South African doctors are going head to head with the government over alleged unregulated clinical trials on HIV-positive South Africans using the controversial Dr Matthias Rath’s unregistered vitamins.
The South African Medical Association (Sama) has joined the Treatment Action Campaign (TAC) in suing the South African government, in the form of the minister of health and her director general, as well as the chairperson of the Medicines Control Council, the Registrar of Medicines and the Western Cape health minister. Rath and his associates are also respondents.
Sama legal adviser Marius Otto said: ”Our claim, in saying that the [respondents] are diverting attention from the real issue, is not that you cannot use vitamins. Rath is experimenting on human beings without the necessary approval being followed. He is distributing a Schedule Two medicine without it being registered.”
Sama and the TAC are asking the court to stop the Rath Foundation from conducting ”illegal clinical trials and distributing medicines in violation of the Medicines Act”, and also to prevent it ”from publishing false claims in adverts (including pamphlets and posters)”.
The TAC is also asking that, if the court finds against Rath, the judge will give the regulatory bodies a month to prove that they have enforced the ruling.
The latest court case against the government came just days before the Human Sciences Research Council released a bleak report on the local Aids pandemic.
In the second South African National HIV Prevalence, HIV Incidence, Behavioural and Communication Survey, commissioned by the Nelson Mandela Foundation, the researchers produced an estimate of HIV incidence in the country using a new blood test that can detect whether infections have occurred within the past 180 days. Incidence is the number of new infections a year, while preva-lence measures the number of existing infections at any time.
High prevalence can mean people are living longer with the virus because of access to anti-retroviral treatment; low prevalence can indicate that people are dying of Aids.
Among 15- to 24-year-olds, incidence was 3,3%, that is, three out of every 100 youngsters became infected within six months of the survey being conducted. But this hid a huge gender discrepancy. Infections among young women were eight times those of young men. The researchers found that among all 15- to 49-year-olds, new infections among women were twice that of men.
Comparison of the latest results with the first survey, which the council conducted in 2002, showed that prevalence among adults aged between 15 and 49 had risen to 16,2%, up from 15,6%. Nationally, 10,8% of South Africans older than two years had HIV, down slightly from 11,4% in 2002. This may signal that the HIV epidemic has reached a plateau, although such a conclusion can only be drawn when the next survey is done in three years’ time.
Other hints of good news included an increase in the number of people who had gone for an HIV test in the past year, more people reporting that they used condoms and the diminution of stigma.
The council’s survey raised questions about the effectiveness of and strategy behind South Africa’s HIV education and prevention campaigns.
These campaigns have failed to overcome the ”it won’t happen to me” mindset: one of the most damning findings was that more than half the people who thought they were HIV-negative were already carrying the virus. This translates into about two million people who are less likely to practise safe sex.
Another particularly distressing point is the high level of HIV infection among children, with an estimated 129 621 children aged between two and four and 214 102 aged between five and nine carrying the virus. Of the new infections identified, 3,3% were in prepubertal children between the ages of five and nine, with sexual abuse and contaminated medical treatment being the most likely causes.
At the other end of the age spectrum, the survey found high levels of HIV infection among people older than 50. In this group, men were much more likely to be infected than women — 14,2% of men aged 50 to 54 had HIV, compared to 6,4% of women.