Women, Hemophiliacs and the FDA
Toward Ethical Research for Women Living with AIDS
Maxine Wolfe, National Conference on Women & HIV,
The FDA must require the inclusion of women in all phases of clinical research so that meaningful analysis can be done.
The Committee of Ten Thousand, hemophiliacs infected with HIV through blood products, also has concerns about the FDA and a list of demands. The following is reprinted From COTT -918 Pennsylvania Ave. SE, Washington DC 20003, 202.543.0988
"Why, in the face of repeated warnings, did the FDA allow the manufacturers to continue collecting plasma from prison populations and the gay community when the industry and the FDA had been told that these populations were at a significantly high risk for infection with the AIDS virus? Why was this allowed to continue a full year after these warnings were common knowledge within the industry and the FDA? Why were FDA officials such as Harry Myer and David Aronson so indifferent to the clearly understood daily danger of infusing blood products produced from donors known to be at high risk for AIDS?...Many of the problems that existed during the 1980's at the FDA remain unchanged today. In essence you have self-regulation. This ultimately means that those who produce the products which they will reap millions in profits from are also left to regulate the safety of those product.
What is to be Done
Safety must always be the primary consideration, never to be unduly impacted by concerns regarding the economic survivability and profit picture of the manufactures and producers of blood and blood products.
Since 1992, The National ACT UP Women's Caucus, Women Alive, The HIV Law Project, and others have been attempting to force the FDA to end discrimination against women in trials for drugs intended to treat life-threatening illnesses.
The U.S. Food and Drug Administration proposed a regulation that would theoretically force pharmaceutical firms to stop excluding women from studies of promising new drugs for fear they will get pregnant during the research. AIDS activists have been especially vocal in calling for a change, asserting that HIV-infected women are being unjustly prevented from participating in AIDS drug research.
Under the new measure, the FDA would be allowed to halt or prevent clinical trials that exclude women for reproductive reasons, when the drugs being tested are for treatment of serious or life-threatening diseases. Clinical trials designed to study male-only conditions would not be covered. The pharmaceutical industry has not publicly commented on the proposed rule. you decide
This new regulation does not mandate that women be included in all phased of trials. If it passes it would allow the FDA to exercise power to place a clinical hold (stop the study) on studies that have no, or insignificant numbers of women.
Is it a step in the right direction, or is it the same old thing that always happens to women; accepting only crumbs when we want, need and deserve the whole cake? For a copy of the proposed new regulation and for public comment contact:
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.