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Date: March 14, 1996
For Release: Immediate
Contact: NIH/Anne Thomas, (301) 496-4461

MAJOR REPORT ON AIDS RESEARCH AT NIH

The U.S. government's AIDS research program has made substantial progress, but needs an infusion of new investigators into AIDS research, more emphasis on vaccine development, and augmented research to understand the human immune system, according to a report released today by a panel of over 100 scientists and other experts from outside the government. This evaluation is the first comprehensive review of AIDS research at the National Institutes of Health (NIH), which has been conducting and supporting AIDS research since 1981 when the AIDS epidemic was first recognized. NIH's commitment to AIDS research is $1.4 billion in fiscal year 1996.

The 40-page report was developed by an independent, cross- disciplinary panel that included Nobel laureate scientists, clinicians, researchers, senior representatives of major

pharmaceutical companies and HIV community representatives. This group was appointed in February 1995 to provide its report to the advisory council of NIH's Office of AIDS Research (OAR). Dr. Arnold Levine of Princeton University chaired the evaluation. As noted in the report's introduction, this effort "provides a blueprint for restructuring the NIH AIDS research program to streamline research, strengthen high-quality programs, eliminate inadequate programs, and ensure that the American people reap the full benefits of their substantial investment in AIDS research". "Over the past 15 years, much has been learned about the AIDS virus, and we have come a long way in treating the consequences of the infection--people are living longer with the virus, we now have 7 antiretroviral drugs approved, and there are dozens of treatments and preventive measures for opportunistic infections," said Dr. Harold Varmus, NIH Director, "but it was clearly time for a review of NIH's efforts. That's why I welcomed this evaluation, under the auspices of the NIH Office of AIDS Research, looking at every component of the NIH research effort and assessing how these components fit together and whether as a whole the program is moving effectively and

efficiently toward the goal of preventing and curing AIDS." The Office of AIDS Research (OAR), which was established by Congress in 1988, was given new authorities by Congress in 1993 to plan, coordinate, evaluate and fund all AIDS research at NIH. OAR also develops an annual comprehensive plan and budget for all NIH AIDS research. "The release of this report is a significant milestone in our efforts to combat HIV and AIDS," said Dr. William Paul, Director of NIH's OAR. "The report indicates that we are at a turning point in AIDS research, and provides a chart for the future so that we may capitalize on the advances we have made thus far. We now know the steps we need to take now to move us forward with the most effective and well-coordinated program across NIH for the future of AIDS research," he said. The report and recommendations were presented to the advisory council to the OAR on March 13. The report was accepted by the advisory council, which is chaired by Charles Carpenter, M.D., of Brown University, and was conveyed to Dr. Paul and Dr. Varmus for consideration and development of implementation plans. The detailed evaluation reports of the six individual panels set up to review the areas of Clinical Trials, Drug Discovery, Vaccine Research and Development, Biology and Pathogenesis, Behavioral and Social Sciences Research, and Natural History and Epidemiology will be released on April 2. "I am looking forward to reviewing and considering the report in detail and working on our implementation plans with the OAR and the directors of all the NIH components that conduct and support AIDS research, " said Varmus.

There are 14 major points to the blueprint drawn by the Evaluation Working Group. Among the recommendations are the following:

The proportion of the NIH AIDS research budget allocated to support unsolicited investigator-initiated research should be doubled.

A trans-NIH vaccine effort should be developed--under the administrative structure of the National Institute of Allergy and Infectious Diseases--that will include major investments in fundamental human immunology and vaccine biology.

OAR should develop a coordinated and comprehensive Prevention Science Agenda combining biomedical, behavioral, and social interventions.

A single integrated adult clinical trials network should be created, as well as a uniform standard for clinical trials databases.

Research to better understand the human immune system should be accelerated and the basic science research effort on AIDS-associated opportunistic infections should be reinvigorated. Further, the report calls for the development of "a clear definition of AIDS and AIDS-related research through an evolving process" to permit multi-year analysis and ensure that AIDS research funds are effectively and efficiently utilized. In addition, the report calls for a "strong Office of AIDS Research to provide leadership and coordination to the entire NIH AIDS research program." "AIDS is a relentless enemy, but recent scientific advances provide us with a real sense of optimism," said OAR Director William Paul, M.D. "We must use this report to ensure that every research effort is as clearly focussed, well-designed, and well-coordinated as possible. We cannot afford to lose a moment's time, or to waste a single research dollar."

A list of Working Group members is attached.

For a copy of the report, contact the Office of AIDS Research at (301)- 496-0357.