Charlene Smith and Aaron Nicodemus
The company that produced the controversial Aids drug Virodene has conducted more human trials without the approval of the Medicines Control Council (MCC), according to papers filed before the Pretoria High Court.
In 1997 the MCC suspended human trials of the drug. The documents reveal that despite no apparent financial backing, those involved in making and promoting Virodene have spent more than R3,1-million on trials in South Africa, England, Germany and the Czech Republic.
According to meeting minutes of the interim board of directors of Virodene Pharmaceuticals, filed as part of a court case between the company’s directors, Virodene trials were conducted in Bloemfontein at Pharmoff and at Clindi Pharm in Pretoria on six healthy and 36 HIV-positive individuals in August 1998.
MCC director Dr Helen Rees said this week that the council “had never given approval for clinical trials of Virodene. The only position we have taken is one of disapproval. They have to prove that there is a science behind it and a good sense that the product is not toxic.”
Acccording to the minutes, the directors were under the assumption that the MCC would approve trials for Virodene. The minutes say: “In two or three days the MCC will approve the addendum as they have already indicated what they wish to be done on the patients.”
Another line says: “It was confirmed by Olga [Visser, a scientist for Cryopreservation Technologies, the makers of Virodene] that approval had indeed been given by the MCC conditional upon the ethics committee approval.”
Without the approval in hand, Virodene Pharmaceuticals went ahead with the human trials, which lasted for a week. Each test subject was given one dose of the drug.
The company’s minutes also suggest that a facility was found to produce Virodene at an unnamed place in Ga-Rankuwa, after trials in Europe. If so, Ga-Rankuwa has become a hotbed of testing on supposed Aids cures. Last week the Ga-Rankuwa-based Medical University of South Africa announced that it had achieved tremendous success in limited human trials of Inactivin, a drug originally developed in Ireland. This week representatives of the university denied any connection with Virodene.
The difference between the trials of Virodene and Inactivin are clear: while the MCC said it had approved clinical trials for Inactivin in December last year, the council said it had rejected an application for trials for Virodene.
Virodene’s active ingredient is an industrial solvent, dimethyl formamide (DMF). It has been blocked for human use in South Africa and elsewhere due to dangerous side effects. In September 1997, the journal Aids Research and Human Retroviruses printed a report suggesting that DMF might actually activate HIV.
According to the papers, the company may have gone ahead with the trials because it believed it had the support of Deputy President Thabo Mbeki and Minister of Health Nkosazana Zuma, who were supposed to smooth over any MCC opposition to the drug’s approval. Although minutes and court papers note meetings with Mbeki and Zuma, including the assertion that “Mbeki has supported our efforts in the past”, there is no evidence of their financial involvement in Virodene.
Last month Public Protector Selby Baqwa found that neither Zuma nor Mbeki were involved in funding or business transactions around the drug. His inquiry came after repeated suggestions – most loudly from the Democratic Party – that the African National Congress, or members of the party, were secret backers of Virodene. The DP also charged that the ANC’s support of Virodene was the reason why the use of the drug AZT to prevent mother/child transmission of HIV/Aids was being blocked by government officials.
In March last year, Mbeki took the unprecedented step of writing a 1 400-word article explaining why he had intervened directly in the Virodene fiasco. He attacked detractors of Virodene, suggesting its researchers had been pilloried: “Those who seek the good for all humanity have become the villains of our time!”
Mbeki consulted with the MCC about its refusal to allow the use of Virodene on humans. He wrote: “Neither the ANC nor anyone in its leadership … has been or will be involved in any financial arrangement related to Virodene.”
Minutes of a January 26 1998 Cryopreservation Technologies meeting record that its CEO, Dr Hugo Snyckers, reported on a meeting with “Mr Mbeki and Dr Zuma, [who] both continue to be supportive, but we must do things properly [with regard to the] (MCC). Their concern is to ensure an affordable supply of the treatment for Southern Africa. HHS [Snyckers] can approach Dr Zuma if further assistance is required.”
