5.How involvement in Virodene led to Thabo Mbeki’s AIDS ‘denialism’

The Virodene affair (IV)

James Myburgh

20 September 2007

How the involvement in Virodene led to Thabo Mbeki’s AIDS ‘denialism’

It is now generally assumed that the ANC government’s prolonged refusal to provide anti-retrovirals through the public health-care system was due to Thabo Mbeki’s adherence to the ‘dissident’ view of “HIV and AIDS.” The problem with this explanation is, firstly, that it mistakes the cart for the horse; and, secondly, that the chronology does not fit. The opposition to AZT predated Mbeki’s conversion to AIDS ‘dissidence’ by about a year. The following instalment will try and identify the possible motives at play when the decision to block AZT was made. It will also document how Mbeki’s involvement in Virodene led into his conversion to AIDS ‘denialism’.

I

In his defence of Virodene on March 7 1998 Deputy President Mbeki had stated that “Neither the ANC nor anyone in its leadership, whether working inside or outside government, has been or will be involved in any financial arrangement related to Virodene.”

On May 15 Zigi and Olga Visser sent a fax to Mbeki. It stated that they had had problems raising funds “from investors prior to MCC approval, and now run the risk of having our world patents being abandoned due to lack of investments.” They warned that patent fees fell due in late May 1998 which had to be paid if the patents were not to be lost. “Due to the time constraints, and urgency of this matter we request any possible assistance from the Deputy State President, in the form of introductions to possible partners/funders for a joint venture which will be beneficial to all.”

Mbeki’s response is not recorded. But on June 19 1998 the Mail & Guardian reported that Cryopreservation Technologies was going to be sold to a consortium of mysterious black investors. The article claimed, “The multi-million-rand deal was struck three weeks ago” at the end of May. The consortium which bought CPT was led by Ngengelezi Zaccheus “Zach” Mngomezulu and it included Joshua Nxumalo, who replaced Dr Snyckers as interim manager Both Mngomezulu and Nxumalo had deep ANC backgrounds.

In terms of the deal the patent and intellectual property rights to Virodene were to be bought from CPT for R5 million and would be vested in a company, to be called Virodene Pharmaceutical Holdings (VPH). R4.8 million was to be paid by the consortium, and R200 000 by Quinton van Rooyen, a Namibian investor proposed by the minority shareholders in CPT. The new owners would fund the development of the drug.

The basic structure of the deal was that the existing shareholders in CPT would receive thirty percent of VPH and Van Rooyen ten percent. The remaining sixty percent share was held by a company called UBE Trading which was established in July 1998. Mngomezulu, Nxumalo, and one John Waithaka, only held ten percent shares of this company. The structure of the deal was designed in such a way as to hide the identity of the ultimate owners and investors. There were apparently two further companies above UBE trading with ultimate control exercised, according to one account, by something called the “African United Trust.”

On May 26 Waithaka had loaned VPH just under R700 000 for the urgent payment of the patent application fees that had fallen due. Mngomezulu secured the loan with a bond over his house. This money fell due the following year by which time just over R1m was owed. The repayment was recorded in a VPH receipt as “Mngomezulu Cash from TG”. The Mail & Guardian later claimed that “TG” was a reference to the treasurer-general of the ANC, Mendi Msimang.

II

Up until March 1998 any real anti-retroviral treatment for HIV/AIDS was simply unaffordable for the South African government. However, in that month Glaxo-Wellcome announced that it was cutting the price of AZT by three-quarters for the developing world. This was after a clinical trial in Thailand revealed that a short course of the drug in the final weeks of pregnancy could reduce the risk of transmission of HIV from mother-to-child by around fifty percent. In July that year Rose Smart, head of the HIV, AIDS and sexually transmitted diseases directorate in the health department, announced that this treatment would be piloted in Gauteng, the Western Cape, and Kwa-Zulu Natal. A “short-course” of AZT would be provided to HIV positive pregnant women at the cost of just over R300 per patient. The projected cost of a nation wide roll-out was R80 million or 0,4% of the national health budget.

By the second half of 1998 Virodene was rapidly fading from public consciousness; and for this reason alone has been discounted in the literature as a possible factor in subsequent government decision-making. In reality, the promoters of the drug had simply taken its development underground and out of the country. Indeed, from their point of view, they were now making rapid progress towards the clinical trials needed to finally prove its efficacy.

