1
Introduction

A nation's blood supply is a unique life-giving resource and an expression of its sense of community. In 1993, voluntary donors gave over 14 million units of blood in the United States (Wallace, et al. 1993). However, the characteristic that makes donated blood an expression of the highest motives also makes it a threat to health. Derived from human tissue, blood and blood products can effectively transmit infections such as hepatitis, cytomegalovirus, syphilis, and malaria from person to person (Institute of Medicine 1992). In the early 1980s, blood became a vector for HIV infection and transmitted a fatal illness to approximately half of the 16,000 hemophiliacs in the United States and to over 12,000 blood transfusion recipients (CDC, MMWR, July 1993).

Each year, approximately 4 million patients in the United States receive transfusions of over 20 million units of whole blood and blood components. The blood for the transfused products is collected from voluntary donors through a network of nonprofit community and hospital blood banks. Individuals with hemophilia depend upon blood coagulation products, called antihemophilic factor (AHF) concentrate to alleviate the effect of an inherited deficiency in a protein that is necessary for normal blood clotting. Bleeding due to this deficiency can cause serious damage to muscles, tissues, and joints, and can be fatal when there is bleeding into the brain. The AHF concentrate is manufactured from lots of ''pooled" plasma derived from 1,000 to 20,000 or more donors, exposing individuals with hemophilia to the high risk of infection by blood-borne viruses.

The safety of the blood supply is a shared responsibility of many organizations—the plasma fractionation industry, community blood banks, the federal government, and others. Public concern about the inherent risks of blood and blood products has led the federal government, through the agencies of the Public Health Service, to take the lead in ensuring blood safety. The Food and



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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 1 Introduction A nation's blood supply is a unique life-giving resource and an expression of its sense of community. In 1993, voluntary donors gave over 14 million units of blood in the United States (Wallace, et al. 1993). However, the characteristic that makes donated blood an expression of the highest motives also makes it a threat to health. Derived from human tissue, blood and blood products can effectively transmit infections such as hepatitis, cytomegalovirus, syphilis, and malaria from person to person (Institute of Medicine 1992). In the early 1980s, blood became a vector for HIV infection and transmitted a fatal illness to approximately half of the 16,000 hemophiliacs in the United States and to over 12,000 blood transfusion recipients (CDC, MMWR, July 1993). Each year, approximately 4 million patients in the United States receive transfusions of over 20 million units of whole blood and blood components. The blood for the transfused products is collected from voluntary donors through a network of nonprofit community and hospital blood banks. Individuals with hemophilia depend upon blood coagulation products, called antihemophilic factor (AHF) concentrate to alleviate the effect of an inherited deficiency in a protein that is necessary for normal blood clotting. Bleeding due to this deficiency can cause serious damage to muscles, tissues, and joints, and can be fatal when there is bleeding into the brain. The AHF concentrate is manufactured from lots of ''pooled" plasma derived from 1,000 to 20,000 or more donors, exposing individuals with hemophilia to the high risk of infection by blood-borne viruses. The safety of the blood supply is a shared responsibility of many organizations—the plasma fractionation industry, community blood banks, the federal government, and others. Public concern about the inherent risks of blood and blood products has led the federal government, through the agencies of the Public Health Service, to take the lead in ensuring blood safety. The Food and

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Drug Administration (FDA) has regulatory authority over plasma collection establishments, blood banks, and all blood products. The Centers for Disease Control and Prevention (CDC) has responsibility for surveillance, detection, and warning of potential public health risks within the blood supply. The National Institutes of Health (NIH) supports these efforts through fundamental research. AIDS emerged as a threat to the safety of the blood supply in the early 1980s because of a unique confluence of events. Medical breakthroughs in cardiac surgery and other areas resulted in greater use of whole blood and its components. A new treatment for hemophilia, home infusion of AHF concentrate, grew rapidly and significantly improved the health and increased the life span of individuals with hemophilia. In addition, much of the medical community, as well as the country as a whole, believed that epidemics of infectious disease were a thing of the past. There were also many changes occurring in the government and society, such as a presidential mandate to lessen the regulatory role of government and increased public awareness that the homosexual population was enduring stigmatization and discrimination (Bayer 1983). As evidence for blood-borne transmission of AIDS accumulated in 1982 and 1983, the Public Health Service had to deal with a very difficult problem. On the one hand, the U.S. blood supply was barely adequate to meet the urgent needs of day-to-day patient care. On the other hand, there was growing evidence that a blood transfusion posed a risk of causing a disease that was proving to be fatal for many. However, both the magnitude of the risk and the prognosis were still unknown. An examination of the efforts of the Public Health Service and others to cope with this problem provides a remarkable window into the making of public policy under duress and uncertainty. The syndrome that came to be called AIDS was first noticed in homosexual men in 1981, but within a year epidemiologic evidence suggested that AIDS might also be a threat to recipients of blood and blood products. Several blood banks, blood collection agencies, and blood product manufacturers (i.e., plasma fractionators) took some actions to increase blood safety (e.g., donor education and screening to exclude known high-risk groups; terminating plasma collection from prisons; and encouraging autologous donations to reduce the risk of infection as early as January 1983), yet thousands of individuals and members of their families became infected before the implementation of a blood test for HIV in 1985. Perhaps no other public health crisis has given rise to more lasting anger and concern than the contamination of the nation's blood supply with HIV. In response, blood recipients and individuals with hemophilia who were infected during this period, their families and their physicians, and public and private officials with responsibility for blood safety have asked a series of questions: Could this tragedy have been averted? What institutions, policies, or decision processes, had they been in place in the early 1980s, could have helped to

