Advances in Radiation Therapy

ETHICAL ISSUES IN CANCER PATIENT CARE SECOND EDITION

Cancer Treatment and Research Steven T. Rosen, M.D., Series Editor _____________________________________________________________________ Mittal, B.B., Purdy, J.A., Ang, K.K. (eds): Radiation Therapy. 1998. ISBN 0-7923-9981-1. Foon, K.A., Muss, H.B. (eds): Biological and Hormonal Therapies of Cancer. 1998. ISBN 0-7923-9997-8. Ozols, R.F. (ed.): Gynecologic Oncology. 1998. ISBN 0-7923-8070-3. Noskin, G. A. (ed.): Management of Infectious Complications in Cancer Patients. 1998. ISBN 0-7923-8150-5. Bennett, C. L. (ed.): Cancer Policy. 1998. ISBN 0-7923-8203-X. Benson, A. B. (ed.): Gastrointestinal Oncology. 1998. ISBN 0-7923-8205-6. Tallman, M.S., Gordon, L.I. (eds): Diagnostic and Therapeutic Advances in Hematologic Malignancies. 1998. ISBN 0-7923-8206-4. von Gunten, C.F. (ed.): Palliative Care and Rehabilitation of Cancer Patients. 1999. ISBN 0-7923-8525-X Burt, R.K., Brush, M.M. (eds): Advances in Allogeneic Hematopoietic Stem Cell Transplantation. 1999. ISBN 0-7923-7714-1. Angelos, P. (ed.): Ethical Issues in Cancer Patient Care 2000. ISBN 0-7923-7726-5. Gradishar, W.J., Wood, W.C. (eds): Advances in Breast Cancer Management. 2000. ISBN 0-7923-7890-3. Sparano, J. A. (ed.): HIV & HTLV-I Associated Malignancies. 2001. ISBN 0-7923-7220-4. Ettinger, D. S. (ed.): Thoracic Oncology. 2001. ISBN 0-7923-7248-4. Bergan, R. C. (ed.): Cancer Chemoprevention. 2001. ISBN 0-7923-7259-X. Raza, A., Mundle, S.D. (eds): Myelodysplastic Syndromes & Secondary Acute Myelogenous Leukemia 2001. ISBN: 0-7923-7396. Talamonti, M. S. (ed.): Liver Directed Therapy for Primary and Metastatic Liver Tumors. 2001. ISBN 0-7923-7523-8. Stack, M.S., Fishman, D.A. (eds): Ovarian Cancer. 2001. ISBN 0-7923-7530-0. Bashey, A., Ball, E.D. (eds): Non-Myeloablative Allogeneic Transplantation. 2002. ISBN 0-7923-7646-3. Leong, S. P.L. (ed.): Atlas of Selective Sentinel Lymphadenectomy for Melanoma, Breast Cancer and Colon Cancer. 2002. ISBN 1-4020-7013-6. Andersson , B., Murray D. (eds): Clinically Relevant Resistance in Cancer Chemotherapy. 2002. ISBN 1-4020-7200-7. Beam, C. (ed.): Biostatistical Applications in Cancer Research. 2002. ISBN 1-4020-7226-0. Brockstein, B., Masters, G. (eds): Head and Neck Cancer. 2003. ISBN 1-4020-7336-4. Frank, D.A. (ed.): Signal Transduction in Cancer. 2003. ISBN 1-4020-7340-2. Figlin, R. A. (ed.): Kidney Cancer. 2003. ISBN 1-4020-7457-3. Kirsch, M.; Black, P. McL. (ed.): Angiogenesis in Brain Tumors. 2003. ISBN 1-4020-7704-1. Keller, E.T., Chung, L.W.K. (eds): The Biology of Skeletal Metastases. 2004. ISBN 1-4020-7749-1. Kumar, R. (ed.): Molecular Targeting and Signal Transduction. 2004. ISBN 1-4020-7822-6. Verweij, J., Pinedo, H.M. (eds): Targeting Treatment of Soft Tissue Sarcomas. 2004. ISBN 1-4020-7808-0. Finn, W.G., Peterson, L.C. (eds.): Hematopathology in Oncology. 2004. ISBN 1-4020-7919-2. Farid, N. (ed.): Molecular Basis of Thyroid Cancer. 2004. ISBN 1-4020-8106-5. Khleif, S. (ed.): Tumor Immunology and Cancer Vaccines. 2004. ISBN 1-4020-8119-7. Balducci, L., Extermann, M. (eds): Biological Basis of Geriatric Oncology. 2004. ISBN Abrey, L.E., Chamberlain, M.C., Engelhard, H.H. (eds): Leptomeningeal Metastases. 2005. ISBN 0-387-24198-1 Platanias, L.C. (ed.): Cytokines and Cancer. 2005. ISBN 0-387-24360-7. Leong, S.P.L., Kitagawa, Y., Kitajima, M. (eds): Selective Sentinel Lymphadenectomy for Human Solid Cancer. 2005. ISBN 0-387-23603-1. Small, Jr. W., Woloschak, G. (eds): Radiation Toxicity: A Practical Guide. 2005. ISBN 1-4020-8053-0. Haefner, B., Dalgleish, A. (eds): The Link Between Inflammation and Cancer. 2006. ISBN 0-387-26282-2. Leonard, J.P., Coleman, M. (eds): Hodgkin’s and Non-Hodgkin’s Lymphoma. 2006. ISBN 0-387-29345. Leong, S.P.L. (ed): Cancer Clinical Trials: Proactive Strategies. 2006. ISBN 0-387-33224-3. Meyers, C. (ed): Aids-Associated Viral Oncogenesis. 2007. ISBN 978-0-387-46804-4. Ceelen, W.P. (ed): Peritoneal Carcinomatosis: A Multidisciplinary Approach. 2007. ISBN 978-0-387-48991-9. Leong, S.P.L. (ed): Cancer Metastasis and the Lymphovascular System: Basis for rational therapy. 2007. ISBN 978-0-387-69218-0. Raizer, J., Abrey, L.E. (eds): Brain Metastases. 2007. ISBN 978-0-387-69221-0. Woodruff, T., Snyder, K.A. (eds): Oncofertility. 2007. ISBN 978-0-387-72292-4. Angelos, P. (ed): Ethical Issues in Cancer Patient Care, Second edition. 2008. ISBN 978-0-387-73638-9.

ETHICAL ISSUES IN CANCER PATIENT CARE SECOND EDITION edited by

Peter Angelos, MD, PhD, FACS Professor of Surgery and Chief of Endocrine Surgery Associate Director of the MacLean Center for Clinical Medical Ethics University of Chicago Medical Center Chicago, Illinois, USA

Peter Angelos, MD, PhD, FACS Professor of Surgery and Chief of Endocrine Surgery Associate Director of the MacLean Center for Clinical Medical Ethics University of Chicago Medical Center 5841 South Maryland Avenue, MC 4052 Chicago, Illinois 60637 USA

Series Editor: Steven T. Rosen Robert H. Lurie Comprehensive Cancer Center Northwestern University Chicago, IL USA

Ethical Issues in Cancer Patient Care, Second edition ISBN-13: 978-0-387-73638-9

e-ISBN-13: 978-0-387-73639-6

Library of Congress Control Number: 2007930270 © 2008 Springer Science+Business Media, LLC All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper. 987654321 springer.com

For Meghan, Christian, Audrey, and especially G race

CONTENTS

Contributors

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Introduction

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1. An Open Letter to Doctors Parvez Kamangar

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2. Physicians and Cancer Patients: Communication and Advance Directives Peter Angelos and Muneera R. Kapadia

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3. Information is Not Enough: The Place of Statistics in the Doctor–Patient Relationship Kathryn Key Montgomery and Ellen Key Harris-Braun

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4. Cross-Cultural Issues in Caring for Patients with Cancer Tod Chambers

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5. Hope and Communication in Cancer Care: What Patients Tell Us Susan Hedlund

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6. Addressing the Spiritual Needs of Patients Christina M. Puchalski 7. Pediatric Cancer Care: Special Issues in Ethical Decision Making Sarah Zieber and Sarah Friebert 8. The Ethics of Responding to Pain and Suffering Timothy F. Murphy

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93 117

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9. Are There Limits to Oncology Care? (Futility) Gary R. Shapiro

Contents

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10. The Role of Palliative Medicine in Cancer Patient Care 159 William M. Mitchell and Charles F. von Gunten 11. Holding On and Letting Go: Ethical Issues Regarding the Care of Children with Cancer Aviva Goldberg and Joel Frader 12. Communicating Errors Christian J. Vercler and Peter Angelos 13. Research Ethics and the Ethics of Research: Should We Offer Clinical Trial Participation or Clinical Research Partnership to Oncology Patients in the New Millennium? Heather Sampson 14. Does Reimbursement Affect Physicians’ Decision Making? Examples from the Use of Recombinent Erythropoietin June M. McKoy, Cara C. Tigue, and Charles L. Bennett Index

173 195

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235 253

CONTRIBUTORS Peter Angelos, MD, PhD, FACS Professor of Surgery and Chief of Endocrine Surgery Associate Director of the MacLean Center for Clinical Medical Ethics University of Chicago Medical Center 5841 South Maryland Avenue, MC 4052 Chicago, IL 60637 Charles L. Bennett, MD, PhD, MPP Division of Hematology/Oncology Northwestern University Feinberg School of Medicine 303 E. Chicago Avenue Olson Pavilion, Suite 8-250 Chicago, IL 60611 Tod Chambers, PhD Associate Professor of Medical Humanities and Bioethics Northwestern University Feinberg School of Medicine 750 N. Lake Shore Drive, #634 Chicago, IL 60611 Joel Frader, MD, MA University of Manitoba Department of Pediatrics, Section of Pediatric Nephrology Winnipeg Children’s Hospital FE009-840 Sherbrook Street Winnepeg, Manitoba Canada R3A 1S1 Sarah Friebert, MD Director, Haslinger Division of Pediatric Palliative Care Pediatric Hematology/Oncology Akron Children’s Hospital One Perkins Square Akron, OH 44308

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Aviva Goldberg, MD Assistant Professor, University of Manitoba Department of Pediatrics, Section of Pediatric Nephrology Winnipeg Children’s Hospital FE009-840 Sherbrook Street Winnepeg, Manitoba Canada R3A 1S1 Ellen Key Harris-Braun Harris-Braun Enterprises 19 Berkshire Ridge Road Canaan, NY 12029-2900 Susan Hedlund, MSW, LCSW Director of Counseling Cancer Care Resources 439 N. Broadway Portland, OR 97227 Parvez Kamangar 1177 California Street, #1124 San Francisco, CA 94108 Muneera R. Kapadia, MD McGaw Medical Center of Northwestern University Feinberg School of Medicine 676 North St. Clair Street Chicago, IL 60611 June M. McKoy, MD, MPH, JD Assistant Professor, Division of Geriatrics Northwestern University Feinberg School of Medicine 676 North St. Clair Street, #200 Chicago, IL 60611 William M. Mitchell, MD, PhD Fellow, Hematology/Oncology University of California, San Diego 9500 Gilman Drive #9111-E La Jolla, CA 92093

Contributors

Kathryn Key Montgomery, PhD Professor of Medical Humanities and Bioethics and of Medicine Director, Medical Humanities and Bioethics Program Northwestern University Feinberg School of Medicine 750 N. Lake Shore Drive, Suite 625 Chicago, IL 60611 Timothy F. Murphy, PhD Professor of Philosophy in the Biomedical Sciences University of Illinois College of Medicine at Chicago Department of Medical Education 808 South Wood Street, Room 986 DME M/C 591 Chicago, IL 60612-7309 Christina M. Puchalski, MD, FACP Director, The George Washington Institute of Spirituality and Health Associate Professor of Medicine, Healthcare Sciences The George Washington University School of Medicine Associate Professor of Heath Management and Leadership The George Washington University School of Public Health School of Medicine and Health Sciences 2300 K St NW Suite 313 Washington, DC 20037 Heather Sampson, RN, CCRP, MHSc Office of Research 825 Coxwell Avenue Toronto, Ontario Canada M4C 3E7 Gary R. Shapiro, MD Chairman, Department of Oncology Johns Hopkins Bayview Medical Center 4940 Eastern Avenue, A-113 Baltimore, MD 21224

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Cara C. Tigue, BA Northwestern University Feinberg School of Medicine Division of Hematology/Oncology 303 E. Chicago Avenue Olson Pavilion, Suite 8-250 Chicago, IL 60611 Christian J. Vercler Clinical Ethics Fellow Surgical Resident Center for Ethics at Emory University 201 Dowman Drive Atlanta, GA 30322 Charles F. von Gunten, MD, PhD Director, Center for Palliative Studies San Diego Hospice & Palliative Care 4311 Third Avenue San Diego, CA 92103 Sarah Zieber, MD Vanderbilt Children’s Hospital Department of Pediatrics Division of Pediatric Hematology-Oncology 2220 Pierce Ave 397 PRB Nashville, TN 37232-6310

Contributors

INTRODUCTION Peter Angelos

Numerous ethical issues arise in the care of oncology patients. Although much has been written in the last several decades on ethical issues in caring for patients, few volumes have sought to focus the exploration on ethical issues particularly relevant to the care of cancer patients. In 1999, the first edition of this book was published. Since that time, many changes have occurred in how some cancers are diagnosed and treated, but the central ethical issues have continued to challenge patients, families, and their health care providers. All of the chapters from the prior edition have been updated and there are seven new chapters in this expanded edition. In this second edition, the perspectives on what is an ethical issue have been broadened by bringing authors of differing backgrounds into the discussion. In Chapter 1, the perspective of a cancer patient is provided as an open letter to physicians. Although Parvez Kamangar is providing only one patient’s perspective, this is an essential voice that is not often heard in texts on medical ethics. In Chapters 2 and 3, the issues of communication and the physician-patient relationship are explored in order to better understand how the needs of patients and families can be met. In Chapter 4, Professor Tod Chambers highlights the challenges to providing ethical care to patients in a multicultural society. In Chapter 5, the issue of “hope” is explored by a social worker with an extensive background in helping cancer patients manage their hopes and expectations in the course of living with cancer. In Chapter 6, Christina M. Puchalski explores how the spiritual needs of patients can be appreciated and addressed. In Chapter 7, the specific ethical issues of pediatric cancer patient care

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are explored. In Chapter 8, Professor Timothy F. Murphy examines the ethical issues associated with responding to the pain and suffering of patients. Chapters 9, 10, and 11 explore different aspects of oncology care near the ends of life. The difficult concept of “futility” is explored first. Subsequently issues in palliative medicine are considered for both adults and children. In the remaining three chapters, specific important aspects of caring for cancer patients are raised. In Chapter 13, the issue of how to communicate about errors is addressed. As cancer patient care becomes increasingly complex, errors inevitably occur and an ethical approach to communicating about them is needed. In Chapter 14, the important role of clinical trials in oncology care is discussed. Since many patients participate in, or at least consider entering, a clinical trial, this aspect of oncology care cannot be ignored. In the final chapter, potential financial motives for decision making are considered in an attempt to better understand how such factors might influence the care of cancer patients. The goals of this volume are multiple. First, to raise the awareness of doctors, nurses, and other members of the health care team to the important ethical issues that must be addressed in providing medical care to cancer patients. Second, to influence caregivers to think about how to be better prepared to address such issues when they inevitably arise. Finally, to encourage members of the health care team to take the ethical issues seriously so that we can improve the circumstances of a vulnerable group of patients— those with cancer.

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AN OPEN LETTER TO DOCTORS* Parvez Kamangar

The subject of “Ethics in Medical Care” is a subject very close to my heart. I started “The Humanity in Surgery Lectureship” in 1997 at Northwest Society of Colon and Rectal Surgeons. I am forever grateful to this fine organization to allow a cancer patient to take part in their annual meeting for the first time and perhaps open a small window into the mind and soul of their most valuable assets…their patients. These lectures are still continuing. Later in 2003, I was very honored when “The American Society of Colon and Rectal Surgeons” (the “ASCRS”) allowed me to start a National Lectureship in the annual meetings. My invited guests have brought the subject of ethics and the humane treatment of critically ill patients to the forefront of discussion and debate. All members are in total agreement that this subject is too important to be ignored. In a 5-day meeting packed with hundreds of scientific subjects, a mere 30 minutes can be found to remember ethics. *Editor’s Note: Mr. Parvez Kamangar is a successful businessman who has funded an annual Humanities in Surgery lectureship at the American Society of Colon and Rectal Surgeons meeting. Mr. Kamangar is also a cancer survivor. I have asked him to write an open letter to doctors about his experiences. Note that for a patient, the experience of illness is always personal—unlike the situation for health care providers who can generalize. Mr. Kamangar’s unquestioned acceptance of his gastrointerologist’s recommendations led to his subsequent intense feeling of betrayal. We should pay particular attention to the details of the experience that are so memorable to this patient, but are not always emphasized by health care providers. Despite some very critical things Mr. Kamangar states about physicians, he has taken both his positive and — his negative experiences with doctors as an incentive to try to improve the ethical care of patients.

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In this process, they have enriched my life and have rewarded me with their sincere concern for treating the patient as well as treating the illness. I have found with undiluted pleasure and surprise that some of the finest human beings I’ve ever met are in your noble profession, and that should give all of us patients room for hope and improvements. The anatomy of my illness and the history of this lectureship are closely connected and may be of interest to you. Here is a very brief version…. Prior to 1993, I had never had a major health problem. I was a healthy 52 year old white male workaholic. I had stress at work, but who doesn’t? No history of cancer in my family. Cancer did not enter into my wildest imagination. You only see those things in the news. In the spring of that year, I did not feel well. Nothing specific. Just not well. I was tired…did not enjoy doing the things I used to…stopped socializing and stayed home more often. My appetite was not the same. I got irritated more often. I should have gone to my primary doctor, but put it off thinking, it was just a phase I’m going through. By June of that year I was getting worse…my digestive system was messed up; more importantly, I was bleeding. I knew then it was time to go to the doctor. My primary doctor was very concerned. I saw the fear in his eyes. He did not even want to examine me. He sent me straight to a specialist. It was much later that I realized my primary doctor was a great doctor, but unfortunately not a good judge of specialists! My gastroenterologist was in the same building. After a brief discussion, he assured me that I had nothing to fear…most likely I had a parasite!!! He gave me some pills to take and told me to keep in touch. This was the beginning of my problems. This is where I wished that I had known better. My symptoms got worse. I went back to see him and complained. He started by asking me if I had traveled to any exotic destination: South America? China? Etc. When I answered “yes”, he thought he had it all figured out. Another pill!!! During the entire

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period, there was no discussion of colonoscopy, colon cancer, or any other internal difficulties. When I brought up the subject of cancer, he assured me that I should not worry about such things!!! My third prescription consisted of 30 cure-all mega tablets…one a day for 30 days. Although painful with some side effects, they will cure anything and everything, even if it is from China. While this was going on, my colon cancer had entered stage III and was progressing. My bleeding more constant. No appetite. Abdominal pain. Diarrhea. As I look back at those days, I ask myself how naïve could I have been? Where was my head? What was I thinking? Why didn’t I take better control of my care? Why didn’t I get a second opinion? As complicated as the answer may be, it is really simple. It goes back to the roots of my upbringing and my unquestionable respect for the medical profession. The doctor was knowledgeable, educated, and concerned. The doctor was someone I automatically looked up to and at times envied. A doctor would never do anything to hurt a patient. So sad how times have changed. So sad that I no longer feel that way at all. I could not finish the pills. I was really sick. I knew there was something wrong. Upon my insistence and only then, he agreed to do a colonoscopy. During this procedure, unlike many others I have had since then, I was quiet, alert, and looking at the monitor. I could see everything. It did not look good. I knew right then this monster should have never been allowed into medical school. In the recovery room (Waiting? Room) I was drinking the apple juice as the doctor walked in. “You were right all along,” he said. “We should have done a colonoscopy earlier. You do have colon cancer and it has progressed. It doesn’t look too good.” There was no emotion in his face, no compassion, no feeling, nothing. He was a monster. “We are going to send the samples to the lab for test and we will have the answers in a few days.” I was speechless. I was frozen to my seat. I was angry––not at my illness, but at my doctor. I had never known anyone (closely)

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with cancer. No one in my family had ever had cancer. This was my first experience. Just like that, my life was over. He and I never had much chemistry for each other. He was a large, overwhelming man. He never sat down…just stood there and looked down at me. He never took the time to ask me any questions. He never asked about my family. I tried hard to look into his eyes, but they were not there. Ever since this experience, I’ve encouraged my friends and family to change doctors or to get second opinions if they didn’t believe in the one they had, or disliked him/her from the start. I had so many questions. I forced myself to ask him one. “What are my chances?” “Not good,” he said. “You most likely need a colostomy.” Then I made a big mistake and asked, “What is colostomy?” As he was leaving the room, he assured me that his secretary would give me the name of a few surgeons that could do my operation. There was no discussion of follow-up or any offer of help. It was very mechanical. He was a sick man; the entire medical profession should be ashamed of him. I don’t know the result of those tests. I never went back to that office. I still get angry—13 years later—driving around that neighborhood. Somehow, I made it home. It was not easy. I didn’t know what I should do next. My doctor did not give me any direction or guidance. I decided to call my friend, who is a doctor here in town. He was really very nice and understanding. “Sit still,” he said. “I’ll get back to you.” He called back. He had it all arranged for me to see a friend of his. A colon and rectal surgeon. The next two days somehow went by. Don’t ask me how, but they did. I kept it all to myself. I did not share it with anyone. It was the worst two days of my life. I entered the office of my new colon and rectal surgeon without much hope. No matter how hard I tried, I couldn’t hide my feeling of hopelessness. He was very pleasant. He listened, did a short exam, and had a long talk with me. Here I wish I could write well and explain the difference between these two doctors.

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This surgeon was a great human being before anything else. He expressed his disappointment about how I had been treated. He emphasized the importance of putting my first doctor out of my mind for the time being and to look forward to positive things. “You cannot afford to be angry. Cancer is not a death certificate,” he said. “Many forms of cancer can be treated, controlled, managed, and cured.” My surgeon said that if I was willing to go through the difficulties ahead, he would put together a team that will fight for me and with me. One thing that I will never forget is how this doctor was concerned about how many days of work I was going to miss after my operation! He assured me that if this was a big problem, he could arrange for a private telephone and fax machine in my room! He wanted me to be strong and optimistic. He had heard from our mutual friend that I had had many challenges in the course of my business. This was “no different,” he said. “Just another challenge…this time we are here to help you.” I asked him about colostomy. “You do not need that,” he said. “A gastroenterologist is not qualified to make such a statement. That is the surgeon’s decision.” I was shocked, angry, and happy all at the same time. Could my first doctor be purposely trying to hurt me? Is he a psychopath? How is he still practicing medicine? We made arrangements for my operation. “Precious time has been lost; we have catching up to do.” He was careful not to give me any false promises or hope, but he emphasized the importance of being positive. I was so happy to meet someone that cared. I did not feel alone anymore. This man was born to be a doctor. I left his office a totally different man. The highs and lows are not easy for me to describe. I wish I could. Perhaps you could share it with your students and some of your colleagues. How can all this be possible? Earlier that day, I had spoken with my trust attorney and asked him for an urgent meeting with him to go over my will and rewrite a few things…he was very understanding, expressed his sympathy, and arranged a time. I called him back that afternoon and cancelled. I was going to live. The day of my operation started well. In the prep room I was greeted by a very nice lady with a big smile. My surgeon was there

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when they rolled me into the operating room. He welcomed me and introduced me to everyone in the room who were busy making the last minute preparations. I was very surprised and pleased to hear my first and last name pronounced correctly. Small details like that are important. It signifies the doctor’s interest in his patient and in his profession. The atmosphere in the room was good. I had a feeling that everything was going to be just fine. I was determined to fight. They started to hook me up with wires and needles. My surgeon explained to me what everyone’s duty was and what he hoped to accomplish. He did this in language that I could understand…not in medical jargon. I don’t like blood or knives, so I was glad that he did not go into details. Then I counted to 10… My recovery got a little complicated. I had to stay in the hospital a few days longer than expected. My surgeon assured me that the operation had gone well and he was even more hopeful than before. “These difficulties are not uncommon and they will pass.” I believed him. During those difficult days I learned some valuable lessons. First, I realized how underappreciated the nurses are, and how all of us—including doctors—should learn from them. My nurses were professional, kind, compassionate, and hardworking. They gave me hope and positive energy. During my most difficult night, my nurse stood by my bed, held my hand and assured me that what I was going through was expected, part of the operation, and would pass. She was right. I also realized how important and valuable my family and friends were to me at such a difficult time. Their love and understanding healed my wounds. It really did. I felt as I had to recover and go home for them, if not for myself. It was during this time that I also realized how imperfect medical science was. As patients, we expect perfect results and often we are disappointed. This was all so new to me. I did a lot of thinking in the hospital. How imperfect is this profession?

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How many specialists like my first doctor are practicing in this hospital? Are there any more doctors like my second doctor, or was I just lucky? I wondered if Ethics and Rules of Conduct were ever discussed during the many years of scientific studies in medical schools. These and many other questions were keeping my mind very busy. I promised myself that if I ever recovered from cancer, I would try to find out and try to make a difference. I wasn’t sure how, but I wanted to do something constructive. Something to help others. The rest of my recovery took about one year. During my chemotherapy and radiation, I had lots of ups and downs. My tumor board included some great individuals. They were all the best I could hope for. During my lowest days and most painful times, they never allowed me to lose my focus or my concentration. They did it skillfully and patiently. As time went by, my tests looked better and better, and I was able to spend quality time with my family and friends and conduct some business. One of the first orders of business was to bring legal action against my first doctor. Not for money, which I did not need, but to make sure he did not do to others as he did to me. When my doctors found out about this, we had our first disagreement. “You don’t need such a burden and negative energy around you at this time,” they said. “It will hurt you. You need to do the things that you enjoy at this time. You need to concentrate on your recovery. Be with your family and friends…” “Forget and forgive your first doctor. Hopefully someone else will do the job for you. Forget he even exists!” I could not say no to my doctors. As much as I hate to compromise my principles, I did. To this day, I try to put that chapter behind me. During the following years I spoke to many cancer patients and doctors. I heard many good and bad stories. I discovered that during 8 to 14 years of higher education, doctors are not required to

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take a single hour in ethics! One professor told me that I had to prove to him that ethics cured diseases before he agreed with me! Why does a doctor make an appointment at the time of his choosing, the day of his choosing, and the place of his choosing, and is routinely late? Isn’t there a better excuse than “the doctor has an emergency?” Let us be honest here, if you had respect for your patient, you can be on time most of the time, and if not, you could explain and apologize to the patient. That could go a long way. We are more patient than you think. I also have spoken to many great doctors. It is just human nature and justifiably so to expect goodness in doctors and never forget the bad ones. What I’ve learned about the medical profession has been mostly a wonderful experience. There were those who listened to my complaints with absolute attention, those who encouraged me to start the lectureship, and those who wanted me to rechannel my frustration. It is with much pleasure that I see ethics moving to the forefront of medical discussions. Things are changing for the better. I see it every day. It is up to all of you to take your great profession to the height it once was and deserves to be again. How can you stand by and allow a small minority to give you a black eye just because they passed the tests in medical school? Why are you afraid to take them on and kick them out? The American Medical Association cannot find these people and revoke their licenses? Are they waiting for an attorney to do the job and then complain about it? Where is the Association of American Medical Colleges in all this? Isn’t it time for a serious review of what we teach in our medical colleges and to whom? These and many other questions need to be addressed and answered as your profession enters the new age of contemporary American culture. Please do not be afraid to ask your patients for input. Everything you all do is for them, and they need to be involved.

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Never forget that sooner or later every one of us, even you, will be a patient. How can you ignore such a huge constituent? I ask for your support in considering all the issues I raise in this letter. It has been an honor for me to associate with each and every one of you.

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PHYSICIANS AND CANCER PATIENTS: COMMUNICATION AND ADVANCE DIRECTIVES Peter Angelos and Muneera R. Kapadia

INTRODUCTION Over the previous several decades, numerous changes have occurred in the medical care of cancer patients in the United States. Medications and technologies not previously dreamed of are now commonplace as physicians treat patients with various malignancies. In the midst of these diagnostic and therapeutic advances, another significant change has occurred in how physicians talk to patients with cancer. Just a few decades ago, physicians routinely would not discuss a diagnosis of cancer with a patient. Today, such an approach would be unthinkable to most physicians and patients in the United States. In fact, the current emphasis upon advance directives assumes that a level of communication between doctor and patient has occurred. In the following chapter, we will explore the changes that have occurred in what physicians disclose to patients about their disease. A historical approach will be taken to emphasize the contrast between what is accepted today as standard of care as compared to that which was the standard in the past. Truth-telling can be seen as but one component of physician–patient communication, yet this aspect of communication is particularly illustrative of the underlying physician–patient relationship. Truth-telling is a complex issue in communication. It involves the philosophical question of, What is truth?” Truth about a patient’s condition is a combination of both subjective and objective factors, and may change over time; it is dynamic.1 ”

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Furthermore, it involves the historical, cultural, and social influences that affect how illness is understood by physicians and patients. In the upcoming chapters, Kathryn Hunter and Tod Chambers will address broader issues of communication and cultural influences, respectively, that influence the care of cancer patients. In the current chapter, truth-telling by physicians will be taken to mean the honest transmission of what is accepted medical knowledge at a given time. In other words, truth-telling is what doctors tell their patients about the diseases from which the patients suffer. Medical knowledge must be seen as changing. In order to be truthful, physicians must acknowledge the uncertainty of medical “facts” when they are communicated to patients.2 The changes in communication with cancer patients that can be traced over previous decades largely reflect the changing paradigms of the physician–patient relationship. The earlier paradigm conceived of the patient as passive, whereas this has now shifted to a paradigm in which the patient is an active participant in the decision making. In this context, the current emphasis on advance directives can be seen as an attempt to further extend patient autonomy. Living wills and durable power of attorney for healthcare documents will be considered in relation to doctor– patient communication. Recent studies of the use of advance directives will be examined in relation to the possible benefits to patients. THE PHYSICIAN–PATIENT RELATIONSHIP AND COMMUNICATION Paternalism Until recently, the longstanding paradigm model of the physician– patient relationship was that of paternalism. According to this model, the doctor was cast as the knowledgeable and concerned father, who is active, and the patient as the passive child, dependent on the father. Physicians were best positioned, according to this view, to make decisions for their patients because physicians possessed superior medical knowledge. The physician could thereby

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make decisions for patients because the physician knew best what would be of medical benefit to the patient. This view of the physician–patient relationship assumed that patient benefit always was identical to medical benefit. In other words, when determining how to best benefit a patient, a physician needed only to consider what would be best from a medical point of view. There was no need to consider the patient’s particular values or goals because they were irrelevant to the issue of what decision would best treat his or her disease or illness. Of course, this view fails to acknowledge an individual patient’s value system, cultural beliefs, or religious beliefs. Truth and Communication Based on this conception of the physician–patient relationship, there was little need for physicians to communicate potentially upsetting information to patients about diagnoses of cancer because the physicians were the ones making decisions for their patients. Review of the literature of the 1950s and 1960s suggests that the majority of physicians would not discuss a diagnosis of cancer with a patient. In 1953, Fitts and Ravdin surveyed 442 Philadelphia physicians regarding what they tell patients with cancer.3 Of the respondents, 57% said that they “usually do not tell,” and 12% said they “never” tell the diagnosis of cancer to the patient. In a 1961 study from Michael Reese Hospital in Chicago, Oken reported similar results with 88% of physicians interviewed stating that they generally did not tell the patient a diagnosis of cancer.4 The justification for not communicating a diagnosis of cancer with a poor prognosis was the belief that it might lead the patient to lose hope. In contrast to the widespread practices of physicians in not communicating a diagnosis of cancer, a number of studies show that patients, even at that time, did not agree with the approaches taken by physicians. In each of three separate studies of cancer patients or their families published between 1950 and 1957, at least 81% of patients wanted to know of their diagnosis of cancer.5,6,7 The discrepancy between what physicians reported they told patients about cancer and what patients wanted to know is not an

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isolated finding within the United States. In 1964, 350 Christian Japanese doctors were asked what they would tell patients regarding a diagnosis of cancer. Of the 132 respondents, only 16% of the physicians reported telling the patient the diagnosis, while 76% answered that they would only tell the diagnosis to the patient’s family and not directly to the patient.8 In comparison, a 1963 survey of 4300 Japanese citizens revealed that 90% wanted to be told their diagnosis if they were to develop cancer.8 SIGNS OF CHANGE In recent decades, many changes in society have occurred which have affected the paternalistic paradigm of the physician–patient relationship. For numerous reasons, people came to increasingly question authority. Physicians, seen as figures of authority, were questioned and “what the doctor said” came to be seen as just a recommendation rather than a decision. Within society, the rise of the consumer rights movement further encouraged patients to become dissatisfied with paternalism as a paradigm for medical care. Patients increasingly wanted to assert control over their bodies by participating in medical decision making. In competition with paternalism, respect for patient autonomy arose as a new paradigm for medical care.9 According to this conception of the physician–patient relationship, decision making had to be shared between physician and patient. The patient’s values and choices needed to be respected in determining what would be best for the patient. As such, patient benefit became distinct from medical benefit. In order to determine what would most benefit a patient, the patient’s values needed consideration. For example, a physician could no longer assume that prolonging life was the best thing for every patient. Depending on the particular patient’s values, a shorter life with less pain or suffering might be considered the most beneficial for a particular patient. By according respect for patient autonomy a central role in medical decision making, the paternalistic paradigm of the relationship needed to be exchanged for a shared decision making paradigm. In order for shared decision making to occur, patients needed to be informed of their diagnosis, prognosis, and treatment options.

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Without such information, patients could not participate in decision making with their physicians. It is impossible to determine whether the shift to shared decision making resulted in physicians communicating more information to patients or whether the drive for more information led to the shift toward shared decision making. Regardless of the temporal relationship between these changes, they occurred in close conjunction with one another. Additionally, improvements in diagnostic methods, treatment strategies and prognosis for certain conditions resulted in an increasing need to better inform patients to increase compliance and understanding of complex interventions.10 If patients do not understand their disease process and the proposed plan of action, they are less likely to comply. The dramatic changes that occurred in doctor–patient communication can be seen by examining the 1979 study by Novack et al.11 These investigators, also working at Michael Reese Hospital in Chicago, administered a virtually identical survey to the one reported by Oken in 1961. In contrast to Oken’s finding that 88% of physicians generally did not tell the patient a diagnosis of cancer, the later investigators found that 98% of physicians reported that their general policy is to tell the patient of a diagnosis of cancer. This dramatic change in a single institution reflects many influences on the physician–patient relationship and provides evidence that in contemporary practice, there are few physicians who withhold the diagnosis of cancer from their patients. Moreover, numerous authors in the medical ethics literature have suggested that there can be little, if any, justification for withholding the diagnosis of cancer (or anything else) from a patient. 9,12,13,14 In the contemporary medical care of the cancer patient in the United States, little can be found in the literature exploring whether patients are told their diagnosis. The importance of shared decision making has so fully supplanted the previous paternalism that few physicians would ever think of not communicating a diagnosis of cancer with a patient. Currently, the question is not whether to tell, but how much to tell. In other words, even though patients are told they have cancer, how much detail they should be provided about prognosis and treatment options continues to be an issue. Outside the United States, questions of truth-telling involving the diagnosis continue to be raised.15 However, within the

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United States, despite the general acceptance of the importance of patients making informed decisions, evidence suggests that some patients may be given less evidence than they would like. A 1982 national survey found that 96% of Americans wished to be told if they have cancer and 85% said that they wanted a “realistic estimate” of their life expectancy if their type of cancer “usually leads to death in less than a year.”16 Nevertheless, in the same year, when faced with a patient who has confirmed lung cancer at an advanced stage, only 13% of physicians surveyed said that they would give the patient a “straight statistical prognosis.” Twentyeight percent of physicians stated that they would merely tell patients that the prognosis was uncertain, but that “in most cases people live no longer than a year.”16 These numbers suggest that even though patients are told of their diagnosis, they may still lack the detail of information that they want to make decisions. How much Should Patients Be Told About Poor Prognoses? The issue of the detail of information provided to patients was raised formally in a lawsuit involving a patient with recurrent pancreatic carcinoma.17 In his insightful examination of this case, Annas describes the central issue as, “whether the law should require physicians to report statistical life-expectancy data to their patients in cases of illness that is likely to be terminal.”18 Although some of the legal issues raised in the case are beyond our scope of interest for this chapter, the case is worthwhile to review because of its emphasis on the questions of what the patient was told and when. The Case of Miklos Arato18 A 43 year old electrical contractor undergoing exploratory laparotomy was found to have a tumor in the tail of the pancreas. The surgeon resected the tumor and on pathological evaluation, it was found to be 2 centimeters in size with two out of twelve resected lymph nodes positive for metastases. After surgery, the surgeon told Mr. Arato and his wife that he thought all the tumor had been removed and referral was made to an oncologist. (One might

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consider at this point whether the lack of discussion of Mr. Arato’s prognosis by the surgeon is problematic.) The patient was subsequently evaluated by an oncologist. During the initial evaluation, Mr. Arato filled out an 18-page survey in the physician’s office. He answered “yes” to the question, “If you are seriously ill now or in the future, do you want to be told the truth about it?” The patient was told that there was substantial chance of recurrence, and that a recurrence would mean that the cancer is incurable. The oncologist recommended chemotherapy and radiation treatments on an experimental protocol, even though he acknowledged to the patient that there is a substantial chance of recurrence. The oncologist was neither asked for, nor volunteered a prognosis. (Again, the expected prognosis was not discussed with Mr. Arato or his wife.) While participating in the clinical trial and receiving treatment, 9 months after the initial diagnosis of carcinoma was made, a recurrence was detected. Even though the physicians treating Mr. Arato believed that his life expectancy could be measured in months, they did not tell him so. The patient died three months later. After his death, the wife and two adult children brought suit against the surgeon and oncologist alleging that the patient was never told that approximately 95% of the patients with pancreatic cancer die within 5 years. They claimed that Mr. Arato would have made different decisions regarding his business and his choice to participate in the clinical trial if he had been given a “statistical prognosis.” The doctors justified nondisclosure of statistical prognosis largely on grounds of medical paternalism. They claimed that reporting extremely high mortality rates might “deprive a patient of any hope of a cure.”18 The physicians noted that in over 70 visits with them over a one year period, the patient avoided ever specifically asking about his own life expectancy and this indicated that he did not want to know the information. In addition, all the physicians testified that the statistical life expectancy of a group of patients has little predictive value for a specific patient. Although on appeal to the California Supreme Court, the case in the lower court was ultimately decided in favor of the

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physicians. The legal decision reached in this case is less important than the questions raised. Specifically, what does it mean to inform a patient of something? Treatments are not begun on patients without informed consent. Does a patient need to be given statistics in order to be fully informed? Certainly there is much more to good communication than the recitation of statistics. Yet, either by design or by default, the doctors in the Arato case seem to have kept silent about important information regarding the patient’s prognosis. Quirt and co-authors have shown that doctors often are poor judges of whether their patients actually understand the prognosis and goals of medical treatment.19 Nevertheless, one would hope that a good physician–patient relationship would give the physicians sensitivity to the patient or family’s unreasonable expectations of the patient,s life span. Despite this suggestion that there is some problem with how the physicians communicated with the patient and his family in this case, there is also clearly a problem with the relationship on the , patient s side as well. Mr. Arato should have played a more active role in seeking information about his prognosis if he was making significant business decisions on the basis of his assumptions about life expectancy. Often a lawsuit is a good indication of a problem with a relationship. In the Arato case, the physician–patient relationship seems to have failed to develop to the point where good communication between the parties was possible. The most important lesson to be learned from this case is that truth-telling must be grounded in a physician–patient relationship. The Arato family would have had little to complain about if the physicians had communicated their suspicions of his life expectancy even if they had not used statistics. EXTENDING PATIENT AUTONOMY: ADVANCE DIRECTIVES In the previous paragraphs, we have traced changes in physician– patient communication from one of often withholding the diagnosis of cancer from patients in a paternalistic approach to medical decision making, to one of uniformly communicating such a

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diagnosis in a shared decision making approach. Over the last two decades the emphasis on respect for patient autonomy has led to the concept of advance directives. Advance directives commonly take the form of a living will or durable power of attorney for healthcare document. These instruments may be seen as methods for patients to extend autonomy into periods of their lives when they are not competent to make choices for themselves. Living Wills and Durable Power of Attorney for Healthcare Just as a physician has a moral obligation to abide by a competent patient’s choices, a physician also has a moral obligation to abide by the choices designated in an advance directive. If the advance directive takes the form of a living will, the patient has defined a set of circumstances and therapies that are not acceptable. For example, a patient with widely metastatic breast cancer and recurrent malignant pleural effusions may decide that should she be in a situation where intubation and long term ventilation are required to prolong her life, she does not want to have her life prolonged in such a manner. Even if the patient is not competent at the time that intubation and ventilation are required, the choices that she made earlier in refusing such therapy can be acted upon and the patient’s previous autonomous choices respected. If the advance directive takes the form of a durable power of attorney for healthcare document, rather than setting forth guidelines for choices of therapy, the patient designates a person that will make decisions for him or her once the patient can no longer do so. Although advance directives have only become widely discussed in the medical ethics literature over the last 10–15 years, they are not a new development. In fact, living wills and durable power of attorney for healthcare documents are best thought of as simply formal advance directives. In contrast, informal advance directives are the instructions that patients have been giving family members and friends for decades as guides to what the patient would want done in certain situations. For example, even though a 70-year old man having a left hemicolectomy for cancer may have never filled out any documents or forms, by telling family members that he

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would never want to be kept alive on dialysis, he has expressed a clear informal advance directive. The Patient Self-Determination Act The benefits of formalizing one’s choices so that family, friends, and physicians abide by one’s choices have made formal advance directives increasingly appealing to many patients. Furthermore, the Patient Self-Determination Act (PSDA) has encouraged more widespread use of advance directives.20 This federal regulation of 1991 mandates that any hospital participating in Medicare ensure that all patients admitted to the hospital be asked if they have an advance directive and be given information about advance directives. Despite the PSDA and efforts to increase the use of advance directives, several studies have shown that among large groups of patients, advance directives are not widely used and have not significantly affected patient care.21,22,23,24 There are several possible reasons for the lack of use and effectiveness of advance directives in these studies. First, not enough patients have seriously considered the possibility that they could benefit from an advance directive. Thus, too few patients have an advance directive. Second, even if they have an advance directive, few patients bring them to the hospital or inform their physicians that they have one. Third, even if a patient has advance directives, these advance directives must be interpreted appropriately by surrogates and physicians. Ditto and colleagues reported a randomized controlled trial in which patients were instructed to complete advance directives and surrogates were asked to predict their loved one’s wishes. Surrogates given advance directives were no more successful in their predictions than those who had not been given advance directives.24 Additionally, a patient’s desires for type and extent of treatment may vacillate depending on their emotional or physical state, making it more difficult for family and physicians to accurately predict.25 Finally, the PSDA itself may be poorly conceived as a means of increasing advance directive use. The PSDA requires information about advance directives to be given to patients at the time they are admitted to the hospital if they do not already have an advance

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directive. In the midst of a hospital admission, a patient may be poorly prepared to have the types of thoughtful discussions with family, friends, or physicians that are necessary prior to implementing an advance directive. Advance Directives and the Cancer Patient Among cancer patients, one might expect to find greater use of advance directives. In contrast to the average person, most patients with cancer have at least considered the possibility of their mortality. Furthermore, they have often had numerous interactions with physicians and other health care providers over a longer period of time. Despite these assumptions, there is evidence to suggest that even among patients with cancer, significant impediments to advance directive use are present. As part of the SUPPORT Study, Haidet and colleagues have examined preferences for resuscitation among patients with metastatic colorectal cancer.26 These investigators found that there is substantial misunderstanding between patients and their physicians about prognosis and treatment preferences. Even though 37% of patients did not want cardiopulmonary resuscitation (CPR) in the event of a cardiopulmonary arrest, less than half of this group had a DNR note or order in the chart. Furthermore, physicians incorrectly identified CPR preferences in 30% of cases. Angelos and Johnston suggested that patients with malignancies undergoing elective high-risk surgical procedures might be best situated to benefit from an advance directive.27 However, in their review of patients undergoing esophagogastrectomy for esophageal cancer or Whipple procedure for pancreatic cancer, very few patients had an advance directive at the time of admission for surgery. In a subsequent study, Yang and colleagues examined the use of advance directives in a similar patient population over a 6 year period.28 Interestingly, the number of patients with advance directives increased over time from 3/43 in 1996 to 20/46 in 2001, suggesting increased awareness of advance directives since the study began. However, the number of advance directives actually found in patient charts remained low, and thus the effect of advance directives on patient care was determined to be uncertain.

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Even if oncology patients have discussed their wishes with family members and even if they have formal advance directives, they often do not share that information with their oncologists.29 Lamont and Siegler administered a verbal survey to cancer inpatients to determine the frequency of advanced care planning in hospitalized patients. Only 33% reported having an advance directive. Of the 111 patients surveyed, only 9% discussed their advanced care preferences with their oncologist; even more surprising, of the remaining patients, only 23% expressed wishes to do so. Three general reasons were given for not wanting to discuss advanced care planning with oncologists: 41% felt it was personal or a family matter; 33% thought it was not medically warranted at the time; 22% felt it would interfere with their optimism towards their condition.30 Undoubtedly psychological factors on the part of physicians and patients often impede discussions of advance directives among patients with cancer. Sahm and colleagues conducted a survey among cancer patients, healthy patients, nurses and physicians (n = 100 per group) to determine who should initiate the process of designating advance directives. The most popular choice in all surveyed groups was the physician; however, of physicians surveyed, only 39% had ever mentioned advance directives to their patients.31,32 Moreover, physicians may not want to raise the issue for fear that patients will be upset about the discussion of end-of-life issues. Patients may not want physicians to believe that they are “giving up.” Nevertheless, the presence of an advance directive can be particularly beneficial in the long term care of the cancer patient. The patient and physician both acknowledge the issues that may be relevant at a later stage of the disease and lay the foundation for continuing discussions. Often patients may benefit if these discussions involve both the primary physician and the oncologist.33 The patient then has the opportunity to discuss the issues with different physicians as well as family or friends over a longer period of time. Even if the advance directive never actually makes a significant difference in the patient’s treatment, the very fact that an advance directive was present may be comforting to the patient (and possibly even the physician). The closest analogy to this potential

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benefit is that of a life insurance policy for a 25 year old with dependents. Even though the likelihood that any 25 year old will actually use the life insurance policy is low, the fact that the policy is present may have tremendous psychological benefits. Similarly, advance directives may prove to have benefits to cancer patients beyond what can be measured in medical interventions or outcomes. Such potential benefit would argue in favor of physicians caring for cancer patients adopting a means of raising the issue of advance directives in a consistent manner early in the care of such patients. Perhaps someone involved in the patient’s care other than the physician should initially raise the topic. For example, a nurse or social worker might be able to begin the discussion with the expectation that the physician and patient will continue the dialogue. By so doing, patients and physicians might be more consistently able to have the important discussions necessary for an advance directive to be useful. CONCLUSIONS Over the preceding pages we have explored the changing paradigms of the physician–patient relationship and how physician–patient communication has been affected by these paradigms. The paternalistic approach with the tradition of not disclosing a diagnosis of cancer to a patient has given way to a shared decision making approach in which patients must be informed in order to participate in the decisions about what is the optimum care. In current medical practice, patient’s autonomy must be respected and they must therefore be adequately informed in order to make decisions. In this setting, the issue is not whether to tell a patient he or she has cancer, but how to best inform them of their condition and prognosis. As with so much of medical care, an individualized approach to communication with a patient is the optimum. By being sensitive to the patient’s particular needs, a physician will be able to honestly and effectively provide the patient with the information needed to make good decisions. Advance directives can be seen as an extension of respect for patient autonomy and a natural goal for physician–patient communication. Even though living wills and durable power of

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attorney documents are not currently widely used, they may provide benefits in the cancer patient that go beyond the measurable outcomes of duration of life or resuscitation attempts. Consideration of advance directives may provide patients the impetus to discuss significant issues with family, friends, and physicians that might otherwise be avoided. Furthermore, the presence of an advance directive might give the cancer patient a comforting sense of control over decisions that would need to be made should the patient ever lack the ability to exercise autonomy. For these reasons, physicians caring for cancer patients should consider any method possible to enable such discussions to routinely be raised with their patients. REFERENCES 1.

Surbone A. Telling the truth to patients with cancer: what is the truth? Lancet Oncology 2006; 7:944–950. 2. Norton L. Truth, science and the oncologist. Ann N Y Acad Sci 1997; 809:66–71. 3. Fitts W, Ravdin I. What Philadelphia physicians tell patients with cancer. JAMA 1953; 153:901–904. 4. Oken D. What to tell cancer patients: a study of medical attitudes. JAMA 1961; 175:1120–1128. 5. Kelly WD, Friesen SR. Do cancer patients want to be told? Surgery 1950; 27:822–826. 6. Branch CHH. Psychiatric aspects of malignant disease. CA: Bull Can Prog 1956; 6:102–104. 7. Samp RJ, Curreri AR. Questionnaire survey on public cancer education obtained from cancer patients and their families. Cancer 1957; 10:382–384. 8. Akabayashi A, Fetters MD, Elwyn TS. Family consent, communication, and advance directives for cancer disclosure: a Japanese case and discussion. J Med Ethics 1999; 25:296–301. 9. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 1994. 10. Gordon EJ, Daugherty CK. Hitting you over the head: Oncologists’ disclosure of prognosis to advanced cancer patients. Bioethics 2003; 17:142–168. 11. Novack DH, Plumer R, Smith RL Ochitil H, Morrow GR, Bennett JM. Changes in physicians’ attitude toward telling the cancer patient. JAMA 1979; 241:897–900.

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12. Veatch RM. A theory of medical ethics. New York: Basic Books; 1981. 13. Pellegrino E, Thomasma DC. A philosophical basis of medical practice: toward a philosophy and ethic of healing professions. New York: Oxford University Press; 1981. 14. Katz J. The silent world of doctor and patient. New York: The Free Press, 1984. 15. Surbone A, Zwitter M. Communication with the cancer patient: information and truth. Ann N Y Acad Sci 1997; 809. 16. Making health care decisions: the ethical and legal implications of informed consent in the patient-practitioner relationship. In President’s commission for the study of ethical problems in medicine and biomedical and behavioral research. Washington, DC: US Government Printing Office; 1982:245–246. 17. Arato v Avedon, 5 Cal. 4th 1172,23 Cal. Rptr.2d 131,858 P.2d 598, 1993. 18. Annas GJ. Informed consent, cancer, and truth in prognosis. N Engl J Med 1994; 330:223–225. 19. Quirt CF, Mackillop WJ, Ginsburg AD, Sheldon L, Brundage M, Dixon P, Ginsburg L. Do doctors know when their patients don’t? A survey of doctor-patient communication in lung cancer. Lung Cancer 1997; 18:1–20. 20. Cox DM, Sachs GA. Advance directives and the patient selfdetermination act. ClinGeriatr Med 1994; 10:431–443. 21. Emanuel EJ, Weinberg DS, Gonin R, Hummel LR, Emanuel LL. How well is the patient self-determination act working – an early assessment. Am J Med 1993; 95:619–628. 22. Teno JM, Lynn J, Phillips RS, Murphy D, Youngner SJ, Bellamy P, Connors AF, Desbiens NA, Fulkerson W, Knaus WA. Do formal advance directives affect resuscitation decisions and the use of resources for seriously ill patients. J Clin Ethics 1994; 5:23–30. 23. Silverman HJ, Tuma P, Schaeffer MH, Singh B. Implementation of the patient self-determination act in a hospital setting – an initial evaluation. Arch Intern Med 1995; 155:502–510. 24. Ditto PH, Danks JH, Smucker WD, Bookwala J, Coppola KM, Dresser R, Fagerlin A, Gready RM, Houts RM, Lockhart LK, Zyzanski S. Advance directives as acts of communication – a randomized controlled trial. Arch Intern Med 2001; 161:421–430. 25. Ditto PH, Hawkins NA. Advance directives and cancer decision making near the end of life. Health Psychol 2005; 24:S63–S70. 26. Haidet P, Hamel MB, Davis RB, Wenger N, Reding D, Kussin PS, Connors AF, Lynn J, Weeks JC, Phillips RS. Outcomes, preferences

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27. 28. 29. 30. 31. 32.

