]. Drawing from data which demonstrate that the

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structure of the contribution disclosure form influences the number of contributions reported and author compliance with the ICMJE authorship criteria [31], the Committee on Publication Ethics (COPE) has generated an algorithm to guide editors’ decision-making when ghost, guest, or gift authorship is suspected [32]. Many propose that journal editors discourage the practice of ghost-managed articles by enacting more vigilant parameters on disclosure and by publishing the specific contributions of each author [33].

Analysis of Cases The case studies presented at the beginning of this chapter illustrate the facts discussed here. An ethical analysis of the case studies follows. In considering Case 1 and Case 2, one must acknowledge the degree of harm that can result from ghostmanaged work. In both cases, there is omission of data, which subsequently depicts a biased perspective of the therapeutic agent under consideration by readers (i.e. physicians and other health care providers). The dilemma of Case 2 could have been avoided if journals had policies in place that would disallow the publication of industry-sponsored supplements. However, the suggestion that editors refrain from dealing with MECCs and insist that contact people on submitted manuscripts be authors, assumes that this measure would ensure greater contact with manuscripts than authors often currently have [34]. These authors also suggest that journals, such as in Case 2, should refuse to publish any industry-sponsored trials, and point out the discrepancy between MECCs acceptance rates (80%) and journal rejection rates (above 90%). Opponents of this solution believe that refusing to publish industry-sponsored trials is a form of censorship [35]. Given the continued presence of ghostwritten articles in the medical literature, through awareness of the issue perhaps journal editors will be more careful to identify signs of ghost written work [12]. Case 1 also illustrates how academic researchers may feel that their participation in ghost-managed publication is the most efficient way to publish their research. In addition, without recognizing the ethical implications of agreeing to “author” a manuscript to whose development they contributed little, most researchers participating in ghost-managed articles do so, perhaps out of desperation given how difficult it can be to

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obtain research funding. In Case 1, Dr. X was undoubtedly pressured by the financial constraints that restrict today’s investigator. Individuals, such as Dr. X, require alternatives to participating in disguised marketing. Furthermore, investigators need to be cognizant of the functional components that drive ghostwriting and refuse to participate when appropriate. Had Dr. X perhaps been more familiar or aware of this practice, then he would have likely been better equipped from an ethical decision-making standpoint, and less likely to agree so readily to the company’s offer. “Ghostwriting” should be part of a physician’s vocabulary and discussed in residency training [36]. In conclusion, ghostwriting puts patients at risk by providing biased information for medical practice. Multiple parties engage in and promote ghost-managed articles and practices. Efforts should be directed at enhancing awareness of ghost practices. Journal editors, reviewers, and authors should be educated on the mechanisms and detection of ghostwriting, and take appropriate measures to require that financial disclosures are identified. Editors and authors have an obligation to refrain from participating in ghostwritten articles as they jeopardize public health in exchange for financial or reputational gain.

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11.

12.

13. 14. 15. 16. 17. 18. 19. 20.

21. 22. 23. 24.

References 25. 1. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. www.icmje.org. Accessed 14 Dec 2009. 2. Rennie D, Flanagin A. Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin. JAMA. 1994;271:469–71. 3. Rennie D, Yank V, Emanuel L. When authorship fails. A proposal to make contributors accountable. JAMA. 1997;278:579–85. 4. Relman AS. Separating continuing medical education from pharmaceutical marketing. JAMA. 2001;285:2009–12. 5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Intern Med. 2008;149:251–8. 6. Singer N. Medical papers by ghostwriters pushed therapy. The New York Times. 4 Aug 2009;Health. 7. Grant B. Merck published fake journal. The Scientist.com. Vol 2010. The Scientist, Magazine of Life Sciences; 2009. 8. Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry. 2003;183:22–7. 9. Sismondo S. How pharmaceutical industry funding affects trial outcomes: causal structures and responses. Soc Sci Med. 2008;66:1909–14. 10. Wislar J, Flanagin A, Fontanarosa PB, DeAngelis CD. Prevalence of honorary and ghost authorship in 6 general

26. 27. 28.

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medical journals, 2009. In: JAMA, ed. Sixth International Congress on Peer Review and Biomedical Publication. Vol Vancouver, BC, Canada 2009. Perlis CS, Harwood M, Perlis RH. Extent and impact of industry sponsorship conflicts of interest in dermatology research. J Am Acad Dermatol. 2005;52:967–71. Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007;4:e286. Anekwe TD. Profits and plagiarism: the case of medical ghostwriting. Bioethics. 2010;24:267–72. Elliott C, Landa AS. Commentary: what’s wrong with ghostwriting? Bioethics. 2010;24:284–6. Zerhouni EA. Research funding. NIH in the post-doubling era: realities and strategies. Science. 2006;314:1088–90. Mervis J. U.S. budget. Promising year ends badly after fiscal showdown squeezes science. Science. 2008;319:18–9. Kirshenbaum S. Plight of the post doc. Science Progress. Washington, DC, Center for American Progress, 2008. Schachman HK. From “publish or perish” to “patent and prosper”. J Biol Chem. 2006;281:6889–903. Hand E. 222 NIH grants: 22 researchers. Nature. 2008;452:258–9. Wilkes MS, Kravitz RL. Policies, practices, and attitudes of North American medical journal editors. J Gen Intern Med. 1995;10:443–50. Ray JG. Judging the judges: the role of journal editors. QJM. 2002;95:769–74. Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ. 2003;326:1202–5. Smith R. Curbing the influence of the drug industry: a British view. PLoS Med. 2005;2:e241. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005; 2:e138. Glassman PA, Hunter-Hayes J, Nakamura T. Pharmaceutical advertising revenue and physician organizations: how much is too much? West J Med. 1999;171:234–8. Altman LK. Inside medical journals, a rising quest for profits. New York Times. 24 Aug, 1999;F7. Singer N. Report Urges More Curbs on Medical Ghostwriting. The New York Times, 25 June, 2010;P.B4. Levsky ME, Rosin A, Coon TP, Enslow WL, Miller MA. A descriptive analysis of authorship within medical journals, 1995–2005. South Med J. 2007;100:371–5. Schultz HY, Blalock E. Transparency is the key to the relationship between biomedical journals and medical writers. J Invest Dermatol. 2007;127:735–7. Journal of the American Acadmy of Dermatology Information for authors 2010. http://secure.elsevierhealth. com/periodicals/ymjd/authorinfo. Accessed 24 May 2010. Marusic A, Bates T, Anic A, Marusic M. How the structure of contribution disclosure statements affects validity of authorship: a randomized study in a general medical journal. Curr Med Res Opin. 2006;22:1035–44. Wager L. What to do if you suspect ghost, guest, or gift authorship. In: Ethics CoP, ed. 2008:11. Jones N. Ghosts still present in the medical machine. Nature. 2009;461:325. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics. 2009;24:1467–8519.

