[Email to Various from Bruce Weniger]

licensed medications to treat the virus and the various
opportunistic illnesses which may ensue. Additionally,
ongoing research should be conducted to identify more
efficacious interventions to decrease vertical transmission
of HIV from mother to infant. Finally, despite a decreased
incidence of HIV/AIDS among children, it is imperative that
clinical trials for HIV-infected children continue to
receive a high priority and adequate funding.
1. The Administration should require the Office of
AIDS Research (OAR) to maintain an ongoing review
of the numbers of children enrolled in NIHsponsored clinical trials, to assure compliance
with the right to access.
2. The Administration should instruct the FDA to
require sponsors to file a pediatric plan that
includes studies on safety and pharmacokinetics,
prior to the filing of the New Drug Application
(NDA). Under no circumstances should accelerated
or full approval of a drug be delayed while
awaiting results in the pediatric population;
however, a pediatric plan must be submitted by the
sponsor.
The consensus among scientists is that an effective vaccine
to prevent AIDS is possible. Approximately 40,000 to 60,000
Americans still become newly-infected with HIV each year,
despite extensive efforts to reduce risky human behaviors.
The principal long-term and most cost-effective solution for
the epidemic is a preventive vaccine, for which a
high-priority, expedited research and development program is
justified. Suitable organizational and administrative
structures would facilitate such a program. Collaboration
and cooperation are necessary between various governmental
agencies, non-profit entities, academia, international
organizations, industry and the public. International
participation is essential.
The Presidential Advisory Council on HIV and AIDS is
examining the vaccine issue closely, and will supplement the
following initial recommendations as events ensue in this
area, including progress in the ongoing efforts of the
Office of AIDS Research (OAR) to reform priorities and
restructure AIDS research at the NIH.
3. Research and development for AIDS vaccines should
receive a substantial increase in the proportion
of funds devoted to it in the Federal biomedical
research budget for AIDS.
4. An expedited program to produce an AIDS vaccine --
targeted to fill gaps in knowledge, product
development, and testing -- should be supported.
This role would best be filled by a non-profit
international AIDS vaccine initiative, which
should be strongly supported by U.S. Government
contributions of funding, expertise, and other
resources, as well as by philanthropic, private
sector, and multinational donors.
END

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