Division of Blood and Blood Products, reported his interpretation of the BPAC review (Donohue 1983). Dr. Donohue concluded that it was clear that the benefits of the availability of AHF concentrate as a protection against life-threatening or disabling hemorrhage far exceeded the risks of acquiring AIDS from the administration of AHF (Donohue 1983; Novitch 1983). What is not clear is why Dr. Donohue came so firmly to that conclusion given the evidence that was presented to BPAC—that is, why the prospective loss or shortage of AHF concentrate appeared to eclipse the threat of AIDS. Nor is it clear why the BPAC evidence and recommendations became the sole basis for FDA's recall policy. There may have been independent investigations and analyses done within FDA that supported these conclusions, but they do not appear in the record that has survived and been made available to the Committee.

The Committee believes it is not possible to conclude that the FDA made a decision that was clearly in the interest of public health given available information as of July 19, 1983. A close reading of the data suggests that a policy, not only of automatic recall, but of delicensing AHF concentrate until further information was available concerning its role in the transmission of AIDS might have been justified on public health grounds. This would have included, of course, a recall of all stocks of AHF then on the market and withdrawal of all AHF concentrate in the inventory of producers. On the other hand, the Committee would like to reiterate that the facts clearly did not compel such an aggressive approach.

To return to the first unanswered question, how effective could the policy that was adopted have been expected to be? It appears to have been extremely poorly conceived—indeed, virtually a nonpolicy. The case-by-case review was to use three criteria: (1) the reliability of the diagnosis, (2) the time lapse between the donor's donation and the appearance of AIDS symptoms, and (3) the effect on the availability of AHF concentrate (Donohue 1983). None of these criteria has any operational content, and in some cases they seem to ask for information that would be very difficult to acquire or process. There are no standards for what is a "good" diagnosis, no time period is established as an appropriate interval between donation and diagnosis, and no quantitative or qualitative guidance is provided concerning how large an effect on availability would be too great to tolerate. Indeed, no latency period had been established for AIDS and it is not obvious how anyone could rapidly determine how much AHF concentrate from a particular donor was still in stock or what proportion of existing stocks it represented.

Because there was no established system of tracking the health of blood donors, the Committee is puzzled by how plasma fractionators were to learn that a donor had AIDS. There is no suggestion that the CDC would or could legally share its lists of AIDS cases with the manufacturers. It was difficult to diagnose AIDS, and AIDS was not, at this time, a notifiable disease except in a few states



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