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35. Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals. Mayo Clin Proc. 2009;84:811–21.

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36. Williams HC, Naldi L, Paul C, Vahlquist A, Schroter S, Jobling R. Conflicts of interest in dermatology. Acta Derm Venereol. 2006;86:485–97.

Telling the Same Tale Twice: Déjà vu and the Shades of Grey in Self-Plagiarism

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Andrea L. Suárez, Jeffrey D. Bernhard, and Robert P. Dellavalle

The integrity of medical and scientific publishing depends on responsible and honest practices by authors. Some of the practices that threaten the integrity of scientific publication include publishing the same paper in more than one journal (i.e. duplicate publication), presenting data from one study in multiple small papers (i.e. salami-slicing), copyright infringement, and text recycling [1]. While this subject is of vital interest to authors and investigators, as well as to journal editors and reviewers, it is also relevant to the readership of these publications. This chapter will explore and analyze examples of these practices.

Case Scenarios Case 1 Dermatologists are specialists in the diagnosis, treatment and management of cutaneous diseases. However, the spectrum of practitioners concerned with skin is broad and includes plastic surgeons, general surgeons, and internists, to name a few. So is it surprising that a review article by Dr. Jones on advances in molecular therapeutics in blistering diseases was published with almost identical content in three different journals, each with very different target audiences?

Case 2

A.L. Suárez Department of Dermatology, Denver VA Medical Center, School of Medicine, University of Colorado Denver, Aurora, CO, USA J.D. Bernhard University of Massachusetts Medical School, Worcester, MA, USA R.P. Dellavalle (*) Department of Dermatology, Denver VA Medical Center, School of Medicine, University of Colorado Denver, Aurora, CO, USA Department of Epidemiology, Colorado School of Public Health,Aurora, CO, USA Department of Veterans Affairs, Dermatology Service, Eastern Colorado Health Care System, Denver, CO, USA e-mail: [email protected]

A group of clinical researchers conducted a randomized controlled trial testing the effect of cream X vs. placebo on the number of actinic keratoses (AKs). In addition to observing a decreased number of AKs with cream X, they also noted that a subset of eczema patients reported a decrease in the severity of their eczema. The investigators wrote up the actinic keratosis results as one manuscript, and the eczema result as another manuscript. Because they utilized the same patient database, the authors copied and pasted the bulk of the methods section from the first manuscript to the other. Is this permissible?

Duplicate Publication Case 1 illustrates duplicate publication, a practice in which an author or group of authors publishes the same material more than once. The problem with this practice is that it disrupts research integrity by exaggerating the

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significance of results, ultimately skewing meta-analyses, and thereby jeopardizing evidence based treatment decisions [2, 3]. Furthermore, while publication space is vast, selection of appropriate manuscripts is an arduous and time-consuming task for reviewers and editors. Duplicate publications displace other articles from publication, and are a misuse of editors’ and peer reviewers’ time. The above arguments suggest discordance between duplicate publication and ethical publication. However, some authors and editors provide counterpoints for the appropriateness of text re-use (i.e. “copying”). Publishing the same article in multiple journals, they suggest, expands the audience for the work. Regrettably, it is also common to submit a new manuscript using data from an experiment previously described and analyzed in an earlier publication [4]. This is a violation of publishing best practices; authors should appropriately cite all related work and be transparent in their motives [5]. Review articles emphasize the significance of insights derived from new data and evolving theories. When a topic is “hot,” journals might approach an author many times over a short period of time, soliciting multiple reviews on that specific topic. Naturally, this practice may lead to repetition. Although it is argued that “repetition is the mother of learning,” this dictum applies to the classroom rather than scholarly publication practice [4]. Regardless, full disclosure to the editor of prior submissions on the same subject should be the minimum ethical obligation of authors.

Salami-Slicing The investigators in Case 2 are producing “salamislice” publications in which different manuscripts are drawn from data collected from a single research study or data collection interval. Such publications may be derived from data that was reported and analyzed previously, but now include a larger repeat analysis or addition of new data or analysis not previously reported. The new and revised Good Publication Practice 2 (GPP2) guidelines for the publication of industry sponsored medical research, recommend that the same study results should not be published in more than one peer reviewed journal article unless the results are substantially re-analyzed, re-interpreted for a different audience, translated into a different language, or explicitly acknowledged in the text and the citation [6]. Determining whether there has been substantial re-analysis involves distinguishing between shades of

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grey rather than than black and white, but in general salami-slicing is not acceptable when the aim is simply to get as many individual papers from a single project as possible. When authors neglect to unveil all germane data and related publications and submissions, they deprive editors, reviewers, and readers the ability to assess full significance [6, 7]. The primary publication must be clearly acknowledged and cited, and when in doubt, authors should enclose other papers that might be part of the same “salami” as the paper under consideration [8]. Authors should give thoughtful and careful consideration to whether or not the results of a single complex study are best represented as a single manuscript or as bite sized pieces [9, 10]. Arguably, there is considerable overlap between some “salami sliced” publications and duplicate publication, and for authors, reviewers, and editors, distinguishing between the two can be difficult [11]. With both duplicate and salami-sliced publication, text from one publication may appear in another, a commonality between these two practices that carries a potential for copyright infringement.

Copyright Infringement The act of stealing informs our understanding of plagiarism, so self-plagiarism is an ambiguous concept in that it is counter-intuitive to the notion that one cannot steal from oneself. Copyrights are legal documents in which the author assigns certain rights to the publisher, or another party, and are put into place to safeguard economic rights. Because the content must be original and not under copyright elsewhere, the authors are obliged to avoid duplicate publication [12]. A publisher pursuing legal action against an author for selfplagiarism is unlikely to be successful given the following: (a) the defendant is the original author and (b) lack of compensation paid for the original work [13]. In addition to the potential threat of copyright infringement, the Council of Science Editors points out that some journal editors may not be willing to consider submissions containing content published elsewhere as this might suggest that the study contributes only marginally to the literature [12]. The GPP2 guidelines suggest that rather than reporting previously published results as “primary” results, an article must explicitly report any information as an analysis derived from previously published primary results, rather than

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Table 38.1 Tips for authors to avoid violating journal prior publication policies [18] • Check prior publication/embargo rules in the author information of the target journal • Detail any prior reports or presentations at a conference in a covering letter • When presenting at conferences, emphasize that the material has not been peer reviewed and could be subject to change • Confine information given to journalists to posters and abstracts, and answering questions at the conference • If articles are posted on public servers, ensure the provider is a scientific rather than a commercial entity and refrain from attracting a wider audience by hyperlinks • Avoid issuing press releases, which are a prior publication unless published by conference organizers or journals

reporting the information as primary results, so as to respect copyright laws [6].

