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I find it a little difficult to accept that non-scientific 'guests' can
participate in the deliberation of the drug approval process.  Of course,
there was a time when drug approval was based totally on the scientific
evidence provided by the drug sponsor and evaluated on the merits of this
evidence.

However, the advent of AIDS has corrupted this evaluation to include
political agendas and promptness of approval became a greater goal to a
group of consumers that did indeed appear to be helpless and very
vulnerable.   But unfortunately, the increase of new drug entities as well
as new formulations of old drugs that have been approved has been
accompanied by a much greater number of adverse reactions reported and
recalls.  This is because of the incompleteness of the scientific review
process and the superficiality of the review.

This does not mean that the non scientific member of society should abstain
from participation in working with the agency or agencies that would benefit
them in the long run.  For instance, I think that seed money that NPF is
contributing to Centers of Excellence is a superb contribution to finding a
cure.  However, the direction of the research must be directed by the
scientists themselves.

Michel Margosis
'Carpe Diem'