By Gregg Gonsalves and Mark Harrington
VIII International Conference on AIDS, Amsterdam, the Netherlands, July 20, 1992
From the 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. If AIDS activists ever leave any legacy other than their own bodies, it will be, among other things, a movement for national health care and the democratization of research.
The pattern of Federal AIDS research funding from 1981 through 93 is:
NIH AIDS Budget by Year (with rate of increase from previous year)
After several years (in the mid 1980s) of program growth, the NIH AIDS budget is now falling relative to inflation (a 3.8% increase for AIDS research next year, while inflation is predicted to reach 5.1%, according to the Biomedical Research and Development Price Index computed by the Commerce Department). From 1982 to 1989, Congress always appropriated much more for AIDS than the Administration requested. That pattern has now been reversed. In 1991, Congress authorized $3 million less than the President requested for AIDS research. For several years, Congress has imposed new demands on the NIH AIDS program without authorizing new funds with which to carry them out. For example, in 1990 the Congress earmarked $40M for research on children with AIDS, especially for clinical trials. Since there was no new money appropriated for this purpose, the funds came directly from the adult AIDS Clinical Trials Group (ACTG). The result is that now, in 1992, the US Government is spending $105.00 for research on every child with AIDS in America, compared with just $1.00 for each adult. The Pediatric ACTG is now as large as the adult ACTG, which has been cut to make ends meet.
When it comes to research policy, Congress is often like a bull in a china shop, dropping in to make a mess and then storming out again. For example, also in 1991, Congress imposed new restrictions on the right of NIH personnel to travel for work. This was ostensibly because some Congressmen feared that junketeering NIH employees would litter the streets of Florence swilling cappucino rather than negotiating with drug companies and attending seminars. The result of this mini-scandal was a $10-million reduction in the overall NIH AIDS budget and severe, ongoing restrictions on NIH travel. This makes it even more humiliating to work for the government. For the last two years, activist groups have sent more members to the international AIDS conferences than has the NIAID Division of AIDS, the lead agency charged with conducting Federal AIDS research. NIH can still spend other funds sending extramural experts to Bethesda for meetings, but its own employees are virtual prisoners on the campus.
While Congress is careless and capricious, the Administration, from the White House down to the Secretary of Health + Human Services [HHS], has adopted an AIDS strategy of “malign neglect,” apparently hoping the problem will solve itself. Recently, the US National Commission on AIDS, a third of whose members were named by the President, condemned the Administration for its inadequate, inconsistent, and heavily politicized AIDS policy. Barring a change in administration, it would be foolish to expect leadership from the White House or HHS on AIDS anytime soon. This creates a conundrum; officials relatively low within the Executive Branch are delegated leadership on AIDS policy more or less by default.
At the NIH level, de facto AIDS policy decisions are made by Associate NIH Director for AIDS Research Anthony S. Fauci, who is Director of the Office of AIDS Research (OAR), Director of the National Institute of Allergy + Infectious Diseases (NIAID), and Chief of the Laboratory of Immunoregulation. Extraordinary responsibilities rest by default on a man who turned down the chance to become NIH Director in order to stay more in contact with AIDS research, yet who wears so many hats which demand very different skills and decisions.
In addition, there is a dizzying array of advisory committees which advise every level of NIH, from the overall AIDS effort to specific Institute and Division councils. Every major new program initiative must be approved by an external advisory council, yet these decisions are often simply an elaborately choreographed rubber stamp.
The NIH is actually a collection of fiercely autonomous fiefdoms (designated Institutes, Centers, or Divisions, known as ICDs) loosely administered under an NIH Director. Each ICD Director develops and administers his or her own budget, and there is little the NIH Director can do to allocate resources across institutes (although she now has her own $20M “emergency fund”). Some ICDs, such as the National Cancer Institute (NCI), have worked out special privileges within the Executive Branch – the NCI “Bypass Budget” skips the desks of Assistant Secretary for Health Mason, Health and Human Services Secretary Sullivan, and Office of Management and Budget Director Darman, and goes straight to the President’s desk. (This didn’t stop the President from slashing the 1993 NCI request just as much as he slashed those of of every other ICD.) OAR Director Fauci, who is supposed to coordinate AIDS research across ICDs, has little real say in the half he does not directly control as NIAID Director. Thus, there is no truly centralized planning and execution of AIDS research, and no adequate oversight from either Congress or the Administration. Neither is there enough systematic, comprehensive information about existing NIH AIDS programs. Since 1990, activists, the Congress, and the Institute of Medicine (IOM) have all encouraged the NIH to develop a comprehensive plan for its AIDS efforts, and NIH has been working for the last year on a “Strategic Plan for HIV-Related Research.”