Tanzania Investigates Human Trial of Experimental AIDS Drug
Tanzania Department of Health Chief Medical Officer Gabriel Upunda has announced that the department is investigating whether a human clinical trial of the experimental AIDS drug Virodene PO58 was conducted without following proper regulatory approval, the Wall Street Journal reports (Schoofs/Idudu, Wall Street Journal, 8/15). Virodene, which is derived from an industrial solvent known as dimethylformamide (DMF), has been hailed as a "potential wonder drug" by its supporters and "vehemently" criticized as a "modern-day snake oil that could conceivably make AIDS worse" by its opponents (Kaiser Daily HIV/AIDS Report, 7/19). Tanzanian health officials said that the trial required approval from the country's National Institute for Medical Research, which had rejected the proposal. But study leaders Jacques Siegfried Visser and Michelle Olga Patricia Visser said that institute approval was not necessary because they had "worked closely" with the Tanzanian military and police to test the drug on 64 HIV patients. They added that the trial, held in Dar es Salaam between September 2000 and March 2001, was "properly approved" and "conducted with the highest ethical standards." The health department's examination of the study is not a criminal investigation; after reviewing the approval procedures officials will decide whether any action is warranted. Virodene "caused an uproar" in 1997 when South African researchers tested the drug on 11 HIV-positive patients without ethics board approval, and South African drug regulators "eventually refused" to permit further human tests of the compound (Wall Street Journal, 8/15).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.