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Executive Summary

The National Task Force for AIDS Drug Development will hold its first meeting in February or early March, HHS Assistant Secretary for Health and task force Chairman Philip Lee, MD, told a Nov. 30 press conference at the National Institutes of Health in Bethesda, Md. Nominations for the 15-member panel were solicited through a Federal Register notice published Dec. 2. After a 30-day nomination period, HHS will name members to the task force, with two to three members drawn from "government, the pharmaceutical industry, academia, medicine and the AIDS-affected communities," HHS said. Government representatives will probably include FDA Commissioner Kessler and an NIH representative, presumably the new Office of AIDS Research director. NIH is searching for someone to fill that position. Operations for the task force will fall under the purview of FDA's AIDS Coordination Staff headed by Randy Wykoff, MD. The task force will bring in outside experts as needed to form working groups on specific issues of interest to the panel. FDA expects the group to meet roughly four times a year. National AIDS Policy Coordinator Kristine Gebbie said creation of the task force will "formalize channels of communication among the partners who must be involved to successfully bring new drugs into use." HHS Secretary Shalala said "the National Task Force on AIDS Drug Development...has a clear and critical mission: to identify, and remove, any barriers or obstacles to developing effective treatment." Despite progress in streamlining FDA review procedures and in understanding the disease, Shalala said, "the sad fact today is that not a single NDA for an anti-retroviral agent awaits FDA approval." Shalala announced the formation of the task force to coincide with World AIDS Day on Dec. 1. Asked to elaborate on the "barriers" the task force will address, FDA Commissioner Kessler said: "The first barrier is the biology of the virus itself...that's what we need to overcome." Other "areas that I think we need to look hard at," Kessler continued, "are the screening of drugs, the toxicology requirements...clinical trial design, and how we can improve the whole drug discovery/development process." A June 4 memo to Shalala from Kessler and National Institute of Allergy and Infectious Disease Director Anthony Fauci, MD, suggests proposed topics for the task force, including: "barriers to drug development" such as the need for effective animal models, the use of surrogate endpoints in early clinical trials, and the inclusion of minorities and women in clinical trials; "barriers to novel medical intervention" such as preventative vaccines and products to treat HIV in childhood; accelerated review and approval; access for people with missing or inadequate health care to clinical trials and to products on expanded access; and health policy issues, such as early distribution of the results of clinical trials and problems with reimbursement for unapproved uses. FDA and NIH pointed out that since the task force constitutes an advisory committee, it is being established in the face of a recent executive order to reduce the number of outside committees. However, the agencies note that "because the White House has expressed interest in this task force, we believe its formation" is justified. Lee said the idea for the task force was prompted by the creation in April of the Inter-Company Collaboration for AIDS Drug Development proposed by Merck. "That innovation...was the first major step," Lee said. "Discussions then with Tony Fauci and David Kessler, with [Merck Chairman] Roy Vagelos and others in industry made it very clear that the government had to take an initiative as well." An internal planning group made up of representatives from FDA, NIH, and the Centers for Disease Control and Prevention has been working on the task force since June. The Merck-initiated intercompany group already has been establishing contact with government and other entities. A summary of its most recent meeting in October reports that subcommittees were formed "to facilitate interactions with various third-party groups and organizations" including NIH, FDA, the HIV community and the Future Directions in AIDS Research group. A meeting with HIV community activists took place Dec. 3. By expanding the intercompany initiative into the public sector, the industry has an opportunity to join, symbolically, in a nonadversarial relationship with Administration officials such as Lee and Shalala. "I'm very pleased that we have [the national] task force now," Vagelos said. "More communication is always extremely useful and helpful." Merck was the only company represented on the dais at the Nov. 30 press conference. Merck has been the catalyst in putting together a cooperative AIDS campaign. However, by monopolizing the publicity Surrounding the project, Merck may be undercutting some of its effort to create an industry-wide project. The Pharmaceutical Manufacturers Association issued a statement Nov. 30 in support of the task force. PMA maintained that "the pharmaceutical industry's major efforts have produced substantial progress" in the AIDS area. A survey of members shows that "74 companies now have 103 medicines in human clinical trials or awaiting approval at FDA," PMA added. The association estimates that members will spend $1.6 bil. this year on research directed "to treat AIDS and other infectious diseases." The Biotechnology Industry Organization said it will urge Shalala to include representatives from its membership on the task force. BIO used the occasion of the Task Force announcement and World AIDS Day to repeat its claims that elements of the Clinton Administration health plan will hurt the biotech industry's access to capital. A survey of BIO members found that "63% predicted AIDS research would be hampered in the future if Clinton's proposal to control drug prices becomes law," the organization declared. BIO's message continues to win at least a rhetorical response from the Administration. In enumerating the "barriers" to be addressed by the task force, Shalala said "there are numerous examples of small companies that can't afford to move to the next stage that require a collaboration." Shalala's comments intimate one of the potential drawbacks of the project for industry: if the government really believes it has played a collaborator role in the development of an AIDS treatment, it may well demand a say over pricing or marketing. Merck Research Labs President Edward Scolnick, MD, who chairs the intercompany collaborative group, reported that its meetings are "leading to standardization and information transfer across companies." The summary of the Oct. 8 meeting reports "that a consensus protocol was established for determining cell culture antiviral activities of novel anti-HIV therapeutic agents." The companies are also "putting together a comprehensive database on resistance with all drugs so that all companies will be able to access all the information...on the mechanisms the virus uses to become resistant to therapies," Scolnick said. The scientific work of the group thus far has involved presentations by member companies of development projects. In its two meetings, the group has been briefed on: Roche's protease inhibitor Ro 31-8959 and TAT antagonist Ro 24-7429 (since discontinued); Bristol-Myers Squibb's nucleoside analog d4T (Stavudine); Merck's nonnucleoside reverse transcriptase inhibitor L-697,661 and protease inhibitor L-735,524; Glaxo's nucleoside analog 3TC; Astra's CMV product Foscavir; Boehringer-Ingelheim's nonnucleoside analog nevirapine; Burroughs Wellcome's nucleoside analog 935U; Hoechst's pentoxyfilline; and Lilly's nonnucleoside analog LY300046. A goal of the collaboration is to encourage early research on combinations. At its next meeting in early 1994, the group plans to begin to address areas where combination therapy may be appropriate. In his remarks to the press conference Nov. 30, Vagelos presented a general assessment on the progress of AIDS research. "The focus has been moving as we've tried to get closer and closer to a drug to the enzyme protease and the effort to find an appropriate protease inhibitor," he said. Repeating statements made in other public appearances, Vagelos declared that he is "overall an optimist." The Merck chief exec added, however, "I will never predict [the timing] because I've been in the business long enough to know that that is unpredictable." In November 1990, Vagelos was more sanguine, assuring the financial community that "we will see a product within the next couple of years" ("The Pink Sheet" Nov. 19, 1990, p. 9).

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