Mail & Guardian (Johannesburg) - February 14, 1997
Jim Day

THERE are people with Aids in South Africa who want to take Virodene now - and they want no part of what they see as bureaucratic meddling by the Medicines Control Council.

Patients interviewed this week condemned the council's ban of the drug, and said its insistence on following procedure is denying them the chance to try a drug which could save their lives.

The council halted testing of the drug after concerns in the scientific community about possible side-effects and about the way its inventors handled both research into the drug and its introduction to the world at large.

"We're dying anyway, so why not give us the bloody Virodene?" asked one out-patient at the Sparrow Nest Home for People with Aids. "We pray and pray and pray for a cure, then something comes along, and people jump all over the researchers."

The council is examining the research programme followed by the University of Pretoria scientists who patented the drug, as well as ethical and legal questions that have been raised in connection with the research.

"There is no one in the world who knows if it can offer even a glimmer of hope," said council head Peter Folb. "No patient is going to be exposed to this chemical until we know if it could be acceptable."

Research results at this stage have given no indication that Virodene has any effect on the virus that causes Aids, he said. "We're not in a position to even suggest it is effective," he said, adding that the researchers' claims to the contrary amounts to "misrepresentation to the patients".

But one of the original participants in early trials of Virodene, who asked to identified only as Mike, accused the council of "making a mountain out of a molehill".

The drug was working for him, he said. When his bi-weekly dosages were stopped two weeks ago, following the council's ban, his mouth ulcers came back and he started feeling weaker. "I'm not feeling as well now as I was two weeks ago. I'm a bit worried," he said.

Mike, like other people with Aids interviewed this week, said he doesn't care about possible side-effects, or that the active ingredient is an industrial solvent, or that it could cause liver damage. He doesn't care where the test results were first published, whether it was in scientific journals or in the media.

He and others believe the researchers are on to an affordable, effective remedy. They don't want access to it two years from now after all sorts of tests have been done; they want it now.

Five patients at Sparrow Nest have signed a statement that they would not hold the researchers - Olga Visser, Dr Callie Landauer and Professor Dirk du Plessis - responsible for any negative effects caused by Virodene. They have asked to be admitted to Virodene trials immediately.

Larry Heidebrecht, representative of the Virodene researchers, said requests from would-be volunteers have been coming in from around the world. The researchers are drawing up a waiting list.

Aids care-givers, working in hospices and other programmes, admit they are advising patients to put their names on the list. They predict the researchers will be swamped as soon as they get the green light to resume drug trials.

The council halted testing because procedures followed by the researchers were "entirely unacceptable," Folb said. Research will not resume until proper guidelines are implemented.

These guidelines are being developed by a committee from the University of Pretoria and the Gauteng Health Department. A final report is due out in two weeks. Committee members would not say when Virodene research could begin again, but it could be shortly after the council reviews the committee report.

Heidebrecht said he hopes that research will include testing on human subjects, but Folb said in his view the researchers will "have to go back to square one".

Funding for further research is still up in the air, though Heidebrecht said the researchers were still hoping to receive government funding. Alan Hirsch, chief director of industrial and development technology strategy in the Department of Trade and Industry, said government funding was still under consideration.

The controversy over Virodene started when the researchers went before the Cabinet to ask for R3,7-million to continue their research. Their presentation, arranged by Health Minister Nkosazana Zuma, shocked the scientific and research community.

People with Aids and care-givers, however, continue to support Zuma. They see her as someone who cut through cumbersome procedures to get Virodene on to the market quickly and cheaply. Current cutting-edge treatment for Aids is prohibitively expensive.

Like most people with Aids, Gert Tolmay cannot afford the expensive medications. Emaciated and ill, his immune system all but shut down, he lives at St Christopher's Home for People Living with Aids. He says all he wants to know about the Virodene researchers is: "Can they help me? Can they help other people? It's a risk you've got to take. You've got to try."

Hendrik Nel, who also has Aids, agrees. He has not formally applied to be admitted into the research programme, but given the opportunity, he would use Virodene. "If you don't want to take a chance you will not know. Give these guys a chance, at least they are doing something."

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