33.

P. Angelos and M.R. Kapadia for resuscitation, and physician-patient communication among patients with metastatic colorectal cancer. Am J Med 1998; 105: 222–229. Angelos P, Johnston C. Advance directive use among patients undergoing selected high-risk surgical procedures. Quality Management in Health Care 1999; 7:1–3. Yang AD, Bentrem DJ, Pappas SG, Amundsen E, Ward JE, Ujiki MB, Angelos P. Advance directive use among patients undergoing highrisk operations. Am J Surg 2004; 188:98–101. Lamont E. With whom will oncology patients discuss advanced care planning? 1998. Presented at The Tenth Annual Mrs. John MacLean Conference. Lamont EB, Siegler M. Paradoxes in cancer patients’ advance care planning. J Palliative Med 2000; 3:27–35. Sahm S, Will R, Hommel G. Attitudes towards and barriers to writing advance directives amongst cancer patients, healthy controls, and medical staff. J Med Ethics 2005; 31:437–440. Sahm S, Will R, Hommel G. What are cancer patients’ preferences about treatment at the end of life, and who should start talking about it? A comparison with healthy people and medical staff. Support Care Cancer 2005; 13:206–214. Doukas DJ, Doukas MA. Considering advance directives for oncology patients. Primary Care 1998; 25:423–431.

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INFORMATION IS NOT ENOUGH: THE PLACE OF STATISTICS IN THE DOCTOR–PATIENT RELATIONSHIP Kathryn Key Montgomery and Ellen Key Harris-Braun

INTRODUCTION The hero of Leo Tolstoy’s The Death of Ivan Ilych is a man of “incorruptible honesty,” who prides himself on his work as an examining magistrate. “He never abused his power…,” but the consciousness of it and of the possibility of softening its effect supplied the chief interest and attraction of his office.... [H]e very soon acquired a method of eliminating all considerations irrelevant to the legal aspect of the case, and reducing even the most complicated case to a form in which it would be presented on paper only in its externals, completely excluding his personal opinion of the matter….1 This professional disinterest, a bureaucratic ideal after the 1861 Russian judicial reform, was a great improvement on the favoritism and bribery that preceded it, and Ivan Ilych polishes detachment to an art, devoting his career to its perfection. His goal is to exclude everything fresh and vital, which always disturbs the regular course of official business, and to admit only official relations with people, and then only on official grounds…. Ivan Ilych possessed this capacity to separate his real life from the official side of affairs … in the highest degree and by long practice and natural aptitude had brought it to such a pitch that sometimes, in

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the manner of a virtuoso, he would even allow himself to let the human and official relations mingle. He let himself do this just because he felt that he could at any time he chose resume the strictly official attitude again and drop the human relation. And he did it all easily, pleasantly, correctly, and even artistically.2 When Ivan Ilych seeks advice from a physician about a persistent pain in his side, he encounters a professional with a demeanor very like his own: There was the usual waiting and the important air assumed by the doctor, with which he was so familiar…and the questions which called for answers that were foregone conclusions and were evidently unnecessary…. To Ivan Ilych, only one question was important: was his case serious or not? But the doctor ignored that inappropriate question. From his point of view it was not the one under consideration; the real question was to decide between a floating kidney, chronic catarrh, or appendicitis. It was not a question of Ivan Ilych’s life or death, but one between a floating kidney and appendicitis. And that question the doctor solved brilliantly….3 Not entirely daunted, Ivan Ilych presses the matter: He…rose, placed the doctor’s fee on the table, and remarked with a sigh: “We sick people probably often put inappropriate questions. But tell me, in general, is this complaint dangerous, or not?” The doctor looked at him sternly over his spectacles with one eye, as if to say: “Prisoner, if you will not keep to the questions put to you, I shall be obliged to have you removed from the court.” “I have already told you what I consider necessary and proper. The analysis may show something more.” And the doctor bowed.4

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A century and a quarter later, medical care differs in many crucial ways, but every patient’s most important question is still, like Ivan Ilych’s, a question about life and death. As Nicholas Christakis has documented, when the outlook is grim, physicians too often shrink from offering a prognosis.5 Their patients’ burning question may not be as rudely deflected as it was by Ivan Ilych’s physician, but in contemporary practice the answer is avoided and statistics offered in its place. The patient’s cancer, let’s say, has a 5-year disease-free survival rate of 75%. Good odds, as things go. What should the physician say to the patient? How much information does the patient need? And what part should statistics play in the answer? WHAT DO PATIENTS WANT? Physicians know that patients want to know about their diagnosis, but research shows they underestimate how much. Peter Angelos’s study of the quality and quantity of information provided to patients with breast, colon, and pancreatic cancer suggests that two in thirteen patients receive too little information and that they want physicians to supply more detail than physicians themselves are comfortable offering.6 Not only do some patients want more information than physicians think they do, the concept of “enough” differs substantially among patients. This mismatch of expectation can have benign sources. Physicians who are confident of the therapy they offer want to prevent worry, preserve hope, and insure that needed procedures are done in a timely fashion. They are reluctant to disturb the patient, delay treatment while fears are allayed, or diminish the patient’s trust and thus perhaps lessen any placebo effect that might speed recovery. Yet D. D. Kerrigan and colleagues found that patients awaiting elective hernia repair experienced no increase in presurgical anxiety following a very detailed account of what might go wrong during the procedure. They argue that full disclosure would reduce the potential for malpractice claims without adverse consequences for patients.7 There are also practical obstacles to providing more information. Time pressure shortens conversations, and when physicians do attempt to inform patients more fully, there is no

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guarantee that information given today will be recalled tomorrow. It is not uncommon for a physician to explain a diagnosis, outline the prognosis, and describe the treatment choices, only to have the patient later seem never to have been told much at all. When cancer is the diagnosis, there is the added burden, one that never entirely disappears, of delivering truly bad news. Although only a handful of patients—far fewer than in the past—want not to know, no one really wants to hear that he or she has cancer. Even if the cure rate were 100%, the treatment is still severe and life-altering, and the social meaning of the disease remains complicated and dire. It cannot be easy to be the agent of a patient’s painful discovery of an altered body, limited potential, or a shortened life. Thus, it is not surprising that even the most experienced clinicians often recoil from this repetitive duty to inform, especially since—despite its value in the patient-physician relationship—it seems to many to have been imposed on that relationship by lawyers and bioethicists.8 Physicians understandably move to spare their patients—and spare themselves in the bargain. Even a subtle reluctance is likely to affect the time and attention they give the task and the amount and character of the information transmitted. INFORMATION AND REASSURANCE A failure to provide enough information may also be fueled by the physician’s sense that patients and their families are asking for more than information, a perspective on mortality that physicians may not be prepared to provide. Sick people facing prolonged treatment need reassurance, especially when the treatment is painful and lifethreatening or toxic in itself. Most reassuring would be prognostic certainty, the confidence that treatment will work and the patient will be cured and restored to normal life. A great many patients and their families look to science for this reassurance, as our culture has taught us to do. Gathering information about their disease and the treatment choices is an attempt to hold on to a sense of predictability in the world. If life eludes control, at least we can understand how it has gone awry and how best to restore normality. But scientific information is only part of what patients need, even those “intellectualizers” who are hungry for the facts. Data must be interpreted, evidence pieced together, and information

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sorted for its relevance to one particular patient. Just as most physicians have found a wide middle ground between lying to patients and “truth-dumping,”9 so it is possible to find a way between the stonewalling “trust me” (with a pamphlet at best) and launching into a short course in pathophysiology with a brief excursus into cell and molecular biology. The middle ground is large enough for every physician to find a comfortable position for almost every patient. What is less clear is whether the numbers—the statistical results of clinical studies required by evidence-based medicine—should be a part of the information that is offered to patients. IN PLACE OF CERTAINTY A cancer diagnosis heightens the question of the role statistics should play in good patient care. If the prognosis is at all hopeful, there is no certainty. Except near the end of life, patients and physicians are stuck with the odds. Facts are helpful for both decision-making and for a sense of control, but the limits of biomedical information are nowhere more pointed and painful than in the use—and almost unavoidable abuse—of statistics. In their need for certainty, patients ask for scientific answers. What they get—or find on the Internet—is probabilities. Chance. The numbers are, after all, “the facts”—or their most nearly accurate representation. Yet, especially for prognosis, statistics are profoundly unsatisfying. In part this is because they are perceived so variously and so subjectively. In the 1970s Daniel Kahneman and Amos Tversky studied the psychology of risk assessment and the wide range of attitudes to risk that influence behavior. They described how the way a statement of probability is framed influences its effect and how common decision strategies, themselves based on probabilities, lead people to do such things as overestimate the importance of very low and very high percentages.10 Education and experience do not alter this subjectivity. When one of us (KKM) began to teach in a medical school, she kept a folder of articles and stories labeled “Sick Docs,” and the best was by a physician at Johns Hopkins, who after his treatment

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for cancer became obsessed with the insidious threat of recurrence. His prognosis was good: the chance of disease-free survival for his diagnosis was solidly above 90%. He understood the statistics as well as anyone, but the number was no help. After weeks of debilitating anxiety, he realized that to get on with his life he had to come to terms with his lifelong record of ranking in the very top percentiles. He had been assuming he would be in that last decile this time, too. Should he not have been told that percentage? Should he have been discouraged from investigating the studies on his own? It’s hard to think such restraint would have been successful, even before the Internet. Survival statistics, especially the facts about recurrence, long ago entered the consciousness of the average citizen without a medical degree. These days, patients regularly ask physicians whether they will recover from their disease knowing that clinical studies offer the best available data. They expect to hear the numbers that pertain to them and their diagnosis. It’s science, after all. The beauty of statistics is that they provide a scientific answer; they seem to represent a sometimes difficult but desirable honesty. They sum up the most, the best that is presently known about a disease and its stages. Statistics are the best science can do. Surely they should answer the patient’s most pressing question. But, of course, they do not. Even as patients want more information than they presently receive—including statistics—those facts are only a stand-in for the reassurance patients need. Statistical information not only does not provide this reassurance but is often counter-productive. A wise oncologist once said he uses statistics all the time in making clinical decisions but seldom mentions them to his patients. When, as often happens, they arrive in his office armed with printouts hot off the National Cancer Institute Web site, he suggests they not put too much stock in them: “You don’t want to be like the man with his head in the oven and his feet in the refrigerator,” he tells them. “His head was hot, his feet were cold, but on average he was just fine.” Not that the information they find is wrong, but it may not apply usefully to their circumstances. And even when it does, who’s to say what their particular fate will be? There is no certainty. If physicians are to provide support and honest reassurance, they must use something more than numbers.

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Besides, once known, the numbers deceive. Statistics, however helpful, are inevitably limited and misleading. “Does it look bad for me?” Statistics don’t say. No one survives 82%. Survivors survive entirely; those who die are completely dead. Nor does the number predict the disease-free interval. Although it can happen, a person with an 82% chance of surviving 5 years without a recurrence is unlikely to find the disease recurring a month and a half into the fifth year, when only 18% of the 5 years remains. No matter how promising the numbers, there is no certainty that this particular patient will do well. And worse, as Alvan Feinstein argued in his last dozen years, medicine’s reliance on imported mathematical models—including Bayesian inference and evidencebased medicine—eliminates the very clinical details that may be useful for discriminating among cases.11 Not only do statistics fail to answer the patient’s life-or-death question, they may exacerbate the uncertainty while making it painfully real. What then should a physician tell a patient? STATISTICS AND TREATMENT CHOICE The prognostic numbers are non-specific gamblers’ odds that apply uncertainly to a particular patient. But when it comes to treatment choice, the statistical results of clinical studies can be quite useful. Patients are not then in search of certainty—though it would be welcome—but rather some guidance in choosing the therapy that will shape their lives for at least the coming months. They need to be told as much as they want to know about the available regimens, their side effects, and how they can be lessened: therapy for the therapies. When treatment options are evenly weighted or when a loss, temporary or permanent, will be the consequence of disease or its treatment, every scrap of data helps many people to make the necessary decisions. Once the decisions are made, study results enable patients to understand and follow their treatment plans. They make sense of tests, justify adjuvant chemotherapy, and restore a sense of choice that can ease the disaster of having cancer. Data may even offer hope, sustaining patients through bad times. No wonder many patients want the most minute detail. Conveying this avalanche of information is difficult. Some recommend that patients bring a family member to the appointment,

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or a tape recorder, or both. Sidney Bogardus and colleagues suggest that physicians use a variety of formats—qualitative, quantitative, graphic—to communicate information about risk: numbers, words, and charts.12 Numbers alone, they argue, are inadequate. All this is good advice. But what is most important, we believe, is the physician’s time and attention to the task. A cancer diagnosis sends patients down the rabbit hole into a confusing new world of tests, specialists, specialized vocabulary, trials, treatments, side effects, side-effect medications, and support organizations. Patients who want help in making the decisions about their treatment need a guide and educator, not just a pamphlet or a Web site or a tape recording of one of the 13 worst times in their life. When one of us (EKH-B) was diagnosed with breast cancer in the mid-1990s, she was sent to a surgeon who enjoyed explaining the details of breast-cancer surgery and staging to her and her husband. Both appreciated this help in becoming competent in the details of her illness. When it was time for chemotherapy, she searched for and found an oncologist who was willing to meet her need for information, provide context for studies, and lay out her treatment options in a way that was usefully clear and complete. Her first oncology appointment, after surgery, took up the allotted time in a busy clinic without coming to closure on a treatment choice. The physician had a lecture to deliver, but suggested the patient and her husband return in an hour to finish the discussion. Over ice-cream cones, the patient and her husband organized the information they had been hearing into a rough five-column chart, one column for each of five treatment options (Fig. 1). “Oh, great!” said the oncologist when they showed it to her, and began filling in the blanks, explaining as she went and adding more rows for side effects. They left the appointment having heard a great deal about breast-cancer treatment in general and with a tool for not only recalling that information but for deciding which treatment choice was right for them. The multi-celled page reflected their own plans and worries, the importance they placed on various side effects, and their level of comfort with new therapies.

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Fig. 1. Treatment options for a young woman with early breast cancer (1995)

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The main elements of this exemplary patient encounter were first, that the physician was willing and able to give them her attention and time, and second, the personalized chart that captured the information they needed. Keys to the chart ,s success as a tool were that it was created during the appointment, guided by and guiding the discussion among patient, spouse, and physician; that the physician provided explanations as she filled in the cells, making sure they understood them; and that the chart was customized to cover their available therapy choices alone. While a skeleton chart could be made up in advance, filling in the boxes—and sketching in new, relevant ones—was a far better way of introducing a patient to the complexities of adjuvant therapy for breast cancer than giving out a pre-printed handout covering the same information. BEYOND THE NUMBERS The yawning chasm between the probable facts and the need for certainty is not unique to cancer care. Given that there is little certainty in other aspects of life—even aspects equally governed by the laws of science (think of flying, cooking, meteorology)—why should it exist in medicine? Reassurance, however, is less about certainty than the concerns that lie behind the patient’s quest for certainty. Will the physician do his or her best? Will the patient not be abandoned in making important decisions about treatment or if treatment fails? Physicians can offer reassurance even in the most inauspicious circumstances: that their patients will be well taken care of; that they will make the best possible decisions in their case; that they will not lie to them. Farther along, there can be reassurances about the relief of pain and about not deserting them. Such assurances are not the manifestation of biomedical facts but the manifestation of medical attention, clinical judgment, and a physician’s wisdom and fidelity. These things, too, provide human beings with a sense of control in their lives. There are barriers to providing such non-statistical reassurance. In the United States, the fragmented delivery of health care and the division of clinical labor by subspecialties constitute two of them. A third barrier, however, is more personal and well within an individual physician’s power to remove. It is the failure to acknowledge the patient’s life-or-death question and the temptation

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to avoid it altogether. Knowing that the science of medicine cannot provide anything like the certain answers the patient seeks, some physicians may become cynical about that desire and ignore it, thereby missing an opportunity to offer a different but ultimately more valuable kind of reassurance. How best to live one’s life is the central moral question for every human being, well or ill. A life-defining illness only sharpens the need for an answer. Providing such answers may not be the duty of the surgeon or even the oncologist; but if they are not to be mere technicians, they at least must recognize the existence of the question. This and some advice about ways to address the day-today aspects of life-threatening illness are part of the physician’s work. Such advice may be as simple as pointing out that medicine cannot do the whole work of recovery: even when it cures the disease, the patient will have to work at recovering from the illness and, with cancer, from its treatment. Unless physicians are to become mere biotechnicians, it is never true that they have “nothing more to offer.” There are referrals, Hospice, simple presence. Chronic and degenerative diseases impose an even stronger duty. Dewitt Stettin, Jr’s plea to alter subspecialty practice is still as useful as the day he wrote it. After his macular degeneration was diagnosed, the best physicians in the country, some of them his colleagues, said they “could do nothing more for him.” His New England Journal of Medicine article is a damning enumeration of all the conveniences—a talking watch, the Kurzweil reader, Talking Books—that he was left to discover on his own.14 Physicians’ reluctance to offer non-statistical advice and reassurance is one of the side-effects of medicine’s claim to be a science. The word “science” itself is noble, and the aspirations it evokes are praiseworthy, but the claim—and its eager acceptance by patients and society as a whole—has led to the expectation that medical knowledge is invariant, objective, replicable, and a basis for reliable prediction.15 Yet medicine is not a science, however scientific its knowledge or technological its therapies. It is, as it has always been, the diagnosis and treatment of sick people. Although biology is now the frame for much of medical knowledge, and evidence-based practice draws upon aggregated analyses of clinical studies, clinical knowing is focused on the interpretation of what is happening over a course of time with a particular patient. Such

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knowledge is still called an opinion; the skill used in arriving at that opinion is still called judgment. No one understands this better than surgeons. In their case-based interpretive use of knowledge, physicians resemble judges and medical rationality resembles jurisprudence, the interpretive reasoning lawyers use to construct their cases. Both professions are engaged in practical reasoning, which, Aristotle observed, they also share with practitioners of navigation and moral reasoning.16 In these practical realms, knowledge is particular, experiential, conventionally agreed upon, finely interpreted. Although the areas of agreement may be large, even international and transcultural, physicians (like lawyers, moral reasoners, and navigators) rely on skill and judgment that are taught and practiced, improved and clarified case by case. Biology grounds clinical knowledge and promotes valuable technological advance, but this simply means that medicine has both a body of basic scientific information and, like other practices, a fund of established practical wisdom. That double resource means that clinicians work more like naturalists or economists or archeologists than biochemists or physicists. Medicine’s double store of knowledge and experience is what patients call upon: not just scientific facts but also clinical judgment—including hunches and intuition. This is wisdom of a real-life, practical kind. Some patients may want scientific information; many more will want statistics; but all hunger for information about the world of illness they have entered. “Is it serious, doc?” What we all need to know, in one way or another, is whether we can live with our diseases. Biomedical science, millennial technology, and the advances of evidence-based medicine make this possible for many diagnoses to an extent (and for a length of time) unimaginable a short while ago. But to provide the reassurance patients need, physicians must be willing to go beyond the statistics. CONCLUSION Good physicians have always sensed what patients need. If they cannot assure them of a cure for their disease, then they can speak about the manageability of the disease or, when death is in prospect,

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offer reassurance about the relief of pain and their commitment not to abandon the patient. If these last tasks are not ones that a specialty like surgery usually assumes, then a promise to help the patient find a physician who can make these commitments ranks a close second. Such assistance may threaten a physician’s long-standing wariness about making an empathic connection with patients, but to avoid offering this help risks the opposite danger: protective detachment can harden into an unfeeling shell that will impoverish a physician’s daily experience. The chill professionalism of Ivan Ilych’s day is a misplaced norm. Rita Charon has pointed out that “detached concern” was a description of practice observed by the sociologist Renée Fox and not a prescription for physicians’ attitude to patients.17 Instead, as William Branch and Anthony Suchman suggest, connection with the patient is for many physicians much less exhausting and painful than its avoidance.18 If contemporary practice provides no time for physicians to be more than a bare statistical informant, contemporary practice must be changed. The alternative is the loss of medicine’s identity as a profession, its reduction to a technology or a business enterprise. In the short run—and at the very least—physicians who care for cancer patients need to recognize Ivan Ilych’s burning question in whatever shape their patients ask it. “What are the chances of recovering?” Reliable factual information is needed for choosing treatment. But the best answer for prognosis is not statistics. Numbers are of little use in deciding how to live a life altered by disease and its treatment or one shortened altogether. The best answer to a patient’s life-ordeath question is an acknowledgment that the question is terrifyingly important. “Am I going to die of this?” Whatever the numbers, the answer—details of which the patient must ultimately supply—is how to live with whatever time we have. NOTE The authors are indebted to Peter Angelos, Barbara Burtness, John Merrill, and Henry Ruder. An earlier version of this essay, which appeared in the first edition of this collection, was adapted for inclusion in chapter 12 of Kathryn Montgomery, How Doctors Think: Clinical Judgment and the Practice of Medicine (New York: Oxford University Press, 2006), 189–207.

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REFERENCES 1. 2. 3. 4. 5. 6.

7. 8.

9.

10. 11. 12. 13.

Tolstoy L. The death of Ivan Ilych [1886] translated by Aylmer Maude in The Death of Ivan Ilych and Other Stories (New York: Signet, 1960), 107. Tolstoy, 117–18. Tolstoy, 121. Tolstoy, 122. Christakis N. Death Foretold: Prophecy and Prognosis in Medical Care (Chicago: University of Chicago Press, 1999). Angelos P. Patterns of physician–patient communication: Results of preliminary studies, presented to a symposium in honor of David L. Nahrwold, Northwestern University Medical School, 27 February 1998. Kerrigan DD, Thevasagayam RS, Woods, TO et al. Who’s afraid of informed consent? BMJ 1993, 306: 298–300. Howard Brody, a practicing physician, has nevertheless made information the core of the conversational ethics he describes as essential to primary care—and highly useful in sub-specialty medicine; see The Healer , s Power (New Haven: Yale University Press, 1992). This phrase has been in colloquial use for more than a decade, but there is no better illustration than Reynolds Price’s account of being told his cancer diagnosis in a busy hallway of the Duke University Hospital by two young specialists who then turned and rushed off to other, more important tasks; A Whole New Life: An Illness and a Healing (New York: Penguin/Plume, 1994). Kahneman D, Tversky A. The framing of decision and the psychology of choice. Science 1974, 185: 1124–31. Feinstein AR. Clinical Judgment revisited: The distraction of quantitative models. Ann Int Med 1994, 120: 799–805. Bogardus ST, Holmboe E, Jekel JF. Perils, pitfalls, and possibilities in talking about medical risk. JAMA 1999, 281:1037–41. Roy FH. The functioning brains of physicians should be

“guidance systems,” not “books of knowledge.” Medscape: general medicine editorial (http://www.medscape.com), 12/08/2006. Accessed 1/15/07 at http://www.medscape.com/ viewarticle/548125. 14. Stettin D. Coping with blindness. NEJM 1981, 305: 458–60. 15. Montgomery K. How Doctors Think: Clinical Judgment and the Practice of Medicine (New York: Oxford University Press, 2006).

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16. Aristotle. Nicomachean Ethics II 2, 1104a7. 17. Charon R. Narrative medicine: A model for empathy, reflection, profession, and trust. JAMA 2001, 286: 1899. 18. Branch WT, Suchman A. Meaningful experiences in medicine. Am J Med 1990, 88: 56–59.

4

CROSS-CULTURAL ISSUES IN CARING FOR PATIENTS WITH CANCER Tod Chambers

INTRODUCTION In 1994, the parents of a 15-year-old were ordered by a California court to have their daughter undergo chemotherapy treatment for ovarian cancer. The director of the County Social Services Department stated that they asked for the court order “because clearly there was a medical neglect issue. If there is a medicine that will cure a child, and the parents do not want to use that medical treatment or medicine, then it’s viewed a medical neglect case.”1 Ironically, the parents, Hmong refugees, might well have agreed with the director’s assertion, for they believed that they were using medicine that would cure their child of her illness; they disagreed, however, with the California officials about what her illness was and what medical treatment she needed. Many Hmong believe that certain illnesses are caused biologically, so these illnesses can be treated with Western allopathic treatments. They also hold that some illnesses are caused by supernatural agents, and these illnesses require the attention not of an allopathic physician but of a shaman.2 In this case, the family disagreed with the physicians’ diagnosis of cancer, and they wished their daughter to be treated with traditional Hmong medicine. After her first chemotherapy session, the girl “ran away” from home. The California police believed that the family were hiding their daughter; they “admit there’s little they can do if the parents don’t want her found.” The family said that a shaman has told them that their daughter is doing well.

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Cross-cultural issues can profoundly affect many of the traditional concerns of medical ethics, and, when attempting to resolve issues rooted in cultural conflicts, the moral principles developed in the United States over the past few decades do not always provide satisfactory guidance. Customarily cultural issues are perceived as something that needs to be “overcome” in order to inform patients and get their consent for procedures.3 The Hmong, thus, are thought to have cultural beliefs that prevent them from fully understanding the medical issues involved in the care of this girl; in short, they have “beliefs” and we have “scientific evidence.” Framing the problem in this way portrays “culture” as a foreign intrusion brought into the clinical setting. We should, however, conceive of cultural conflicts as the result of an incongruity between cultures. Cultural values are often presented as a stagnant set of rules and customs. This impression leads to several problems. First, some clinicians believe that “knowing” a culture involves familiarizing oneself with a list of beliefs; cultural competence seems to entail simply knowing what “Italians believe” or what “Buddhists think.” The anthropologist Margaret Lock suggests that this tendency toward seeing culture as a list of “things” is “in order to systematize and ‘tidy up’ culture in the same way as . . . other epidemiologic variables, such as smoking, age, gender, or fertility rates.”4 Second, culture is thought of as a straightforward entity that one is either inside or outside. In fact, people often have overlapping membership in several communities. Cultural identity for many only becomes an “issue” when they come into contact with someone who does not share their assumptions about values or worldview. Consider someone who might identity themselves as gay or Hispanic or Catholic depending with whom they are speaking. These two assumptions can mislead some clinicians to view culture as a predictor of individual behavior and as an entity lacking diversity— both unsound assumptions. An intimate familiarization with a culture often leads one to see not only the common patterns of practice among individuals but also the diversity permitted within the group. An intimate familiarity with cultural beliefs should permit opening a conversation between patients and health care

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professionals. Let us say that a physician is faced with the need for surgical procedure with a new patient, who the physician knows is a devout Jehovah’s Witness. 5 This knowledge of the patient’s religious background (even with the information of enthusiastic adherence to the faith tradition) should not lead the physician to assume that the patient would be unwilling to accept any form of blood products. Knowledge of the beliefs of Jehovah’s Witnesses concerning blood transfusions will permit the surgeon to understand if the patient expresses distress concerning this issue, especially if the patient wishes to receive blood products if necessary. One pragmatic way to conceive of culture is as a communal pattern of life negotiated by individuals. This interaction between shared patterns and individual negotiation constitutes one of the central dynamics of our social existence. An awareness of the argument against blood transfusions, the history of these beliefs, and the diversity within the Jehovah’s Witnesses community are central factors in permitting one to have a sophisticated conversation with this particular patient. Such cultural information should open a discussion with one’s patient concerning how he or she has negotiated the traditions, beliefs, even if this has resulted in the patient’s complete acceptance of the tradition’s stances. The late cultural anthropologist Clifford Geertz observed that “culture is not a power, something to which social events, behaviors, institutions, or processes can be causally attributed; it is a context, something within which they can be intelligibly … described.”6 In the end, knowledge of a culture does not grant predictability of individual behavior but rather understandability of that behavior. SOURCES OF CROSS-CULTURAL CONFLICT One of the sources of conflict is a consequence of clinicians not having the time to learn the cultural beliefs of particular patients. We should perhaps distinguish those conflicts that arise in caring for a single person of a different culture from those that arise in caring for a particular ethnic group in one’s community. The grounds for conflict in each instance may be identical, but one cannot expect clinicians to become familiar with all the cultural beliefs that may potentially conflict with their own. When something is a singular

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event, the moral framework created by bioethics can serve clinicians well. Bioethics in the United States has been concerned with the response to strangers, or as H. Tristram Engelhardt describes it, “a stranger in a strange land.”7 The American emphasis on the primacy of respecting patient autonomy can be readily evoked in the face of caring of strangers. However, the procedural ethics of much of clinical ethics should come to be viewed as crutches if there are ongoing conflicts with members of a local and numerically significant community. Two of the central themes of this chapter are that clinicians have an ongoing responsibility for being conscious of their own cultural assumptions and that they need to establish an ongoing relationship with those communities that do not share these assumptions. The issue of time remains an important one in dealing with cultural issues, and for this issue a procedural ethic usually is the best source for moral guidance, but in cross-cultural issues our ultimate concern should be toward prevention and, thus, in the end, time spent on familiarizing oneself with the cultural beliefs of one’s patients should save time. In preventing conflicts, we must attend to the common sources for conflict: language, worldview, values, and ethos. Language The most identifiable occasion for conflict is when patients and health care professionals do not share the same language. Sometimes to communicate with their patients, clinicians must rely on a thirdparty. The question of who this third-party should be raises additional ethical questions and may bring forth moral problems that would not normally have arisen if the physician and patient shared the same language. Translation is usually from one of three sources (1) professionals, (2) amateurs (outsiders with no relation to the patient), or (3) intimates (family members or friends). Of the three, intimates of the patients can be the most perilous, both in making a medical diagnosis and in inadvertently raising moral issues. In some instances patients may feel certain types of information—such as sexual history and family secrets—can be told to a clinician but should not be revealed to these intimates. In recounting his medical history, an individual may be willing to share with the physician

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information about a sexually-transmitted disease but unwilling if a spouse, child, or a neighbor is also present. Furthermore intimates can often in the act of translation add or subtract information. As many clinicians know, especially during times of emergency, intimates may be the only ones who can provide assistance in gaining a patient’s consent for necessary medical interventions. Nonetheless one should not settle for intimates, for it can result in more problems than the time saved in its apparent convenience. Even when patients and physicians share the same language, in some instances conflict in communication can still arise because they do not share the same non-verbal language. Various ethnic groups in the United States use English as their primary language yet still have difficulty communicating with one another as the result of differences in the physical space required between individuals for a trusting conversation. 8 The human body functions as a central medium for communication; one social scientist divides the different ways information is presented through the body into ten codes: bodily contact, proximity, orientation, appearance, head nods, facial expression, gestures, posture, eye contact, and non-verbal aspects of speech. 9 Body posture and gestures are also signs that are often unintended sources for conflict. The simple physical gesture of touching someone on the shoulder can, according to different cultural semiotics, be read as either “commiseration” or “invasion.” The problem with the non-verbal aspects of communication is that often they feel “natural” to each party and not acts of communication. When these unspoken rules of communication are broken, we tend to experience them in a visceral manner; while a touch on the shoulder can be experienced as comforting and thus desired, a touch on the neck can feel offensive. Clinicians need to be aware as well that silence in some cultures does not represent a pause in communication but can itself be a meaningful form of communication.10 We need to be aware that there is nothing “natural” about our reactions and that we have as much internalized our nonverbal language as we have the conjugation of the past perfect conditional of our native tongue.

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Worldview A “worldview” is a community’s conception of the way the reality “truly is.” The conflict between the Hmong and the California Social Services department occurred partly because they do not share the same worldview. In the Hmong worldview, illnesses can have both natural and supernatural causes; in the social services workers’ worldview, illnesses can only be the result of a natural cause. All people have a worldview; our worldview often seems the only “reasonable” way to operate in the world, so it is difficult for a person who holds a naturalistic worldview even to accept the Hmong perspective as rational. The problem is that our worldview is not a rationally constructed entity but is rationally derived from our assumptions about the way the world ultimately is. Consequently if we believe in supernatural entities—in the same way I suspect most of the readers of this chapter were raised to believe in “germs” and “viruses”—then illness from supernatural forces may be viewed as a “natural” consequence of the way the world is.11 Ethos The ethos of a community concerns the “tone, character, and quality of their life, its moral and aesthetic style and mood.”12 An ethos, the character of our daily lives, can often be the source of conflict in health care in that often medical care in various cultures is not only built upon a view of how illness is caused but also upon the kind of lives we should be living. For example, we in the United States believe that privacy between patient and physician are essential elements of the therapeutic alliance, but such concerns as privacy are a particular expression of the Anglo ethos, which can only be understood when placed alongside other beliefs such as the importance of the individual self. The Hmong possess a different ethos of the person, one which challenges the Western notion of the radically individualized self and upon reflection may make some Anglos feel their ethos may overemphasize the individual.13

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Values The most common explanation for conflicts within the clinical setting is that patients possess values that are different from those of the health care professionals. In 1990, health care professionals wished to discontinue a ventilator for Helgie Wanglie, an elderly woman in a persistent vegetative state.14 The family did not disagree with the clinicians concerning the medical facts concerning her condition; they did, however, value her life in this condition. The disagreement here did not seem to be primarily the result of differences in language, worldview, or ethos but it appears to have been the result of a conflict over valuing the life of person in a persistent vegetative state. Although there was a hope in the discourse of bioethics that such concepts as quality of life and best interest could be determined without a need to appeal to specific cultural frameworks of values, this has proven to be an elusive goal. Does the life of a patient who can experience simple pleasure but is unable to be employed or live independently represent a good quality of life? The answer to this depends largely on whether one’s conception of a person is forged within the protestant ethic of work and independence. Is suffering always detrimental or is it sometimes a source for personal growth or spiritual redemption? There is no culturally neutral ranking of values. TECHNIQUES FOR RESOLUTION When one finds oneself caught within a conflict resulting from a cultural clash, there are some simple techniques that can guide one toward a resolution. Active Self-Reflection Ironically perhaps the most profitable technique for understanding another culture is first to understand one’s own. One of the reasons that cultural issues arise in the practice of medicine is that both groups in the conflict see their beliefs as selfevident and natural. W.E.B. Du Bois referred to the heightened selfconsciousness of many minority ethnic groups as “double

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consciousness,” an awareness of oneself that is entangled within the perspective of another ethnic group. Lacking this double consciousness, many Anglos feel as if they do not “have” an ethnic identity. If asked about their identity, some respond that they do not feel as if their beliefs and practices are particularly “cultural” or “ethnic.” Anglo culture infuses our media, health care, jurisprudence, and educational system. The argument that we should take temporary custody of the Hmong child until she is old enough to make her decisions for herself indicates an implicit belief that allopathic medicine should be the default healing practice. Our courts tend to accept the allopathic physician’s perspective as normative. We must recognize that the reason that we are not predisposed to recognize Anglos as an “ethnic” group is because the values of this group are so much a part of what is traditionally identified as “American”; consequently the addition of “Anglo” to American (as in African-American or Asian-American) can seem redundant. We need to recognize some of the patterns of the Anglo ethos and worldview; in other words, to view the culture of this dominant group as if we were observers from another culture (something that most of the members of the minority cultures in the United States already do). For the sake of space, the following observations will be limited to how Anglo culture affects the practice of medicine. A good––and often interesting––source for general observations about these cultural patterns are guides written for people who are coming to the United States to work.15 The worldview of Western allopathic medicine can generally be characterized as positivistic. Knowledge about the world is thought to be best derived through the “scientific method”; although such scholars as Kathryn Montgomery persuasively argue that medicine is not a “science,”16 the desire to be thought of in this way signifies the power this perspective holds in the American worldview. Accordingly Western medicine values quantification and tends to believe the most accurate and realistic form of representation is that which can be communicated through percentages of occurrence or risk. Western medicine emphasizes the material and physical over the spiritual and the emotional. This emphasis is mirrored in how the culture values the various medical fields. The psychiatrist and cultural anthropologist Arthur Kleinman

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observes that there is a “cultural logic” deeply embedded in Western medicine between soft and hard fields: “Talk and cognitive activities more generally are ‘soft’; procedures that enter the body . . . are ‘hard.’ ” 17 In the United States we tend to demonstrate something’s value through money, so the “hard” medical specialties (such as surgery) are highly rewarded and the “soft” specialties (such as psychiatry) are given the lowest salaries. The value placed on those items that can be clearly measured and tested is greater than items that are more ambiguous. Related to this prizing of the “hard,” Western medicine does not admit supernatural agents as the potential cause of illness; all causes (and consequently all treatments) must be attributed to the natural world. Dwight Conquergood in his description of the Hmong worldview observes the clash of epistemologies that can result when comparing health practices across cultures: Many of my Hmong consultants know about my detached retina that resulted in blindness in one eye. With great fascination, they questioned me in detail about the two three-hour surgeries I underwent. I could see the incredulity in their eyes when they learned that I had subjected myself to such a bizarre (in their view) ritual. (Traditional Hmong have an aversion to surgery or any cutting on the body because they believe that tampering with the body will have negative consequences for the next reincarnation). They were not at all surprised that the surgeries did not restore my sight. But they were truly shocked that I would allow myself to be subjected to such a patently unnatural procedure not once, but twice. Like well-integrated members of most cultures, however, I have little difficulty accepting modern medicine’s failure to restore my eyesight even while maintaining my belief in most of its basic assumptions. 18 Although allopathic medicine may seem to be a monologic practice, its application is contingent upon specific cultural beliefs. Lynne Payer, a journalist, suggests that even in societies that share the

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allopathic tradition of healing, cultural assumptions arise in surprising ways. She observes, for example, that there seems a link between the French treatments for cancer (which tend toward radiotherapy and away from surgery) and the importance of the cosmetic results; unlike the Americans, the French are concerned with the aesthetics of any form of treatment. Characteristic of the American attitude toward cancer has been the need not only “to do something” but “to do it fast.” 19 The American ethos influences how we practice medicine and in particular the need for action and aggressiveness in our response to cancer. Western medicine in the United States is also affected in its practice by the particular moral ethos of the country. Most notable has been the emphasis upon personal autonomy. In Democracy in America, Alexis de Tocqueville observed that the social life made the people “form the habit of thinking of themselves in isolation and imagine their whole destiny is in their own hands.”20 Even in specialties that explicitly demonstrate the dependence patient’s can have upon others, medicine has emphasized the “maximizing” of autonomy. Although in recent years there has been a call for communitarian values in bioethics,21,22,23 this is a prophetic challenge that strives to counter the prevailing ethos of individualism. The ethos of individualism is expressed in many of the key terms of the contemporary medical ethics movement: advance directives, informed consent, decisional capacity, assisted suicide. Related to these ideas, there has arisen an expanded use of “rights” language in the United States to discuss moral issues. Issues of end-of-life care have become a “right to die”; abortion is formulated as either a “right to choose” or a “right to life”; access to medical care is translated into a “right to health care.”24 The United States health care system is intimately tied to consumerism, a concept allied with notions of rights and autonomy. Although Anglos may believe that they have a right to select the type of health care they desire, many do not believe that there is a positive right for health care, unlike their northern neighbors in Canada. Access to health care in the United States is considered a principle of charity rather than a right by many. For them, health care is no less a commodity than other elements of life such as housing and food.

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Our particular cultural assumptions also affect how we view illnesses such as cancer. In Illness as Metaphor, Susan Sontag argues that the West has understood various illnesses through metaphors that carry with them a moral import. Sontag observes that the “controlling metaphors” in the West’s representation of cancer have been ones of warfare. When we describe a body with cancer, we use such words as “invasive” and “colonize,” and we speak of medical treatment as “bombarded,” “chemical warfare,” and “killing cancer cells.” This metaphoric language works both ways, she observes, in that we draw upon cancer itself as a metaphor for social problems. We speak, for example, of crime, communism, and terrorism as a “cancer” in the society that “spreads” throughout the social body. Sontag compares the adverse portrayals of cancer in Western art to the romantic ones of tuberculosis: “The dying tubercular is pictured as made more beautiful and more soulful; the person dying of cancer is portrayed as robbed of all capacities of self-transcendence, humiliated by fear and agony.”25 The stigma of cancer is perhaps best illustrated by the fear of even voicing the word. In At the Will of the Body, Arthur Frank, someone with the dubious distinction of having a heart attack and being diagnosed with cancer within 2 years, reflects that, “We do not call heart attack “h.a.” Cancer alone is mythologized as some savage god, whose very name will invoke its presences.”26 Breaking the Cultural Frame The social scientists Gregory Bateson and Erving Goffman applied the concept of a “frame” to social situations; they argued that all social interactions are framed in ways that signal to the various participants how we are to understand what is going on.27,28 For example, in order for someone to know that we are “joking” with them instead of insulting them, we use various signals in facial expressions and tone, and, if one misunderstands our intentions, we can explicitly declare “I am just kidding you!” We can then quickly reframe the situation by stating, “Let me be serious for a moment.” Deborah Tannen, a linguist, recommends that during periods when communication is difficult, we “break” the frame and talk about the difficulty we are having talking.29 She believes

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that often miscommunication occurs when people have different signals. These signals are socially learned, and, Tannen suggests, we should, on occasion, expressly talk about the signals—what Bateson referred to as “metacommunication”—when we are having difficulty conveying our ideas or feelings. In a similar manner, health care professionals can break the cultural frame of an interaction by explicitly exploring the difficulty understanding the patient’s cultural frame for communication. By making statements such as “in my culture we believe that,” “I was raised to think,” or “as a physician I tend to value,” health care professionals are able to talk about the cultural frame of allopathic medicine to their patients. In breaking the cultural frame, a health care professional is also acknowledging the contingent nature of their beliefs. By admitting that one’s ideas are not the only way of thinking, one licenses others to share their perspective. This type of self-conscious dialogue has been a standard technique social scientists have used to understand other cultures. Paul Rabinow argues that when an ethnographer engages a member of a community to explain something about that world a new “language” must be created.30 When one breaks the cultural frame of an encounter with the patient, one does so by creating a temporary liminal language, which enables both to understand and be understood. Ethnographers, unlike health care professionals, normally have the luxury of time to construct this liminal language. Even in extended periods of fieldwork this shared language will create only a “partial and thin” understanding for the ethnographer, and health care professionals must make do with an even more tenuous understanding. Making Translators Part of the Team As mentioned above, the use of intimates as translators should be considered only when one has first sought out professional translators and failed. Professional translators are, however, often misused. Some health care professionals treat translators as if they were language machines that simply dole out equivalent words and phrases. Health care professionals need to make translators feel that they are a part of the medical team or at the very least they are there

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to assist in reaching specific medical goals. Since communication entails more than merely words but also the body and an entire array of cultural signs, translators must be able to provide information that make the patient’s statements intelligible to the health care professional and vice versa. Ideally such individuals should function more as cultural translators than language translators. If one expects translators to provide assistance in the language and also to address cultural meanings and nuances of the medical problems, they can serve as important sources for crosscultural understanding. Translators should feel comfortable to indicate areas of the medical interview where there are potential conflicts or where particular styles of communication can indicate a vital cultural subtext. One should always convene with translators prior to meeting with the patient so that one can quickly state the goals of this encounter and any concerns that one has about the patient.31 Translators should also be told that they are being depended upon to provide information that they think outsiders need in order to understand the patient’s statements. Afterwards there should be a short meeting between translator and the health care professional to allow them both to evaluate the encounter and to raise issues that need to be explored further. TECHNIQUES FOR PREVENTION Rather than responding to each new crisis, it is better to draw upon techniques that can anticipate problems. These techniques are best employed when one has a large and distinct ethnic population within your area. Locate Cultural Informants The concept of a cultural informant is borrowed from qualitative social science. An informant is a member of a community who assists the ethnographer in understanding the culture. Informants tend to be unusual people, who are able to act in a bridging fashion, so they need to have or acquire the kind of self-reflexivity mentioned above. The best informants generally are individuals on the social fringe of their culture. These socially marginalized

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individuals are often highly conscious of the cultural categories, for they themselves do not fit completely within them. Ascertain the Community’s Clinical Experience Clinicians rely on their “clinical experience” to make sense of their problems. In a similar manner, communities have their own experiential knowledge in that they learn about medical problems through sharing narratives with each other. There is nothing unusual about this sharing of stories (it is a part of Anglo culture as well); communities (especially those who do not have members trained allopathically) draw upon each other’s experiences in order to understand and predict how allopathic physicians will respond to particular situations. Not knowing these narratives can place a clinician at a disadvantage. Understanding, for example, that a previous family member has died of cancer may assist one in explaining how this instance of cancer is both like and different from the other family member’s illness. Furthermore individuals may learn about cancer and the various medical treatments through other members of the community. Some individuals who are recent immigrants to the United States or live in culturally isolated communities are often unfamiliar with what are considered reliable sources of information or are not fluent enough in the language to be able to understand information from such sources. As with the Hmong family, there can be an entire array of other medical consultants who help make the diagnosis. A clinician needs to learn about these experiences and, when appropriate, revise the community’s perceptions. In some communities, going to a physician is––for economic or cultural grounds––an act of last resort, and patients may elect to consult professional and nonprofessional healers within their community before coming to the allopathic system. Although it seems (as in the issue concerning this Hmong family) that allopathic medicine is viewed as a binary opposite to “alternative” or traditional forms of treatment, many people mix several forms of medical treatments. The recent movement in the United States to think of non-allopathic treatments as “complementary” rather than “alternative” mirrors how many people already conceive of these treatments. A clinician should

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whenever possible think of these other healers as colleagues rather than as competitors and be open to learning about their practices. One of the issues that was involved in the Hmong example is that the family saw the allopathic treatment as making their daughter sick (which was in some ways true) and did not trust that causing pain could in the end help their daughter. In order to prevent these conflicts, health care professionals are obligated to learn the stories of the community: their religious, mythic, and paradigmatic ones and their particular experiences with allopathic medicine. Identify Redressive Actions When moral conflicts in many hospitals rise to a crisis level, health care professionals can call a meeting of an ethics committee. The concept of gathering together a group of individuals to discuss the problem and provide some recommendations seems to be a sensible way to deal with social conflict. Many cultural assumptions underlie this practice, assumptions that may not be shared by others. The cultural anthropologist Victor Turner observed that within the life of a community there are periods of social tension or, what he termed, social dramas.32 Social life is not a stagnant entity but one awash in crisis and resolution. Turner discerned four phases in social dramas: 1. Breach, in which there is a break in the normal social relations 2. Crisis, in which there is an escalation and people “take sides” 3. Redressive action, in which a formal structure comes forth to contain and resolve the problem 4. Reintegration, in which following the redressive action a resolution occurs and harmony restored. A meeting of the ethics committee is one of the redressive actions that can take place within a hospital environment. These committee meetings are a part of the larger pattern of moral crisis management within the hospital environment.

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Other communities have other means of resolving problems, means that do not necessarily entail a gathering together of individuals in a committee. Some communities contact a particular individual, as the traditional Jewish method of requesting the opinion of a rabbi, and some communities believe that one should turn directly to a divine entity for assistance. In the Hmong case, it was reported that the health care professionals should have contacted the elders of the community. Obviously the redressive action of the court hearing was not recognized by the Hmong family. Consequently, health care professionals should have a general understanding of the various redressive actions common within the community and how to work with these mechanisms in order to resolve moral conflicts. ABIDING QUESTIONS Morally and legally the United States has reached a consensus that competent adults have the right to refuse any medical treatment; the seemingly tragic outcome of some of these decisions are the anticipated consequences of a politically liberal society. This policy provides helpful guidance for resolving many moral conflicts, especially in problems that arise from cultural conflicts, but it can seem unworkable when health care professionals are faced with marginal cases. Children and Adolescents Perhaps the most difficult and contentious issues surround the care of minors. Like the case involving the Hmong family, such issues seem to bring into question our liberal concepts of respect for others and ask how far we are willing to honor the worldview of others. The prevailing response to this issue is that society has a responsibility to temporarily take custody away from the parents; this is justified by the claim that children have yet to “choose” the cultural beliefs of their parents and we do not know if as adults they will do so. There are a number of problems with this argument. First, what does it mean to choose a worldview? People can alter the worldview they were raised in but this usually entails a radical

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revision of their values. Second, even if people can choose a worldview and upon maturation people tended to reject the worldview of their upbringing, why should the default worldview be that of allopathic medicine? There is no way to argue rationally for the superiority of one worldview over another (otherwise we would have to accept that all other people in the world were irrational), so we must accept that the selection of allopathic medicine is the result of the political dominance of people who accept this worldview. If the majority of this culture were Hmong, then perhaps Anglo parents would be forced to undergo shamanism. Third, forcing families to accept allopathic medicine can result in their reluctance to use the system when they believe that their control over the care of their children will be jeopardized. Adolescents, of course, further complicate this issue, for they can sometimes demonstrate the intellectual and emotional maturity we expect to find in adults. The legal concept of a “mature minor” makes sense in such cases, and we should feel comfortable giving some adolescents the right to refuse (or accept) medical treatments that fit their personal religious or cultural perspectives. The Cultural Catch-22 In a study of informed consent on a Navajo reservation, Joseph Carrese and Lorna Rhodes discovered that in the Navajo worldview a discussion of the potential risks of a medical treatment would make such events more likely to take place.33 Language, from the Navajo perspective, is not simply a mirror of the world but can alter reality. Informed consent as it has been traditionally practiced in American bioethics is thus viewed as a harmful practice. The problem this raises is how do you inform a Navajo patient in order to determine if they wish to receive information? This creates a kind of cultural catch-22 that can be found in other areas of cross-cultural medicine. For example, it has been shown that for some communities, it is considered taboo to reveal to patients that they have cancer.34 Yet once again if such a belief is found to be culturally based how does one ask someone whether they wish to know if they have cancer? Although one could respond that one should discuss with patients about the future possibility of such a

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situation, once again this is a luxury of time and continuity of care that not all clinicians possess. Even then, how does one know that the patient who said that they did not wish to know several years ago still does not wish to know? CONCLUSION In this chapter some tools have been offered for assisting health care professionals in caring for people from different cultures. Although the initial impulse for many is for a simple list of beliefs and practices, we should be wary of this desire. It represents a need to place people in easily identifiable categories and sometimes this need can cause conflicts and tragic mistakes. Instead, we should first become conscious of the cultural assumptions within our own healing practices; we need to identify how our own practices are part of larger cultural patterns (of language, worldview, values, and ethos), which seem to us “self-evident” and “natural.” The techniques for resolution proposed in this chapter are rooted in this exercise of self-awareness. Once we are aware of this assumption, we can begin to find the parallel beliefs and practices of others. Through the assistance of translators and consultants we can acknowledge and on occasion break our cultural frames. REFERENCES 1. 2.

3. 4. 5.

