Weird Science

Toward Ethical Research for Women Living with AIDS
Maxine Wolfe, National Conference on Women & HIV,
Pasadena 5/97

The FDA must require the inclusion of women in all phases of clinical research so that meaningful analysis can be done.

• The pharmacokinetics of any drug to be used by women must be assessed in women, and dosing and dose intervals determined accordingly. Without this information, no Phase II studies should be approved.
• Animal fetal toxicity and reproductive studies should be completed before an IND is accepted for Phase I trials. An information bank should exist describing any and all such studies and their findings. If such studies demonstrate fetal toxicity or reproductive genetic problems, women and men should be informed and should be allowed to participate if they wish.
• Pharmaceutical companies with approved anti-HIV and opportunistic infection drugs must complete Phase I studies in women and remaining animal fetal toxicity studies within 1 year.
• New drugs must not be approved unless sponsors present meaningful analyses by gender, including dosing information by gender. Statistical analyses for NDAs cannot be presented for only one gender.
• All previously approved, as well as new anti-HIV treatments and treatments for opportunistic infections must be labeled to indicate whether or not they have been tested in women.
• Women living with HIV/AIDS should be represented in all review committees for INDs and NDAs, and accelerated approvals.

FDA Crimes

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

• Congress must promulgate and implement new conflict of interest rules that will ensure those with an economic interests in the business of blood will be barred from the regulatory decision making processes as well as from exerting undue influence upon FDA regulation of blood and blood products.

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.

• The FDA needs a "look back" system so they can go back and review the safety of products that have already been approved to reassess safety in light of technological advances and improved techniques for addressing viral contamination.
• The FDA must require significant changes in the blood collection system. The Red Cross and the independent blood banks must be held accountable for their operations and required to meet national standards established by the FDA.
• The FDA must mandate the usage of smaller donor pools for the production of blood-plasma products such as factor concentrates and IVIG.
• The FDA must promulgate and enforce stringent new national standards for blood collection, processing, manufacturing and distribution."

New Regs?

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:

Dockets Management Branch, FDA
12420 Parklawn Drive
Rm. 1-23
Rockville, Maryland - 20857