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking reduce the number of people infected with HIV? What should be done now to thwart future blood-borne infections? Mindful of the risks of retrospective analysis, this report attempts to answer these questions. HIV INFECTION VIA BLOOD TRANSFUSION Transmission of HIV occurred via fresh blood (whole blood, packed cells) and fresh blood components (platelets, fresh frozen plasma, etc.) as well as AHF concentrate. Most of the individuals were tested when the HIV test became available in 1985 and thus, the number of those that became infected is well documented. In December 1987, the CDC reported that of the estimated 15,500 hemophiliacs in the United States, approximately 9,465 (63 percent) were infected with HIV (CDC, MMWR, 1987b). Estimates of HIV infection in other patients (medical and surgical) due to transfusion are more difficult to obtain. A study by the CDC summarized data up to June 1992, by which time 4,619 persons (excluding hemophilia patients) had been reported with transfusion-associated AIDS. This number is thought to be an under-reporting because patients die from their basic disease before developing AIDS (as 50 percent of patients receiving transfusions die within six months) (Barker and Dodd 1989). On the other hand, some patients that are infected may not have been tested up to this day. In addition to the documented cases of transfusion-associated AIDS, the CDC routinely estimates the transmission of HIV to blood recipients, as there continue to be a few cases each year (even since the implementation of the ELISA test). According to the CDC, the number can be approximated using prevalence of infection in donors, the efficiency of transmission, and the number of units transfused per year. In 1985, 0.04 percent of donations were positive for HIV antibody by Western blot assay. If 0.04 percent had been the seroprevalence among donors the years prior to screening, if all seropositive units had transmitted infection, and if each unit had gone to a different recipient, then 7,200 of the approximately 18 million components transfused in 1984 might have transmitted infection. If 60 percent of these recipients have died from their underlying disease, then approximately 2,900 living recipients who acquired transfusion-associated HIV infection in 1984 would remain. Most of these would be asymptomatic. … Mathematical projections from reported transfusion-associated AIDS cases estimate that approximately 12,000 people now [1987] living in the United States acquired a transfusion-associated HIV infection between 1978 and 1984 [CDC, MMWR, 1987a].

