approach to blood safety regulation when there is uncertainty and danger to the public.
As evidence accrued on the possibility that the blood supply was a vector for AIDS consumers of blood and blood products and their physicians found themselves in a complex dilemma about how to reduce the risk of infection. Restricting or abandoning the use of blood and blood products could lead to increased mortality and morbidity. On the other hand, continued use of these products apparently increased the risk of AIDS. The Committee investigated the processes by which physicians and patients obtained information about the epidemic and the costs, risks, and benefits of their clinical options.
A wide range of clinical options were available by late 1982 and might, in some instances, have reduced or eliminated dependence on AHF concentrate and thereby reduced the risk of HIV transmission. 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. Both physicians and individuals with hemophilia expressed reluctance about returning to the era of clinical treatment before the introduction of AHF concentrate. The National Hemophilia Foundation (NHF) and physicians, in their effort to find the right balance between the risks and benefits of continued use of AHF concentrate, tended to overweight the well-established benefits of AHF concentrate and underestimate the risks of AIDS, which were still uncertain.
In addition, the Committee found that prevailing assumptions about medically acceptable risks, especially regarding hepatitis, led to complacency and a failure to act with sufficient concern upon reports of a new infections risk. Ultimately, assumptions about medical decisionmaking practices in which patients played a relatively passive role led to failures to disclose completely the risks of using AHF concentrate and thereby did not enable individuals to make informed decisions for themselves. As the potential dimensions of the epidemic among individuals with hemophilia became clear, communication between physicians and patients was further compromised by physicians' reticence to discuss the dire implications of widespread infection with their patients and families.
Institutional barriers to patient-physician communications and relationships between relevant organizations also impeded the flow of information. If the NHF