Sunday Times (Johannesburg) - August 11, 2002

The political manipulation of the Medicines Control Council is a threat to our democracy, says Zackie Achmat.

THE Medicines Control Council is contributing to anguish, fear and confusion among people living with HIV/Aids. At the root of this confusion is its mishandling, since November 1999, of the registration status of nevirapine for the purpose of preventing the transmission of HIV from mothers to children.

Thousands of South Africans take nevirapine every day as part of treatment for HIV/Aids, and thousands of women have taken it via the mother-to-child transmission prevention sites.

People with HIV face a barrage of illinformed statements not only from politicians but also from the regulatory authorities.

Nevirapine is registered in more than 50 countries for mother-to-child transmission prevention and is recommended for this purpose by the World Health Organisation, UNAIDS and the Centre for Disease Control. It is a life-saving medicine that keeps people with HIV living longer and healthier lives. It also prevents many new paediatric infections.

Like all powerful medicines, it can have side effects - some of them very serious - when used chronically. But for mother-to-child transmission prevention, where one dose is taken, not a single serious adverse effect has been reported in the many thousands of women and children around the world who have used it for this purpose.

Contrary to the rumours begun by Aids denialists and perpetuated by others, it is used in the US for mother-to-child transmission prevention when HIV-positive women go to a clinic late in their pregnancy and as a part of combination therapy.

An independent Medicines Control Council concerned with the safety, efficacy and quality of medicines is in the interest of all people in South Africa.

Independence from drug companies and the government is essential to ensure public confidence in the regulatory authorities. Such independence can only be strengthened by an active engagement with the social, economic and development priorities of the country.

However, the council must have an unbending scientific independence.

The MCC undermined its legal, ethical and scientific obligations when it entered the mother-to-child transmission prevention court case on the side of the minister of health. Not only did some of its members give misleading evidence on the side of the government, but the council issued statements designed to influence the judicial proceedings.

During the early part of the court proceedings, Peter Eagles, head of the MCC, argued in a radio interview that nevirapine had been tested only by US researchers for mother-to-child transmission prevention and therefore further testing was needed in the developing world. Yet it is very much in the developing world - Uganda and South Africa especially - where nevirapine has been tested for this use.

Eagles seems to have a habit of putting his foot in it. This week he was quoted in the Cape Times as saying that his council was impartial in the mother-to-child transmission case. But transcripts and selected MCC documentation were made available to Treatment Action Campaign lawyers at the latest possible opportunity, after our experts had already made their affidavits.

On the evening of the last working day before the first Constitutional Court hearing, the MCC announced that it would review the registration of nevirapine for mother-to-child transmission prevention.

The MCC is generally media-shy because it has to strike a balance between public interest and ensuring that it does not release unnecessarily corporate secrets to which it is privy. With the nevirapine saga, however, Eagles and Precious Matsoso, the registrar of medicines, have made numerous confusing and misleading statements to the media. We would prefer the MCC to be more transparent and release more information in the public's interest, but here their statements have been highly selective, giving the impression that the MCC acted at the minister of health's behest.

We hear repeatedly from the MCC that it is concerned about the resistance associated with nevirapine in about 25% of mother-to-child transmission prevention cases, and the documentation problems of the Uganda study. But we fail to hear from the council that the South African Intrapartum Nevirapine Trial study conducted with the MCC's assistance has confirmed both the safety and efficacy results of Uganda, or that there has not been a single serious adverse event recorded with nevirapine for mother-to-child transmission prevention, despite its use around the world.

We also fail to hear that resistance is an issue with many, perhaps most, registered medicines or that there is evidence that the nevirapine-resistant strain of HIV is supplanted by the non-resistant virus over time.

The MCC also ignores recent studies in the US, Europe and developing countries showing the safety of single-dose NVP prophylaxis in pregnancy.

Everyone knows that the once-off nevirapine protocol used in SA's mother-to-child transmission prevention sites is one of the least effective antiretroviral protocols. In Brazil, North America and Europe, the paediatric epidemic has been virtually eliminated through the use of more complex and expensive regimens involving the use of three drugs from early pregnancy.

It was SA Health Minister Manto Tshabalala-Msimang who decided to use nevirapine because it is easier and cheaper. Nevertheless, the Treatment Action Campaign decided to support the government's choice because it represented an important start to the management of the HIV epidemic. It is ironic and tragic that we eventually had to go to court to get the government to implement a protocol it adopted, and that attempts to undermine the Constitutional Court judgment continue.

The arbitrary interventions by the MCC are fuelling the agenda of Aids denialists, recalcitrant health MECs in the Northern Cape, Limpopo and Mpumalanga, and a minister of health who is intent on preventing the use of antiretrovirals, irrespective of the consequences to millions.

It is critical that the public has confidence in the MCC. Should this confidence fail, the consequences for the safety and efficacy of medicines distributed in South Africa will be catastrophic. We risk having people using unsafe medicines and failing to take useful ones.

Therefore, the TAC has resolved to campaign for an independent MCC.

Many events over the last few months have given us cause for concern. For example, MCC member Jonathan Levin, who wrote a disingenuous affidavit for the council in the court case, sits on the government's mother-to-child transmission prevention committee, while another member, Phillip Onyebujoh, has finessed his publicly stated views on antiretrovirals like nevirapine in his affidavit.

The minister of health is not satisfied with appointing members of the MCC; she now wants to give herself legal powers to overturn its decisions. At the same time, she commands the council to be independent.

Earlier this week the MCC took bold steps to register generic antiretrovirals that are patented. This remarkable step will ensure improved access to medicines for more people. But, it is undermined by the constant equivocation and misleading statements on nevirapine.

The issue of independence from political tampering goes beyond the MCC.

The South African Human Rights Commission inexplicably withdrew from the mother-to-child transmission court case, one of the most important human rights cases in this country's history, after initially indicating its intention to participate. Its publicly stated reasons for doing so remain unconvincing.

Furthermore, the minister of health and other politicians have systematically attacked the former president of the Medical Research Council, Dr Malegapuru Makgoba, and other scientists.

These worrying developments and the constant barrage of misinformation to ANC branches on HIV-related issues - including the lies that nevirapine is not registered in Germany and not used for mother-to-child transmission prevention in the US - are a serious threat to the effectiveness of independent institutions, public interest and, ultimately, democracy.

It is regrettable that the slowness of resolving the nevirapine and mother-to-child transmission prevention debacles has obscured Boehringer Ingleheim's role. The drug company has been able to use its donation of nevirapine for mother-to-child transmission prevention to score a public relations success. But what is really needed is for it to grant non-exclusive licences to generic manufacturers so that the price of nevirapine for the purpose of treatment (as opposed to prevention) can be massively reduced.

Bureaucratic bungling and malicious efforts to block antiretroviral treatment have taken the focus off drug company profiteering and patent abuse, which are among the fundamental causes of lack of access to treatment.

If the Medicines Control Council wishes to demonstrate its independence and concern for the public interest, in particular the safety, efficacy and quality of medicines, it should release all the information and reports at its disposal on nevirapine.

TAC lawyers have constantly appealed to the council to allow us to make representations and to gain access to all their information. At best, they have given half-hearted acknowledgments of our requests. We ask: "What are they hiding or what information do they pretend to have?"

Any attempt to change the registration status of the drug without clear, scientifically verified information will undermine the MCC. Should it suspend registration of or deregister nevirapine for mother-to-child transmission prevention without sufficient reason, the TAC will take legal action to ensure that more unnecessary HIV transmissions and deaths do not occur.

Achmat is the chairman of the Treatment Action Campaign

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