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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
HIV AND THE BLOOD SUPPLY
AN ANALYSIS OF CRISIS DECISIONMAKING
Lauren B. Leveton, Harold C. Sox, Jr., and Michael A. Stoto, Editors
Committee to Study HIV Transmission Through Blood and Blood Products
Division of Health Promotion and Disease Prevention
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
Washington, D.C.
1995
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
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 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 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 study was provided by the Office of the Assistant Secretary of Health, Department of Health and Human Services (contract no. 282-93-0045).
Library of Congress Cataloging-in-Publication Data
HIV and the blood supply : an analysis of crisis decisionmaking / Committee to Study HIV Transmission Through Blood and Blood Products, Division of Health Promotion and Disease Prevention, Institute of Medicine ; Lauren B. Leveton, Harold C. Sox, Michael A. Stoto, editors.
p. cm.
Includes bibliographical references and index.
ISBN 0-309-05329-3
1. AIDS (Disease)—United States. 2. Blood banks—Risk management—United States. 3. Blood banks—Law and legislation—United States. 4. Medical Policy—United States. I. Leveton, Lauren B. II. Sox, Harold C. III. Stoto, Michael A. IV. Institute of Medicine (U.S.) Committee to Study HIV Transmission Through Blood and Blood Products.
RA644.A25H579 1995
362.1’969792—dc20 95-20469
CIP
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking is available for sale from the
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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 logo-type by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemusseen in Berlin.
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
COMMITTEE TO STUDY HIV TRANSMISSION THROUGH BLOOD AND BLOOD PRODUCTS
HAROLD C. SOX, Jr. (Chair),
Dartmouth Medical School
SHULAMITH BAR-SHANY,
Magen David Adom Blood Bank, TelAviv, Israel
DAVID BLUMENTHAL,
Massachusetts General Hospital, Boston
ALLAN M. BRANDT,
Harvard Medical School
BARBARA A. DEBUONO, State Health Commissioner,
New York Health Department, Albany
MARTHA DERTHICK,
University of Virginia
ROGER DETELS,
University of California, Los Angeles
WILLIAM DULANY,
Dulany & Leahy, Westminster, Maryland
MARK FEINBERG,
University of California, San Francisco
JERRY MASHAW,
Yale Law School
DOROTHY NELKIN,
New York University
MADISON POWERS,
Kennedy Institute of Ethics, Georgetown University
IRWIN M. WEINSTEIN,
Hematologist, Los Angeles, California
CAROL O'BOYLE WILLIAMS,
Minnesota Department of Health, Minneapolis
Project Staff
MICHAEL STOTO, Director,
Division of Health Promotion and Disease Prevention
LAUREN LEVETON, Study Director
CYNTHIA ABEL, Program Officer
LAURA COLOSI, Research Assistant
KRISTINA BECKER, Project Assistant
DONNA THOMPSON, Division Assistant
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Preface
The transmission of HIV through the blood supply in the early 1980s has led to considerable concern and controversy. Many individuals with hemophilia and many recipients of blood transfusions were infected with HIV through treatment with contaminated blood and blood products before there was an HIV antibody test for screening these products. These individuals—and their families, some of whom also became infected—face considerable suffering and emotional and financial hardship as a result. They believe they were betrayed by the very people and organizations with whom they had entrusted their safety. They ask if human error, or conflicting motivations, led to this tragic course of events. These questions become even more salient in so far as threats to the safety of the blood supply persist today (e.g., because of Creutzfeldt-Jakob disease, hepatitis C, and cytomegalovirus) (IOM 1992).
