The Virodene Affair (III) [politicsweb, 2007-09-18]

Publication: politicsweb Issued: Date: 2007-09-18 Reporter: James Myburgh

The Virodene Affair (III)

Publication	politicsweb
Date	2007-09-18
Reporter	James Myburgh
Web Link	www.politicsweb.co.za

How the MCC was eventually taken out; and why Virodene was nonetheless still banned in SA

The previous article documented how between February 1997 and January 1998 there had been a on-going struggle between the Virodene researchers - backed by Health Minister Nkosazana Zuma and Deputy President Thabo Mbeki - and the Medicines Control Council, headed by Peter Folb. The MCC had refused to allow the testing of Virodene on humans, and it had also called in the police when it discovered that the substance was being illegally distributed. The Virodene promoters had, in turn, upped the political pressure on the MCC; all the while trying to work out a way of breaking its resistance. This long running battle eventually reached crisis point in March 1998.

The degree of the involvement of Mbeki and Minister Zuma in the affairs of Virodene, was exposed by Mike Ellis, a Democratic Party MP, on March 2 1998. On that day he called a press conference in parliament in which he publicised the court papers which had flowed out of the dispute between the minority and majority shareholders in Cryopreservation Technologies (CPT).

In particular, he pointed to the memorandum which suggested that the ANC had been promised a six percent share in Virodene. This, Ellis said, showed that there were "very strong grounds for suspecting" that various interventions "by senior members of the Cabinet" in Virodene "were made to advance the financial interests of the ANC".

Ellis said he was writing to the Public Protector, Selby Baqwa, to ask him to investigate whether the ANC had a financial interest in Virodene. He also requested that he look into Mbeki's and Minister Zuma's efforts to promote the drug; as well as their involvement in the affairs of Cryopreservation Technologies.

The ANC's response was threefold: Firstly, they categorically denied any financial interest in the development of Virodene. In an interview with Rapport however Carl Landauer said that he believed the Vissers had promised the ANC a six percent share.

Secondly, the ANC defended their promotion of Virodene as a cure for AIDS. While denying any financial interest the ANC insisted that they would "continue to encourage research into the development of an anti-AIDS drug in the context of the global fight against the AIDS epidemic. It will be unfortunate if it were to be found that those opposing further research into the Virodene P058 AIDS Drug are in fact motivated by opposing interests rather than the welfare of AIDS victims."

And, thirdly, they went on the offensive against both the DP and the MCC. Zuma told a reporter from The Star that the DP did not care for the majority of South Africans but "for the few that they represent". "The DP hates ANC supporters. If they had it their way we would all die of AIDS". Mbeki meanwhile claimed that "The DP cannot hide its pathological hatred of the ANC. Let us, however, not be deflected by activities of those who have no interest in the welfare of our people."

The National Working Committee of the ANC, meeting on March 3 1998, discussed the matter and released a statement accusing the DP of holding the "ANC and the masses it leads in utter contempt". "Unlike the DP, when the ANC pursues the needs of the sick and the vulnerable, it is driven not by interests of pecuniary gain, but because it cares." It accused Ellis of consistently pursuing "the interests of pharmaceutical monopolies and other forces opposed to health policies and programmes of the government."

On March 5, the ANC produced the letters between Zuma, the ANC, and the Vissers - produced in December the previous year - which, it claimed, proved that the alleged share allocation "did not in fact exist. Neither was the ANC aware of such a shareholding nor did it consent to it." It accused the DP of hoping to "frustrate further research into the development of an anti-AIDS drug as it does with all measures aimed at social transformation":

"The ANC will not allow itself to be diverted from its mission of creating a better life for all. As a consequence, the ANC will continue to encourage further research into the development of an anti-AIDS drug to address the plight of AIDS victims primarily because the ANC Cares! In this regard, we call on the MCC to expedite the process that will allow for clinical tests to be conducted on Virodene to determine once and for all the efficacy of the drug against the AIDS epidemic."

The ANC proceeded to up the pressure on the MCC. On Friday March 6 ANC Secretary General, Kgalema Motlanthe, held a press conference, where he accused the MCC of having ulterior motives in banning tests on Virodene and implied that it was doing the bidding of pharmaceutical manufacturers. "The rationale of the MCC should be questioned" he stated, "I surmise that the council is driven by other interests than concern for proper control of medicines".

