Xenotransplantation

Science, Ethics, and Public Policy

Committee on Xenograft Transplantation: Ethical Issues and Public Policy

Division of Health Sciences Policy

Division of Health Care Services

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1996



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--> Xenotransplantation Science, Ethics, and Public Policy Committee on Xenograft Transplantation: Ethical Issues and Public Policy Division of Health Sciences Policy Division of Health Care Services INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.1996

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--> NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 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 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 for this project was provided by The Greenwall Foundation, the Food and Drug Administration (Award No. FDA D66112 00 95 TD 00), the Health Resources and Services Administration (Award No. 103HR941095P000-000), and the Centers for Disease Control and Prevention (Award No. 0009564092). Funds were provided by the National Institutes of Health through the National Cancer Institute (Award No. 263-MQ-436187), the National Institute of Diabetes, Digestive, and Kidney Diseases (Award No. 263-MK-521072) the National Heart, Lung and Blood Institute (Award No. 263-FJ-520288), and the National Institute of Allergy and Infectious Diseases (Award No. N01-OD-4-2139). Additional funds were provided by the U.S. Department of Defense (Award No. N00014-95-1-0920), the Charles River Laboratories, the W.R. Grace and Company-Connecticut, and the Howard Hughes Medical Institute. Additional support for dissemination of this report was provided by The Greenwall Foundation. The views presented in this report are those of the Committee on Xenograft Transplantation and are not necessarily those of the funding organizations. International Standard Book Number: 0-309-05549-0 First Printing: July 1996 Second Printing: May 1997 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington Metropolitan Area). Copyright 1996 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.

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--> COMMITTEE ON XENOGRAFT TRANSPLANTATION: ETHICAL ISSUES AND PUBLIC POLICY NORMAN G. LEVINSKY (Chair),* Wade Professor and Chairman, Department of Medicine, Boston University Medical Center NANCY L. ASCHER, Chief, Liver and Kidney Transplant Services, University of California, San Francisco ROBERT A. BURT,* Alexander M. Bickel Professor of Law, Yale University Law School CLIVE O. CALLENDER, Professor and Chairman, Department of Surgery, and Director, Transplant Center, Howard University Medical College ROGER EVANS, Head, Section of Health Services Evaluation, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota DENISE FAUSTMAN, Director, Immunobiology Laboratories, Massachusetts General Hospital, and Harvard Medical School RENEE C. FOX, * Annenberg Professor of Social Sciences, Department of Sociology, University of Pennsylvania JOAN K. LUNNEY, Research Leader, The Immunology and Disease Resistance Laboratory, Agriculture Research Service, U.S. Department of Agriculture, Beltsville, Maryland MARIAN G. MICHAELS, Assistant Professor of Pediatrics and Surgery, Children's Hospital of Pittsburgh, and University of Pittsburgh School of Medicine STEPHEN MORSE, Assistant Professor of Virology, The Rockefeller University KEITH REEMTSMA, Professor of Surgery, Columbia-Presbyterian Medical Center, New York DAVID ROTHMAN, Professor of Social Medicine and Director, Center for the Study of Society and Medicine, Columbia College of Physicians and Surgeons, Columbia University HAROLD Y. VANDERPOOL, Professor of History and Philosophy of Medicine, Institute for the Medical Humanities, University of Texas Medical Branch, Galveston *   Member, Institute of Medicine.

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--> Staff VALERIE P. SETLOW, Director, Division of Health Sciences Policy CONSTANCE PECHURA, Co-Study Director, Director, Division of Neuroscience and Behavioral Health RALPH DELL, Co-Study Director, Professor of Pediatrics, College of Physicians and Surgeons, Columbia University YVETTE BENJAMIN, Research Associate KATHLEEN LOHR, Director, Division of Health Care Services (through February 1996) CLYDE BEHNEY, Director, Division of Health Care Services (as of February 1996) LINDA A. DEPUGH, Administrative Assistant MARY J. BALL, Project Assistant NANCY DIENER, Financial Associate

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--> Contents     EXECUTIVE SUMMARY   1 1   SETTING THE STAGE   6     Introduction,   6     Study Process and Report Organization,   8     Approaching Questions of Opportunities and Risks,   9     The Potential Benefits of Xenotransplantation,   10     Risk: Precedent and Uncertainty,   15 2   ASSESSING THE SCIENCE BASE   17     Introduction,   17     Stages of the Immune Response,   18     Progress in Molecular and Cellular Biology,   21     Novel Therapeutic Approaches,   26     Limitations of Immunosuppression in Xenotransplantation,   26     Modification of the Source Animal,   27     Modification of the Host,   33     Modification of the Graft: Encapsulation,   37 3   INFECTIOUS DISEASE RISK TO PUBLIC HEALTH POSED BY XENOGRAFTING   39     Animal Infections and Xenotransplantation,   40     Basis for Public Health Concern,   42     Methods of Risk Evaluation,   45     Detection Methods,   52

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-->   Need for a Registry, 54   Summary, 56 4  ETHICS AND PUBLIC POLICY 57   Patients, Ethics, and Society, 57   Patients' Perspectives, 57   Informed Consent, 62   Justice and Fairness Issues: Organ Allocation and Research, 64   Social Acceptance of Xenotransplants, 68   Social Acceptance of Infectious Disease Risk, 70   Value and Use of Animals, 72   Ethical Theory, 72   History of Social Responses to Xenotransplantation, 75   A Moderate Ethical Perspective of Xenotransplantation, 77   Application to Xenotransplantation, 77   Economic Issues Regarding Xenotransplants, 78   Aggregate Expenditures for Organ Transplantation, 78   Transplant Procedure Expenses, 79   Ethics and Public Policy, 80   Expenditures for Xenotransplantation, 80   Insurance Coverage, 81   Impact of Managed Care, 83   Justice, Fairness, and the Ability to Pay, 84   Reviewing and Monitoring Xenotransplantation, 85   FDA Regulation of Xenotransplantation, 88   Current Regulatory Framework, 88 5  CONCLUSIONS AND RECOMMENDATIONS 92  REFERENCES 97  APPENDIXES A  Workshop Agenda, 103 B  List of Participants, 111 C  Immunosuppression in Allotransplantation, 123

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