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U.S. Opposition to Using Fixed-Dose Generic Antiretroviral Drugs in Africa Could Be 'Lethal,' Opinion Piece Says
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While the United States claims that it opposes distributing fixed-dose combination antiretroviral drugs in Africa because the medicines have not been approved by FDA and could be unsafe, such opposition could be "lethal to many of the 26 million people living with HIV/AIDS in sub-Saharan Africa," Dr. Mardge Cohen, founder of the Women and Children With HIV Program at Cook County Hospital in Chicago, and Dr. Gordon Schiff, director of clinical quality, research and improvement at the hospital, write in a Chicago Sun-Times opinion piece (Cohen/Schiff, Chicago Sun-Times, 5/5). Generic FDC antiretroviral drugs combine three different medicines into one pill that is administered less often and costs less than the patented versions of the drugs. The drugs have been approved by a World Health Organization prequalification system, but U.S. officials want to ensure that the medicines will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use and are proposing guidelines for reviewing FDCs (Kaiser Daily HIV/AIDS Report, 4/29).
It is a "cruel irony" that concerns over the safety of generic FDC drugs are being used to "hold up [patients'] only chance of life-saving therapy," Cohen and Schiff say. FDCs are the "simplest first-line regimens" and the "best offense" for fighting HIV/AIDS internationally and the claim that the United States is "protecting African patients by denying them drugs" must be viewed with "skepticism," Cohen and Schiff say. Although the Bush administration has "stepped forward" by promising $15 billion over five years to fight HIV/AIDS in Africa and the Caribbean, the president's goal of treating two million individuals by 2005 "will be possible only if the plan relies on the least expensive medications," Cohen and Schiff conclude (Cohen/Schiff, Chicago Sun-Times, 5/5).
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