Social and Ethical Decision Making in Biomedicine

Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, Editors

Committee on the Social and Ethical Impacts of Developments in Biomedicine

Division of Health Sciences Policy


Washington, D.C.

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Society's Choices: Social and Ethical Decision Making in Biomedicine SOCIETY'S CHOICES Social and Ethical Decision Making in Biomedicine Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, Editors Committee on the Social and Ethical Impacts of Developments in Biomedicine Division of Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1995

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Society's Choices: Social and Ethical Decision Making in Biomedicine NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support of this project was provided by the Howard Hughes Medical Institute and National Research Council, National Academy of Sciences/National Academy of Engineering independent funds, and Institute of Medicine independent funds. Library of Congress Cataloging-in-Publication Data Society's choices: social and ethical decision making in biomedicine / Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, editors; Committee on the Social and Ethical Impacts of Developments in Biomedicine, Division of Health Sciences Policy, Institute of Medicine. p. cm. Includes bibliographical references and index. ISBN 0-309-05132-0 1. Medical ethics. 2. Bioethics. I. Bulger, Ruth Ellen. II. Bobby, Elizabeth Meyer. III. Fineberg, Harvey V. IV. Institute of Medicine (U.S.). Committee on the Social and Ethical Impacts of Developments in Biomedicine. R724.S598 1995 174'.2—dc209439354 CIP Copyright 1995 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staalichemuseen in Berlin.

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Society's Choices: Social and Ethical Decision Making in Biomedicine COMMITTEE ON THE SOCIAL AND ETHICAL IMPACTS OF DEVELOPMENTS IN BIOMEDICINE HARVEY V. FINEBERG, M.D., Ph.D.,* Chair, Dean, Harvard School of Public Health, Boston W. FRENCH ANDERSON, M.D., Director, USC Gene Therapy Lab, University of Southern California, School of Medicine, Noris Cancer Center, Los Angeles JOHN ARRAS, Ph.D., Associate Professor of Bioethics, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, N.Y. ALEXANDER CAPRON, LL.B.,* University Professor of Law and Medicine, The Law Center, University of Southern California, Los Angeles TROY DUSTER, Ph.D., Director, Institute for the Study of Social Change, University of California, Berkeley ALFRED P. FISHMAN, M.D.,* Chairman, Department of Rehabilitation Medicine, Hospital of the University of Pennsylvania, Philadelphia THEODORE FRIEDMANN, M.D., Professor of Pediatrics and Bioethics, Department of Pediatrics, Center for Molecular Genetics, University of California, San Diego WILLIAM D. FULLERTON,* Consultant to "Health Policy Alternatives," Crystal River, Fla. WALTER HARRELSON, Professor Emeritus, The Divinity School, Vanderbilt University SHEILAJASANOFF, J.D., Ph.D., Professor and Chair, Department of Science and Technology Studies, Cornell University ALBERT R. JONSEN, M.D.,* Chairman, Department of Medical History/Ethics, School of Medicine, University of Washington PATRICIA KING, J.D.,* Professor of Law, Georgetown University Law Center JOANNE LYNN, M.D., Center for the Evaluative Clinical Sciences, Dartmouth Medical School JAMES A. MORONE, Ph.D., Associate Professor, Department of Political Science, Brown University STANLEY REISER, M.D., Ph.D., Director, Program on Humanities and Technology in Health Care, University of Texas Health Sciences Center, Houston DANIEL WIKLER, Ph.D., Professor, Departments of Medical Ethics and Philosophy, University of Wisconsin, Madison *   Member, Institute of Medicine

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Society's Choices: Social and Ethical Decision Making in Biomedicine Staff RUTH ELLEN BULGER, Ph.D., Study Director and Division Director (until August 1993) VALERIE P. SETLOW, Ph.D., Division Director (from August 1993) ELIZABETH MEYER BOBBY, Research Associate PHILOMINA MAMMEN, Study Assistant and Administrative Assistant NANCY DIENER, Budget Analyst

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Society's Choices: Social and Ethical Decision Making in Biomedicine Preface So often, new developments in biomedicine are hailed as panaceas, as answers to problems, as hopes of finally having conquered an adversary. Even when a discovery may lead to a valuable treatment or even a cure for disease, it can also bring with it troublesome social and ethical issues. This report illustrates-through examples like genetic technology, with its power to alter human nature, and health care reform, with its emphasis on cost control-how developments in biomedicine can affect the fabric of society in significant and lasting ways. The report explores mechanisms for confronting these challenges and describes the strengths and weaknesses of various approaches to social and ethical deliberation. Appreciating the subjective nature of their own judgments, members of the committee endeavored to synthesize the available literature, the judgments of its consultants, and the relevant experiences of its members into a thoughtful analysis of mechanisms for bioethics deliberation. The result is a report that differs from many Institute of Medicine reports in that it constitutes an interpretive essay rather than a predominantly data-based analysis. The development of renal dialysis and transplantation technologies is a salient example. Dialysis and transplantation were (and are today) tremendous advantages for patients with permanent kidney failure, because the procedures gave them many more years of life than they would have had prior to the advent of these technologies, when a diagnosis of endstage renal disease meant certain death. When more patients needed the technology than could be treated, however, society was faced with a troublesome question: How do we decide who should benefit from these life-

