AIDS Research at the NIH: A Critical Review

* NIAID should streamline and coordinate its 4-5 clinical research networks. The ACTG needs
CPCRA subjects for its large antiretroviral efficacy and OI prophylaxis trials. Yet the CPCRA
cannot conduct such data-intensive research; the ACTG needs to simplify its larger trials to make
them less high tech and more accessible. Statisticians and research nurses must play a more vocal
role in streamlining the NIAID research behemoth. Analysis and publication of results must be
accelerated;
* The ACTG must develop new, effective links with research groups funded by other NIH institutes
such as the AIDS Lymphoma Network (NCI), SOCA (NEI), Pediatric ACTG (NICHD), and the NIH
Clinical Center (NIHCC);
* Previously underrepresented populations must be allowed to enroll in therapeutic and not just
observational studies if the hollow promises of Dr. Sullivan are ever to be replaced with a true
commitment to diversity in clinical research.
11/2. National Cancer Institute (NCI)
NCI, the largest and oldest of the NIH, was founded in 1937. President Nixon's 1971 "War on Cancer"
brought NCI (and NIH) funding to new heights. The ensuing decades brought great improvements in
molecular biology - subsidized by the war on cancer - but actual therapeutic progress against the 200 or
so human neoplasms, or even a coherent pathogenetic picture of their etiology, lagged far behind. This
set the template for NIH AIDS research a decade later. AIDS supplanted cancer as the ultimate scourge
in the popular imagination. Initially, the NCI was the leading AIDS agency at NIH. The NCI has five
divisions: Cancer Biology and Diagnosis; Cancer Etiology; Cancer Prevention and Control; Cancer
Treatment, and; Extramural Activities. The NCI's budget, the largest at NIH, was $1,711,646,000 in FY
1991. It rose to $1.95 billion this year. The NCI Director is Samuel Broder, MD, who was born in Poland
in 1945, graduated from the University of Michigan School of Medicine in 1970, completed his training at
Stanford, and joined NCI in 1972. In 1981 he became associate director of the Division of Cancer
Treatment's Clinical Oncology Program (DCT's COP). There he, along with Hiroaki Mitsuya, Robert
Yarchoan and others, developed the in vitro screen for HIV reverse transcriptase inhibitors which led in
1985 to the identification of the dideoxynucleosides (AZT, ddC, ddA/ddl, etc.) as potential antiretroviral
agents. President Reagan named Broder NCI Director in 1988, after Vincent DeVita, Director through most
of the 1980s, left in disgust with the state of Federally-supported biomedical research. Broder was the first
chairman of the NIH AIDS Drug Selection Committee, created in 1986. While his current responsibilities
are considerable, Dr. Broder remains involved in AIDS research at NCl.
NCI's appropriations for AIDS are second only NIAID's. Its AIDS allocation in FY 1991 was 20% of NIH's
total, and 10% of the NCI total budget. This amounted to $160,869,000 in 1991. NCI's budget skips PHS,
HHS and OMB and goes straight to the President under a special "budget bypass" provision. In spite of
this privilege, President Bush slashed $44M from NCI's 1993 AIDS budget request, from $217.5M to
$175.8M, or less than the rate of biomedical inflation. NCI spends more on AIDS intramurally than any
other ICD (including NIAID: NCI $75M, NIAID $47M). NC's AIDS budget is half extramural ($79.5M), half
intramural ($75.2M). Over half the extramural R+D contracts (N01s) support NCI's intramural work as well
(e.g., two contracts totalling $24.8M support the NCI Frederick Cancer Research Facility). While NIAID has
a Division of AIDS, which conducts most (72%) of its AIDS research, NCI's AIDS work is distributed
throughout the institute. This makes it harder to get an overview of the entire program and to figure out
where responsibility for various programs lies.

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