The Virodene affair (II)
In early 1997 the Medicines Control Council - which had halted the Virodene trials as soon as it heard about them - was an independent and highly professional body. While Peter Folb was the chairman, the two senior civil servants were Johann Schlebusch, the registrar, and Christel Brückner, his deputy. At this time, it should be remembered, many of the "levers of state" power had yet to be captured by the ANC. Over the course of the year the Virodene researchers would attempt to prevail upon the MCC to allow the human testing of the drug. They were able to persist with these efforts because - as this article will try and document - they enjoyed the support of both Deputy President Thabo Mbeki and Health Minister Nkosazana Zuma.
For the medical establishment, it soon became evident that the 1996 pilot study of Virodene had broken all the ethical and scientific rules. Minister Zuma - who was intensely suspicious of that establishment - remained supportive of the Virodene researchers and deeply invested in the whole enterprise. A day after the MCC announced their decision to halt further testing on February 5 1997 Zuma said that she would still support giving the researchers government money to continue with their research. "Any glimmer of hope to get treatment should be encouraged by all of us," she told journalists.
By contrast Folb stated that initial research results had given no indication that Virodene had any effect on the HI virus "We're not in a position to even suggest it is effective" he said. "There is no one in the world who knows if [Virodene] can offer even a glimmer of hope. No patient is going to be exposed to this chemical until we know if it could be acceptable."
Behind the scenes Zigi and Olga Visser continued to lobby Minister Zuma. In early March -after the University of Pretoria and Gauteng Health Department had issued their report - Zigi Visser addressed a letter to Minister Zuma contesting its findings. He also requested permission to provide "mercy treatment" for those in the advanced stages of AIDS; and for those patients who had been on Virodene to continue with this treatment. Behind the scenes they channelled information to Zuma which they though buttressed their case. There is no evidence that this request was granted.
The Virodene researchers were clearly confident of their political support from very early on. On June 10 1997, Zigi Visser wrote to an American businessman that the MCC's rejection of Virodene was of little import:
"MCC approval will be obtained, but this will happen when it happens. Even if it takes the minister to replace the head of the MCC [who] is thought to be unreasonable. We have the president and cabinet support."
In late August Zigi Visser wrote another letter addressed to Zuma which thanked her "for her brave support of this research, which quite possibly will turn out to be the only hope for this pending epidemic."
The MCC refused to relax its requirements. In late July it rejected a research protocol from the Virodene promoters. After the decision was announced their press officer, Larry Heidebrecht, warned that the team would resume its clinical trials in another country if the MCC rejected a further submission. In early August the researchers submitted another protocol. The researchers appeared confident that they had finally complied with the MCC's requirements-stating on the submission of their protocol that they foresaw "no further delays for approval".
Behind the scenes Minister Zuma tried to pressure Folb into lifting the ban on Virodene. As Folb stated in a 2004 interview for this author's doctoral research:
"She had been asking me and cajoling me and threatening me. And she was saying that here was a chance to cure AIDS and I - because she kept on refusing to accept that this was a management committee decision [of the MCC] - she was telling me that I was playing God ... That I had no right to stop a cure for AIDS when people were suffering, and so on."
Since she was not making progress she asked Folb to speak to Deputy President Mbeki. "I saw myself" he said "as being brought by the teacher to the headmaster". At the meeting at Mbeki's residence in Cape Town in August Folb explained the scientific reasons for the MCC's decision. At the end of it he thought that Mbeki had been persuaded. He [Mbeki] "expressed himself as having come to the conclusion that I had been entirely reasonable fair minded, objective, scientific. And I thought it was all over."
At the meeting it became clear to Folb that Mbeki was having contact with the Virodene researchers. He offered to meet with him - if Mbeki so wished - in order to clarify and explain the points he had just made. Two weeks later he was summoned to a meeting in Pretoria at the Deputy President's residence at 7 pm on a Friday evening. Folb commented:
"I went to his home and about sixteen to eighteen people came from the investigators including a lawyer, and they came with papers and files as if they were coming to the MCC with their argument and science. And I was amazed at the arrogance, not so much with myself, for I was used to these kind of people, but with Mbeki. They walked around that house as if they owned it."