Text Recycling In case 2, the “copy and pasting” of methods between manuscripts evokes suspicion of (self-) plagiarism or, at the very least, inappropriate paraphrasing. However, text recycling of complex methodology in duly cited studies is common and accepted practice, and some have proposed that up to 30% of the text from one article can be reused in another article without constituting self-plagiarism [9, 13–15]. Similarly, background literature reviewed in the introduction of one paper may be similar or exactly the same as that of related papers by the same author. Therefore, the researchers in case 2 could easily produce two papers, on legitimately different outcomes of cream X, with both papers containing very similar methods, literature reviews, or discussions. However, the relationship of the two papers must be clarified via explicit comment and citation. So how much text or data can an author recycle among manuscripts? Currently, few official guidelines are in place to properly answer this question. In their policy on plagiarism, The US Department of Health and Human Services’ Office of Research Integrity (ORI) indicates that this practice, with regards to recycling parts of methodology, is not considered significant or misleading [16], and recently published a set of guidelines and examples of acceptable, borderline, and unacceptable text recycling (available at http://ori.hhs. gov/education/products/plagiarism/index.shtml) [10].

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Solutions When submitting a paper, authors should disclose all related manuscripts, including those in press and under review. In general, editors consider “related” manuscripts to be those with more than 10% overlap with the current submission [17]. Table 38.1 provides guidelines for authors on how to avoid duplicate publications [18]. Biomed Central defines permissible and non-permissible forms of duplicate publication, and provides editors with some basic guidance for appropriate textual re-use and overlapping publication [19]. The Journal of the American Academy of Dermatology has also published a frequently asked questions (FAQ) editorial on avoiding text re-use [20]. Instances of dual publication are reviewed by the Council of Dermatology Editors, whose purpose it is to discuss common editorial interests and concerns in the publication of dermatologic research [21] Several journals, such as Anaesthesia and Critical Care [22], are turning to sophisticated software engineered for detecting highly similar citations. Initially developed as a tool for more efficiently searching the scientific literature, computational biologists came to appreciate that their similarity-searching software, such as eTBLAST v3.0 [23], could easily detect plagiarism. Software such as Déjà Vu [24] and eTBLAST v3.0 can detect publications with striking overlap in language or content. While some journals have embraced Déjà vu [24], its opponents have concerns that because it “casts a wide net” many benign cases (such as translations) are innocently flagged alongside blatant duplications [4]. After identifying highly similar citations, Déjà vu then classifies the citation into one or more duplication category [25]. While some of these categories, such as “duplicate” may indicate truly inappropriate duplication, the program reserves categories such as “distinct,” “sanctioned,” and “erratum” to indicate acceptable instances of duplicate publication, thus protecting innocent cases. Paying particular attention to the “self” in selfplagiarism, authors are central to the issue of duplicate publication. They have an obligation to respect a journal’s expectation to receive original manuscripts. Failure on the part of the individual author to uphold these requirements is a violation of trust between authors, editors, and readers. While technologies such as Déjà vu and eTBLAST are not universally accepted means for editors to identify self-plagiarism and duplicate publication, lead authors may use electronic

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detection software as a tool for ensuring that they have appropriately cited all co-authors’ previously published and closely related work. Elimination of self-plagiarism from dermatology publications is a shared effort, requiring improved definitions and evolving guidelines to help authors. In conclusion, investigators, editors, reviewers, and journals need to maintain keen awareness for ethical issues surrounding possible duplicate publication, salami sliced publication, and inappropriate textual re-use.

References 1. von Elm E, Poglia G, Walder B, Tramer MR. Different patterns of duplicate publication: an analysis of articles used in systematic reviews. JAMA. 2004;291(8):974–80. 2. Martin JBD, Cheng D. Duplicate publication in meta-analysis of off-pump versus on-pump coronary artery bypass. CC Testing Journal 2004. http://www.imbi.uni-freiburg.de/OJS/ cca/index.php/cca/article/view/2584. Accessed 8 Nov 2011. 3. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ. 1997;315(7109):635–40. 4. Couzin-Frankel J, Grom J. Scientific publishing. Plagiarism sleuths. Science. 2009;324(5930):1004–7. 5. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. ICMJE website. 2008. www.icmje.org. Accessed 25 Nov 2011. 6. Graf C, Battisti WP, Bridges D, et al. Research methods & reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330. 7. Kassirer JP, Angell M. Redundant publication: a reminder. N Engl J Med. 1995;333(7):449–50. 8. Iverson C, Flanagin A, Fontanarosa PB, et al. American Medical Association manual of style. A guide for authors and editors. 9th ed. Batimore: Williams and Wilkins; 1998. 9. Roig M. Re-using text from one’s own previously published papers: an exploratory study of potential self-plagiarism. Psychol Rep. 2005;97(1):43–9.

A.L. Suárez et al. 10. Roig EP. Avoiding plagiarism, self-plagiarism, and other questionable writing practices: a guide to ethical writing. 2009; http://ori.hhs.gov/education/products/plagiarism/ index.shtml. Accessed 10 July 2010. 11. Norman I, Griffiths P. Duplicate publication and ‘salami slicing’: ethical issues and practical solutions. Int J Nurs Stud. 2008;45(9):1257–60. 12. Scott-Lichter D. Council of science editors white paper on promoting integrity in scientific journal publications, 2009 Update. 2009; 77. Available at: http://www.councilscienceeditors.org/editorial_policies/whitepaper/entire_whitepaper.pdf. Accessed 10 July 2010. 13. Samuelson P. Self-plagiarism or fair use? Institute of Computing Machinery. Commun ACM. 1994;37:21–5. 14. Scanlon P. Song from myself: an anatomy of self-plagiarism. Plagiary. 2007;2(17):1–10. 15. Boisvert R, Irwin M. Plagiarism on the rise. Association of Computing Machinery. Commun ACM. 2006;49:23–4. 16. Office of Research Integrity. Policy on plagiarism: US Department of Health and Human Services; Dec 1994. 17. Szklo M, Wilcox A. On the failure to disclose sibling manuscripts. Am J Epidemiol. 2003;157(4):281. 18. Langdon-Neuner E. When does previous disclosure become a ‘prior publication’ problem? Chest. 2009;135(1):233–7. 19. BioMed Central. Guidance on duplicate publication for BioMed Central journal editors. http://www.biomedcentral. com/info/about/duplicatepublication. Accessed 6 Mar 2010. 20. Dellavalle RP, Banks MA, Ellis JI. Frequently asked questions regarding self-plagiarism: how to avoid recycling fraud. J Am Acad Dermatol. 2007;57(3):527. 21. Dobson RL. Dual publication and manipulation of the editorial process. J Am Acad Dermatol. 1990;23(6 Pt 1): 1181–2. 22. Loadsman JA, Garner HR, Drummond GB. Towards the elimination of duplication in Anaesthesia and Intensive Care. Anaesth Intensive Care. 2008;36(5):643–5. 23. Errami M, Wren JD, Hicks JM, Garner HR. eTBLAST: a web server to identify expert reviewers, appropriate journals and similar publications. Nucleic Acids Res. 2007;35(Web Server issue):W12–5. 24. Errami M, Hicks JM, Fisher W, et al. Deja vu–a study of duplicate citations in Medline. Bioinformatics. 2008;24(2):243–9. 25. Errami M, Sun Z, Long TC, George AC, Garner HR. Deja vu: a database of highly similar citations in the scientific literature. Nucleic Acids Res. 2009;37(Database issue):D921–4.