In April 1993, in response to concerns voiced by the hemophiliac community, Senators Edward Kennedy (D-MA), Robert Graham (D-FL), and Representative Porter J. Goss (R-FL) requested that Secretary of Health and Human Services Donna Shalala open an investigation into the events leading to the transmission of HIV to individuals with hemophilia from contaminated blood products. The Secretary agreed that it would be useful to gain a more complete understanding of the use of blood and blood products for the treatment of individuals with hemophilia and those receiving transfusions in the early years of the AIDS epidemic. Thus, with the intention of preparing for future threats to the blood supply, the Department of Health and Human Services requested that the Institute of Medicine (IOM) establish a committee to study the transmission of HIV through the blood supply. As a result, the Committee to Study HIV Transmission Through Blood and Blood Products was formed. Through this historical analysis, the Department of Health and Human Services
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
expects to improve both decisionmaking and public health policy in meeting future challenges to the blood supply.
To carry out this year-long study, the IOM established a committee of 14 people. The creation of an IOM committee emphasizes the importance of providing an objective and impartial review of the decision-making processes and policies that surrounded the contamination of the blood supply with HIV. The Committee was asked to examine the decisions made from 1982 through 1986 to safeguard blood and blood products, and to evaluate the actions taken to contain the AIDS epidemic. The Committee held four meetings in which members formulated explanations and discussed information that had been collected to test their hypotheses. This report, the product of the Committee's efforts, attempts to provide both a comprehensive account of the events that led to the contamination of the U.S. blood supply and a critical assessment of the difficult decisions that were made in the context of the uncertainty of this period. This report does not seek to determine liability or affix blame for any individual or collective decisions regarding HIV transmission through blood or blood products during this time period. The Committee's conclusions and recommendations are intended to provide future leaders who will have responsibility for the blood supply with lessons gained from the experiences of those who tried to slow the tide of the AIDS epidemic among recipients of blood and blood products. The Committee undertook this assignment fully aware of the benefits and risks of hindsight. Hindsight offers an opportunity to do better the next time. The risk of hindsight is unfairly finding fault with decisions made by people who had to act long before scientific knowledge became available to dispel their uncertainty. To avoid this risk, the Committee has made every effort to conduct a thorough and objective review of what was known during 1982-1986 about the transmission of HIV through the blood supply. The Committee recognized the importance of conducting an organizational analysis of the major players involved in the blood supply system and attempted, in some instances, to understand and describe their various roles, responsibilities, and responses.
To understand the views of the many organizations involved in the blood supply, the Committee's first meeting included an opportunity to hear representatives of the Office of the Assistant Secretary for Health of the U.S. Public Health Service, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the American Association of Blood Banks, the Council of Community Blood Centers, the American Blood Resources Association, the American Red Cross, the National Hemophilia Foundation (NHF), the Committee on Ten Thousand, the HIV/Peer Association, and congressional staff of Senator Graham and Representative Goss. The Committee's second meeting included a public hearing in which the Committee heard presentations from interested parties. Fifty-nine speakers provided oral testimony to the Committee and an additional 50 provided written statements. A transcript of the public hearing is available
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
through National Technical Information Services (Record Locator No. PB95142345). A list of all individuals who provided oral and written testimony appears in Appendix B. The Committee carefully considered all of this testimony as it formulated its conclusions and recommendations over the course of the following two meetings.
One of the advantages of conducting this study at this time is that many of the key participants in the 1982-1986 decisionmaking were available to speak to the Committee and staff. The Committee believed it was critical to hear firsthand accounts of the assumptions and beliefs that influenced critical decisions about the safety of the blood supply. Fact-finding interviews were held with 76 individuals knowledgeable about all aspects of the blood supply system. These interviews included representatives of FDA, CDC, NIH, NHF, the Office of the Assistant Secretary of Health, industry, and blood banks; physicians and scientists; and individuals with hemophilia. A list of all the people the Committee interviewed appears in Appendix A. The Committee also benefited from expert advice and background papers provided by consultants in plasma fractionation, blood supply systems, anthropology, risk assessment, virology, and organizational behavior. The Committee and staff also reviewed over 700 documents provided by each of the major organizations involved and other sources. Some of the key documents not readily available elsewhere are provided in Appendix D. Other documents reviewed by the Committee are available through the archives of the National Academy of Sciences.
