International Health Officials End Talks Over Standards for Generic Antiretroviral Drugs
International health officials on Tuesday ended a meeting to discuss standards for generic antiretroviral drugs for use in developing countries, the Associated Press reports (Motseta, Associated Press, 3/30). Officials from HHS, the World Health Organization, UNAIDS and the Southern African Development Community at a two-day meeting in Gaborone, Botswana, discussed the draft Scientific and Technical Principles for Fixed-Dose Combination Drug Products, which outlines issues dealing with the safety, effectiveness and approval process for certain generic drugs used to treat HIV/AIDS. The fixed-dose combination, or FDC, antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, which combine stavudine, lamivudine and nevirapine into one pill that is taken twice a day. A regimen of the same three drugs purchased separately from patent holders GlaxoSmithKline, Bristol-Myers Squibb and Boehringer-Ingelheim requires six pills a day (Kaiser Daily HIV/AIDS Report, 3/30). Medecins Sans Frontieres said that the generic FDCs costs as little as $140 per person per year, compared with $562 for the brand-name drugs, according to the Associated Press (Associated Press, 3/30).
Concerns Over Delays
Although Triomune and Triviro have been approved by WHO -- which has a voluntary drug screening process through which pharmaceutical companies can submit both brand-name prescription drugs and unpatented generics for evaluation -- U.S. officials have questioned whether the screening process is thorough enough (Kaiser Daily HIV/AIDS Report, 3/30). U.S. officials want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use of the medications, according to the Associated Press (Associated Press, 3/30). Provisions in the President's Emergency Plan for AIDS Relief -- which seeks to provide treatment to two million HIV-positive people living in 14 African and Caribbean countries -- in principle require drugs to be approved either by FDA or through a mechanism established by PEPFAR (Kaiser Daily HIV/AIDS Report, 3/30). Critics of the U.S. position have said that setting up another review system could delay attempts to roll out antiretroviral drug programs in African countries, according to the Associated Press. In addition, MSF has accused the U.S. government of seeking to protect the patents of large pharmaceutical companies, a charge that U.S. officials have "strenuously denied," the Associated Press reports (Associated Press, 3/30). According to the conference Web site, a planning group is scheduled to meet following the conference to make revisions to the draft principles document based on the conference deliberations. The co-sponsors hope to agree on the content of a final document within about two weeks, according to the Web site (Conference Web site, 3/30).
A group of 381 nongovernmental organizations from 70 countries on Monday sent a letter to Ambassador Randall Tobias, head of the new State Department Office of the Global AIDS Coordinator, calling on him to accept WHO's prequalification system, which they said is supported by UNICEF, the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Columbia University Mailman School of Public Health's MTCT-Plus Initiative and many national governments and international humanitarian agencies. The letter states, "We object to any and all efforts by the Bush administration and your office to block the use of WHO prequalified generic medications, and any efforts to discredit the standards of WHO's prequalification project that would impose new barriers to generics entering the global market" (Letter text, 3/29). According to a Health GAP release, Tobias on Wednesday is scheduled to appear before the Senate Appropriations Subcommittee on Foreign Operations, where the issue may be discussed (Health GAP release, 3/30).
Boston Globe Editorial
Although President Bush's announcement of his global AIDS initiative 14 months ago provided a "rare celebration" for people fighting HIV/AIDS worldwide, U.S. funding since the announcement has been "a fraction of the promised amount," a Boston Globe editorial says. In addition, the United States is refusing to buy generic drugs, "which cost far less than brand-name drugs," the editorial says. History a "generation from now ... is likely to judge world leaders as much on what they have done to keep these diseases in check as on their efforts against terrorism," the editorial says, adding that the United States must "relent on its opposition to the generics and fulfill Bush's $15 billion pledge." The editorial concludes that doing so -- in addition to the "new resolve" shown by many African governments -- "could open a more hopeful chapter in mankind's halting war against infectious disease" (Boston Globe, 3/31).
WAMU's "Diane Rehm Show," a syndicated NPR program, on Wednesday in the first hour of the show will include a discussion on the U.S. role in the international effort to fight international HIV/AIDS. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Joe O'Neill, deputy coordinator and chief medical officer for the State Department Office of the Global AIDS Coordinator, are expected to be guests on the program (Rehm, "Diane Rehm Show," WAMU, 3/31). The complete segment will be available online after the broadcast.