Cutting Edge or Cutting Corners? Innovative Care

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Jolion McGreevy and Clifford Perlis

Despite an ever-increasing body of scientific evidence, clinical situations often arise for which there are no well-accepted therapies. A physician may respond, for example, by using a drug “off-label” (i.e. to treat a condition for which it is not FDA-approved) or develop a new procedure with the aim of providing more benefit to the patient with less harm than standard approaches permit [1]. An innovative therapy is an unproven treatment approach used in clinical practice for the benefit of a patient. It contrasts with clinical research, which aims at testing the efficacy of an investigational therapy. However, since clinical practice and research often take place in the same facility under the supervision of the same physicians and the use of a novel therapy may both benefit a patient and generate new scientific knowledge, it is not always clear whether a novel therapy is innovative or investigational. The Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, clarifies the difference between clinical practice and research as follows: “The term ‘practice’ refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success….By contrast, the term ‘research’ designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable J. McGreevy Department of Emergency Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA C. Perlis (*) Fox Chase Cancer Center, Philadelphia, PA, USA e-mail: [email protected]

knowledge…When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research” [2]. The distinction is significant because Institutional Review Boards (IRBs) must approve and oversee investigational therapy but not innovative therapy. A proposed innovative therapy should be reviewed by independent clinicians (i.e. not involved in the care of the particular patient for whom the therapy is proposed) to determine whether the therapy is 1) properly considered innovative, rather than investigational, and therefore exempt from IRB oversight; and 2) a reasonable approach to the care of the patient based on available evidence. Medical advances rely on both creativity and rigorous science. A creative therapeutic approach may offer a patient the best possible hope for cure or improved quality of life. On the other hand, it may turn out in the end to be ineffective, or even harmful. Thus, innovative therapy should be used carefully and with the informed participation of the patient. Although some therapies may be conceived in a laboratory and brought into clinical care only after rigorous scientific study, many now standard therapies were once clinical innovations. Innovative therapy may be particularly important in dermatology. One reason is that there may not be convincing data on the efficacy of therapies for certain disorders. Some diseases, such as pseudoxanthoma elasticum (PXE), may be difficult to study due to their rarity. Other disorders, such as paronychia, are quite common but do not draw sufficient funding for largescale trials due to their limited morbidity (and lack of mortality). A second reason why innovative treatments may be particularly relevant to dermatology is that many common dermatologic agents are quite safe.

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That is, the risk of utilizing an innovative therapy may be relatively low, so the therapy may be worth trying even if the prospect of benefit is limited.

Case 1 At a recent national meeting, your friend, who practices dermatology in Brazil, tells you about a new cream used to treat cellulite. She tells you that her patients have achieved fantastic results. The cream is not available in the United States and not FDA approved, so she offers to send you some to use with your patients who are concerned about cellulite. What do you do?

Case 2 At a tumor board meeting, you present a patient with a newly diagnosed 1 cm Merkel cell carcinoma on his upper eyelid. The Mohs surgeon recommends Mohs surgery for improved tissue conservation in this critical anatomic location. The general surgeon counters that there is no evidence that Mohs surgery effectively cures or conserves tissue when treating Merkel cell carcinoma. The Mohs surgeon explains that there will never be convincing evidence of this because it is such a rare cancer. She argues that it’s intuitive that Mohs surgery would be more effective in this scenario than wide local excision. To further complicate matters, the radiation oncologist shows pictures of two patients treated with radiation alone who were tumor free (and still had intact eyelids) five years after treatment. What treatment do you recommend for your patient?

Discussion Innovative therapies are provided in the context of clinical care for the benefit of a patient when there is no acceptable standard approach. In general, if there is a standard of care, supported by evidence and acceptable to the patient, then it should take precedence over innovative approaches. Whether or not standard therapy is acceptable to the patient may be a difficult question. Patients have the right to accept or refuse any medically-indicated treatment, and they make these decisions based on the information provided by their physicians and their own experience, values and beliefs [1]. Physicians must, therefore, provide the patient

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with an honest assessment of not only the immediate risks and benefits associated with standard treatment, but also the potential long-term impact on quality of life. The physician should ask, “What sort of life will the patient have during and long after the treatment?,” recognizing that quality of life is a complex, often individualized concept [1]. In recent years, there has been public pressure, with the support of some government officials, to make investigational drugs available to patients, particularly those dying of cancer [3]. While some argue that it is unjust to withhold potential treatments from individual patients who have no other options, others believe that the use of unproven drugs and procedures endangers the public health. The experience in the 1990s with high dose chemotherapy followed by stem cell transplant for breast cancer provides a cautionary tale. Patient and physician advocacy for the treatment encouraged medical insurance coverage for this costly therapy before adequate scientific data had accumulated to support the practice. After adequate scientific study, it appeared that the approach led to more adverse effects and offered no survival advantage compared to standard treatment [1]. An additional concern is that providing investigational treatment outside of ongoing clinical trials, especially for rare diseases, reduces study enrollment and slows the development of the body of evidence needed to make effective treatment available for everyone. Innovative therapy is considered in cases where there is no acceptable, evidence-based therapy. The absence of standard treatment, however, does not in itself justify alternative treatment. At least three further considerations guide the appropriate use of innovative therapy. First, there must be some reason to expect that the innovative therapy will be effective. Rationale to support an innovative treatment could range from published reports of responses in similar patients to sufficient similarity between one disease process and another that a drug used off-label can reasonably be expected to work. Consider the following example: A novel polyomavirus was recently found to be associated with Merkel cell carcinoma. Some antiviral medications developed to treat human immunodeficiency virus (HIV) inhibit polyomaviruses in vitro. In a patient with advanced Merkel cell carcinoma, for which there is no accepted treatment, one could argue that utilizing an antiviral agent could be justified as an innovative therapy. Second, the therapy should be delivered in such a way that it supports later systematic efforts to gather

