The debate surrounding low-cost generic anti- AIDS medications for AIDS-ravaged poor countries became contentious after US officials raised doubts about these combination drugs. The US Department of Health and Human Services, the World Health Organization (WHO), the Joint United Nations Program on HIV/AIDS, and the Southern Africa Development Council recently held a conference in Botswana's capital to discuss the safety, effectiveness, and approval process for fixed-dose combination therapies.
The drugs combine 3 antiretroviral medicines into 1 pill. Produced by generic drug manufacturers, the pills are considerably less costly, compared with single patented equivalents. US officials at the conference dismissed claims that they are protecting big pharmaceutical companies by raising questions about the suitability of widespread use of fixed-dose combination drugs. They argue that they want internationally accepted standards to prevent drug resistance.
"We know from a decade of clinical experience that if you do not maximally suppress the virus, you significantly increase the risk of resistance," said Mark Dybul, MD, deputy chief medical officer for the US Global AIDS Coordinator's office. "That's why we use 3-drug combinations, not 1 or 2." Yet, opponents fear that putting in place another review system could impede attempts to get low-cost drugs to African countries.
"There are very clear signals that the US government does not support ? the use of fixeddose combinations" made by generic manufacturers, said Ellen ?t Hoen of the medical aid group M?decins Sans FrontiPres. "We are very worried that these arguments about the safety of medicines? will lead to loss of confidence in the products" that are recommended by WHO," she said.
In 2003, WHO set up guidelines on appropriate therapy for HIV in resource-limited countries. Several combination therapies have been prequalified under these guidelines, including Triomune and Triviro. These generic drugs, manufactured in India, combine in a single pill the recommended treatment of stavudine, lamivudine, and nevirapine.