Both Zuma and Mbeki were present at the meeting. According to Folb Zuma asked if he would please discuss all this again with the MCC at its next meeting and to phone her afterwards, and she would communicate the decision to the Deputy President, who would then be in Switzerland.
In their meeting on September 5 however, the MCC once again rejected the protocol, much to Zuma's distress. The MCC stated that safety issues had not been addressed, efficacy remained unproven, and there were outstanding problems with the dosage, stability, concentration, purity and dependability of the final preparation.
On October 8 1997 Zigi Visser wrote again to Minister Zuma. He noted that "subsequent to our conversation" on September 24 1997 "I have met again with the DP [Deputy President] on the following Sunday September 28 1997 to resolve the MCC rejection. We reached an agreement with the DP...as to strategy and the way forward." He requested a face-to-face meeting as the "contents of the outcome of the meeting cannot be conveyed by fax." Visser also stated that "according to the DP we can not lose two or three weeks on resubmission of protocol, but should go straight to appeal via the Health Minister on the trials. Mercy treatment is self explanatory, and needs no endorsement."
Members of the research team travelled to Europe where they commissioned reports from European specialists in an effort to buttress their position. These were handed on to Zuma and Mbeki as they became available. The Virodene researchers now formally appealed to Minister Zuma to overturn the decision of the MCC.
On October 30 1997 The Star ran an article, seemingly sourced from the minister's office, which stated that the Virodene team had been abroad; found an (unnamed) foreign toxicologist who believed the toxicity levels of the drug were acceptable, and that they had now appealed to the minister herself. Zuma was quoted as stating:
"The people who work with Virodene are adamant they have something they think can work, but until it is tested it will be very difficult to know. Recently, they have been abroad and they now have a report from one international toxicologist who was recommended to them by the MCC, which has disputed [the finding about the toxicity] of the drug. The toxicologist said that, everything being equal, they could go ahead, but monitor [the effect of the drug], which is normal for scientists. That process is still on, but it hinges really on the MCC to give them approval for the research to be done".
In an interview at this time, Mbeki told Die Burger that he thought young Afrikaners were eager to help overcome South Africa's problems. He referred in particular to the Vissers who - whatever the problems with their research - were, he said, amongst the "most exciting people" he'd ever met.
Sometime in October the minority shareholders of Cryopreservation Technologies (CPT) - who included the two medical doctors on the team, Dirk Du Plessis and Carl Landauer - became aware of the illicit provision of the drug in South Africa.
Before a meeting of the members of CPT on October 29 1997 Zigi and Olga Visser - who were the majority shareholders - were presented with a series of questions, some of which related to the illegal distribution of Virodene. In question 11 they were asked particulars of: "To whom Virodene was sold and/or given and/or dispensed"; "Where Virodene is manufactured"; and, "Under what authority Virodene is manufactured and/or sold and/or given and/or dispensed to other entities."
At the meeting itself, the Vissers agreed to answer all questions except this one. The reason, they presented, "for not disclosing information under 11 is due to a confidentiality agreement with the Deputy President of South Africa".
Landauer would later tell Rapport newspaper that Zigi Visser had claimed that he got "secret" permission from Mbeki and Zuma to restart testing on humans, but that he did not believe this.
On November 4 Zigi Visser addressed a letter to Mbeki which requested a meeting to discuss various issues around the development of Virodene. These included the issue of indemnity or amnesty in regard to Virodene.
On November 20 it was reported in the press that Virodene was being illegally distributed to AIDS patients, and that the MCC had raided the offices of Olga Visser. According to the statement issued by Folb the following day, the MCC had "received reliable reports of widespread administration to patients with HIV infection and AIDS of Virodene" and that an investigation had been initiated. The statement noted that the provision of Virodene "as a medicine is illegal and unethical" and the MCC had "accordingly, handed the matter to the police for urgent investigation and appropriate action".