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Society's Choices: Social and Ethical Decision Making in Biomedicine saving technologies, and who should die? This question stimulated philosophers and theologians to study the criteria for fair allocation of a lifesaving resource. Is it ethical, they asked, to choose persons on the basis of their social worth or by a lottery? At the same time, a political response to the problem began to build momentum to cover affected patients under Medicare. Congress passed such legislation in 1972. In so doing, it removed the financial barrier to access yet left untouched the remaining social and ethical quandaries. The arguments of the philosophers and theologians were set aside as no longer relevant. Society continues today to struggle with many of the questions related to allocation of scarce lifesaving technologies. Often individuals making biomedical decisions must contend with personal moral dilemmas: a woman who is pregnant with a desired child learns that the fetus she carries is afflicted with a serious genetic or congenital disorder and agonizes over whether she should have an abortion; parents agonize about discontinuing life support for a child who the doctors say has permanently lost all brain function. These are deeply personal dilemmas, and, as a rule, American society has given latitude to such private choices. We have made our own the dictum of the British philosopher, John Stuart Mill, who wrote a century ago, The individual is not accountable to society for his actions, insofar as these concern the interests of no person but himself. (Mill, On Liberty, 1859) However, the qualifying clause, "in so far as these concern the interests of no person but himself" may loom large. Indeed, even when individual choices may benefit another, we may hesitate to endorse them. Thus, the prospect that some person ill with a neurological or metabolic disorder might be cured by transplantation of tissue from an aborted fetus, or that the organs of a brain-dead child might save the life of another, immediately raises ethical questions that go beyond the personal and private. They become matters of public policy because other parties now enter into the range of those who can be harmed or can benefit. Examples such as these suggest that ethical decisions that are exclusively matters for personal deliberation may be exceptional in modern biomedicine. Despite the difficulty of resolving ethical dilemmas in the public sphere, society has made notable progress in the past two decades in confronting the social and ethical impacts of developments in biomedicine, partly to the credit of a number of "ethics" bodies. The work of many of these bodies, including the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission), and

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Society's Choices: Social and Ethical Decision Making in Biomedicine the Human Genome Project's Ethical, Legal, and Social Implications (ELSI) Working Group, among others, is described in this report. While the contributions of these groups have been significant, their work is not complete. Technologies and practices in biomedicine continue to evolve, and as they do, novel social and ethical quandaries will undoubtedly take shape. Moreover, many of the social and ethical dilemmas that arose in the past are still in need of resolution. In fact, a principal motivating factor behind this report was indeed the fact that little public bioethics activity took place in the 1980s when the country was sharply divided on several ethical issues. After the closing of the President's Commission, no mechanisms for public discussion and consensus building were being employed effectively. The charge to this committee had two parts, the first of which was to assess the mechanisms employed by our society to deliberate social and ethical issues stemming from developments in biomedicine. The committee's first step in addressing this charge was to come to an understanding of the circumstances defining such issues. The committee recognized early in its deliberations that not all ethical dilemmas related to biomedical developments have resulted from a new discovery or novel technology. Some scientific developments diffuse into medical practice quickly, and ethical issues related to these developments get overlooked. The development becomes part of accepted practice and, while not novel, ethical quandaries about the application of the development remain and may eventually assert themselves. Techniques of assisted reproduction, such as in vitro fertilization, provide an example. Social and ethical quandaries can also be raised when numerous small developments accumulate to present a novel situation. An example lies in this country's growing population of elderly persons. Immunization and antibiotics have reduced the risk of death due to infectious disease; surgical advances save more and more people from early death due to cardiovascular disease and cancer. The aggregate effect of these and other medical advances has been the prolongation of life, which in turn raises social and ethical concerns about quality of life and end-of-life care. Lastly, social and ethical dilemmas can arise from organizational innovation and change. As our society restructures its health care system, for example, ethical issues related to allocation and rationing of health resources will undoubtedly surface. The second part of the committee's charge was to provide guidance to professionals, institutions, and the general public about utilizing and improving existing mechanisms for deliberation and, where applicable, creating new mechanisms. The value of such mechanisms was clear to this committee from the outset, as was the idea that the more our society can recognize and effectively deal with the social and ethical impacts of devel-

