First it was Virodene, now it’s “oxihumate-K” the University of Pretoria is at the centre of a new saga about another state-backed Aids treatment
Nawaal Deane, David Macfarlane and Mungo Soggot
The South African government’s oil agency, the Central Energy Fund, has pumped at least R80-million into an unproven, coal-based HIV/Aids treatment that is being tested on Tanzanian soldiers.
There are striking parallels between the drug trials, conducted under the auspices of the University of Pretoria, and experiments recently carried out involving the notorious and discredited Aids treatment Virodene.
The Virodene researchers were this month expelled from Tanzania in high dudgeon, claiming that they had support from the top levels of the South African government.
Now it has emerged that a little known affiliate of the Central Energy Fund, Enerkom, has, with the University of Pretoria, also been testing an equally unproven Aids treatment at a Tanzanian medical facility. As with the Virodene trials, the tests are being done at a military hospital.
The drug, oxihumate-K, is derived from burnt coal. While Enerkom and Pretoria University’s ethics committee claim the drug is non-toxic in animals and humans, there is no scientific evidence yet of its backers’ claim that it boosts the human immune system.
Although South Africa’s Medicines Control Council (MCC) vetted an exploratory trial of oxihumate-K back in 1999, it knows nothing of the current experiments being conducted in Tanzania.
Enerkom said this week its initial trials on oxihumate-K in 1999 were sanctioned by the MCC. However, MCC chairperson Peter Eagles this week said oxihumate-K is not registered or endorsed by the MCC, and that the MCC knows nothing of the current Tanzanian trials.
“The trials that took place in South Africa are just the initial ones but there are three more phases that need to be completed before it can be marketed here,” Eagles says.
He says he does not know why Enerkom did not apply to complete the tests in South Africa. “They may have been influenced by other factors.” He emphasised that the MCC has no link with the ongoing clinical trials in Tanzania. “We cannot stop clinical trials in other countries and even if they are successful it does not mean that we will accept the results here.”
When the Mail & Guardian published on the expulsion of the Virodene researchers from Tanzania this month, African Eye News Service said in the same report that Tanzanian inspectors had seized a consignment of oxihumate-K drugs at Dar es Salaam International airport. The news agency said the drugs were marked for the attention of a doctor at Lugalo military hospital, where some of the Virodene trials were carried out. According to African Eye News, the consignment was marked as having been imported by the country’s chief of defence forces. Enerkom has stressed its trials are not being done in conjunction with those of Virodene.
The Central Energy Fund falls under the Department of Minerals and Energy, which, Pretoria University academics say, is keeping track of the programme. Minister of Health Manto Tshabalala-Msimang visited one of the Tanzanian hospitals where Virodene was tested, but her spokesperson Jo-Anne Collinge this week said the minister knew nothing about the oxihumate-K trials.
Collinge said minerals and energy department researchers informed the health department about their plans to do research on how oxihumates could “boost immunity. The advice of the health department was that the researchers should apply to the MCC for approval to conduct clinical trials in South Africa. The department of health has no knowledge of the trials that are no being conducted in Tanzania.”
Despite this, Enerkom says in a statement this week that it secured the health department’s approval to import HIV-infected blood to South Africa.
The trials raise serious ethical questions. South African medical ethicists say it is highly questionable that informed consent crucial for an ethically sound trial can be obtained from groups such as soldiers, prisoners or people in institutions.
Some South African institutions on principle decline to okay trials on such people.
The secretary for Pretoria University’s ethics committee, Dr Rita Sommers, says the committee had problems last year with the proposed trials, but the researchers then satisfied the committee that oxihumate-K is non-toxic. They also satisfied the committee that they had got “permission from the Tanzanian authorities”.
It is unclear what position Tanzania’s National Institute for Medical Research is taking on the trials. One representative said this week Enerkom had submitted plans for trial and had been asked to make revisions, “but that now there is another process”.
Another spokesperson subsequently said the matter is confidential.
Connie Medlen, the professor at Pretoria University’s immunology department who is handling the trials, referred all queries to Enerkom. She said when first approached for comment: “I can’t speak … I have to speak to Enerkom first.” Asked to confirm her involvement in the Tanzanian trials, she said: “Yes, we are doing [them].” She also said that Pretoria University’s medical ethics committee had given permission for the trials to go ahead. “I suppose you’ll want to know about [the issue of] informed consent [from the Tanzanian soldiers on whom the tests are being done],” she said, and referred the M&G to Enerkom acting CEO Tony Surridge. Asked about the scientific basis of the trials, she said: “I could say a lot about that,” but, again, would have to speak with Enerkom first. “But these are definitely not trials with Virodene.”
Shortly after Medlen spoke to the M&G, Enerkom executives approached the minerals and energy department to draw up its press statement. The statement confirmed the trials, but did not name Tanzania as the country where they are being conducted. The statement says Enerkom was approached “through an intermediary” to conduct a clinical trial on Aids patients “in one of our northern country partners”.
Scientists familiar with oxihumate-K say that although the substance appears non-toxic there is no scientific or documented proof that it can boost the immune system of human subjects.
One local ethics expert, Professor Udo Schuklenk, head of bioethics at the University of the Witwatersrand, says he is unfamiliar with this study and with oxihumates, but observed: “You need to question why soldiers were used. It doesn’t seem necessary to use them unless the researchers are claiming that they represent a scientifically and medically distinct group. That’s where I would start worrying and criticising.”
Schuklenk says it would be interesting to know how the researchers obtained information about the HIV status of the soldiers. “That is supposed to be confidential.”
It is now four years since the Virodene scandal, the first of many blunders by the government over HIV/Aids. Virodene turned out to be no more than an industrial solvent, although the main researcher behind it, Olga Visser, was only this month still proclaiming its powers.
The Virodene researchers, who managed to secure government funding and an audience with the Cabinet four years ago, were also originally from the University of Pretoria, which stopped the programme after the scandal erupted.
The M&G first reported on Enerkom’s oxihumates in February. At the time Enerkom downplayed claims that the substance could be used to combat HIV/Aids. It was also unknown at the time that the University of Pretoria arranged for trials to be carried out at the Tanzanian military hospital.
Enerkom said after the M&G article that the Central Energy Fund had given Enerkom R80-million to research and develop a pilot production programme.
Enerkom’s statement this week heralded the substance as a possible treatment for HIV-infected people. “Due to the devastating effect of HIV/Aids pandemic … Enerkom has undertaken research aimed at treating people suffering from HIV/Aids.”
Enerkom’s statement said its earlier South African trials took place at Kalafong hospital, and “confirmed the non-toxic nature of oxihumate-K and also showed some improvement in clinical signs of the patients”. It was these trials that were sanctioned by the MCC in 1999.
Key figures at the University of Pretoria failed to return phone calls about the Tanzanian trials. They included the principal, Professor Callie Pistorius, the dean of health sciences, Professor T Mariba, and the chairperson of the ethics committee, Professor Jacques Snyman. The head of immunology, Professor Ronnie Anderson, could not be reached for comment.