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Cutting Edge or Cutting Corners? Innovative Care

data. Innovative therapies are employed to benefit an individual patient, not to test a scientific hypothesis. However, at a minimum, complete records should be kept so that the experience using the agent as an innovative therapy serves as meaningful data. In the future, these data may help generate hypotheses and research protocols leading to more robust evidence regarding the therapy’s efficacy. Ultimately, evidence-based practices are more desirable than innovative approaches, and clinicians should ensure that the use of innovative therapies moves the medical community toward—and not away from—better evidence. In cases where a phase 3 clinical trial is available for a disease, the trial should take precedence over innovative therapy. Trials have been reviewed for safety and benefit society. Such systematic attempts to treat the disease and gain information will, inevitably, provide closer, structured monitoring for the trial participant, as well as help generate evidence-based recommendations for future care. Third, adequate steps must be taken to ensure that patients are fully informed of the nature of the innovative treatment. As with all therapies, patients should understand the risks, benefits and alternatives. This may be particularly challenging with regard to innovative therapies because the risks and benefits are poorly understood by the medical community. Since there may be little evidence about the agent’s safety and efficacy in a particular situation, patients must be provided with the best information that can be drawn from similar experiences. However, patients must understand that an unproven treatment may have serious, unanticipated consequences for health and quality of life. Innovative therapies provide an important option for patients when standard treatment options or welldesigned clinical trials are unacceptable or unavailable. These treatments, importantly, differ from research in that they are employed primarily to treat patients rather than to generate additional scientific knowledge or hypotheses. Ethical implementation of innovative therapies requires: compelling rationale for efficacy, thorough documentation to support future research, and appropriate informed consent from patients.

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Patients rely on physicians to base recommendations on concern for the patients’ well-being and, as much as possible, sound scientific evidence. There is no wellsupported remedy for cellulite; however, some patients may consider the problem sufficiently serious to warrant the risks of an unproven approach. Physicians who provide innovative cosmetic treatments to meet the expressed concerns of their patients should be confident that the treatments are safe and effective. Physicians should discuss potential risks and benefits as conscientiously as they would medically-indicated procedures and accurately describe the quality of evidence on which they base their recommendations. The physician should keep complete records that can be used to support future systematic study of the therapy. Although this chapter is about ethics, and not law, one should recognize that results patients perceive as sub-optimal from unproven treatments may provide justification for malpractice claims. In addition, innovative treatments may have far-reaching, but as yet unidentified, consequences for the health of patients and public trust in the medical profession. The physician in this case should carefully consider the reasons for offering the unproven cream to patients who express concern about cellulite. The physician should not minimize the patients’ concern but at the same time should carefully consider his or her motivation for using an unproven treatment. A further critical concern in this case is the justification for the use of a cream that is not approved by the Food and Drug Administration (FDA). While there may not be any well-documented, evidence-based treatments for cellulite, the risks associated with treating this benign condition should be carefully weighed. When is it appropriate to take a risk—however small—to treat a relatively common and benign condition? Physicians should consider the legal, social and economic context in which the care of the patient takes place. For an innovative treatment to be considered, it must be medicallyindicated (likely to be safe and effective based on the limited evidence available), and it must be freely chosen by patients in accordance with their personal preferences and definition of a “quality life.”

Analysis: Case 1 Analysis: Case 2 Many cosmetic procedures lack compelling scientific evidence. In the presence of a (perceived) need and absence of strong evidence for a preferred treatment, some cosmetic procedures may be considered innovative.

Merkel cell carcinoma is a rare but deadly disease [4, 5]. Depending on the stage, National Comprehensive Cancer Network guidelines recommend wide local excision,

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sentinel lymph node biopsy and radiation therapy to the tumor and the draining nodal basin [6]. Treatment recommendations, however, are based on limited clinical experience and scientific evidence [7], and the path by which patients and physicians arrive at the best treatment course is fraught with difficult clinical and ethical questions. First, physicians should determine which treatments are medically-indicated based on available data. Physicians should consult published case reports and studies and seek the advice of colleagues. Since Merkel cell carcinoma is a rare disease, treatment experience and evidence are limited. A number of the potential treatments may be considered innovative. Physicians should do their best to accurately identify the risks and benefits of standard treatment, innovative treatment, and no treatment so that the patient can make an informed choice. The patient in this case may value his appearance or intactness more or less than his potential 5-year survival and, in the event that the two outcomes conflict, may choose treatment based on this judgment alone. The patient’s informed consent to treatment is an ethical and legal requirement, but the higher standard of informed participation in decision-making is preferred. Shared decision-making is especially important in the context of innovative treatment, where the evidence is incomplete. In this case, the quality of life assessment may depend on the importance of an intact eyelid for the patient’s ability to continue in his social roles and for his emotional state and sense of well-being. The burden of treatment itself on the patient’s time and personal and professional commitments may factor heavily, as may the long-term implications of the treatment options for his life. Patients and physicians may not have the same opinion of the impact of acceptance or refusal of treatment on the patient’s quality of life. But it is the patients’ assessment that carries the most moral weight. Since quality of life is primarily a longterm consideration, relevant data may be especially limited for innovative treatments. Physicians should ensure that their statements about the impact of a proposed innovative treatment will likely have on the patient’s quality of life are honest and that their recommendations are based on the patient’s definition of a good life under the circumstances.

J. McGreevy and C. Perlis

Conclusion Physicians recommend innovative treatments based on the belief that they offer more benefit with less harm than standard treatment modalities. Since the use of an innovative treatment is aimed at curing or improving the quality of life of an individual patient rather than at producing generalizable scientific information, it is not considered clinical research. It should, nonetheless, be delivered in such a way that valuable scientific information can be obtained to inform future controlled study of the treatment. Even though innovative treatments are not research per se, it may be advisable to consult the Institutional Review Board about whether the treatment should be provided outside of a clinical trial [1]. This may be especially important if the treatment is “investigational,” meaning that studies are being conducted to test its efficacy, although none has yet to provide convincing evidence either way. Prior to recommending an innovative treatment, physicians must establish that no acceptable standard treatment exists. Once this criterion is met, there are at least three additional considerations: reasonable justification for the approach, thorough record-keeping to support future research, and appropriate patient informed consent. When thoughtfully embraced, innovative therapies provide an ethical and potentially beneficial therapeutic option to patients without other acceptable options.