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking THE COMMITTEE'S CHARGE Individuals with hemophilia, transfusion recipients, and their families have raised serious concerns about why there were not better safeguards and warning systems to protect them from viruses transmitted by blood products. Could viral inactivation processes for blood products have been developed more rapidly? Were appropriate measures taken to eliminate high-risk donors from the blood supply? Were the necessary regulations to ensure the safety of blood and blood products enforced? Were consumers of blood and blood products appropriately informed of the possible risks associated with blood therapy and were alternatives clearly communicated? In response to these concerns, the Secretary of the Department of Health and Human Services (DHHS) asked a Committee of the Institute of Medicine (IOM) to review the scientific evidence that was available to decisionmakers during the early 1980s when the AIDS epidemic emerged, to examine the decisionmaking processes, and to evaluate the actions taken to contain the epidemic. Of equal importance, the Secretary asked the Committee to recommend a framework for steps that could prepare the nation to deal effectively with future threats to the blood supply. The IOM established a committee whose charge was to review and evaluate the following areas: the history of efforts to assure blood and blood product safety, efficacy, and availability; the regulatory process for governing blood and blood products; the history of the transmission of the AIDS virus through the blood supply; the roles and responses of government and other agencies, health organizations, plasma fractionators, and medical care providers; research on blood and blood products; and the decisionmaking processes that followed the first suspicions that the blood supply was a vector for transmitting AIDS. The Committee's charge did not include the development of assertions about what should have been done at the time, nor did it include conducting a comprehensive organizational analysis. Within the emotion-laden and potentially adversarial atmosphere of a public health tragedy, the Committee engaged in a systematic inquiry. The Committee framed its approach by examining four topics that are essential components of a focused strategy for ensuring the safety of the blood supply: blood product treatment; donor screening and deferral; regulation of removal of contaminated products from the market; and communication of risk to physicians and patients. The Committee then tested a range of hypotheses to explain why decisionmakers acted as they did. These hypotheses take account of the legal authority of relevant organizations; the information available to them; the countervailing public health considerations and scientific knowledge that influenced particular decisions; the resource limitations that constrained organizations; the institutional, social, and cultural obstacles; the public or private interest motivations of organizations; and the economic and political incentives that influenced decisions.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking To understand how events unfolded over the course of the AIDS epidemic and to develop a chronology, the Committee sought to identify the critical events that would illuminate the decisionmaking process. The Committee asked each of the major organizations to list several events that they felt were the most important and to give the reasons for their choices. The Committee used this information to develop a chronology and focus its analysis on specific events. Historical information was obtained from the key contacts at each of the organizations. The Office of the Assistant Secretary of DHHS identified sources of information within the federal service; and others representing nongovernment agencies made themselves known to the IOM Committee and staff. Among the topics for literature searches were: history of hemophilia; history of blood collection activities; scientific knowledge about HIV; viral inactivation processes; hepatitis; risk communication; social and ethical implications of AIDS; and regulations concerning blood products. The Committee obtained, largely through requests and voluntary contributions, court depositions, congressional hearings, internal office memoranda, minutes of meetings, and scientific articles. The evaluation of policy decisions and actions taken over a decade ago is a problematic enterprise. On one hand, the historical record consists primarily of contemporaneous notes and explanations that make the decisions appear inevitable. On the other hand, the difficulties that beset decisionmakers at the time do not appear so compelling in light of our current knowledge—exemplifying the risk that hindsight knowledge can easily and anachronistically be transposed back to the period in question. Finally, the documentary record is often incomplete, ambiguous, or vague, and current testimony about past events may be filtered by years of subconscious reinterpretation in the light of new knowledge. Even when the record is reasonably complete and apparently "clear on its face," interpreting its meaning demands the reconstruction of an always elusive historical context, without which no individual actions or statements can properly be understood. In addition to these difficulties, the events under discussion are highly charged emotionally, as pointed out above. The infection of individuals with HIV through the use of blood and blood products has created almost unimaginable suffering among those who were infected and their families (some of whom themselves became infected). Many, particularly in the hemophiliac community, believe that they were betrayed by the very scientific establishment, nonprofit organizations, physicians, and governmental agencies on whom they relied to assist them in managing their chronic conditions and acute episodes. Those in official positions, by contrast, almost uniformly believe that they did everything that could and should have been done given the scientific uncertainty and public health considerations that constrained the range of realistic options.

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking ORGANIZATION OF THE REPORT Chapter 2 describes institutions and organizations that comprise the national blood supply system and presents an overview of how blood is collected and distributed. Chapter 3 presents the history of the unfolding AIDS epidemic and the evolving knowledge base about the risk of AIDS from blood and blood products. The main analysis of this report appears in Chapters 4–7. Chapter 4 provides a review of the development of processes to inactivate viruses in blood products such as AHF concentrate, examining the efforts made by the FDA, NIH, and the plasma fractionators, going back to the 1970s when it first seemed possible to inactivate hepatitis B virus and thereby enhance the safety of blood products. Chapter 5 addresses strategies for protecting the safety of the blood supply by screening potential donors, examining closely the factors that influenced decisions regarding the implementation of donor screening measures. Chapter 6 examines the role of the FDA in regulating blood and blood product safety, highlighting several critical events, such as the FDA's guidance for implementing donor screening practices, recall of potentially contaminated products, and procedures to inform recipients of contaminated products. Chapter 7 describes how the risks of HIV and the options for risk reduction were communicated to individuals with hemophilia, to transfusion recipients, and to physicians. The chapter also addresses the institutional, social, and cultural obstacles to effective communication about risk. In Chapter 8, the Committee presents conclusions and makes several recommendations that draw upon the analysis in the preceding chapters. REFERENCES Barker, Lewellys F., and Dodd, Roger Y. Viral Hepatitis, Acquired Immunodeficiency Syndrome, and Other Infections Transmitted by Transfusion, from Petz, Lawrence D., and Swisher, Scott N. Clinical Practice of Transfusion Medicine (second edition). New York: Churchill Livingsone, Inc., 1989. Bayer, Ronald. Gays and the Stigma of Bad Blood. Hastings Center Report; April 1983. Centers for Disease Control. Morbidity and Mortality Weekly Report, July 23, 1993. Centers for Disease Control. Morbidity and Mortality Weekly Report, March 20, 1987a. Centers for Disease Control. Morbidity and Mortality Weekly Report, December 1987b. Institute of Medicine. Emerging Infections. Washington, D.C.: National Academy Press, 1992. Wallace, E.L., et al. Collection and Transfusion of Blood and Blood Components in the United States. Transfusion, vol. 33, 1993.