GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Derek Link

The NIH AIDS effort, which incorporates funding for outside investigations as well as for projects within the Institutes' walls, accounts for more than 85 percent of the world's publicly funded AIDS research. Twenty-four separate programs, conducted by each of the NIH's independent research institutes, make up the overall undertaking. The AIDS program at the National Institute of Allergy and Infectious Diseases (NIAID) is the largest and most prominent, but NIAID's endeavors account for only 40 percent of the entire NIH AIDS research budget.

The report assessed how the 24 AIDS research programs fit together and determined whether NIH AIDS research as a whole is moving effectively and efficiently toward an AIDS cure and vaccine.

The Working Group found that the NIH has made substantial progress over the last fifteen years, helping to identify the causative agent of AIDS, establish AIDS research as a scientific discipline, and improve treatment of HIV and associated infections. But a cure and vaccine remain elusive. The panel concluded that the federal government must restructure its AIDS research effort to meet the scientific challenges posed by AIDS.

The evaluation panel was convened by the new NIH Office of AIDS Research (OAR) in late 1994. In 1993, the Congress commissioned the OAR to review how prudently the NIH spent its AIDS research money and strengthened the OAR's authority to coordinate and plan this spending. Since the 1994 Congressional elections, when Republicans won majorities in both houses of Congress, the OAR's authority has been under constant assault. Ironically, just as the Working Group was releasing its findings, Congressional leaders were trying to strip the OAR of its authority to implement the report's recommendations. As Treatment Issues goes to press, the OAR's authority remains an unresolved issue.

Promoting the Nongovernmental Sector

Six themes emerged from the OAR review. First and foremost is the need for stronger oversight and participation by non-government scientists (such as the academic researchers constituting most of the OAR Working Group). Further concerns were better integration and coordination of the NIH's individual AIDS programs; more collaboration between NIH and the drug industry; an increased emphasis on basic research initiatives; and more research on the prevention of HIV transmission, including both biomedical and behavioral approaches. The Working Group's final overarching point was expressed by a strong statement advocating greater involvement of affected communities in the research process.

From these general themes came fourteen specific recommendations:

Increase support for and improve peer-review of investigator-initiated research. "Investigator-initiated research" refers to research that is developed and conducted by independent scientists. It stands in contrast to "directed research," which is controlled and designed by staff scientists of the NIH. Investigator-initiated research is advanced in the report as the best way to enhance the diversity and productivity of scientific investigations. The report calls for doubling the level of investigator-initiated AIDS research over five years. It notes that only twenty percent of NIH AIDS research is investigator-initiated, far less than the approximately 50 percent that occurs other fields.

Restructure the nation's AIDS vaccine research.

Calling an AIDS vaccine a crucial public health priority, the report calls for a national task force to guide all government AIDS vaccine research programs and urges that distinguished non-government scientists be placed in control of the program. The report sharply criticizes HIVNET, an NIH-funded network of research sites working on an AIDS vaccine, and calls for a comprehensive plan for its organization, governance, research priorities and funding.

Develop an HIV prevention science agenda.

The report suggests the creation of a prevention science agenda that is practical and evidence-based. It says an "ideal" strategy would include behavioral and social interventions and biomedical technologies (topical microbicides, anti-addiction treatments, etc.) in addition to vaccines.

Augment research efforts to better understand the human immune system.

More research into the human immune system is critical for the development of an AIDS vaccine and better therapies. The report recommends more research on human and primate immunity, noting a heavy emphasis to date on mouse immunity.

Integrate all adult clinical trial programs into a single network.

The NIH maintains twelve adult trials networks to test therapies for HIV and related conditions. Among the most prominent are the ACTG and CPCRA at NIAID; the Study of the Ocular Complications of AIDS, or SOCA, at the National Eye Institute; and the AIDS Malignancy Consortium, or AMC, at the National Cancer Institute. Currently, there is no mechanism for cooperation and collaboration between them. The report observes that "there has been overlap and, in some instances, unnecessary competition between these diverse programs that are funded by different institutes with different self-defined missions. The scientific productivity of these independent clinical trials efforts has been quite variable." A single clinical trials network should be run by NIAID with support from other institutes, and the network's scientific leadership should be provided by non-government scientists.

