burden for blood banks, and blood bank officials were not convinced that these programs significantly increased the safety of the recipient (Bove, Perkins, Pindyck, Sandler interviews). The joint statement thus strongly recommended against conducting directed donation programs.

On July 19, 1983, the FDA's Blood Products Advisory Committee (BPAC) discussed the criteria for deciding to withdraw lots of AHF concentrate, and recommended product withdrawal only if there was good evidence that plasma from a donor with AIDS had been present in the pooled plasma from which the lot had been manufactured. The Pharmaceutical Manufacturers Association expressed concern about the impact of a recall on the supply of AHF concentrate. The NHF's Medical and Scientific Advisory Council (MASAC) had stated that recall of a product should be automatic if a donor was either suspected of having or diagnosed with AIDS. Dr. Louis Aledort, medical director of the NHF, stated his personal view that the NHF/MASAC recommendation would adversely impact the continued supply of AHF concentrate (Aledort, Hoyer interviews). Because of concern about maintaining an adequate supply of AHF concentrate, and skepticism that blood products were a vector for transmitting AIDS, the BPAC advised the FDA to recommend a case-by-case decision rather than automatic withdrawal for each lot that included plasma from an individual who had AIDS or was suspected of having AIDS (see Chapter 6 for further discussion).

On December 15–16, 1983, the BPAC met to consider all possible options of surrogate marker tests. The discussion focused on the implementation of the hepatitis B core antibody (anti-HBc) test as a possible surrogate screening test for HIV. Arguments against using the test in blood banks included (a) it would eliminate too many noninfected donors and would therefore threaten the adequacy of the blood supply; (b) the test was not useful in differentiating high-risk homosexuals (e.g., those with multiple partners) from other male homosexual donors; and (c) the prevalence of anti-HBc antibodies was high among certain ethnic groups (e.g., Asians) and would cause deferral of these donors. The BPAC did not recommend surrogate testing, but agreed with a suggestion to create an industry task force to consider the logistics of testing plasma for anti-HBc as a surrogate for AIDS.

Summary and Comment

Blood safety policies changed very little during 1983. Many officials of the blood banks, the plasma fractionation industry, and the FDA accepted with little question estimates that the risk of AIDS was low ("one in a million transfusions"), and they accepted advice that control strategies (such as automatic withdrawal of AHF concentrate lots containing blood from donors suspected of having AIDS, or a switch from AHF concentrate to cryoprecipitate



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