An 'Iterative Process'

Sidebar: The AIDS Research Evaluators The 100-plus members of a newly constituted National Institutes of Health task force have begun their daunting task: a comprehensive reevaluation of NIH's entire $1.4 billion AIDS portfolio, including both intramural and extramural research. Compounding the challenge for the scientists and AIDS activists who make up the task force is a withering schedule. They will have to produce a report due in January 1996, to aid in planning the 1998 Office of AIDS Research (OAR) budget. Some panel members wonder if they can pull it off. They worry about getting the information they need quickly from 24 NIH institutes and centers that are not always in sync. More important to many task force members, a number of whom have sat on AIDS panels before, is whether their efforts will make a difference this time--whether their recommendations will become the government's AIDS agenda. But interviews with several panel members reveal widespread confidence that their recommendations will mean something and not just "sit on the shelf," as one put it. Panelist Spencer Cox, a member of Treatment Action Group (TAG), a New York- based activist organization, comments, "My experience with these sorts of committees is that everyone knows [at the start] what they are going to say when they come out, but that is not my impression of this one. This is not a setup; it's the real thing." The reevaluation was mandated by the NIH Revitalization Act of 1993, which was intended to strengthen OAR and give it the power to set priorities for United States AIDS research. Shortly after the act passed, immunologist William Paul was named to direct OAR. After preparing his first budget and hiring staff, planning this overview was his next obligation, says Paul, who discovered interleukin-4, a chemical messenger that stimulates B-cell growth and helps immune system cells communicate. Most of the task force members serve on one of six panels examining research in specific fields. A working group of 14, made up of prominent scientists and one AIDS activist, will integrate the reports of the six panels and issue its own recommendations on the priorities for AIDS research in a final report.The unusual size of the group is necessary, Paul maintains, because of the broad scope of its mission. The six panels--made up of some researchers who work on AIDS and others who do not, as well as people associated with the AIDS community and activist groups--will examine research in the following fields: clinical trials, drug discovery, vaccine research and development, etiology and pathogenesis, behavioral and social science research, and natural history and epidemiology (see accompanying list of panel members). These subject-oriented committees, officially known as Area Review Panels, will review research across institutes and make recommendations about which programs to keep and which to jettison, according to Paul. For example, the natural history and epidemiology panel will focus on transmission, reports its chairman, King Holmes, director of the Center for AIDS and Sexually Transmitted Diseases at the University of Washington. He says the panel will examine research on the natural history of HIV infection and determine the needs for epidemiological research into transmission risk factors. The AIDS Research Evaluation Working Group is headed by Arnold Levine, a virologist and chairman of the molecular biology department at Princeton University. Levine is known for his work on the p53 tumor suppressor oncogene and, like OAR director Paul, does not conduct AIDS research. The group does include prominent AIDS researchers--such as microbiologist David Ho, director of New York's Aaron Diamond AIDS Research Center--and several other notable biological scientists, such as Nobelist Phillip Sharp from the Massachusetts Institute of Technology. One activist, Mark Harrington of TAG, rounds out the Working Group. Levine was tapped by OAR director Paul after consultations with Brown University's Charles Carpenter, chairman of the AIDS Program Advisory Committee to NIH, and others. Paul, Carpenter, and Levine then began choosing other members of the Working Group. According to Paul, it was an "iterative process"--new members of the group helped pick others. Paul and the group picked the chairmen of the Area Review Panels, and then all participated in choosing the panel members. Levine's lack of AIDS research experience appears to be a plus in the minds of scientists and activists on the task force. "We're bringing a new, bright guy into the field," is how Carpenter, also a member of the Working Group, puts it. Levine, who accepted the assignment with enthusiasm, according to Carpenter, could not be reached for comment. The panels began their work in early May. Most have now had one or two meetings and several conference calls. Panelists interviewed for this article express satisfaction about the tone these initial meetings have set. The members "are anxious to do something real and represent a wide range of viewpoints," states Bill Snow of ACT-UP/Golden Gate, a member of the vaccine panel. "No one wants to be on another panel and have nothing come of it." Snow is the lone representative of ACT-UP, which is generally looked on as a militant, direct- action group but also includes people, like Snow, who do the quiet work on committees and advisory boards. Each panel will report to the Working Group, which must make judgments about