HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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Executive Summary
Executive Summary
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The AHF concentrate is manufactured from blood plasma derived from 1,000 to 20,000 or more donors, exposing individuals with hemophilia to a high risk of infection by blood-borne viruses. The safety of the blood supply is a shared responsibility of many organizations including the plasma fractionation industry, community blood banks, the federal government, and others.
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With intent to prepare the guardians of the blood supply for future threats concerning blood safety, the Department of Health and Human Services commissioned the Institute of Medicine to study the transmission of HIV through the blood supply. The Committee to Study HIV Transmission Through Blood and Blood Products undertook this assignment fully aware of the advantages and dangers of hindsight.
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Despite these and other opportunities to review new evidence and to reconsider earlier decisions, blood safety policies changed very little during 1983. Many officials of the blood banks, the plasma fractionation industry, and
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However, research into other potential ways to safeguard the blood supply such as the use of surrogate tests was not pursued vigorously, and there was relatively little research on blood safety issues per se. FINDINGS 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 to physicians and patients.
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For a variety of reasons (e.g., concern about possible development of inhibitors and higher costs) , however, neither physicians caring for individuals with hemophilia nor the Public Health Service agencies actively encouraged the plasma fractionation companies to develop heat treatment measures earlier.
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The Committee concluded that when confronted with a range of options for using donor screening and deferral to reduce the probability of spreading HIV through the blood supply, blood bank officials and federal authorities consistently chose the least aggressive option that was justifiable. In adopting this limited approach, policymakers often passed over options that might have initially slowed the spread of HIV to individuals with hemophilia and other recipients of blood and blood products, for example, by screening male donors for a history of sexual activity with other males and screening donated blood for the anti-HBc antibody.
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These focused on the reach of the agency's legal powers, the information available at the time in relation to relevant public health considerations, the agency's resources, the FDA's institutional culture, the economic costs of particular actions, and the prevailing political climate. The analysis of these four events led the Committee to identify several weaknesses in the FDA's regulatory approach to blood safety issues.
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As often happens in times of intense scientific and medical uncertainty such as in the early 1980s, individuals with hemophilia and transfusion recipients had little information about risks, benefits, and clinical options for their use of blood and blood products. The dramatic successes of treatment with AHF concentrate in the 1970s provided a context in which thresholds for abandoning or radically restricting the use of these products for individuals with severe hemophilia were high.
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They include U.S. Public Health Service agencies such as the CDC, the FDA, and the NIH, and private-sector organizations such as community blood banks and the American Red Cross, blood and plasma collection agencies, blood product manufacturers, groups like the National Hemophilia Foundation, and others.
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They must monitor more systematically the long-term outcomes of blood transfusion and blood product infusion to anticipate both new technologies and new threats to the safety of the blood supply. The Committee believes that the Public Health Service should plan what it will do if there is a threat to the blood supply.
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This failure led to less than effective donor screening, weak regulatory actions, and insufficient communication to patients about the risks of AIDS. In the event of a threat to the blood supply, the Public Health Service must, as in any public health crisis, insist upon coordinated action.
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To this end, the Committee makes Recommendation 2: The PHS should establish a Blood Safety Council to assess current and potential future threats to the blood supply, to propose strategies for overcoming these threats, to evaluate the response of the PHS to these proposals, and to monitor the implementation of these strategies. The Council should report to the Blood Safety Director (see Recommendation 1~.
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The no-fault principles outlined in this recommendation might serve to guide policymakers as they consider whether to implement a compensation system for those infected in the 1980s. The Centers for Disease Control and Prevention The CDC has an indispensable role in protecting our nation's health: to detect potential public health risks and sound the alert.
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In order that the perfect not be the enemy of the good, the Committee makes Recommendation 6: Where uncertainties or countervailing public health concerns preclude completely eliminating potential risks, the FDA should encourage, and where necessary require, the blood industry to implement partial solutions that have little risk of causing balm. In all fields, decisionmaking under uncertainty requires an iterative process.
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To ensure the proper degree of independence between the FDA and the BPAC, the Committee makes Recommendation 11: The FDA should develop reliable sources of the infonnation that it needs to make decisions about the blood supply. The FOA should have its own capacity to analyze this information and to predict the effects of regulatory decisions.
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The Blood Safety Council called for in Recommendation 2 would deal primarily with risk assessment and actions in the public health domain that would reduce the chance that blood products could be vectors of infectious agents. The primary responsibility of the expert panel on best practices called for in Recommendation 13 would be to provide the clinical information that physicians and their patients need to guide their individual health care choices.
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Public health officials, the medical professions, and private organizations must uphold this new, difficult standard. Failure to do so will threaten the fabric of trust that holds our society together.
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