AIDS Research at the NIH: A Critical Review

INTRODUCTION

Since 1987, the activist critique of AIDS research has worked its way back: from drug approval at the
regulatory level of the US Food + Drug Administration (FDA), to expanded access for drugs still under
study (Parallel Track), to the design and conduct of the controlled clinical trials themselves by the
National Institutes of Health (NIH), pharmaceutical companies and, community-based clinical trial
centers. While this work has generated some useful reforms in an inefficient system (and expanded
access and expedited approval for several useful therapies), it often seems that all these
accomplishments go for naught. HIV keeps spreading, AIDS keeps striking people down, and
researchers appear to have little confidence in the rapid development of a therapeutic cure or an
effective vaccine.
Against a background of deepening political reaction, declining research subsidies, and pervasive
pessimism about the prospects for a scientific breakthrough, some activists have grown unsure of the
continued value of engaging the scientific infrastructure. What is the point of streamlining access and
approval when the result is merely to replace AZT with other mediocre, toxic, expensive nucleoside
analogues? What is the point of developing prophylaxis and better treatment for opportunistic infections
when these measures simply allow someone to survive long enough to develop lymphoma, visceral
Kaposi's sarcoma, wasting syndrome or neuropathology?
If the reforms won by activists are not to become mere stratagems for craven pharmaceutical
companies swiftly to develop and market a whole series of additional nucleoside analogues (d4T, FLT,
3TC, etc.), activists must become more involved in the basic research process itself, forcing academic
and industrial researchers to turn their attention to novel treatment approaches of HIV-induced immune
suppression, including immune based therapy, cytokine inhibition, and active immunotherapy, with the
ultimate goals of elucidating the pathogenesis of AIDS, stopping its progression, and reversing its
damage.
The task requires that activists become as familiar with the $800 million AIDS program of the NIH as
they have with its major clinical component, the AIDS Clinical Trials Group (ACTG).
This report is a preliminary effort to map the NIH AIDS Program, evaluate it, suggest useful reforms,
and highlight the gruesome cost of the Bush administration's refusal to adjust AIDS research funding to
even the rate of inflation, to say nothing of the adjustment appropriate to the opportunities now within
reach. These opportunities are graphically documented in the institute directors' "Wish List" for fiscal
year 1993, which contains hundreds urgent new programs, few or none of which may be funded.
As a consequence of Administration policy, new initiatives are being smothered in the cradle to pay for
large ongoing programs. Prevention competes with care for limited funds. Basic research competes
with clinical trials. Immunology competes with virology. Treatment research competes with vaccine
research. Adult clinical trials compete with pediatric ones. Entire areas such as oncology, gynecology,
wasting, and neurology go begging for funds.
* Just as the precondition for access to therapies for all who need it is single-payor national
health care, so the prerequisite for a rational national biomedical research policy is the
immediate doubling of the NIH budget to $16 billion a year, with high-priority, high-mortality
areas like AIDS, cancer and Alzheimer's disease given the lion's share of the newly released
funds.
* In order to justify such new public investment, the NIH must take steps to incorporate
community views in its work across the board - not just in the ACTG or in AIDS - but for all the
other diseases against which its efforts are directed.