Why has HIV in South Africa affected the reasoning ability of so many prominent people? asks Belinda Beresford
HIV can cause dementia, but the events of the past week have shown that it can cause mental confusion even among people apparently uninfected by the virus.
It has infected Minister of Health Manto Tshabalala-Msimang who, in an often incoherent broadcast, appeared to say that she would stand firm against a high court order that the government give nevirapine to HIV-positive pregnant women wherever feasible. It also leaped to a colleague, Minister of Justice Penuell Maduna, who suggested that since it was just a Pretoria High Court decision, it wasn’t binding on the government anywhere else in the country and then had to backtrack two days later and apologise for his remarks.
Meanwhile, half a world away, a company intent on improving its advertising campaign for a well-known drug discovered it didn’t have all its paper ducks in a row. Boehringer Ingelheim then tempora-rily withdrew from registering its drug the anti-retroviral nevirapine with the United States Food and Drug Administration (FDA).
Nevirapine given during labour can cut by up to 50% transmission of HIV from mother to child during the period surrounding birth.
With the pharmaceutical company’s move, South Africa again hit the G-spot of international attention. It came days after the circulation to some African National Congress offices of the hottest property on the journalist circuit: a 114-page document that tackles head-on the issue of HIV, Aids, and the ”Humanisation of the African”, resplendent in the name of ”Castro Hlongwane, Caravans, Cats, Geese, Foot and Mouth and Statistics”.
It is a prime example of some of the alternative, dissident, denialist, flat-Earth or plain lunatic thinking, which concludes that HIV doesn’t cause Aids, and that people aren’t really dying younger and in greater numbers than they were, say, 10 years ago.
Why has HIV in South Africa affected the reasoning ability of so many prominent people? It appears to have first struck with the Virodene escapade, when the homegrown ”cure” for HIV/Aids turned out to be useless and dangerous. Since then anti-retroviral drugs have almost become the enemy and debate on HIV/Aids in South Africa has sowed confusion, fear, animosity and prejudice.
Over the past couple of years it has become apparent that HIV has had extraordinary side effects on some people’s ability to grasp the point of the debate. They mutter impressively scientific and tongue-rolling mantras such as ”triphosphorylation” and ”cytotoxic” and recite important-sounding bits of information and research that are seriously out of date, out of step or even out of this world.
To say, as dissident Anita Allan has done, that because Judge Edwin Cameron doesn’t understand the chemistry of triphosphorylation he doesn’t understand why anti-retroviral drugs don’t work is, with all due respect, ridiculous. Judge Cameron knows that the drugs he takes regularly work simply because he’s alive. He started taking them because he was dying.
Pointing out illogicality, inaccuracy and distortion doesn’t work. Aids dissidents pounce on valid scientific queries and uncertainties to bolster a world view that says HIV, Aids and above all anti-retroviral drugs are frauds that kill people. Especially black people.
The tragedy is that real debate is being killed and issues lost in a fog of confusion, muttering in the shadows and intellectual dishonesty.
Take nevirapine, which has been registered by South Africa’s Medicines Control Council (MCC) for use against mother-to-child transmission of HIV. South Africa was the first country to register nevirapine for this use just as it was the first to register the use of a cow-blood derivative for blood transfusion into humans.
In making its decision, the MCC relied on data from a mainly Ugandan study, HIVNET 012, but has also been given information from other research.
Boehringer Ingelheim says paperwork problems have led to the withdrawal of its application, and that a team from the US-based National Institutes of Health is already correcting the problems.
The exact problems are unclear. Normally a trial as significant as HIVNET 012 would have FDA input from the beginning to ensure smooth compliance with all its notoriously tough conditions. But HIVNET was not expected to lead to an FDA registration, and so the record keeping was not maintained at the exhaustive level this would require. Different regulatory bodies have different procedures, so a drug that gets FDA approval may be rejected by European Union countries.
Scientists involved in similar research suggest there may be other procedural problems, such as failure to always get written informed consent, or alternatively in the recording of health problems, however irrelevant, presented by participants in the trial.
But if the worst-case scenario is true and that in their enthusiasm the researchers on HIVNET 012 did interpret the study in a more positive light than other scientists would have, they should be punished for any breach of ethical or scientific standards, and the consensus on nevirapine reassessed.
But the debate on whether to use nevirapine or whether its registration should be withdrawn in South Africa should be based on scientific knowledge.
Although there has been no questioning of the safety and efficacy of nevirapine, Tshabalala-Msimang promptly and publicly suggested that it did raise such issues and therefore justified the government’s lethargy in providing the drug.
Some of the world’s most respected research and health organisations have come out fighting on behalf of the drug. David McCoy of the Health Systems Trust this week pointed out that given the data on nevirapine, the question should not be why are so many people willing to leap to defend the drug, but rather why it is coming under such attack? This government’s antagonism to the drug is widely perceived, both at home and abroad, as political rather than scientific.
Nevirapine is not yet registered in the US for cutting mother-to-child transmission of HIV, but it is given to pregnant women there as part of chronic anti-retroviral therapy. HIV-positive pregnant women presenting in labour at US hospitals who have not been on such therapy are offered the one-dose regime of nevirapine alone.
No sane individual blindly trusts doctors, scientists or politicians. That is why research has to be so intensively checked and double checked. And that is why democratic countries build in checks and balances for the state as well such as independent bodies like the MCC, or the courts.
On Monday Pretoria High Court Judge Chris Botha denied the government leave to appeal against a compulsion order won by the Treatment Action Campaign (TAC) that nevirapine be supplied, where possible, to HIV-positive pregnant women pending the Constitutional Court hearing. In his judgement Judge Botha briefly referred to the government’s inferences from HIVNET 012. ”What is conspicuous is that the respondents have not produced any evidence, after almost a year of dispensing nevirapine to approximately one-tenth of the affected population, of any deleterious effects encountered in its programmes,” he said.
In a month, in a calm, quiet room, the Constitutional Court will listen to the lawyers for the government and the TAC. Some time after that, the matter will be settled. If the TAC’s winning streak continues, the government will have to accelerate the provision of nevirapine within a set time frame or give reasons why it can’t. If the TAC turns out to have won all the battles but lost the legal war, the government can continue with its pilot studies.
And in an ideal world the MCC will keep in contact with researchers working on the HIVNET data and make its own decision on nevirapine when the problems are clarified.