Vu T. Laotian Teen Defies Court-Ordered Chemotherapy. National Public Radio/Morning Edition. 22 Nov, 1994. For an excellent introduction to the Hmong and their conflicts with western health care professionals, see Culhane-Pera KA, Vawter DE, Xiong P, Babbitt B, Solberg MM, eds. Healing by heart : clinical and ethical case stories of Hmong families and Western providers. 1st edn. Nashville: Vanderbilt University Press; 2003. Herne HE, et al. The difference that culture can make in end-of-life decision making. Cambr Quar Hlthcare Ethics 1998; 7:27-40. Lock M. Education and Self Reflection: Teaching about Culture, Health and Illness. In: Masi R, Mensah LL, McLeod KA, eds. Health and cultures. Oakville ; London: Mosaic Press; 1993. , Dixon, J.L. and M.G. Smalley. “Jehovah s Witnesses: The Surgical/Ethical Challenge.” JAMA, 1981; 246:2471-2472

4 Cross-Cultural Issues in Caring For Patients with Cancer 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24.

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Geertz C. The interpretation of cultures; selected essays. New York,: Basic Books; 1973. Engelhardt HT. The foundations of bioethics. New York: Oxford University Press; 1986. Hall, ET, The Hidden Dimension. Garden City: Anchor BooksDoubleday, 1966. Argyle, M. Non-verbal Communication in Human Social Interaction. In: Hinde, R.A. ed. Non-Verbal Communication, Cambridge: Cambridge University Press, 1972. Myers, GE and MT Myers. The dynamics of human communication. 4th edn. New York: McGraw-Hill, 1985. Helman C. Culture, health, and illness:an introduction for health professionals. 2nd edn. London ; Boston: Wright; 1990. Geertz, C. 1973, p. 127 Conquergood, D, Thao P, and Thao X. I Am a Shaman: A Hmong Life Story with Ethnographic Commentary. Minneapolis: University of Minnesota, 1989. Capron, A.M. “In Re Helga Wanglie.” Hastings Center Report 1991; (September-October): 26-28. Lanier AR, Gay CW. Living in the U.S.A. 5th edn. Yarmouth, Me.: Intercultural Press; 1996. Montgomery K. How doctors think : clinical judgment and the practice of medicine. New York: Oxford University Press; 2005. Kleinman A. Writing at the margin : discourse between anthropology and medicine. Berkeley: University of California Press; 1995. Conquergood, D, Thao P, and Thao X. I am a shaman: a hmong life story with ethnographic commentary. Minneapolis: University of Minnesota, 1989, 58. Payer, L, Medicine and Culture. New York: Penguin, 1988, p. 137. Quoted in Fox RW, Kloppenberg JT. A companion to American thought. Oxford; Cambridge, Mass.: Blackwell Publishers; 1995, p. 337. Emanuel EJ. The ends of human life : medical ethics in a liberal polity. Cambridge, Mass.: Harvard University Press; 1991. Kuczewski MG. Fragmentation and consensus : communitarian and casuist bioethics. Washington, D.C.: Georgetown University Press; 1997. MacIntyre AC, Knight K. The MacIntyre reader. Notre Dame, Ind.: University of Notre Dame Press; 1998. Glendon MA. Rights talk : the impoverishment of political discourse. New York Toronto New York: Free Press; Maxwell Macmillan; 1991.

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25. Sontag, S. Illness as Metaphor and AIDS and Its Metaphors. New York: Doubleday, 1990, p. 16. 26. Frank AW. At the will of the body : reflections on illness. Boston: Houghton Mifflin; 1991. 27. Bateson G. Steps to an ecology of mind: collected essays in anthropology, psychiatry, evolution, and epistemology. San Francisco; Chandler Pub. Co.; 1972. 28. Goffman E. Frame analysis : an essay on the organization of experience. New York: Harper & Row; 1974. 29. Tannen D. That's not what I meant! : how conversational style makes or breaks your relations with others. 1st edn. New York: Morrow; 1986. 30. Rabinow P. Reflections on fieldwork in Morocco. Berkeley: University of California Press; 1977. 31. Boston City Hospital. The Bilingual Medical Interview, 1991. 32. Turner VW. Schism and continuity in an African society; a study of Ndembu village life. [Manchester, Eng.]: Published on behalf of the Rhodes-Livingstone Institute Northern Rhodesia by Manchester University Press; 1957. 33. Carrese JA, Rhodes LA. Western bioethics on the Navajo reservation. Benefit or harm? JAMA. Sep. 13 1995; 274(10):826-829. 34. Surbone A. Truth telling to the patient. Jama. Oct. 7 1992; 268(13):1661-1662.

5

HOPE AND COMMUNICATION IN CANCER CARE: WHAT PATIENTS TELL US Susan Hedlund

Years of caring for patients with cancer have led this author to consider the complexities of hope, despair, and resilience in diverse patients coping with the enormous challenges associated with the diagnosis and treatment of cancer. This chapter will attempt to evaluate the role of hope in dealing with cancer, consider how medical professionals can either promote or destroy hope, how hope changes over the course of illness, and the potential “negative consequences of hope.” Finally, and perhaps most importantly, this chapter will consider what patients tell us is most helpful to them. Does hope, for all its clear advantages, actually make a difference in how well and how long one survives? How do health care professionals balance the needs of both patients and themselves, for offering help and hope during the challenge of cancer, without promoting false hope? How do health care professionals support a patient’s hopes, even if the professional does not share the same hopes? At what point is it essential to have the difficult, but frank conversations about the futility of treatment, and the inevitable approach of life’s end? Jerome Groopman, medical oncologist, in his book Anatomy of Hope: How People Prevail in the Face of Illness, reflects on why some people find hope despite severe illness, and others do not, and how hope can help people prevail, or not. When physicians consider the topic, it is often with some skepticism and certainly a question about how hope can be operationalized in a way that is consistent with truth-telling. A vast popular literature exists contending that positive emotions affect the

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body in health and disease. “Much of it is vague, unsubstantiated, merely wishful thinking.”1 There exists emerging research that a change in mindset has the power to alter neurochemistry. Belief and expectation––key elements of hope––can block pain by releasing the brain’s endorphins and enkephalins, mimicking the effect of morphine. In some cases, hope can also have important effects on fundamental physiological processes such as respiration, circulation, and motor function.2 An emerging body of evidence suggests that hope does make a difference in how well patients survive. Hopeful patients have less distress and cope better. One aspect of this is that hopeful patients are more likely to take active steps that contribute to their overall well-being. They are conscientious about treatments, take control of their own care, and contribute more to the management of their disease than do those who are pessimistic about their survival. Having hope has been associated with more effective coping and a better quality of life,3 and a stronger sense of coherence and positive orientation toward living.2,4 One study suggested that hope gave cancer patients a reason for living and for continuing to invest energy.2 The following will consider hope as a quality of life issue for patients, a relationship issue between patient and physician, and the promotion of hope as a clinical skill for medical professionals. HOPE AS A CLINICAL CONCEPT For the individual and for the family, cancer can have a profoundly negative impact, yet hopefulness and a positive future orientation are important components for quality of life in cancer survivorship. When faced with cancer, a sense of hope can provide meaning, direction, motivation, and a reason for being. What is hope? Is there such a thing? How can it be defined? Is it helpful or harmful? Is it necessary? Hope is a complex concept that is often misunderstood by many people including health care professionals. People define hope differently. Health care professionals tend to think in terms of therapeutic hope which is hope based on therapy and is related to cure or remission of disease.5 However, there are other ways to consider hope.

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Hope is recognized as a powerful and dynamic life force in the writings of philosophers, theologians, psychologists, and many health care professionals. Hope is characterized by a confident, yet uncertain anticipation of future good.6 The hoping person identifies the future good as something that really matters; it is personally significant and desirable. The future good of hope is also evaluated as something that is realistically possible; a conclusion arrived at through reality inspection. If the good is not realistically possible, then it is viewed as a wish but not a hope. Hope has implications for behavior both in terms of the hoping person taking action, as well as in terms of being energized by hope to cope in a positive way. Research indicates that commonalities exist between hope and adaptation. People who coped best have been identified as more hopeful.7,8 Maintaining a sense of control is identified as an important component of hope.9 Hope is often confused with optimism; however, it is not the same. Hope does not arise from being told to “think positively,” or from being given an overly optimistic forecast. Groopman maintains that hope is rooted in “unalloyed reality”.1 Optimism, on the other hand, primarily emphasizes the positive aspects of a situation, and while optimism may be specific in nature, the individual does not necessarily have clear plans for where he or she wishes to go.10 Optimism may tend to minimize painful feelings and may be inflexible because it only focuses on a positive outcome. While there is certainly a role for optimism, rarely is it enough when facing the rigors of a cancer diagnosis and treatment; the emotional sequelae that accompanies adjustment; or in dealing with enormous uncertainty about the future. Thus, it is important to understand the meanings and functions of hope. Hope constitutes an essential experience of the human condition. It functions as a way of feeling, a way of thinking, a way of behaving, and a way of relating to oneself and one’s world.11 Hope also means desirability and the ability of the individual to exert a degree of influence on the surrounding world, and is essential for healthy coping. It allows people struggling with life-threatening illnesses to avoid despair, to feel more empowered, and allows life to be more bearable. Hope is also seen as a cognitive-affective resource that becomes greater in times of threat.12

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Hope is a dynamic process, and involves a consideration of the future. Hope changes as situations and circumstances change. Victor Frankl’s work on logotherapy, considered how hope changes as circumstances change.13 He suggests that there are two sources of hope, generalized and particularized. Generalized hope is hope that supports the idea of maintaining quality of life or of finding meaning, despite the circumstances. Particularized hope identifies specific outcomes that are desirable. Frankl’s work has been applied to clinical work in oncology, suggesting that generalized hope in cancer care may apply to hope for quality of life and strength to endure versus particularized hope which identifies specific outcomes, such as cure or lengthened life.14 It is important to acknowledge that hope changes over time, as the person with cancer may acknowledge that hope for cure may no longer be possible; however particularized, or specific hopes may be sustained through other desires, such as to survive to attend a child’s graduation or wedding. Hope is thought to be dynamic and change over time as situations and the ability to adapt change.15 Farran also identified key features among hopeful patients that included several variables; the ability to stay engaged in life, be flexible, and envision possibilities. Of note, she observed that hope among these patients was realistic but strategic; when hope for one thing was no longer possible, they envisioned new possibilities.11 HOPE, DENIAL, AND DEPRESSION Well-functioning hope does repress doubts and fears, but hope is not the same as denial.10 Denial is a psychological defense which functions to protect the individual from information or circumstances that are too difficult to comprehend or accept all at once. As Groopman suggests, hope is always based in reality. Callan notes that the main difference between hope and denial is that hope transcends reality, while denial avoids it. Patients hopeful enough to actively accept a situation generally cope better than those who cope through avoidance; however, it is important to remember that sometimes hope and acceptance arrive by degree. It may take time for the person to grieve their actual and perceived losses, and eventually regain a hopeful perspective.

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Depression is a somewhat common reaction to the diagnosis of cancer, and it is estimated that approximately 25% of all cancer patients will experience a clinical depression over the course of illness. Feelings of loss and sadness are common after the diagnosis of cancer, yet research suggests that people with cancer are no more depressed than persons with other serious illnesses.16 If “normal” reactive depression following a cancer diagnosis becomes severe and interferes with daily activities, active treatment should be pursued. Depression may be related to bad news, and the loss of hope. Poorly controlled pain is also correlated with higher rates of depression. Hopelessness and helplessness have been strongly linked with poorer clinical outcomes and decreased quality of life;17 thus, when depression is evident, it should be aggressively treated by a health care professional who understands cancer-related issues. Counseling and the possibility of treatment with medication should be considered. HOPE AS A RELATIONSHIP ISSUE Hope also has implications for interpersonal relatedness with other people, both living and dead, or with God. The interrelational dimension of hope has important implications for health care professionals because it emphasizes that we can play a role in influencing another’s hope just as we can be influenced by others in our hoping.17 Hope is often a component of physician–patient interactions, whether the conversations consider informed consent, the communication of bad news, statistics, disclosure of errors, or consideration of clinical trials. Hope may be an active component of the conversations, as a physician offers alternatives to otherwise devastating news, or hope may be implied, relative to the physician offering support, truth telling, and non-abandonment. Clearly, how the health care professional communicates with a patient is determined in part by how much a patient wants to know, which also may be influenced by cultural or religious variables. There is, however, significant literature that suggests that in the communication of bad or difficult news, honest and direct information conveyed in a clear and compassionate way is desired

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by most patients, but also has a positive impact on patient–provider relationships, compliance with prescribed treatment, and clinical outcomes. 18,19 Other literature suggests that clear communication actually decreases the experience of stress on the part of the health care practitioner.20 Clear communication and accurate truth telling, conveyed in a compassionate manner, has a significant impact on accurate hope and hoping for people with cancer. IS THERE A “DOWN SIDE” OF HOPE? Eric Cassell, MD, in The Nature of Suffering and the Goals of Medicine, discussed the question of suffering and its relation to illness. He purported that the failure of physicians to understand the nature of suffering can result in interventions that not only fail to relieve suffering but becomes a source of suffering itself.21 At a recent meeting of the American Society of Clinical Oncology, Dr. Craig Earle, after an extensive review of Medicare records, reported that nearly 12% of cancer patients who died in 1999 received chemotherapy in the last two weeks of life. This was up from nearly 10% in 1993, and the researchers speculate that the percentage is probably even higher today. Neither patients nor physicians like to “give up”; however, overly aggressive treatment gives false hope and puts patients through grueling and costly ordeals when there is no chance of a cure. “There is a time to stop. It is sometimes easier to just keep giving chemotherapy than to have a frank discussion about hospice and palliative care.”22 Still, many health care professionals are fearful that telling the truth about prognosis and the failure of treatment will destroy hope. There is significant evidence that not only is this not true, but rather, if health care professionals offer false hope to the patient, that trust in the provider is actually eroded. This author has worked with numerous surgical and medical oncologists over the years, most of whom are extremely skilled both clinically and interpersonally. However, a few examples come to mind in which the physicians would not guide the conversations with patients regarding treatment failure or approaching end of life. Most literature on medical communication suggests that patients

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wait for and expect the physician to initiate such discussions.18 When this does not occur, and the patient hesitates to ask, there is an implied assumption that both patient and provider share a perspective on the clinical realities before them. This is not always so. Patients have reported feeling “betrayed” by physicians if active treatment continues despite its obvious futility. Family members report feeling “blindsided” by the death of their loved ones. Nurses report feeling frustrated and helpless as they watch the patient be “hijacked” from their own death experience by an overly optimistic physician. Patients often rely upon the physician to tell the truth, guide treatment decisions, and be honest when cure is no longer possible. At the same time, clearly there are patients and family members who push for aggressive treatment despite its limited promise, and careful consideration must be given with regards to conversations and communication with these individuals. It is important to attempt to achieve some level of agreed upon understanding regarding treatment’s potential benefits and limitations. Conversely, patients and families report that sometimes physicians seem so intent on making sure that the patient understands that they are dying, or that treatment has limited value, that the physician is perceived as blunt, uncaring, or lacking in compassion. “She was so intent on telling me that my disease was incurable, that she told me three times. I understand that I will more than likely die of my disease. But at 39 years old, I’d like to work with a physician who hasn’t already given up on me. Needless to say, I found a new doctor. She seemed so cold” (Jenny, age 39, personal communication with patient, 2005). CONVERSATIONS How does a physician finesse conversations with patients that allows for truth telling that doesn’t destroy hope, compassion that conveys non-abandonment, and allows for hope that is realistic versus not? Patients tell us, and research validates, that healthcare professionals contribute to realistic hope through specific behaviors that convey caring and being “present.” Determining how much a patient wants to know, giving accurate information, and presenting it in a

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compassionate manner, does not promote “false” hope, but rather contributes to “functional” hope. Miller, described ways that health care professionals decreased hope. 23 Specifically, the author suggested that doctors decreased hope for patients primarily through poor communication skills that included the perception of being “cold,” disrespectful, appearing to “trivialize” the situation, being blunt, or in appearing to feel “sorry” for the patient. Additionally, conflicting information between physicians was noted to erode hope. Additionally, the author noted that nurses eroded hope by seeming to be “mean” or “disrespectful,” and that the health care system decreased hope by being cold or institutional. There are numerous situations in which the physician is challenged to give specific, sometimes difficult information, yet to do so in a way that leaves a patient feeling informed, supported, and non-abandoned. Such situations include informed consent, delivering bad news, giving statistics, disclosure of errors, information about genetics, clinical trials, research, and end of life decision-making. “ Telling me that everything would be all right when I suspected it would not, was not helpful to me. Telling me the truth, but kindly, and reassuring me that I would not be abandoned, gave me hope. It gives a person with a terminal disease a chance to see one’s self as having some control versus being a victim of an impending death sentence. It is a wonderful gift. ” (Lisa, age 35, personal communication, 2006). Another patient, who happens to be a physician, told this author after undergoing autologous transplantation, “You know, I talk to my one oncologist and leave her office feeling informed but hopeful. I talk to my transplant doc, who gives me the exact same scientific information, and I leave his office feeling demoralized, depressed, and hopeless about the future. It’s not helpful” (John, age 52, personal patient communication, 2006). One study in the Journal of Clinical Oncology found that 98% of the patients surveyed reported that they wanted their doctors to be realistic but they valued hope-giving strategies as well (2005). Doctor behaviors rated as the most “hope giving” by patients include

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offering the most up-to-date treatment, appearing to know “all there is to know” about the patient’s cancer, and saying that pain would be controlled. Interventions that engender hope include adequate control of a patient’s symptoms and fostering and developing interpersonal “connectedness” and relationships. Assisting the patient in attaining practical goals and developing an open relationship, are ways that healthcare providers can engender hope.24 HOPE AND TERMINAL ILLNESS Maintaining hope in the face of terminal illness is one of the great challenges facing patients near the end of life. Most patients with advanced diseases tell us that they are challenged to face mortality issues and the threat of dying, while also attempting to live life and maintain hope for the future. This paradoxical dilemma is difficult for patients to hold simultaneously, and their families are often struggling to do the same. Families have the additional dilemma of trying to anticipate the death of their loved one without making the dying person feel abandoned, and of staying emotionally involved with the patient while anticipating having to “let go.” It is one of many inherent dilemmas for families of those that are dying. It may exist for some health care providers as well. Still, patients tell us that they need for both truth and hope to co-exist. Dying patients need honesty from their physicians regarding their diseases and prognoses.24 Sometimes health care providers fear that in the face of terminal illness, honesty is cruel because it will force the patient to lose hope. However, one may be honest with patients and still maintain hope through a change in focus away from hopes that are long term to hopes that are either short term or spiritual. Maintaining hope through realistic short-term goals is extremely important for patients and families. Examples include: • • •

Ask the patient if they have long-term hopes and dreams that have been threatened by the illness. Normalize feelings of loss, anger, sadness, and denial. Encourage the patient to talk with loved ones.

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• •

Ask if there are particular upcoming events the patient wishes to participate in, i.e., a wedding, a trip, a birth, etc. Encourage the patient to make short-, medium-, and longterm goals, understanding that the course of terminal illness is often unpredictable.

When the prognosis is bad, we must help the terminally ill patient deal with the prognosis and alternatives for treatment, without destroying all hope. This can be done by reassuring the patient that he or she will not be abandoned and that symptoms will be attended to, and by emphasizing hopeful measures. Some patients will hold on to hope for a “miracle.” There is no reason that a health care provider must take this away from the patient. Patients may, however, need guidance in goal-setting and decision-making. As physicians and caregivers for the dying, it is essential that we recognize our role in continuing to provide care and reassurance, to understand that we are a source of hope to those entering the last stages of life. While it may no longer be possible to hope for cure or extension of life, people who are dying need the reassurance that our partnerships with them will continue, that we will assist in managing symptoms, that we will be honest and compassionate, and that we will help them to make end of life decisions based on the preferences and values that we have elicited from them. It is important not to be biased against hope in general, not to think only in terms of therapeutic hope, and not to favor solutions simply because they are reality based. It is essential to understand the importance of hope for patients, and to help them use their hope to enhance their quality of life. MAINTAINING PROFESSIONAL HOPE Sometimes, as caregivers, it is difficult to maintain professional hope. When professionals find that their own vision of hope is slipping, it may be helpful to reevaluate one’s own measure of success. This may require moving beyond disease outcome measures to focus more on quality of life issues and psychosocial successes. Psychosocial successes are those identifiable and significant events that contribute to the emotional well-being of the patient and

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family.25 Helping a patient meet a goal should be hope-reinforcing for the professional. It may be helpful to take note of these events and use them to rediscover one’s vast capacity for professional and personal hope. CONCLUSIONS It is essential to remember that cancer, as is true with any severe illness, threatens the very integrity of the person. A component of healthy coping is functional hope. Maintaining hope and expectation for a favorable outcome can be important in facing uncomfortable side effects, continuing with daily activities, maintaining a functional role in the family, and possibly even surviving cancer. Having hope has been associated with more effective coping and a better quality of life, spiritual healing, and a stronger sense of coherence or positive orientation to living. With disease progression, hope is often modified from the goal of attaining or retaining remission or cure to achieving more immediate personally focused goals. Some patients need to continue fighting; others will need permission not to. Denial about one’s illness can be both a blessing and a curse. Caregivers must continually assess and validate the patient’s concept of hope and avoid imposing their own values on the patient. Hope is always possible. Perhaps, among the many things that we can offer cancer patients and their loved ones, is a “community of hope”; that is, that we are hopeful about cancer survivorship, the attainment of personal goals, and that their life is meaningful.25 A community of hope fosters trust and openness and teamwork. It provides support and continuity of care. It allows for individual differences in coping with cancer and accepts all visions of hope that patients and families bring to the treatment process. No matter what the disease stage, every patient has the right to remain hopeful, and every health care professional has an obligation to support his or her patients and their vision of hope. It will support quality of life for patients and their families, allow for more effective communication, and perhaps add to the personal satisfaction of the medical provider. “Above all, I know that my physician is doing the best he can to help

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me…whether that help results in remission or cure, longer survival, or the best, most comfortable time at the end of my life, I know I won’t have to do this alone. I trust him completely. That helps me face this uncertainty with so much less fear. It gives me a lot of hope.” (Mike, age 58, personal communication, 2006). REFERENCES 1. 2. 3. 4.

5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

Groopman J (2004) The Anatomy of Hope: How people prevail in the face of illness. New York: Random House. Herth K (1989) The relationship between the level of hope and level of coping response and other variables in patients with cancer. Oncology Nursing Forum, 16, 67–72. Antonovsky A (1979) Health, Stress, and Coping. San Francisco: Jowey-Bass. Post-White J (1994) The role of sense of coherence in mediating the effects of mental imagery on emotions, immune function, and cancer outcomes. In HI McCubbin, EAThompson, AIThompson & J Fromer (Eds.), Sense of Coherence and Reiliency. Madison: University of Wisconson System, pp. 279–291. Nuland S (1994) How We Die, New York: Alfred A. Knopf. Dufault KJ (1983) Maximizing hope. Proceedings of the Fourth National Conference on Cancer Nursing. Mishel MH, Hosttetter T, King B, & Graham V (1984) Predictors of psychosocial adjustment in patients newly diagnosed with gynecological cancer. Cancer Nursing, 7, 291–299. Weissman AD & Worden JW (1976–1977) The existential plight in cancer: Significance of the first 100 days. International Journal of Psychiatry in Medicine, 7, 1–15. Hinds PS & Martin J (1988). Hopefulness and the self-sustained process in adolescents with cancer. Nursing Research, 37, 336–340. Clark EJ (1995) You have the right to be hopeful. National Coalition of Cancer Survivorship. New York: Albany Medical Center. Farran C, Herth K, & Popovich J (1995) Hope and Hopelessness. Critical Clinical Constructs. Thousand Oaks: Sage Publications. Staats S & Stassen M (1985) Hope: An affective cognition. Social Indicators Research, 17:235–242. Frankl V (1977) Man’s Search for Meaning. Beacon Press: New York. Callan D (1989) Hope as a clinical issue in oncology social work. Journal of Psychosocial Oncology, 7(3):31–46.

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15. Nowotny ML (1989) Assessment of hope in patients with cancer: Development of an instrument. Oncology Nursing Forum, 16, 57–61. 16. Massie MJ (1989) Depression, in Handbook of Psychooncology: Psychological Care of the Patient with Cancer. New York: Oxford University Press; 283–290. 17. Brandt BT (1987) The relationship between hopelessness and selected variables in women receiving chemotherapy for breast cancer. Oncology Nursing Forum, 14(2), 35–39. 18. Buckman R (1992) How to Break Bad News: A Guide for Health Care Professionals. Baltimore: Johns Hopkins University Press. 19. Baile WF, Glober G, Lenzi R, Beale EA & Kudelka AP (1999), Discussing disease progression and end of life decisions, Oncology 13 (7), 1021–1031. 20. Armstrong J & Holland J (March, 2004) Surviving the stresses of oncology by improving communication, Oncology, 18 (3), 363–368. 21. Cassel E (1982) The nature of suffering and the goals of medicine, N Engl Med, 306, 639–645. 22. Earle CC, Neville BA, Landrum MB, Ayanian JZ, Block SD, Weeks JC, (2004). Trends in Aggressiveness of Care at the End of Life; JClinOncology, 22 (2), 315–332. 23. Miller JF, (1989). Hope Inspiring Strategies of the Critically Ill; Applied Nursing Research, (2), 23–29. 24. Ambuel B (1999) Improving End-of-Life Care: A Resource Guide for Physician Education. Milwaukee: The Medical College of Wisconsin. 25. Clark EJ (1989) Offsetting burnout in the thanatologic setting: Recognition and emphasis on “psychosocial successes” in social work intervention. In Wessells D, et al. (Eds.) Professional Burnout in Medicine and the Helping Professions. New York: The Haworth Press.

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ADDRESSING THE SPIRITUAL NEEDS OF PATIENTS Christina M. Puchalski

INTRODUCTION Increased recognition of the importance of patient-centered care has resulted in a greater acceptance of a biopsychosocialspiritual model of care, where all dimensions of a patient’s care are attended to, including the spiritual, religious and existential issues that patients may face, particularly with a serious illness, such as cancer.1,2 Research has demonstrated that spirituality can impact patient coping with suffering as well as some healthcare outcomes.3 Spirituality is also helpful to caregivers of patients with cancer.4 In addition, there are theoretical, ethical guidelines, and institutional support for interdisciplinary spiritual care, especially for patients with serious illness such as cancer.5 Finally, there are successful models of professional education in spirituality and health, with the majority of medical schools in the US having required courses in spirituality and health, lending credibility to the importance of this subject area.6 Balboni and colleagues recently published a study which concluded that many cancer patients’ spiritual needs are not supported by the medical system nor by religious communities. The study also demonstrated that spiritual support was associated with improved quality of life.7 As Betty Ferrell noted in her editorial,8 “It is a strong statement of a seriously unmet need in the vast majority of patients in our care.”

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SPIRITUALITY: A PATIENT NEED The majority of patients with serious illness want their spiritual issues addressed in their care. 9,10,11,12,13 Patients cite a variety of reasons, including increased trust in their physician, feeling that their wishes are respected, feeling their realistic hopes can be encouraged, that their spiritual beliefs help them cope with their illness, and that it gives them a sense of meaning in their lives. Spirituality has been defined in many different ways. Some unifying principles include finding a sense of ultimate meaning and purpose, connecting with others or with a transcendent, finding hope in the midst of despair, and being able to reconcile or forgive. Spiritual values such as hope, faith, and altruism can help people handle adversity and cope with suffering and illness. Religions offer people a language of hope and ways to understand their suffering.14 Religious and other spiritual communities also offer people social support and a community. A definition that has been used in the medical school courses and developed by consensus is: Spirituality is recognized as a factor that contributes to health in many persons. The concept of spirituality is found in all cultures and societies. It is expressed in an individual’s search for ultimate meaning through participation in religion and/or belief in God, family, naturalism, rationalism, humanism, and the arts. All of these factors can influence how patients and health care professionals perceive health and illness and how they interact with one another.15 Thus the definition includes a personal expression of spirituality and also a relational one. Spirituality is broader than religion. In listening for spiritual themes from patients, it is important to recognize that spirituality can be expressed in many different ways. Thus, for some patients, church is the spiritual community and for others it may be likeminded friends or family. Spiritual practices may range from prayer and meditation to walking in the woods or listening to music, or painting.

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SPIRITUAL ISSUES PATIENTS FACE In the clinical setting, patients may face spiritual issues, particularly when they are told about a difficult diagnosis, dealing with crisis or serious life changes, and when dealing with serious illness or end of life issues. The spiritual issues include: • • • • • • •

Lack of meaning and purpose in life Hopelessness Despair Guilt/shame Lack of connection or love to others or to God Anger at God/others Abandonment by God/others

Meaning and purpose is something that all people seek; the inability to find that meaning and purpose can lead to depression and anxiety. People find many sources of meaning and purpose throughout their lives that may be transient––jobs, relationships, accomplishments, and financial success. However, the challenge for all people, especially those with serious illness, is to find meaning and purpose even in the midst of failed jobs, relationships, accomplishments and unattained successes. Ultimate meaning and purpose is that meaning that sustains individuals in the emptiness of their external lives or as people face their dying. Spiritual and religious beliefs play a significant role in how people transcend their suffering in order to find such ultimate meaning.16 Hopelessness often arises in the midst of serious illness. Studies have indicated that people who are more hopeful do better with regards to depression and other health indicators.17,18 How people come to understand hope also varies. Initially, hope may be dependant on a cure or recovery, but, when that is not possible, people may have a hard time tapping into resources of hope. In those times, hope may be manifested as acceptance, finishing important goals or activities, living life fully in the face of difficulty, finding meaning, and eventually experiencing a good quality of life and death. Helping people restructure their thinking so that they can see hopefulness in the midst of despair is an essential part of therapy.

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Spiritual and religious beliefs offer people a language of hope. Religious and spiritual communities offer people support as people try to find hope and meaning for themselves. Profound despair can stem from an existential crisis, lack of meaning and purpose, hopelessness, and extreme loneliness. People need a sense of connection to others and a sense that they are loved and cared for. Spiritual and religious communities offer that sense of love and connection for people. Thus, in listening to a patient’s story one might hear themes of support from the church community or family. But one can also hear themes of abandonment and anger at the community of support or at God. This sense of abandonment by or anger at the community that offered solace at one point in a person’s life can lead to a profound sense of despair and isolation. Religious themes can cause distress in people’s lives. Anger at God is often normal in the face of serious illness. Yet, it can lead to conflict, guilt, and despair. It is important to allow people to talk about that anger in a safe environment where they do not feel they will be judged. It is often in the clinical setting that patients will share such feelings. In their religious communities, they may be told that it is wrong to be angry at God, or that it reflects a weakening in one’s faith to be angry at or feel abandoned by God. Yet, in the clinician’s office, the patient may find a safe haven to explore these feelings in greater depth. Koenig and colleagues19 found that negative religious coping was associated with poorer physical health, worse quality of life, and greater depression in medically ill hospitalized older adults, but that positive religious coping was associated with better mental health in those patients. Understanding how spirituality and religion relate to patients’ understanding of their illness and their ability to cope is an important aspect of providing comprehensive patient-centered care. SPIRITUALITY AND HEALTH: HEALTH OUTCOMES There have been many studies that indicate that spiritual and religious beliefs and practices may impact health care outcomes, including mortality, cardiovascular disease and depression.20,21 Research in meditation and prayer has shown positive health benefits for these practices and has suggested a role for spiritual

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beliefs in resiliency and coping with stress.22 Finally, at end of life, spirituality has been shown to impact quality of life.23 This has important implications for the potential inclusion of spiritual practices in the treatment plan of patients with serious illness. Extensive research has documented the effect of caregiver burden and stress on the lives of caregivers.24,25,26,27,28 It is well documented that providing supportive care during the diagnosis and treatment of cancer may affect the mental health and stress levels of the family caregiver.29,30,31,32 The stress of caregiving responsibilities can result in poor health, depression, social isolation, and financial strain.33 In one study, Wyatt29 found that the caregivers of patients with cancer had more depressive symptoms than the general public. Depression was passively correlated with negative thinking and inversely correlated with positive outlook and with spirituality. Caregivers endorsed the following spiritual items: • • • •

I believe in a power greater than myself; I know what is important in life; My values and beliefs help me meet daily challenges; and, I accept the mysteries of life and death.

SPIRITUAL CARE In a consensus conference between the Association of American Medical Colleges and the George Washington Institute for Spirituality and Health, medical educators, clinicians, medical ethicists, and chaplains developed guidelines for spiritual care.34 Of particular importance was the consensus that clinicians should create environments where patients feel they can trust their clinician and share whatever concerns that patient has, including spiritual concerns. Thus, the first step in communicating with patients about spiritual issues is to communicate a genuine interest and compassion for the patient. By creating an atmosphere of caring compassion and a willingness to be open to whatever concerns the patient, the interaction becomes focused in a patient-centered model of care. In this model there is recognition that a patient’s understanding of illness can be impacted by many factors, including spiritual and religious beliefs and practices.35

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Some of the key elements of communicating with patients about spiritual issues include: • • •

Responding to spiritual themes Recognizing spiritual clues Taking a formal spiritual history

The patient in conversation with the healthcare professional, as listed above, may bring up spiritual themes. Some examples include: • • • • •

Doctor, why is this happening to me? I have led a good life, why is God punishing me now? My life is meaningless. I have no value in my life—I am a nothing. Look at me—why would anyone care about me?

The first step in communicating with patients is simply to listen for these themes and then offer the patient the opportunity to discuss the issues more fully. This requires open-ended questions, respect for the inherent dignity of each person, and openness to diversity of belief systems and values. It also requires the healthcare professional to be open to the source of the question. For example, when a patient asks “Why is this happening to me?” the temptation may be to answer from the mindset of one’s training, namely the physical etiology of the illness. So one might answer, “You have a family history of breast cancer which contributes to your increased likelihood of getting this illness.” This answer focuses on the physical aspect of her illness. Instead, one could ask an open-ended question, such as, “What do you think is happening?” which then affords the patient the space and invitation to discuss whatever is on his or her mind––physical or spiritual or existential. Patients may wear religious jewelry or have spiritual or religious readings at the bedside or with them in the office. For example, a patient may be reading the Koran or Bible or may have a book on spiritual issues. One can then refer to that book as a way of finding out the importance of that reading material in the patient’s life. Sometimes patients may use religious expressions in the midst of their healthcare professional breaking bad news: “Oh God, help

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me, Lord have mercy, etc.” The healthcare professional can respond, “You seem upset. Is God important to you as you face what we are talking about?” THE SPIRITUAL HISTORY A spiritual history refers to more formal questioning of the patient about their spiritual beliefs and practices. As in any other part of the history, listening to themes alone will not elicit all the information needed to provide good medical care. Thus, specific questions need to be asked to target specific areas of information, such as depression, social support, domestic violence, sexual preferences, and practices. Patients may not think to volunteer information to a clinician unless they are invited to share that specific area. This is particularly true of spirituality. While patients are interested in having spirituality integrated into their care, it is not yet a common practice to have physicians and other healthcare professionals address spiritual issues. Patients may need an invitation to share in this area. A spiritual history is simply a set of targeted questions aimed at inviting patients to share their spiritual and/or religious beliefs if desired. There are a number of tools that have been developed to use for spiritual history taking. These include FICA,36 SPIRIT,37 and HOPE.38 A spiritual history can be done as part of a social history in the intake exam or annual history and physical. The goal of the spiritual history is to: • • • • •

Invite the patient to share spiritual and religious beliefs if they choose to , Learn about the patient s beliefs and values Assess for spiritual distress (meaninglessness, hopelessness, etc.) as well as for spiritual resources of strength (hope, meaning and purpose, resiliency, spiritual community). Provide an opportunity for compassionate care whereby the healthcare professional connects to the patient in a deep and profound way Empower the patient to find inner resources of healing and acceptance

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•

Learn about the patient’s spiritual and religious beliefs that might impact healthcare decision making

FICA, a tool I developed with several colleagues, can be used in a time efficient manner. It is outlined below: FICA©––Taking a Spiritual History F––Faith and Belief “Do you consider yourself spiritual or religious?” or “Do you have spiritual beliefs that help you cope with stress?” If the patient responds “No,” the physician might ask, “What gives your life meaning?” Sometimes patients respond with answers such as family, career, or nature. I––Importance “What importance does your faith or belief have in your life? Have your beliefs influenced how you take care of yourself in this illness? What role do your beliefs play in regaining your health?” C––Community “Are you part of a spiritual or religious community? Is this of support to you and how? Is there a group of people you really love or who are important to you?” Communities such as churches, temples, and mosques, or a group of like-minded friends can serve as strong support systems for some patients. A––Address in Care “How would you like me, your healthcare provider, to address these issues in your healthcare?” Often it is not necessary to ask this question but to think about what spiritual issues need to be addressed in the treatment plan. Examples include referral to chaplains, pastoral counselors, or spiritual directors, journaling, and music or art therapy. Sometimes the plan may be simply to listen and support the person on their journey.

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The questions outlined above are meant to serve as a guide for the discussion about spiritual issues. The history is normally done during the social history section of the history and physical. As one is asking the patient about their living situation and significant relationships, the clinician can transition into how the person cares for himself or herself. Questions about exercise and how one deals with stress and difficult situations are an important part of self-care. In this context, the clinician then raises the question of whether spiritual beliefs and practices are important to the patient. This lodges the spiritual history within the clinical context. The spiritual history is patient-centered. The clinician should not force the questions if the patient does not identify himself or herself as spiritual or religious, or if the person does not wish to discuss their spirituality. It is important to respect the patient’s privacy in these issues. Clinicians must also be careful how the questions are asked and what kind of information should be discussed within the clinical context. Proselytizing is not allowed in the clinical setting as this would violate the trust that patients place in clinicians. There is a power differential between clinicians and patients. Patients may feel vulnerable with their clinicians and that vulnerability needs to be honored and protected. A well meaning clinician can share their personal beliefs with the patient. The patient may adopt or superficially agree with the clinician’s beliefs out of fear that their medical care could be compromised if they don’t agree. This is why clinicians must be sensitive to appropriate boundaries and honor those boundaries. Clinicians, as a whole, are not trained spiritual care providers. Chaplains, clergy, pastoral counselors, and spiritual directors are trained to work specifically with patients’ spiritual issues. Chaplains are certified by chaplaincy organizations to work specifically with patients in healthcare settings in helping them work through spiritual crisis or distress. Chaplains are also trained to participate and lead rituals that may be important to patients and to facilitate connection with the patients’ clergy, if needed, within healthcare settings. Chaplains work with patients of any religious or non-religious backgrounds. Clergy are ordained, trained in religious care, and usually work predominantly with patients from their religious denomination. Pastoral counselors are masters or doctoral

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trained counselors. Half of their training is in how spiritual and religious issues affect the manifestation of and coping with the presenting symptoms. Spiritual directors are not counselors, rather they are trained to assist people in their spiritual journey by helping them discern how God or the divine is working in their lives. The spiritual history is a screening tool to help identify spiritual issues. But more in-depth spiritual counseling should be done with trained spiritual care providers. Some mental health professionals may have more training in spiritual assessment, diagnosis, and treatment than other healthcare professionals, but, even then, the focus of the training is different from trained spiritual care providers. Many patients can benefit from the unique training of all these different professionals. CONCLUSIONS Spiritual needs are important to many patients, including those with cancer. There is institutional support for the inclusion of spiritual care in the holistic care of patients. There is also data showing that not only do patients want their spiritual beliefs integrated into the care by their healthcare providers but that spiritual beliefs may benefit patients with some healthcare outcomes, with resiliency to stress and adverse situations, and with coping with suffering. Studies have indicated that cancer patients’ spiritual needs are not regularly met. One way to do this is to communicate with patients about their spiritual beliefs. A spiritual history provides an opportunity in the clinical encounter for the patient to share their spiritual beliefs, if that is what they choose to do. It helps the clinician identify spiritual distress as well as spiritual resources of strength and to provide the appropriate therapy and referrals needed to give the patient the best care. REFERENCES 1. 2.

National Cancer Institute: Spirituality in cancer care http://www.nci. nih.gov/cancertopics/pdq/supportivecare/spirituality. Puchalski CM. Chap. 58, Spirituality. In: Berger A, Portenoy R, & Weissman D (eds.). Principles and practice of palliative care and supportive oncology. Lippincott Williams & Wilkins, 2006: 633–644.

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5. 6. 7.

8. 9. 10. 11. 12. 13. 14. 15. 16. 17.

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Koenig HG, McCullough ME, & Larson DB. Handbook of religion and health. New York: Oxford University Press, 2001. Puchalski CM, (2007 in press). Caregiver stress: The role of spirituality in the lives of family/friends and professional caregivers of cancer patients. In R. C. Talley (Series Ed.) and R. C. Talley, R. McCorkle, & W. F. Baile (Vol. Eds.), Providing care for individuals with cancer: Challenges for professional and family caregivers. New York: Oxford University Press. Puchalski, CM, Lunsford B, Harris MH, & Miller T. Interdisciplinary spiritual care for seriously ill and dying patients: A collaborative model. Can J, 2006; 12 (5), 389–416. Puchalski CM. Spirituality and medicine: Curricula in medical education. J Can Edu, 2006; 21(1), 14–18. Balboni T, Vanderwerker L, Block S, et al. Religiousness and spiritual support among advanced cancer patients and associations with end-of-life treatment preferences and quality of life. J Clin Onc, 2007; 25(5), 555–560. Ferrel B. Meeting spiritual needs: what is an oncologist to do? J Clin Onc, 2007; 25(5), 467–468. McCord G, Gilchrist VI, Grossman SD, et al. Discussing spiritual issues with patients: a rational and ethical approach. Ann Int Med, 2004; 2(4), 356–361. Peteet J. Religious issues presented by cancer patients seen in psychiatric consultation. J Psycosoc Onc, 1985; 3, 53–66. Gall TL, Comblatt MW. Breast cancer survivors give voice: a qualitative analysis of spiritual factors in long-term adjustment. Psycooncology, 2002; 11, 524–535. Jenkins PA, Pargament KI. Religion and spirituality as resources for coping with cancer J Psycosoc Onc, 1995; 13, 51–75. Roberts JA, Brown D, Elkins T, et.al. Factors influencing views of patients with gynecologic cancer about end-of-life decisions. Am J Obstet Gynecol, 1997; 176, 166–172. Puchalski CM & O’Donnell E. Religious and spiritual beliefs in endof-life care: how major religions view death and dying. Tech Reg Anes Pain Man, 2005; 9, 114–121. Association of American Medical Colleges. Report III. Contemporary issues in medicine. Medical school objectives project (MSOP III). Washington, DC: AAMC, 1999; 27. Wong, PT & Fry P. The Human Quest for Meaning Lawrence Erlbaum Associates, Publishers, Mahwah, NJ, 1998. Breitbart W, Heller K. Reframing hope: Meaning centered care for patients near the end of life. J Pall Med, 2003; 6(6), 979–988.

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18. Snyder CR, Irving LM, Anderson JR. Hope and health: measuring the will and the ways. In: Snyder CR & Forsyth DR (eds.), The handbook of social and clinical psychology: the health perspective, Elmsford, Pergamon Press, 1991: 285–307. 19. Koenig HG, Pargament KI, & Nielson J. Religious coping and health status in medically ill hospitalized older adults. J Nerv Ment Dis, 1998; 186(9), 513–521. 20. Koenig H, Larson D, & McCullough M. Religion and Health, Oxford University Press, 2000. 21. Powell LH, Shahabi L & Thoresen CE. Religion and spirituality. Linkages to physical health. Am Psycho, 2003; 58(1), 36–52. 22. Komaroff AL. Mind/body medicine: a special report (ed.). Boston: Harvard Health Publications, 2001. 23. Cohen SR, Mount BM, Strobel MG, et. al. The McGill quality of life questionnaire: A measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Pall Med, 1995; 9, 207–219. 24. Jivanjee P. Enhancing the well-being of family caregivers to patients with Alzheimer’s Disease. J Geront Soc Wk, 1994; 23(1/2), 31–48. 25. Brody E. “Women in the middle” and family help to older people. The Geront, 1981; 21(5), 471–479. 26. Montgomery R, Gonyea J, & Hooyman N. Caregiving and the experience of subjective and objective burden. Res on Ag, 1985; 7(1), 137–152. 27. Pruchno JR, & Resch N. Husbands and wives as caregivers: Antecedents of depression and burden. Geront, 1989; 29(2), 159–165. 28. Zarit S, Todd P, & Zarit J. Subjective burden of husbands and wives as caregivers: A longitudinal study. Geront, 1986; 26(3), 260–266. 29. Wyatt G, Friedman L, Given C, et.al. A profile of bereaved caregivers following provision of terminal care. J Pall Cr, 1999; 15(1), 13–25. 30. Miller B, McFall S, & Montgomery A. The impact of elder health, caregiver involvement, and global stress on two dimensions of caregiver burden. J Geront, 1991; 46(1), S9–S19. 31. Miaskowski C, Kragness L, Dibble S, et. al. Differences in mood states, health status, and caregiver strain between family caregivers of oncology outpatients with and without cancer-related pain. J Pn Sym Man, 1997; 13(3), 138–147. 32. Schott-Baer D. Dependent care, caregiver burden, and self-care agency of spouse caregivers. Can Nur, 1993; 16(3), 230–236. 33. Robinson K. The relationship between social skills, social support, self-esteem, and burden in adult caregivers. J Adv Nur, 1990; 15, 788–795.

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34. Puchalski CM, Anderson MB, Lo B, et al. (2007, in preparation). Ethical issues in spiritual care. AAMC monograph. 35. Patient-Centered Care 2015 Scenarios, Vision, Goals and Next Steps. Picker Institute 2004. 36. Puchalski CM, Romer A.. Taking a spiritual history allows clinicians to understand patients more fully. J Pal Med, 2000; 3 (1), 129–137. 37. Maugans TA. The spiritual history. Arch Fam Med, 1996; 5, 11–16. 38. Anandarajah G, & Hight E. Spirituality and medical practice: Using the HOPE questions as a practical tool for spiritual assessment. Am Fam Phy, 2001; 63(1), 81–88. Retrieved July 7, 2006, from http://www.aafp.org/afp/ 20010101/81.pdf.

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PEDIATRIC CANCER CARE: SPECIAL ISSUES IN ETHICAL DECISION MAKING Sarah Zieber and Sarah Friebert

CASE REPORT MS, a 7 month-old Amish female, was brought to an outlying Emergency Department by her parents because of persistent cough. Her mother reported that she had not been eating well and seemed to have difficulty breathing while she was eating. Parents were also concerned because she had not stooled in more than 5 days. During the assessment in the Emergency Department, she was found to have significant hepatosplenomegaly and respiratory distress. Chest x-ray showed pleural effusion and a mediastinal mass. She was intubated prior to transport and a chest tube was placed on arrival in the receiving Pediatric Intensive Care Unit. Pleural fluid drained from the chest tube was analyzed and demonstrated lymphocyte proliferation. She was subsequently diagnosed with T-cell lymphoblastic leukemia. After appropriate staging, the diagnosis was discussed with the family and she was given a 60% chance of cure. Despite this prognosis, the family refused chemotherapy and requested that all medical interventions be stopped. An ethics consultation was called to explore the issue. The parents’ feelings were that 2–2.5 years of therapy would pose greater burdens to their child, family and community than the potential benefits, even though they understood clearly that their daughter would die without treatment. Their religious beliefs did not include utilizing aggressive measures to support life. The ethics committee agreed that the family held decision making authority and

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could choose not to pursue further therapy. At the family’s request, MS was extubated and returned home in the care of hospice. INTRODUCTION Cancer in the pediatric population is a relatively rare occurrence, although it is estimated that 12,400 children younger than 20 years of age will be diagnosed with some form of cancer each year. Cancer-related deaths remain the number one cause of diseaserelated death and are the fourth leading cause of death among children age 1–19 behind unintentional injuries, homicide and suicide.1 Despite relatively small numbers, however, pediatric oncology is ripe with ethical dilemmas that begin with diagnosis and continue through end-of-life care.2 The core principles that guide adult bioethics also form the backbone of pediatric bioethics; as with adult ethics, the tenets of respect for persons, beneficence, nonmaleficence and justice are at the center of pediatric ethics. Additionally, the idea of weighing benefit versus burden when making decisions about care and treatment becomes a crucial factor. All of these principles must be considered when approaching any situation; importantly, every patient’s individual circumstances must be given particular deliberation, as illustrated by the case of MS.3 While adult and pediatric ethics share the same tenets, unique dilemmas are often encountered in pediatric practice; no pediatric subspecialty is perhaps more illustrative of these differences than pediatric oncology. Children differ from adults in age and also in developmental abilities, currently rendering them legally incapable of making decisions for themselves under the age of 18 years in the United States, except in special circumstances. Pediatric oncology presents further difficulties because often children present with life-threatening illness, and the treatments for these illnesses are based in research protocols, adding another layer to the ethical milieu.2,4 This chapter will focus on consideration of specific pediatric issues as they relate to decision making, informed consent and assent, and participation in research studies. Full treatment of all ethical issues involving children is outside the scope of this chapter, and the issues therein are not necessarily unique to

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children with cancer; for further discussion on other important ethical topics such as withholding/withdrawing care, end-of-life decision making, complementary therapy, and palliative care, the reader is referred to other excellent sources of information.5,6,7,8,9,10,11 DIFFERENCES IN CHILDREN Fundamental to the practice of ethical medicine is the premise of maximizing benefit and limiting the amount of harm done. Paramount to an understanding of pediatric ethics, however, is the idea that children are not small adults, that they are members of a family whose members are also stakeholders in outcomes related to their care, and that their best interests are determined, in most circumstances, by their parents. A major difference between children and adults that is easily recognized is that both the pathology and physiology of disease seen in children varies from that of adults. This is particularly true in pediatric oncology where the number, presentation and type of oncologic processes usually differ from those seen in adult oncology. Children undergo significant changes in many aspects of growth and maturation, including changes in body composition and proportion as well as organ function and psychological development.12 All of this variability makes it impractical to assume that children will respond to treatments and therapies in the same way as adults, and highlights the importance of research in children in the treatment process.13 As such, research participation becomes a crucial topic in any discussion of pediatric ethics. Decision-making capacity and autonomy also set children apart from adults. Children are at varying stages of developing the cognitive and emotional capacities necessary to make decisions. Buchanan and Brock14 determined that decision-making competence is relative to each individual situation and its particular risks. At a minimum, however, competent decision making requires the following basic tenets: an understanding of the information; an ability to communicate that understanding; skills to reason and deliberate choices in decisions; and possession and articulation of a value system upon which to base decisions. The level of maturity of the individual child and the level of risk will dictate the extent of a

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child’s involvement in his or her own health-care decision making.14 It has been proposed that children as young as 7 years have some capacity for understanding and decision making, and that children 14 years and older have virtually the same cognitive maturity as many adults.15,16,17 In dissent to Wisconsin v. Yoder18 Supreme Court Justice Douglas cited “substantial agreement among child psychologists and sociologists that the moral and intellectual maturity of the 14-year old approaches that of the adult.”19 Because of this, it has been asserted, “children have a right to be treated as developing persons, as persons with a developing capacity for rationality, autonomy, and participation in health-care decision making.”20 Most children need only comprehend the impact that treatment alternatives will have on their lives, not the complicated medical aspects that are often presented, in order to make decisions.14 Finally, competent whole-person pediatric care requires the physician to establish a close relationship with not only the patient but also the family. Surrogate decision-makers are a major force in the determination of health-care decisions in pediatrics.13 While the pediatrician’s primary responsibility is to the child, decisions relating to care cannot be made in isolation and must be made with careful consideration of all individuals involved.21 DECISION MAKING Competence Central to all aspects of pediatric care are the issues of competence and surrogate decision making. Until recently, it was thought that all children under 18 years of age were “incompetent” and unable to make informed decisions regarding their health care. For children with lifethreatening diseases, decisions with regard to treatment intervention often have profound effects on children’s bodies as well as many nonphysical domains of their lives. Comprehensive care by its nature involves decisions about treatments that may cause significant burdens, including pain and suffering.22 Automatic presumptive incompetence based on age alone severely limits children’s ability to participate in these decisions about their health care.