References 1. Jonsen A, Siegler M, Winslade W. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw-Hill; 2006. 2. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research(os) 78-0012. DHEW. 3. Annas GJ. Cancer and the constitution–choice at life’s end. N Engl J Med. 2007;357(4):408–13. 4. Lemos B, Nghiem P. Merkel cell carcinoma: more deaths but still no pathway to blame. J Invest Dermatol. 2007;127(9):2100–3. 5. Bichakjian CK, Lowe L, Lao CD, et al. Merkel cell carcinoma: critical review with guidelines for multidisciplinary management. Cancer. 2007;110(1):1–12. 6. NCCN clinical practice guidelines in oncology: merkel cell carcinoma. In: Network NCC, ed. 2010. 7. Busse PM, Clark JR, Muse VV, Liu V. Case records of the Massachusetts General Hospital. Case 19-2008. A 63-yearold HIV-positive man with cutaneous Merkel-cell carcinoma. N Engl J Med. 2008;358(25):2717–23.

Index

A Account billing. See Client billing Adenomatous polyposis coli (APC), 200 Adverse medical events definition, 38 disclosure caregiver, 41 definition, 38 lawsuits, 40 need for, 38–39 process of, 39–40 professional standards, 39 risk management principles, 39 special circumstances, 41 substitution test, 39 timing of, 39 melanoma, 37, 42 MRSA infection, 37, 42 Age-related skin changes improvement, 143 Aging, of physician, 98, 102–103 Alcohol abuse, impaired behavior, 97, 101–102 American Academy of Dermatology (AAD) botulinum toxin injection, 131–132 conflict of interest management procedure, 188–189 dermatopathology, 169, 175 office dispensing and product pricing, 138 physician extenders, guidance of, 56 American Board of Dermatology (ABD), 85 American Medical Association (AMA) botulinum toxin injections, 131–132 dermatopathology, 169, 205 epidermolysis bullosa, 207 physician advertising, 147–148 therapeutic privilege, 34 American Psychiatric Association (APA), 100 Aromatherapy corporate organizational structure, 157, 161 ethical considerations, 159–160 flyers, ethical considerations for, 157–158 legal considerations, 158–159 legal partnership, 157 medical directorship, 157, 160–161 medical spas, 158 profit-sharing facilitation, 157, 161 Assent, 26–27 Atopic dermatitis treatment, conflicts of interest, 185–186

Author anonymity, 222–223 Authorship credit, 227 Awrah, 86

B Belmont report, 194, 207, 208, 237 Best Doctor programs, 149 Bone marrow biopsies (BMBx), 123 Botox® and basal cells continuing medical education, 133 cosmetic procedural training, 131, 134–135 lentigo maligna, 134 lucrative cosmetic procedures, 134 medical ethics, 131 physician assistant, 133 physician extenders, 133 primary care, 131, 133, 134 risk factors in training, 133–134 telephone tag, 132 Boundary crossing, 62 Boundary violation, 62 Byline integrity. See Ghost busting, dermatology publications Bystander phenomenon, 5

C Canadian Patient Safety Institute (CPSI), 38 Carrier testing, 199 Cellulite, 238, 239 Client billing contractual joint ventures, 181–182 dermatopathologists, 179, 182 ethical issues, 178–179 fee splitting practices, 180 Friendly Derm Services, 177 innovative dermatology ventures, 177 legal issues, 180–181 pathology services billing, 177, 182 patient unawareness, 177 professional component, 178 technical component, 177–178 valuing cost over quality, 180 Clinical ethics teaching. See Teaching, for clinical ethics Clinical investigator, responsibilities of

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242 Clinical investigator, responsibilities of (cont.) ethics of, 194–195 history, 193 psoriasis treatment, 194, 195 research goal, 193 Committee on Publication Ethics (COPE), 229 Confidentiality breach of, 48 in iPLEDGE program, 21 in pediatric dermatology, 27–28 in teledermatology, 47, 48 Conflicts of interest atopic dermatitis treatment, 185–186 cutaneous T-cell lymphoma, 185, 189 definition, 186 eliminating, 188 ethical considerations, 186–187 financial, 185 financial inducements, 187 identify and management, 188 non-financial, 189 pharmaceutical and medical device industries, 187 pharmaceutical manufacturer lecture, 185 policies and remedies, 187–188 principles, 189–190 psoriasis treating guidelines, 185, 188–189 Contractual joint venture (CJV), 181–182 Copyright infringement, 234–235 Cosmetic procedural training, 131, 134–135 Council of Medical Specialty Societies patients, physicians and society, 144 skincare products, 144 Council of Science Editors (CSE), 216 Council on Ethical and Judicial Affairs (CEJA), 84–85 Cross-gender modesty, 86 Cultivation, mentor-mentee relationship, 110 Cultural and linguistic barriers, 84 Cultural competence, 85 Culturally and linguistically appropriate services (CLAS), 85 Cutispas, 157, 160 Cyclin dependent kinase 2A (CDKN2A), 198, 203

D Data and Safety Monitoring Board (DSMB), 211 Data and Safety Monitoring Committee (DSMC), 211 Data Monitoring Committee (DMC), 211 Declaration of Helsinki, 194 Delusions of parasitosis, 34–35 Dermal nevi, 9, 11 Dermatology publications ghost busting in authorship credit, 227 ethical analysis, 229–230 ghost authorship, 228 ghost management, motivating factors, 228–229 guest authorship, 227–228 literature, 227 self-plagiarism copyright infringement, 234–235 duplicate publication, 233–234 elimination of, 236

Index salami-slicing, 234 solutions, 235–236 text recycling, 235 Dermatopathology actinic keratosis diagnosis, 171 biopsy specimens samples, 173–174 clinical practice, 169 ethical and legal debate, 169–170 fellowship training, 170 histology laboratory, 169 medical malpractice, 172 pathological quality, 173 patient care, 170 professional judgment, lab, 174 surgical pathology, 171 treatment, 171–172 unethical testimony, 173 Dermethica, 157 Direct billing, 178 Direct-to-consumer (DTC), 203–204 Direct-to-consumer drug advertising (DTCDA) critics of, 14–16 definition, 15 divisions of, 15 genital warts, 13, 16 help-seeking advertisement, 14 inherently biased nature of, 15 injectable psoriasis medication, 13, 15–16 product claim advertisement, 14 reminder advertisement, 14 Disclosure, adverse medical events caregiver, 41 definition, 38 lawsuits, 40 need for, 37–39 process of, 39–40 professional standards, 39 risk management principles, 39 special circumstances, 41 substitution test, 39 timing of, 39 Disruptive physician behavior, 103–104 Diverse society, physicians in bias and prejudice, 84 cultural and linguistic barriers, 84 cultural and religious beliefs, patients, 86 cultural competence, 85 decision-making process in, 85 ethical and professional obligations, 84–85 language barriers, patients, 84–85 physician conscience, 85–86, 88 prejudiced patients, 87 trust, 84 Double-blind peer review, 222 DTCDA. See Direct-to-consumer drug advertising (DTCDA) Duplicate publication, 233–234

