ANC has no financial stake in Virodene

Article by Thabo Mbeki.

March 1998

From the day it entered the public domain, Virodene has been attended by impassioned controversy and strident charges of dangerous and unethical behaviour.

As it proceeds towards a seemingly uncertain future, which more recent events suggest, it continues to drag behind it more controversy and yet more strident charges of dangerous and unethical behaviour.

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 2,8 million 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!

Time will tell what lies behind this behaviour, which has produced in me feelings of exasperation, anger and sadness.

However, let us come to the matter which has caused the latest rumpus around Virodene.

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.

Neither has there been any discussion between any of these and any other person which related to financial arrangements involving the ANC and any among its leadership.

The allegation that the ANC has been involved in such arrangements or discussions is both completely false and gravely insulting.

To satisfy those who seem perversely attached to the notion that the ANC and the Government are guilty until proven innocent, the independent Public Protector will, in due course, pronounce on these matters.

A question has also been posed as to why I interacted with the researchers on matters affecting the company handling Virodene affairs, Cryopreservation Technologies cc (CPT). Last year, differences emerged among the researchers. Ultimately, the courts facilitated a resolution of this dispute.

The dispute threw up two dangers.

One of these was that CPT could be auctioned to the highest bidder. The second was that the dispute could block the clinical trials to which the Medicines Control Council (MCC) ultimately agreed, but later changed their mind.

If the first eventuality 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.

The consequences of the second eventuality are obvious enough. Taking these matters into account, the Minister of Health and I decided that we should assist the researchers to resolve the differences among themselves to facilitate the carrying out of the critical clinical trials that would test the efficacy of Virodene.

The judicial process resulted in the appointment of a neutral Administrator to oversee the affairs of CPT. We have met the Administrator and conveyed to him our support as he carries out his important tasks.

Should a similar situation emerge in future, requiring that we intervene to encourage the researchers not to allow anything to compromise their legitimate scientific work, we will intervene.

Of course, this would happen on condition the researchers continue to accept that we would be honest brokers.

During the course of their interaction with the MCC, the researchers have submitted at least four versions of their research proposal, the Protocol, in response to the critical appraisals of the MCC.

As it became more and more difficult to understand the attitude adopted by the MCC, the Minister of Health and I held meetings with both the researchers and the Chairperson of the MCC, to help facilitate the resolution of any outstanding problems.

Once again, should the need arise for us to play such a role, we will not hesitate to do so. Again, this will depend on the willingness of all parties concerned, freely to interact with us, as they did on all previous occasions.

At this point we should perhaps go back to the beginning.

More than twelve months ago, emanating from a request the Minister of Health presented through me, the Cabinet listened to a presentation by the Virodene researchers.

Cabinet also had the privilege to hear the moving testimonies of AIDS sufferers who had been treated with Virodene, with seemingly very encouraging results.

The Cabinet took the decision that it would support the Virodene research, up to the completion of the MCC processes. So far, this has not necessitated any financial or other material support.

The Cabinet has not changed its mind on this issue. Those in Government who deal with this matter directly, including the Minister of Health and myself, will continue to do so until Government policy changes.

The importance of this is further emphasised by the fact that our entire system of government, from the national to the local level, has begun implementing a programme of action of sustained national mobilisation to intensify the offensive against the spread of HIV/AIDS.

The Government has established an Inter-Ministerial Committee on HIV/AIDS to lead this critical campaign. I chair this Committee and the Minister of Health heads its Secretariat.

Both I and the Minister of Health, as well as the rest of our colleagues in our country's system of governance, will try as best as we can to discharge our responsibilities in the supremely important fight against HIV/AIDS, including support for all relevant bona fide medical research.

As we frittered away time by promoting our various agendas rather than do the important thing of investigating the efficacy of Virodene, the world scientific community has been subjecting the Virodene Protocol to a detailed assessment.

Dr Rosado and Professors Trindade and Lourenco of Portugal say: "We support the proposed study with agenda as proposed. We believe that most of the speculation could be resolved by getting clinical trials off the ground."

Professor Morisset of Canada says: "In fact, if this protocol, in its final version, would be presented to the 'Scientific Committee' and the 'Ethics Committee' of the University of Montreal Medical Center, it will satisfy the strict rules and criteria of acceptance of this institution."

Dr Lefesvre of France says: "I find the Protocol well thought through and do not think it will be necessary to modify the present version, which I approve of in its present version, which I approve of in its present form."

Dr Mraz of the Czech Republic says: "I approve that the proposed study is conducted after the analytical procedures are prepared and described adequately and the discrepancies throughout the text are clarified."

Professor Dayan of Great Britain says: "I must congratulate you on the membership of the Ethics Review Board. You have collected a set of appropriately learned and highly qualified professionals. I was glad to see that none had any major objections to the draft Protocol, nor were major changes suggested. You have already seen my views, which were also directed to improving the quality of the document without altering its substance I hope the local Review board accepted the application?"

Alas, "the local review board", the MCC, still refuses to accept the application, despite its knowledge of the unanimous opinion of these "learned and highly qualified professionals", and whose credentials it is perfectly aware of.

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.