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Assumed competence does not exist in the world of the child––it is a capability pediatric patients must prove to have mastered. Most often, the decision of what is best for the child outweighs the question of who will be making the decision. In this way, best interest trumps autonomy in many instances.23 Widespread agreement exists, however, that competence is a fluid concept that can be shaped by the complexity of the decision and alternatives as well as the emotional and psychological state of the individual. One way to look at this is that the higher the risk involved, the more stringent the definition of competence must be.24 It is important that the idea of competence not become static; in other words, as the child matures or becomes more emotionally fit, it is the responsibility of the care team as well as the family to modify their concept of competence accordingly to include the child when and at what level it becomes appropriate. Surrogates In the past, the burden of decision making for children was placed upon or assumed by the physician. With advances in the complexity of society and information technology has come increasing recognition that patients have rights which include disclosure of information about their health and options for treatment; this trend has, in turn, shifted the burden of decision making to the patient and family.22 In pediatrics, most often a surrogate, namely a parent/guardian (hereafter referred to as “parent”), is placed in the position of decision-maker and is expected to act with the best interests of the child at the forefront. This is in keeping with a utilitarian approach that would offer that parents should control decisions for their children because they will bear the consequences of the decisions. Surrogate decision making increases complexity but also provides benefits in pediatric medicine. First, many children hold a rather limited view of the world and tend toward egocentricity as a guide to decision making. Surrogates are able to extend this view and ensure future autonomy. Second, because children possess limited abilities to reason abstractly about treatment implications, it is often necessary to employ a surrogate who is able to understand

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the more complex alternatives of treatment and to consider the spectrum of relevant issues. Third, children often possess concrete ideas of wellbeing and utilize these notions in their decision-making processes. Surrogates offer a more forward-thinking approach ensuring, again, preservation of future autonomy.14 Surrogate decision making is not without its drawbacks. Inherent is the assumption that parents will always act with the best interest of the child as the guiding factor. The needs of the parent as well as siblings may be subordinated to the best interests of the ill child. However, parents may breach their obligations toward their children. One significant drawback to surrogate decision making is that while parents have the right to give permission for treatment, they also have the right to refuse treatment, including life-sustaining treatment. This leaves open the concept that a surrogate may have a right to endanger or neglect a child. Because of this possibility, it is crucial for the child’s pediatrician to remember that “responsibilities to his or her patient exist independent of parental desires or proxy consent.”22 While parental/surrogate input is important and should weigh heavily, exclusive rights as final decision-makers should not be granted to parents/guardians with carte blanche in all cases.25 In certain instances, minors are able to consent for treatment without the consent or permission of a surrogate. This is particularly true in situations in which the need for consent might interfere with the child seeking treatment. Currently, many jurisdictions recognize certain minors as “emancipated” and deem them able to make health care decisions with the same authority as adults. This includes those minors that are: (1) self-supporting/not living at home; (2) married; (3) pregnant or a parent; (4) in the military; or (5) declared emancipated by the court. In addition to emancipated minors, many states also recognize mature minors as those with the decisionmaking capacity to consent for treatment of sexually-transmitted diseases, drug and alcohol use and pregnancy.26 Ethics within Pediatric Oncology While much of the previous discussion dealt with general pediatric ethics, we begin an examination of pediatric oncology and the special ethical conflicts that are seen within this particular field.

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The Team Approach Pediatric oncology is a subspecialty that is largely practiced in major tertiary centers with highly trained staff who have one common goal: providing quality care to children with cancer and their families. In comprehensive pediatric cancer centers, a multitude of services and therapies are brought together to form a multidisciplinary team that is ultimately able to achieve the larger goal of delivering high-quality care. Studies have shown that when this level of coordination is achieved, patients enjoy better outcomes.27 Physicians must not only coordinate their efforts with the larger group but must also agree to enter into therapeutic relationships with the patient as well as the family: “Each party–– child, parents, and health care staff––has particular obligations and responsibilities in this relationship.”28 The relationships among the physician, family and patient are the key to ensuring compliance and success of treatment. “Inadequate doctor/patient/family dialogue, relationship, trust, and mutual information is one the most important causes of noncompliance.”29 The three-cornered process must include all parties, with the child as the focal point and the parents and physicians as supporting elements as both advocates and decision makers. All sides must participate equally for successful treatment.30 The relationship must remain flexible, however, because as treatment and procedures change over the course of time, so do the roles and importance of each individual.31 Competence Integral to the success of pediatric oncology therapy is the involvement and investment of children in their medical care. It is imperative that children be active participants to the extent that they are capable.32 Much of what children with cancer must endure involves painful procedures, extensive courses of medications with burdensome side effects, long days spent in clinic, and general disruptions to the life that they were experiencing prior to diagnosis. Respect for the child’s feelings and decisions regarding care is a critical determinant of the success or failure of therapy.33

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At the same time, the breadth and complexity of decisions in pediatric oncology, along with the concomitant increased level of anxiety surrounding a cancer diagnosis, can make it difficult, if not impossible, for the patient to make truly informed decisions. Nevertheless, children have a moral right to receive explanations regarding their disease, procedures involved and risks and benefits of therapies. This should be offered at a level that is appropriate for their current developmental and psychological capacity.25 While in many instances children will not be able to make the ultimate or final decision, they should not be left out of the decision-making process. Parents and other caregivers must be mindful of changes that allow or prohibit children from making choices in their health care. In cases where the decision is complex and of a high-risk nature, increased surrogate involvement may be beneficial. In less complex instances where relatively few options are available and the risk is minimal, the child may benefit from the opportunity to have more decision-making power. Put another way, “High-risk situations require an exacting standard for the determination of competence whereas a lower standard may be accepted where risk is relatively minor.”24 Disclosure of Information The initial discussion with patients and their families regarding the diagnosis of a life-threatening illness, especially cancer, is the most powerful and important conversation a health care provider may have. Within that conversation is the power to gain the family and child’s trust, to begin to assuage fears about the future, and to empower families to initiate the process of incorporating the ramifications of the illness into their everyday lives. The diagnosis conversation can also taint any future interactions if not done well and can cause distrust or even destruction of the therapeutic alliance, which can ultimately impact the success of treatment. It is crucial to recognize the importance of the first encounter and to be aware on all levels of the interchanges occurring. As the initial interview is such a monumental occurrence, it should not be expected that a young house officer would necessarily possess the skills needed to make it a success. Beverly Myers set

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forth numerous characteristics that a health care professional must acquire in order to have success at delivering bad news to families. These include: competence, warmth and interest, the ability to listen, patience and acceptance, tolerance of the expression of emotion, sensitivity to feeling states, the ability to be direct and honest, good clinical judgment, use of language that families can understand, and tolerance of parental non-acceptance.34 Mastery of these qualities goes a long way toward making the presentation of the initial diagnosis a successful and meaningful event for the family, child and physician. In fact, for providers, “this beginning to the therapeutic relationship often teaches us most clearly what is extraordinary about our patients and families.”35 While the initial discussion is the most important, it is only the first step in a long journey that the family and physician have embarked on. At initial diagnosis, anxiety and emotion are very high, and families are often searching for information and hope. Though it is important to be direct and honest with families, they may not be able to hear and process all of the information presented. “A well planned and extensive initial session should be followed by continuing discussion” in order to maintain the relationship with families and children.28 When families become overwhelmed and unable to prioritize, they risk losing their ability to exercise autonomy. Effective communication strategies must therefore include an inherently relational, multidimensional approach which examines different perspectives, including the impact that each aspect has on every other. Decision making must be acknowledged as an evolving process in which current information builds upon previous discussions and dilemmas.36 Such a step-wise approach to the provision of information maximizes the family’s ability to exercise autonomy; however, providers must be careful to balance nonmaleficence and overt paternalism. The establishment of a support structure for the child and family is extremely useful in guiding them through the initial stages of diagnosis. It is important that all significant family members or support people be present at the time of the initial discussion. The roles and the relationships in the family will change dramatically, and all key parties must be prepared for the evolution. The support system will be essential to the family throughout the cancer

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experience, allowing them to progress from initial shock and emotional chaos, to begin to assimilate to their new life, and eventually to confront the grief that accompanies the loss of the normalcy they once knew. Disclosure of Information to Children Children should also be included in the initial discussion about their illness as they will be enduring the day-to-day trials and burdens of the disease. The child’s understanding of the illness and sense of involvement will offer a sense of investment in the situation and improve compliance. In the 1950s and 1960s, medicine was based in paternalism and children were often shielded from knowledge about their diseases. This approach has been questioned in a number of studies; evidence has shown that children, sometimes despite the best efforts of family and health care workers to keep information from them, are able to deduce the reality about their illness and may even attempt to protect their parents by not disclosing their knowledge.37 Thus, in the current treatment era, the pendulum has swung in the opposite direction toward an imperative to offer children the truth about what is happening and what is likely to happen to them. Indeed, the thrust now is toward guiding children to “fit the awareness of their illness, even fatal illness into their ongoing lives.”14 Simply put, the child must be recognized as a crucial participant and treated as such. Children are often very astute at reading non-verbal communication, in many cases better than verbal communication, so it behooves the family and caregivers to be aware of non-verbal messages when communicating with each other and with the child. There should be a conscious effort to avoid lecturing or presenting facts. Truthful disclosure about the nature of the disease, treatment, potential complications and side effects as well as necessary procedures should be presented in an ageappropriate manner. Such an approach helps to instill trust in the child and to allay feelings of isolation and fear. Addressing the child’s questions directly and honestly, while helping them to attain an understanding of the implications of illness on their day-to-day life, will help to decrease confusion. Acknowledging fears and

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concerns as well as promoting strengths, including resiliency, humor and tolerance, are a few of the keys to successful and empowering communication with children.27 CHILDREN AS RESEARCH SUBJECTS Justification for Research Participation Research is described as “a class of activities designed to develop or contribute to the general knowledge.”39 It is estimated that 70–80% of children with cancer are enrolled in clinical trials,40 and those that are not formally enrolled are generally treated with protocols derived from prior studies.4 Pediatric oncology and research initiatives share a unique and often obligatory symbiotic relationship in that much of the advances in treatment have been as a result of clinical trials.4 Research within the adult population is without many of the complicating factors that often plague those attempting research in the pediatric realm. Economics, ethics and other technical constraints limit the ability of researchers to obtain pediatric data.41 As a result, a vast number of studies are carried out in adults as compared to pediatrics (though the percentage of adults with cancer who are enrolled on therapeutic trials is far, far lower). It is then left to clinicians to extrapolate these adult study results to the pediatric population, which is clearly inappropriate for many reasons.42 For instance, a majority of the cancers afflicting pediatric patients are seen only in childhood. Also, children may have substantially different responses or tolerances to therapy as compared with adults.42,43 Initiatives have been undertaken to improve the availability of clinical trials in pediatrics as well as to provide incentives to drug companies to include children in studies.44,45 For the vast majority of cases in pediatric oncology, initial therapy is prescribed with intent to cure. To this end, any research trial involving initial therapy must demonstrate “the prospect of direct benefit.”4 Most pediatric cancer protocols are administered through the Children’s Oncology Group and involve randomized (Phase III) clinical trials, in which the goal is to determine the therapy for a particular diagnosis that is most effective yet least toxic. In successive generations of research trials, new

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chemotherapy agents or schedules or routes of administration are compared against the “winner” of the previous protocol. The “standard treatment arm” thus incorporates the therapy which has been proven to be most effective or least toxic, while the “experimental arm” becomes the therapy that is hypothesized to be more effective or less toxic. Pediatric patients who are not entered into research trials––either because no open study is available or because of family or investigator choice––usually receive therapy according to the standard arm for a given diagnosis. Phase I clinical trials, which investigate safety and tolerability, maximum tolerated dose and pharmacokinetics of candidate drugs, create special ethical challenges for children. Unrealistic hopes for cure in combination with low responses rates to Phase I agents (on the order of 5–8%) create the possibility of unintended coercion for families who are desperate to save their children with advanced cancer. On the other hand, parents may make ethical decisions to enroll their children on Phase I trials and may point to a number of intangible benefits, including added time to spend with family or to find a cure.46 In fact, many parents, and pediatric patients themselves, do not feel that abandoning curedirected therapy is a tenable option and choose to pursue experimental therapy.47 At the very least, enrollment of a child onto a phase I clinical trial should be offered in concert with available comprehensive pediatric palliative care services.46 For a more complete discussion on clinical trials, the reader is referred to other excellent resources within this text and elsewhere.2,5,48,49 Informed Consent Enrollment onto any research protocol requires informed consent. Accurate informed consent must include discussion and disclosure about treatment goals and procedures, particularly randomization, risks and benefits, alternative therapies or procedures, and voluntariness of participation.50,51 Understanding of information must also be secured. Technically, informed consent builds upon patient autonomy; the ethical principle underlying the doctrine of informed consent is respect for persons. In pediatrics, however, children are deemed

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incompetent to make medical decisions, as previously discussed; thus, securing informed consent actually involves garnering permission or authorization from surrogate decision-makers for children (usually parents or guardians).3 Many variables affect the environment surrounding informed consent in pediatric cancer care, not the least of which is that children with cancer represent a particularly vulnerable population requiring protection from research risks.52 Recent studies have begun to analyze both the process and the content of informed consent more carefully to help elaborate whether true informed consent can really exist for this population4,50,53; at a minimum pediatric investigators must recognize the necessary elements, must surmount language and cultural differences that may impede true understanding, and must minimize extraneous stressors for their patients and families. Particular attention must be paid to ensure that families understand the difference between treatment protocols and research studies.50 For further discussion of informed consent in pediatrics, the reader is referred to the Committee on Bioethics report from the American Academy of Pediatrics (AAP), and the Institute of Medicine report on ethical clinical research practices involving children.22,54 Assent Informed consent within the pediatric realm can only be considered ethical if it involves both the permission of the parents as well as the assent of the child.53,54 Assent should be less focused on avoiding dissent from the child and more geared toward empowering and providing information that allows the child a critical role in the consent process.55 It is the responsibility of the health care professional to treat all children with honesty and respect. In ethical terms, obtaining parental permission presumes that parents will act in their child’s best interest, but focusing on a child’s assent entitles the child to respect for persons.56 Specifically, the AAP issued a statement in 1997 that patients should be involved in decision making as is appropriate for their developmental age, and should have the authority to provide assent as is reasonable.17 It is worth remembering that assent for treatment differs from assent in research participation; typically research participation is optional and

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therefore obtaining assent should be considered mandatory unless waived on capacity or benefit grounds,54 while in the clinical situation, it may be meaningful but not obligatory. Tenets of Assent As discussed previously, health care professionals have an obligation to provide pediatric patients with developmentallyappropriate, understandable information about their condition. Eliciting patient understanding of the information provided and estimating capacity to make difficult decisions are fundamental tenets of the assent process. When assent is solicited, it must be respected; in other words, assent should not be sought if there is no intention of honoring a child’s dissent. In obtaining assent, clinicians should make it clear to the child that he or she has the right to choose, and there should never be any attempts to coerce or manipulate.17 Research suggests that children aged 14 years and above are capable of understanding research-related information at a level that approximates that of adults; under the age of 9, such ability is limited. Between the ages of 9 and 14 exists great individual variability, and the careful assessment of the health care team is required.56,57,58,59,60 Adolescents Adolescence can be a unique and challenging period for many young people but can be particularly challenging for those with chronic diseases, especially cancer. The period of adolescence is traditionally thought to include ages 11–19 years. This is a time of dramatic physical change, as well as social and psychological upheaval, which can make this one of the most difficult times in a child’s life. During adolescence, a concept of death is formed with an understanding of its permanence and universality.61 This understanding can make the diagnosis of a potentially terminal disease even more devastating. Both therapeutic and end-of-life decision making can be complicated in the case of the adolescent. In many instances, adolescents are cognizant of their condition and have definitive ideas

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about their treatment. As mentioned earlier, it is now widely accepted in the field of pediatrics that children greater than 14 years of age possess in most cases enough capacity to understand information and sufficient ability to foresee the implications of their decisions so as to constitute adult-like autonomy.56,57,61 While adolescents may possess all the skills required to make difficult medical decisions, they may be plagued by psychosocial distractors that impede the decision-making process. For example, appearance is often very important, thus making it difficult for an adolescent to make an informed decision about a therapy that may be detrimental to appearance, however beneficial to health. For adolescents who are able to demonstrate adult-like decisional capacity, decisions regarding their treatment should almost always be respected, even in cases where an adolescent disagrees with his/her parents.14 Unless the adolescent’s position is not durable or is frankly dangerous, the health care team’s primary allegiance should remain with the teenage patient.62,63 The Hastings Report in 1997 devised recommendations regarding cases involving decision making in the adolescent population. In general, adolescents should be involved in decisions about therapy from the outset and should be included throughout the process. As with younger children, it is important to provide an adequate support system as times of illness are often the times when emotional stress is at its highest; honesty as well as openness to questions have been shown to be paramount in cases involving adolescents. The Hastings Report details more specifically the concepts of advanced directives and medical legal issues surrounding adolescent decision making.63 Treatment Refusal A discussion of consent and assent issues would not be complete without addressing patient and/or family refusal of treatment, as described in our first case. Currently in the US, parents are the presumed decision-makers for their children because they are in the best position to determine how their child’s medical treatment fits within the context of their own family’s value system, needs of other family members and community, and hopes for their child’s future.22

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Parents are usually given great leeway in making decisions over a range of possibilities, all of which are compatible with the patient’s best interest. However, a number of factors may lead parents to make choices outside a “normal” range between too little treatment and too much treatment; these factors may include personal/cultural or communal values, external constraints such as financial considerations, inability to comprehend alternatives, religious beliefs, or direct conflict of interest, as in abuse cases. Cases in which parents disagree with recommended treatment for their children need to be evaluated on an individual basis, with attention to the benefits and burdens of the proposed treatment, the chance of a successful outcome, and the amount of risk to the child in acquiescing to the parents’ wishes.64 As a general guideline for religious objections to treatment, freedom of religion can never be used as a cover for direct harm to a child; in other words, the right of a parent to freedom of religion is subordinate to the child’s right to protection from harm.65 Other obvious examples exist in which parental rights should be limited: abuse and/or neglect; parental incompetence; obvious conflict of interest; conflict between parents regarding medical decisions; and instances wherein a minor has expressed a strong and well-reasoned opinion. Most of the time in pediatric practice, however, the issues are seldom obvious. But at what point does treatment refusal constitute neglect that should prompt health care professionals to involve state authorities? Diekema has outlined “The Harm Principle,” eight conditions which he proposes must all be met in order for state intervention to be activated. Two of his conditions are particularly relevant to the case of MS: would this situation be considered harmful if generalized to all other similar situations, and would there be agreement on the part of “most parents” that state intervention is reasonable?66 Recently, noted bioethicist Art Caplan authored an oped piece on a teenager’s right to refuse standard therapy for recurrent Hodgkin disease. While Caplan opined that the state should have taken jurisdiction in that particular case, he noted that “consideration must be given to the impact of forcing medical care on the stability and integrity of the family.”67 Clearly the ethics in the case of MS rest on a determination of what constitutes acceptable risk, in the

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inseparable context of this child’s Amish community and culture, and “the difficulty lies in defining a threshold of therapeutic success where treatment should be initiated against the wishes of the parent or guardian.”68 Whatever the outcome, it is prudent to keep in mind that conflicts in judgment and decision making are inevitable as the complexity of medical care grows logarithmically and as paternalism fades farther and farther from family-provider interactions; in fact, conflict can be seen as a healthy result of shared decisionmaking.33,61 CONCLUSION The field of bioethics is rapidly expanding in every direction. In pediatric ethics, we are witnessing an explosion of interest, research and exploration. Ethical issues are part and parcel of daily life for children and adolescents with cancer and their families, as they struggle with overwhelming amounts of information that is constantly changing. The world wide web, while dramatically increasing patient, family and provider access to information, also brings with it ethical challenges of privacy and confidentiality and easier access to unproven therapies. Complementary therapies are becoming mainstream, and palliative care is increasingly becoming integrated into cure-directed treatment centers. Newer therapies, such as biological modifiers and gene therapies, are no longer the stuff of science fiction. Our patients and families are more educated and informed, asking more questions, and have more options available to them. All of these changes and others are, of course, the beneficial result of tremendous advances in biomedical and information technology realms and are, for the most part, welcome progress. However, they bring with them an increasingly complex ethical landscape which requires constant study and exploration for providers. There are many different ethical issues, minor and major, that come to light in discussions of cancer therapy in 2007. Central to every ethical discussion, however, are issues of communication and truth telling. In this chapter, we have chosen to focus our attention on the special issues of decision making, information disclosure, and informed consent/assent that differ for pediatric

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oncology patients and families. From the foundation presented here, the interested reader can pursue particular issues of interest in the references provided herein. Fundamentally, it is imperative that providers remember the following core principles: every pediatric patient beyond infancy should be given an opportunity to participate at some level in decisions being made about his or her care; parental decisions should be respected unless and until parents demonstrate that they do not have their child’s best interest at heart; and “the child’s own perception of the issue at stake should occupy a place of foremost importance in the minds of pediatric caregivers.” 38 REFERENCES 1.

2. 3.

4. 5. 6.

7.

Ries LAG, Smith MA, Gurney JG, Linet M, Tamra T, Young JL, Bunin GR, eds. Cancer Incidence and Survival among Children and Adolescents: United States SEER Program 1975–1995, National Cancer Institute, SEER Program. NIH Pub. No. 99-4649; Bethesda, MD, 1999. Joffe S, et al. Ethical considerations in pediatric oncology. Pizzo PS, Poplack DG, eds. Principles & Practice of Pediatric Oncology, 5th edn. Philadelphia, PA: Lippincott Williams & Wilkins, 2006. Friebert SE, Kodish ED. Kids and cancer: ethical issues in treating the pediatric oncology patient. Angelos P, ed. Ethical Issues in Cancer Patient Care. Norwell, Mass: Kluwer Academic Publishers, 1999; 99–135. Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the Children’s Cancer Group: results of preliminary research. Cancer 1998; 82(12): 2467–2481. Wolfe J, Friebert S, Hilden J. Caring for children with advanced cancer: integrating palliative care. Pediatric Clinics of North America 2002; 49: 1043–1062. Hilden JM, Himelstein B, Freyer D, Friebert S, Kane J. End-of-life care: special issues in pediatric oncology. Foley KM, Gelband H, eds. Improving Palliative Care for Cancer. Washington DC: National Academy Press, 2001; 161–198. Hilden JM, Friebert SE, Himelstein B, Freyer D, Wheeler J. Children and adolescents with cancer. Carter B, Levetown M, eds. Palliative Care for Infants, Children, and Adolescents: A Practical Handbook. Baltimore, Maryland: The Johns Hopkins University Press, 2004; 348–373.

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Cohen MH, Kemper KJ. Complementary therapies in pediatrics: a legal perspective. Pediatrics 2005; 115 (3): 774–780. Johnston DL, Nagel K, O’Halloran C, Sencer SF, Kelly FM, Friebert S, Hilden JM, Friedman DL. Complementary and alternative medicine in pediatric oncology – availability and institutional policies in Canada: a report from the Children’s Oncology Group. J Ped Hem/Onc 2006; 47(7): 955–958. Kane JR, Barber RG, Jordan M, Tichenor KT, Camp K. Supportive/palliative care of children suffering from life-threatening and terminal illness. Am J HospPalliat Care 2000; 14 (3): 165–172. Himelstein BP, Hilden JM, Boldt AM, Weissman D. Pediatric palliative care. N Engl J Med 2004; 350 (17): 1752–1762. Grodin MA, Glantz LH, eds. Children as Research Subjects: Science, Ethics & Law. New York: Oxford University Press, 1994; 29–30. NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. March 6, 1998. Buchanan AE, Brock DW. Deciding for Others: The Ethics of Surrogate Decision Making. New York: Cambridge University Press, 1989. Brock DW. Children’s competence for health care decisionmaking. Kopelman LM, Moskop JC, eds. Children and Health Care: Moral and Social Issues. Boston: Kluwer Academic Publishers, 1989; 181–212. Melton GB, Koocher GP, Saks MJ, eds. Children’s Competence to Consent. New York: Plenum Press, 1983. Weithorn LA. Children's capacities to decide about participation in research. IRB. 1983 Mar–Apr; 5(2): 1–5. The OYEZ Project, Wisconsin v. Yoder, 406 U.S. 205 (1972). Piaget, Jean. The Moral Judgment of the Child. New York: The Free Press, 1965. Bartholome WG. Care of the dying child. The demands of ethics. Second Opin1993; 18(4): 25–39. Jonson AR, Siegler M, Winslade WJ. Clinical ethics. A Practical Approach to Ethical Decisions in Clinical Medicine, 2nd edn. New York, NY: Macmillan Publishing Co, 1986; 176. Committee on Bioethics, American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 1995; 95(2): 314–317. Chappuy H, Doz F, Blanche S, Gentet JC, Pons G, Treluyer JM. Parental consent in paediatric clinical research. Arch Dis Child 2006; 91(2): 112–116.

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24. Zutlevics TL, Henning PH. Obligation of clinicians to treat unwilling children and young people: an ethical discussion. J Paediatr Child Health 2005 Dec; 41(12):677–681. 25. Spinetta JJ, Masera G, Jankovic M, Oppenheim D, Martins AG, Ben Arush MW, van Dongen-Melman J, Epelman C, Medin G, Pekkanen K, Eden T. Valid informed consent and participative decision-making in children with cancer and their parents: a report of the SIOP Working Committee on psychosocial issues in pediatric oncology. Med Pediatr Oncol 2003; 40(4): 244–246. 26. Holder AR. Legal Issues in Pediatrics and Adolescent Medicine, 2nd edn. New Haven, CT: Yale University Press; 1985: 127–128. 27. Corrigan JJ, Feig SA; American Academy of Pediatrics. Guidelines for pediatric cancer centers. Pediatrics 2004; 113(6): 1833–1835. 28. Masera G, Chesler MA, Jankovic M, Ablin AR, Ben Arush MW, Breatnach F, McDowell HP, Eden T, Epelman C, Fossati Bellani F, Green DM, Kosmidis HV, Nesbit ME, Wandzura C, Wilbur JR, Spinetta JJ. SIOP Working Committee on psychosocial issues in pediatric oncology: guidelines for communication of the diagnosis. Med Pediatr Oncol 1997; 28(5): 382–385. 29. Spinetta JJ, Masera G, Eden T, Oppenheim D, Martins AG, van Dongen-Melman J, Siegler M, Eiser C, Ben Arush MW, Kosmidis HV, Jankovic M. Refusal, non-compliance, and abandonment of treatment in children and adolescents with cancer: a report of the SIOP Working Committee on psychosocial issues in pediatric oncology. Med Pediatr Oncol 2002; 38(2): 114–117. 30. King NM, Cross AW. Children as decisionmakers: guidelines for pediatricians. J Pediatr 1989; 115(1): 10–16. 31. Masera G, Spinetta JJ, Jankovic M, Ablin AR, Buchwall I, Van Dongen-Melman J, Eden T, Epelman C, Green DM, Kosmidis HV, Yoheved S, Martins AG, Mor W, Oppenheim D, Petrilli AS, Schuler D, Topf R, Wilbur JR, Chesler MA. Guidelines for a therapeutic alliance between families and staff: a report of the SIOP Working Committee on psychosocial issues in pediatric oncology. Med Pediatr Oncol 1998; 30(3): 183–186. 32. Whitney SN, Ethier AM, Fruge E, Berg S, McCullough LB, Hockenberry M. Decision making in pediatric oncology: who should take the lead? The decisional priority in pediatric oncology model. J Clin Oncol 2006; 24(1): 160–165. 33. Bartholome WG. A new understanding of consent in pediatric practice: consent, parental permission, and child assent. Pediatr Annals 1989; 18(4): 262–265.

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34. Myers BA. The informing interview: enabling parents to ‘hear’ and cope with bad news. Am J Dis Child 1983; 137(6): 572–577. 35. Mack JW, Grier HE. The day one talk. J Clin Oncol 2004; 22(3); 563–566. 36. Kunin H. Ethical issues in pediatric life-threatening illness: dilemmas of consent, assent, and communication. Ethics & Behavior 1997; 7(1): 43–57. 37. Waechter EH. Children's awareness of fatal illness. Am J Nurs 1971; 7(6): 1168–1172. 38. Spinetta J, Maloney J. Death anxiety in the outpatient leukemic child. Pediatrics 1975; 56(6): 1035–1037. 39. Levine RJ. Ethics and regulation of clinical research, 2nd edn. New Haven, Conn: Yale University Press, 1988. 40. Kupst MJ, Patenaude AF, Walco GA, Sterling C. Clinical trials in pediatric cancer: parental perspectives on informed consent. J Ped Hem/Onc 2003; 25(10): 787–790. 41. Balis FM. Clinical trials in childhood cancers. Oncologist 2000; 5(3): xii–xiii. 42. Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet 2004; 364(9436): 803–811. 43. Leventhal BG, Graham ML. Clinical trials in pediatric oncology. Semin Oncol 1988; 15(5): 482–487. 44. Barfield RC, Church C. Informed consent in pediatric clinical trials. Curr Opin Pediatr 2005; 17(1): 20–24. 45. American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995; 95: 286–294. 46. Ulrich CM, Grady C, Wendler D. Palliative care: a supportive adjunct to pediatric phase I clinical trials for anticancer agents? Pediatrics 2004; 114: 852–855. 47. Deatrick JA, Angst DB, Moore C. Parents’ views of their children’s participation in phase I oncology clinical trials. J Pediatr Oncol Nurs 2002; 19: 114–121. 48. Shah S, Weltman S, Langevin A, Bernstein M, Furman W, Pratt C. Phase I clinical therapy trials in children with cancer. J Ped Hem/Onc 1998; 20: 431–438. 49. Pratt C. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 1991; 19: 304–309. 50. Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol 2004; 22 (13): 2708–2717.

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51. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001; 358(9295): 1772–1777. 52. U.S. Department of Health and Human Services. Code of Federal Regulations 46. Subpart D: Additional protections for children involved as subjects in research. Federal Register 1983 March 8; 48: 9818. 53. Olechnowicz JQ, Eder M, Simon C, Zyzanski S, Kodish E. Assent observed: children's involvement in leukemia treatment and research discussions. Pediatrics 2002; 109(5): 806–814. 54. Institute of Medicine Committee on Clinical Research Involving Children, Board on Health Sciences Policy. Field MJ, Behrman RE, eds. The ethical conduct of clinical research involving children. Washington, DC: National Academies Press, 2004. 55. Leikin SL. Minors’ assent or dissent to medical treatment. J Pediatr 1983; 102(2): 169–176. 56. Leikin SL. Minors’ assent, consent or dissent to medical research. IRB Review of Human Subjects Research 1993; 15(2): 1–5. 57. Dorn LD, Susman EJ, Fletcher JC. Informed consent in children and adolescents: age, maturation and psychological state. J Adolesc Health 1995; 16: 185–190. 58. Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Develop 1982; 53: 1589–1598. 59. Susman EJ, Dorn LD, Fletcher JC. Participation in biomedical research; the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992; 121: 547–552. 60. Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical research. J Med Ethics 1998; 24: 158–165. 61. Freyer DR. Care of the dying adolescent: special considerations. Pediatrics 2004; 113(2): 381–388. 62. Weir RF, Peters C. Affirming the decisions adolescents make about life and death. Hastings Center Rep 1997; 27(6): 29–40. 63. Fleischman AR, Nolan K, Dubler NN, Epstein MF, Gerben MA, Jellinek MS, Litt IF, Miles MS, Oppenheimer S, Shaw A. Caring for gravely ill children. Pediatrics 1994; 94(4): 433–439. 64. International Confederation of Childhood Cancer Parent Organisations. SIOP Working Committee on psychosocial issues in pediatric oncology. Guidelines for refusal, non-compliance, and abandonment of treatment in children and adolescents with cancer.

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65. Committee on Bioethics, American Academy of Pediatrics. Religious objections to medical care. Pediatrics 1997; 99: 279. 66. Diekema DS. Parental refusals of medical treatment: the harm principle as threshold for state intervention. Theoret Med 2004; 25: 243. 67. Caplan AL. Challenging teenagers’ right to refuse treatment. Virtual Mentor 2007; 99: 56–61. 68. Hord JD, Rehman W, Hannon P, Anderson-Shaw L, Schmidt ML. Do parents have the right to refuse standard treatment for their child with favorable-prognosis cancer? Ethical and legal concerns. J Clin Oncol 2006; 24(34): 5454–5456.

8

THE ETHICS OF RESPONDING TO PAIN AND SUFFERING Timothy F. Murphy

The ancient Hippocratic Oath makes no specific mention of pain and suffering, and neither does the contemporary oath – the 1948 World Declaration of Geneva – that is widely administered by United States medical schools. Adherents to the Oath of Maimonides do swear “never to see a patient as anything but a fellow creature in pain.”1 In this Oath, written not by Maimonides but in his honor, the mention of pain is very much the exception to the rule, however, when it comes to medical oaths, and this 1800s oath is almost never used in graduation ceremonies.2 In fact, most prominent documents in medical ethics scarcely mention the relief of pain and suffering as a goal or standard of conduct, not even, for example, the Principles of Medical Ethics of the American Medical Association.3 In one sense, this silence about pain and suffering is not especially surprising: the relief of pain and suffering are so fundamental to medicine that in many contexts they are simply taken for granted and do not require explicit articulation. Whether explicit in professional standards or not, the goal of controlling pain and responding to suffering are core ethical goals of medicine and addressing them directly helps to identify the practices of medicine that best serve those goals. Having clear ethical standards for the management of pain is essential in the treatment of people with severe and chronic diseases, especially those toward the end of their lives. THE NATURE OF PAIN AND SUFFERING In a biological sense, the term pain describes the sensation of noxious stimuli emanating from disorders, disease, injury, or stresses. Some mechanisms of pain are well studied, while others

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remain the object of ongoing investigation.4 Beyond its neurological aspects, pain has cognitive dimensions as well. People interpret noxious stimuli in various ways, estimate their significance differently, and respond in a variety of ways to the sensations of their disorders and disease. What is crippling pain to one person might be tolerable to others who incorporate the pain into their lives in a way that minimizes its effect. (For example, some people interpret pain as an opportunity for religious growth.) Moreover, pain is always experiential in the sense that it is experienced by a subject, and it never appears as an object that is directly observable to others except through biological and behavioral correlations. That pain is subjective in this way makes it difficult to measure and quantify. Some commentators believe that reports of pain – namely statements by people that they are in pain – are the central starting point for all pain medicine.5 By contrast, some commentators worry that this threshold might be too low: they worry that it opens the door to unnecessary treatment and nonmedical drug use. While there is no shortage of drug-seeking people complaining of pain, one can never ignore reports of pain; they are central to medical decision-making. This worry is also offset by the fact that many analysts believe that pain is widely undermedicated. Pain is not, of course, the whole story of human affliction, and healthcare must also respond to suffering. Suffering involves overarching distress that profoundly undermines important aspects of life, such as one’s sense of identity or overall expectations of life. Not all suffering involves physical pain: a person dislocated by war or natural disaster may well suffer loss and deprivation in the extreme but without any biological correlates of pain. As the physician Eric Cassell has pointed out, suffering requires some sense of projection into the future.6 Suffering occurs when people see in their future further pain, further loss of health, further loss of social status, further assaults on one’s identity, further disruption of family bonds, and similar sorts of disordering harms and deprivations. In a very real sense, suffering involves dread of the future in which one’s well being is under assault. Pain management is not, therefore, the only responsibility that falls to health professionals as they do their work. As necessary, they will also have to respond to suffering rooted in disease and disorders.

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CONTROLLING PAIN Medicine has a variety of agents at its disposal to control pain: various kinds of analgesia, anesthesia, opiates, and even placebos, hypnosis, and relaxation techniques. Physicians can also turn to more complex pain interventions such as nerve blocks, neurosurgical procedures, and implantation of drug delivery devices. Some pain medications are readily available to consumers, and these can be attractive to patients because of their ease of access and relatively low cost, so long as they provide meaningful relief from pain. Other medications are available only through prescription because they are more potent, dangerous, and lead to dependence. It is also true that the value of some psychoactive drugs used in the name of pain relief remains a matter of some debate, both scientific and social.7 A great deal of pain medicine involves helping people bridge periods of noxious stimulation. The pain of a broken limb, for example, resolves as the bone heals, and the pain of surgery also abates as healing occurs. In cases like these, pain medicine is an adjunct to healing, not a permanent intervention. However, some pain is more difficult to manage, especially with chronic conditions. Some people experience more or less permanent pain in their lives because underlying conditions are not tractable to medical interventions that resolve a problem once and for all. For example, when it comes to people with chronic and/or idiopathic pain, physicians must be especially sensitive to addictive properties of medication. Contemporary medical ethics emphasizes the importance of informed consent in treatment decisions, but pain medication that is proportionate to the need of people with serious pain can undercut their powers to participate in their own health care. To what extent should a patient be medicated if doing so undermines the ability of the patient to participate in decisions about his or her medical care? The answer to this question can vary: some patients wish to have periods of consciousness in order to interact with family members and experience day-to-day routines, which means they will tolerate periods of pain in exchange for those opportunities. Heavy medication may undercut their ability to be conscious and, therefore, their ability to make decisions about further medical care. In general,

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patients should guide decisions so far as they are able, and surrogates may step in as necessary. As a general rule, decisions about the degree of medication should be revisited during the course of treatment, giving patients and their families opportunities to reconsider their original preferences so no one becomes locked into a given medical strategy even as circumstances change. One issue that is not so easily resolved is the way in which aggressive treatment of pain sometimes leaves patients vulnerable to dependencies on the medication. This may be of less concern for persons approaching the end of their lives, but it is a very real concern for others with chronic and/or idiopathic pain. While working to control pain reported by patients, physicians should nevertheless avoid medication strategies that open their patients to dependency. Monitoring patients for risks and signs of dependence is necessarily a part of good pain medicine. One further ethical concern that emerges in regard to pain medicine is that sometimes no medication may be necessary at all to control pain. Research has shown that the placebo effect can control some aspects of pain.8 The placebo effect occurs in patients who behave as if they have received a genuine drug or medical intervention when they have received only an inert or sham treatment. If they believe they have received an effective treatment, they may report relief from pain. Precisely because of the moral significance of patient autonomy, the use of placebos is ethically problematic in general, no less so when it comes to the management of pain. Critics argue that placebos should not be used because they undermine trust in healthcare.9 By contrast, other commentators defend the use of placebos under some circumstances, for example, when there are inadequate supplies of pain medication or when patients are at risk of some harm from the medication itself.10 As a matter of ethics, anyone proposing to use a placebo in pain management bears a heavy burden of proof as to why the deception is necessary. In other words, placebos ought to be very much the exception – if they are used at all – rather than the rule.11 Worries about wrongful use of pain medication do not belong to patients alone, of course. Some physicians and nurses use pain medications recreationally and in ways that impair their professional duties, while others make pain medications available to

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people for non-therapeutic reasons.12 Because regulatory agencies monitor the use of certain pain medications, aggressive medication of pain may lead licensing and criminal agencies to investigate whether physicians are prescribing drugs for non-therapeutic purposes or catering to addicts.13 Licensing and regulatory agencies that discover this kind of lapse will discipline a physician and potentially revoke a license. These physicians might also be prosecuted under the criminal law, although it is sometimes very difficult to tell whether this kind of professional misbehavior has occurred. In general, medicine operates and should operate to mitigate and prevent pain rooted in disease, disorder, and injury. Healthcare workers are therefore morally entitled to use drugs, devices, and surgical interventions that achieve those goals. These interventions should, of course, be used in a way proportionate to the degree of pain, with due attention to their risks and benefits. As in other domains of medical care, patients are entitled to know diagnoses related to the source of their pain, the prognosis of their condition, and options for treating the underlying pathology and its pain. Furthermore, because the drugs involved in pain medication are sometimes understudied and misused, healthcare workers shoulder a degree of responsibility for improving pain research, establishing effective pain medication practices, and working for a legal environment in which pain medicine can be used as necessary without fear of legal reprisal. WHEN TREATING PAIN INCREASES THE RISK OF DEATH OR HASTENS DEATH Some pain treatment can put people at risk of death because of the drug’s physiological effects. Even so, medical ethics has achieved some degree of consensus that treating pain under these circumstances can be justified, the risk of death notwithstanding. Defenses of pain treatment that can hasten death typically invoke the “principle of double effect” as justification.14 According to this moral principle, the treatment of pain is justified even if it hastens the death of an individual or even causes the death of the individual outright because the motive for the pain treatment is defensible on its own. There are a variety of ways of articulating the

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principle of double effect, but in general the administration of pain medication that could endanger life must meet the following conditions in order to be morally justified. First, the intervention must not be morally problematic in itself (and the administration of pain medication is not inherently objectionable) and unavoidable (no other means of controlling the pain is available). Second, the physician administering the pain medication must not directly intend the death of the patient (even if he or she foresees it as a possible, even likely outcome, it is not the death of the patient that the physician hopes to accomplish). The intended effect – relief from pain – must also not be achieved by the unintended effect (it is the medication, not death, that is used to control pain). And last, the expected beneficial effects (relief from very severe pain) from the medication must be at least as important as the unintended effect (death). In circumstances that meet these conditions, most medical ethics commentators agree that the treatment of severe pain can be justifiable even if it also hastens death. For example, the A.M.A. advises that “Patients near the end of life must continue to receive emotional support, comfort care, adequate pain control, respect for patient autonomy, and good communication.”15 Obviously, because of the grave consequences, administration of pain medication under these circumstances should always be deliberate and fully considered. In every instance, of course, caution must always be observed in order to protect against indiscriminant use of pain medication. RESPONDING TO SUFFERING Suffering is a generalized distress growing out of profound shocks to health, identity, and relationships. Suffering involves those dislocations that go to the core of our self-conceptions. What is a physician’s obligation when it comes to relieving the suffering of patients? First of all, effective medical management of pain – when it is present – for patients is crucial. The relief of pain can go a long way toward the relief of suffering. For example, someone in chronic pain may not be able to see how he or she can live a meaningful life if the pain continues. Someone with pain from extensive skin burns might rather see their lives end than live further with uncontrollable

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and/or unendurable pain. Diseases and disorders cause pain and suffering in varying magnitudes, and suffering comes into being when there is not only pain but the expectation of pain and debilitation on a scale someone can no longer tolerate. Even if they have not explicitly articulated the relief of suffering as one of the goals of medicine, physicians, nurses, and other healthcare providers have not ignored the issue either. For example, the American Medical Association identifies one of its core principles of medical ethics this way: “A physician shall, while caring for a patient, regard responsibility to the patient as paramount.”16 Physicians cannot walk away from patient’s suffering, therefore, or assume that pain management is the sole responsibility they have for patients. For their part, healthcare workers can help identify ways to protect against the losses that pose the greatest threat to a patient’s future. For example, the diagnosis of a terminal illness can unmoor people and throw them into psychological shock as they imagine the losses looming ahead in their lives. Helping patients negotiate the steps toward a life that is fulfilling to terminally ill patients in their changed circumstances will go a long way toward the relief of suffering. The responsibilities of healthcare workers are not, of course, infinite: healthcare workers must protect themselves from being overwhelmed by the pain and suffering of their patients. To enter too deeply into the pain and suffering of patients is of no benefit to anyone. Nevertheless, healthcare workers can often help patients cope with the shocks that underlie suffering by helping them identify goals that take account of their changed circumstances. For example, people who understand that they will die within a fairly short period of time may find it valuable to talk to others in similar circumstances (through support groups) or act on long-held wishes (such as taking that long delayed trip or becoming an organ and tissue donor). Physicians, nurses, and medical social workers can play an important role in referrals to services and opportunities that can be of comfort and use to dying people. Just as important as medical treatment and services is the relationship that caregivers have with patients. For this reason, some commentators have called for more empathetic relationships with all patients. And this kind of relationship would be all the more

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important for dying patients. While these commentators vary in the way they see empathy exactly, in general they all believe that an emotional identification with the patient – an emotional connection to the patient – enables physicians and nurses to undertake a kind of patient advocacy that gets otherwise lost in the mix of professional equanimity, technological evaluations, and distancing techniques common in medicine today.17 HOSPICE Most Americans die in a hospital, even though many Americans say they do not want to die in hospitals. This reluctance grows out of a fear that too much will be done at too much cost, with too little benefit and perhaps because of a rosy misconception that dying at home is somehow easier and better for all concerned. Hospice has positioned itself as an alternative to over-medicalized death in hospitals and underprepared deaths at home. The hospice movement began in earnest in the United Kingdom in the 1960s and came to prominence in the United States somewhat later, despite some early worries that it represented a misplaced approach to the care of the dying.18 In general, hospice works to resist over-treatment in hospital settings and resists treating death as evidence of professional failure. While there are various schools of hospice philosophy, they all share a common interest in providing compassion and choices for the dying and their families. In general, hospice services try to focus on the needs of people who are close to death but who do not want extensive medical interventions to try and rescue them from every medical crisis. Some hospice services are provided in dedicated facilities, some hospitals provide degrees of hospice care, and other hospice services are provided in people’s homes.19 Hospice services are not available to all, for reasons of economics and geography, and accessibility is an ethical question of considerable interest.20 For all the benefit that hospice philosophy can provide in protecting against unwanted treatment, some commentators have raised ethical concerns about hospice practices, including worries about excessively limited care, possible overuse of opiates, the capacity for informed consent in the dying, and the extent of

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permissible research.21 Of course, it is the logic of hospice to make trade-offs: to accept shorter lives in order to avoid unwanted medical interventions. Even so, some commentators worry that too many treatments may be given up, with the result that people receive too little treatment even as they avoid too much treatment. Some commentators also worry that there can be lapses in informed consent in presenting the benefits of hospice. It is possible that by accentuating the benefit of forgoing medical treatments, hospice advocates may misrepresent or under-emphasize the benefit of certain medical treatments. Some commentators also worry that some patients are vulnerable to pressure coming from family members and even healthcare personnel to enter hospice, contrary to their own actual but unexpressed wishes. To the extent these lapses in informed consent exist, healthcare workers and administrators should, of course, work to identify and resolve them. On balance, hospice institutions and services have done a great deal to help people order their dying days in ways that make sense to them, and not only when it comes to the medical management of pain. Hospice practices also offer a way to help make judgments about one’s future – beyond accepting every possible intervention that might offer some benefit – and these decisions work to reduce suffering in their own way, primarily by avoiding unwanted circumstances of death. EUTHANASIA OR DIRECT KILLING AS RESPONSE TO PAIN AND SUFFERING When they find themselves in states of pain and suffering they can no longer endure, some patients hope to have their physicians administer a lethal substance and kill them. As they see only further degradation of their lives ahead of them, they want their physicians to do something to bring the suffering to an end. People who have struggled against chronic diseases for a very long time can be especially interested in looking to choose the time and circumstances of their death, for symbolic reasons that are important to them, and a physician’s direct actions can meet those expectations. Of course, some patients may turn to physicians for this kind of help even before unendurable pain sets in, when they experience sudden

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changes in health, such as a diagnosis of ALS or the onset of Alzheimer symptoms. Some patients already know first hand the painful and debilitated states associated with their disorders and diseases – they’ve seen a relative go through it, for example – while others do not want to have those experiences at all. The very idea that they will endure pain, become dependent, and die a prolonged death constitutes part of their suffering. These people want to avoid exactly that. Every major professional medical association in the United States uniformly condemns actions by physicians that directly cause the death of a patient, or euthanasia. The American Medical Association says in one of its ethics advisories, for example, “Euthanasia is fundamentally incompatible with the physicians’ role as healer, would be difficult or impossible to control, and would pose serious societal risks.”22 On this view, physicians should not directly administer any lethal substances or interventions that have the effect of causing death, not even if the patients themselves believe they would be better off dead than in their current circumstances. This administration of lethal substances is different from the administration of pain medicine which could hasten death. The difference here represents a very fine line sometimes, but the line is still there, distinguishable by intent. The law in the United States also uniformly prohibits euthanasia, defined as direct killing, and a patient’s request for this kind of intervention would be no shield against criminal prosecution if a physician complied with a patient request to kill him or her. Any physician or nurse who injected a patient with a lethal drug would be open to professional and legal sanction even if the patient asked for that injection in full knowledge of its effects. After all, it was a lethal injection that sent long-time advocate of euthanasia and physicianassisted suicide, Jack Kevorkian, to jail, notwithstanding incontrovertible evidence that the man who died wanted that injection: Dr. Kevorkian videotaped both the multiple requests for the injection and the injection itself.23 Despite these professional and legal prohibitions, some degree of euthanasia probably occurs in the United States, with or without the consent of patients, in the name of protecting patients from pain and suffering. A few examples have come to light

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through legal prosecution, though the overall number of cases is very small.24 In the wake of 2005 flooding in New Orleans, several accusations emerged that physicians and administrators had conspired to kill patients apparently without their consent, as a way of protecting them from intolerable circumstances – extreme heat, lack of water and medication – brought on by the flooding there.25 We may never know exactly what happened in New Orleans, because instances of euthanasia occur – to the extent they occur – behind closed doors beyond scrutiny by the public, professional agencies, and law enforcement. Physicians who do intentionally kill patients through a lethal injection, for example, have no incentive whatsoever to come forward and expose themselves to professional and legal repercussions. In 1989, one physician who did tell a story of killing a patient through lethal injection did so only through an anonymous report in a leading medical journal, prompting a furious debate about the physician’s actions and the journal’s ethics.26 To date, the author of that report has never come forward. Professional and legal standards notwithstanding, is there a moral case to be made that physicians should be able to kill their patients, so long as their patients agree? As mentioned, some commentators find the very idea abhorrent. Yet some commentators disagree and believe that under some conditions – with the consent of the patient – it is appropriate to inject a drug that caused death, and Jack Kevorkian tried and failed to get this question before the U.S. Supreme Court.27 Or at the very least, some commentators point out that the supposed line between active euthanasia and passive euthanasia, in which people are simply let die, can be very blurry indeed.28 PHYSICIAN-ASSISTED SUICIDE AS RESPONSE TO PAIN AND SUFFERING For all the debate about active euthanasia, most commentators now focus on another approach. Physician-assisted suicide has gained far more attention than direct killing, becoming legal in one U.S. state and being practiced without apology in the Netherlands.29 One country has even become a destination for “euthanasia tourism” because of its liberal policies in regard to assisting suicide.30 In a

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turn of events that would have been hard to predict 50 years ago, medical ethics is now divided about whether physicians should help patients who ask for a lethal overdose they can ingest through their own actions. Before he was convicted of murder, Dr. Kevorkian had a fairly thriving constituency for his “suicide machine.”31 People from around the country – some with terminal illnesses, some with less advanced conditions – sought his help in putting an end to their lives, and he helped a number of them do exactly that. Kevorkian would insert intravenous lines into people’s blood vessels, and the people who sought his help would themselves operate switches that started the flow of lethal substances into their blood. As Kevorkian saw it, these men and women were causing their death, not him. Law enforcement agencies prosecuted Kevorkian, but the state in which Kevorkian helped more than 130 people die had no law explicitly forbidding assistance in suicide (at the time), and this retired pathologist was never convicted for his involvement in any of these deaths.32 Most advocates of physician-assisted suicide do not build contraptions like Kevorkian’s; they advocate the use of a lethal, ingestible overdose which people can take at a time and place of their own choosing, and they have considered and deliberate conversations about the implications of the overdoses.33 What is common to both approaches is that it is the patient’s actions that cause his or her death; the physician is at a moral remove from the death. Even so, every major medical organization declares that physicians should not honor any requests for assistance in death. For example, the American Medical Association uses the exact same language to condemn euthanasia as it uses to condemn physicianassisted suicide: “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.”34 Many professional groups say that requests for assistance in dying are evidence that some psychological or social need of the patient is going unmet, that the requests for help in dying are psychological artifacts and not a genuine expression of a patient’s wishes. For example, if someone with a terminal illness fears grave pain in the

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future, reassurance about the availability of pain medication may sway that patient to prefer more, not less, life. As a matter of law, U.S. physicians who assist the death of others open themselves to legal prosecution in all states but one. In most of the country, the law has mechanisms to prosecute any physician who would aid a patient dying through a prescribed overdose, for example. As in the case of euthanasia, there appears to be an underground practice of assisting death, though its exact extent is impossible to gauge. The deaths that are the consequence of assisted suicide are not even always identifiable as such, and selfhelp books are readily available to help guide the public on exactly how to give themselves a lethal overdose and how to shop for a physician to help.35 Cutting against the grain of professional and legal standards, some physicians and medical ethicists have defended the involvement of physicians in helping patients die, when patients ask for that help. Armed with the distinction of assisting rather than causing death, many commentators call for greater acceptance of physician-assisted suicide. Some physicians have written personal stories about their involvement in assisting death, but only in ways that do not disclose specific information about possible crimes.36 Physicians like these believe that it is not irrational or immoral to prefer to die rather than to submit to the foreseeable and unforeseeable damages of disease, and they believe some people with terminal illnesses are fully capable of understanding the consequences of their wish to die. An increasing number of commentators have argued that physicians should be entitled to help their patients die: among others, physician Timothy Quill has advocated exactly this view, as have physician Howard Brody and attorney David Orentlicher, both of whom write extensively about topics in healthcare ethics.37,38 The Supreme Court has opened the door to legalizing physician-assisted suicide in both direct and indirect ways. In 1997, the U.S. Supreme Court decided Vacco v. Quill and Gregoire v. Glucksberg, determining that there was no Constitutional right to physician-assisted suicide, either on the grounds of equal protection or personal liberty. Yet the Court did not say that physician-assisted suicide must be unlawful. The Court noted that this question was too

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important to be decided once and for all through a consideration of these two cases alone. In effect, the Court concluded that while there was no Constitutional right to physician-assisted suicide, the states of the Union could decide the matter for themselves. After years of legal and political wrangling, the state of Oregon put in place a system that allows physicians to make lethal doses available to some patients under certain conditions. To receive assistance-in-dying, a patient must initiate the request for help, must be diagnosed with a terminal illness, and have a foreseeable life expectancy of fewer than 6 months. That diagnosis must be confirmed by another physician, the patient must be evaluated by a psychiatrist, and the patient must repeat the request. The physician can then write a prescription for a lethal overdose, which patients must take by themselves. Since this law went into effect, approximately 20 people per year die in Oregon following this process.39 This practice does not sit well with everyone. Even after the Supreme Court decisions of 1997, under the George W. Bush administration, the U.S. Department of Justice challenged Oregon’s laws, claiming that the use of drugs under these circumstances was outside the practice of medicine, and therefore unlawful on that account. In other words, the drugs were not used for any defensible medical reason. In 2006, the U.S. Supreme Court rejected this challenge, and Oregon’s practice of physician-assisted suicide remains legally intact.40 It remains an open question whether other legal challenges will follow or whether other states will follow Oregon’s lead in this matter. Efforts to adopt similar legislation in other states, such as California, have failed to date. TOWARD BETTER PAIN MANAGEMENT There is considerable room for improvement when it comes to pain management of severe disorders and disease, and many professional healthcare groups work to improve healthcare worker recognition and treatment of pain.41 There has also been increasing research on effective pain management in patients of different ages, races, and ethnicities. Yet more remains to be done than has already been done. Of particular worry in pain management is that legal and social aspects of pain medications may cause some healthcare

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professionals to shy away from levels of treatment that are appropriate for a given condition, for a given patient. What’s true for recognized pain treatments is also true for substances lacking formal recognition as pain treatment. The use of marijuana in medicine remains socially controversial, for example, and the Food and Drug Administration continues to reject smoked marijuana as beneficial in pain relief, yet the American Medical Association has over the years called for study of this drug.42,43 There will be no resolution to this debate without better information, and research on pain control should remain an important feature in healthcare funding. Control of pain is not, however, the whole story in healthcare. Some pain treatments come at a cost that is unacceptable to patients. Protection from pain may sometimes mean extended unconsciousness, which is not the kind of life many people wish to have. Moreover, even when pain treatments are effective, some patients will nevertheless suffer by reason of the profound changes disorders and diseases introduce into their lives. As a matter of professional ethics, healthcare workers should not neglect suffering even if it is difficult to find solutions that help patients cope with their changed circumstances, even if it is personally difficult to face this suffering in others. Because of their disorders and diseases, some people will wish to die without accepting all the treatments that might extend their lives for a time. They may decline treatment in order to avoid pain, suffering, and even the treatment necessary to help avoid pain and suffering. It is well within the bounds of medical ethics for adults and even some maturing adolescents to forgo treatments that might extend their lives. Parents can also make these difficult decisions for their children.44 Decisions to forgo treatment should not be made lightly, but it is entirely appropriate for physicians to discuss degrees of treatment open to dying patients – from minimal to aggressive – when talking about options for their care. For some patients with aggressive and/or serious chronic diseases, declining treatment may comport better with their values than pursuing every possible treatment until no treatment will do any possible good. In effect, withdrawal of treatment can be an ethically defensible response to suffering.