He said the rejection of the Virodene protocols should be seen in the context of rival pharmaceutical companies jockeying for position. "We can only surmise that perhaps there is more at stake than meets the eye. This is a highly contested terrain." When asked why the ANC had such an interest in Virodene he replied: "Because this is a major issue-it confronts the entire humanity. If society is on the brink of a major breakthrough on the scourge of AIDS, [it is wrong] if there is no will and readiness to bring this work to a conclusion."

Motlanthe said decent researchers were being "hounded like criminals" and accused the MCC of "playing god". "Given the devastating effects of AIDS the research must be brought to its logical conclusions", he stated. Motlanthe also dismissed the view that Virodene was toxic as "any medicine had side-effects".

The following day an article by Thabo Mbeki, entitled "The War on Virodene" was sent to all the Sunday newspapers in the country. In the article Mbeki denied the ANC had any financial interest in the drug, but launched a passionate defence of the Virodene researchers, and his government's involvement.

"The Virodene researchers themselves have had unbounded contumely heaped upon them. As expected, the Minister of Health has not been spared the poisoned barbs. On top of all that, researchers been subjected to a provocation by a person who falsely claimed to have fallen seriously ill as a result of being treated with Virodene. Hot on the heels of this fraud, night raids directed at some of the researchers were carried out by investigators in search of information about alleged criminal behaviour. Shots have been fired at one of the researchers by unknown gunmen, leading to the need to provide armed protection. How alien all these goings-on seem to be the pursuits of medical research! In our strange world, those who seek the good for all humanity have become the villains of our time!"

The great sand storms generated by all these vexatious proceedings have served to obscure the fact that what confronts us all is the pressing crisis of an escalating pandemic of HIV/AIDS. Two thirds of those affected world-wide are in Sub-Saharan Africa, including a 2 800 000 strong South African contingent. Often I have wondered whether those who have generated sand storms with the greatest enthusiasm, did not, in fact, seek to achieve precisely this result!"

Mbeki then quoted supportive statements by the various foreign scientists, who had been approached by the Virodene researchers. "Alas", he continued, "the MCC, still refuses to accept the application [for clinical trials], despite its knowledge of the unanimous opinion" of these scientists. Mbeki then launched into an attack on the MCC:

"To confirm its determined stance against Virodene, and contrary to previous practice, the MCC has, with powers to decide who shall live or die, also denied dying AIDS sufferers the possibility of ‘mercy treatment' to which they are morally entitled. I and many others will not rest until the efficacy or otherwise of Virodene is established scientifically. If nothing else, all those infected by HIV/AIDS need to know as a matter of urgency. The cruel games of those who do not care should not be allowed to set the national agenda."

In his response Folb stated that the MCC had solicited more than seven independent reports both locally and internationally that unanimously backed their decision not to allow human experiments. "The MCC has never agreed to the use of Virodene in human trials and will not do so until the basic requirements are met". "This in no sense precludes ongoing research and experiments", Folb added, "though not on humans, and I want to reassure people, the government and the cabinet that the MCC has continued to discharge its duty in the interests of public health and with no other purpose in mind."

III

On March 24 1998 Peter Folb was removed as chairman of the MCC. Johann Schlebusch, the registrar, and Christel Brückner, his deputy, were summoned - one after the other - to the office of the Director-General, Olive Shisana. They were presented with two choices: they could either sign a letter of resignation - and receive a severance package - or they would be suspended immediately and charged with misconduct. Schlebusch was then escorted to his office. He was required to surrender his office keys and entry card, his computer and cellphone. He was only allowed to take his briefcase. The same happened to Brückner. The locks to their offices were changed, and guards were placed outside Schlebusch's secretary's office. Staff at the MCC were instructed not to make contact with them.

On Friday March 27 it was first reported, in the press, that these officials had been removed from their positions and barred from their offices. Folb told the Mail & Guardian that the MCC had effectively ceased to function and that "As far as has been explained to me, the operation of the MCC does cease forthwith." A departmental spokeswoman, Gonda Perez, denied that anybody had been locked out of MCC offices.

