AIDS Research at the NIH: A Critical Review

* Track Survival. After ten years of AIDS and five years of AZT, we still don't know for sure
whether it, or its cousins ddl or ddC, actually extend survival. No mechanism is in place (as it is
in cancer) to assess long-term survival rates. To capture rare toxicity and long-term survival data,
and to register interested persons in cohorts for future clinical studies, NIAID and NCI should
develop a simple, lean long-term follow-up mechanism for participants in the most important AIDS
trials.
* Let Industry Pay. NIH still pays through the nose for the privilege of letting drug companies
develop their drugs at public expense. We concur with the IOM that industry should pay for and
conduct post-marketing studies and assist the NIH with site support for NIH-sponsored trials,
especially now that it can generate revenue earlier due to accelerated approval.
* Establish a Clinical Immunology Initiative. Immunology is poor stepsister of NIH's clinical trials
effort. Primary infection and Ols have received enormous support within the networks (the latter
after vociferous hounding by activists) while immunology languishes, running around conducting
flow cytometry for its haughty siblings. The NIH must make a commitment to greater funding for
immunological studies within its clinical trials programs for several reasons: first, to generate new
and more powerful surrogate markers, which will allow for smaller, faster studies to evaluate
antiretroviral agents; second, to increase our knowledge of the immunopathogenesis and
progression of the disease; and third, to develop biological response modifiers which will
complement antiviral therapies in the treatment of HIV infection.
* Design Appropriate Trials for HIV+ Children and Their Families. HIV-infected children must
be seen in a real-world context -- as members of HIV-infected families. NICHD and the pediatric
clinical trials networks at NIH should support research studies of the mothers of HIV+ children and
other seropositive members of the family.
VACCINE DEVELOPMENT
* Appropriate New Funds for Vaccine Development. The government must allocate new funds
for vaccine development rather than taking them from treatment research. Work on vaccines is
going to cannibalize the NIH budget as money is drawn away from existing programs to fund the
mandate from Congress and the Executive Branch. For instance, the FIC and NIAID are being
asked to prepare the infrastructure for the vaccine trials in the developing world, but are getting no
new money for this. The risk prevention programs which they have been developing in conjunction
with countries in Africa, Asia, Latin America and the Caribbean will probably have to surrender
some financial support for the new initiatives. NIH must go to Capitol Hill to fight for new money.
* Address Ethical Issues in Vaccine Development. The seronegative vaccine trials raise
unprecedented ethical issues which need to be dealt with early on by the NIH with active and
demographically diverse community representation. The NIH must devise ways to:
- Separate the educational/prevention aspects from scientific research. The two are
obviously in conflict; the greater the success of the educational and prevention programs
in the study, the smaller the rate of seroconversion and statistical power of the trial.
- Involve communities of color, which will be a target study population in the US because
of their increasing rate of HIV infection, in the decision-making process for the trials and
the NIH program as a whole.
- Deal with the false" seroconversions which will occur when the immunogen is
administered. Seropositivity can involve all kinds of discrimination in insurance,
employment etc..
- Assure the participation of diverse communities in these trials.

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