6.Efficacy of Virodene finally put to test, the war on anti-retrovirals ended

The Virodene affair (V)

James Myburgh

21 September 2007

How the efficacy of Virodene was finally put to the test, and why the war on anti-retrovirals ended

The previous article documented how Deputy President Thabo Mbeki and Health Minister Nkosazana Zuma put a stop to the provision of AZT treatment in October 1998 – the month after phase 1 trials of Virodene began in London. It also traced how Virodene led to Mbeki’s introduction to the “alternative viewpoint” on AIDS. This final instalment concerns the confluence between Mbeki’s challenge to the scientific orthodoxy of AIDS between 2000 and 2002 and the culmination of the Virodene project.

I

Thabo Mbeki’s descent into AIDS ‘denialism’ has been documented at length elsewhere. But, to briefly reiterate the chronology: President Mbeki began seriously exploring the ‘dissident’ viewpoint on HIV/AIDS in November 1999 with the help of the journalist Anita Allen. In late January 2000 the president’s office contacted David Rasnick, a leading proponent of the ‘dissident’ theory on AIDS, and asked him to comment on various aspects of the science of HIV/AIDS.

At the end of February the health department announced that, at Mbeki’s instigation, it was putting together an international panel of experts to re-assess various aspects of the science of HIV/AIDS. On May 3 cabinet announced the composition of the thirty member panel, of whom almost half were AIDS ‘dissidents.’ Between July and October 2000 Mbeki began openly challenging the causal link between HIV and AIDS. It was only in mid-April 2002 that his government would suddenly relent in its opposition to anti-retroviral drugs.

At the time Mbeki’s decision to challenge the science of HIV/AIDS was regarded as utterly inexplicable. An editorial in the Mail & Guardian (March 31 2000) asked, “Why has Mbeki embarked on this stubborn, silent crusade? There are no obvious reasons…” No-one knew then what we know now, namely that the ANC was still deeply involved in the development of Virodene. Even today the implications of that mind-boggling conflict of interest have not been factored into accounts of Mbeki’s denialism.

Counter-intuitive though it may seem, Mbeki’s long-running involvement in Virodene does help explain his receptivity to AIDS ‘denialism’. The Virodene promoters were clearly looking for reasons to justify their opposition to AZT – until their drug had finally been validated – and this is why they (initially) seized upon Anthony Brink’s claims about its toxicity. Moreover, despite the (supposedly) miraculous results of Virodene as an AIDS treatment, the researchers could never show that their drug acted against HIV. This may have awoken Mbeki’s doubts about the aetiology of HIV/AIDS.

At a deeper psychological level the decision to block the provision of AZT in October 1998 had – if the scientific establishment was to be believed – already resulted in thousands of newborns (avoidably) receiving the death sentence of HIV infection. The argument that HIV was relatively harmless, and anti-retrovirals poisonous, would have provided an easy answer to already difficult questions of moral responsibility. Lastly, what would have given Mbeki confidence to directly challenge the science of AIDS was the knowledge that the efficacy of Virodene – the African solution – was soon to be proven scientifically.

Coincidentally or not, it was also in November 1999 that the phase 2 trials of Virodene in Tanzania began to be put in motion. In a letter addressed to Max Maisela early that month Zigi Visser stated that there was a chance of trials being conducted in that country, but the protocol needed to be finalised and the laboratories prepared for testing. Visser also mooted the possibility that the renowned scientist, Luc Montagnier, could be brought on board “should the President [Mbeki] agree we use his services.” On November 30 1999 he addressed another letter to Maisela dealing with the Tanzanian trials – which would be conducted by the Tanzanian Defence Force. He raised a sensitive issue, which had potential political repercussions, and asked: “Would you please brief the President for his opinion and guidance?”

On March 17 2000 Visser addressed a letter to Maisela informing him that “we have obtained the permission of the Minister of Health in Tanzania to conduct trials on patients with HIV/Aids.” The Virodene team would be departing that week for a pre-clinical meeting.

It was really from mid-April 2000 that the serious money started flowing to the Virodene researchers to finance the trials. Over the following year a sum of between R30m to R40m was was spent on “Project V”. The Mail & Guardian has previously claimed that it was the ANC who had arranged this funding – money then channelled (mainly) through Max Maisela to Virodene Pharmaceutical Holdings. The ANC Treasurer General, Mendi Msimang – husband of the Minister of Health – was said to have played a lesser role.

Fiona Forde recently revealed that this money was often picked up directly from the presidency; “on numerous occasions, money was collected from ‘the presidency, in the Union Buildings’ in briefcases and ‘always in US dollars, and always $100-bills. One source claims to have done ‘the Union Buildings run’ three times throughout 2000.”