how the disparate programs should fit together. "We need a [group] of 'wise men' at the top to take what [the panels] make and create a single whole," says Paul. "That's the reason we needed a two-tier system." The schedule for the group's research evaluation is ambitious, to say the least. Each panel is supposed to issue a report on research priorities in its field to the Working Group by the end of the summer or early fall. The Working Group will then provide a single report with recommendations for priorities to guide AIDS research at NIH over the next five years. Paul and several members of the review panels express confidence that the schedule is both realistic and necessary. "Many activists have said they don't want to see another two- year review grinding away, and we agree with that," says Paul. Nevertheless, just two months into the process there is at least an indication that the deadlines may be hard to meet. The clinical trials panel, for example, met in early May and was scheduled to meet again in late June. That meeting was canceled, according to panel member Lynda Dee, because at least some of the material requested from the various institutes of NIH would not arrive in time for panel members to review it. Another meeting was scheduled for August, says Dee, who is executive director of AIDS Action Baltimore, a research-advocacy and patient-services organization. She is also a former member of the executive committee of the AIDS Clinical Trials Group, the NIH-sponsored clinical trials network for adults. According to Dee, getting information from some of NIH's 24 institutes and centers has been difficult. In part, she says, this may stem from the fact that AIDS research is carried out in all the institutes and there is little coordination among them--which is what the revamped OAR is supposed to do. Dereck Hodel, the director of federal affairs for New York's Gay Men's Health Crisis (GMHC)--and not a panel member--agrees that "the structure of NIH doesn't lend itself to this kind of review." While he sees NIH's organization as a possible detriment to review, "there is nothing in the makeup of the panels that is an impediment," he says. "I am very hopeful that the evaluation will be thorough and they'll get a clear picture of research across the institutes. That hasn't been done effectively before, and it's critical." Dee, meanwhile, says she feels "all dressed up with nowhere to go," as she awaits more data to review. Activists and scientists have largely expressed satisfaction with the membership of the panels. Noteworthy is the representation from TAG, which has one member, Mark Harrington, on the Working Group, and two panelists. The organization has a reputation as one whose activists have done their homework and have developed expertise on many of the thorny issues at the nexus of AIDS science and policy. Indeed, a 1992 report by Harrington and Gregg Gonsalves, a member of the etiology and pathogenesis panel, strongly influenced the NIH Revitalization Act of 1993. Their report called for strong central leadership of AIDS research and a reinvigorated OAR. The panel makeup does not please everyone, however. Arthur Gottlieb, chairman of the department of microbiology and immunology at Tulane University Medical Center, says he was nominated for the panel but not chosen. He is concerned that some quarters are not represented. "I don't see people identified with thinking of this disease as an immune problem," he says. He has long been a critic of the virus-centered approach to AIDS and is involved in research to develop immune-based therapeutics (A. Gottlieb, The Scientist, March 20, 1995, page 13). The most frequent concern mentioned by panel members is that recommendations issued by the Working Group might end up, like past government reports, on a shelf at NIH. Ashley Haase, a University of Minnesota microbiologist who chairs the etiology and pathogenesis panel, says that Paul "assured us that this is an exceptionally important exercise" and that the committees' recommendations will be crucial in setting the next budget. Brenda Lein of San Francisco's Project Inform, an HIV treatment-information and patient-advocacy organization, continues to harbor some doubts. A member of the drug discovery panel, she asks, "are we wasting our time or will they implement reforms coming out of our panel?" She points out that the evaluation of the efficiency of funding for various categories of work is difficult because data are not uniform across institutes and the institutes do not cooperate well. Even within an institute, data are not necessarily consistent. For example, she says, a grant might be labeled epidemiology one year and relabled basic science in a later year. "How can we say too much money is going into one area and not enough into another," she asks, "if all the figures are arbitrary?" For GMHC's Hodel, the task force will be successful if its analysis "is critical and makes suggestions for changes. "It's hard to imagine that you could evaluate a $1.4 billion program and say, status quo is fine. I'd almost go so far as to say that a successful evaluation will make some people angry--and I don't think that's a bad thing." Billy Goodman, a freelance science writer based in Montclair, N.J., is online at goodmanb@ios.com. (The Scientist, Vol:9, #14, pg.1 , July 10, 1995) (Copyright, The Scientist, Inc.) garfield@aurora.cis.upenn.edu

An 'Iterative Process'

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