From Jim Reed
Phoenix, Arizona
Kurt Kleiner and New Scientist did a tremendous service for the
American haemophilia community by bringing two issues regarding haemophilia and
HIV infection to the forefront
(This Week, 10 May, p 12). One is the potential
liability of the US Food and Drug Administration. The other is the median
midpoint of HIV seroconversion of the US haemophiliacs: the point at which half
of haemophiliacs were infected.
However, I do wish to clarify a few points. First, the FDA did not order any
pharmaceuticals companies during either 1983 or 1984 to implement heat treatment
viral inactivation techniques of factor VIII. In 1984, the FDA did license three
pharmaceuticals companies to use heat treatment, a process commercially licensed
and in use in Germany since 1978, to destroy the hepatitis B virus.
Secondly, I believe that the median midpoint of infection occurred somewhere
between 1 January and 1 July 1983. The FDA had more than enough information to
require patient warnings, to demand surrogate plasma testing for HIV by testing
for the hepatitis B core antibody, and by implementing mandatory donor
questionnaires. Prompt action by the FDA could perhaps have avoided HIV
seroconversion in more than half of American haemophiliacs. Even today, the FDA
does not require manufacturers of clotting factor concentrate to warn of the
possibility of infection with HIV.
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