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The debate about physicians playing a more direct role in the death of their patients will almost certainly remain controversial, as it has been from the earliest days of medical ethics. This debate is deeply intertwined with larger social questions about our moral identity (who we believe ourselves to be as a matter of values) and our relationships (what we believe we owe one another in matters great and small). What the debate about physician involvement in death makes clear is that some requests for assistance in death are artifacts or adverse preferences that are brought on by unaccustomed pain or suffering, from which death seems (wrongly) the only escape. Physicians and healthcare workers should attend to underlying needs of patients that might be driving these requests. In the care of the dying, simply asking more frequently about a patient’s comfort or helping a patient fulfill one last request might alleviate not only pain but suffering and render moot any interest in euthanasia or physician-assisted suicide. Not all patients are equally situated when it comes to the healthcare services that can ease the worst burdens of their illness, and this inequality extends to the circumstances in which patients die as well. Many hospice advocates point out the limited availability of hospice, for example, which deprives people of important options in the management of pain and suffering. To take pain seriously sometimes means swimming uphill against taboos and misconceptions about the nature and meaning of pain. This means not only working toward better pain medications but also toward improved access to healthcare as well. REFERENCES 1. 2. 3. 4.

Steven H. Miles, The Hippocratic Oath and the Ethics of Medicine (New York: Oxford University Press, 2004). Audiey Kao, Kayhan Parsi, “Content Analyses of Oaths Administered at U.S. Medical Schools in 2000,” Academic Medicine 2004 (79) 9: 882–887. American Medical Association, “The Principles of Medical Ethics,” http://www.ama-assn.org/ama/pub/category/2512.html. G. Pacheco-Lopez, H. Engler, M.B. Niemi, M. Schedlowski, “Expectations and Associations that Heal: Immunomodulatory

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5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

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Placebo Effects and its Neurolobiology,” Brain, Behavior, and Immunity 2006 (20) 5: 430–436. http://www.painmed.org/productpub/statements/pdfs/basic_principles _of_ethics.pdf. Eric Cassell, “Pain and Suffering,” in Warren T. Reich ed., Encyclopedia of Bioethics, vol. 4 (New York: Macmillan, 1995), pp. 1897–1905. Matti Hayry, “Prescribing Cannabis: Freedom, Autonomy, and Values,” Journal of Medical Ethics 2004 (30): 333–336. L. Colloca, F. Benedetti, “How Prior Experience Shapes Analgesia Placebo,” Pain 2006 (124): 126–133. Chalmers C. Clark, “The Physician's Role, 'Sham Surgery,' and Trust,” American Journal of Bioethics 2003 (3): 57–58. Ann Harrington, ed., The Placebo Effect: An Interdisciplinary Investigation (Cambridge: Harvard University Press, 1999). A. Hrobjartsson, P. Gotzsche, “Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment,” New England Journal of Medicine 2001 (344): 1594–602. M.C. Holtman, “Disciplinary Careers of Drug-Impaired Physicians,” Social Science and Medicine 2006 [Epub ahead of print]. B. Jung, M.M. Reidenberg, “The Risk of Action by the Drug Enforcement Administration against Physicians Prescribing Opioids for Pain,” Pain Medicine 2006 (7): 353–357. Don B. Marquis, “Four Versions of Double Effect,” Journal of Medicine and Philosophy 1991 (16): 515–544. American Medical Association Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 (Chicago: AMA, 2005), Advisory 2.21. American Medical Association, Code of Medical Ethics, p. xiv. Howard Spiro, Mary G. McCrae Curnen, Enid Peschel, Deborah St. James, Empathy and the Practice of Medicine (New Haven: Yale University Press, 1993). Inge B. Corless, Zelda Foster, eds., The Hospice Heritage: Celebrating Our Future (New York: Haworth, 1999). R.S. Morrison, C. Maroney-Galin, P.D. Kralovec, D.E. Meier, “The Growth of Palliative Care Programs in United States Hospitals,” Journal of Palliative Medicine 2005 (8): 1127–1134. Bruce Jennings, ed., Ethics in Hospice Care: Challenges to Values in a Changing Health Care Environment (New York: Haworth Press, 1997).

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21. B.M. Kinzbrunner, “Ethical Dilemmas in Hospice and Palliative Care,” Supportive Care in Cancer 1995 (3): 28–35. 22. American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics, 2004–2005 edn (Chicago: AMA Press, 2004), advisory 2.21, p. 88. 23. “A Death on Videotape,” New York Times, Nov. 24, 1998, A26. 24. James Rachels, The End of Life: Euthanasia and Morality (New York: Oxford University Press, 1986). 25. Denise Grady, “Medical and Ethical Questions Raised on Deaths of Critically Ill Patients,” New York Times, July 20, 2006, A1, A18. 26. Anonymous, “It’s Over, Debbie,” Journal of the American Medical Association 1988 (259) 2: 272. 27. Neal Nicol, Harry Wylie, Between the Dying and the Dead: Dr. Jack Kevorkian's Life and the Battle to Legalize Euthanasia (Madison, WI: University of Wisconsin Press, 2006). 28. James Rachels, “Active and Passive Euthanasia,” New England Journal of Medicine 1975 (292): 78–80. 29. A. Janssen, “The New Regulation of Voluntary Euthanasia and Medically Assisted Suicide in the Netherlands,” International Journal of Law, Policy, and Family 2002 (16): 260–269. 30. Alison Langley, “Suicide Tourists’ go to the Swiss for Help in Dying,” New York Times, Feb. 4, 2003, A1. 31. Lisa Belkin, “Doctor Tells of First Death Using his Suicide Device,” New York Times, June 6, 1990, A1. 32. Tamar Lewin, “Doctor Cleared of Murdering Woman with Suicide Machine,” New York Times, Dec. 4, 1990, B6. 33. Timothy E. Quill, “Dying and Decision Making: Evolution of End-of-Life Options,” New England Journal of Medicine 2004 (20): 2029–2032. 34. American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics, 2004–2005 edn (Chicago: AMA Press, 2004), advisory 2.211, p. 90. 35. Derek Humphrey, Final Exit: The Practicalities of Self Deliverance and Assisted Suicide for the Dying, 3rd edn (New York: Delta, 2002). 36. Timothy E. Quill, “I Want to Die, Will You Help Me?” Journal of the American Medical Association 1993 (270): 870–873. 37. Brody, H., “Assisted Death – A Compassionate Response to Medical Failure,” New England Journal of Medicine 1992 (327): 1384–1388. 38. David Orentlicher, “Physician Participation in Assisted Suicide,” Journal of the American Medical Association 1989 (262) 1845. 39. http://egov.oregon.gov/DHS/ph/pas/index.shtml

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40. Gonzales v. Oregon (04-623) 368 F.3d 1118. 41. Ben A. Rich, “A Legacy of Silence: Bioethics and the Culture of Pain,” Journal of the Medical Humanities 1997 (18): 233–259. 42. Gardiner Harris, “F.D.A. Dismisses Medical Benefit from Marijuana,” New York Times, April 21, 2006, p. A1. 43. Council on Scientific Affairs, American Medical Association, “Report 10: Medical Marijuana,” http://www.ama-assn.org/ama/pub/ category/print/13580.html 44. R.F. Weir, C. Peters, “Affirming the Decisions Adolescents Make about Life and Death,” Hastings Center Report 1997 (27): 29–40.

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ARE THERE LIMITS TO ONCOLOGY CARE? (FUTILITY) Gary R. Shapiro

INTRODUCTION Just when it looked like we had finally decided that patients were in charge, doctors and patients are again at odds over just “whose life it is anyway.” Not long ago it was the patients and their families taking the doctors and their hospitals to court for the right to have unwanted life support withdrawn.1 Now it seems that the tables have turned. It is the doctors and their hospitals who are going to court2,3 to “deal...with families who demand inappropriate medical treatment for moribund patients.”4 Death is no stranger to the cancer clinic. End-of-life concerns are the constant backdrop in front of which cancer doctors and cancer patients make treatment decisions. Although oncologists face these ethical dilemmas every day, surprisingly few cancer journals deal with end-of-life issues in their publications.5 This is particularly true when it comes to discussions of “futility.” The concept of futility entered the medical literature in the late 1980s.6,7,8 Though the annual number of publications dealing with futility has remained stable, fewer than 1% are found in cancer journals.9 Oncologists don’t do themselves or their patients any favors when they sit out the futility debate. These discussions often assume that most anticancer therapy is futile, and cite a diagnosis of cancer as sufficient justification to withhold or withdraw life-prolonging therapy.6,10 Futility claims may justify policies that categorically limit access to certain cancer care. Armed with ethical analyses about a doctor’s duty,11 outcomes’ data,12,13 and the latest policy statements,14,15 doctors have raised the flag of futility with great passion. In their attempts to

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defend the profession, many doctors have forgotten that the doctor patient relationship is based on dialogue and education. Specific treatment decisions should be the natural conclusion of this dialogue not its beginning. Acceptable decisions regarding cancer treatment can be reached when attainable goals and patients’ wishes are clearly identified. THE ILLUSION OF FUTILITY: QUANTITATIVE/QUALITATIVE AND PHYSIOLOGIC STANDARDS Through all the years of debate, resuscitation of the cancer patient has served as a standard case for advocates of medical futility. Citing the zero per cent discharge rate of resuscitated patients with metastatic cancer in Bedell’s 1983 study,16 Leslie Blackhall was among the first to use this argument against the practice of resuscitating patients with cancer.6 Some years later, Kathy FaberLangendoen also grounded her very similar conclusions in the concept of “quantitative” futility.10 Two different standards have emerged for doctors to use to determine when a particular treatment is futile. Lawrence Schneiderman and his colleagues advocate that a treatment should be considered futile when it has proven useless in the last 100 cases (“Quantitative Futility”); or when it merely preserves permanent unconsciousness, or cannot end dependence on intensive medical care (“Qualitative Futility“).17,18,19 On the other hand, Robert Truog and his colleagues accord the concept a very narrow role in medical decision making. By this restrictive standard, futility is limited to cases where a treatment cannot sustain physiologic life or it cannot achieve a desired physiologic effect.20 A report from Memorial Sloan-Kettering Cancer Center that appeared in the Journal of Clinical Oncology one month before the Faber-Langendoen review, readily demonstrates the problem with these types of analyses. This report showed a 10% discharge rate in the group of patients who had metastatic cancer. This compared favorably to resuscitated patients with non-cancer diagnoses.21 As though she were anticipating the Memorial SloanKettering report, Blackhall buttresses her case with an argument

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from “qualitative” futility: “Furthermore...there are risks involved...including the development of a chronic vegetative state— which many believe is worse than death—or...survival after the initial resuscitation but with death occurring after an indefinite stay ,, 6 in the (ICU). The likelihood of either of these calamitous events occurring in a patient with advanced cancer is extremely low. Rational patients might just take the gamble. Although the “physiologic” standard of futility makes fewer value judgments than either the “quantitative” or “qualitative” standard, it has become increasingly clear that no definition of futility is value free.22 Indeed, studies23,24 have confirmed that the multiple, often contradictory, ways doctors use “futility” usually support value judgments based on quality of life considerations. Despite numerous proposals25,26,27,28 to facilitate decision making, “futility” is no less illusionary today than it was two decades ago.8 It remains an elusive concept that is wielded as a “trump card” by doctors who believe that they know what is best for their patients. It is no surprise that the courts have consistently regarded such unilateral decisions as unacceptable paternalism.29 PATERNALISM VS. INFORMED-CONSENT In his 1995 essay,30 Bruce Zawacki correctly identifies paternalism and informed consent as the two ethical concepts that have come to be competing paradigms in the futility debate. Paternalism has a long history in medical decision making.31 Although codes of medical ethics32 no longer encourage doctors to act paternalistically toward their patients, arguments over paternalism continue to be at the heart of most moral problems in medicine. Doctors who once believed that they were supposed to act paternalistically toward their patients, are now told that they should never act paternalistically. Paternalism is not always wrong, and it is no wonder that such dogmatism has led doctors to develop the concept of “medical futility” to take “precedence over patient autonomy and permit...physicians to withhold or withdraw care deemed to be inappropriate without subjecting such a decision to patient approval. 30 “

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Informed consent is one of the cornerstones of medical ethics. Doctors have a mora1 duty to provide their patients with comprehensible, adequate information concerning any suggested treatment. A physician may not coerce a patient into consenting, and the physician must disclose to the patient the nature of the intervention, its risks and benefits, as well as the alternatives with their risks and benefits.33 Given this information, rational patients may vary among themselves with regard to how they rank the harms and benefits of a suggested treatment. Although there are many clinical situations in which patients face only one rational choice, there are also a great many situations that permit more than one rational choice. On the other hand, “informed consent does not mean that patients can insist upon anything they might want. Rather, it is a choice among available...” and medically accepted treatment options.34 MEDICAL TREATMENT The Theoretical Sense In the theoretical sense, a given intervention is considered a treatment for a malady or a symptom only if it has, by some specific function inherent to that intervention, a capacity to eliminate, relieve, or prevent the harm caused by that malady or symptom. For example, penicillin is a treatment for pneumococcal pneumonia because it has certain inherent qualities that make it efficacious against pneumococci. On the other hand, penicillin is not a treatment for herpes simplex virus because it lacks an inherent capacity to meet the goal of treatment: elimination, relief, or prevention of any of the harms caused by the herpes simplex virus infection. Other examples include Laetrile or coffee ground enemas for Hodgkin‘s Disease, and ampicillin for meningitis caused by an ampicillin-resistant strain of hemophilus influenza. The Common Medical Sense Our common use of the word treatment contains a qualification that is not given in the theoretical definition provided above. In this more

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common medical sense of the word, an intervention is considered a treatment for a malady or a symptom if by some specific function inherent to that intervention it will eliminate, relieve, or prevent the harm caused by that malady or symptom and it does not inherently (irrespective of any particular patient) involve unacceptable medical side effects. Penicillin is also a treatment for pneumococcal pneumonia in this sense, because it has a high probability of meeting the goal of eliminating the harms caused by a pneumococcal infection. This outweighs the harms that might be caused by any one of a number of adverse side effects listed on the package insert. On the other hand, though the therapeutic goal of removing a plantar wart can be achieved by a below the knee amputation (and amputation is therefore theoretically treatment for plantar warts), amputation is not considered medically to be a treatment for plantar warts; the harm caused by this “treatment” far outweighs any benefit of removing the wart in this manner. Radiation therapy for acne, chloramphenicol for streptococcal pharyngitis, and thalidomide for morning sickness are just a few of the long list of interventions that are treatments in the theoretical sense, but not treatments in the more common medical sense. Medically Acceptable Treatment For a medical intervention to be a medically acceptable treatment, it must not only be a treatment in the common medical sense, but it must also be appropriate for the particular patient being treated. Penicillin may be a medically acceptable treatment for one patient with pneumococcal pneumonia, but it is certainly not a medically acceptable treatment for a patient who has a history of anaphylaxis to penicillin. The medical acceptability of a treatment is determined by the inherent qualities of the medical intervention as they relate to the unique nature of the individual patient. A medical intervention is not medically acceptable treatment if: (A) for the specific patient being treated it results in harms indisputably greater than those harms eliminated, relieved, or prevented, or if (B) it is unable to meet its therapeutic goal for that specific patient.

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Examples of the former situation are, the use of intravenous Heparin in a patient suffering from an acute deep venous thrombosis with a bleeding ulcer; and the case of the patient with the penicillin allergy referred to earlier. The latter situation is exemplified by the case of a patient who also has an acute deep venous thrombosis, but who, in this case, has an anti-thrombin III factor deficiency that makes Heparin an ineffective drug in his body. Therefore, a medically acceptable treatment may be defined as a medical intervention that, for a particular patient, has a reasonable probability of eliminating, relieving, or preventing the specific harm(s) for which the treatment was intended without causing the patient some other harm (death, pain, disability, loss of freedom, or loss of pleasure35) that is indisputably greater than the harm eliminated, relieved, or prevented. What constitutes “reasonable” is of course open to debate, but we can state that at a bare minimum, there must be some probability (“at least a modicum of potential benefits”36) of meeting the therapeutic goal considering both the nature of the treatment and the nature of the patient. Desirable Medical Treatment Even when all of the resources necessary to carry out a medically acceptable treatment are available, a medically acceptable treatment may still not be given to a patient if he does not desire it.37 A patient’s decision that certain goals are not worth pursuing is best seen as an assertion of personal values (ranking the harms caused by the treatment greater than the harms prevented) rather than of futility. It is essential to recognize that any decision to provide a treatment to a patient depends upon two features. The establishment of medical acceptability is the necessary component, but this alone is not sufficient to lead one to subject the patient to the treatment. One must also take into account all of the modifying non-medical features. These include, but are not limited to, familial, racial,38 ethnic,39 fiscal, and social concerns. Of the non-medical features none is more important than how the patient ranks the harms involved.

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However important such non-medical concerns may be in determining how desirable a medically acceptable treatment is, it is necessarily conditional upon the efficacy of the treatments primary function vis-a-vis the specific harms to be eliminated, relieved, or prevented. In this light we can see that there is no conflict between what constitutes the patient‘s role in the decision making process and the doctor‘s prerogative. Therapeutic decisions are purely medical when there is no question about the harms or their ranking. If however, the ranking of harms is disputable, the patient’s input is morally required. In other words, the only value decisions that doctors should make without consulting the patient are those where there is no rational disagreement. Clearly, these cases are exceedingly rare. A DOCTOR’S DUTY Except in emergencies, a physician has no duty to achieve the best consequences for his competent patients. Consent (or refusal) to a particular treatment is ultimately the sole prerogative of the patient,40 but the ideal of shared decision making requires physicians to ensure that their patients are well informed.41 Abiding by a patient’s values does not mean that a doctor should passively accept irrational choices or decisions that are unreasonable given the patient’s ranking of the harms and benefits involved.42,43 When a doctor guides a patient toward the treatment option that is most in keeping with the patient’s ranking of harms and benefits, he is truly fulfilling his duty toward his patient. This is not unjustified paternalism. IRRATIONAL AND UNREASONABLE DECISIONS Rational persons usually have no desire to consider ineffective treatments as viable alternatives, and a physician has no duty to inform patients about treatment options that are not medically acceptable. Acting rationally requires only not acting irrationally. A patient (or his family) acts irrationally when he acts in a way that he knows, or should know, will significantly increase the probability that he, or those he cares for, will suffer death, pain, disability, loss

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of freedom or loss of pleasure; and he does not have an adequate reason for so acting. An adequate reason is a conscious rational belief that can make doing what would otherwise be an irrational action rational. Such beliefs will always involve, either directly or indirectly, a belief that someone (oneself or others) will avoid a harm (death, pain, disability, loss of freedom, loss of pleasure) or gain a good (ability, freedom, or pleasure).40 A Rationally Allowed Decision This analysis explains the behavior of an elderly Russian immigrant patient whom I took care of several years ago. Days before he was likely to die of metastatic pancreatic cancer he asked me to cancel his long standing Do Not Resuscitate (DNR) order. This seemed like an irrational decision until he explained that he wanted to suspend the DNR order just long enough for his daughter to have a chance to see him. After 15 years of separation, she was due to arrive from Moscow the following day. By ranking the pleasure that she would derive from the opportunity to see him one last time (even if he was unresponsive and on a ventilator) higher than the harm that would come to him from such a resuscitation attempt, he had an adequate reason for what would otherwise be an irrational action. With my help, he also decided to have the ventilator stopped within 24 hours of his daughter’s visit, in the event that a successful resuscitation left him ventilator dependent. The final point is especially important. Cancer patient’s and their doctors usually know each other quite well,42 and, therefore, have the unique opportunity to develop this type of preventive ethics approach.44,45 This approach includes, but is not limited to, making Advance Directives. This example also illustrates the importance of doctor-patient communication regarding the goals of treatment and the ranking of harms and benefits. Neither Schneiderman’s “qualitative” or “quantitative” standards, nor Truog’s “physiologic” standard explain why this patient’s decision was rationally allowed. Both of these futility standards fail because they focus on outcome and not on process.

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Though I would allow everyone in a similar position to make a similar decision, some may argue that such public advocacy would have harmful results. One such outcome could be the demoralizing effect that this type of decision might have on the medical and nursing staff required to participate in what they view as a “futile” endeavor.46 Despite admonitions to the contrary,47,48 concerns over bad financial outcomes and the utilization of scarce medical resources have been associated with the futility debate since it began. These concerns must be taken seriously, but they have no place at the bedside. They properly belong to those concerned with the formulation of public policy and legislative consensus.49 UNDERSTANDING THE BENEFITS AND HARMS OF TREATMENT We have seen how pronouncements of futility serve to mask paternalism or prejudice, and excuse bedside rationing. Ultimately the appropriateness of a particular medical treatment is determined by how the patient ranks the benefits and harms. Leukemia in an Octogenarian Several years ago I cared for an 86 year old man with acute myelogenous leukemia. The previous year an article appeared in the British Journal of Haematology reporting the outcome of acute myelogenous leukemia in patients aged 80 years and above. The journal article concluded “that currently available therapy cannot be recommended for patients aged 80 and over.”50 The harms of this expensive treatment were clear: certain loss of freedom and pleasure; a high probability of pain, disability, and even death. Weighing the evidence he concluded that, as awful as the harms of treatment were, there were no harms greater than the certainty of death from leukemia within the weeks to come. The 86 year old man lived for another 3 years; enjoying his family and running his business. With the benefit of hindsight, it is certainly hard to argue that induction chemotherapy for this gentleman was futile, and that this “natural-end cancer”51 should have been allowed to bring him a

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peaceful death to close his long and fulfilling life. Even those who argue for the “compression of morbidity”52 (a shorter period of illness prior to death in old age) as a method of saving dollars, would be hard pressed to balance the books against this factory owner. Critics will maintain that exceptional cases like this should not be used to make policy decisions, but it is just such bedside cases that expose the conflict of values that underlie all discussions of futility. Society has the duty to make rational decisions to allocate medical resources, contain costs, and balance medical needs against other social concerns. Good public policy is made by facing these hard issues straight on, not by obscuring them under the rubric of futility. Trade-Offs: Survival vs. Quality of Life Although this patient’s outcome was unusual, his decision making was not. Contrary to the opinion of most medical professionals, many patients are willing to accept severe toxicity from treatment for the small chance of extended life.53 Even cancer chemotherapy patients are generally unwilling to trade-off survival rate for improved quality of life.54,55 This is particularly true of the very old.56 Doctors frequently decide to withhold life-sustaining treatments from seriously ill patients. The SUPPORT report57 eloquently demonstrates how physicians’ tendency to underestimate elderly patients’ desire for aggressive treatments results in high rates of withholding CPR (cardiopulmonary resuscitation), and other lifesustaining treatments. Family members are no better at making these predicitions.58,59 Levels of Evidence Most cancer patients want to actively participate in decision making with their doctors. Assessments regarding the likelihood of a particular medical intervention meeting its therapeutic goal are essential components of the decision making process. These assessments are subject to the scientific method, and can be

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classified into three grades depending on their supporting levels of evidence. Grade A and B recommendations are those supported by level I (large randomized clinical trials with clear-cut results) and level II (small randomized clinical trials with uncertain results) evidence, respectively. Grade C recommendations are based on evidence from levels III (nonrandomized, concurrent cohort comparisons), IV (nonrandomized, historical cohort comparisons), or V (case series without controls).60 Classification of Medical Interventions Sharpe and Faden61 have shown how these Grades of Evidence bring comprehensible, adequate information to the process of informed consent. By correlating the level of evidence with the preponderance of anticipated harms and benefits, their system helps us understand how doctors make recommendations regarding the medical appropriateness of treatment, and how patients can then make rational decisions regarding the desirability of treatment based on their own values. Possibly Beneficial These interventions are thought to be preponderantly beneficial, but only on the basis of weak, Grade C evidence. Adjuvant interferon therapy for completely resected, localized cutaneous melanoma would fit into this category. Indicated and Highly Indicated These interventions are also thought to be preponderantly beneficial, but, unlike the previous category, the evidence (Grade B and A, respectively) supporting their efficacy is strong (Indicated) or definitive (Highly Indicated). Examples in these categories are adjuvant chemotherapy regimens for women with lymph node positive breast cancer.

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Possibly Harmful These interventions are thought to be preponderantly harmful based on only anecdotal evidence, case reports, or uncontrolled studies (Grade C). Adjuvant radiation therapy for completely resected, early stage, non-small cell lung cancer falls into this group. Equivocal The ratio of benefit to harm is roughly the same in these interventions that are also supported by weak levels of evidence (Grade C). The use of adjuvant chemotherapy in stage II colon cancer is in this category. Contraindicated Good evidence (Grade A or B) is sufficient to place these preponderantly harmful interventions outside of medically acceptable care. Laetrile, and adjuvant chemotherapy (in the absence of radiation therapy) for gastric cancer are both examples of interventions that are not medically acceptable. Non-Indicated When good evidence (Grade A or B) establishes that the benefit/harm ration is roughly equivalent, treatments are generally not indicated. A number of chemotherapy regimens for asymptomatic chronic lymphoctyic leukemia may fit into this group. These treatments may be rationally allowable if the patient has an adequate reason to justify his desire. TYPE OF TREATMENT Standard Treatment The ability of a particular intervention to accomplish its goal defines the limits of oncology care. When the evidence is strong, and when there are no harms indisputably greater than the harm eliminated,

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relieved or prevented, the treatment is medically appropriate, and morally permissible if the patient desires it. Highly Indicated and Indicated treatment plans need no justification. Contraindicated and non-indicated interventions are not medically acceptable, and must be justified on the rare occasion that a doctor or his patient desires them. Though in a cost conscious society it would seem wise to put limits on the use of contraindicated and non-indicated cancer treatments, it is sometimes difficult to adhere to such an evidence based standard.62 Innovative Treatment Where the standard of evidence is weak (Group C), treatments should be regarded as innovative. This designation extends across the spectrum of harms and benefits to include treatments in the following categories: Possibly Beneficial, Equivocal, and Possibly Harmful. It is the doctor’s duty to communicate this to his patient whether or not he is a subject in a formal research study under the protection of an Institutional Review Board. Since most cancer treatments fall into one of these categories, cancer patients are often asked to decide about the desirability of a medical intervention that is not a medically accepted treatment. Therefore, doctors are on higher moral ground when they present these innovative treatments as part of a formal research study. This is, however, not always practicable. “N-of-1” trials,63 and time-limited trials are alternative approaches. Deciding to limit access to innovative treatment to patients enrolled on formal studies may be tempting, but this runs the risk of hindering progress and depriving large numbers of cancer patients of Possibly Beneficial Treatments. A more rational approach might be to distinguish between the categories of innovative treatment, and limit access to Equivocal and Possibly Harmful treatments to some form of protocol study. At the same time that we embrace this approach, it is essential that we appreciate its inherent mixed message. Despite the uncertain, and often marginal, benefits, patients usually enter cancer clinical trials (especially the phase I studies that are particularly

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appealing to patients whose choices might otherwise be considered “futile”) with unrealistic goals and expectations.64 Oncologists, who may well share their patient’s therapeutic optimism, must take great care to present these research studies in the context of the patient’s disease and overall prognosis. Failure to do so will only intensify the conflict when we next tell the patient that there is nothing more that we can do to change the course of their cancer. GOAL OF TREATMENT: CURE VS. PALLIATION Regardless of whether the treatment is standard or innovative, doctors have a moral duty to provide their patients with comprehensible, adequate information about it, and the alternatives. Studies clearly show that patients want this detailed information.65 Oncologists fail in their duty when their patients do not adequately understand whether the goal of treatment is cure or palliation,44,66 and, if it is the latter, whether the intent of the palliative treatment is to prolong life or to control symptoms. Truly informed consent requires this information.41,64 Cancer patients routinely overestimate the value of their treatments:64 be they patients with breast cancer receiving potentially curative adjuvant chemotherapy;67 patients with metastatic cancer receiving potentially palliative chemotherapy;68 or patients with refractory cancer receiving chemotherapy as part of phase I clinical trials.69 Their enthusiasm for chemotherapy is not always shared by others;70 not even their oncologists. Indeed, a survey of Maryland medical oncologists found that the vast majority believed strongly in the value of first-line chemotherapy for metastatic breast cancer. They were, however, unenthusiastic about second-line regimens. Despite their attitude, they had little hesitation in recommending second-line treatments for their patients.71 Not surprisingly, conversations about the limits of anti-cancer treatment are very difficult for most oncologists. Fearing that such frank discussions will destroy hope, they are often willing to administer additional treatment against their better judgment.72,73,74 The stage is set for arguments over the futility of care when patients and their families develop unrealistic hopes and

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expectations because their doctors have not adequately discussed the goals of treatment. Without undermining hope, or paternalistically imposing our ranking of the harms and benefits, doctors can, and are duty bound, to advise patients whether a medically acceptable treatment is palliative or curative, and, for example, indicated or possibly harmful. Indeed, the recent emphasis on palliative care in many of our nation’s cancer programs has sensitized oncologists to the continuum of palliative care; from palliative chemotherapy, to comfort care, to hospice care.75,76,77 We are beginning to recognize that “to continue to allow patients and caregivers to put their hope in things that are highly likely to fail (e.g., further chemotherapy) is at best ill advised and at worst avoiding the real issue.”44 We still have a ways to go, but we are becoming more adept at helping the patient and family focus on obtainable goals (like pain control, and maximizing meaningful time with family and friends) when the cancer has become refractory to anti-tumor therapy. Oncologists are used to thinking about and accepting goals that are less than absolute. Although we prefer that our treatments produce complete responses, we know that this occurs infrequently, and we have come to count partial responses and even disease stabilization as acceptable and “good.” We are often criticized for putting too much emphasis on the rate of response and not its duration. Cure is desirable, but our goals are usually more modest: prolonging life or simply the relief of symptoms. Perhaps oncologists are so used to dealing on the margins of efficacy that they do not experience futility as a “profound sense of disproportion,”78 in the same way that other doctors do when they face treatment options with extremely high harm-benefit rations. Medical oncologists are different. When compared to nononcologists caring for cancer patients, we tend to write DNR orders much later in the course of our patients’ disease. However, our decisions to withhold life-sustaining treatment tend to be more all encompassing than those of our non-oncologist colleagues.79 Though we tend to fight longer and harder, when it’s over it’s over. This is reflected in our use of hospice and our efforts to provide quality comfort care at the end of life. Patients with cancer are more likely to opt for intensive chemotherapy than people who do not

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have cancer. Similarly, medical oncologists are more likely to accept aggressive treatments for potentially small benefits than nonmedical oncologists.71 NEXT STEPS There is certainly no rational reason to continue the practice of blindly administering chemotherapy without defined end points and time lines. Oncologists must prospectively define realistic goals for the treatment that their patients are to receive, and, with their patients, they must monitor the balance of harms. The vast majority of these goals will be measurable end points (a tumor getting smaller, or a symptom relieved), but some, like those of the Russian immigrant waiting to see has daughter, may be more symbolic. Established early in the course of cancer treatment, expectations and alternatives can be built into “next step” scenarios for our patients and their families. This preventive ethics approach was used successfully to diffuse the inevitable arguments about the futility of ventilator support in the Russian patient with advanced pancreatic cancer. The circumstances of most cancer patients are well suited to similarly designed action plans and decision trees. These “next steps” are as likely to be plans for second line chemotherapy as they are for hospice care. As doctors and patients share their goals and values, rational limits can usually be placed on cancer care. REFERENCES 1. 2. 3. 4.

In the Matter of Karen Ann Quinlan, an alleged incompetent 355A 2d 647; or 70 NJ 10. March 31, 1976. In Re: The Conservatorship of Helga M. Wanglie, PX-91-283, Fourth Judicial District (District Court Probate Court Div.) Hennepin County, Minnesota. Daar JF. Medical futility and implications for physician autonomy. Am J Law Med. 1995;21:221–240. Crippen D. Dealing with families who demand inappropriate medical treatment for moribund patients. Intensive Care World. 1992;9: 78–80.

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Heffner JE, Brow LK, Barbieri CA. Publications in subspecialty journals on end-of-life ethics. Arch Intern Med. 1997;157:685–690. Blackhall LJ. Must we always use CPR? N Engl J Med. 1987;317:1281–1285. Tomlinson T, Brody H. Ethics and communication in do-notresuscitate orders. N Engl J Med. 1988;318:43–46. Lantos JD, Singer PA, Walker RM, Gramelspacher GP, Shapiro GR, Sanchez-Gonzalez MA, Stocking CB, Miles SH, Siegler M. The illusion of futility in clinical practice. Am J Med. 1989;87:81–84. Shapiro GR. Unpublished Medline keyword search. Dec. 2006. Faber-Lagendoen K. Resuscitation of patients with metastatic cancer. Arch Intern Med. 1991;151:235–239. Jeker NS, Schneidermann LJ. When families request that everything possible be done. J Med Philosophy. 1995;20:145–163. Escalante CP, Martin CG, Elting LS, et al. Dyspnea in cancer patients: etiology, resource utilization and survival—implications in a managed care world. Cancer. 1996;78:1320–1325. Rubenfeld GD, Crawford SW. Withdrawing life support from mechanically ventilated recipients of bone marrow transplants: a case for evidence-based guidelines. Ann Intern Med. 1996;125:625–633. American Medical Association Council on Ethical and Judicial Affairs. Medical futility in end-of-life care. JAMA. 1999;281: 937–941. Texas Advance Directives Act of 1999. Texas Health and Safety Code ch. 166 (Vernon Supp. 1999). Bedell SE, Delbanco TI, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation in the hospital. N Engl J Med. 1983;309:569–576. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med. 1990;112: 949–954. Schneiderman LJ, Faber-Langendoen K, Jecker NS. Beyond futility to an ethic of care. Am J Med. 1994;96:110–114. Schneiderman LJ. The rise and fall of the futility movement. New Engl J Med. 2000;343:1575. Truog RD, Brett AS, Frader J. The problem with futility. N Engl J Med. 1992;326:1560–1564. Vitelli CE, Cooper K, Rogatko A, Brennan MF. Cardiopulmonary resuscitation and the patient with cancer. J Clin Oncol. 1991;9: 111–115. Truog RD. Progress in the futility debate. J Clinical Ethics. 1995;6:128–132.

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23. Solomon MZ. How physicians talk about futility: making words mean too many things. J Law Med Ethics. 1993;21:231–237. 24. Curtis RJ, Park DR, Krone MR, Pearlman RA. Use of the medical futility rationale in do-not-attempt-resuscitation orders. JAMA. 1995;273:124–128. 25. Council on Ethical and Judicial Affairs. Medical futility in end-of-life care: report of the Council on Ethical and Judicial Affairs. JAMA. 1999;281:937–941. 26. Lofmark R, Nilstun T. Conditions and consequences of medical futility: from a literature review to a clinical model. J Med Ethics. 2002;28:115–119. 27. Halevy A, Brody BA. A multi-institution collaborative policy on medical futility. JAMA 1996;276:571–574. 28. Murphy DJ, Barbour E. GUIDe (Guidelines for the Use of Intensive Care in Denver): a community effort to define futile and inappropriate care. New Horiz. 1994;2:326–331. 29. Helft PR, Siegler M, Lantos J. The rise and fall of the futility movement. New Engl J Med. 2000;343:293–296. 30. Zawacki BE. The “futility debate” and the management of Gordian knots. J Clin Ethics. 1995;6:112–127. 31. Katz J. The Silent World of Doctor and Patient. New York: Free Press. 1997. 32. American College of Physicians Ethics Manual Ann Intern Med. 2005;142:560–582. 33. United States Department of Health and Human Services Policy for the Protection of Human Subjects. Fed Register. Vol 46, No 17:8951. January 27, 1981. 34. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington, DC: Government Printing Office. 1982:42–44. 35. Gert B. Morality: its nature and justification. New York: Oxford University Press. 2005. 36. Brett AS, McCulloug LB. When patients request specific interventions: defining the limits of the physician’s obligation. N Engl J Med. 1986;315:1347–1351. 37. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Deciding to Forego Life-Sustaining Treatment. Washington, DC: Government Printing Office. 1983.

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38. Caralis PV, Davis B, Wright K, Marcial E. The influence of ethnicity and race on attitudes toward advance directives, life-prolonging treatments, and euthanasia. J Clin Ethics. 1993;4:155–165. 39. Shapiro GR. Not telling Russian immigrants the truth about cancer: cultural sensitivity or misplaced paternalism? Psycho-oncology. 1996;5:196. 40. Gert B, Culver CM, Clouser KD. Bioethics: a return to fundamentals. New York: Oxford University Press. 1997. 41. Von Gruenigen VE, Daly BJ. Futility: clinical decisions at the end-oflife in women with ovarian cancer. Gynecol Oncol. 2005;97:638–644. 42. Tomlinson T. Futile care in oncology: when to stop trying. Lancet Oncol. 2001;2:759–761. 43. Brock DW, Wartman SA. When competent patients make irrational choices. N Engl J Med. 1990;322:1595–1599. 44. Harnett PR, Moynihan TJ. “But doctor, what have I got to lose…?”. J Clin Oncol. 2001;19:3294–3296. 45. Doukas DJ, McCullough LB. A preventive ethics approach to counseling patients about clinical futility in the primary care setting. Arch Fam Med. 1996;5:589–592. 46. Ferrell BR. Understanding the moral distress of nurses witnessing medically futile care. Oncol Nurs Forum. 2006;33:922–930. 47. Jecker NS, Schneiderman U. Futility and rationing. Am J Med. 1992;92:189–196. 48. Persaud R. “Futile” care in the intensive care unit. Mayo Clin Proc. 2006;81:1506–1507. 49. Gatter RA, Moskop JC. From futility to triage. J Med Philos. 1995;20:191–205. 50. DeLima M, Ghaddar H, Pierce S, Estey E. Treatment of newlydiagnosed acute myelogenous leukaemia inpatients aged 80 years and above. Br J Haematol. 1996;93:89–95. 51. Kitagawa T, Hara M, Sano T, Sugimura T. The concept of tenjugann, or “natural-end cancer.” Cancer. 1998;83:1061–5. 52. Callahan D. What Kind of Life: The limits of medical progress. New York: Simon & Schuster. 1990. 53. Slevin ML. Quality of life: philosophical questions or clinical reality? Br Med J. 1992;305:466–469. 54. Silvestri G, Pritchard R, Welch HG. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. Br Med J. 1998;317:771–775. 55. Brescia FJ. Lung cancer—a philosophical, ethical, and personal perspective. Crit Rev Oncol/Hemalol. 2001;40:139–148.

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56. Tsevat J, Dawson NV, Wu AW, et al. Health values of hospitalized patients 80 years or older. JAMA. 1998;279:371–375. 57. Hamel MB, Teno JM, Goldman L, et al. Patient age and decisions to withhold life-sustaining treatments from seriously ill, hospitalized adults. Ann Intern Med. 1999;130:116–125. 58. Covinsky KE, Fuller JD, Yaffe K, et al. Communication and decision-making in seriously ill patients: findings of the SUPPORT project. J Am Geriatr Soc. 2000; 48:S187–S193. 59. Way J, Back AL, Curtis JR. Withdrawing life support and resolution of conflict with families. Br Med J. 2002;325:1342–1345. 60. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services: An Assessment of the Effectiveness of 169 Interventions. Baltimore: Williams & Wilkins. 1989. 61. Sharpe VA, Faden AI. Appropriateness in patient care: a new conceptual framework Milbank Quarterly. 1996;74:115–138. 62. Rosenbaum S, Frankford DM, Moor B, Borzi P. Who should determine when health care is medically necessary? N Engl J Med. 1999;340:229–232. 63. Guyatt GH, Keller JL, Jaeschke R, et al. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern Med. 1990;112:293–299. 64. Varma G, Stein R, Jacobson J, Briggs N, Shapiro GR. The goal of chemotherapy: little agreement between patients and their doctors. Proc Am Soc Clin Oncol. 2001;20:1542. 65. Hagerty RG, Butow PN, Ellis PA, et al. Cancer patient preferences for communication of prognosis in the metastatic setting. J Clin Oncol. 2004;22:1721–1730. 66. Gregory DR, Cotler MP. Futility: are goals the problem? Part two. Cambridge QHealthcare Ethics. 1994;3:125–134. 67. Ravdin PM, Siminoff IA, Harvey JA. Survey of breast cancer patients concerning their knowledge and expectations of adjuvant therapy. J Clin Oncol. 1998;16:515–521. 68. Weeks JC, Cook EF, O’Day SJ, et al. Relationship between cancer patients’ predictions of prognosis and their treatment preferences. JAMA. 1998;279:1709–1714. 69. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995;13:1062–1072. 70. Slevin ML, Stubbs L, Plant H, et al. Attitudes to chemotherapy: comparing views of patients with those of doctors, nurses, and general public. Br Med J. 1990;300:1458–1460.

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71. Benner SE, Fetting JH, Brenner MH. A stopping rule for standard chemotherapy for metastatic breast cancer: lessons from a survey of Maryland medical oncologists. Cancer Invest. 1994;12:451–455. 72. Gordon EJ, Daugherty CK. ‘Hitting you over the head’: oncologists’ disclosure of prognosis in advanced cancer patients. Bioethics. 2003;17:142–168. 73. Baile WF, Lenzi R, Parker PA, et al. Oncologists’ attitudes toward and practices in giving bad news: an exploratory study. J Clin Oncol. 2002;20:2189–2196. 74. Gattellari M, Voigt KJ, Butow PN, Tattersall MHN. When the treatment goal is not cure: are cancer patients equipped to make informed decisions? J Clin Oncol. 2002;20:503–513. 75. Abrahm JL. The oncologist’s expanding role. Cancer. 1999;85: 1645–1648. 76. Task force on cancer care at the end of life. Cancer care during the last phase of life. J Clin Oncol. 1998;16:1986–1996. 77. Schofield P, Carey M, Love A,Nehill C, Wein S. “Would you like to talk about your future treatment options?” discussing the transition from curative cancer treatment to palliative care. Palliat Med. 2006;20:397–406. 78. Prendergast TJ. Futility and the common cold: how requests for antibiotics can illuminate care at the end of life. Chest. 1995;107:836–844. 79. Shapiro GR, Stocking CB, LaPuma J, Silverstein MD, Roland D, Siegler M. Do not resuscitate orders & life-sustaining therapy: a comparison of oncologists’ & nononcologists’ attitudes. Proc Am Soc Clin Oncol. 1988;7:269.

10

THE ROLE OF PALLIATIVE MEDICINE IN CANCER PATIENT CARE

William M. Mitchell and Charles F. von Gunten

INTRODUCTION There continues to be an unexplained paradox in American cancer care. On one hand, the impact of cancer is substantial. More than one third of Americans will be diagnosed with some type of malignancy during their lifetime.1 Roughly 50% will be cured. Most of these cures are due to surgical intervention. This proportion has remained relatively unchanged over the past 30 years.2,3 During the course of their illness all cancer patients, particularly those whose cancer is not cured, will experience suffering. That suffering has physical, psychological, social, and spiritual components. On the other hand, academic oncology has resisted addressing the broad issue of suffering and its management beyond tumordirected therapies. Medical school and residency curricula have devoted little, if any, time to the subject. Only a handful of scholars are supported to develop expertise in this area. Multiple studies have demonstrated that patients’ and families’ suffering is not met by the current medical system.4,5,6 Many major cancer centers now make some effort to address patient suffering beyond solely treating malignancies, but most have only begun to do so in recent years. It is the purpose of this chapter to outline the role of palliative medicine in cancer care. First, palliative medicine will be defined. Then, a conceptual framework for its role in the comprehensive care of patients with cancer will be presented. Finally, models of how palliative care may be integrated into a cancer center will be described.