The Sunday newspapers reported that Zuma planned to announce the replacement of the MCC with a new regulatory body on the Monday. However, she was unable to do so as she did not have the legal power to disestablish the body. She said however that she supported the broad recommendations made by a review committee established in January, which had reported on March 24, and proposed a new drug regulatory body. She confirmed the reports that Schlebusch and Brückner were currently on leave. Zuma was quoted in newspaper reports as saying: "Its formation [the MCC] in the 1960s was not meant to be for eternity"; and that, "They [Schlebusch and Brückner] will not be in the jobs they [were] in, that is for sure."

What gave the Ministry the political cover to pursue such action was that Zuma had acted upon the recommendations of, what was described as, an "independent review committee". For instance, an editorial in the Financial Mail commented, "Though there is a need for cautionary statements, it should in fairness be noted that Zuma is acting in accordance with the recommendations of a review committee made up of international and local experts on the control of medicines."

The allegations made by the Committee on the alleged malfunctioning of the MCC were also extensively reported on in the press. Schlebusch was replaced by Precious Matsoso, a political appointee close to the Minister. At the end of April Helen Rees, another political appointee, was appointed as the new chairman of the MCC. Rees said that the axing of Folb as head of the MCC had nothing to do with his disagreements with the government over Virodene. "An independent committee was set up to examine the role of the MCC long before the controversy over Virodene broke out. That committee was chaired by experts recommended by Professor Folb."

The review committee had been established by Minister Zuma in January 1998. Although much was made of its ‘independence' it was not particularly independent in composition, nor did it display much independence in the manner in which it conducted its inquiry. The Commission was composed of two outside experts, Prof Graham Dukes, Emeritus Professor of Drug Policy Studies at the University of Groningen (The Netherlands), the only person whom Folb had recommended, and Dr Suzanne Hill, a Research Academic in Clinical Pharmacology at the University of Newcastle, Australia.

In addition, the team was composed of five locals - four of whom held line functions in the ministry of Health. The fifth was an advisor to the Minister. Folb would later testify that Dukes and Hill had made clear to him at the start of the inquiry that they were going for a "consensus" report and that they planned to call for his removal, as well as the removal of the registrar and deputy-registrar because they were part of the "old-guard".

The committee submitted two reports: a public one calling for the immediate suspension of the MCC and its replacement by another body (a recommendation that could not be implemented as it was ultra vires) and a secret report calling for the purging of the MCC's top officials.

The allegations made by the Review Committee against these individuals, and the MCC as a whole, were later examined at length during an arbitration at the Commission for Conciliation, Mediation, and Arbitration (CCMA), between the Department of Health and the Public Servants Association, representing Schlebusch and Brückner. The CCMA Commissioner found that the allegations made against the MCC by the Review Committee were without substance.

Furthermore, the departure of these officials had led to a collapse of the proper functioning of the MCC-a year after their removal the backlog in drug registration had quadrupled from between 400 to 800 to around 2600. "Schlebusch and Brückner had been unceremoniously removed from office," he wrote, "escorted from the premises and treated like criminals. In addition, no convincing operational reasons for this action have been shown."

The tribunal noted that the department "should have known from the outset that its conduct was wrongful and unfair, especially as far as the manner in which it had acted, is concerned. Notwithstanding this, it steadfastly refused to reinstate the applicants in their former positions." (The CCMA report can be accessed here.)

Despite this ruling the department continued to refuse to reinstate the two officials. The department took the matter on review - although it had no reasonable prospect of success - in an effort to delay their reinstatement. The application for review was duly dismissed by the Labour Court in August 2001. Schlebusch was then given his office back, but not his former duties. He was eventually prevailed upon to accept a severance package.

Although Brückner was eventually given back her office and her title, she was not given back her responsibilities. A new post of director of medicines registration had simply been created above her. She had applied for the position but one of her juniors was appointed over her. Nine-and-a-half years after her illegal sacking - and against numerous judicial rulings - she still has not been given back her responsibilities.

The whole breakdown of proper medicines control in South Africa - manifested today in all the bogus AIDS treatments currently on the market - can be directly traced back to the destruction of the MCC as an institution in early 1998.