In early December - shortly before the MCC were due to meet again to discuss yet another Virodene protocol - Zuma told a media briefing that she wanted the power to overrule the decisions of the MCC so that unregistered drugs could be provided to dying patients. "One day I will have the power to overrule the MCC" she said. "There should be no one on earth, not even the president of the country, with powers to refuse patients the right to use drugs of their choice if it will make a difference to their lives. But in this country surprisingly, the MCC has such powers."
She added that it "breaks my heart to see the number of letters I receive from patients who are dying wanting Virodene to be administered to them. I often cry in my office as I feel powerless. I am, however, convinced that one day I will have an enabling law that will allow me to overrule the MCC."
A few days later her spokesman, Vincent Hlongwane, announced that Minister Zuma was considering introducing legislation that would allow "compassionate" access to unregistered medicines. Hlongwane said Zuma was "not making a case specifically for Virodene", but that her comments should be seen "in context. There are patients who are dying and who strongly believe Virodene can help them. She wants to help people prolong their lives. Her main concern is that we do not have an alternative for these people."
Yet again, despite the heavy political pressure it was being placed under, the MCC turned down the researcher's application to test Virodene on people. The statement issued by the MCC reiterated its previous position: that the "product is made from an industrial solvent with unknown impurities, and is known to be toxic" and there had "been almost no good laboratory data on whether Virodene has any action against the HIV virus".
After the MCC's rejection of the Virodene protocols Zuma signalled her intention to remove certain members of the MCC board, including Prof Folb.
According to Business Day (December 12 1997) "Zuma said regulations to be promulgated next year would change the base of experts outlined in old legislation...and replace those members who had served on the drug regulatory body for more than 10 years". As the article noted this would lead to the removal of Prof Folb, and several other members who had served on the board for longer than that duration.
When asked about Virodene Zuma said she held the "same position as earlier this year", which was "to support every research effort that may give us a glimmer of hope in terms of AIDS. At the moment, no one knows if (Virodene) works." She added that she still supported the "compassionate" use of unapproved drugs, but emphasised that neither she nor the MCC had exercised available legal options in allowing even controlled dispensing of the drug. She denied supporting the earlier "illegal use" of the drug.
In early December 1997 the dispute between the different shareholders in CPT broke out into the open when the minority shareholders - including Landauer and Du Plessis - were granted an interim interdict by the Pretoria High court against the trade, dispensing of, or further research on Virodene by the Vissers.
This dispute - and the resultant court documents - would first reveal the extent to which Mbeki and Zuma were intimately involved in the day-to-day affairs of the Virodene researchers.
On Friday December 5 the Visser's were requested to attend a meeting on the Saturday with Mbeki in order to discuss (inter alia) the court application by the University of Pretoria scientists.
The meeting was attended by Mbeki, Minister Zuma, Zigi and Olga Visser, and others. In a subsequent affidavit Zigi Visser stated that Mbeki had made clear, at this meeting, that "the dispute which had arisen between the parties should be resolved as soon as possible". Mbeki gave instructions for Du Plessis and Landauer, the applicants in the court case, to be contacted, and he met with them the following day "for the purposes of resolving the dispute".
The following morning (December 7) Mbeki and Zuma met with both sides. "The purpose of this meeting", Zigi Visser explained, "was once again to ensure that the further development of Virodene was in no way to be jeopardised by the dispute which had arisen between the parties".
However, the meeting ended with the different parties agreeing to consult their legal representatives in order to seek out a resolution to the matter. The result was inconclusive, and no settlement was reached. Zigi Visser phoned Mbeki that evening to report that no progress had been made. Mbeki called him back, and said that he had arranged that Du Plessis would meet them at his residence on early Tuesday morning.
Only Mbeki, Zigi Visser, and Du Plessis would be present, with Mbeki acting as the mediator. According to Zigi Visser's version, the meeting took place and an agreement was reached.
