From GREGG GONSALVES
I am writing to clarify my position regarding the Federal Drug Administration’s
consideration of full marketing approval for the AIDS drug ddC, as described
in your article ‘AIDS activists change tack on drugs’ (This Week, 2 October).
Along with representatives of other AIDS advocacy and patient empowerment
groups, I testified before the FDA’s Antiviral Drug Advisory Committee against
any change in the regulatory status of ddC. As the FDA had already granted
the drug an Accelerated Approval, which includes commitments to further
characterise the drug’s safety and efficacy, this does not amount to a request
to ‘withdraw approval’ from the drug, as described in your article. Rather,
we were attempting to assure that study of the therapy would continue, while
safeguarding patient access to the drug.
Unfortunately, AIDS activists have often allowed members of the pharmaceutical
industry to characterise our interest as limited to patient access to new
treatments. We hope that our testimony before the FDA Committee has disabused
them of this notion. Thorough characterisation of the efficacy of new treatment
is vital to the ability of AIDS patients to make rational decisions regarding
the use of these potentially toxic and often marginally useful drugs.
Gregg Gonsalves Treatment Action Group New York, USA
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