BIOMEDICAL POLITICS

Kathi E. Hanna, Editor

Division of Health Sciences Policy

Committee to Study Biomedical Decision Making

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1991



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BIOMEDICAL POLITICS BIOMEDICAL POLITICS Kathi E. Hanna, Editor Division of Health Sciences Policy Committee to Study Biomedical Decision Making INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1991

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BIOMEDICAL POLITICS 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 competences 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 National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Frank Press is president of the National Academy of Sciences. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Samuel O. Thier is president of the Institute of Medicine. Support for this activity was provided by the Howard Hughes Medical Institute. The opinions and conclusions expressed here are those of the authors and do not necessarily represent the views of the Howard Hughes Medical Institute, the National Academy of Sciences, or any of their constituent parts. Library of Congress Cataloging-in-Publication Data Biomedical politics / Kathi E. Hanna, editor ; Division of Health Sciences Policy, Committee to Study Biomedical Decision Making, Institute of Medicine. p. cm. Includes bibliographical references and index. ISBN 0-309-04486-3 1. Medical policy—Case studies. 2. Health planning—Case studies. I. Hanna, Kathi E. II. Institute of Medicine (U.S.). Committee to Study Biomedical Decision Making. [DNLM: 1. Decision Making. 2. Health Policy—United States. 3. Politics—United States. WA 540 AA1 B52] RA393.B48 1991 362. 1—dc20 DNLM/DLC for Library of Congress 91-18394 CIP Copyright © 1991 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purpose of official use by the United States Government. 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 Staatlichemuseen in Berlin.

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BIOMEDICAL POLITICS COMMITTEE TO STUDY BIOMEDICAL DECISION MAKING CARL W. GOTTSCHALK (Chair), Kenan Professor of Medicine and Physiology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina PAUL BERG, Director, Beckman Center for Molecular and Genetic Medicine and Willson Professor of Biochemistry, Stanford University, Stanford, California PETER F. CARPENTER, Visiting Scholar, Center for Biomedical Ethics, Stanford University, Stanford, California LEON EISENBERG, Presley Professor and Chairman, Department of Social Medicine, Harvard Medical School, Boston, Massachusetts WALTER HARRELSON, Distinguished Professor of Hebrew Bible, emeritus, The Divinity School, Vanderbilt University, Nashville, Tennessee WILLIAM HUBBARD, Jr., Retired President, The Upjohn Company WILLIAM R. KENNEDY, Professor of Neurology, University of Minnesota Health Center, Minneapolis, Minnesota PATRICIA A. KING, Professor of Law, Georgetown University Law Center, Washington, D.C. ERNEST R. MAY, Charles Warren Professor of History, Kennedy School of Government, Harvard University, Cambridge, Massachusetts DOROTHY NELKIN, Professor, Department of Sociology and Affiliated Professor, School of Law, New York University, New York, New York STANLEY JOEL REISER, Griff T. Ross Professor of Humanities and Technology in Health Care, University of Texas Health Science Center, Houston, Texas PAUL SLOVIC, President, Decision Research and Professor of Psychology, University of Oregon, Eugene, Oregon STAFF RUTH ELLEN BULGER, Division Director, Division of Health Sciences Policy KATHI E. HANNA, Study Director CATHARINE CHETNEY, Senior Secretary LOUISE GILLIS, Senior Secretary LEAH MAZADE, Staff Editor SHELLEY MEYERS, Senior Secretary APRIL POWERS, Senior Secretary

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BIOMEDICAL POLITICS This page in the original is blank.

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BIOMEDICAL POLITICS Preface Scientists like to believe that they operate in a rational world, one in which interpretations and predictions are based on objective data and evaluated through a systematic process. While some question whether these suppositions hold true for science, they certainly fall apart when science becomes a public issue, as it so often does in biomedicine. Decisions about how to proceed with the funding, ordering, and use of biomedical research are made in the public arena. The interests of scientists, regulators, politicians, patients, practitioners, and interest groups converge and often clash. These clashes may slow the progression of science and medicine while simultaneously advancing moral, ethical, or democratic causes. Sometimes, the interests of all groups can be advanced. In other cases, rigid deadlock occurs with little movement in any direction. Is there a better way by which to deal with controversial biomedical issues confronting us today? Can we better anticipate the forces that will emerge on the various sides of an issue, or are we destined to muddle through and make policy incrementally and contentiously? These were some of the questions posed in the summer of 1989 to our committee, a group of individuals with diverse backgrounds and experiences. We were given the task of using case studies as a first step toward answering some of these questions. This document is the result of our efforts. As we chose the topics for case study we were mindful of the fact that we were exploring possibilities, not necessarily testing hypotheses. We knew we needed to understand in great

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BIOMEDICAL POLITICS detail how several decisions were made before we could attempt to postulate guidelines or prescriptions for better decision making. What we found was both illuminating and complex. The politics of decision making are easily described but difficult to predict. Each decision or set of decisions faces different paths, publics, and constraints, as the cases in this book so beautifully demonstrate. In our deliberations, we stopped short of recommending a normative approach to decision making. Case study methodology militates against such an approach. What we chose to do was define areas of research to be examined that would move the study of decision making to a more analytical level. Our greatest contribution may well be providing six individuals the opportunity to tell compelling stories about how we arrive at public biomedical decisions. ACKNOWLEDGMENTS The committee thanks all who contributed to its work. We greatly appreciate the opportunity provided by the Howard Hughes Medical Institute to investigate the process of biomedical decision making. The committee is grateful to the six individuals who prepared and presented the case studies. These studies were the information base for the committee's deliberations. We wish especially to thank and to acknowledge the contributions of Kathi E. Hanna, the study director and editor. With the able assistance and advice of Ruth E. Bulger, division director, she planned and organized the meetings, analyzed the data, edited drafts, and prepared the Introduction and Conclusions sections. The project was also assisted by the excellent support work of Catharine Chetney, Shelley Meyers, Louise Gillis, and April Powers, and the thorough copyediting of Leah Mazade. Carl W. Gottschalk, Chair Committee to Study Biomedical Decision Making

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BIOMEDICAL POLITICS Contents     Introduction   1     Unproven AIDS Therapies: The Food and Drug Administration and ddI Jeffrey Levi   9     Commentaries: Leon Eisenberg   38     Peter F. Carpenter   41     A Political History of RU-486 R. Alta Charo   43     Commentaries: William Hubbard   94     Peter F. Carpenter   97     The Human Genome Project: The Formation of Federal Policies in the United States, 1986-1990 Robert Mullan Cook-Deegan   99     Commentaries: Paul Berg   169     Ernest R. May   173

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BIOMEDICAL POLITICS     Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972 Richard A. Rettig   176     Commentaries: Carl W. Gottschalk   209     Stanley Joel Reiser   212     Deliberations of the Human Fetal Tissue Transplantation Research Panel James F. Childress   215     Commentaries: Patricia A. King   249     Walter Harrelson   255     Asilomar and Recombinant DNA: The End of the Beginning Donald S. Fredrickson   258     Commentaries: Dorothy Nelkin   299     Paul Slovic   302     Conclusions   308     APPENDIXES       A.  The Public and the Expert in Biomedical Policy Controversies Stanley Joel Reiser   325     B  Biographical Notes on Authors and Commentators   332     INDEX   339