International Trials of Experimental AIDS Drug Reveal Gaps in Regulatory Framework

Although requests to conduct clinical trials on the "experimental" AIDS drug Virodene P058 have been turned down in a number of countries, the drug has "quietly" been tested in Tanzania "with the help of the Tanzanian police and military," the Wall Street Journal reports. 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. The idea to test Virodene was originally conceived by medical technician Michelle Olga Patricia Visser, who noted during laboratory tests on animal organs that DMF can kill "some kinds of bacteria." Questioning whether the drug might also work against viruses such as HIV, Visser organized a small study of 11 HIV-positive people in South Africa. Although Visser said that the drug produced "magnificent results" in study participants, South Africa's Medicines Control Council barred additional human trials of Virodene, stating that the substance "was potentially harmful and there was scant evidence it would work." The council cited a 1997 study published in the journal AIDS Research and Human Retroviruses that "suggested that DMF could actually inflame HIV." Visser and her former husband Jacques Visser left South Africa and traveled to England to conduct a study of the drug in 15 HIV-negative people, but the results of the tests have not yet been published. After the England study, the Vissers went to Tanzania to conduct additional human trials of Virodene. But the National Institute of Medical Research, a "key" Tanzanian health agency, denied their proposal for the tests, noting "major methodological problems which need rectification." The Vissers then contracted with the military and police to hold a study of 64 HIV-positive people. The trial was held in two places -- a military hospital and a medical clinic owned by the country's inspector general of police. Jacques Visser said that he "obtained all necessary authorization" for the study, citing a letter written by Dr. Aaron Chiduo, who was then serving as Tanzania's minister of health. Chiduo, however, said that he told the trial organizers and the military to obtain approval from the NIMR, which they failed to do. Jacques Visser, however, said that Chiduo's "positive letter 'basically overruled'" the NIMR and that the military "doesn't need health department approval to run clinical trials," although the Journal states that many of the trial participants were civilians. The Journal also reports that Michelle Visser's "academic credentials" are in "question." She says that she is a full professor and head of the Department of New Technologies in Medicine at Modern University in Portugal, but the university said there is no such department and does not have a record of Michelle Visser on the university faculty.

Raising Ethical Questions
The case of the Virodene trials "shows how even an experimental drug with little scientific backing can win adherents," the Wall Street Journal reports. The Vissers say that all Virodene trials "were conducted following the highest international ethical, scientific and safety standards," but the Journal reports that much about the tests "remains unknown." The Vissers declined to name the owner of Virodene Pharmaceutical Holdings, the private, South African firm sponsoring the tests. The Vissers' tests have been endorsed by "prominent" figures such as South Africa's former Minister of Health Nkosazana Zuma and South African President Thabo Mbeki, who was serving as deputy president of South Africa at the time of the Vissers' South African trial (Schoofs, Wall Street Journal, 7/19).