are not inclined to share the details of their research efforts; and the FDA is legally barred from sharing a company's research findings among competitors. Companies interacting among each other could be in violation of antitrust laws and face potential criminal charges, fines, and sanctions. Furthermore, the very nature of the competitive world of business is one that normally would cause a company to preserve manufacturing processes and research results for its own benefit, to enable the marketing of products at a competitive advantage.

The Committee found that the plasma fractionators did not seriously consider alternative inactivation processes (e.g., the detergent process) because they placed a low priority on developing inactivation procedures for AHF concentrate and because heat inactivation had been successful for other blood products. Further, inactivation of pooled source plasma before fractionation would have required individual relicensure of all plasma products (Bacich, Hammes, Shanbrom interviews). In addition, inactivation methods used on plasma products could cause neoantigenicity, a problem that would negate the clinical effectiveness of AHF concentrate and possibly render the patient untreatable with these concentrates. The difficulty of testing the efficacy of inactivation procedures was due to the lack of correlation between antigen testing and infectiousness, and the absolute need for (and scarcity of) chimpanzees, which slowed progress in developing inactivation methods (Shanbrom pers. com. 1995; Epstein and Fricke 1990).

Once the initial inactivation methods were developed and shown to be effective in limiting the transmission of hepatitis B and NANB infection in experimentally inoculated chimpanzees, there was a relatively short interval between the product licensing application submission to the FDA and the licensure of the heat-inactivated products. The fact that the plasma fractionation industry was able to produce an inactivated product for license consideration concurrent with, and shortly after, the first reports of AIDS in individuals with hemophilia suggests that hepatitis infection (rather than AIDS) provided the major motivation for the ultimate development of viral inactivation methods.

SUMMARY

Overall, the record of the plasma fractionators and the FDA with respect to the development and implementation of heat treatment is mixed. The Committee's analysis focused on whether scientific information and technology was available earlier for the development of viral inactivation methods for AHF concentrate, and whether industry had appropriate incentives (from the FDA, the NIH, the National Hemophilia Foundation, or others) to develop these processes. In the Committee's judgment, heat treatment processes to prevent the transmission of hepatitis could have been developed before 1980, an advance that would have prevented many cases of AIDS in individuals with hemophilia.



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