The Virodene researchers had clearly hoped that the new chairman of the MCC, Dr. Helen Rees, would be more sympathetic to their cause. Rees took a less combative stance in public. But, when it came to allowing the testing of the drug, she turned out to be, as one of the Virodene promoters put it, "worse than Peter Folb."

The basic problem facing the Virodene researchers - even as they began to address the MCC's concerns about toxicity - was that they were unable to produce a plausible description of how their compound acted against HIV. At a meeting between representatives of the MCC and CPT on January 27 1998 the researchers were told that the decision to reject the protocol (at an earlier meeting on January 22) had been unanimous.

Professor Antoine van Gelder - head of the clinical committee which had evaluated the protocol - told the researchers that their protocol "failed to show antiretroviral activity", lacked "efficacy data based on a scientific and ethical study" and lacked evidence for mechanism for the working of the drug. The researchers were also told that in the absence of any evidence that the Virodene actually worked "we find no basis to expose people or animals to this drug".

In 1997 the Virodene researchers commissioned Ana/lysis GmbH, a German company based in Frankfurt, to conduct in-vitro tests on Virodene P058. According to Andreas Immelmann, the researcher on the project, they submitted the compound to "in vitro cell culture and did not find any significant anti-HIV activity. Our conclusion was that this compound has no direct antiviral effect." (Financial Mail April 24 1998)

The only evidence that the researchers could produce for the efficacy of the drug were the results of the ethically and scientifically flawed 1996 pilot study. Although there were compelling reasons to completely disregard the results of the study the MCC decided, in December 1997, to do a "comprehensive review of all the available data on Virodene" to finally bring the matter to a resolution.

The Virodene researchers were requested to provide all original documentation from this study. Through the course of 1998 there was a long running battle between the MCC and the Virodene researchers for a full disclosure of this data.

It was the results of this audit - which was conducted by Van Gelder - which led, in December 1998, to the MCC rejecting clinical trials of Virodene once and for all. The MCC stated that "no acceptable evidence of efficacy on pre-clinical or clinical data was presented during the period 22 January 1997 to 10 December 1998, in which time the Virodene application was under review." Furthermore, "The clinical data that was presented to council to support the investigators' argument for efficacy contained duplications, incorrect figures and omissions". "As Virodene is unregistered, with no proven benefit for the treatment of HIV/AIDS, the use of the product is unlawful." Professor William Makgoba, head of the Medical Research Council (MRC), leant his support to the rejection of Virodene.

In January 1999 the Public Protector, Selby Baqwa, reported back to Mike Ellis. In his letter he stated that during the course of a preliminary investigation he could not "find any evidence that the Minister of Health; the Deputy President or any other person performing a public function have had any financial interest in the development of Virodene P058. Both the Minister of Health and the Deputy President became involved in this matter in their capacities as the Minister responsible for the National Health Department and the Chairperson of the Cabinet Committee on HIV/AIDS respectively."

Baqwa had invited verbal and written comments from the various parties involved, including: the Minister, the Deputy President, and the Medicines Control Council, and from the several different parties connected to the development of Virodene (or their legal representatives). The investigation could only be described as cursory.

He simply accepted the ANC's statements and correspondence at face value, and did not attempt to test their validity. After reiterating the ANC's denials, which had already been made public in March 1998, he announced that there was no need for a full investigation into the matter.

The last word on Virodene was seemingly uttered by Makgoba in September 1999. Presenting the MRC's annual report to parliament, he commented, "Virodene is nonsense. It does not have any scientific integrity".

Despite the purge of the MCC, and decimation of its professional staff - the efforts by the Virodene promoters to have the drug tested in South Africa had been checkmated by Van Gelder's audit in mid-1998. At this point further investigation into the conduct of the Virodene promoters was undoubtedly warranted. Instead, the whole messy affair - embarrassing as it was to the ANC - was swept under the carpet. And so the whole Virodene saga was allowed to slip out of the public consciousness. Yet this was not the end of the affair, or of Minister Zuma's and Thabo Mbeki's involvement in it.

To be continued...

With acknowledgements to politicsweb and James Myburgh.