It is not clear where this money originated. But in their account the M&G did claim that – according to their information – the dollar bills had come from Wafic Said, the Saudi-born English businessman with close links to BAe. Said denied that he had personally invested anything in the project.

II

The actual testing of Virodene on humans began in September 2000 and ran until March the following year. It was a double blind, placebo-controlled trial, the purpose of which – a later VPH brochure stated – was to evaluate the “safety, tolerability, pharmacokinetics and efficacy of multiple doses of Virodene PO58 on 64 HIV/AIDS infected male volunteers.” The trials were conducted by the Tanzanian military under the supervision of a clinical trial manager at two sites in Dar es Salaam: Lugalo General Military Hospital and Chadibwa Medical Clinic. According to the brochure the former site was selected as the main centre with the latter handling the overflow of patients.

As the trials were winding down the Minister of Health, Manto Tshabalala-Msimang, paid them a visit. The details were outlined in a fax sent to the minister’s Cape Town office by Olga Visser on February 27 2001. The fax confirmed “that the main purpose of the visit, will be to inspect the sites where the Phase II Virodene Trials are taking place so that you will be in a position to obtain a clear picture of the progress and furthermore to avail yourself of the success of the Phase II Virodene Trials to date.” It added that the minister’s office must ensure that the visit “carries both the blessing and approval of the president of the Republic of South Africa and the president of the Republic of Tanzania”.

In reply to a subsequent parliamentary question the minister acknowledged that she had visited both trial sites along with her advisor, Mr VR Mabope, and her private secretary, Ms N Zigana. She had been accompanied on her inspection by Zigi and Olga Visser; the purpose of which, she said, was “to evaluate the usefulness of Virodene.”

Because the Tanzanian study was double-blinded neither the patients nor the researchers knew who was receiving Virodene and who was receiving the placebo. Olga Visser nonetheless claimed that it had once again performed wonders. On May 6 2001 Luc Montaigner – then in negotiations with the Vissers about performing in-vitro testing of Virodene – composed a draft letter to Maisela in which he reported on a meeting with Olga Visser two days previously. She had told him that half the 64 HIV infected patients in the Tanzanian trial “showed after a 6 week period of weekly applications of Virodene, a ten times drop in viral load in their blood and a significant increase of CD4+ T cells”. “Such changes” Montaigner commented, “are generally not observed so quickly with classical antiretroviral therapy”.

In another communication Olga Visser claimed that the “preliminary results have proved the safety of the Drug in HIV infected patients and anecdotal evidence of efficacy is indicated, however, we are presently awaiting the unblinding of the study and the completion of the statistical analysis of the study.” In September 2001 Zigi Visser told the Mail & Guardian that “Our work is top secret so I can’t say much, but large international pharmaceutical companies and elements of the media are afraid of Virodene. We have had excellent results so far…” (It is worth nothing that in an interview with Mark Schoofs of the Wall Street Journal in July 2001 Zigi Visser said he doubted whether “HIV causes AIDS and even whether the disease is transmitted through sex.”)

III

In early 2002 the Mbeki-ites were still vehemently opposing the provision of any kind of anti-retroviral treatment by the state. Mbeki’s denialist manifesto – Castro Hlongwane, Caravans, Cats, Geese, Foot & Mouth and Statistics: HIV/Aids and the Struggle for the Humanisation of the African – claimed that both Parks Mankahlana and Nkosi Johnson had been killed by the “anti-retroviral drugs” they had consumed. This document had been distributed at a key ANC National Executive Committee held on 15 to 17 of March. The meeting effectively came out in support of Mbeki’s opposition to the provision of anti-retrovirals – even if it did not completely side with his ideological justifications. The NEC affirmed government policy on nevirapine, and stated that anti-retrovirals “could not be provided in public health institutions” for either the victims of sexual assault or needle-stick injuries.

In March 1998 Mbeki had promised that he would not rest “until the efficacy or otherwise of Virodene is established scientifically.” It was just over four years later – in around late March 2002 – that the promoters of Virodene received the report on the unblinded results of the Phase 2 trial in Tanzania, and the statistical analysis thereof. This revealed that Virodene was no cure for HIV/AIDS. It had no effect on the HI virus, although some marginal improvement in the CD4+ count seems to have been recorded. For those invested in Virodene these results were, quite obviously, a massive disappointment.

