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 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 National Academy Press, 2101 Constitution Avenue, N.W. , Box 285, Washington, D.C., 20055. Call 800-624-6242 or 202-334-3313 (in the Washington metropolitan area). 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 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 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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