Johannesburg | Tuesday
THE supplement being tested on Tanzanian soldiers by the Central Energy Fund as an Aids treatment is a legal nutritional supplement in South Africa at present.
But soon Enerkom, the CEF-owned company concerned will have to make a decision on whether it should market the product — also sold as a plant food — as a medicine or reduce the levels of chromium it contains.
The product’s chromium levels are higher than those recommended by new Health Department guidelines. But Enerkom has been given some time by the department to comply with the new regulations.
Enerkom’s Dr Tony Surridge said this week his company will re-analyse the product, to keep its chrome content within the prescribed levels. However, he said he believed many similar products had much higher chrome levels. They were subject to the same departmental prescriptions.
”We have had at least 18 months of clinical trials and found no toxic effect.”
No permission for Tanzanian trials
Meanwhile, it turns out that the company has been running its trials in Tanzania without the approval of the Tanzanian authorities.
Tanzania’s National Institute for Medical Research, which rejected the Virodene experiments, said yesterday that it has not given its imprimatur to current trials of the coal-derived HIV/Aids treatment, oxihumate-k. The institute’s director general, Dr Andrew Kitua, says the institute has applied to the Tanzanian military to visit Lugalo hospital, where the trials are being conducted. He says there ”seems to be a connection” with the Virodene trials, but wants to investigate further.
Whereas Virodene was an industrial solvent, Oxihumate-K is sold as plant food On Friday, the M&G revealed that the trials are taking place at the same military hospital where the notorious South African HIV/Aids concoction, Virodene, was recently being tested until the researchers running the experiments were expelled from Tanzania earlier this month.
Four years ago Virodene researchers secured South African government funding and an audience with the South African Cabinet to develop their drug, which turned out to be toxic industrial solvent. The scandal was the first of many blunders by the government over Aids.
Enerkom, the state-owned company which developed oxihumate-k, nevertheless says its trials, which have been carried out under the auspices of the University of Pretoria, have been running since 1999 ”with the appropriate [Tanzanian] authorizations”. It has spent about 8-million [pounds] developing the drug.
Unlike the Virodene backers, Enerkom does not purport to have discovered a cure for Aids, but says its drug helps boost the immune system. Enerkom started developing oxihumate-k in 1984, and markets it as a nutritional supplement called Oximate.
Enerkom and the South African government have struggled to explain the decision to run trials in Tanzania. The acting director general of the minerals and energy department, Smunda Mokoena, said the Tanzanian military approached Enerkom to conduct the trials. ”The opportunity presented itself and Enerkom took it up,” he said.
No permission to claim anti-Aids efficacy
”It is important to mention that there is no permission to make any claims [in marketing or packaging] that the product may have any effects on conditions related to HIV/Aids,” said Sibani Mngani, Health Department spokesman, according to a Monday report from Sapa.
Dr Tony Surridge, acting chief executive officer of Enerkom, and Dr Connie Medlen, immunologist at the University of Pretoria, said on Friday the Oxihumate-K capsules distributed had improved the condition of many of the 350 soldiers and civilians participating in the Tanzanian test. It had, they said, been proved to boost their immunity against opportunistic infections.
Another point of controversy surrounding Oxihumate-K is the R80-million spent on its development.
Surridge on Tuesday pointed out that amount was not a grant, but a loan Enerkom had obtained from the CEF.
”We must pay it back when we become commercially viable.”
About R3,4-million of the amount had been spent on trials, and the rest on the development and the manufacturing plant, he said. – Mail & Guardian reporters, Sapa