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Pa l l i a t i v e Me d i c i n e Since the time of Hippocrates there have been two overall goals of medical care: 1. Cure of disease. 2. Relief of suffering. These goals are shared by the patient as well as health care providers. The relative emphasis on cure versus relief of suffering is determined by both the underlying medical condition and the overall goals of the person who has the illness. The term palliate originated with the Latin term pallium which means “cloak” or “cover.” Palliative Medicine is the term coined to denote the field of medicine concerned with the covering of suffering. Quality-of-life rather than quantity-of-life is the chief aim of those engaged in the delivery of palliative care.7 Because suffering is experienced by persons, its existence, character and criteria for relief are defined by the patient rather than by the physician. Because persons do not exist in isolation, the relief of suffering requires attention to the care of patients and their families. Suffering is caused by many factors that are rarely limited to the physical domain. In providing whole-person care to relieve suffering, palliative medicine attends to all domains of the human experience of illness that may be involved: physical, psychological, social and spiritual.8,9 Tending to the relief of suffering in these domains cannot possibly be accomplished by a single medical discipline—a team approach is required. Therefore, palliative medicine may be defined in the following way. Palliative medicine: the interdisciplinary care of patients focussing on the relief of suffering and the improvement of quality of life. The Royal College of Physicians in Great Britain recognized palliative medicine as a physician specialty in 1987.10 This recognition came only after it had been demonstrated that there was an established body of medical knowledge that uniquely pertained to

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a distinct patient population. Further, there was recognition of a 4year training program to follow general medical training for those physicians wishing to be recognized as specialists in the field. Later, the Royal College of Physicians and Surgeons in Australia recognized the specialty. The Royal College of Physicians and Surgeons and the College of Family Physicians of Canada recognized palliative medicine and established 1-year postgraduate training programs in 1999. Mainstream medicine in the United States has been slower to offer formal recognition of palliative medicine as a distinct specialty. Progress towards this goal in the US has been hindered in part by the fact that hospice programs were introduced and established in the United States in a manner different from that in other countries. Nurses or volunteers established the majority of programs as a reaction against the inadequacies of the medical establishment in caring for terminally ill patients. Until recently, physician participation has not been prominent. Consequently, there developed a polarity that prevented hospice medicine from becoming incorporated into the academic mainstream. Despite this separation from mainstream medicine, the hospice movement in the United States has grown to include 3650 individual hospice programs caring for over 1 million patients with terminal illnesses in 2004.11 Fortunately, there are initiatives in a growing number of the cancer centers in the United States that suggest that mainstream medicine and palliative care are negotiating a rapprochement. Nearly every national organization is calling for increased clinical and academic focus in hospice and palliative medicine including the Institute of Medicine,12,13 the National Institutes of Health,14,15 the American Board of Internal Medicine,16 the American College of Physicians,17 the American Society of Clinical Oncology,18 National Comprehensive Cancer Network,19 and the American Medical Association.20 And after much working and waiting, formal recognition of hospice and palliative medicine as a subspecialty by the American Board of Medical Specialties (ABMS) and the Accreditation Council for Graduate Medical Education (ACGME) was achieved in 2006. 21

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Co n c e p t u a l Fr a m e w o r k The concepts that undergird the field of palliative medicine have only been articulated in the past century and have arisen in reaction to the single-minded application of the scientific method in medicine. Until a century ago, medical care was primarily directed at the relief of suffering while the underlying illness ran its natural course. With the multitude of advances in medical care, the relief of suffering as a goal of medical care was subjugated or lost in many settings in the quest to achieve cure and/or prolongation of life. While the impetus for the rigor of science to provide insight into cancer and its treatment is unquestionable, it should not obliterate the emphasis on caring for the human being who has the disease. It is a mistaken assertion that treating the cancer is equivalent to treating a person with cancer. This model has led contemporary oncology, in some circumstances, to cause suffering while pursuing a cure. The misapplication of an exclusively “cure-oriented” approach to cancer can be conceptualized in the following diagram where the time course and goals of such treatment are illustrated (Fig. 1). Curative/Life-prolonging Therapy

Diagnosis

Death

Fig. 1. Cure-oriented cancer care A patient is first evaluated for some constellation of symptoms for which a diagnosis of cancer is made. Evaluation and treatment is directed toward the eradication, reversal, or substantial control of the disease. Symptoms are important insofar as they help elucidate the diagnosis and course of treatment. This model of treatment can be characterized as disease-oriented and pathophysiologically-based. Clinicians are engaged in a “war on cancer” and the patient dies in spite of “doing everything” and maintaining a “fighting spirit” to the end.

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It should be apparent that treatment which is exclusively focused on cure will be considered a failure if the patient dies. It should be apparent that this model may actually cause suffering. This model promotes the ethically dubious practice of administering anti-cancer therapy that will have no benefit, but may be perceived as still trying to “fight” the cancer. It is this orientation, however well-meaning, that has led to the disparaging way that clinicians outside of medical oncology refer to medical oncologists. There is that gruesome joke that still makes the rounds, “Why do they put nails in coffins? To keep the oncologists out.” In recognition of the situation when the disease is progressive and treatment modalities are no longer effective, “comfort care” measures may be instituted. This last period, if it occurs at all, is often of short duration (sometimes hours to days). Furthermore, this medical care model does not include explicit consideration of non-physical aspects of a person’s illness experience or that of the person’s family. This model of medical care leads to several important sources of societal dissatisfaction with the medical field—physicians “over-treat,” physicians “don’t give patients enough information about their condition and what to expect,” and physicians are “merely scientists who are uninterested in the lives of the patients they treat.” Further, once “comfort care” has been recommended, there is an accurate perception that the physicians are no longer engaged in the care of the patient. Physicians, in their defense, will say that their job is to treat the cancer. When they can’t treat the cancer anymore, there is nothing for them to do. This orientation misses some of the fundamental ethical imperatives of the profession. For physicians who try to modify the approach diagrammed in Fig. 1 to include only medical care which is appropriate for the stage of disease and the likely outcomes of treatment, the patient and family may perceive the care to be more like that shown in Fig. 2:

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Curative/Life-Prolonging Therapy

Comfort Care Death

Diagnosis Fig. 2. Disease-oriented cancer care The patient and family perceive, often quite correctly, that the physician shows diminished attention to the patient over time. This leads to another fundamental cause for patient and family dissatisfaction with the health care system—abandonment. Although the severity of illness may be increasing, the attention of the physician and other health care providers diminishes when there is “nothing more to do” for the disease. In addition, the implication of abandonment may lead to strident demands from patients and families to “do more, do everything.” In the absence of an appropriate treatment framework that addresses these issues, the physician may pursue medical treatment that is futile in the service of patient autonomy. Such treatment results in increased suffering for the patient and family because the important issues that surround death and dying are ignored. In appreciation that the models diagrammed in Figs. 1 and 2 do not adequately address issues of patient suffering, Dr. Cicely Saunders in England introduced the hospice model of palliative care.9 Working primarily with patients with cancer, she recognized that suffering might be produced not only from the cancer, but also by medical efforts to control the disease. She also recognized that the physical, psychological, social, and spiritual aspects of suffering were inadequately addressed. Culminating in the establishment of St. Christopher’s Hospice in south suburban London in 1967, she developed a model of inpatient care for patients for whom curative therapy was not available, or was no longer desired. In this model there is an interdisciplinary team approach to the care of the patient and family that continues into a bereavement period after the patient’s death. The hospice concept has been widely adopted

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because of its demonstrated benefits for patients and families. Figure 3 shows the most common position of hospice care in the overall scheme introduced in Fig. 1. There is generally a sharp demarcation between disease-oriented therapy and hospice care. Curative/Life-Prolonging Therapy

Hospice Care Fig. 3. Hospice care after cure-oriented care stops Although hospice care addresses aspects of patient suffering not addressed during “standard medical treatment,” this period is often short. The median length of stay on hospice in the United States in 2004 was 22 days with 35% of patients receiving hospice care for 7 days or less.11 Also, with this model there is a sharp discontinuity between the previous medical care and hospice care. Conceptually, one of the chief problems with this model is the dichotomy between curative/life-prolonging care and hospice care. This model suggests that the goal of medical care is first cure, then relief of suffering. Yet, good sense dictates that the two goals are not mutually exclusive and should be pursued simultaneously. Why wait to introduce measures to alleviate suffering and improve quality of life until all attempts at cure have been exhausted or the patient and family plead for such efforts to stop? It would seem to be generally appropriate to integrate curative or life-prolonging treatments with the relief of suffering. In other words, palliative treatments are not adjuncts or complementary to “conventional” cancer care, but are an essential part of cancer care. It should be self-evident that many palliative care approaches to illness should precede the point at which referral to a hospice program is appropriate. For example, aggressive control of pain, other bothersome symptoms, and the psychosocial effects of a cancer diagnosis should characterize the very beginning of contemporary cancer care. This approach can accompany aggressive anti-cancer therapy with curative or lifeprolonging intent (such as in lymphoma or breast cancer) as well as

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for diseases where death is inevitable. Neither type of treatment is inherently more valuable than the other. Instead, in addition to their disease status, a patient’s goals and priorities determine which treatments will be most valuable to them. A treatment plan that is directed by those goals should be provided.22 And these goals and treatment plans will usually evolve as the illness changes. This scheme is shown in Fig. 4. Curative/Life-Prolonging Therapy

Palliative Care

Hospice Care

Fig. 4. Comprehensive cancer care combining disease-oriented and palliative care from diagnosis In this model, hospice care represents the completion of medical care, not an alternative to, or an abrupt change from, the preceding care plan.23 MODELS OF PALLIATIVE CARE IN CANCER CENTERS While the discussion about the need for palliative care as a necessary part of good cancer care has continued, another separate but related discussion has commenced: how to implement palliative care in our nation’s cancer centers. There is precious little information in the literature about how such programs might be organized and financed. There is little question that palliative care is needed in cancer centers. There is also broad agreement that this should be interdisciplinary and that it needs to commence early in the course of cancer treatment. It also needs to be patient-specific in nature, addressing the multiple domains of suffering that patients experience in the course of a cancer. Beyond some of these basic points of agreement, there remains much to be discovered about how to best provide palliative care to cancer patients. Critical questions remain

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unanswered: which patients need palliative care; how should we identify them; where should we interact with patients; what is the ideal structure of the relationship between oncologist and palliative specialist and patient; and, how should we overcome preconceived and often incorrect ideas about palliative care by the cancer establishment? Several major cancer centers are establishing palliative care services. Two that have published data about their experiences are The Cleveland Clinic Taussig Cancer Center24 and The University of Texas M.D. Anderson Cancer Center.25 We will mention some of their published data, then mention ongoing work we are a part of at The University of California San Diego Moore’s Cancer Center as examples of current models being implemented. The palliative medicine program at the Cleveland Clinic is a multi-faceted program which was serially implemented over a decade. The program is administratively contained within the department of medical oncology. The program began with an inpatient consult service in 1987 and subsequently has added outpatient clinics which run in the cancer center alongside traditional oncology clinics for post-discharge follow-up, home hospice and home palliative care programs which are owned and operated by the Cleveland Clinic, and an acute-care inpatient unit for acute symptom management. In 1998 they saw 834 consults, 60% (505) were inpatient, and 35% (294) were from the department of hematology/oncology. That year they admitted 633 patients to their inpatient unit and saw 1,374 scheduled clinic visits. Functionally, they operate as a distinct service in parallel with oncology, receiving referrals when deemed appropriate by other physicians. The Department of Palliative Care at The University of Texas M.D. Anderson Cancer Center is another group that has published results of their experience providing palliative care in a major cancer center. Their service began in 1999 with an ambulatory care center where patients are seen in a dedicated palliative care clinic by an interdisciplinary team and also a mobile consultation service seeing inpatients as requested by primary oncology teams. Based on experiences with this model of care, they felt that there was a group of patients with severe distress who would benefit from primary care by the interdisciplinary palliative team. In 2002 the Palliative Care Inpatient Service was established. This service

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receives patients who are most often transferred from other inpatient oncology services, but also admitted from palliative care ambulatory clinic and the emergency department. Patients admitted have agreed to accept the palliative team as primary caregivers and oncologists serve as consultants as needed. Initially they shared beds on oncology wards, but in response to frustration reported by nursing staff they moved to a dedicated unit. They provided care for 320 patients in the first year of operation. They report a mean stay of 9.6 days (median 7 days), improvement in most symptoms scores that were tracked, a decrease in mean daily charges of 38% compared to the rest of the hospital and no change in the overall hospital death rate. Fifty-two percent of patients were discharged to hospice (either inpatient or outpatient), 23% died as inpatients in their unit and 15% went home. They also report a mean reimbursement for all palliative care charges of 57% by third-party payers. They operate as a distinct alternative to the standard oncology services available at the cancer center. At The University of California at San Diego Moores Cancer Center, we have pursued a model of care which seeks to integrate oncology and palliative care as closely as possible. Our service was opened at the cancer center in the fall of 2005. A consult service consisting of attending and fellow physicians, a nurse practitioner and social worker currently serve as the palliative care team. Rather than position this team as inpatient or outpatient consultants, or in a separate palliative care unit or clinic, we have asked permission of the two inpatient oncology teams (solid tumor and bone marrow transplant) to attend daily rounds with them, to see patients along with the oncologist, rather than instead of the oncologist. During rounds we make recommendations for symptom management if the problem is relatively simple, or offer to return later for a full consult if the situation seems to merit this level of attention. Additionally, the palliative care team sees patients along with the primary oncologist in their clinic if there is a particular palliative need. Obviously, under this unique model of palliative care there have been challenges. The oncology teams frequently must decide whether an unfamiliar treatment is appropriate for their patient. Also, the frequent rotation of team members both on the oncology teams and the palliative team has meant a period of education and

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re-education about this unique model of care. And it remains clear that the needs for palliative care far out-distances our ability to identify and meet those needs. We have also remarkable positive outcomes working within this model. Since the service is in its infancy, we have not yet assembled a sizeable data set to report, but some benefits of this model have been starkly apparent. First, while working with the oncology teams, we have been allowed to participate in the care of many patients who would otherwise not have been referred for palliative care. This has been particularly true of patients often thought of as “inappropriate” for a palliative care, such as patients who are receiving aggressive cure-directed treatments including bone marrow transplant, younger patients and patients who have been offered and declined enrollment in hospice. Also, we have been able to encounter patients much earlier in the course of their illness, sometimes within hours or days of diagnosis. The opportunity for oncology and palliative team members to learn from each other has been another benefit. The ultimate benefit has been improved patient care. We believe that the statement of a patient who was undergoing bone marrow transplant for lymphoma effectively reflects the collective view of cancer patients when he said, “Where was that treatment four days ago?” We believe this closely integrated model will offer profound benefits to a greater number of patients earlier in the course of illness, particularly as colleagues in oncology see the benefits to patients. CONCLUSION Until we can reliably, predictably, and easily cure cancer, it is imperative that the principles of palliative care be incorporated into mainstream comprehensive cancer programs. While much progress has been made, there remains a great deal of suffering in the lives of the patients cared for in our modern cancer centers.

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REFERENCES 1. 2. 3. 4.

5. 6. 7.

8. 9. 10. 11. 12.

13.

Cancer Facts and Figures 2004, American Cancer Society, Inc., 1599 Clifton Road, NE, Atlanta, GA 30329 Bailar JC III, Gornick HC. Cancer undefeated. N Engl J Med 1997;336:1569–1574. Bailar JC III, Smith EM. Progress against cancer? N Engl J Med 1986;314:1226–1232. The SUPPORT Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients. JAMA 1995;274:1591–1598. Vachon ML, Kristjanson L, Higginson I. Psychosocial issues in palliative care. J Pain Symptom Manage 1995;10:142–150. Vachon ML. Caring for the caregiver in oncology and palliative care. Semin Oncol Nurs 1998;14:152–170. Doyle D, Hanks GWC, MacDonald N. Introduction. In: Oxford Textbook of Palliative Medicine, 2nd edition, Derek Doyle, Geoffrey W.C. Hanks, Neil MacDonald (Eds). Oxford University Press, New York 1998. Cassel EJ. The nature of suffering and the goals of medicine. Oxford University Press, New York, 1991. Saunders C. Introduction-history and challenge. In: The Management of Terminal Malignant disease, Cicely Saunders and Nigel Sykes (Eds). Edward Arnold, Boston 1993. Doyle D. Palliative medicine: a UK specialty. J Palliat Care 1994;10:8–9. NHPCO’s 2004 Facts and Figures, National Hospice and Palliative Care Organization, 1700 Diagonal Road, Suite 625, Alexandria, VA 22314. Approaching death: improving care at the end of life. Committee on care at the end of life, Division of Health Care Services, Institute of Medicine, National Academy of Sciences, 1997. Foley K, Gelband H, Eds. Improving Palliative Care for Cancer, National Cancer Policy Board, National Research Council, National Academy of Sciences, 2001.

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14. National Institute of Nursing Research, National Institutes of Health 6701 Rockledge Drive Room 1040 MSC 7710 Bethesda, MD 20892-7710 15. National Institutes of Health State-of-the-Science Conference Statement on Improving End-of-Life Care, NIH Consensus Development Program, December 6–8, 2004. 16. American Board of Internal Medicine. Caring for the Dying: identification and promotion of physician competency. Philadelphia 1996. 17. Cassel C. Palliative care is the real focus of end-of-life medicine. ACP Observer. 1996;July/August:2. 18. Task Force on Cancer Care at the End of Life. Cancer care during the last phase of life. J Clin Oncol 1998; 16(5): 1986–1996. 19. Clinical Practice Guidelines in Oncology, National Comprehensive Cancer Network, 2005; accessed through web page www.nccn.org. 20. Good care of the dying patient. Council on Scientific Affairs. JAMA 1996;275:474–478. 21. Portenoy R, Lupu D, Arnold R, Cordes A, Storey P. Formal ABMS and ACGME recognition of hospice and palliative medicine expected in 2006. J Palliat Med 2006; 9(1):21–23. 22. Gillick M. Rethinking the central dogma of palliative care. J Palliat Med 2005; 8(5):909–913. 23. MacDonald N. The interface between oncology and palliative medicine. In: Oxford Textbook of Palliative Medicine, 2nd edition, Derek Doyle, Geoffrey W.C. Hanks, Neil MacDonald (Eds). Oxford University Press, New York 1998. 24. Walsh D. The Harry R. Horvitz Center for Palliative Medicine (1987–1999): development of a novel comprehensive integrated program. Am J Hosp Palliat Med 2001;18(4):239–250. 25. Elsayem A, Swint K, Fisch M, Palmer J, Reddy S, Walker P, Zhukovsky D, Knight P, Bruera E. Palliative care inpatient service in a comprehensive cancer center: clinical and financial outcomes. J Clin Oncol 2004; 22(10):2008–2014.

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HOLDING ON AND LETTING GO: ETHICAL ISSUES REGARDING THE CARE OF CHILDREN WITH CANCER Aviva Goldberg and Joel Frader

The issues that apply to cancer care in adults often have equal relevance in the care of children, but pediatric care also involves special challenges, especially when conventional therapy will not achieve remission or cure. In this chapter, we discuss two ethics issues that apply particularly to children with cancer: children’s involvement in phase I research trials and the disclosure of a terminal diagnosis to a child with cancer.

Part I––Phase I Research Trials in Pediatric Oncology Patients INTRODUCTION Largely due to the concerted effort of the Children’s Oncology Group (COG) and its predecessor cooperate research groups, and the fact that most children with cancer receive their treatment in tertiary care centers, children with cancer commonly participate in controlled clinical trials; indeed most children with cancer will be asked to participate in at least one clinical trial. Many of these trials involve assessment of the anti-tumor effects of single or multimodal interventions, with or without comparison to “standard” treatment, i.e., phase II or III trials. Increasingly, however, pediatric oncologists engage in efforts to identify new therapies for the 25–30% of children for whom current treatment will not effect a

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cure. As a result, institutional review boards (IRBs) increasingly receive protocols for phase I trials for cancer regimens. Phase I trials generally test the maximum tolerated dose, optimal biological dose, dose-limiting toxicity, or pharmacokinetic and pharmacodynamic properties of a novel anticancer agent. These trials provide little chance of direct medical benefit to the subjects and participation is usually limited to patients with relapsed or refractory disease despite conventional therapy. In the United States, IRBs can approve phase I trials in children under two subparts of the Code of Federal Regulations (CFR) as promulgated by the Department of Health and Human Services (45 CFR 46). Section 405, subpart D authorizes approval of trials with the prospect of direct benefit to the child and some argue that phase I cancer trials do offer both medical and psychological benefits.1 Alternatively, an IRB could approve the trial under Section 406, subpart D, meaning the trial offers no reasonable prospect of direct benefit to the research subject, but where “the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition.” Since phase I trials are the first step in a plan to find better therapy for incurable conditions, they seem to fulfill this regulatory requirement. Despite the fact that phase I pediatric cancer trials can qualify for approval under the federal regulations, ethicists, oncologists and parents may question the ethical justification of offering early phase trials not designed to achieve meaningful clinical outcomes to children dying of cancer. This section outlines the ethical dilemmas that may arise when a phase I trial addresses cancer in pediatric patients. Classic Arguments Over Research in Children—Ramsey vs. McCormick Paul Ramsey and Richard McCormick famously debated the morality of involving children in non-therapeutic research. Ramsey maintained that non-therapeutic research in children should be banned, stating it violates society’s duty to protect vulnerable

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children and that children cannot enter into valid supererogatory relationships.2 Conversely, McCormick argued that research involving children was morally obligatory, as children could and should be independent moral agents and that disallowing research in this age group would disadvantage the pediatric population as a whole.3 Today’s ethicists still struggle with these issues, trying to balance the needs of the community with the rights of the individual. The Demand for Phase I Trials in Pediatric Oncology Clearly developing safe and effective new treatments for childhood cancer requires phase I trials. Relying on adult data in pediatrics confers neither safety for children nor much practical help, as the pharmacokinetics and pharmacodynamics of medications can differ significantly based on body size, different fat-to-lean body mass, differences in kidney and liver function, hormonal balance and many other factors.1 Drugs approved for use in adults may prove ineffective or more toxic in children, like the increased CNS toxicity seen with all-trans retinoic acid in children.4 In some cases, children may tolerate drugs better than older patients because of different metabolic pathways of drug distribution or elimination or because children have fewer comorbidities than their elders, as with the general tolerability of nifedipine for blood pressure control in the pediatric population.5 Also, some serious diseases of childhood simply have no adequate adult counterpart. In pediatric oncology, neuroblastoma, Wilms tumor, and yolk sac tumors stand as obvious examples, but many diseases may have very different prognoses in the pediatric population.6 Without phase I trials, there is little chance to improve the prognosis for these diseases, leaving children the “therapeutic orphans” of oncology research.6,7,8 Families of children with cancer and some older children/adolescents may also expect or even demand participation in clinical trials. Nevertheless, children have been identified as a vulnerable population when involved in research, largely due to the history of exploitation in previous medical research. Infamous trials like the Fernald School radiation experiments emphasize the dangers of using children in trials where they will not directly benefit.9,10In the response to these abuses, the U.S. federal government and other

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agencies aimed to restrict the use of pediatric subjects in research to later phase studies or, in some cases, completely exclude children from clinical research.11 More recently, however, regulations have changed to accommodate the patient driven perspective, which sees research participation as a right that should be offered to all patients, instead of an obligation or means of exploitation.12 Many now view research as more than an altruistic act for the primary benefit of society, instead seeing it as an avenue to the most recent, and by implication, most “advanced” clinical developments available. Research grant applicants for U.S. National Institutes of Health phase III trials must now justify excluding groups, including children, from participation in their studies. Applicants need to give clear reasons for the exclusion, such as “children do not get lung cancer,” lest they face accusations of unfairly discriminating against the excluded groups. Other pressures may bear on the research community to enroll children in early phase research. The U.S. Food and Drug Administration requires pediatric enrollment for drug approval unless the manufacturer can demonstrate little or no potential use of the agent in pediatrics. Moreover, companies facing expiring patents now have a powerful incentive to carry out pediatric trials,12 namely a 6 month extension of their exclusive patent rights if the manufacturer conducts some research on possible use of their drug for children. Kodish points out the conflicts of interest that the ethical oncology researcher may face in enrolling pediatric patients in phase I trials: career advancement, institutional pressures to enroll subjects, and a genuine desire to further knowledge about a particular disease. These forces may coalesce and place the clinician-researcher in an awkward position as he or she struggles to offer the “best” choices—including participation in a research trial with only a tiny likelihood of helping his or her patient.13 As Oberman and Frader have commented, the demand for early phase research from families, the medical community, and regulatory agencies does not, in and of itself, justify such research. If the research will harm some children and exists only for the benefit of other, future children, it is ethically problematic: it is wrong to hurt one child solely for the benefit of others.12

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So the ethical researcher may imagine herself in the same position as Dostoyevsky’s Alyosha in The Brothers Karamazov: asked whether he would be the architect of a world in which all suffering would cease if a single small child were killed, Alyosha refuses, as he cannot accept a world built on the blood of innocents. Similarly, the ethical researcher may worry that he or she must expose an already disadvantaged child to the extra burden of phase I chemotherapy, only to help others. Are we really in Alyosha’s nightmare, or can we justify phase I trials in children with cancer, not because there is a need for them, but because the participation in such a trial offers some benefit to both the child and his or her family? Benefits and Burdens of Phase I Research in Pediatrics The risks of participation in phase I trials include both the medical complications and the non-medical implications of the research. The medical complications generally involve those expected from standard chemotherapy and may actually be lower, at least for those receiving the relatively low doses of drugs given to the first cohorts of enrollees in these studies. Of course, catastrophic complications can and do occur, as each drug, by definition, has little or no track record in children. Non-medical risks to the patient can occur, as well. Phase I participation may require the subjects to spend more time in the hospital than would occur were supportive or hospice care alone in use. Some families may prefer to de-medicalize the last months of life as much as possible and trial participation may preclude this. Other intra-familial relationships, including the care of other children, may suffer because the parents focus on this “last best chance.” For children too young to meaningfully participate in research and care decisions, research participation may offer psychological benefits to the parents, but not for the child. Another risk to research participation in the late phases of illness involves the danger of the “therapeutic misconception.” Phase I trials, by design, aim to test escalating doses of medication to find a maximum tolerated dose, not to find a dose that will actually bring about a therapeutic effect. Patients and families may

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not grasp the non-therapeutic intent of these trials and may confuse their participation in early-phase clinical trials with the personalized clinical attention characteristic of medical care, often provided by the same oncologist who solicited enrollment in the toxicity trial. First described by Applebaum and colleagues in 1982 to describe what they observed in psychiatric patients enrolled in research trials, the therapeutic misconception has been observed in phase I research participation by many ethicists and philosophers.14,15,16 More recent research by Applebaum’s group shows that the misconception still remains an issue for many research participants, 20 years later.17 Even without deliberate deception of the research participant and family, the false hope evoked by the therapeutic misconception may make families less able to adequately prepare for a child’s impending death, as they do not have a realistic picture of their child’s prognosis. Michael Miller has called phase I trials “a collusion of misunderstanding,” arguing that these studies can trade on the hopes of desperately ill individuals who see no other reasonable choice.18 Notably, clinicians may also fall prey to the therapeutic misconception when recommending trials to their patients; a study by Kodish and colleagues found that 94% of clinical researchers felt that phase I trials offered some chance of therapeutic benefit to participants.19 On the other hand, phase I trial participation20 may confer some real benefits. While only a small minority of patients will show some tumor response in phase I trials (2–7.9%, depending on the review), some patients and families may prefer that option to the zero percent chance of remission that standard therapy may offer.1,13 Ackerman has argued that phase I chemotherapy may have a benefit, even if it does not result in disease remission, as it may stabilize disease and reduce pain.1 Also, some have suggested that participation in trials, in and of itself, may improve outcomes, presumably because of the motivation and close monitoring that trial participation requires.21,22 Participation in such research may help maintain hope, if not of cure then of some other benefit, although this claim has been challenged by a meta-analysis of clinical cancer trials.23 Trial participation may help some families find meaning or purpose in their child’s suffering, providing a chance to act altruistically for future children with similar conditions.1 Given that

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researchers, patients, and loved ones may measure the risks and benefits of trial participation in very different units (dose at which toxicity appears, or for phase II trials, percent of subjects demonstrating tumor response vs. degree of hope, for example) weighing the pros and cons for any particular child’s participation seems a daunting task. Patients, Parents and Pediatricians’ Involvement in Phase I Research When surveyed, pediatric oncologists generally have a positive attitude toward their patient’s participation in phase I trials, although most also admit that these trials raise troubling ethical difficulties. They identify possible benefits to the child and family as expressing altruism (41%) and maintaining hope (39%).24 But even seasoned physicians seem to express a therapeutic misconception when it comes to this type of research. In a survey of pediatrician members of the United Kingdom Children’s Cancer Study Group and the Pediatric Oncology Group, 59% perceived some potential medical or palliative benefit to the child from participation in a phase I trial. Non-oncologists may have a less optimistic view of early phase research. In a survey of British and Canadian pediatricians and researchers, about half the respondents felt that children should only be enrolled in trials for which there is a possibility of direct benefit.25 Some question whether patients and their families, obviously experiencing an emotionally difficult period in their lives, should even be approached about early-phase research participation. Concerns include the question of whether parents in an emotionally fragile state can adequately understand the risks and benefits of trial participation. Others worry whether the mere mention of phase I trial participation may worsen the parents’ grief, as research involving phase I agents concretely signals that conventional treatments no longer offer any chance of a cure. These concerns may have some merit. Informed consent in all types of research, including pediatric oncology trials, often fails to live up to the ideal.26,27 Professionals’ assumptions that parents lack the emotional fortitude to be included in research do not stand

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up to data. Several studies have shown that the majority of parents in emotionally stressful situations (ICU admission, critical illness, or grieving the loss of a child) have a positive attitude towards research participation.28,29,30 For example, Dyergov’s study of bereaved parents found that the parents described the interview experience as “painful,” but felt “positive” or “very positive” about their research participation.28 Michelson et al.’s study of families with children in the PICU found that the vast majority of parents (92%) felt that researchers should continue to investigate end-of-life decision making.30 To be sure, parents’ feelings that they and/or their children can take part in research in the midst of a stressful situation may reflect the natural tendency to maintain hope, even in the most difficult circumstances. The staff perspective that trial participation confers no benefit does not always match the family’s view that research enrollment offers the last best hope for the patient and family with cancer. Parents may feel they cannot refuse the “one in a million” chance of clinical improvement or the sense that refusal will result in future haunting by questions of “what if?” In this situation, we also need to ask about the ethics of offering these trials to families who may feel that they have no choice but to agree to participate. As Eric Kodish points out, “the raw power of the hope dynamic gives significant momentum to any option with any chance for clinical benefit, especially if it carries the imprimatur of cuttingedge science.”13 While it often seems worthwhile to foster hope whenever possible, when does holding out the potential for benefit actually become a cruel offering of utterly false expectations? Research by Oppenheim and colleagues showed that excessive confidence can exacerbate feelings of anger, criticism and guilt down the road.31 The therapeutic misconception raises especially troubling questions in the context of the dying child, as in the throwing out of the proverbial lifesaver when no reasonable chance of rescue exists. Can Children Express Altruism? When describing research to parents, oncologists may suggest that altruism be a consideration for patients and parents when

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considering research participation. An analysis of pediatric research trial informed consent discussions by Simon et al. showed that altruism arose in 80% of the meetings, most frequently raised by the oncologist, rather than the patient or parents.32 As noted, physicians see the chance to be altruistic as a real benefit of trial participation. Although the chance to demonstrate altruism may benefit some adults facing participation in phase I trials, there is some debate whether children can and should exhibit altruism through such research participation. Observers of children may be struck by the helping and caring behavior even small children sometimes demonstrate. Altruism may be a “hard-wired part” of the human psyche. A study by Warneken and Tomasello showed that children as young as 18 months displayed helping behavior to adult experimentors, even though they received no praise or other benefit for doing so.33 Other studies have confirmed that this “prosocial” behavior in small children can correlate to positive personality characteristics later in life.34,35,36 One must exercise caution, however, in equating the “altruism” seen in everyday behavior or laboratory settings with a decision asked of a child regarding participation in non-beneficial research. The children’s cancer ward differs radically from the childcare center and children with terminal cancer face very different pressures than those faced with choices about sharing a toy. Merle Spriggs has commented that, while we may teach altruism and encourage it in children, “the medical research setting is probably not the most appropriate place to introduce or promote altruism in children.”37 On the other hand, sick children may have unique capacities and opportunities to act in a self-sacrificing manner; they know what it is like to be dying of cancer and may reasonably want to do something to help other children with similar fates. Although children may understand their circumstances, some have a strong drive to conform to adult expectations even if they know their actions may cause themselves harm. That is, some children may decide to please their parents and other caregivers despite unwanted risks. Not all children feel a need to protect or help their parents and the professionals they trust; many adolescents can make research participation decisions discordant from the wishes of their parents.38,39 Professionals may find it difficult to assess whether

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children are making an autonomous, altruistic decision or whether their patients are simply doing what the children think the adults in their lives expect of them. The ethical researcher should try to determine what factors may be influencing a child’s assent to phase I participation and help explain to the child that he or she can make a choice independent of what their parents or doctors may “want” them to do. Of course, altruism, by definition, constitutes supererogatory action and ethically we cannot expect potential research subjects to give generously of themselves, especially in the midst of serious medical crises. We praise “selfless” behavior precisely because one has no moral obligation to take on such risks for the sake of others. We cannot presume that a child or family with cancer wants to behave altruistically by participating in a phase I trial and we must assume that participation involves inappropriate choices for at least some patients and their families. The process of informed consent should ensure that patients and families have the information—and an adequate understanding of it—to make decisions about research participation, including the freedom and support to say “no” even when many families in a similar situation may choose to participate. CONCLUSION Practically, several steps can help minimize the risks to pediatric phase I participants. Preparatory research is essential to the design of an ethical phase I trial for pediatric cancer. If studies in adult subjects can apply, they should proceed as a first step. Preclinical data from xenograft models of several childhood cancers have been developed, including those for rhabdomyosarcoma, acute lymphoblastic leukemia, pediatric brain tumors, neuroblastoma, and osteosarcoma, and these can play an important role in developing studies before they reach phase I clinical trials in pediatrics.1,4Researchers should choose the diseases and therapies they wish to take to phase I pediatric trials carefully. The relatively small numbers of pediatric oncology patients, compared to adult cancer populations, means that only a handful of potential phase I agents can actually undergo phase I testing in children. It makes

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sense to prioritize those agents with the greatest chance of offering benefit or lowest likelihood of toxic effects in the pediatric population. It behooves the research community to ensure that the ethical concerns raised by phase I trials in pediatric patients do not fall by the wayside as such research becomes a “standard” practice in pediatric oncology. We must continue to assess how professionals do and should present these trials to patients and their families and how child subjects and their loved ones respond to trial participation. Careful and regular re-examination of these matters will ensure we meet our ethical obligations to vulnerable patients and family members.

Part II––Disclosing a Terminal Diagnosis to Children with Cancer Parents and professionals often struggle with how, if at all, to talk to children about diagnoses of life-threatening conditions and the possibility of death due to their diseases. Sometimes, parents refuse to disclose a terminal diagnosis and ask for complicity from health care workers with this decision. Care teams wrestle with how to approach these situations and whether to respect parental decision making authority when the parents’ request counters what the professionals consider good psychological care for their patient. The Realities of Non-disclosure in the Pediatric Setting Non-disclosure remains surprisingly common in families with dying children. In a recent, large Swedish survey by Kreicbergs and colleagues of families whose children had died from cancer, 58% of parents did not discuss death with their school age or adolescent children, even though about half sensed that their child had some awareness of his or her imminent death.40 Parents understandably resist discussing a terminal diagnosis with their child. They seek to protect the child from unnecessary sadness and pain and may feel that disclosing the possibility of death will make the child feel hopeless or depressed. Commonly, parents assume that their young children, and even adolescents, cannot

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understand death and the dying process. They may want to shield a child from the diagnosis, expressing a perception that “children should not have to deal with death.”41 Parents themselves may be in a state of denial and fear disclosure which forces them to also confront the possibility of their child’s death. As Lawrence Wolfe eloquently observes, “In telling the child, do we not have to truly hear it ourselves?”42 Although one can sympathize with the parents’ unconscious and articulated fears of disclosing a terminal diagnosis, nondisclosure can make the dying process even more difficult for the child. Research in this area, while not new, remains underrecognized by both parents and physicians. Until the 1970s, professionals generally assumed that school age children could not adequately understand the concept of death. Most agreed that health care professionals need not discuss fatal prognoses with dying children. This paradigm changed when Eugenia Waechter, John Spinetta and other researchers showed that ill children can and do understand their own diseases and their potentially fatal outcomes. In a study comparing school age children (aged 6–10 years) with potentially fatal illness to their healthier peers, Waechter showed that the children with chronic illness showed both a greater understanding and greater anxiety about death.43 The process of illness and hospitalization sometimes leads children into an earlier understanding about death than they would otherwise have. Spinetta and colleagues confirmed that children with leukemia suspected that their illness might be fatal even as early as the first hospital admission, even if no one directly discussed the prognosis in their presence.43 Even though ill children may have awareness and anxiety about death, they often do not express this fear to their parents. Bluebond-Langner described this phenomenon in children with leukemia and dubbed it the “mutual pretence” in which both parties conceal information in an attempt to protect the other.44 Parents try to protect their children by choosing not to disclose bad news and the ill children try to protect their caregivers by feigning ignorance or choosing not to ask questions they suspect or know will upset their elders.

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While mutual pretence may seem a useful coping strategy in the short term by allowing the suppression of difficult emotions, most research shows that truthful discussions provide more help to the dying child. Spinetta’s group found that frank discussions could help reduce children’s anxiety and Slavin and colleagues showed that open communication can improve long term adjustment in children with cancer.43,45 Although these studies show that disclosure usually serves the child’s interests, putting disclosure into practice poses challenges, as demonstrated by the lack of universal implementation of policies based on the implications of the research. As the Swedish survey showed, frank discussions about death remain relatively uncommon in pediatric oncology. In contrast, programs that emphasize a formalized and standard approach to disclosure have extremely high rates of parental cooperation.46 This suggests that the medical staff too often stand ready to comply with parents’ wellintentioned but typically misguided requests for non-disclosure. Health care team members may also feel despair and grief over the impending loss of a patient with whom they have formed strong bonds. This personal distress can leave the professionals unprepared to provide sufficient support for the dying child and his or her family.47 Also, staff may worry that confrontation on this issue may fracture a fragile trust with the family. And, staff members in a busy medical facility feel so pressured by attending to the physical aspects of the child’s care that they have neither the time nor the psychosocial where-with-all to respond adequately to a parent’s request for non-disclosure. The Concept of Parental Autonomy in the Decision to Disclose Inadequate education and dysfunctional psychological defense mechanisms employed by the medical staff can improve with better training and a systematic approach to disclosure, which will be addressed later in this section. More difficult to change, however, is the parent or health care worker who appeals to the concept of “parental autonomy” to halt further negotiations regarding disclosure.

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Parental autonomy refers to parents’ usual rights to make decisions that affect their children. The concept has been used to justify parental refusals of newborn screening, resuscitation of extremely premature newborns and prenatal sex selection.48,49,50 With the paradigm shift in medical ethics from paternalism to autonomycentered medical care over the last 50 years, the notion has appeared more and more frequently. Professionals aim to respect parental decision-making authority in all but the most extreme cases. Parental authority can be abrogated, but only when parents’ decisions seem very out of keeping with decisions that a “reasonable person” would make and then only in the most serious or life-threatening situations. The minor child of Jehovah’s Witnesses who needs a simple blood transfusion to ensure recovery from an accident provides a classic example; we feel justified in seeking state authorization to provide the transfusion because the state’s interest in relatively simple and low risk preservation of the child’s life, and the child’s later opportunity to endorse or reject any particular faith, outweigh the parent’s rights to act on the basis of their religious beliefs.40,51,52 If we wholeheartedly accept the concept of parental autonomy, it may seem reasonable to respect a parent’s request for non-disclosure of a terminal illness. Since a decision about disclosure will likely have no life-threatening implications, ceding to the request appears to respect the parents’ right to make all decisions for their children. However, the “parental autonomy” construct relies on rights-based arguments in a situation that more appropriately requires obligation-based reasoning. Society has an obligation to protect the interests of our children, who lack adequate decisionmaking capacity. On the other hand, adults have rights to make personal choices, including those that may be either wise or foolish. Since parents, in general and on balance, act in their child’s best interests, and thus fulfill their obligations to their children, society presumes that they should have decision-making authority over the children. In disputes about what to do for a child, when no clear best solution emerges and reasonable persons may reasonably disagree, then parents justifiably have final decisional authority. Resting authority with the parents because it usually serves the child’s interests does not mean that professionals should honor

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every request from parents in order to maintain respect for the family. We do not, for example, accept parental autonomy as a reason to deny a child education or adequate nutrition. Three decades of evidence now points to the benefits of disclosure of a terminal diagnosis or prognosis to children with fatal conditions, leaving little room for parental autonomy in this situation. Just as the medical profession has rejected “therapeutic privilege” to justify a physician withholding information from an adult patient who can understand it, so too should we reject “parental autonomy” to justify a parent withholding information from a child who can process that information. While the modern shift from paternalism to autonomy recognized that professionals do not always know what is “best” for patients, the emphasis on parental autonomy fails to account for situations when well-intentioned parents seeking to protect their child may not appreciate how the child may benefit from admittedly painful truth. Rejecting absolute parental authority over disclosures of fatal prognoses does not mean that professionals will take away all the “big” decisions from parents and placate them with control only over inconsequential minutiae. Parents should still make meaningful choices for their dying children with respect to such matters as who will make the terminal disclosure (parents or members of the medical team or both together), whether to frame the concept of death in religious terms, and how the child and family should spend their child’s final days (for example whether death should occur at home or in the hospital). These choices have great significance for many families. As a pediatric oncology colleague put it, “I tell all the parents that discussing the diagnosis is mandatory. What the parents can decide is how we will do it.” Practicalities of Disclosure Even if the parents and health care team agree to disclose a difficult diagnosis, many challenges remain. Several barriers to disclosure exist:

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1. Different timelines for accepting a terminal diagnosis. Parents and physicians often realize that a child has entered the terminal phase of a disease at different points. A study by Wolfe et al. found as much as a 3-month delay between the time physicians recognized that there was no realistic chance for a cure and when the parents understood the prognosis.53 If the parents and physicians cannot agree that a child has entered the terminal phase of an illness, it will be difficult to plan for disclosure of that diagnosis. 2. Caregivers’ inadequate education and experience. Even subspecialty pediatricians who care for the bulk of dying children generally have inadequate training for delivering bad news and discussing death.54 In a survey from the Society of Clinical Oncology, only 2.2% of pediatric oncologists reported a rotation in palliative or hospice care as part of their training and most stated that their skills with terminal illness in children came primarily from “trial and error.”55 3. Insufficient guidelines. Although published guidelines stress the importance of open, honest communication with dying children, they often offer only vague suggestions and lack concrete, practical help with disclosure and post-disclosure support.56,57 Some groups have developed strategies that appear to work. At the Children’s Hospital of Oklahoma, Nitschke and colleagues have found that the Final Stage Conference (FSC) helps many children and families in the terminal stage of illness. The FSC uses a multidisciplinary, open communication approach that gives children “the opportunity to express their concerns and to formulate their wishes on how to spend the remainder of their lives.”46 The approach stresses the importance of focusing the terminal phase of life on accepting a new reality and the setting of new goals, allowing personal growth and fulfillment for the child and family. Another approach, outlined by Beale et al. is called the “6 E’s” strategy.47 It sets out goals to:

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1. Establish an agreement for open communication early in the disease 2. Engage the child in discussions at an opportune time 3. Explore what the child already knows 4. Explain medical information in an age-appropriate manner 5. Empathize with the child’s emotional reactions 6. Encourage the child with reassurance and support. These approaches and others emphasize early, honest, and interactive communication. Early communication helps to ensure that the transition to palliation is not abrupt. Throughout the disease, symptom relief and psychosocial support need to go hand-in-hand with curative therapy. Although everyone focuses on the hope for cure shortly after disease diagnosis, Goldman has shown that questions about death and dying can be addressed even at the early stages of disease.58 Such an approach allows palliative care teams to establish solid relationships with families who will need help with end-of-life care months or years down the line. Parents and health care providers need to remember that children often express fears about death and dying in indirect ways. Separation anxiety, generalized anxiety disorders and expressing a fear that something will happen to parents or caregivers can all signal the desire of children to discuss, or otherwise communicate, their feelings about death and dying.47 Children may more willingly express their feelings indirectly, using stuffed animals, puppets, or other play or art techniques.59 The pediatric care giver needs to stay attuned to these subtle clues, and stand ready to initiate unconventional communication. Besides helping the child achieve a “good death,” a systematic and committed approach to disclosure from the health care team can also reduce parental anxiety and refusals to disclose. In Nitschke et al.’s experience, only 5 out of 78 families refused to have their child participate in the FSC, and most participating parents and children reacted positively to the approach.46 Reluctant parents can feel reassured by knowing that other parents, in similar situations, have generally found disclosure positive for themselves and their children. In Kreicbergs et al.’s

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study from Sweden, almost one quarter of parents who did not discuss death with their children later regretted their decision, but none of the parents who discussed death expressed regret.40 Parents with concerns may benefit from meeting with other parents who have faced similar situations and can supportively share their experiences. Exceptions to Disclosure While disclosure generally proves the right thing to do, it may not be the right choice for every child. We know that some adult cancer patients decide that they want very limited information about their disease and prognosis.60 Similarly, adolescents with sufficient capacity to understand the consequences of their decisions may have the right not to know the details of their situation. Requests for limited information, however, should only come from or involve the child directly and not arise solely from parents based on their presumptions about their adolescent. Professionals must provide room for flexibility in exceptional cases. In some children with serious, previouslyrecognized psychiatric co-morbidities, for example, disclosure could worsen depression or anxiety.46 Health care workers must realize that most of the time family members—principally parents—really do know their child better than the staff and their impressions of the child’s ability to process difficult information deserve careful consideration. As with any guideline, one size does not fit all situations; disclosure needs to match the child’s age, developmental stage, and psychological make-up. CONCLUSION Disclosure of a terminal diagnosis to a child presents a very challenging task for parents or practitioners. When professionals and parents disagree on the appropriateness of presenting the truth to a child, one should not assume that an appeal to a single ethical principle can, in all cases, adequately resolve the strongly-felt opposing views. “Honesty is the best policy” or “father knows best” may be convenient aphorisms, yet do little to help parents and health

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care workers deal with painful realities in a caring and compassionate manner. Openness seems best for most situations, but it requires commitment and training for both families and providers. As we learn more about how children think and react, we can better tailor these strategies to help dying children and their caregivers cope with difficult diagnostic and prognostic information. REFERENCES 1. Ackerman TF. Phase I pediatric oncology trials. J Pediatr Oncol Nurs 12:143–145, 1995. 2. Ramsey P. The enforcement of morals: nontherapeutic research on children. Hastings Cent Rep 6:21–30, 1976. 3. McCormick RA. Proxy consent in the experimentation situation. Perspect Biol Med 18:2–20, 1974. 4. Smith M, Bernstein M, Bleyer WA et al. Conduct of phase I trials in children with cancer. J Clin Oncol 16:966–978, 1998. 5. Yiu V, Orrbine E, Rosychuk RJ et al. The safety and use of shortacting nifedipine in hospitalized hypertensive children. Pediatr Nephrol 19:644–650, 2004. 6. Pratt CB. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 19:304–309, 1991. 7. Janofsky J, Starfield B. Assessment of risk in research on children. J Pediatr 98:842–846, 1981. 8. Shirkey H. Therapeutic orphans. J Pediatr 72:119–120, 1968. 9. Krugman S, Friedman H, Lattimer C. Hepatitis A and B: serologic survey of various population groups. Am J Med Sci 275:249–255, 1978. 10. West D. Radiation experiments on children at the Fernald and Wrentham schools: lessons for protocols in human subject research. Account Res 6:103–125, 1998. 11. Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001). 2000. 12. Oberman M, Frader J. Dying children and medical research: access to clinical trials as benefit and burden. Am J Law Med 29:301–317, 2003. 13. Kodish E. Pediatric ethics and early-phase childhood cancer research: conflicted goals and the prospect of benefit. Account Res 10:17–25, 2003. 14. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5: 319–329, 1982.

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15. Glannon W. Phase I oncology trials: why the therapeutic misconception will not go away. J Med Ethics 32:252–255, 2006. 16. Miller FG. Ethical significance of ethics-related empirical research. J Natl Cancer Inst 94:1821–1822, 2002. 17. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB 26:1–8, 2004. 18. Miller M. Phase I cancer trials. A collusion of misunderstanding. Hastings Cent Rep 30:34–43, 2000. 19. Kodish E, Stocking C, Ratain MJ et al. Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol 10:1810–1816, 1992. 20. Kodish E. Phase I cancer trials: therapeutic research? Hastings Cent Rep 31:4–5, 2001. 21. Schmidt B, Gillie P, Caco C et al. Do sick newborn infants benefit from participation in a randomized clinical trial? J Pediatr 134:151– 155, 1999. 22. Wagner HP, ngeldein-Bettler I, Berchthold W et al. Childhood NHL in Switzerland: incidence and survival of 120 study and 42 non-study patients. Med Pediatr Oncol 24:281–286, 1995. 23. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 363:263–270, 2004. 24. Estlin EJ, Cotterill S, Pratt CB et al. Phase I trials in pediatric oncology: perceptions of pediatricians from the United Kingdom Children’s Cancer Study Group and the Pediatric Oncology Group. J Clin Oncol 18:1900–1905, 2000. 25. Sammons HM, Malhotra J, Choonara I et al. British and Canadian views on the ethics of paediatric clinical trials. Eur J Clin Pharmacol 63:431–436, 2007. 26. Eder ML, Yamokoski AD, Wittmann PW, Kodish ED. Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 119:e849–e859, 2007. 27. Kodish ED, Pentz RD, Noll RB et al.. Informed consent in the Childrens Cancer Group: results of preliminary research. Cancer 82:2467–2481, 1998. 28. Dyregrov K. Bereaved parents’ experience of research participation. Soc Sci Med 58:391–400, 2004. 29. Kreicbergs U, Valdimarsdottir U, Onelov E et al. Anxiety and depression in parents 4–9 years after the loss of a child owing to a malignancy: a population-based follow-up. Psychol Med 34: 1431–1441, 2004.

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30. Michelson KN, Koogler TK, Skipton K et al. Parents’ reactions to participating in interviews about end-of-life decision making. J Palliat Med 9:1329–1338, 2006. 31. Oppenheim D, Geoerger B, Hartmann O. Ethical issues in pediatric oncology phase I-II trials based on a mother’s point of view. Bull Cancer 92:E57–E60, 2005. 32. Simon C, Eder M, Kodish E, Siminoff L. Altruistic discourse in the informed consent process for childhood cancer clinical trials. Am J Bioeth 6:40–47, 2006. 33. Warneken F, Tomasello M. Altruistic helping in human infants and young chimpanzees. Science 311:1301–1303, 2006. 34. Eisenberg N, Guthrie IK, Cumberland A et al. Prosocial development in early adulthood: a longitudinal study. J Pers Soc Psychol 82:993– 1006, 2002. 35. Hay DF, Castle J, Davies L et al. Prosocial action in very early childhood. J Child Psychol Psychiatry 40:905–916, 1999. 36. Hoffman ML. Personality and social development. Ann Rev Psychol 28:295–321, 1977. 37. Spriggs M. Can children be altruistic research subjects? Am J Bioeth 6:49–50, 2006. 38. Brody JL, Annett RD, Scherer DG et al. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health 37:229–235, 2005. 39. Brody JL, Scherer DG, Annett RD et al. Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk. Pediatrics 118:e356–e362, 2006. 40. Kreicbergs U, Valdimarsdottir U, Onelov E et al. Talking about death with children who have severe malignant disease. N Engl J Med 351:1175–1186, 2004. 41. Hilden JM, Watterson J, Chrastek J. Tell the children. J Clin Oncol 18:3193–3195, 2000. 42. Wolfe L. Should parents speak with a dying child about impending death? N Engl J Med 351:1251–1253, 2004. 43. Spinetta JJ, Rigler D, Karon M. Anxiety in the dying child. Pediatrics 52:841–845, 1973. 44. Bluebond-Langner M. Mutual pretense: causes and consequences. The Private Worlds of Dying Children. 210–230. 1978. Princeton, NJ, Princeton University Press.