In September 1998 Olga Visser and her team approached the health ministry in Botswana with a proposal to carry out a formal clinical trial of Virodene. They claimed that it was a safe and highly effective anti-retroviral agent which would transform the AIDS scene in developing countries if only given the chance.

In that same month Phase I trials of Virodene began at Guy’s Drug Research Unit (GDRU) in London. According to a later company brochure a double blind, placebo-controlled study was conducted – on twenty healthy male volunteers (10 of whom received the placebo) – to evaluate “the safety, tolerability and pharmacokinetics of a single dose of Virodene® PO58.”

By this time senior ANC leaders had clearly become deeply emotionally and financially invested in the development of Virodene as an African cure for AIDS. This created a massive conflict of interest when it came to assessing ‘rival’ AIDS treatments from ‘competing’ pharmaceutical companies. This conflict was sharpened by the Virodene promoter’s belief that they had already fallen victim to the machinations of the big Western pharmaceutical companies. The MCC had blocked human trials of Virodene, it was believed, only because “other interests” had influenced their decision making. This was what warranted, in their minds, the purge of the MCC in March 1998.

On October 2 1998 it was formally decided by Minister Nkosazana Zuma, along with the various provincial health MECs, not to continue with the piloting of AZT for the prevention of mother-to-child transmission.

The R80m it would have cost to roll out this programme was to be spent instead on an anti-AIDS advertising campaign. This was launched on October 9 1998 by Mbeki in a nationally televised address. At this time Mbeki was not an AIDS ‘denialist’ as evidenced by the fact that the speech reflected a perfectly standard view of AIDS as a sexually transmitted disease caused by the HI virus. Mbeki stated, for instance, that “HIV spreads mainly through sex” and that “for many years, we have allowed the HI Virus to spread, and at a rate in our country which is one of the fastest in the world. Every single day a further 1 500 people in South Africa get infected. To date, more than 3 million people have been infected.” Although the speech acknowledged that “There is still no cure for HIV and AIDS. Nothing can prevent infection except our own behaviour” there was perhaps an obscure reference to Virodene in the line: “We shall work together to support medical institutions to search for a vaccine and a cure.” At this launch Minister Zuma announced the decision to put the pilot projects on hold. “It [AZT] is not cost-effective because we don’t have the money,” she said.

On that same day (October 9) Zigi Visser wrote two letters addressed to Deputy President Mbeki. The one informed him that the Botswana cabinet was on the verge of approving funding for Phase II trials of Virodene in that country. The other reported back on the phase I trials at GDRU. “The study is nearing completion,” he wrote, “with excellent results and absolutely no toxicity at proposed levels of doses.” He requested Mbeki’s “urgent consideration for financial assistance (bridging capital) as this account has to be settled immediately to avoid suspension.” The payment asked for from GDRU was for the sum of £95,423.

On Sunday (October 11) the Sunday Times reported as its front page lead Zuma’s decision to block the provision of AZT. The headline was “Save our babies, Dr Zuma.” The sub-heading was “Decision against drug treatment puts thousands of infants at risk.” In the article Carol Paton wrote that “doctors are begging” Zuma to reverse her decision; the consequence of which would be that “200 babies a day will continue to be born with HIV” of whom half could have been saved by AZT.

On Wednesday October 14 GDRU’s financial controller, Herman Patel, sent a letter to Zigi Visser acknowledging receipt of the money the previous day (Tuesday 13 October). In subsequent VPH accounts this R1m payment – along with a further R600 000 for patent fees in December – is coded as having come from “No2”.

On October 27 the Department of Health released a press statement which reported that “The Inter-Ministerial Committee on AIDS, chaired by Deputy President Mbeki” had endorsed the October 2 1998 decision not to introduce the AZT for the prevention of mother to child transmission at this point in time. It stated that, “A detailed study in South Africa has shown that introduction of [AZT] would cost about R80 million resulting in a further strain on an already limited health budget.”

III

This rationalisation, that the introduction of such AZT treatment was unaffordable, made no sense whatsoever. The arithmetic presented by Zuma to the Sunday Times was that thirty out of a hundred babies born to HIV-positive mothers would contract HIV at birth. The provision of a short course of AZT during pregnancy would reduce the number from 30 to 15. “If you take all that into account” Zuma said “and compare it to the benefit you would get from prevention then we really have to deal with prevention”. In 1998 22,8% of pregnant women attending government ante-natal clinics were HIV positive. Thus, providing AZT during pregnancy would have reduced the number of HIV positive newborns from 6,8% of the total to 3.4%.