Refocus and restructure the drug discovery research effort.

The NIH drug discovery effort for AIDS includes many different programs in different scientific areas. Some programs, such the National Cooperative Drug Discovery Groups and the HIV structural biology program, are praised by the Working Group. The panel singles out the National Cancer Institute's Developmental Therapeutics Program (DTP) for particular criticism. The DTP annually screens thousands of compounds, both natural and synthetic, for activity against HIV, but the report finds that this vast effort is hobbled by antiquated techniques and a lack of follow through on the potential antiviral drugs it uncovers. The DTP's AIDS resources and enormous collection of compounds should be restructured, serving as a resource for the entire NIH AIDS program.

Augment basic research on AIDS-associated infections and facilitate transfer of new findings for early clinical evaluation.

Although opportunistic infection treatment and prevention have achieved impressive gains over the last decade, few new drugs have been developed specifically for AIDS OIs. (Most OI drugs were first developed for other more common maladies.) The panel concluded that an increased emphasis on the fundamental biology of these pathogens is necessary, given that drug companies have limited incentive to investigate these normally uncommon diseases. Its report specifically recommends greater use of Small Business Innovation Research grants to facilitate transfer of NIH basic science research to the pharmaceutical industry.

Strengthen the scientific base for the assessment of alternative therapies for HIV disease.

The panel found that alternative therapies are widely used by people with HIV and that alternative therapies have the potential to both benefit and harm recipients. To collect more information on the effects of such therapies, the report urges greater collaboration between the AIDS research effort and the NIH Office on Alternative Medicine.

Reorganize the Regional Primate Research Centers to ensure they are responsive to outside scientists.

The RPRCs are a crucial national resource, especially for research into primate models of HIV infection. The panel found the RPRCs do not always support the most meritorious research, and recommends that their resources be refocused on the most promising research ideas. The RPRCs should develop a competitive process to ensure that the best science is supported and allow outside scientists greater access to their primate resources.

Strengthen AIDS Research Centers to foster multidisciplinary research on the disease.

The sixteen NIH-supported AIDS research centers are multidisciplinary organizations that bring together basic and clinical researchers from many medical sub-specialties. The centers "provide a central pool of resources, capable of a flexible and coordinated response to scientific opportunities." The report advocates doubling the funding for AIDS Research Centers.

Ensure that central repositories of biomedical specimens and databases are of the highest quality and accessible to qualified investigators.

Over the last decade, the NIH has generated enormous repositories of specimens and large databases, which represent a "potential national treasure" for AIDS research. But, the report says that these repositories and databases are poorly coordinated, and many investigators have little or no access to them. It recommends that databases use a common, user-friendly information system, and that access to them be peer-reviewed and open to all scientists with meritorious research ideas.

Upgrade the NIH AIDS Research Information System and increase the information base.

The panel said its review was hampered by the lack of an adequate information system at the NIH for AIDS research. Available databases do not accurately and thoroughly track all AIDS research expenditures at the Institutes, producing many gaps in grasping the nature of AIDS research there.

Develop and implement a clear definition of AIDS and AIDS-related research through an evolving process.

The panel found that each NIH institute has its own definition of what constitutes "AIDS research." A clear NIH-wide definition of AIDS research is urgently needed, because, in some institutes, inappropriate classification has led to allocation of a significant amount of AIDS funding toward activities with little or no relevance to AIDS (see Treatment Issues, October, 1995, page 9 on the National Cancer Institute's misallocation of tens of millions of dollars). The panel urges that these funds be redirected to more appropriate projects.

Preserve a strong Office of AIDS Research to provide leadership and coordination to the entire NIH AIDS research program.

The panel "unanimously agreed" that the NIH AIDS research program needs central leadership and oversight. In particular, the panel emphasized that the OAR will be crucial for implementing the recommendations in its report.

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