A special acknowledgment is extended to those people who wrote background papers for the study—Jeffrey McCullough (whose paper provided much of the information contained in Chapter 2), Salman Kashevjee, Sheri Weiser, and Arthur Kleinman—and those who helped the Committee obtain important documentation—Val Bias, Wendy Donath, Corey Dubin, Bruce Evatt, Joseph Fratantoni, William Hammes, Dana Kuhn, Beth Leahy, Bruce Lesley, Jeanne Lusher, Clyde McAuley, Dick Merritt, Marla Persky, Andrea Posner, Dick Valdez, Jonathan Wadleigh, and many others. The Committee would also like to give special thanks to Lauren Leveton, Study Director, for her tireless efforts and guidance throughout the study. Thanks are also extended to the professional staff, Laura Colosi, Cynthia Abel, Kristina Becker and to summer law student intern Kathryn Astarita, for their commitment, assistance, and insight. Finally, the Committee thanks Michael Stoto, Director of the Institute of Medicine's Division of Health Promotion and Disease Prevention, for his contributions to this study.
REFERENCE
Institute of Medicine. Emerging Infections. Washington, D.C.: National Academy Press, 1992.
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Contents
EXECUTIVE SUMMARY
1
1
INTRODUCTION
19
HIV Infection via Blood Transfusion
21
The Committee's Charge
22
Organization of the Report
24
2
THE U.S. BLOOD SUPPLY SYSTEM
25
Introduction
25
Blood and Blood Products
25
Blood Collection Organizations
34
Professional Associations
36
Hemophilia Organizations
38
Role of the U.S. Public Health Service
41
Blood and Blood Product Regulation
47
Regulatory Authority of the FDA
51
Summary
53
3
HISTORY OF THE CONTROVERSY
57
Introduction
57
The Risk of AIDS
60
Immediate Responses to Evidence of Blood-Borne AIDS Transmission
70
Reconsidering the Evidence: Further Attempts to Formulate Policies
74
Research Activities
76
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
4
PRODUCT TREATMENT
81
Introduction
81
Critical Time Period: 1970-1983
83
Analysis and Conclusions
92
Summary
95
Afterword
96
5
DONOR SCREENING AND DEFERRAL
101
Introduction
101
Donor Screening Practices
103
Analysis and Findings
105
Conclusions
122
Afterword
128
6
REGULATIONS AND RECALL
135
Introduction
135
Framework of Analysis
136
Findings and Conclusions
142
Influence and Responsibilities of Other Organization
160
The Advantages of Marginal Thinking
163
Summary
166
7
RISK COMMUNICATION TO PHYSICIANS AND PATIENTS
169
Introduction
169
Framework for Analysis
170
Risk Reduction Options
175
Case Studies
181
Obstacles to Communication
192
Conclusions
201
8
CONCLUSIONS AND RECOMMENDATIONS
207
General Conclusions
207
Recommendations
217
APPENDIXES
A Individuals Interviewed by the Committee
239
B Individuals Providing Oral and Written Testimony
243
C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Assessment, Clinical Options, and NHF Actions
247
D Key Documents Provided to the Committee
263
E Glossary of Acronyms and Terms
303
F Committee and Staff Biographies
315
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
INDEX
323
TABLES AND FIGURES
Tables
2.1
Major Organizations Comprising the Blood Supply System and Their Functions
26
2.2
Components Produced by Blood Banks and the Medical Use of the These Components
29
2.3
Plasma Derivative Products and Their Uses
32
3.1
Chronology of Critical Events
58
3.2
Reported Cases of Opportunistic Infections and AIDS, Risk Groups Identified, and Evolving Knowledge Base: June 1981 Through May 1985
61
4.1
Chronology of Fractionator License Applications and Approvals for Heat-Treated Factor VIII Concentrate
92
7.1
Summary of Clinical Options, Status and Sources of Recommendations, and Data Recommended
176
8.1
Triggers for Taking Actions in Response to Uncertain Risks
215
Figures
2.1
Organization of the plasma and plasma products industry
28
8.1
Blood Safety Council relationship
220
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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
HIV AND THE BLOOD SUPPLY
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