Treatment Issues: Newsletter of Current Issues in HIV/AIDS - Volume 18, Number 1 & 2, January / February 2004
Gregg Gonsalves

Back in 1992, I co-authored a report about the AIDS research program at the National Institutes of Health (NIH) documenting redundancies and gaps in the effort and the lack of leadership in the program as a whole. Subsequently, Senators Edward Kennedy and Orrin Hatch with Representative Henry Waxman passed a bill substantially re-organizing the AIDS effort at NIH based on our report's recommendations. When the Clinton Administration took office, a new Director of the Office of AIDS Research (OAR) at NIH was appointed. That Director, the eminent immunologist William E. Paul presided over a new era of AIDS research, in which the best scientists in the U.S. and around the world, in consult with community groups, came together to provide strong outside oversight and advice for the nearly billion dollar program.

Paul was a strong force for reform at the NIH but he paid for it dearly — after pushing too hard for change in the NIH vaccine program, the bureaucrats struck back and Paul was pushed from power. However, his successor, noted virologist Neal Nathanson proved no more palatable to the NIH good old boys (and girls) as he continued to seek change. With the ascent of George Bush in 2000, reform came to an end as the scientific leaders of the Clinton years fled back to academia.

The NIH under Bush is notable for its inability to attract senior scientists of the caliber of Paul and Nathanson willing to accept administrative positions. It has also been under siege from conservative ideologues who would like to privatize research or who regularly conduct witch hunts for research on sexual behavior and drug use. The AIDS program at the NIH since 2000 has retreated to the bad-old-days of insular decision-making by second-rate administrators who regularly dole out bad advice, or, like toadies at the court of Louis the XIV, tell their leader, Anthony Fauci, what he wants to hear. Strong countervailing voices of senior scientists like Harold Varmus, David Baltimore, Paul and Nathanson are now generally locked out of decision-making at NIH.

This was clearly evident in the NIH's decision to go ahead with a large phase III trial of two discredited vaccine candidates in Thailand. Despite howls of protest from the best AIDS researchers in the country, NIH has decided to push ahead with the $100 million folly, claiming a duty to the Thai researchers.

The second boondoggle to emerge from NIH over the past few months has been the plan to renew funding for its major AIDS treatment and prevention clinical trials networks, both in the U.S. and in the developing world. In a fleeting moment of courage a few years ago, the NIH arranged for all of the networks' grants and contracts to expire during 2004/2005 so a comprehensive plan could be considered and the entire system reshaped to meet current and future challenges in HIV research. Most of the networks were set up well over a decade ago, and although they've undergone minor changes, their leadership is restricted to a small group of investigators who run the show, each playing musical chairs with the other when their terms on important committees expire.

NIH could have brought in a group of non-network scientists, including experts in newly relevant fields (e.g. hepatitis; TB; operational, outcomes, and health services research; tropical medicine), and a diverse collection of community groups, to offer independent review and analysis and intelligently plot a course for the years ahead. This kind of open, scientific debate on the future of HIV clinical research would have been good for the field and good for the process, but NIH caved in to the political strength of the entrenched network leadership and cut back-room deals with them, reinforcing their power by creating a mega-network with a coordinated leadership structure, putting the good old boys in charge of everything.

So the pendulum has swung. From the reforms of the early 90s, we're now seeing the reaction: NIH has turned inward, neglecting and even spurning the advice of outside scientists and community groups, while relying on its own limited in-house expertise to shuffle around millions of dollars in research money. Such inbred thinking and opaque decision-making is not what AIDS research needs right now. We need greater openness, input and transparency and we need to demand it again, like we did in 1992.

20040110
GM180108

Copyright © 2004 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011  fredg@gmhc.org  http://www.gmhc.org

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.