Experts wonder why researchers did not come to them with their startling find. Science editor Lesley Cowling reports
THREE Pretoria scientists broke every rule of scientific method this week when they took their research to a Cabinet meeting, saying they might have a cure for Aids. But the man representing them says they did this because they had been “blocked” by the Aids research establishment, who refused to collaborate with them when they wouldn’t share their patent rights.
The three scientists, who are attached to the University of Pretoria – cryogenics researcher Olga Visser, and cardio-thoracic surgeons Professor Dirk du Plessis and Dr Kallie Landauer – have patented a formula they call Virodene, which they say kills HIV. They presented their findings to the Cabinet this week and asked for R3,7- million to continue their research.
But although Deputy President Thabo Mbeki said the government would consider funding the scientists, and members of the Cabinet applauded at the end of the presentation, real doubts have emerged about the validity of the research. These include:
* The National Institute of Virology has confirmed that the researchers approached the institute some months ago and asked it to run laboratory tests on certain compounds. HIV research specialist Dr Des Martin said the tests had been inconclusive – in other words, had no effect on the virus. However, he said he didn’t know whether the substances they had tested were the constituents of Virodene, as the researchers could have changed the formulation.
* The researchers have not submitted their work for peer review (either by publishing, announcing their findings at the recent Aids conference in the United States, or presenting it to experts in the field of HIV research). They have also not released the details of the compound called Virodene, which it makes it difficult to assess the validity of their conclusions.
The dean of the University of Cape Town’s Medical School, Professor JP van Niekerk, said: “We don’t know enough to comment properly, because we were informed by the media. It would be usual if there was a breakthrough of a medical kind to first inform the scientific community, which would need to hear it and evaluate it.”
Zigi Visser, Olga Visser’s husband, who is representing the researchers, said they “have been blocked” by the Aids establishment, and implied that they had received little co-operation because they weren’t prepared to share their patent rights.
* The strongest evidence was human – the patients themselves, who told the Cabinet that their condition had miraculously improved. But David Spencer, who runs the Johannesburg Hospital’s Aids clinic, said it was not possible to assess the trial because the researchers have not shown what controls they used. “We need to know that they controlled for other drugs, for example.”
Medical Research Council president Dr Walter Prozesky said testing the drug on 12 patients was known, in pharmacological practice, as a Phase 1 trial. “There are many Phase 1 trials for drugs run all over the world, but they don’t give the correct answers. They don’t give the side effects, which only become known after a few years.”
* An HIV researcher from the Aaron Diamond Aids Research Centre in New York called the scientific evidence presented in a South African Press Association story on how Virodene works “far-fetched”. The story quoted Visser saying Virodene attacks the RNA of the virus. However, the researcher pointed out that Visser has not explained how Virodene distinguishes between human RNA (made up of the same basic building blocks as the viral RNA) and the viral RNA.
* The researchers are not experts in HIV, or in virology and microbiology. The Medical Research Council, which funds the work of medical scientists, has no record of any of the researchers receiving grants or awards from the council in the past 10 years.
Pretoria University was unable to provide curriculum vitae for the scientists, or information on their research achievements and funding. However, the researchers have had some international success in their field of cryogenics – the preserving of live organs.
* A senior Aids researcher at a leading drug company said it appeared irresponsible of the scientists to make such a fanfare when they had not put their drug through controlled clinical tests. It was very unusual to approach the government directly for funding. If the team had approached his company or any other company, their work would have been given very serious consideration. “The money involved in Aids drugs is huge. Any company would be mad to pass up an opportunity.”
Zigi Visser said: “We did follow procedures, going to major pharmaceutical companies, who originally supported us, but as soon as results began to prove more and more successful, they pulled out,”
He said some of the companies wanted them to give them substantial shares of the patent in order to continue with the research.
“When we realised some people were not happy with what we are doing, we went underground and had to pay for the research ourselves.”
Dr Ute Jentsch of the South African Medical Research Institute, a microbiologist with an interest in Aids, said she had not heard of the Pretoria University work until Wednesday’s press announcement. She said all new treatments had to be approached with a degree of scepticism until controlled clinical tests had been executed. “Lots of people claim breakthroughs which come to nothing.”
Despite the doubts, it seems unlikely three established scientists would go public in this fashion if they did not have good evidence that Virodene works. And, according to Zigi Visser, all the research to date – about R800 000 worth – had been funded by his wife and himself, an investment they would have been unlikely to make without some hope of a return.
He said the researchers had taken their work to HIV experts, who sometimes helped them, but they always hit problems “when the subject of patents came up”. They would be publishing in the next few months, he said.
The three researchers want to experiment on 30 more people within the next six months, and hope to have the medicine commercially available by 2000.
Additional research by Mungo Soggot, Marion Edmunds, Tangeni Amupadhi, Andy Duffy