Overseas Tests of AIDS Drug Skirt Regulators

A South African couple whose attempts to test an experimental AIDS drug caused an uproar in 1997 have quietly tested the compound on humans in Tanzania with the help of the police and military. The experimental drug, Virodene P058, is purified from an industrial solvent known as dimethylformamide (DMF). The compound has reportedly never been tested against AIDS in animals and is vehemently opposed by many mainstream scientists. Still, its developer, Michelle Olga Patricia Visser, and her former husband, Jacques Siegfried "Zigi" Visser, have organized three human trials of Virodene in three separate countries.

In the first trial of the drug, Ms. Visser and her colleagues noted "magnificent results" from a Virodene patch given to 11 patients with HIV. The University of Pretoria reprimanded two study doctors of this first trial, however, for conducting the trial without approval, and the South African drug regulatory agency, the Medicines Control Council, blocked further human testing of the compound, saying that there was scant evidence that it worked. Results of a second study of 15 HIV-negative subjects in England between late 1998 and 1999 haven't been published. Results of a third trial in Tanzania between September 2000 and March 2001 aren't complete, according to the Vissers, who also will not disclose the source of the $3.5 million to $4 million they say the study cost.

Andrew Kitua, director general of Tanzania's National Institute for Medical Research (NIMR), said the Tanzanian trial did not receive proper authorization. Initially the researchers' proposal to conduct human trials was rejected by the NIMR, which noted "major methodological problems which need rectification." But Visser says his company had already "contracted with the defense forces to do the trial for us." In an interview, he showed letters from international, military and private review boards. He also had an approval letter from Dr. Aaron Chiduo, who was Tanzania's minister of health at the time. But Chiduo says he instructed the company and army officials to get approval from the NIMR. Mr. Visser says the trial began anyway because Chiduo's positive letter "basically overruled" NIMR, a contention Chiduo strongly disputes. Mr. Visser also says the military didn't need health department approval to run the trials, even though many trial subjects were civilians.

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