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Society's Choices: Social and Ethical Decision Making in Biomedicine opments-through whatever mechanism-the greater the likelihood that these developments will affect society positively. One of the key steps in the committee's work was to identify and review the groups that have functioned in this capacity in the past. Several groups convened during the past two decades to deliberate ethical issues in biomedicine have been widely recognized as having made important contributions. The impact of these groups is evident in, for example, the enduring nature of their guidance on the protection of human research subjects (National Commission) and the continued citation of their arguments in legal cases pertaining to termination of life-sustaining treatment (President's Commission). In addition to reviewing the work of these well known groups, the committee explored the efforts of a number of other bioethics institutions whose impact has been less conspicuous. It did so with the recognition that bioethics deliberation takes place at many levels: national, state, community, institutional, and individual. The committee found that there were lessons to be learned at each level about the integration of moral reasoning into decisions in medicine and health. The committee apprehended that just as there are various forms and styles of bioethics deliberation, so are there various definitions of success. Success may be the fulfillment of a group's intended function, which may take numerous different forms; it may be the citation of a group's work in courts and classrooms; it may be the translation of a group's recommendations into legislation; it may be the mere stimulation of thought among others. Success may also be in the eye of the observer; a group may be perceived as successful by one person or faction and not by another, depending upon what each expected the group to achieve. The members of the committee brought to their task a wide range of expertise. Several had served as members or staff of ethics bodies of the past, such as the National Commission and the President's Commission. Several were active members of ethics bodies such as the ELSI Working Group and the New York State Task Force on Life and Law. Their fields of expertise covered public health, basic science research, bioethics, law, social science, medicine, theology, medical history, clinical sciences research, political science, and science and technology studies. The committee also benefitted from the expertise of other professionals not on the committee. Papers were commissioned on a variety of topics, including the implications of labeling an issue an ethical issue, the value of consensus, and the dynamics of moral reasoning in public. The committee discussions stimulated by these papers were unfailingly enlightening and helped shape the orientation of the report. The 12 papers commissioned by the committee are compiled in Part II of this report. In an attempt to understand the current environment in which policy-making in science and health takes place, the committee also invited the contributions of

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Society's Choices: Social and Ethical Decision Making in Biomedicine several people from federal health and science agencies who balance scientific and ethical concerns on a daily basis. Their insights into the kinds of guidance needed by the scientific community were especially valuable. In sum, what is presented in this volume is a historical and social analysis of public moral reasoning in medicine and health, from which this committee has drawn conclusions, principles, and recommendations based on its shared judgments. The report is intended to serve as a source of ideas for those wishing to utilize or redefine mechanisms for considering the social and ethical impacts of developments in biomedicine. It sheds new light on criteria that contribute to the success of such mechanisms at a variety of levels and with a variety of intended functions. It speaks to the critical importance of forethought and communication in turning developments into "advances." It is the committee's sincere hope that policymakers, scientists, health care providers, patients and their families, students, and others concerned with the social and ethical impacts of biomedical developments will find the report valuable. Harvey V. Fineberg, M.D., Ph.D., Chair

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Society's Choices: Social and Ethical Decision Making in Biomedicine Acknowledgments The committee wishes to express its gratitude to many individuals who helped during the course of this study. They included the authors of the background papers published with this volume, those who wrote drafts of materials used in the text, including Beth Kosiak, Katherine Taylor, and Roger Bulger, and the many individuals who shared their insights with the committee, particularly Michael Yesley, Eric Juengst, Jay Moskowitz, and Sandy Chamblee. The committee would like to thank Philomina Mammen, study assistant, for her unfailing help in planning and logistics, materials distribution, manuscript and report preparation, and general support to the committee. The committee members also appreciated the many letters we received from scientists concerning the issue and the processes that are currently being followed in their areas of science. These individuals included Alan R. Fleischman, M.D.; Fred Rosner, M.D., F.A.C.P.; Neil A. Hotzman, M.D., M.P.H.; Beverly Torok-Storb, Ph.D.; David W. Martin, Jr., M.D.; Alvin H. Moss, M.D.; Norman G. Levinsky, M.D.; Arnold S. Relman, M.D.; Nancy Boucot Cummings, M.D.; Robert S. Balaban, Ph.D.; Robert G. Shulman, Ph.D.; Gary Nabel, M.D.; and Ralph Crawshaw, M.D. Thanks also to Enriqueta Bond for her support and advice during the study process, Paul Phelps for his improvements and editing of the report, Mike Edington for his help with the publication of the manuscript, Claudia Carl for coordination of the review process, and Nancy Diener for budget oversight. The committee expresses its special appreciation to Elizabeth Meyer

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Society's Choices: Social and Ethical Decision Making in Biomedicine Bobby and Ruth Bulger for their excellent and constant support. Their contributions permeate this report, which would have been a different and much diminished product without their participation. Finally I would like to thank the members of the committee for their generous sharing of time and knowledge and their stimulating insights expressed during what were very productive meetings of the group. Harvey V. Fineberg, M.D., Ph.D., Chair