Publication: politicsweb
Issued:
Date: 2007-09-21
Reporter: James Myburgh
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
*1.
EndsWith
acknowledgements to politicsweb and James Myburgh.
*1 Ignorance and Greed
*2.
*2 Just like the Strategic Defence
Packages.