Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 15, Number 10, October 2001
Gregg Gonsalves

Congress has wisely chosen to not allow the advent of a recession and the unexpected billions of dollars needed to respond to the events of September 11th to imperil current levels of funding for biomedical research. Yet in this time of upheaval and adjustment it has become critical that we evaluate our priorities for basic and applied AIDS research and start planning for a new era.

Help Basic Research Get Out of the Box

• Tomorrow's AIDS researchers: where are they? There is no certainty that once the first generation of researchers on AIDS heads into retirement that we are going to have new recruits to follow them into the battle on HIV. We need to train more clinician-scientists, those MD/PhDs who have a foot in both care and basic research, and make it worthwhile for plain-old MDs and PhDs to head into the AIDS research field.
  
  

• New targets for antiretroviral therapy: the drug companies won't do it and the NIH doesn't know how. Drug companies usually wait for new therapeutic developments from academic molecular biology to be well established before embarking on novel drug discovery and development programs for AIDS (e.g. T-20). NIH-funded academics studying previously untargeted HIV proteins don't have an incentive to apply their basic insights to the development of new drug screens. So we have a no-man's land where drug discovery on approaches other than RT and protease inhibition are languishing. We need a mechanism to link the best molecular biologists on HIV's other enzymes with the best industry minds in drug screening, discovery and development.
  
  

• Man can't live by antivirals alone: AIDS is a disease of the immune system and there should be a way to harness the body's own disease fighting know-how to fight HIV. This will take a substantial new investment in HIV immunology and basic human immunology as well. The best basic immunologists are happy working on mice, and the HIV immunologists are often simply shackled to doing specialty assays for vaccine studies.
  
  

• We need to ask for the resignation of Judith Vaitukaitas, the Director of the National Center for Research Resources, who has presided over an acute and growing shortage of rhesus macaques for vaccine studies for almost a decade and done nothing to respond to it. She has been raked over the coals in Science magazine, by Harold Varmus, the former NIH director, and by Neal Nathanson, the former director of the NIH's Office of AIDS Research, but no one seems to be able to get rid of her. Large, comparative studies of vaccines in monkeys would be a boon to our vaccine effort, but Dr. Judy doesn't seem to care.
  
  

Protect the Public Health with Longer-Term Research

AIDS activists worked successfully to expedite drug approvals to get new agents to market at speeds unheard of twenty years ago. Now the industry should give back something to the community by endowing a fund to conduct rigorous post-marketing surveillance studies of their drugs by independent researchers or clinical trials networks.

Industry has no incentive to study its drugs after FDA approval and the NIH clinical trials networks have been timid about conducting meaningful studies that industry won't support. Someone has to invest in studying the long-term effects of these drugs and public funding should pay for these public health studies. Alternatively, industry can work hand in hand with the community to get Congress to authorize and fund the Agency for Health Care Policy and Research (AHCPR) and its Centers for Education and Research on Therapeutics to conduct such studies.

This is a short list, but it's a start. Let's take advantage of this time of change to make changes that matter.

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