Zuma told the Mail & Guardian (October 16 1998) that while she could understand why a parent or doctor might want a different policy “I have to look at the whole picture. If you have limited resources, you may decide to put your resources into preventing mothers getting infected in the first place.”

This reasoning was strongly disputed at the time. As Glenda Gray told Carol Paton “Here’s a real way we can prevent transmission and the government is not intervening. They prefer incoherent campaigns instead of things that will really turn the tide against AIDS.” She pointed out that “Whatever money you put in [to providing AZT] you get out, in terms of [saving on] the costs of treating HIV-positive babies.”

It was also at this time that the final touches were being put on South Africa’s multi-billion rand arms deal. On August 31 1998 a cabinet sub-committee, chaired by Deputy President Mbeki, had selected the preferred bidders for each of the strategic defence packages. It was this meeting which selected BAE’s Hawk – the “non-costed option” – for the lead-in fighter trainer programme. This was despite the fact that it was twice as expensive as the better Italian alternative. On November 18 1998 the cabinet announced that it was going to be spending R4,7bn on purchasing these 24 Hawk training jets as part of the R29,8bn arms deal.

IV

From mid-November 1998 the Visser’s requests for funding were re-directed from Mbeki to Max Maisela-a businessman and political confidante of the deputy president. Maisela was a member of Mbeki’s “consultative council” in 1996 before being appointed chairman of the Post Office in 1998.

Between January 1999 and March 2000 approximately six million rand flowed through Maisela to the Virodene developers. Maisela would later tell Rapport that he had simply been a conduit for the money, which was not his or his company’s.

Most of this money was spent on protecting the patent rights to Virodene, and on lawyers fees – after the minority-shareholders in VPH brought legal action against the majority shareholders. For some reason the June 1998 deal was never properly consummated, and the R4,8m purchase price was not paid across. However, Zigi Visser did direct his requests for the payment of this sum to Maisela as well.

The Visser’s remained in close contact with Minister Zuma. Over the course of early 1999 they kept her informed of developments; providing her with the patent documents, accounts, the structure of the Virodene holding companies, status reports, and the results of the report from the Phase 1 trial at GDRU.

V

In December 1998 the Treatment Action Campaign (TAC) had been founded to campaign for (inter alia) equitable access to anti-retroviral treatment. From early 1999 onwards the government began to come under growing pressure for its strange and stubborn reluctance to provide AZT either for HIV positive pregnant women or as post-exposure prophylaxis for victims of rape. In January 1999 the opposition controlled Western Cape broke ranks with the other provinces and announced that it would go ahead with a pilot project in the township of Khayelitsha.

There was also increasingly critical editorial comment in the newspapers. The Saturday Star commented on January 30 1999 that “The cost of saving the life of the most pathetic, vulnerable human being – a baby – from a grim Aids death is surprisingly small: just R400. Yet Health Minister Dr Nkosazana Zuma doesn’t seem prepared to pay it.” In May 1999 it was reported that the health ministry was still resisting Glaxo-Wellcome’s offer of a reduced price for AZT.

The possible trials of Virodene in Botswana had fallen through sometime in the first half of 1999, after the government there decided not to go ahead with them. For the next several months the Virodene promoters would have to play for time, until some other source of funding came online.

VI

On March 17 1999 Anthony Brink, an advocate from Maritzburg, published an article in the Citizen entitled “AZT a Medicine from Hell”. Brink was an adherent of the ‘dissident’ scientific view that the link between HIV and AIDS was unproven, and that the anti-retroviral drugs used to treat the disease were toxic.

The article commended Zuma for refusing to allow the provision of AZT to pregnant mothers, stating that while she had defended her decision on purely financial grounds, one day she would be commended for her “great prescient wisdom” in keeping this ‘toxic’ drug from “pregnant women and their foetuses”. The article also claimed that “several actions for loss of support have been launched against Glaxo-Wellcome in England and the US, arising out of the deaths of family members killed by their doctors’ prescriptions of AZT”. At the end of the article he listed his email address “for references and elucidation”. He also stated that “an exhaustive literature review of the pharmacology of AZT is in press for publication in a special supplement to the medical journal, Current Research and Medical Opinion“.