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45. Slavin LA, O’Malley JE, Koocher GP, Foster DJ. Communication of the cancer diagnosis to pediatric patients: impact on long-term adjustment. Am J Psychiatry 139:179–183, 1982 46. Nitschke R, Meyer WH, Sexauer CL et al. Care of terminally ill children with cancer. Med Pediatr Oncol 34:268–270, 2000 47. Beale EA, Baile WF, Aaron J. Silence is not golden: communicating with children dying from cancer. J Clin Oncol 23:3629–3631, 2005 48. Annas GJ. Extremely preterm birth and parental authority to refuse treatment––the case of Sidney Miller. N Engl J Med 351:2118–2123, 2004 49. Newson A. Should parental refusals of newborn screening be respected? Camb Q Healthc Ethics 15:135–146, 2006 50. Scully JL, Banks S, Shakespeare TW. Chance, choice and control: lay debate on prenatal social sex selection. Soc Sci Med 63:21–31, 2006 51. In re Guardianship of L.S. and H.S. (87), 521–527. 2004. Wests Pac Report. 52. Penson RT, Amrein PC. Faith and freedom: leukemia in Jehovah Witness minors. Onkologie 27:126–128, 2004 53. Wolfe J, Klar N, Grier HE et al. Understanding of prognosis among parents of children who died of cancer: impact on treatment goals and integration of palliative care. JAMA 284:2469–2475, 2000 54. Papadatou D. Training health professionals in caring for dying children and grieving families. Death Stud 21:575–600, 1997 55. Hilden JM, Emanuel EJ, Fairclough DL et al. Attitudes and practices among pediatric oncologists regarding end-of-life care: results of the 1998 American Society of Clinical Oncology survey. J Clin Oncol 19:205–212, 2001 56. Masera G, Spinetta JJ, Jankovic M et al. Guidelines for assistance to terminally ill children with cancer: a report of the SIOP Working Committee on psychosocial issues in pediatric oncology. Med Pediatr Oncol 32:44–48, 1999 57. Nitschke R, Meyer WH, Huszti HC. When the tumor is not the target, tell the children. J Clin Oncol 21:40, 2003 58. Goldman A, Heller KS. Integrating palliative and curative approaches in the care of children with life-threatening illnesses. J Palliat Med 3:353–359, 2000 59. Faulkner KW. Talking about death with a dying child. Am J Nurs 97:64, 66, 68–69, 1997 60. Leydon GM, Boulton M, Moynihan C et al. Cancer patients’ information needs and information seeking behaviour: in depth interview study. BMJ 320:909–913, 2000

12

COMMUNICATING ERRORS Christian J. Vercler and Peter Angelos

INTRODUCTION Despite a relatively straightforward ethical obligation to disclose harm-causing errors to patients, Thomas Gallagher and others have provided evidence that many physicians and surgeons believe and do otherwise.1,2,3,4 Nondisclosure of medical error undermines the public’s trust in the profession and undermines efforts to improve patient safety.5 This chapter will examine issues around the definition of error, the rationale supporting a policy of full disclosure, and how to overcome barriers to error disclosure. We focus on errors in surgery where errors are more closely tied to an individual surgeon, but the same issues apply in non-surgical fields where physicians must disclose errors. Defining Error In the preface to the second edition of the classic text Forgive and Remember: Managing Medical Failure, Charles Bosk notes that “what constitutes an error is, at many levels, ‘an essentially contested concept.’ Was this failure the result of error? If so, was the error foreseeable and preventable? And, if so, did the error make a difference in the outcome?”6 The contested nature of what qualifies as an error contributes to the difficulty in reporting adverse events to individuals outside of the Morbidity and Mortality conference, specifically to patients and their families as well as patient safety organizations. Every surgery department is required to have regular Morbidity and Mortality conferences where deaths and complications are openly discussed in an effort to identify errors or choices that perhaps should have been made differently. Bosk

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examined the communication of errors in a surgery department’s Morbidity and Mortality conference and showed how the handling of errors as a means of social control led to the moral development of residents. He categorized errors into four groups: errors in technique, errors in judgment, normative errors, and quasi-normative errors.7 These categories apply to the way attending physicians view housestaff failures and have not been used in the recent literature on medical error. An appendix to the book Medical Error: What Do We Know? What Do We Do?8 lists 34 definitions of medical error from a survey of the literature. Two of the more salient definitions are the ones used by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Institute of Medicine (IOM). JCAHO defines error as “an unintended act, either of omission or commission, or an act that does not achieve its intended outcome.”9 The IOM defines error as “the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).”10 What these definitions stress is the intention. John Banja points out the inadequacy of these definitions when applied to surgery: certainly removing the outer layer of a portion of bowel while dissecting through an abdomen with dense adhesions (a “concrete abdomen”) is an unintended and foreseeable possible complication. However, does it really count as an error when such an event may occur to even the finest surgeon in the country?11 Sometimes an operation may not achieve its intended goal, it may even harm the patient, but that does not necessarily mean than an error has occurred. For example, the goal of a pancreatic resection for pancreatic cancer may be to remove all cancer and cure the patient, yet the disease may have progressed to the point where a curative resection is not possible. Thus, even though the goal of operative cure is not met, no error may have occurred. A recent survey of members of an operating room team found that the most common definition of error was a deviation from standards of practice.12 Participants in this study also relied on negative outcomes to define error in situations where no clear deviation from the standard practice occurred (e.g. if dropping a specimen led to confusion about which margin was positive). Errors

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and negative outcomes are clearly distinct entities, but how they interact seems to affect how individuals and institutions respond. Harm-causing medical errors are the most dreaded and also the most difficult to disclose to the patient.1,2,4,3 While it is straightforward enough that harm-causing errors require discussion with the patient and the institution, there may be reasons to disclose “harmless” errors as well.13 We will address those reasons later in the chapter. Surgeons usually begin with the adverse event and then identify and classify the error. Thomas Krizek used trained observers to prospectively gather information about adverse events in a burn unit, a surgical ICU, and a surgical floor.14 He categorically excluded from analysis all errors that did not negatively affect the patient. He identified five types of errors: judgmental errors, technical errors, expectation errors, systems errors, and mechanical errors. Errors in judgment and in technique are the two most familiar to surgeons. These are the errors we discuss at surgical morbidity and mortality conference and are usually associated with lack of experience. Interestingly, these two categories accounted for less than 30% of the errors recorded in Krizek’s study. Expectation errors result from an inappropriate delegation of responsibility. This refers not only to expecting the intern on call to be able to handle certain problems alone, but also to expecting “floating” nurses to be familiar with certain protocols regarding dressings or drains on surgical floors. Krizek’s study failed to identify an individual responsible for an adverse outcome in over 60% of cases. Review of these cases identified an error within the systems in place in the hospital. Finally, mechanical errors were the most infrequent in this study. The distinguished Italian surgeon Alfred Cushieri has suggested a classification in analyzing the causes of errors in a surgical setting.15 He classifies proximal errors as those “imposed by the system operated by the organization and the process used by practitioners” and distal errors as those “enacted by surgeons working within the system.” The error itself is defined as a deviation from standard performance regardless of consequence. Hence, the “near-miss” or “harmless hit” is included in his analysis whereas they were excluded in the study by Krizek. Drawing on the work of James Reason16,17 Cushieri attributes errors to chance and “latent

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defects within the system in which the individual operates.”15 These definitions are essential to Cushieri’s larger project of decreasing medical error by focusing on systems-level changes of organizational control. This leads to a significant change in the role of the surgeon in error disclosure that we will examine more closely later in the chapter. Albert Wu and colleagues define a medical mistake as: a commission or an omission with potentially negative consequences for the patient that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences. This definition excludes the natural history of the disease that does not respond to treatment and the foreseeable complications of a correctly performed procedure, as well as cases in which there is reasonable disagreement over whether a mistake occurred.18 This seems to be the best working definition so far. The strengths of Wu’s definition of error are that it includes a concept of the standard of care, that it includes events that are potentially harmful, and that it provides a space for the sometimes inherently ambiguous situations encountered in clinical medicine. Full Disclosure “Full disclosure is the right thing to do. It is not an option; it is an ethical imperative.”19 Lucian Leape, professor of health policy at Harvard and a former pediatric surgeon, has been a champion of full disclosure after harm-causing error. This entails “timely, open, complete information on the causes and circumstances that led to their injury, delivered in a compassionate manner by the responsible caregiver.” Leape presents both a theoretical and practical justification for this position. His theoretical argument consists of both ethical and therapeutic reasons. Ethically, patients have a right to know what happened to them. Furthermore, there is no ethical justification for withholding information from a patient regarding a

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harm-causing error. Leape also argues that full disclosure is required to maintain the trust that is the foundation of the patient–physician relationship. For full emotional healing to occur after a patient has suffered harm as a result of a medical error, the patient needs someone to take responsibility for the error and to apologize. The practical argument for full disclosure is initially counterintuitive. There is evidence to suggest that a policy of full disclosure actually results in fewer malpractice suits and costs hospitals and physicians less money. This goes against conventional wisdom as well as what many malpractice insurers have told physicians: never admit liability. The prospect of a lawsuit is chilling and prompts us to choose our words carefully.1 But there is evidence to suggest that it is not a harm-causing error that prompts a lawsuit per se, but the way in which the situation is handled. Patients who sue are often angry, want revenge, or are suspicious of a coverup and want more information.20,21,22,23 Forthright disclosure and apology may mitigate against patient anger and desire for revenge. In this sense, ironically, physician self-interest may motivate full disclosure and apology. While one of the hallmarks of the medical profession has been to put the interests of the patient ahead of one’s own self-interest, clearly ethically appropriate behavior is reinforced when it provides additional benefits to the physician. Philosophical Analysis Philosophers have developed three approaches to ethics: deontological, teleological, and aretological. Traditionally these approaches have examined, in turn, duties, consequences, and virtues. Proponents of these approaches often stress the superiority of one approach over the other. For example, the deontologist Immanuel Kant felt that it is one’s duty to tell the truth in every situation regardless of the consequences. Jeremy Bentham and John Stuart Mill felt that ethically appropriate behavior could only be determined by calculating the consequences of one’s action. Aristotle, on the other hand, was concerned about the type of person one was to become, and what virtues were necessary to cultivate in order to bring that about. Regarding harm-causing medical errors, we will see that full disclosure and apology is supported by all three

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ethical analyses. Albert Wu and colleagues use teleological and deontological argument to ground a policy of disclosure.18 We turn to those now. Trust is essential to the relationship between a patient and a physician. In order to maintain this trust, the physician has certain duties to her patient. The most prominent and well known are respect for patient autonomy, beneficence, nonmaleficence, and justice.24 Respecting the autonomy of the patient is based on regarding her as an equal member of the moral community. It flows from the respect of each person’s inherent dignity. As such, it requires truthfulness. Apart from the Ten Commandments, Immanuel Kant represents the most classic formulation of the duty of truthfulness,25 which is also supported in the AMA Code of Medical Ethics: It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. …Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.26 Withholding information about errors from patients affects their ability to exercise their autonomous decision-making capacity because they would be making decisions based on less than the whole truth. The duty “to do good and not to do harm”27 has its origins in the Hippocratic corpus and has its contemporary formulation as the sister duties of beneficence and non-maleficence.

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Ostensibly this duty has already been breached in the event of a harm-causing error. The duty to ameliorate the harm and to avoid further harming the patient is a strong injunction for full disclosure and apology. Justice concerns giving people what is their due. Patients who are seriously injured may require further medical interventions, may lose wages due to a loss of function, and could have significant pain and suffering. It would be unfair to try to deprive someone of due compensation by not disclosing or partially disclosing a harm causing error. In summary, a deontological or duty-based approach provides a strong argument for full disclosure of medical error.28 This duty is based on the fiduciary nature of the patient–physician relationship. These duties apply to the physician regardless of consequences. Disregarding consequences seems unintelligible in the current context of outcome-based and evidence-based medicine. A teleological or consequentialist approach attempts to maximize the benefits and minimize the harms overall in any situation by weighing potential outcomes against each other to determine the appropriate course of action. Albert Wu and colleagues point out that when weighing the potential consequences of full disclosure, the potential benefits and harms to the patient must be given more significance than the potential benefits and harms to the physician. The nature of the patient–physician relationship mandates this.18 This is an important point to note, because the potential negative outcomes to the physician include loss of referrals, hospital privileges, credentials, or licensure, malpractice suits and increased malpractice premiums, and significant psychological stress. An intern or resident who fully discloses a medical error potentially faces poor evaluations and letters of recommendation, failure to progress, or dismissal from a program. There is an understandably strong incentive to avoid fully disclosing one’s error. However, there are some important potential benefits to the physician. The significant psychological and emotional stress that the physician feels after committing a harm-causing error can sometimes only be relieved by admitting guilt and receiving forgiveness from the patient and his or her family.29,30 Candid error disclosure may strengthen the patient–physician relationship by

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showing the physician’s honesty. A strong relationship with the patient may decrease the chances of a malpractice suit.31 Furthermore, if a suit is filed, failing to disclose information about a harm-causing error may place the physician in even greater jeopardy.32 Finally, physicians learn from one another’s frank discussions of error and may be able to avoid similar errors in the future. Some would argue that full disclosure may potentially further harm the patient. While there are some instances when this may be true, one must be wary that the over-exaggeration of these potential harms are not a rationalization of nondisclosure. What John Banja calls “medical narcissism” is a powerful psychological force at work in the physician who has committed a harm-causing error, making it extremely difficult to fully disclose an error.33 Patients could experience increased anxiety and despondency and lose faith in the medical system that may lead them to possibly reject further beneficial treatments. Some patients do not want detailed information about their medical care. Full disclosure of trivial or non-harm causing errors (near-misses) could add an unnecessary burden to this type of patient.18 One should not place too much emphasis on withholding information from a patient “for her own good” as the potential benefits of full disclosure are many. Full disclosure allows patients to be free from a mistaken understanding of their medical situation. Understanding why further procedures or treatments may be necessary is essential for informed consent. Maintaining an open and honest relationship with the patient is important to facilitate trust in the medical system. Acknowledging the fallibility of individuals and the system helps to decrease unrealistic expectations and hopefully avoid misunderstandings. Furthermore, full disclosure allows the patient to seek compensation, if warranted, through means other than a malpractice suit.18 As becomes clear in using a consequentialist approach, when a physician weighs the risks and benefits of full disclosure the perception of potential harm to self often leads him or her to engage in subterfuge at some level. One could construe the outcomes such that the benefits to the patient always outweigh the possible harms, but this often depends on who the person is doing the weighing. The

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approach of focusing on the person, rather than on the act or the outcome, is called virtue ethics. Aristotle’s philosophy represents the classic account of virtue ethics. Alasdair MacIntyre has revived interest in the virtues and Edmund Pellegrino has adapted virtue theory to medical practice. A person who lacks the virtue of honesty or transparency may not recognize her duty to disclose an error, or may always downplay the benefits to the patient to justify withholding information. Not much attention has been given to the virtues in arguments for full disclosure. John Banja has given significant attention to a psychological account of why he feels physicians do not disclose medical error. The remedy to these psychological barriers that prevent physicians from admitting and disclosing their mistakes is something like developing the virtue of transparency.34 A physician who is in the habit of always having open and honest communication with her patients is one who also respects the inherent dignity and worth of that person and is most likely to consistently follow a policy of full disclosure. Barriers to Disclosure Physicians frequently have a hard time disclosing error.2,1,4,35,36 Impediments to full disclosure include the fear of being sued,2 uncertainty surrounding the nature of error,6 poor communication skills, and certain aspects of the culture of medicine.33,2 The fear of a malpractice suit accompanies any adverse outcome. The strong sense of self-preservation causes one to question the prudence of full disclosure. Is not full disclosure above and beyond the call of duty? Is not transparency a supererogatory ideal, a goal for saints and heroes to strive for, but much too costly a moral requirement for the average person? The answer is “no” for two reasons. The first is that, as Beauchamp and Childress point out, the line between ordinary and supererogatory requirements for physicians is not that clear-cut and for the most part, the nature of the patient–physician relationship does hold the physician to a generally higher moral ideal.37 So, just as the fireman considers it part of his job to run into a burning building to save someone, so the physician needs to consider it part of his or her job to fully inform patients when an

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error has occurred—it comes with the trust society has bestowed upon the profession. The second is that risk of litigation is significantly related to the quality of the relationship between the patient and the physician. Poorly communicating with a patient after an adverse event is a significant risk factor for being sued.20,23,18,4 Furthermore, there is evidence to suggest that institutions that have policies of fully disclosing harm-causing errors, apologizing, and offering compensation for injuries decrease their malpractice suits and overall costs.38 Interestingly, Denver-based COPIC malpractice insurance company has successfully employed this strategy since 2000. A further benefit to the COPIC plan is that the compensation payments that it makes to injured patients are not considered settlements, and hence are not reported to the National Practitioner Data Bank.39 Doing the right thing for the patient after a harmcausing error may not involve as much self-sacrifice as is commonly thought. The relationship between an adverse event and an error is not always straightforward. The causes of certain clinical outcomes can be ambiguous, hence the need for prospective randomized controlled double-blinded clinical trials. There is no control group in everyday clinical medicine, so there is always a possibility for uncertainty regarding the efficient cause of any outcome. These uncertainties have been cited as a major factor impeding full disclosure.35 Furthermore, the distinction between individual and systems error can be contentious. In Thomas Krizek’s prospective study on medical error, he identified an individual responsible for an error less than 40% of the time.14 This means that in some sense a system failure occurred in about 60% of errors. However, surgeons tend to be wary of “systems-based” approaches to error.40 The culture of personal responsibility reinforced by the weekly Morbidity and Mortality conference in surgery departments does not have much use for blaming the system. Adverse events are discussed to uncover the errors made by the individuals involved so that others may learn to avoid those mistakes in the future. Unlike many studies in medical error, at Morbidity and Mortality conferences, an individual is found responsible for an adverse outcome nearly 100% of the time. This way of training began with William S. Halsted and is an invaluable method in teaching residents humility and responsibility.41 While

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there is an heuristic value in surgeons claiming responsibility for error in the Morbidity and Mortality (M & M) conference, there is a distinct difference between, “I should have used sharp dissection instead of Bovie electrocautery to avoid increasing the risk of wound infection” and “Mr. Jones, I made a mistake and used electrocautery in dissecting through your abdomen and caused your wound infection. I’m sorry, it was my fault.” The former statement might not be uncommon at M & M, but the latter is quite rare. Because there is a recognized disconnect between admitting responsibility in M & M and admitting responsibility to the patient for her adverse outcome, this can act as a barrier to full disclosure. JCAHO has identified communication breakdown as the number one cause of sentinel events,42 yet very little time is spent training medical students and residents to be effective communicators. Griffen, in his report on the American College of Surgeons Closed Claims Study, cited failed communication as the underlying factor in the majority of malpractice cases against surgeons.43 This study identified communication failure as the major cause of the adverse outcomes in these suits. This includes several cases where no error was made but communication breakdown between the patient and physician led to a suit. These data suggest that improving communication skills would not only decrease malpractice suits, but also the adverse events behind them. This lacuna in our abilities is another obstacle for full disclosure. Not knowing what to say or how to best say it can lead to an avoidance of the difficult conversation altogether. The American College of Surgeons has recognized the need to educate surgeons in communication skills and offers a course entitled “Surgeons as Effective Communicators: Sharpening Skills for Critical Moments.” One of the more poignant critiques is that there are aspects of the culture of medicine that impede full disclosure. Thomas Gallagher and colleagues drew this conclusion from their study of U.S. and Canadian physicians’ attitudes towards error disclosure.2 They found remarkable similarities in the reluctance to disclose error despite a significantly less threatening legal environment in Canada. They suggest that the similar medical education systems in the U.S. and Canada may account for this hesitancy to disclose. John Banja has imaginatively performed a psychological analysis of this

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situation and has identified a condition he calls “medical narcissism,” which is characterized by lack of empathy, ideological rigidity, and compulsiveness. 33 His basic idea is that many physicians have an idealistic, perfectionist projection of themselves and that acknowledging and disclosing an error is so psychologically damaging to the physician’s sense of self that he or she will go to great lengths to rationalize and obfuscate the facts of the error. To some extent it is a preexisting narcissism that drives individuals to become physicians, but primarily the medical education process is viewed as supporting and encouraging narcissistic ways of thinking. Residency provides an environment where residents develop fantasies of omniscience and omnipotence and learn to buy into deification projections. In the maelstrom of emotions that accompanies residency, the resident develops emotional detachment as a survival strategy, hence becoming less empathetic and more self-centered. It is the loss of empathy coupled with the view of oneself as perfect that presents a major barrier to fully disclosing medical error. Whether or not Banja is entirely accurate in his diagnosis of the problem, he does provide some helpful insights into the psychology of rationalization and tips on ways to empathetically disclose error. How to Disclose In his chapter “The Empathic Disclosure of Medical Error”44 John Banja provides concrete advice on disclosing error. The first thing to do when an adverse event has occurred is to agree on what happened. We have already discussed the difficulties surrounding this aspect of the process, but at the very least risk management should be contacted, which should trigger an investigation into what occurred. The second consideration is who should be present during the error disclosure. Alfred Cushieri has proposed excluding the physician from the discussion and having an error disclosure team that is fully trained in empathic nondefensive disclosure techniques conduct the discussion.15 As previously mentioned, this is part of his strategy to deal with the previously cited fact that a majority of errors are directly related to the system rather than the individual physician. As Charles Bosk has well documented, this is contrary to the prevailing idea of personal responsibility in surgery.6 Generally

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speaking, it is the attending surgeon who should be the one disclosing the error. Having housestaff present is important so that they see proper error disclosure modeled. The patient’s immediate family or surrogate decision maker should also be present. The presence of legal counsel, either the hospital’s or the patient’s, can cast an adversarial tone to the conversation and is not recommended for the initial disclosure. However, if a patient or family requests that their lawyer be present this can present an opportunity to address all concerns up front.5 The Veterans Affairs hospital in Lexington, Kentucky actually advises patients who have been harmed by medical error to obtain legal counsel as part of their full disclosure and compensation policy.38 A third consideration is the setting of the disclosure. It should take place in a quiet, private room. Beepers, cell phones, and other ambient noises that could interrupt or distract the conversation should be eliminated. The physician should deliver the news seated at the same level or lower than the patient, and should avoid having anything, such as a desk or table, between herself and the patient. Standing up or sitting behind a desk or table while disclosing error can reinforce the power differential present, which is less empathic. The most empathic position is seated, leaning slightly forward, knees apart, with the forearms resting on the legs, and the shoulders slightly slouched or slumped.45 Banja also suggests that physicians should anticipate being sued even before they disclose the error. Even though, as we have discussed, lawsuits often do not occur when an error is truthfully and empathically disclosed, assuming that one will be sued allows one to focus on the empathic disclosure of the harmcausing error rather than thinking defensively. Some specific techniques for initiating a bad news conversation is for the communicator to: • • • • •

Rehearse his or her disclosure of the information Deliver it as simply, truthfully, and economically as possible Stop talking Assess how the news is being received Respond empathically46

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Content of Error Disclosure An empathic disclosure of a harm-causing error should include the following47: • • • • • • • • • • •

A description of the nature of the error and the harm it caused When and where the error occurred Consequences of the harm An apology Actions taken to diminish the gravity of the harm Actions taken to prevent future occurrences of the error Who will manage the patient’s continuing care Identification of systemic elements that contributed to the error Who will manage ongoing communications Assurance that associated costs of the error will be removed from the patient’s bill Offer of counseling and support

One should be careful of the obfuscation that can occur by using “medicalese” or by avoiding using the words “error” or “mistake.” Phrases like “misadventure” or “untoward event” and excessive technical language work against the purpose of the disclosure, which is the patient understanding what has occurred in the course of her care. Unfortunately, the work of Gallagher and colleagues has shown that many physicians do not specifically use the words “error” or “mistake” when disclosing a harmful medical error, nor do they explicitly apologize.1 These are exactly the things that patients want to hear after they have experienced harm from a medical error.48 Understanding what is ethically required and what patients want to hear after experiencing harm is the first step towards developing a practice of open and honest communication with patients.

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Special Considerations What should be done in the case where an error has occurred but the patient was not harmed? For example, if the pharmacy sent the wrong dose of an antibiotic but the nurse caught the mistake and administered the correct dose, this could be classified as a “nearmiss.” A “harmless hit” occurs if the mistake reaches the patient, but there is no negative consequence, for example if a multivitamin was inadvertently given instead of the patient’s daily aspirin, and the nurse realized this error and immediately gave the usual dose of aspirin. The imperative to fully disclose in these situations is not as clear. Philip Hébert uses the analogy of disclosing risks preoperatively. Just as the greater the possible risk of an operation, the greater the need to fully disclose that risk, the requirement to disclose an error is proportionate to the actual harm caused.5 Albert Wu sees no absolute requirement to disclose the near-miss medical error to the patient, but points out that reporting these to the institution can facilitate system changes to reduce errors. Furthermore, disclosing a near-miss or a harmless hit allows the physician to practice the virtue of transparency when the stakes are not as high.13 Witnessing an error performed by another member of the healthcare team can be particularly distressing. One’s ethical responsibility is ultimately to the patient. Conversing with the person who committed the error and encouraging disclosure is the first step. If disclosure does not occur, it is appropriate to go up the chain of command. For ancillary staff this may be supervisors or managers, but for physicians this may mean going to the department chief or risk management.18,5 Clearly the “essentially contested” nature of medical error places the onus on the witness of the event to make sure that it is agreed upon that an error actually resulted in harm before taking any action. In the case where a consulting physician clearly harmed one’s patient and is refusing to disclose the error, the attending physician may need to disclose the facts of the event to the patient, making sure that the consultant is allowed to be present to clarify any details.

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CONCLUSION Medical errors are inescapable as long as medicine remains a human profession. Minimizing adverse outcomes due to error is part of the lifelong training of the surgeon. Fully disclosing medical errors should also be part of the ethical physician’s normal routine. The ethical imperative is for open and honest communication regarding harm-causing error. Pragmatic concerns also seem to be served by adopting this policy, as malpractice suits seem to be related to the quality of communication between the patient and physician. Communicating errors is difficult, but specific techniques can be learned to help facilitate empathic error disclosure. The American College of Surgeons has produced a DVD examining the latest work by John Banja and Thomas Gallagher and providing several surgical error disclosure vignettes with questions for discussion.49 Furthermore, given the “systems nature” of many medical errors, mandatory reporting is essential for the institution to be able to examine and repair faults in the system. REFERENCES 1. Gallagher TH, Garbutt JM, Waterman AD, Flum DR, Larson EB, Waterman BM, Dunagan WC, Fraser VJ, Levinson W. Choosing your words carefully: how physicians would disclose harmful medical errors to patients. Arch Intern Med 2006; 166: 1585–1593. 2. Gallagher TH, Waterman AD, Garbutt JM, Kapp JM, Chan DK, Dunagan WC, Fraser VJ, Levinson W. US and Canadian physicians’ attitudes and experiences regarding disclosing errors to patients. Arch Intern Med 2006; 166(15): 1605–1611. 3. Chan DK, Gallagher TH, Reznick R, Levinson W. How surgeons disclose medical errors to patients: a study using standardized patients. Surgery 2005; 138: 851–858. 4. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA 2003; 289:1001–1107. 5. Hébert PC, Levin AV, Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ 2001; 164: 509–513. 6. Bosk CL. Forgive and Remember: Managing Medical Failure 2nd edn., 2003; University of Chicago Press: Chicago, p. xxiii.

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7. Bosk CL. Forgive and Remember: Managing Medical Failure 2nd edn., 2003; University of Chicago Press: Chicago, p. 37. 8. Rosenthal MM, Sutcliffe KM. Medical Error: What Do We Know? What Do We Do? 2002; Jossey-Bass: San Francisco, CA, pp. 267–283. 9. Joint Commision on Accreditation of Healthcare Organizations. 2002 Hospital Accreditation Standards. 2002; Joint Commission on Accreditation of Healthcare Organizations: Oakbrook Terrace, IL, p. 339. 10. Kohn LT, Corrigan JM, Donaldson MS. To Err is Human: Building a Safer Health System. 2000; National Academy Press: Washington, DC, p. 210. 11. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, p. 5. 12. Espin S, Levinson W, Regeher G, Baker GR, Lingard L. Error or “act of God”? A study of patients’ and operating room team members’ perceptions of error definition, reporting, and disclosure. Surgery 2006; 139: 6–14. 13. Wu AW. Is there an obligation to disclose near-misses in medical care? in Sharpe VA. Accountability: Patient Safety and Policy Reform. 2004; Georgetown University Press: Washington, DC, pp. 135–142. 14. Krizek TJ. Surgical error: ethical issues of adverse events. Arch Surg 2000; 135: 1359–1366. 15. Cushieri A. Nature of human error: implications for surgical practice. Ann Surg 2006; 244: 642–648. 16. Reason J. Human Error. 1990; Cambridge University Press: Cambridge, MA. 17. Reason J. Education and debate. Human error: models and management. BMJ 2000; 320: 768–770. 18. 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: 770–775. 19. Leape LL. Full disclosure and apology—an idea whose time has come. Physician Exec 2006; March–April: 16–18. 20. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 1992; 267: 1359–1363. 21. 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: 2565–2569. 22. Penchansky R. Macnee C. Initiation of medical malpractice suits: a conceptualization and test. Med Care 1994; 42: 813–831.

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23. Vincent C, Young M, Phillips A. Why do patients sue doctors? A study of patients and relatives taking legal action. Lancet 1995; 343: 1609–1613. 24. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 5th edn, 2001, Oxford University Press: New York. 25. Kant I. Groundwork of the Metaphysics of Morals. Gregor M, trans., 1997, Cambridge University Press: Cambridge, UK. 26. American Medical Association, Code of Medical Ethics, Ethical Opinions, E-8.12. 1981, updated 1994. Available online at www.amaassn.org. 27. Hippocrates. The History of Epidemics. Farr M. trans. 1780; T. Cadell: London, Book I, Sect. II, p. 10. 28. Bernstein M, Barry B. Doctors’ duty to disclose error: a deontological or Kantian ethical analysis. Can J Neurol Sci 2004; 31: 169–174. 29. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. 2005; Johns Hopkins: Baltimore, MD, pp. 81–91. 30. Hilfiker D. Facing our mistakes. N Engl J Med. 1984; 310: 118–122. 31. Levinson W. Patient-physician communication: a key to malpractice prevention. JAMA. 1994; 272: 1619–1620. 32. Robertson G. Fraudulent concealment and the duty to disclose medical mistakes. Alberta Law Rev. 1986; 25: 215–223. 33. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, p. 48 ff. 34. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, p. 164. 35. Kaldjian LC, Jones EW, Rosenthal GE, Tripp-Reimer T, Hills SL. An empirically derived taxonomy of factors affecting physicians’ willingness to disclose medical errors. J Gen Intern Med 2006; 21: 942–948. 36. Mazor KM, Simon SR, Gurwitz. Communicating with patients about medical errors. Arch Intern Med 2004; 164: 1690–1697. 37. Beauchamp TL, Childress JF. Principles of Biomedical Ethics 5th edn, 2001; Oxford University Press: Oxford: UK, pp. 41ff. 38. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med 1999; 131: 963–967. 39. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. 2005; Johns Hopkins: Baltimore, MD, pp. 74–80. 40. Gawande A. When doctors make mistakes. Complications: a surgeon’s notes on an imperfect science. 2002; Metropolitan Books: New York, NY. 41. Pinkus RL. Mistakes as a social construct: an historical approach. Kennedy Institute of Ethics Journal 2001; 11: 117–133. 42. www.jointcommission.org/sentinelevents/statistics

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43. Griffen FD. ACS closed claim study reveals critical failures to communicate. Bull Am Coll Surg 2007; 92: 11–16. 44. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, pp. 173–191. 45. Buckman R, Kason Y. How to Break Bad News. 1992; Johns Hopkins University Press: Baltimore, MD, pp. 45–46. 46. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, p. 178. 47. Banja JD. Medical Error and Medical Narcissism. 2005; Jones & Bartlett: Sudbury, MA, p. 184. 48. Schwappach DLB, Koeck CM. What makes an error unacceptable? A factorial survey on the disclosure of medical errors. Int J Qual Health Care 2004; 16: 317–326. 49. American College of Surgeons, Division of Education. “Communicating With Patients About Surgical Errors and Adverse Outcomes.”

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RESEARCH ETHICS AND THE ETHICS OF RESEARCH: SHOULD WE OFFER CLINICAL TRIAL PARTICIPATION OR CLINICAL RESEARCH PARTNERSHIP TO ONCOLOGY PATIENTS IN THE NEW MILLENNIUM? Heather Sampson

Umbrellas, pigs and people: is it ethical to offer conventional clinical trial participation or should we be promoting clinical research partnership with oncology patients and their families in the new millennium? This short chapter is dedicated to the clinical trial participant or subject––the individual who agrees to become one of a minority of patients who sign on to become the experimental contributor to the past, present and future. A necessary clarification at the outset is that this chapter is reflective of the adult oncology clinical trial milieu: pediatric oncology operates in a different environment frequently aiming at enrolling upwards of 90% of patients on clinical trials as an integral part of mainstream treatment. In part, I propose to present a relatively provocative perspective for the clinician and oncology team offering clinical trials to our cancer patients; working toward recommending engaging our patients in clinical research partnership in the new millennium. In addition to which as we move from toxic chemotherapies to stem cell and gene transfer treatments: intravenous delivery to oral alternatives: combined radiation and biologic approaches, perhaps we can venture that oncology trials and research ought to be reviewed by institutional review boards in the

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same manner as it is studied: as a specialty. Additionally in this new era of exponential growth in oncology research, it may be argued that oncology clinical trials and clinical research deserve a more focused and specialized patient engagement in research design (generation of research question, development of methodology, data collection, analysis, interpretation of results, and dissemination of results), delivery of combination clinical research care, and finally, also the ethics review process. Late for a urology clinic, dodging traffic as we ran across the road one day between hospitals and caught in a rainstorm huddling under umbrellas, one of our rotating 3 month surgical residents looked up at the umbrellas (similar configuration to the instrument used to deliver Radio Frequency Ablation – RFA) and asked if we had heard that interventional radiology was using RFA to treat multiple small hepatocellular carcinoma lesions successfully. 1 He wondered if we might consider it for small renal cell carcinoma (RCC) lesions. Unfortunately for the folks in the waiting room, we made a detour and stopped at the medical physics department to ask if it might be possible to duplicate the approach in RCC. The head of the department was intrigued and suggested that before we approached the clinical application, we work on a stepwise animal model; extra corporeal cow livers initially, moving to intraoperative porcine work. To make a long story short, we applied for and received a peer reviewed grant to proceed with this work and gained approval from the appropriate animal and subsequently the human research ethics committees. Following suitable animal work and results, we set out to enroll some of our patients in a variety of extra-operative, intra-operative and finally pre-operative radio frequency ablation pilot protocols based on an experimental model designed to treat small RCC lesions. “You are invited to take part”, “We are asking you to join…”, Phase Two/Three Randomized Placebo Controlled Dose Progression Study of ETZ34452qr in Advanced Non-small Cell Lung Cancer/Prostate Cancer/Breast Cancer…”

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What were we thinking when we developed the confusing, frightening entrée into the world of clinical equipoise and scientific rigour via clinical trial enrollment? The standard reported clinical trial enrollment is 3–5% of the potential eligible population; there has been much inquiry into why that is, in spite of public education, transparent and declared conflict of interest by investigators, establishment of mandated clinical trial registration etc.2,3,4 The original two to five-page so-called informed consent has evolved into a 12–15 page and longer document that describes risk benefit ratios and complex trial descriptions and instructions often leaving Institutional Review Boards/Research Ethics Board members struggling to understand what the investigators’ intentions are; whether the consents are meant to inform and protect the participants or to shield sponsors from litigation.5 Research ethics committees do not necessarily understand whom they are protecting and where the responsibilities lie.6,7 We have added pages but not process to our consenting; relying on the informal verbal exchange often held between the primary health care provider and the patient, which many see as a situation of potential conflict of interest, depending on the relationship, with undue influence exerted by a real or perceived power imbalance.8,9,10 The sophisticated trial design has completely outstripped our archaic consenting process; an area that could easily be improved with the addition of interactive CD ROMs and other easily accessible tools. Numerous questions remain unanswered in the ethics of research. The therapeutic misconception is the mistaken belief by participants in Phase 1 or Phase 2 clinical trials that even though they have been told that the trial is designed to study efficacy and toxicity of drugs, many still believe it will be therapeutic. Are patients and families still influenced by the therapeutic misconception or has this issue been resolved?11 According to many oncology patients the problem may be semantics; if there is a chance that a new biologic or novel targeted experimental treatment will slow the inevitable or “kill off a few cancer cells” they want to have the opportunity to make that informed choice.12 Is randomization appropriately described and presented to prospective patient/participants?13 Does it make a difference if this is a surgical clinical trial versus a drug-based trial; is there extra challenge or value added in sham/placebo controlled

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surgical trials that inform best practice decisions?14 Is the approach any different than Phase 3 oncology trials with or without a placebo arm?15 Is the situation unique in the oncology patient population? What have we learned from other patient populations? Is it in fact ethical to ask oncology patients and their families to participate as human subjects in clinical trials or clinical research? According to many that we hear from, the answer is “ yes”. If so, why is enrollment not higher in the new millennium?2 There may be more questions than answers to the dilemma of providing oncology care at the same time as practicing in an ethical clinical research environment; however perhaps solutions and a comfortable decision making framework is more available than we appreciate. And perhaps more transparency and disclosure are required to fulfill autonomous patient decision making models balanced with adequate protection by Institutional Review Boards/Research Ethics Boards. In the U.S., institutions including Johns Hopkins, DanaFarber/Harvard Cancer Center and the Department of Veterans Affairs that have Human Research Protection Programs have taken the steps to become accredited by, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Originally incorporated in Massachusetts under the auspices of Founding Member Public Responsibility in Medicine and Research (PRIM&R), and later incorporated as a non-profit organization in Maryland in 2001, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) offers accreditation to organizations that conduct or review research with humans. Responding to increased public concern for protecting research participants, AAHRPP seeks not only to ensure compliance with federal regulations, but to raise the bar in human research protection by helping organizations reach performance standards that surpass the threshold of state and federal requirements. By establishing a “gold seal” accreditation signifies that organizations are committed to the most comprehensive protections for research participants and the highest quality research.16

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In Canada there is neither national clinical research nor Institutional Review Board/Research Ethics Board accreditation nor central governance in place; although there is strong recommendation to institute such a system, it does not appear imminent.17 This is a paradoxical situation in that the first Clinical Research Organization in the world to be accredited by the US based AAHRPP is the Canadian “ethica Clinical Research, Inc.” in Dorval, Quebec, Canada (December, 2006). As a primary responsibility, Institutional Review Board/Research Ethics Board members are the gatekeepers charged with approving, or not, all clinical trials in Canada. The responsibility for protection of research participants rests at the local Institutional Review Board/Research Ethics Board level. Many Institutional Review Board/Research Ethics Boards in Canada are maintained as volunteer-service committees often with a high membership turnover rate. There is neither formal Institutional Review Board/Research Ethics Board training nor a mandated continuing education process in Canada. At the same time there is increased demand for Institutional Review Board/Research Ethics Board accountability and for ensuring patient safety.6,9 We may extrapolate from that information that the average Institutional Review Board/Research Ethics Board may be woefully unprepared to adequately review the complex oncology clinical research trials in a safe and expeditious manner, protecting all concerned. Each clinical research protocol and consent submitted to an Institutional Review Board/Research Ethics Board must comply with acceptable scientific rigor and ethical standards. As reported in the January 17th, 2004 edition of the British Medical Journal, there is huge variation between research ethics committee reviews, no standardization and many barriers to implementing clinical research, even in simple non-invasive studies. This is an international problem.18 As Ezekiel Emmanuel et al. have given us a functional systematic framework to review clinical research at the Institutional Review Board/Research Ethics Board submission and initiation phase, it is not mandatory to use such a template.19 Initial approval is only one stage of the clinical trial process. Ongoing monitoring of clinical trials is mandated in Canada, but as there is no methodology prescribed in the Canadian guidelines, it is not hard to imagine disparity in applying the

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said guidelines.20 Charles Weijer et al. have formulated and developed a four stage practical approach to effect monitoring clinical research in Canada.21 There are four indications that these authors recommend recommend for obviating transgressions. “…(1) continuing (annual) review; (2) monitoring of the consent process; (3) monitoring for adherence to protocol; and (4) monitoring of data integrity.”21 The authors recommended four monitoring categories that seemed straightforward. The authors were confident in 1995 that as the Institutional Review Boards/Research Ethics Boards fulfilled the then prevalent Medical Research Council responsibilities, that clinical research monitoring would become commonplace with patient–participant safety as the final objective. Despite these recommendations in 2007, there is still no formal clinical trial monitoring in place in Canada. The Institutional Review Board/Research Ethics Board process is firmly grounded in the “what ought to be done” premise of guidelines, rather than being able to rely on criminal or civil code regulations, in most of Canada. This lack of clearly defined responsibilities would presumably make it difficult to determine the extent of any legal duty towards research participants, at least in any province other than Quebec. The codification of the consent to experimental treatment in the Civil Code of Quebec in certain circumstances does lead to legal consequences that would be enforceable in Quebec, but not in the rest of Canada.22 There are no defined standards or review framework for Institutional Review Boards/Research Ethics Boards to use to assess protocols. Similarly the scope and definition of the annual review, ongoing monitoring, data safety, and Institutional Review Board/Research Ethics Board education, to name a selection, is not addressed in any of the guidelines. Without causal relationships being tied to consequences, it is arguably difficult to make a case for finding methods to enforce the present guidelines. The public who trust the Institutional Review Boards/Research Ethics Boards as their gatekeepers, have no formal or informal recourse for learning the results of the studies that they or their families have taken part in. This issue appears to not only be

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Canadian-based. The Canadian Institutes of Health Research TriCouncil Policy Statement defines that there must be a community or lay representative on the Institutional Review Boards/Research Ethics Boards, that participant advocate would be an ideal candidate to promote the benefits of study result disclosure at all levels. This particularly special Institutional Review Board/Research Ethics Board member could be empowered to proactively encourage investigators and sponsors as to the value of sharing study results outside the scientific community and extending that knowledge to the participants. This situation of non-disclosure of research results may be one of the factors discouraging enrollment in clinical trials.3 Subject/participants are asked to agree to possibly experience known as well as unknown side effects with no expected benefit while never knowing the results of the trial and that information is not disclosed in the so-called informed consents. This is ethically unacceptable.23 There is an opportunity to take a lead in encouraging new standards in public awareness and medical disclosure of clinical research, which may lead to new levels of public confidence that may in turn result in increased clinical research understanding and perhaps improved enrollment. As Institutional Review Board/Research Ethics Board memberships evolve and clinical research becomes more intricate, the protocol approval process and monitoring responsibilities take on greater complexities. We can wait for the consequences to arrive and instead of proactive Canadian/US Institutional Review Board/Research Ethics Board reform, this can take the form of reactive decision-making that will necessitate legislation. However, the egregious result will be that a patient–participant (or more than one) will have experienced a serious adverse reaction or outcome that could have been prevented. Governance would be more probable if there were consequences to the actions of noncompliance. As Trudo Lemmens has reported, scandals have certainly appeared to initiate regulations.24 By the very nature of our reliance upon such documents as the Belmont Report to guide us in the areas of autonomy, beneficence and justice to protect patients’ rights in research, waiting for “bad endings” is clearly unacceptable; Institutional Review Board/Research Ethics Board governance and accreditation is needed now.25

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The opportunity to develop a single policy for the appropriate use of placebos in clinical trials 2002–2004 with Health Canada and the Canadian Institutes of Health Research National Placebo Initiative (NPI) provided a rare and privileged insight into patient participation in clinical trials.26 The working committee for the NPI had the expected mix of science, medicine, law, ethics and patient/citizen representation, similar to a Research Ethics Board or Institutional Review Board makeup. Certainly the wisdom and clarity on the appropriate development and delivery of clinical trials with placebos to patient–participants came from the patient/citizen representatives on the NPI. As part of the NPI activities, public focus groups were conducted across Canada to understand what the public understood, recommended and sought as an appropriate use of placebos in clinical trials. That invaluable experience confirmed what our patient/citizen committee members had shared with us; patient/participant autonomy is paramount in clinical trial participation and decision making. Such participation must be respected to the point of inclusion in trial design, operation and facilitation to have full and suitable partnership in clinical research for meaningful, generalizable and reproducible outcomes. It also became evident that this expertise could be easily extrapolated to clinical trials in many areas of medicine, including and perhaps especially oncology, striking the balance between patient autonomy and patient protection. There is extensive literature on the pros and cons of enrolling patients in phase 1 and 2 oncology trials as well as reports discussing low enrollment in phase 3 studies. Having had the privilege of asking oncology patients to participate in clinical trials and clinical research over the years, I have learned many lessons from these men and women. As a research ethicist (as opposed to a clinical ethicist) and clinical trial/research coordinator I have noted anecdotally that the particular segment of the population that appears to embrace participation in clinical trials/research, are the men and women who actively seek to be “partners” in their care rather than recipients of care. Whether they are at the beginning of their treatment journey or at the end, they seem to self-select for participation and describe a desire to be a part of the decisionmaking team. They walk through the lab on the way to an office

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visit and peer at the microscopes and equipment, tentatively ask the lab staff about their work. The staff are inevitably delighted to share their projects. The lab staff in turn report that the interaction “humanizes” their work and the patients report that they feel like they have become part of the team. This demonstration of interest and expressed desire to be active partners in their care by our patients was serendipitous. The fine balance for researchers and Institutional Review Boards/Research Ethics Boards to provide protection while allowing and in fact inviting patient autonomy is a tough but arguably manageable challenge. In the last several years, recognizing the extraordinary level of specialized expertise required to review oncology clinical research, a relatively new institutional ethics review concept has been piloted in Ontario with success. After consultation and deliberation in 2002 the Ontario Cancer Research Ethics Board was introduced with the following description: The Ontario Cancer Research Network in collaboration with Cancer Care Ontario and local Research Ethics Boards in Ontario introduced the Ontario Cancer Research Ethics Board in December 2003 to facilitate scientific and ethical review of multi-centre oncology trials. The Ontario Cancer Research Ethics Board (OCREB) flows from an extensive provincial consultation process involving: Research Ethics Board (REB) chairs, regional cancer centres, host hospitals, investigators, bioethicists, research ethics coordinators and collaborating organizations such as the National Council for Ethics in Human Research, the Canadian Association of Research Ethics Boards, and the Canadian Institutes of Health Research. Several key issues were identified during this consultation process. Through the provincial consultation process, investigators and REBs identified several opportunities to streamline processes and enhance review efforts, centred on the development of a provincial Research Ethics Board.

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The primary goals of the Ontario Cancer Research Ethics Board are to: To protect the safety and rights of the human research subjects at the highest quality of ethical review; To reduce the workload and duplication associated with reviews of the same study by multiple research ethics boards; To simplify and accelerate the initiation of multi-centre oncology trials in Ontario.27 This provincial (analogous to state) Institutional Review Board/Research Ethics Board is an interesting model that is also present in the US as a larger national central Institutional Review Board sponsored by the National Cancer Institute.28 The Canadian version is built on a smaller scale to develop acceptance and credibility with institutional, industry partners while developing public awareness provincially before expanding to a wider audience across the other 10 provincial and 3 territories healthcare systems. In the fifth year of operation, OCREB continues to develop and gain credibility and legitimacy. It is safe to venture that harmonization and streamlining will encourage collaboration; evidence-based change; national acceptance may naturally ensue. Why do people who are already battling cancer take part in clinical trials? I had one patient in his early 40s who took part in a Phase 1–2 trial against the wishes of his family. His family said the trial sounded too stressful and potentially dangerous. He responded that if his participation could in any way prevent patients in the future having to go through long painful hospitalizations in favor of shorter equally effective treatments, he wanted to help with that solution. We discussed his participation in depth with many consultations both alone with him and with his family. We asked him to take the consent and information form home with him to review and contemplate in the privacy of his own surroundings and to have discussions with his family doctor. Following these processes he followed up with the team and asked to be enrolled in the trial and signed the informed consent. He again expressed the wish to contribute to future patient outcomes, and again stated that he understood that there was no discernible benefit to him at that

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time. He died on our study, as an indirect result of the experimental treatment. He would not have died at that time and in that way had he not been in a study with us. We followed up extensively with his family as well as with the Institutional Review Board/Research Ethics Board. His altruistic gift of participation in the trial contributed immeasurably to science; and as importantly, his story continues to humbly remind us of our accountability to our study subjects/participants. What was our responsibility to this man and his family? Did we do anything wrong? Did we do anything right? Practicing retrospective medicine is a luxury none of us has; practicing prudent thoughtful ethical clinical research prospectively is an absolute obligation. Many of us have had the personal or professional e-mail or telephone call that starts out with “I (or my family member) have just been diagnosed with fill-in-the-blank- cancer: what should I do?” Anyone involved in oncology clinical research inherently knows that being involved in a clinical trial is an opportunity to gain “access to care” and that is what patients are frequently either overtly or covertly searching for when they contact us asking for help. Access to care in the new millennium is an ever-increasing ethical dilemma as the burden of oncology care increases. Who do we treat? How much do we spend? What is reasonable treatment or expenditure given long-term survival data? How do we effectively collect rigorous clinical oncology-care outcome data? How do we quantify quality of life and the burden of care in economic terms? In Canada, The Globe and Mail national newspaper published seminal work “Cancer our National Shame” in November–December 2006 as 3 week investigative journalistic foray into the disparities and inequities in cancer care in an economically developed country.29 As the title implies, the imbalance of cancer care between geographic and demographic areas is staggering, particularly when compared to the remarkable Canadian scientific advances being made in areas such as stem cell research. If our patients do not have access to standard of care or established effective therapy in the same country as the scientific advances are being pioneered it is not surprising that the media has taken up the clarion call, which may serve to drive political will.

