Reporter: James Myburgh
Mbeki and Nkosazana Zuma allied with the Vissers against the MCC
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
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
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.
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
"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
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
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
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:
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".
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
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
After the MCC's rejection of the Virodene protocols Zuma
signalled her intention to remove certain members of the MCC board, including
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
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.
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".
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
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".
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.
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
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".
(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
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
To be continued ...
acknowledgements to politicsweb and James Myburgh.