‘Rush’ To Use ‘Untested’ Generic Antiretrovirals ‘May End Up Costing Lives,’ Opinion Piece Says

The "all-too-hasty rush" to use "untested" Indian generic antiretroviral drugs in Africa may have caused new HIV strains to develop and "may end up costing lives," Abner Mason, founder and executive director of the AIDS Responsibility Project, writes in a San Francisco Chronicle opinion piece (Mason, San Francisco Chronicle, 12/1). World Health Organization officials on Tuesday announced they had reinstated to WHO's list of prequalified medications two of Indian generic drug manufacturer Cipla's generic antiretroviral drugs. WHO in June removed Cipla's versions of lamivudine and zidovudine from its approved HIV treatment list because of problems detected during an inspection of an independent laboratory that Cipla had hired to conduct tests to determine whether the generic drugs are bioequivalent to brand-name versions. The Indian generic drug company Ranbaxy last month removed all seven of its generic antiretroviral drugs from the WHO list after discovering discrepancies in bioequivalence tests (Kaiser Daily HIV/AIDS Report, 12/1). The recall of Ranbaxy's antiretrovirals came three years after the drugs were "approved" by WHO and have been used by "tens of thousands of Africans," Mason writes. Groups that distributed the drugs may now "face liability claims for distributing these insufficiently tested knockoffs," Mason writes. "Cleaning up this mess is a tall task," as some of the drugs may have caused drug resistance in the developing world and their approval may have been too "risk[y]," Mason writes, concluding that the "recklessness" of politicians and AIDS advocates who supported the use of generic antiretrovirals has been "dangerous" (San Francisco Chronicle, 12/1).