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Arguably access to treatment is the underlying theme. Whether or not patients are consciously aware of this phenomenon, it rapidly becomes clear to the patient that there is a separate tier of healthcare for the clinical trial or clinical research participant and their families as they wade through the oncology care maze. Clinical trials are used as methods of gaining access to new and promising treatments as well as accessing the present standard of care or established effective therapy that either may not be financially feasible for a patient or may simply not be available in their medical treatment jurisdiction. Work in Canada and the United Kingdom is moving towards developing and facilitating integrated oncology care, part of which is driving clinical care and research “with” patients rather than the traditional model of “for” patients. Clinical research must be designed with patient contribution incorporating economic and quality of life analyses as essential components, not just add-ons as in traditional clinical trials. For example, in England the National Health Service (NHS) has overhauled their oncology care system. The commitment has been that the entire cancer journey is guided by a single nurse, ensuring co-ordinated, consistent, quality treatment. The role is to serve as an educator and an advocate as patients navigate the complex health system. Before the NHS Cancer Plan was launched in 2000, the British system was a chronically under-funded embarrassment, characterized by long waits, a lack of standards and gross disparities in treatment and contempt for patients. Britain had the worst cancer survival rates in the industrialized world.30 Patients were far worse off than those in Canada today. There are many articles discussing perceived and real coercion to participate in clinical trials, outside of healthcare insurance parameters. A recent US economic policy phenomenon is the reported pressure to take part in a patient registry or clinical trial as a condition of Medicare or Medicaid insurance coverage. Pearson, Miller and Emmanuel argue that since the insured individual would not be accessing the treatment only available in the trial otherwise, that this is not a coercive approach to medical insurance coverage.31 There is continuing debate over whether coverage with evidence development, known as CED, is actually research contributing to evidence based medicine or rather an economic tool to measure

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future potential cost effective decision making in health care. Canada’s socialized health care system has not yet tied accrual to clinical trials to coverage by private or public health insurance plans; the continuing struggle between available health care dollars and spending as allocated to the 13 provinces/territories is dominated by national policy determining provincial apportionment. True patient/participant partnership and appropriate representation in clinical research design remains lacking. Certainly we ask patient advocate/representatives to join the Institutional Review Board/Research Ethics Board as precisely a representative, as opposed to being considered an integral member of the clinical research development process. As a member of both the American College of Surgeons Oncology Group and the National Cancer Institute of Canada Clinical Trials Group, I see patient representatives being fully empowered at the clinical research design stage, contributing their wisdom and advice on many levels; frequently they are the voice of experience explaining the reluctance or enthusiasm of patients to take part in particular forms of clinical research that is inherent knowledge gained from experiential education; that we as investigators cannot bring to the process. At annual meetings and national reviews quorum is not achieved unless these patient representatives are in attendance. This level of patient– participant advocacy activity ought to be mandatory in all clinical research design whether investigator driven, peer-reviewed or industry sponsored and the process recorded in the written protocol. Including appropriate patient representation in the research design phase might also have the inadvertent function of contributing to public knowledge, acceptance and perhaps increased clinical research enrollment. Over the years, I have had the opportunity to enroll many patients in clinical trials of varying degrees of risk. Anecdotally the majority of them have done this selflessly. There have been a number of patients and their families looking for last resort treatments that have only been available through clinical trial participation, but they have frequently cited altruistic motives in joining the trial, even if the experimental treatment should prove useless or worse. We have introduced the idea of clinical trial participation to patients with varying degrees of initial acceptance

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and resistance. Patients in active clinical trial treatment and post clinical trial completion cite the patient–care–giver relationship as a key motivator to enter an experimental milieu. These men and women base their decisions to participate in the trial, on a preexisting rapport that has an essential foundation of trust and integrity, or on encouragement and support from the existing circle of caregivers that is building a similar relationship. Although research and therapy can be distinguished, they often occur together: there is an ethical responsibility to provide an even higher level of fiduciary duty of care in the research. Studies have looked at the role of trust in patients’ decisions to participate in research.32 They show that patients trusted that their physicians would never endorse options that were not in their best interests, thus demonstrating the importance of the physician/investigator’s fiduciary role in clinical trials. Involving clinical research participants as partners from the design inception could contribute to increasing trust while demystifying clinical research without adding enormous burden to either faction. In the last 10 years, there appears to have been a ribbon campaign designed for every conceivable cause and reason inducing numerous responses. However, for many, a small looped ribbon worn on a lapel is a powerful representation of a medical message, whether in remembrance or support of an unresolved cause. For example, turquoise blue represents prostate cancer and pink is designated for breast cancer. These ribbons are quiet reminders that there are many challenges and quests for cures in medicine, particularly in oncology, that remain unconquered. Ironically, we ask many of the people who wear turquoise and pink ribbons to take risks that frequently may result in no discernible benefit to them. We invite them to take part in a clinical trial; the compensation clause in the consent is limited to: “If you agree to take part in this study, there may or may not be direct benefit to you. We hope the information learned from this study will benefit other patients with (fill in the blank) cancer/illness in the future.” The daunting possible risks cited in taking part in the trial can go on for pages, finishing with: “While on the study, you are at risk for these (listed) side effects. You should discuss these with your doctor. There also may be other side effects that we cannot predict.” We ask patients to take

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on risks that may or may not be temporary, with no apparent benefits and then we wonder why trial enrollment is so low. 3 If they are in a placebo-controlled study, there is rarely an opportunity to discover which arm of the study they participated in.33 Further, we do not tell patient–participants the actual outcomes of the studies that they sign up for.34 We do not recognize or publicly appreciate the committed partnership that we ask of these people in signing the consent to participate in a clinical trial. We have some ethical challenges here. As a small token of recognition, I propose that a suitably elegant green (for life) and gold (for the top award) tartan ribbon be fashioned and attached to a small ‘thank you card’ for all clinical trial participants.35 I do not suggest that a ribbon can be a substitute for resolving some of these larger ethical issues that do need to be addressed. I suggest the ribbon as a small gesture towards patient/participant recognition. Since the 2004 declaration for the International Committee of Medical Journal Editors (ICMJE) to have all clinical trials that fit the specifications be registered to qualify for publication; there are questions for investigators and patient–participants.36 For investigators, if it’s not registered why are we doing it? The risk of exposing patients to trial risks without being able to use any of the data to advance science is clearly unacceptable. As some investigators have recently discovered, the ICMJE is committed to this policy and will turn down publications that may have been registered, but by not properly populating the fields as instructed by the guidelines, their manuscript will be refused.37 Some question(s) for potential and enrolled patient/participants and their families and caregivers; are they able to search the clincaltrials.gov site easily for trials that may be open to them and/or simply check on the trial status? They must be confident that the registration information is complete and useful. Going to the site to search for open trials, inclusion/exclusion criteria where it is being run, contact for queries etc provides another access route to care. This approach is aimed at the autonomous, assertive, educated and articulate oncology patient population. Issues remain to be dealt with as trials may be registered more than one way and in more than one registry. Some have been

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double registered on the same database; it is not fool proof. As the clinicaltrials.gov site helpfully states: Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.38 Human and electronic “shepherds” are still necessary, but there are tools available to assist them in their role(s) of guiding patients on the oncology treatment journey that includes clinical research. If we want our patients to find a trial sooner than finding out the results in their investment portfolio updates, we need to educate them and ourselves while respecting that many factors including, but not confined to, patient socioeconomic disparities will impact patient healthcare knowledge and their ability to access clinical trials. Of small but important note is that as only a small selection of very different U.S., Canada and the United Kingdom clinical research circumstances have been described, there is a tremendous variation of international and local guidelines and legislation that does not contribute to the harmonization of clinical research. In the economically developed world, peer review research and industry sponsored clinical research alike are frequently expected to function and succeed in a “borderless” environment. For example this chapter does not address issues such as the development and enforcement of acceptable legal contracts for conducting clinical research. This observation is not meant to detract from the importance of these challenges. It is simply to alert the reader to

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some of the realities of the breadth and scope of conducting clinical research in the new millennium. Ostensibly our responsibility and challenge in 2007 and beyond is to design clinical research in partnership with our patients, engaging all of our patients, not only the select few that are presently enrolling. It is no longer satisfactory to base standard of care or established effective therapy on the results of traditional clinical trials that enroll a fraction of our patient population. As our respective national clinical trials groups design and promote phase 1–3 clinical trials with quality of life and economic analyses with contributions from the patient participants and citizen representatives, the research needs to respond to the identified scientific matrix plus the oncology community issues and needs. The greater oncology community must be involved in the various stages of the research (generation of research question, development of methodology, data collection, analysis, interpretation of results, and dissemination of results). Each patient who walks into our clinic ought to be involved in some form of clinical research; this may be as simple (but effective) as being registered appropriately in a treatment outcome database. On the road to the next insulin triumph (while avoiding another thalidomide disaster; learning from AIDS activists and listening to our oncology patients and their families), we need to remain mindful and respectful of not only the possibility, but the moral imperative, that we ought not to be delivering or offering clinical trials to oncology patients in the conventional manner, but deciding collectively on the appropriate progressive way forward, together. We rush to see the new biologics, oral chemotherapies and gene transfer treatments make a difference to long term outcomes, quality of life and strategic economic planning. We attempt to engage patients as they walk through the labs, as the peer review grant applications are reviewed and the protocols and consents are delivered to research ethics boards. We may need to improve the process. Human nature and history dictate that we will make mistakes and follow some errant paths, however ingenuously, in the quest for solutions and iatrogenesis may unfortunately occur. Beauchamp and Childress have given us formalized underpinnings of justice, respect for autonomy, beneficence and non-maleficence

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as guiding principles; these views lean towards a cross between Utilitarianism, Kantianism, liberal individualism, communitarianism and the ethics of care in the conduct of clinical research.39 We need to choose the personal and professional combination that will inform our design and conduct of clinical trials and research with appropriate scientific rigor, transparency, disclosure, fervor and humanism. However as we raise awareness on all fronts while appropriately engaging the entire oncology community, we may be able to offer ethical clinical trial participation plus clinical research partnership to our oncology patients and their families in the new millennium. REFERENCES 1. Radio Frequency Ablation is delivered by inserting a closed umbrellalike instrument under fluoroscopy that is opened once placed to deliver radiofrequency energy to the tumor mass heating the tissue to a temperature that will result in cell necrosis. 2. Lara PN, Jr, Higdon R, Lim N et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment, J Clin Oncol, 2001; 19 (6) (March):1728–1733. 3. Comis RL, Aldige CR, Stovall EL. et al. A Quantitative Survey of Public Attitudes Towards Cancer Clinical Trials, 2000, Coalition of National Cancer Cooperative Groups. 4. Foster C. The Ethics of Medical Research on Humans, Cambridge University Press, 2001. 5. Institutional Review Boards/Research Ethics Boards are the US/Canadian based committees charged with reviewing all clinical trials before being offered to patients. 6. Zlotnik SR. Reviewing the reviewers: the vague accountability of research ethics committees, Critical Care 2002; 6:121–122. 7. Amdur, Robert J, Bankert, Elizabeth A. Institutional Review Board: Management and Function, Jones & Bartlett, 2002. 8. Angelos, P, Murphy, T, Sampson, H et al. Informed consent, capitation, and conflicts of interest in clinical trials: Views form the field, Surgery 2006;140(5):740–748. 9. Eckenwiler L. Moral reasoning and the review of research involving human subjects, Kennedy Inst Ethics J 2001; 11(1):37–69, Johns Hopkins University Press.

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10. Eckstein, S. (ed.), Manual for Research Ethics Committees, Cambridge University Press, 2003. 11. 11.Glannon, W. Phase I oncology trials: why the therapeutic misconception will not go away, J Med Ethics 2006;32:252–255; doi:10.1136/jme.2005.015685. 12. Agrawal M, Grady C, Fairclough D, et al. Patients' decision-making process regarding participation in phase I oncology research, J Clin Oncol Sept 20, 2006; 24 (27):4479–4484. 13. Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants, J Med Ethics 1996; 22:227–231. 14. Macklin R. The ethical problems with sham surgery in clinical research, N Engl J Med 1999; 341:992–996. 15. Final Report of the National Placebo Initiative (NPI) http://www.cihrirsc.gc.ca/e/25139.html, accessed Nov 2006. 16. http://www.aahrpp.org, accessed January 2007. 17. http://www.lcc.gc.ca/en/themes/gr/hrish/macdonald/macdonald_main. asp, accessed November 2006. 18. Hearnshaw, H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study, BMJ 2004; 328:140–141, doi:10.1136/bmj.328.7432.140. 19. Emmanuel, Ezekiel J., Wendler, David, Grady, Christine, What makes clinical research ethical?, JAMA, May 24/31, 2000-Vol 283, No 20 2701–2711. 20. http://www.ich.org/, http://www.nserc.ca/programs/ethics/english/, http://www.cihr-irsc.gc.ca, accessed December 2006. 21. Weijer, C, Shapiro, S., Fuks, A., Glass, KC., Scrutkowska, M., Monitoring clinical research: an obligation unfulfilled, CMAJ, 1995; 152:1973–1980. 22. Civil Code of Quebec, Book I (1991, c.64) Title Two, Chapter I, Section I; 21. 23. Greenwood B, Hausdorff WP. After a trial is over: the ethical issues, Science and Development Network, www.scidev.net, 24 November 2003. 24. Lemmens, T. In the name of national security: lessons from the final report on the human radiation experiments. Eur J Health Law, 1999; 6:7–23. 25. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report (Washington, DC: DHEW Publications OS 78–0012,1978). 26. Final Report of the National Placebo Initiative (NPI) http://www.cihrirsc.gc.ca/e/25139.html, accessed November 2006.

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27. http://www.ocrn.on.ca/ethics_AboutOCREB.htm, accessed January 2007. 28. http://www.ncicirb.org/, accessed January 2007. 29. Globe and Mail Canadian National Newspaper –http://www.theglobe andmail.com, accessed Nov 2006. 30. http://www.gnn.gov.uk/Content/Detail.asp?ReleaseID=246831&News AreaID=2, accessed January 2007. 31. Pearson, SD, Miller FG, Emmanuel EJ, Medicare’s requirement fir research participation as a condition of coverage, JAMA, 2006; 298(8):988–991. 32. Advisory Committee on Human Radiation. The Human Radiation Experiments (New York: Oxford University Press, 1996). 33. Editorial, How consumers can and should improve clinical trials, Lancet, 2002; 357:1721. 34. Greenwood B, Hausdorff WP, After a trial is over: the ethical issues, Science and Development Network, www.scidev.net, 24 November 2003. 35. Credit for this clinical trials ribbon campaign idea rightfully goes to Donald E. Short, LLB and member of the Princess Margaret Hospital Research Ethics Board. 36. DeAngelis CD, Drazen JM, Frizelle FA et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors, JAMA 2004; 292:1363–1364. 37. Drazen JM, Zarin DA, Salvation by Registration, NEJM 356;2 www.nejm.org, January 11, 2007. 38. http://www.clinicaltrials.gov/,accessed January 2007. 39. Beauchamp TL, Childress JF Principles of Biomedical Ethics (2001), 5th Edn, Oxford University Press.

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DOES REIMBURSEMENT AFFECT PHYSICIANS’ DECISION MAKING? EXAMPLES FROM THE USE OF RECOMBINENT ERYTHROPOIETIN June M. McKoy, Cara C. Tigue, and Charles L. Bennett

Background Cancer-related anemia is of vital concern and its treatment with erythropoietin raises many ethical and cost-related concerns. Anemia occurs relatively frequently, with a prevalence of 67% among all cancer patients.1 The World Health Organization (WHO) operationally defines anemia as a serum hemoglobin (Hb) level less than 11 g/dL1 while the National Cancer Institute’s (NCI) definition includes Hb levels below 12 g/dL.2 Independent of the choice of Hb cut-point, clinical studies of anemic cancer patients identify fatigue as the most common symptom, although other less frequently reported symptoms include drowsiness, dizziness, depression, dyspnea, tachycardia, headache, and palpitations.1,2 In cases of chronic or severe anemia (Hb levels between 6.5 g/dL and 8 g/dL), end-organ damage to the lungs, kidneys, immune or central nervous systems may result.2 Since low Hb levels have been linked to worse survival rates and lower health related quality of life (HRQoL) in cancer patients, effective treatment of cancer-related anemia is critically important. Prior to the 1990s, the only treatment option for cancer patients with anemia was a red blood cell transfusion. While red blood cell transfusion raises Hb levels relatively quickly, the effect is short-lived and carries risks such as infectious disease

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transmission, transfusion reactions, allo-immunization, lung injury, and volume-related complications.2 Additionally, transfusions alleviate the symptoms of anemia without modifying or correcting the etiology. In the 1980s, isolation and sequencing of the genes for human erythropoietin (EPO) offered an attractive alternative to transfusions in the form of erythropoiesis-stimulating agents (ESAs). EPO is an acidic glycoprotein hormone that stimulates red blood cell production by binding to receptors on RBC precursor cells in the bone marrow. The use of recombinant human erythropoietin (rHuEPO) to treat cancer-related anemia was approved by the Food and Drug Administration (FDA) in 1993 and is now the standard of care for this condition. rHuEPO has a longer serum half-life than naturally occurring EPO, giving it a delayed effect on Hb levels that lasts longer and involves fewer risks than transfusions. Another ESA, darbopoietin alfa, with an even longer serum half-life than rHuEPO, was approved in 2002 for the treatment of cancer-related anemia. In March 2007, the FDA communicated additional safety information about ESAs in a boxed warning, underscoring the dangers of ESA administration in the following settings: advanced head and neck cancer patients receiving concomitant radiation therapy and administered ESAs to target a hemoglobin >12 g/dL, where a shortening in time-to-progression was noted; shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin >12 g/dL; and increased mortality in cancer patients not receiving chemotherapy or radiation therapy when administered to target a hemoglobin of 12 g/dL.3,4,5 In tandem, the Centers for Medicare and Medicaid Services (CMS) in the United States has instructed national Part B carriers to immediately discontinue coverage of ESA’s for treatment of anemia of cancer.6 Physicians must therefore be careful that as reimbursement losses are realized in this domain, unethical increases are not effectuated in areas of cancer anemia treatment where indications remain and private payers continue to provide coverage or markedly decrease among Medicare covered cancer patients who desperately require this treatment.

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Ethical Considerations The impact of ethics on obligations to patients has been a topic of discussion for the past three decades, as medical care has become more managed and as physicians grapple with shrinking reimbursement dollars.7,8 Much of this discussion has focused on obligations of physicians, rather than on obligations of institutions with which they are affiliated. Reimbursement is increasingly interposed between the physician and patient and there is increased concern about the foundational morality of the current reimbursement structure.9 Differences between for-profit and notfor-profit entities are illusory at best and both entities must take into consideration economic factors in their decision-making. As providers move to protect the rights of each stakeholder in the process and endeavor to maintain their fiduciary duty to their patients, keeping restraint on spending and maximizing reimbursement dollars can provide protection to all involved in the healthcare dynamics. Although medical questions are profoundly important, physicians face an increasing number of equally complex ethical challenges.10 Often, the subject matter of medical and ethical debates overlaps and the ethical discussion is infected by the medical cost/reimbursement concerns. Not unexpectedly, the overarching question that arises relates to how we might best integrate business and medicine, which follow diverging paths. Clinical Guidelines for EPO Use Use of EPO in the treatment of cancer related anemia is now considered to be the standard of care. Since this product is believed by most physicians to represent low-risk and effective anemia treatment, concerns regarding its appropriate use in cancer patients have led to the development of clinical guidelines for its use (Table 1). Specific concerns have been raised by the Health Care Financing Agency, the American Society of Clinical Oncology (ASCO), and the American Society of Hematology (ASH) as they relate to the appropriateness of erythropoietin’s use in the cancer anemia milieu. Consequently, the Agency for Health Research and

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Table 1. Guideline recommendations for target Hb levels for initiation and discontinuation of epoetin and darbepeotin among anemic cancer patients. Guideline ASH/ASCO 200211 NCCN 200612 EORTC 200413

Threshold for initiation ≤10 g/dL <11 g/dL 9–11 g/dL

Target Hb level 12 g/dL 12 g/dL 12–13 g/dL

Quality funded the Blue Cross/Blue Shield Association’s Evidence Based Practice Center in 2002 to review this subject. Following completion of this review, ASCO and ASH convened a joint expert panel to devise evidence-based clinical practice guidelines for the use of epoetin in cancer patients. The ASCO/ASH guidelines recommend that epoetin be used to treat patients with chemotherapyinduced anemia with Hb levels less than or equal to 10 g/dL.11 For patients with declining Hb levels between 10 g/dL and 12 g/dL, the guidelines recommend considering clinical circumstances to determine whether or not epoetin use is appropriate. These guidelines recommend a target Hb concentration of 12 g/dL, and that epoetin should be used to maintain this concentration once it is reached.11 More recently, the National Comprehensive Cancer Network (NCCN) released its own guidelines for epoetin use.12 These guidelines recommend that epoetin therapy be initiated in cancer patients with Hb less than 11 g/dL and that target Hb concentration be maintained at less than 12 g/dL.12 Although the ASCO/ASH and NCCN guidelines differ slightly in the Hb level at which epoetin therapy should be initiated, both organizations raise concern over epoetin use among cancer patients with Hb levels greater than 12 g/dL. Similar concerns over appropriate use of these products have been raised in Europe, where in 2004, the European Organization for Research and Treatment of Cancer (EORTC) convened an independent task force. The EORTC guidelines recommend initiating epoetin therapy among cancer patients with Hb levels of 9 to 11 g/dL and recommend a target Hb concentration of 12 to 13 g/dL.13 The guidelines indicate that the main goals of epoetin therapy in cancer patients are to improve quality of life and

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to prevent unnecessary transfusions. The EORTC guidelines differ slightly from the ASCO/ASH guidelines by recommending therapy initiation at higher Hb levels and from both the ASCO/ASH and NCCN guidelines by recommending a higher target Hb concentration (13 g/dL). Principlism Principlism views people as having different ethical and moral theories from which they reason.14 Physicians therefore come to ethical decision making from different frameworks. Nevertheless, when faced with a particular situation, physicians often turn to a shared common sense morality that assists them in arriving at similar conclusions. The NCCN has published clear algorithmic guidelines for the treatment of cancer related anemia, which can be of much assistance to physicians in making treatment determinations. Principlism therefore seeks to define certain principles (autonomy, nonmaleficence, beneficence, and justice) to which all rational persons will subscribe and recruits these principles to guide us in making ethical decisions.14 Principlism has emerged as a foundation for ethical decision-making and seems particularly suited to tackling the problems of reimbursement-influenced medical decisions. Overuse of EPO: Financial Incentives Normative Ethics Normative ethics attempts to figure out what people should do or whether their current moral behavior is reasonable, and as such embraces the Golden Rule (Do unto others as you would have them do unto you).14 Virtue ethics is one of three major approaches (virtue theory, deontology, consequentialism) in normative ethics.14 It emphasizes virtues, or moral character rather than duties or rules (deontology) or the consequences of actions (consequentialism).14 Virtue ethics aids in our understanding of our humanness and, within the healthcare arena, the nature of the patient-physician relationship. It considers what sort of person we should be (our virtues) and expects our character traits to be expressed in our behavior, even if

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our behavior is generally seen as bad or resulting in undesirable consequences. The virtuous oncologist would be expected to choose the best treatment, irrespective of cost. Beneficence differs from virtue ethics in that beneficence does not focus on our character traits (e.g., courage, wisdom, loyalty, generosity, compassion), but is only concerned with the promotion of right over wrong (choice of anemia therapy based on medical evidence versus reimbursement) and the improvement in the condition or welfare of others. When evaluating epoetin or darbepoetin use, financial and ethical considerations become important. Lyman et al. have shown that the costs of cancer-related anemia are great. They compared total medical expenditures of anemic and non-anemic cancer patients and found that anemic patients had significantly higher mean expenditures over 6 months ($62,499) than non-anemic patients ($36,871).15 Therefore, the incentive to minimize overall medical expenditures through treatment of anemia exists. Other studies have evaluated the cost-effectiveness of EPO treatment compared to RBC transfusions and found that EPO treatment is costeffective when measured by both Hb level and quality of life.13,16 In contrast, Smith et al. reported that in the phase III clinical trial setting, quality of life and clinical outcomes were similar among topotecan-treated anemic ovarian cancer patients who received epoetin therapy versus those who did not, while costs were significantly greater if epoetin were used.17 However, Laird suggests that cost-effectiveness involves more than monetary considerations. He argues that improvement of fatigue and quality of life are complex constructs that are difficult to measure.18 Thus, the evidence in the literature about the effectiveness of EPO in improvement of fatigue and its impact on quality of life remains equivocal from Laird’s perspective. Laird attributes the readiness to initiate EPO or darbepoetin therapy to a desire to avoid transfusions, rather than the goal of improving quality of life.18 However, he acknowledges that the limited blood supply, coupled with increasing donor constraints and concerns over the safety of blood products are valid reasons to minimize the total number of transfusions performed. Taken together, these studies suggest that financial considerations and a strong desire to avoid transfusions can lead to overuse of epoetin or darbepoetin among cancer patients.

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Another factor that arguably determines EPO’s overuse relates to increased recruitment of the business model into the medical environment. While the business model is not per se a pariah, it supports the intimate coupling of performance with increased reimbursement goals. In this type of “business” climate, physicians are expected to increase their practice revenues, making overuse of EPO a tempting proposition. Despite the demise of fee-for-service models, potential economic conflicts of interest continue to exist in medical settings where physicians are compensated by their practices for each diagnostic or therapeutic service rendered to a patient. This type of financial19,20 arrangement encourages physicians to increase the number of services that they perform and might increase physicians’ tendency to overuse EPO in the setting where a patient’s insurance will reimburse the physician, even though hemoglobin levels are already at evidence-based targets. Being cognizant of the physical risks of EPO (VTE, decreased overall survival) when used beyond its target hemoglobin in the cancer setting, overuse of this product here raises serious ethical issues. The Hippocratic Corpus exhorts us to primum non nocere (first do no harm) and is the cornerstone of a physician’s ethical duty in terms of delivery of health care to his or her patient. It assumes a relationship with the patient that is grounded in mutual trust, with the patient’s welfare being of paramount importance and never subjugated to financial constraints. The overuse of EPO beyond its target indication or even within its target hemoglobin range where no differential improvement is expected in QOL is at first blush unethical. Underuse of EPO Abroad Utilitarianism The principle of utility states that an action is “right if it produces as much or more of an increase in happiness of all affected by it than any alternative action, and wrong if it does not.”14 Its basis is the idea that pleasure and happiness are intrinsically valuable, that pain and suffering are intrinsically not valued, and that anything else has value only in its causing happiness or preventing suffering.

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Physicians, by training, are non-utilitarian as they are more concerned with maximizing the value (utility) of each individual patient, rather than all patients as a group per se. When physicians are faced with reimbursement concerns that bring utility to one patient, but carries negative downstream economic ramifications for many patients and for the healthcare enterprise in general, physicians choose to proceed. The moral relevance of cost and appropriate use of resources with attendant reimbursement is therefore juxtaposed against another ethical principle – Justice. Justice Medical ethics has long been associated with the investigation of moral questions arising at the intersection of competing values. Justice seeks to inform this investigation and further, to provide plausible answers and guidance, recognizing that certain medical constraints might ethically dictate a standard of using not the best, but the least expensive intervention that is effective and also just.14 In the case of erythropoetin, there are no better substitutes. While iron supplementation is often used adjunctively, it is rarely used as the primary or single therapy, since medical evidence does not support this decision Guidelines for Erythropoietin Use While guidelines for use of epoetin and darbepoetin now exist, it is not known how closely physicians adhere to them. Based on estimates from 2002, in the United States, about 64.5 % of the 1.24 million cancer patients receiving chemotherapy are anemic (Hb levels below 12 g/dL).21 Approximately 26% of these anemic patients received EPO therapy. Among the 475,000 cancer patients who are not anemic, about 8% of them were treated with EPO.21 However, this same study found that the percentage of cancer patients in the U.S. who received EPO therapy varied by Hb level. Thirty-four percent of patients with Hb levels <10 g/dL received EPO, while 13% with Hb levels of 10.1–12.0 g/dL and 4% with Hb levels >12.1 g/dL received EPO.21 The NCCN estimates that in the United States, 67%, 63%, and 82% of patients receiving

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radiotherapy for colorectal, lung and cervical cancer, respectively, developed anemia by the end of treatment.12 The percent of these anemic patients who received epoetin therapy was not reported. In contrast, the European Cancer Anemia Survey (ECAS) evaluated 15,367 cancer patients in Europe and estimated the prevalence of anemia to be 67% after 6 months.13 Of the anemic patients, only 38.9% were treated for anemia with 17.4% receiving ESA therapy, 14.9% received RBC transfusions, and 6.5% received iron supplementation.13 These data suggest that a lower percentage of anemic cancer patients in Europe receive EPO treatment than in the United States, indicating possible underuse of EPO in Europe. Since clinical practice in many European countries is likely to be constrained by fixed national health care budgets, EPO may be underused for patients without high baseline risk for adverse events. Since anemia in these patients may be treated less effectively, European patients might arguably experience lower health related quality of life. Unlike the United States, most European countries have a National Health Service (NHS) system that is organizationally structured to provide access to care to all and to do so in a costeffective manner in an effort to spread care across the population (utility). The NHS is funded by the taxpayer and managed by the Department of Health, which sets overall policy on health issues and maintains responsibility for providing health services to the general public through its conduit, the NHS.22 Here, under-use of an expensive product, such as EPO, is fueled solely by financial constraints that affect all those who impact the system and is not differentially meted out based on health insurance plans or physician incentive/reimbursements. Since physicians are not being provided with economic incentives to limit the administration of EPO to cancer patients in such a setting, no violation of an ethical principle on the part of physicians occurs. On the contrary, under-use of EPO in a health care market such as the United States may raise ethical questions if the motive behind the product’s under-use is based on the type of insurance that a patient has or on the level of reimbursement anticipated from that patient’s health insurer. Many insurance plans require prior authorization before the administration of EPO can proceed and failure to do so can lead to refusal to

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provide reimbursement for the specified service. Such need to obtain prior authorization can be vexing to many physicians and to their staff due to time necessary to deploy staff to obtain these authorizations. Additionally, different providers (Medicare, Medicaid, Blue Cross/Blue Shield) reimburse at different levels. A physician may therefore deviate from current anemia guidelines and withhold EPO treatment from a patient for whom the benefit is clear, with resultant adverse health outcome.23 Here full disclosure should be made to the patient, affording them the opportunity to make an informed decision about their medical care.20,24,25 It is undoubtedly unethical to withhold EPO or GCSF from a patient because of anticipated poor reimbursement. Rationing Physicians must balance the myriad needs of patients with finite material resources. As physicians we ration subconsciously and incessantly. The insurance reimbursement situation, pay for performance, and expensive targeted drug therapies within the cancer arena have made it more difficult to determine the most appropriate ethical course to follow. In the case of the anemic cancer patient, we ration treatment from an economic vantage point – erythropoietin or other modality, even where the erythropoietin is clearly the superior treatment for the anemia and for the ultimate outcome and quality of life of the patient. Medicare reimbursement to physicians is expected to continue to decrease with an expected reduction of 5% slated for 2007. The situation in which physicians find themselves is akin to the so-called “perfect storm.” The complex nature of medical treatment, declining reimbursements for patient care, and the insertion of the business model within the medical enterprise have placed us at the helm of this “perfect storm.” Within this insidious business model, physicians are expected to account for cost and productivity. Furthermore, it is within this model that oncologists must determine when, if, and how to decide on erythropoietin treatment. There are no legal imperatives under which these oncologists work and they must make their decisions with both care and cost in mind. However, while ethics does not carry the force of

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law, it should not be relegated to the minimalist position or solely viewed as an impotent theoretical construct. One could posit, based on the importance of erythropoietin in the treatment of cancerrelated anemia that in most cases withholding erythropoietin may be economically reasonable, but ethically impermissible. Misuse of EPO in Patients at High Risk for Adverse Events The Physician–Patient relationship The physician–patient relationship constitutes the most enduring foundation for making ethical decisions. Physicians need a guiding principle that exceeds professional codes of conduct, pay-forperformance pressures, and cost/reimbursement decisions. Complicating the ethics arena are the economic challenges, including declining reimbursements and pay for performance. Tension now exists between competing principles and competing needs. When do we ration? How do we select care and when do we pair a particular treatment option with a patient or with a patient’s medical condition? These are important questions with ethical underpinnings. The Role of Physicians in Decision Making Physicians should be held to behavioral standards consistent with the primary objective of service to patients through the provision of quality health care, with reimbursement considerations secondary, but not unimportant. How physicians resolve the tension that exists between their two emerging roles: purist economically driven healthcare delivery and ethical decision-making give pause for much reflection, and recruits several ethical principles into the discussion. While cost may be factored into medical decisions and inform the discussion, they must never be allowed to dominate that discussion, considering that physicians’ decisions impact real persons. A broader approach is needed as the discussion must take into consideration the professional economic responsibilities of physicians within the healthcare enterprise. An ethically dominated discussion might undermine these economic elements that are clearly relevant to the resolution of reimbursement driven decisions.

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Areas of investigation not addressed by clinical guidelines include predictive factors for Hb response, tumor progression, and adverse event and toxicity considerations 26 (Table 2). Table 2. Summary of studies that have addressed safety concerns among cancer patients who receive epoetin or darbepoetin. Safety concern Study Product Epoetin and Venous Cochrane darbepoetin thromboembolism Collaboration (2006)/Blue Cross Blue Shield Association (2006)29 Venous Oncologic Drug Epoetin alfa thromboembolism Advisory (Epogen) Committee (ODAC) meeting of the FDA (2005) Venous ODAC meeting Darbepoetin thromboembolism of the FDA alfa (2004)32 Venous ODAC meeting Epoetin alfa thromboembolism of the FDA (Procrit and (2004)33 Eprex) Venous ODAC meeting of Epoetin thromboembolism the FDA (2004)33 beta Venous MM-009/01034 Epoetin alfa thromboembolism

Cancer type All

Anemic Yes

Solid tumors

Yes

Solid tumors

Yes

Solid tumors

Yes

Solid tumors

Yes

Multiple Yes myeloma (in conjunction with lenalidomide) Venous Phase I clinical Darbepoetin Myelodysplasia Yes (in conjunction thromboembolism trial35 with thalidomide) Venous Bohlius/Cochrane Epoetin and Hematological Yes thromboembolism Collaboration darbepoetin malignancy (2006) Poorer survival Henke et al.28 Epoetin Head and neck No beta Poorer survival Leyland-Jones3 Eprex Breast No

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Observational studies that found that Hb levels above 12 g/dL are associated with increased survival and lower relapse rates in cancer patients led researchers to investigate epoetin and darbepoetin administration to cancer patients who were not anemic.27 Henke et al. reported that among head and neck cancer patients undergoing radiotherapy, mortality was significantly greater among those patients who had high target Hb levels: <14 g/dL for women and <15 g/dL for men.28 After 9 weeks of treatment with epoetin beta, the mean Hb level of patients treated with epoetin beta was 15.4 g/dL versus 12.9 g/dL among the placebo patients. Compared to the placebo arm, more patients who received epoetin beta experienced hypertension, hemorrhage, thrombosis and pulmonary embolism.28 In addition, the rate of locoregional tumor progression was higher in patients who received erythropoietin rather than placebo.28 Another study that evaluated the erythropoetin alfa formulation, Eprex, among nonanemic breast cancer patients was terminated prematurely due to a higher incidence of fatal thrombotic and cardiovascular events in patients who received erythropoietin (2.3%) than in patients who received placebo (0.4%).3 More recently, the updated meta-analyses from the Cochrane Collaboration have found that even among anemic cancer patients, use of epoetin or darbepoetin is associated with a 1.7 fold increase in the likelihood of developing venous thromboembolic complications.29 Additionally, this meta-analysis reported a 3-fold increase in the likelihood of VTE in patients with hematological malignancies versus other cancer types. Consequently, concerns about the safety of epoetin and darbepoetin among cancer patients have been raised.30 More recently, the FDA Oncologic Drugs Advisory Committee (ODAC) will review the safety of erythropoietin agents at its meeting May 10–11, 2007.31 In response to these concerns, it is likely that the FDA will soon add a black box warning to the labels of EPO products, specifically for the indication of cancer-related anemia.31 Therefore, the edict to “Do no Harm,” is raised in patients with supra-normal hemoglobin and increased risks for VTE. Here it is clearly unethical to treat these patients as no improvement in outcome or quality of life has been noted. Indeed, it is ethically irresponsible and impermissible to place patients at risk by making decisions to over-treat with EPO based on reimbursement decisions.

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Taken together, the studies we reviewed suggest that in both the United States and Europe there is the potential for overuse, underuse, and misuse of epoetin or darbepoetin among large numbers of cancer patients (Table 3). While reimbursement considerations appear to drive many of these decisions to over-, under- or mis-administer EPO to patients with cancer related anemia, the ethical underpinnings must not be forgotten. Prospective studies that evaluate both the financial and ethical constructs that gird current use of epoetin, darbepoetin, and red blood cell transfusions and the potential toxicities, quality of life impact, and survival outcome among a broad range of cancer patients are sorely needed. Table 3. Summary of factors potentially associated with potential for overuse, underuse, and misuse of epoetin and darbepoetin in the oncology setting. Clinical factor

Economic factor Non-anemic or Financial Overuse minimally anemic incentives cancer patients to minimize anemiaassociated costs High cost Underuse Anemic cancer of EPO patients without high baseline risk therapy; fixed for venous thromboembolism national health care budgets Minimize Anemic cancer Misuse patients with high anemiarelated baseline risk for costs venous thromboembolism through prophylaxis

Concern Excessive health care costs; patient safety Poor quality of life

Geographic region United States

Europe and Canada

Worldwide Death, pulmonary emboli, or deep vein thrombosis

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CONCLUSION Amid the turmoil of the new medical enterprise, physicians frequently find themselves in situations where the ethical “rules” may be unclear. Rarely is there a single ethical issue to resolve. Rather, numerous intertwined issues involving multiple interested stakeholders (insurers, hospitals, patients) clamor for attention, demonstrating how ethical dilemmas are woven into the decisionmaking process and the reimbursement dilemma. In the case of erythropoietin, the medical evidence that informs this treatment decision mandates that ethics support a decision that is girded primarily by altruism and not dictated by reimbursement concerns. REFERENCES 1. Pronzato P. Cancer-related anaemia management in the 21st century. Cancer Treat Rev 32 Suppl 2:S1–S3, 2006. 2. Bohlius J, Weingart O, Trelle S, et al. Cancer-related anemia and recombinant human erythropoietin–an updated overview. Nat Clin Pract Oncol 3:152–164, 2006. 3. Leyland-Jones B: Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol 4:459–460, 2003. 4. Leyland-Jones B, Semiglazov V, Pawlicki M, et al. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol 23:5960–5972, 2005. 5. DAHANCA 10 Trial. The Cancer Letter 33, February 23, 2007. 6. Centers for Medicare and Medicaid Services (CMS). Available at http://www.cms.hhs.gov/home/medicare.asp. Accessed March 14, 2007. 7. Elliot C: Where ethics comes from and what to do about it. Hastings Cent Rep 22:28–35, 1992. 8. Ackerman T, Strong C: Casebook of Medical Ethics. New York, Oxford University Press, 1989. 9. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions, Vol 1. Washington, DC, Government Printing Office, 1982. 10. Callahan S. The role of emotion in ethical decisionmaking. Hastings Cent Rep 18:9–14, 1988.

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11. Rizzo JD, Lichtin AE, Woolf SH, et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J Clin Oncol 20:4083–4107, 2002. 12. Cancer- and treatment-related anemia v.2.2006.Clinical Practice Guidelines in Oncology. http://www.nccn.org/professionals/physician_ gls/PDF/anemia.pdf (accessed October 6, 2006), National Comprehensive Cancer Network, 2006. 13. Repetto L, Moeremans K, Annemans L. European guidelines for the management of chemotherapy-induced anaemia and health economic aspects of treatment. Cancer Treat Rev 32 Suppl 2:S5–S9, 2006. 14. Beauchamp T, Childress J. The Principles of Biomedical Ethics (ed 4th ed). New York, Oxford University Press, 1992. 15. Lyman GH, Berndt ER, Kallich JD, et al. The economic burden of anemia in cancer patients receiving chemotherapy. Value Health 8:149–156, 2005. 16. MacLaren R, Sullivan PW. Cost-effectiveness of recombinant human erythropoietin for reducing red blood cells transfusions in critically ill patients. Value Health 8:105–116, 2005. 17. Smith DH, Adams JR, Johnston SR, et al. A comparative economic analysis of pegylated liposomal doxorubicin versus topotecan in ovarian cancer in the USA and the UK. Ann Oncol 13:1590–1597, 2002. 18. Laird J: Erythropoietin: can we afford to use it? Can we afford not to? Transfus Med 16:204–205, 2006. 19. Armour BS, Pitts MM, Maclean R, et al. The effect of explicit financial incentives on physician behavior. Arch Intern Med 161:1261–1266, 2001. 20. Miller TE, Sage WM. Disclosing physician financial incentives. JAMA 281:1424–30, 1999. 21. Tchekmedyian NS. Anemia in cancer patients: significance, epidemiology, and current therapy. Oncology (Williston Park) 16:17– 24, 2002. 22. NHS in England. Available at http://www.nhs.uk/England/About TheNhs/History/Default.cmsx. Accessed March 6, 2007. 23. GAO: Medicare. Physician Incentive Payments by Prepaid Health Plans Could Lower Quality of Care. Report to the Chairman, Subcommittee on Health, Committee on Ways and Means. U.S. House of Representatives, December 1988. 24. Brody H. Transparency: Informed consent in primary care. Hastings Cent Rep 19, 1989.

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25. Mehlman M. Fiduciary contracting: limitations on bargaining between patients and health care providers. Univ Pittsbg Law Rev 51:365–417, 1990. 26. Birgegard G, Bokemeyer C. New guidelines on anaemia management in patients with cancer: How do these affect clinical practice? Oncology 69 Suppl 2:17–21, 2005. 27. Engert A. Recombinant human erythropoietin in oncology: current status and further developments. Ann Oncol 16:1584–1595, 2005. 28. Henke M, Laszig R, Rube C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 362: 1255–1260, 2003. 29. Bohlius J, Wilson J, Seidenfeld J, et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 98:708–714, 2006. 30. Randal J. FDA panel scrutinizes safety of anti-anemia drugs. J Natl Cancer Inst 96:1061, 2004. 31. Goldberg P. FDA’s ODAC to review EPO Agents in May; SEC probes Amgen delay in study disclosure. The Cancer Letter 33:1, 7–11, 2007. 32. Aranesp (darbepoetin alfa) Safety. Oncologic Drugs Advisory Committee, 2004. 33. Luksenburg H. Evolving safety issues assocaited with erythropoietin products, 2004. 34. R. Niesvizky AS, M. Wang, D. Weber, C. Chen, M. A. Dimopoulos, Z. Yu, Z. Yu, R. Delap, J. Zeldis, R. D. Knight. Increased risk of thrombosis with lenalidomide in combination with dexamethasone and erythropoietin, 2006 ASCO Annual Meeting Proceedings Part I. J Clin Oncol, 7506. 35. Strupp C, Germing U, Aivado M, et al. Thalidomide for the treatment of patients with myelodysplastic syndromes. Leukemia 16:1–6, 2002.

INDEX AAHRPP, see Association for Accreditation of Human Research Protection Programs, Inc. Ackerman and phase I chemotherapy trials, 178 Advance directives and cancer patient, 23–25 living wills and durable power of attorneys and, 21–22 Patient Self-Determination Act (PSDA), 22–23 Albert Wu’s medical mistake definition, 198 Alfred Cushieri classification of errors, 197 Altruism, analysis of pediatric research trial, 180–182 AMA code of medical ethics, 200 American Society of Clinical Oncology, 237 American Society of Colon and Rectal Surgeons, The, 3 American Society of Hematology, 237 Anatomy of Hope:How People Prevail in the Face of Illness, 65 Angelos and Johnston suggestions, 23 Anti-cancer therapy, see Medical treatment, of cancer patient; Palliative medicine, in cancer therapy Applebaum and psychiatric patients in research trials, 178 ASCO, see American Society of Clinical Oncology

ASCO/ASH guidelines, 238 ASCRS, see American Society of Colon and Related Surgeons, The ASH, see American Society of Hematology Assent of child, 105–106 Association for Accreditation of Human Research Protection Programs, Inc., 218 At the Will of the Body, 55 Belief and expectation, role in brain, 66 Blue Cross/Blue Shield Association’s Evidence Based Practice Center in 2002 review, 238 Breast cancer patient study, 36 treatment options for, 37–38 British Medical Journal, 219 Canadian Institutes of Health Research Tri-Council Policy, 221 Cancer anemia EPO overuse in, 239–241 EPO treatment, 237–239 EPO underuse in, 241–242 guidelines for use of EPO, 242–244 and NCCN algorithmic guidelines, 239 and serum hemoglobin (Hb) level, 235 Cancer anemia of ESA’s for treatment, 236

254 clinical guidelines for, 236–239 ethical consideration and, 237 Cancer patients advanced directives and, 23–25 and autonomy, 20–21 clinical trials and, 224–225 and concept of futility, 138–140 health related quality of life (HRQoL), 235 information and reassurances, 34–35 principlism and, 239 and statistical prognosis, 19 statistics and treatment choice, 37–39 survival rate of, 31 therapeutic experiences of, 3–11 See also Medical treatment, of cancer patient Caregiver burden, 83 CFR, see Code of Federal Regulations Charles Weijer approach for clinical research in Canada, 220 Children, as research subjects adolescents, 106–107 assent of the child, 105–106 informed consent, 104–105 justification for participation, 103–104 treatment refusal, 107–109 See also Ethical decision making, in pediatric cancer care Children in non-therapeutic research, 174–175 Children’s Oncology Group (COG), 173 Children with cancer, terminal diagnosis, 183–190 Cicely Saunders’s model of inpatient care, 164–165 Civil Code of Quebec, 220

Index Cleveland Clinic palliative medicine program, 167 Clinical research and cancer patients, 226 Clinical trials and cancer patients awareness, 228–231 Code of Federal Regulations, 174 Communications, physician-patient hope of, 71–73 issue of information, 18–20 medical decision making model, 16–18 paternalism, 14–15 truth and, 15–16 Competence, 96–97 in pediatric oncology, 99–100 Coping behavior and hope, 66 and spirituality, 80 Cross cultural and clinicians, 47–48 Curative/life-prolonging therapy, 162, 164–166 Daniel Kahneman and Amos Tversky study of psychology of risk assessment, 33 Death of Ivan Ilych, The, 29 Denial and hope, 68 Denver-based COPIC malpractice insurance company, 204 Department of Health and Human Services (45 CFR 46), 174 Depression and hope, 69 and spirituality, 83 Diagnostic methods and improvements, 17 Disclosure of information and children, 100–103 Distal errors, 197 Double effect principle, 121

Index Dyergov’s study of bereaved parents, 180 ECAS, see European Cancer Anemia Survey Edmund Pellegrino’s virtue theory of medical practice, 203 EORTC, see European Organization for Research and Treatment of Cancer EPO, see Erythropoietin Epoetin and darbepoetin in oncology adverse effects, 248 safety concerns, 246 Epoetin therapy for anemic cancer patients, 238 Eric Kodish and clinical benefit, 180 Error disclosure content, 208 Erythropoiesis-stimulating agents, 236 Erythropoietin, 236 ESAs, see Erythropoiesisstimulating agents Ethical decision making, in pediatric cancer care case report, 93–94 See also Children, as research subjects Ethical decision making, in pediatrics adult vs. child, in disease prognosis, 95–96 competence, 96–97 role of surrogates, 97–98 Ethics, in medical profession, 3–11 European Cancer Anemia Survey, 243 European Organization for Research and Treatment of Cancer, 238

255 Euthanasia, as response to pain and suffering, 125–127 Exploratory laparotomy case study, 18–19 Ezekiel Emmanuel and framework for clinical research, 219 False hope and its impact, 70–71 FICA© tool, 86 Futility paternalism and informed consent, 139–140 standards with, 138–139 See also Medical treatment, of cancer patient Generalized hope, 68 God concept, 82 Goldman, early stages of disease, 189 Gregoire v. Glucksberg, 129 Haidet and colleagues, SUPPORT study, 23 Harm-causing errors, 198 Health related quality of life (HRQoL), 235 Hippocratic Oath, 117 Hmong worldview, 50 Honesty and dying patients, 73 Hope, of patients as clinical concept, 66–68 communication of, by healthcare professionals, 71–73 coping behavior, 66 and denial, 68 and depression, 69 elements of, 66 false hope and its impact, 70–71 features of, 68 on physiological processes, 66 professional, 74–75

256 as relationship issue, 69–70 and terminal illness, 73–74 Hopelessness and helplessness, 69, 81 Hospice philosophy, 124–125, 164–165 Human erythropoietin (EPO) genes, 236 Humanity in surgery lectureship, 3 ICMJE, see International Committee of Medical Journal Editors Illness as Metaphor, 55 Immanuel Kant, AMA Code of medical ethics, 200 Informed consent, 104–105 Institute of Medicine, 196 Institutional Review Board/Research Ethics Board, 217, 219–220 Institutional review boards, 174 International Committee of Medical Journal Editors, 229 IOM, see Institute of Medicine IOM definition of medical error, 196 IRBs, see Institutional review boards Ivan Ilych and his goals, 29 JCAHO, see Joint Commission on Accreditation of Healthcare Organizations John Banja “medical narcissism”, 202 Joint Commission on Accreditation of Healthcare Organizations, 196 Journal of Clinical Oncology, 72, 138

Index Lamont and Siegler study for advanced care planning in hospitalized patients, 24 Lucian Leape and health policy, 198 M.D. Anderson Cancer Center palliative care program, 167–168 Medical benefit, 16 Medical error definition of, 195 types of, 197 Medical ethics AMA code, 200 and clinical research protocol and consent, 219–220 philosophical analysis, 199–203 Medical profession and ethics, 3–11 Medical treatment, of cancer patient benefits and harms of, 145–148 common medical sense, 140–141 course of, 152 desirable medical treatment, 142–143 goal of, 150–152 irrational and unreasonable decisions in, 143–145 medically acceptable treatment, 141–142 physician’s duty, 143 theoretical sense, 140 types of, 148–150 Michael Miller and phase I trials for child’s prognosis, 178 Michael Reese Hospital in Chicago surveys, 17 Michelson study of families with children in PICU, 180 Morbidity and Mortality (M & M) conference, 205

Index National Health Service (NHS) system, 243 National Placebo Initiative, 222 National Practitioner Data Bank, 204 The Nature of Suffering and the Goals of Medicine, 70 New England Journal of Medicine, 39 “Normal” reactive depression, 69 NPI, see National Placebo Initiative Oath of Maimonides, 117 OCREB, see Ontario Cancer Research Ethics Board ODAC, see Oncologic Drugs Advisory Committee Oncologic Drugs Advisory Committee, 247 Ontario Cancer Research Ethics Board, 223 Optimism, 67 Pain and suffering benefits of hospice, 125 controlling of, 119–121 and euthanasia, 125–127 nature of, 117–118 pain management, 130–132 physician assisted suicide, 127–130 responding to suffering, 122–124 treatment, 121–122 Palliative medicine, in cancer therapy concepts in, 162–166 definition, 160–161 models of, 166–169 Parental autonomy in decision concept, 185–187 Particularized hope, 68

257 Paternalism, 14–15, 139–140 Patient-centered model, of care, 83 Patient Self-Determination Act, 22–23 Paul Ramsey and Richard McCormick and children in non-therapeutic research, 174–175 Pediatric cancer trials phase I, 174 Pediatric oncology, 94 competence, role in, 99–100 disclosure of information, 100–103 ethics with, 98 patients, research trials, 173–174 relationship with family and patient, 99 Pediatric Oncology Group, 179 Peter Angelos’s study on cancer, 31 on information about diagnosis, 31 Physician assisted suicide, 127–130 Physician/investigator’s fiduciary role in clinical trials, 228 Physician–patient relationship Canadian/US institutional review board/Research Ethics Board reform, 221 and communication, 15–16 EPO misuse in patients at high risk for adverse events, 245–248 ethos of community, 50 language problems, 48–49 model, 14–15 normative ethics and, 239–241 NPI activities and, 222 patient benefit, 16 prognosis and medical treatment, 20

258 therapeutic experiences of cancer patient, 3–11 Physicians and disclosure of error, 203 Physicians role in decision making, 245–248 Placebos use in clinical trials, 222 PRIM&R, see Public Responsibility in Medicine and Research Professional hope, 74–75 Proximal errors, 197 PSDA, see Patient Self-Determination Act Public Responsibility in Medicine and Research, 218 Quantity-of-life, 160 Recombinant human erythropoietin, 236 Research ethics and oncology patients, 215–232 RHuEPO, see Recombinant human erythropoietin Sahm and colleagues, survey on cancer patients, healthy patients, nurses and physicians, 24 San Diego Moores Cancer Center model of care, 168 Spiritual history, 85–88 Spirituality definition, 80

Index guidelines for spiritual care, 83–85 and health, 82–83 in healthcare, 79 issues in clinical settings, 81–82 as a patient need, 80 spiritual history, 85–88 spiritual practices, 80 values in, 80 Surrogate decision making, in pediatrics, 97–98 Terminal illness and hope, 73–74 Therapeutic hope, 66 Thomas Krizek medical error study, 197 study on medical error, 204 Treatment refusal and children, 107–109 Treatment strategies and prognosis, 17 Truth-telling, in communication, 13–14 United Kingdom Children’s Cancer Study Group, 179 Virtue ethics and healthcare arena, 239 World Declaration of Geneva, 1948, 117 Yang and colleagues examination study on advance directives, 23