Health officials fail to agree on guidelines for generic antiretrovirals

On Tuesday in Botswana, international health officials failed to reach an agreement on guidelines for low-cost generic anti-HIV drugs after U.S. officials raised concerns about their use. Fixed-dose combination drugs that contain three medicines in one pill are a key part of the World Health Organization's plan to treat 3 million HIV-positive people in poor countries by 2005. The generic pills are also considerably cheaper than their patented equivalents. Several of the generic combination pills have already been certified as safe by WHO. But U.S. officials at the Botswana meeting questioned whether WHO's screening process was stringent enough, and they worried that widespread, inappropriate distribution of the drugs could contribute to viral resistance. Critics of the U.S. position fear that a parallel review system to attain FDA approval could slow attempts to get the drugs to people in Africa, where more than 25 million HIV-positive people live. The international aid group Doctors Without Borders has charged that the United States is seeking to protect the interests of U.S. pharmaceutical companies that hold the patent rights to the brand-name anti-HIV drugs. U.S. officials, however, deny that claim. Mark Dybul, deputy chief medical officer of the U.S. Global AIDS Coordinator's office, says the U.S. reluctance to endorse the drugs is based solely on the unmet need to develop "an agreed set of principles" for use of the generic medications.