On April 17 2002 the cabinet announced an abrupt reversal of its policy towards anti-retroviral drugs. It stated that not only would Nevirapine be provided to all pregnant women (as it had been instructed to do by the courts) but also that anti-retroviral treatment would be made available to rape victims, something Mbeki had vigorously argued against in 2000. Business Day reported on the announcement under the headline: “Government stages a dramatic about-turn on its AIDS policy.”

Mbeki would remain an AIDS ‘denialist.’ His loyalists in government would remain sullen, suspicious, and obstructive when it came to anti-retroviral drugs; but deeply credulous when it came to the claims of snake-oil and vitamin salesman. But, the conventional war against anti-retrovirals was over, even if the ‘denialists’ have persisted with guerrilla actions to this day.

As the saying goes, success has many fathers but failure is an orphan. Following the release of the report on the trials there was an acrimonious falling out among the promoters of Virodene.  On May 2 – according to a later article in Rapport – Zigi Visser wrote a letter to President Mbeki asking for “urgent” financial help of R2 million to save Project Virodene. In it he acknowledged receipt of more than $3.5 million over the previous three years. He complained that both Mendi Msimang and Max Maisela were frustrating his efforts. “Our situation is critical and our loans have not been paid for the past three months”. He asked if he could “sell the company because without support I cannot go ahead?”

In June Zigi Visser told the Mail & Guardian that he had no sympathy for Maisela, “he’s a total cabbage.” The newspaper reported that Visser still refused to identify the identities of the paymasters of the trials. He told them, “If at the end of the day the drug succeeds and Bill gates says he funded it, he’s a hero. If it does not succeed, he looks silly. That’s the problem.”

In July 2002 it was reported that Olga Visser had withdrawn from the enterprise. In December she ceded all her rights in the various Virodene companies to the ANC-linked businessman and part-owner of VPH, Karim Rawjee.

IV

The involvement of the ANC in the Virodene trials in 2000 casts new light on many of the more bizarre statements of the presidency that year. Indeed, Mbeki seems to have often projected his own motives and conduct onto his critics and opponents. In mid-March, for instance, he wrote how he was “taken aback by the determination of many people in our country to sacrifice all intellectual integrity to act as salespersons of the produce of one pharmaceutical company.”

In October 2000 the Democratic Alliance offered to provide AZT in the municipalities it controlled after the municipal elections in December. The ANC presidency responded by accusing the DA of treating black people “as guinea pigs” and of conning them “into using dangerous and toxic drugs that are detrimental to their own health.” This statement was released a few weeks into the testing of Virodene on black Tanzanian soldiers.

Certain other statements by Mbeki acquire new meaning and significance when placed in this context. In his letter to world leaders (April 3 2000) – written shortly after the go-ahead had been given for the trials in Tanzania – Mbeki promised that, “We will not, ourselves condemn our own people to death by giving up the search for specific and targeted responses to the specifically African incidence of HIV-AIDS.”

In late July 2000 Tony Leon famously accused Mbeki of suffering a “near obsession” with finding African solutions to every problem, even if this meant flouting scientific facts about AIDS, in favour of “snake-oil cures and quackery.” This touched a nerve. Mbeki responded on August 11 2000 by accusing the “white politician” (Leon) of openly speaking “of his disdain and contempt for African solutions to the challenges that face the peoples of our Continent.” Little did Leon know that trials of Virodene – the “snake-oil cure” he was referring to – were due to start the following month.

V

To conclude, throughout the period in which the government was depriving South Africans of any access to life-saving anti-retroviral treatment through the public health-care system, senior figures in the ANC were secretly involved in the development of an alternative cure for AIDS. There can be no doubt that the decision-makers remained convinced that they had discovered a potential cure right up until 2000 and beyond. Why else secretly channel tens of millions of rands into funding the phase 2 trials of the drug in Tanzania? This means of course that at the time the decision was made not to provide AZT, there was an expectation that a cheaper and more efficacious treatment for AIDS was on the way. The investment in Virodene – whether emotional or financial – also created a deep conflict of interest. It is striking that the government put a stop to the provision of AZT within weeks of the launch of phase 1 trials of Virodene in London; and would only relent shortly after the results of the phase 2 trials proved the substance to be inefficacious.

An article in the Economist recently observed that what the siloviki in Russia “are claiming is a special mission to restore the power of the state, save Russia from disintegration, and frustrate the enemies that might weaken it.” Yet such idealistic sentiments “coexist with an opportunistic and cynical eagerness to seize the situation for personal or institutional gain.” Similarly, the mission of the Mbeki-ites has been to restore “African dignity,” validate the black majority, and finally vanquish the “demon of white racism.” But even on AIDS policy one can witness the same strange combination of high ideology and base self-interest.

Ends

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