E Economic value to customer (EVC), 140 Electronic medical record (EMR), 37 Electronic submission management systems, 224

Index Emancipated minors, 27 Epidermolysis bullosa beneficence, 208–209 clinical research, 206 definition, 205 ethical practices development guidelines, 210–211 justice distribution, 209–210 research physician, 206–207 respect for persons, principle of, 207–208 symptoms, 205 Ethical education for residents. See Residents, ethics education for Ethnic and racial disparities, 84 Extravagant gifts, 72, 73

F Facebook, 77 Facebook page, 78 Facebook profile, 78 Facebook wall, 78 Facial hair removal, 149 Family members, treatment to common reasons for treating, 68 immediate, 67 niece, 68–69 optimal patient care, 68 prescription for, 69–70 refusal of treatment, 67 risk of involvement, 70 sister-in-law, 69 Fan Pages, 77 Federal Trade Commission (FTC), 147–148 Financial conflict of interest, 189 Food and Drug Administration (FDA) DTCDA, 14 epidermolysis bullosa, clinical research, 206 isotretinoin, 20 Formal mentoring, 109–110 Friending and tweeting common Web 2.0 Jargon, 78 doctor-patient relationship, 78 Fan Pages, 77 HIPAA violations, 79 online social networking, 78 professionalism, 77, 80 protected health information (PHI), 79 Twitter, 79 unprofessional online content, 80–81 Friendly Derm Services (FDS), 177 Futile care, 9

G Gatekeeper system, ethical implications. See Managed care organizations Genetic Information Non-Discrimination Act (GINA), 202 Genetic testing, dermatological diseases carrier testing, 199 cyclin dependent kinase 2A, 198 diagnostic testing, 199 ethical and legal issues, 199 mannose-binding lectin gene, 199

243 mucocutaneous macules, 197 neurofibromatosis type 1, 198 Peutz Jeghers syndrome, 197, 199–201 pharmacogenetics research, 198 predictive testing, 199 prenatal testing, 199 presymptomatic testing, 199 risk assessment and treatment, 198 STK11 gene mutation, 197 TGM1 gene mutation, 197, 201–202 Genital warts, 13, 16, 26 Ghost authorship, 228 Ghost busting, dermatology publications authorship credit, 227 ethical analysis, 229–230 ghost authorship, 227, 228 ghost management, motivating factors, 228–229 guest authorship, 227–228 literature, 228 Ghost management, motivating factors, 228–229 Gifts on cultural basis, 72–73 definition, 71 extravagant, 872, 73 holiday, 71–72 motives, 72 reasons for offering, 71–72 seasonal Japanese, 72 73 strategies for rejecting, 75 thumb rules, 74 Global health care ethical dilemmas in, 94 global burden of disease, 92 harm from inexperienced trainees, 93 informed consent, 93–94 insufficient communication, 93 principle of non-maleficence, 92–93 technical and cognitive capabilities, 94 Good clinical practice (GCP) guidelines, 195

H Hair growth, unwanted, 14, 16 Health care insurance, 163 The Health Insurance Portability and Accountability Act (HIPAA), 47 Help-seeking advertisement, 14 Hemangioma, infantile, 25, 28 Hospital consultations billing, 52 disciplinary action or civil liability, 53 hospital privileges, 53 in-patient consultations, 53–54 physician inconvenience, 52 primary care physician, 51, 53

I Impaired behavior aging, 103–104 alcohol abuse, 101–102 assessing physician, 100

244 Impaired behavior (cont.) disruptive behavior, 98, 103–104 intervention, 99–100 recovery contracts, 100–101 substance use and mental illness, 99 Infantile hemangioma, 25, 28 Informal mentoring, 109–110 Informed consent epidermolysis bullosa, ethical practices, 211 in pediatrics, 26 in teledermatology, 47–48 Informed permission, 26 Innovative dermatology ventures (IDV), 177 Innovative therapy Belmont report, 237 for cellulite, 238, 239 clinical practice, 237 clinical research, 237 considerations, 238–239 definition, 239 investigational drugs, 238 for Merkel cell carcinoma, 239–240 rationale, 238 International Committee of Medical Journal Editors (ICMJE), 227 International Conference on Harmonisation (ICH), 194 International Ethical Guidelines for Biomedical Research Involving Human Subjects, 194 Internet, 79, 81, 82 Investigational new drug (IND), epidermolysis bullosa, 206 Isotretinoin and iPLEDGE, 20 birth malformations, 20 confidentiality, 21 essential components of, 20, 21 ethical concern, 20–21 in minor, 22–23 for nodulocystic acne, 20 reproductive autonomy, 20 right of conscience, 22 Roche Pregnancy Prevention Program, 20 for scarring nodular acne, chronic, 19 youth risk behavior surveillance system, 21

J Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 103 Journal of American Academy of Dermatology (JAAD), 229 Journal of Cutting-Edge Dermatology Research, 215–216 Journal of Investigative Dermatology (JID), 229

L Lamellar ichthyosis (LI), TGM1 gene mutation, 197 Lentigo maligna, botulinum toxin injection, 134

M Managed care organizations elliptical excision, 165 gatekeeper system, 163–165 health care insurance, 163 nodular basal cell carcinoma, 164

Index patient autonomy, primacy, 165 patient-centered ethics, 166 resource duties, 166 telangiectasia, 163–164 ulcerated lesion excision, 164 Mannose-binding lectin (MBL) gene, 199 Marketing, physician consumer advertisement, 147, 149 cosmetic procedures, 147, 149–150 deceptive advertising, 149 ethical advertising and economic self-interest, 148 merits and demerits, 148 patient autonomy vs. paternalism, 149–150 television advertisement, 147–149 unsubstantiated advertising, 148–149 Mature minor, 27 Medical decision-making, 12 Medical education and communications companies (MECCs), 228 Medical fees, ethical and professional issues discounting, 155 economic hardship, 155 group practice, 153 healthcare insurance, 154–155 healthcare quality, 155 health care system, cost control, 155 history, 154 insurance plan, 153 patient ability, 154 perverse/reverse sliding scale, 155 public calling, 154 sliding scale, 154, 155 specialist visits, copayment for, 153 threshold system, 155 voluntary honoraria, 154 Medical spas, 158 Melanoma, malignant, 5, 9, 11–12 Mentoring. See Mentor-mentee relationship Mentor-mentee relationship concept of, 109 cultivation, 110 good mentor qualities, 111 informal mentoring, 109–110 termination, 110–111 Merkel cell carcinoma, 33, 35–36, 239–240 Minors contraception for, 21 isotretinoin on, 21 privacy and confidentiality, 27–28 rights of, 27 Moral, 52