On March 24 1999 Zigi Visser wrote to Nkosazana Zuma enclosing Brink’s Citizen article, and alerting her to the pending publication of the journal article. Olga Visser contacted Brink who wrote back to her to say that the review was in press as a 30 000 word special supplement to Current Medical Research and Opinion, April/May issue, and he would send it to her as soon as it was published. On April 27 1999 Zigi Visser wrote to Mbeki:

“As discussed, herewith enclosed is a very important article from the Citizen March 17 1999 page 6…Please note that an exhaustive 30,000 word literature review of the pharmacology of AZT is in press for publication in the April/May edition of “Current Research and Medical Opinion”, of which I will obtain a copy for the Deputy President. This completely supports the Honourable Minister of Health’s stance on AZT.”

On October 21 1999 Zigi Visser sent two batches of documents to, now President, Mbeki. The one was a copy of the US patent for Virodene, which had been granted on August 10 1999. Visser stated: “With great pleasure and pride, I herewith enclose a copy of the granted US patent, which we prosecuted beating all objections raised by the examiners and being granted all claims without exception. This effectively means that we will beat any examining country’s objections, since the US is known to be the strictest.” The text of this patent gives some indication of why the Virodene promoters were so convinced of the drugs efficacy. It made the following claims about the results of the 1996 pilot study:

“Within the first 14 days of DMF [Virodene] treatment, there was marked improvement in general fatigue and in appetite. All the patients gained weight. Clinical improvement correlated well with disease status as assessed by viral load and CD4+ T cell count. For five out of eight patients, the relative PCR-measured viral load could be fitted to Gompertz curves; this analysis revealed an 88.8% decline in PCR-measured viral load after 42 days of DMF treatment. For seven out of eight patients, the relative CD4+ T cell counts could be fitted to Gompertz curves; this analysis showed a 73.4% increase in CD4+ T cell counts after 42 days of DMF treatment.”

The other set of documents included the Current Research and Medical Opinion journal article and a copy of Brink’s updated version of his earlier articles, entitled “Debating AZT.” Visser noted that Brink “is running a case in which the scientific merits of AZT will be tried in the High Court in Pietermarizburg next March/April [2000], which could hopefully assist in banning AZT in SA.” “For your untiring dedication and leadership in the fight against HIV/AIDS and corruption,” he concluded, “we thank you.” The following week in an address to the National Council of Provinces, on October 28, Mbeki referred to this material to justify the continued refusal to allow for the provision of AZT. He stated that:

“[W]e are confronted with the scourge of HIV-AIDS against which we must leave no stone unturned to save ourselves from the catastrophe which this disease poses. Concerned to respond appropriately to this threat, many in our country have called on the Government to make the drug AZT available in our public health system. Two matters in this regard have been brought to our attention. One of these is that there are legal cases pending in this country, the United Kingdom and the United States against AZT on the basis that this drug is harmful to health.

There also exists a large volume of scientific literature alleging that, among other things, the toxicity of this drug is such that it is in fact a danger to health. These are matters of great concern to the Government as it would be irresponsible for us not to head the dire warnings which medical researchers have been making. I have therefore asked the Minister of Health, as a matter of urgency, to go into all these matters so that, to the extent that is possible, we ourselves, including our country’s medical authorities, are certain of where the truth lies.”

The MCC was subsequently asked to produce reports on the safety of AZT. The ANC’s 1999 Annual Report now complained, “AZT and the call to make it available to everyone seems to dominate the agenda. The ANC says no, and will not be pressurised into this direction, particularly given the unanswered questions regarding the efficacy and toxicity of these drugs” This argument represented a major shift in rationale from government’s previous position-that it was simply too expensive.

This October 28 speech only signalled the beginning of Mbeki’s conversion to AIDS ‘dissidence’ or ‘denialism.’ Mbeki himself would later tell Allister Sparks that his introduction to Brink’s material was “the first time I became aware of this alternative viewpoint” on AIDS. However, over the following months he proceeded to immerse himself in the ‘dissident’ literature on HIV/AIDS.

To continue on to the final instalment click here

jmyburghemail-virodene@yahoo.co.uk

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