WHO'S "THE CURE" FOR?
Women Living with HIV/AIDS: Towards New Ethical National Research Policies

Chart 2

Donna Shalala, Secretary of Health and Human Services
and Sandy Thurmond, Head of the Office of AIDS Policy and Presidential Advisor:

• Must take responsibility to ensure that research for women living with HIV/AIDS be given top priority on funding.
  
  
• All Public Health Service agency heads must, within the next month, provide them with plans for implementing this priority.
  
  

National Institutes of Health:

• All basic science research funded by the NIH which includes human participants, must include women and men. Animal studies must include both male and female animals.
  
  
• All clinical research grantees, including all ACTG, NIAID and NCI sites, must have a women's health specialist on their primary research teams. This cannot only be an obstetrician.
  
  
• All clinical research funded by the NIH, for anti-HIV treatments or opportunistic infections, must include enough men and women to analyze gender differences and these analysis must be presented in any reports or press releases. Women-specific endpoints, both non-gyn and gyn related, must be assessed.
  
  
• If necessary, all dosing, fetal toxicity and reproductive studies of existing HIV/AIDS treatments should be contracted out within the next 6 months. Subsequently no Phase II studies funded thru the NIH should be allowed to begin without this information.
  
  
• Top priority must be given to basic and clinical research for women's opportunistic infections and all ACTG committees must give priority to the gathering of women-specific information in their specialties.
  
  
• Priority for grants should be given to the development of non-toxic, inexpensive treatments which have simple dosing schedules. If drug companies won't produce these, the government should fund independent researchers who will.
  
  
• All research should be designed to accommodate the daily lives of diverse people, including women, and to give participants immediate feedback about their health as well as the economic and physical supports necessary to ensure participation.
  
  
• Within the next 3 months, the WIGS study must be evaluated by a team of outside evaluators who will propose a clear plan for producing data relevant to disease progression and treatment outcomes within the following 6 months. If the WIGS study is not prepared to immediately do state of the art analyses which relate to immunological function and virological activity to disease progression, these studies should become part of the MAC. In either case, the NIH should guarantee funding for this work.
  
  
• Perinatal transmission trials must be developed in which equal priority is given to women's health as well as decreasing transmission. Unethical research designs, in the US and elsewhere should be unacceptable. No pregnant women should be pressured to follow current or future guidelines. Truly informed consent forms must be provided.
  
  
• Women living with HIV/AIDS who are knowledgeable about research must be represented on all review panels for recompetitions and for basic and clinical research grants. If necessary specific training should be provided.
  
  
• Independent evaluations of women's experiences receiving care at ACTG and CPCRA sites and of being participants in trials should be conducted as part on all ongoing research.

FDA:

• The FDA must require the inclusion of women in all phases of clinical research so that meaningful analyses 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 & men should be informed and should be allowed to participate if they wish.
  
  
• Pharmaceutical companies with approved anti-HIV and opportunistic 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 on all review committees for INDs and NDAs, and accelerated approvals.

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