N National hiring standards, 11 National Resident Matching Program (NRMP), 114 Neurofibromatosis type 1, genetic testing, 198, 202 Nevi, dermal, 9, 11 Nevus, congenital facial, pediatric decision-making in, 26, 28–30 NF-1 neurofibromatosis, 4, 7 Nuremburg code, 194 Nurse practitioners (NP). See Physician extenders

Index O Office dispensing and product pricing benefits, 137, 138 dermatology, 137–138 economic value to customer, 140 opponents, 138 pharmaceutical supply chain, 139–140 practice’s profitability, 137 pricing methods, 137 primary considerations, 139 proponents, 138 purchasing cost, 140 reference value calculation, 140 supply chain, 140 transaction relationships, players, 141 Oral isotretinoin, for acne, 125

P Parasitosis, delusions of, 34–35 Paternalism, 11 Patient privacy, 47 Pediatrics, medical decision-making in assent, 26–27 congenital facial nevus, 25, 28–30 genital wart, 26, 30 infantile hemangioma, 25, 28 informed permission, 26 minors privacy and confidentiality, 27–28 rights of, 27 Peer review author anonymity, 222–223 biased, 221, 224 case analysis, 224 characterization, 216 Committee on Publication Ethics, 216 Council of Science Editors, 216 double-blind, 222 electronic submission management systems, 224 falsification of experiments and fabrication of data, 215–216 fraud-sensing mechanism credible and specific allegation, 217 inquiry and investigation, 217 journal editors, 216, 217 potential fraud, 217 reporting, logical candidates, 216 scientific fraud, 216 negative consequence, open peer review, 221, 224 post-publication criticism, 223 reviewer anonymity, 223 in scientific publication, 216 single-blinded, 223, 224 Peutz Jeghers syndrome (PJS) assent, 200–201 diagnostic testing, 201 novel treatments, 200 predictive testing, 200 pre-symptomatic testing, 200 pre-test counseling, 201 STK11 gene mutation, 197 symptoms, 199

245 Pharmaceutical supply chain, 139–140 Physician advertising. See Marketing, physician Physician conscience, 85–86, 88 Physician extenders economic factors, 57 guidelines, 56 real time on-site supervision, 57 residency-equivalent training, 57 survey, 56 TIME bill, 58 training, 56 Physician-patient dyad, 62 Physician–patient relationship boundaries, 62 charitable donation, 64–65 fiduciary relationship, 64 post-consultation lingering, 63 slippery slope, 63 Physicians Health Programs (PHPs), 100 Plaque psoriasis, 9–11 Pod lab, 182 Post-publication criticism, 223 Post-publication review, 222 Prejudiced patients, 87 Prenatal testing, 199 Product claim advertisement, 14 Product pricing. See Office dispensing and product pricing Professional boundaries, 62 Professional ethics, 52 Professionalism, 77, 80, 98–99 Professional issues. See Medical fees, ethical and professional issues Psoriasis medication, 13, 15–16 plaque, 9–11 treatment conflicts of interest, guidelines185, 188–189 effective therapy, 193–194 FDA-approved therapies, 194

R Real time on-site supervision, 57 Recombinant DNA Advisory Committee (RAC), 206 Reminder advertisement, 14 Research Integrity Officer (RIO), 217 Residency interview federal laws, 116 marital status, 115–116 national hiring standards, 115 National Resident Matching Program (NRMP), 114 risks and benefits of lying or being honest, 113–115 Residents, ethics education for clinical teaching and medical ethics, 121 decision making, influences, 121 ethical obligation, 119, 122 ethical principles, 120–121 inexperience and knowledge gaps, 120 informed consent, 121 medicolegal consequences, 121 patient care, 119, 122 patient refusal, 119, 122

246 Residents, ethics education for (cont.) patients consent, 121–122 personal identity, 120 physician’s role, 119–120 repair risks, 119, 122 Reviewer anonymity, 223 Roche Pregnancy Prevention Program, 20 Royal College of Physicians and Surgeons of Canada (RCPSC), 85

S Salami-slicing, 234 Scientific publishing, 215, 216 Self-plagiarism copyright infringement, 234–235 duplicate publication, 233–234 elimination of, 236 salami-slicing, 234 solutions, 235–236 text recycling, 235 Single-blind peer review, 222, 224 Skincare products anti-aging, 143 application, 143–144 cosmeceutical, 143 developing and marketing, 144 efficacy and ethical perils, 145 ethical red flags, 144 honest and scientific approach, 145 patients, physicians and society, 144 Sliding scale fees, 154 Social media Facebook friending, 77, 78 HIPAA violation, 79 page and profile, 78 patient-physician relationship, 78–79 protected health information, 79 student counsels, 81 tagging photos on, 78, 82 unprofessional online content, 80–81 untagging photos, 78 Web 2.0 application, 77 manager, 77 Social media manager, 77 Society of Dermatology Physician Assistants (SDPA), 56 Stark law, 181 Store-and-forward telemedicine, 46 Sulfonamide experiments, 193 Sunburn, 1, 6 Synchronous telemedicine, 45

T T-cell lymphoma, cutaneous, conflicts of interest, 185, 189 Teaching, for clinical ethics health care cost, 126–127 indigent patients care, 126

Index insurer’s regulations, 126 isotretinoin, 125, 127 Teledermatology confidentiality, 48 definition, 46 ethical issues, 46–48 Health Insurance Portability and Accountability Act, 47 informal, 46–47 informed consent, 47–48 medical information storage, 47 protected health information, 47 telemedicine types, 45–46 Telemedicine, 45–46 Termination, mentor-mentee relationship, 110–111 Text recycling, 235 Therapeutic privilege American Medical Association on, 34 concept, 33 consequentialist arguments, 34 delusions of parasitosis, 34–35 deontological arguments, 33–34 insect infestation, 33 Merkel cell carcinoma, 33, 35–36 TIME bill, 58 Trust, 84 Tuskegee syphilis study, 193 Twitter, 78

U Ulcerated lesion excision, managed care, 164 Unprofessional online content, 80–81Unreasonable demands for care, 9–10 Unsolicited medical opinion benefits and risks of, 5 bystander phenomenon, 5 conditions for offering, 7 legal issues, 6 malignant melanoma, 1, 6 moral obligation, 5 mutilating lesion, 4, 6–7 NF-1 neurofibromatosis, 4, 7 sunburn, 1, 6

W Web 2.0 application, 77

Y Youth risk behavior surveillance system, 21