WHO'S "THE CURE" FOR?
Speech by Maxine
Women Living with HIV/AIDS:
Towards New Ethical National Research Policies
National Conference on Women
Towards an Ethical
National Research Policy and Program
For Women Living With HIV/AIDS
~ For All HIV/AIDS
Related Research ~
Donna Shalala, Secretary of
Health and Human Services
and Sandy Thurmond, Head of the Office of AIDS Policy and Presidential
- 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
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
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
- 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.
- 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
- 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
- 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.