Mail & Guardian (Johannesburg) - October 5, 2001
Mungo Soggot and David Macfarlane
It has also emerged that the coal-based substance, oxihumate-K, that has been administered to HIV-positive Tanzanian soldiers for the past 18 months is used in the gardening trade.
After the Mail & Guardian broke the news last week on these trials, the Director General of Tanzania's National Institute for Medical Research (NIMR), Andrew Kitua, said the institute has received an application for the trials but that they have not yet been approved.
As far as he knew there has been no approval for use of the drug in research testing by the country's pharmacy association. "We [the NIMR] are in the process of investigating what is being done, and what the status is of their trials and why regulations were not followed."
Kitua said the trials were taking place at Lugalo military hospital - the same facility where tests were recently carried out on the discredited Aids drug Virodene. He said the application to test Virodene, whose backers were expelled from Tanzania last month, was turned down.
Kitua said Tanzania was trying to clarify if there was a link between the two sets of researchers.
Enerkom, an affiliate of the South African government's oil agency, the Central Energy Fund (CEF), is conducting the Tanzanian trials in conjunction with the Pretoria University academics and with the backing of the Department of Mineral and Energy Affairs. The CEF has injected at least R80-million into the oxihumate-K research in the form of a loan.
Under Tanzanian law, the trials cannot carry on without the NIMR's permission. Despite this, Professor Connie Medlen, the Pretoria University immunologist who is handling the trials, maintained on the SABC's AM Live this week that "we have the necessary permission from the bodies in Tanzania". The trials are due to continue for another six months.
Medlen said the Tanzanian army had invited Enerkom and Pretoria University to do the trials. South Africa's Department of Health and the Medicines Control Council (MCC) know nothing about these trials.
Medlen at first said the health department "actually do know about this". Then she backtracked: "I think you should ask [Enerkom]."
Pretoria University claims there are "no parallels" between Virodene and oxihumate-K.
Omnia Fertilizers advertises oxihumate-K as a "foliar feed". It is understood the substance helps plants absorb fertiliser. The Department of Health this week questioned the safety of oxihumate-K by drawing attention to its high chrome levels. The department last year sanctioned Enerkom's marketing of the substance as a nutritional supplement, Oximate, but revised its maximum levels of minerals in foodstuffs.
It gave Enerkom time to revise the chrome levels in oxihumate-K, and the company has not yet done this.
But scientists also point out when Enerkom claims oxihumate-K can boost the human immune system, it is implying the substance is a drug. Neither the health department nor the MCC has ever authorised Enerkom to do this, or to conduct trials on HIV-positive patients.
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