Du Plessis was requested, by Mbeki, to record in his own handwriting the settlement which had been reached between the parties. The document, dated December 10, stated that "the primary goal and function of CPT cc is to further the development of ‘Virodene' to a tested, scientifically validated product for use in the management of HIV/AIDS" and the present "potential [legal] deadlock" had to be "resolved to the extent that the development" of Virodene was "not hindered in any way".
On request, Mbeki would appoint a manager from the public sector, who would have full control of the company for the following three months. At the end of this period the status of the manager would be re-evaluated and possibly extended. The salary of the manager, any staff members appointed by the manager, and the premises used by them, would be paid for by the government.
After the meeting concluded Du Plessis had the document typed and sent Visser and Mbeki copies. At about midday that day the parties' legal representatives met to discuss the agreement. But these proved inconclusive and the next day the proposed settlement was formally rejected. Instead, a neutral and well respected administrator from the private sector, Dr Hugo Snyckers, was appointed.
Mbeki later explained that his concern was (inter alia) that - if the dispute had not been resolved -the company which owned Virodene "could be auctioned to the highest bidder". If this "came to pass, the intellectual property represented by ‘Virodene' could fall into the hands of people who could shut down the research effort or sell ‘Virodene' at unaffordable prices, should it be licensed as efficacious medication."
According to the 1999 Public Protector's report on the matter Folb had been named as a respondent in the case between the different parties in CPT and had received the court documentation as a result. In these documents he saw a reference to a promise made by the Vissers to give the ANC a share in Virodene. A memorandum dated November 11 was headed: "Contracts entered into by M.O.P. Visser & J.S. Visser on behalf of the Corporation (CPT)". This document included the lines: "13.2 Gen. Joshua Nxomalo to get 1% for ANC introductions work; 13.3 The ANC is to receive 6% shares in the CPT to be registered subsidiary pharmaceutical company".
Another line (14.2) stated "we decided to remain with the SA Government until all laws are passed and let the SA government finance the project."
Folb then wrote to Zuma expressing his concern that the ANC, or members of government might be seeking "improper advantage" from the Virodene company, and had "requested the Minister's explicit assurance to the contrary".
Folb's letter resulted in a flurry of correspondence between Zigi Visser, Minister Zuma, and the ANC. Zuma wrote to both CPT and the ANC stating she was unaware of any such proposal. In turn George Chaane, the ANC's Legal Co-ordinator, wrote a letter to Zigi Visser, dated December 10 1997, also denying any knowledge of this matter. "You will perhaps be kind enough to inform this organisation, at your very earliest", the letter stated, "the person or persons from the ANC who you have been dealing with as well as indicate under what authority they purported to deal with you."
In his reply to Minister Zuma (December 11) Zigi Visser denied that any member of the government had been promised a shareholding in Virodene. "The description ‘ANC' was the wrong choice of phrase and RDP might have been more accurate in this instance, however not complete...The people under consideration for the future allocation of these shares ... generally happen to be members of the ANC by political alliance, but not members of government." He sent an almost identical letter to Chaane on the same day.
On December 12 Visser sent a follow up letter to Chaane stating that the purported share allocation to these ANC individuals "was done without their knowledge or consent". In addition, "I hereby confirm that the ANC has had no dealings whatsoever with me nor my companies or businesses; that the ANC aligned people referred to in my fax, held no mandate from the ANC and were never asked to produce any."
In early January Callie Landauer said, at a meeting of CPT, that he had sent a letter to Minister Zuma and Deputy President Mbeki requesting a meeting for Dr. Snyckers. Snyckers subsequently met with Mbeki and Zuma and reported back to members of CPT. According to the minutes of a meeting on January 26 he said that "both continue to be supportive but we must do things properly (MCC). Their concern is to ensure an affordable supply of the treatment for Southern Africa." He added that he could approach Dr Zuma "if further assistance is required". At a meeting of CPT in February Dr. Snyckers distributed notes of a meeting he had held with Zuma in Cape Town. He asked the members of CPT whether "they had wanted him to ask the Minister to overrule the Council" but, according to the minutes, Landauer had said that this was not their intention.
To continue on to the third instalment click here.