Minutes from February 13 1998 reflect a further meeting with Zuma. Snyckers “asked members whether they had wanted to ask the minister to overrule the Council. CJL [Cryopreservation Technologies member Carl Landauer] said this was not their intention.”
The court papers also suggest that the company is selling or attempting to sell the drug in Portugal, Ghana, Kenya and Mozambique. On top of the R3,1-million spent on tests, it has spent R2,7-million on promotional trips to Portugal, and an unknown amount in opening a clinic in Portugal. Controversy erupted in Portugal over a clinic owned and run by the Vissers, Clinica Olga Visser, that was using Virodene on patients.
And according to papers filed with court affidavits, the makers of Virodene approached the Ghanaian government in February 1998 about selling the drug there “at cost” through a Nairobi pharmacy, Kencity, and Sterling Laboratories in Kenya.
The latest details about Virodene have emerged due to an ownership conflict around the patent for the drug. According to papers before the court, in March 1998 Cryopreservation Technologies needed a cash injection to protect the patent rights of Virodene and continue trials. They agreed to sell a stake in the patent rights to former Umkhonto weSizwe cadre Ngelezi Zaccheus Mngomezulu, for R5-million.
The final sale of the company has been stalled by disagreements within the ranks of Cryopreservation Technologies. But significant amounts of money are being poured into testing Virodene, which no drug administration in the world has approved. According to court papers:
* more than R1,2-million has been spent on clinical tests at Guys hospital in London;
* about R1,5-million has been appropriated to Adams and Adams patent attorneys in Johannesburg to obtain the worldwide patent for Virodene;
* R76 152 has been spent on tests by Clindata;
lR231 140 has gone to Clindi Pharm;
* R107 000 has gone to a clinical virologist, a Dr Sequeira, plus an additional R20 000 “salary”;
* R14 500 has gone to Dr Anthony Dayan, a London-based toxicologist;
* and R17 000 has been paid to Dr Jaroslav Mraz, a Prague-based DMF specialist.
Mngomezulu put down R200 000 to secure the deal, with the balance to be paid within 60 days of the contract being signed on May 26. However, R4,8-million is owed because he and his co-investors claim Cryopreservation Technologies has not fulfilled all its contractual obligations.
Mngomezulu registered Virodene Pharmaceutical Holdings on June 25 last year with R1 000 in share capital. The chair of the company is another former Umkontho weSizwe veteran, Joshua Nxumalo, who has worked closely with Cryopreservation Technologies for some time.
The Cryopreservation directors, according to court papers, include a Professor du Plessis, Quinton van Rooyen (who represents “Namibian black empowerment groups”), a Mr Wanhaka, Precious Matshozo and attorney Mervyn Smith.
They were attracted by claims from Cryopreservation Technologies that Virodene patches, which would have to be replaced every week, could be sold for R100 each with a 15%profit margin, and that if they treated “28% of the currently infected population in South Africa” they could see a “potential turnover of R14,56-billion with a profit of R2,184-billion”. After research costs, this would be reduced to R1,68-billion.
Despite the incomplete sale, court papers indicate that Mngomezulu and his partners have spent R3-million in clinical trials and tests. Yet Mngomezulu took no legal action to compel the allegedly recalcitrant members of Cryopreservation Technologies (a close corporation) to conclude the deal. Attempts to reach Mngomezulu through Smith were not successful.
Four members of Cryopreservation Technologies, Charles Fourie, Carl Landauer, Gabriel du Preez and Stefanus Maartens, want to liquidate the company, but are being blocked by members Olga Visser, a freelance cryobiologist who freezes sheep brains and rat livers for foreign research institutions, her husband, Jacques Visser, Dirk du Plessis, Anthony Clubley-Armstrong, Larry Heidebrecht and Hugo Durrheim. Landauer and Du Preez have also applied to patent Virodene, but for use in PTK- or CPK-modulated disease or injuries (illnesses including leukaemia, rheumatoid arthritis and Aids).
The case has been postponed to May 24.