In this view, then, the situation from a legal and public health perspective might be summarized as follows: Because, prior to October 1984 at the earliest, the FDA could not demonstrate that heat-treated AHF concentrate was less infective for AIDS than untreated AHF concentrate—label inserts for heat-treated AHF concentrate could not say that it was a safer product [Baxter Product Insert, October 1983]—it had no legal basis upon which to demand that untreated AHF concentrate be recalled while leaving heat-treated AHF concentrate on the market. This is a situation in which the FDA's greater legal power (the probable authority to delicense all AHF concentrate owing to public health concerns) does not necessarily include the lesser (the power to eliminate untreated AHF concentrate on grounds of AIDS risk when it was not demonstrably less safe than heat-treated AHF concentrate). By contrast, the FDA might have required the expeditious elimination of untreated AHF concentrate on grounds of its demonstrated infectivity with respect to hepatitis by comparison with heat-treated AHF concentrate. Here, however, the public health benefits looked small (given the assumptions outlined above) in relation to the substantial economic costs involved in eliminating all untreated AHF concentrate from the market.

Moreover, there was some resistance in the medical community to the use of heat-treated AHF concentrate as it became available (Aledort, Dietrich, Levine, Lusher interviews). The reasons for this resistance included the problem of possible neoantigencity and subsequent inhibitor formation (which renders the patient untreatable with the AHF concentrates), the knowledge that heat treatment was developed to eliminate hepatitis virus, and the higher cost to the patient (Aledort, Dietrich, Lusher interviews). Physicians continued to prescribe non-heat-treated AHF to patients known to be infected with hepatitis (Aledort, Dietrich, Lusher interviews). Under these assumptions, the NHF and physicians treating hemophilia were reluctant to recommend the heat-treated product until there was more clinical evidence to prove that it was effective. Indeed, some manufacturers have suggested that the FDA's concerns about availability and resistance from the medical community probably influenced the FDA not to suspend licenses for untreated AHF concentrate when heat-treated AHF concentrate products were approved (Hammes pers. com. 1995; Leahy pers. com. 1995 McAuley pers. com. 1995; Persky pers. com. 1995).

It is worth noting, however, that there is another perspective on this story which might suggest that more aggressive action would have been warranted based wholly on the protection of individuals with hemophilia against the further spread of hepatitis. It is not clear, for example, exactly how great the economic or political costs would have been to plasma fractionators and to the FDA to remove untreated AHF concentrate from the market more rapidly. The Committee has only fragmentary information about how rapidly untreated AHF concentrate was removed through manufacturer's voluntary efforts or about what FDA action would have added to the rapidity of its removal. However, Alpha



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