FDA in 1983 did not independently verify the estimates of the risk of blood-product-related HIV infection. The FDA did not analyze the public health implications of the BPAC's recommendation against automatic recall of AHF concentrate that contained plasma from donors suspected of having AIDS. The FDA's lack of independent information and its own analytic capacity meant that it had little choice but to incorporate the advice of the BPAC into its policy recommendations. To ensure the proper degree of independence between the FDA and the blood products industry, the Committee makes
Recommendation 11: The FDA should develop reliable sources of the information that it needs to make decisions about the blood supply. The FDA should have its own capacity to analyze this information and to predict the effects of regulatory decisions.
One of the crucial elements of the system for collecting blood and distributing blood products to patients is the means by which to convey concern about the risks inherent in blood products. In today's practice of medicine, in contrast to that of the early 1980s, patients and physicians each accept a share of responsibility for making decisions. Patients' informed consent is required for risky procedures. From early 1983, it was clear that AHF concentrate was a risky product. The failure to tell hemophilia recipients of Factor VIII concentrate about the risks of this treatment and about alternative treatments seems especially serious in the light of present-day emphasis on the autonomy of patients in decisions involving their health.
One powerful lesson of the AIDS crisis is the importance of telling patients about the potential harms of the treatments that they are about to receive. The NHF dedicated itself to providing information to individuals with hemophilia and their physicians. Their strategy, however, was seriously flawed. As discussed in Chapter 7, the NHF provided treatment advice, not the information on risks and alternatives that would enable physicians and patients to decide for themselves on a course of treatment. Hemophilia patients did not have the basis for informed choice about a difficult treatment decision.
Considerable scientific and medical uncertainties characterized the early years of the AIDS epidemic. For individuals medically dependent on the use of blood and blood products, these uncertainties created complex dilemmas about clinical options for their continued care. In instances of great uncertainty, it is