South African court bans vitamin trials for HIV/AIDS

Abstract

A South African court has ruled against German-born Matthias Rath who promoted vitamins and micronutrient compounds as a cure for AIDS and claimed that antiretroviral therapy is toxic. The judgment also took the health ministry to task. Clare Kapp reports from Cape Town. The South African Medical Association (SAMA) and Treatment Action Campaign (TAC) emerged victorious from a lengthy legal battle against a self-proclaimed vitamin guru who took advantage of health minister Manto Tshabalala-Msimang's contempt for antiretroviral (ARV) drugs to peddle his own therapies for HIV/AIDS. Cape Town's High Court ruling on June 13 effectively ordered Matthias Rath to halt his South African operations and instructed the health minister to ensure that the order was respected. TAC said the judgment “unequivocally establishes the duty of the state to enforce the scientific governance of medicines” and should serve as a warning to other promoters of untested and unregistered “treatments”. “Charlatans operate in every society, but they usually operate on the fringes. In South Africa, charlatanism has become mainstream…The Minister of Health has fostered this situation by creating the illusion that people with HIV have a reasonable choice to make between antiretrovirals versus alternative remedies”, TAC said in a statement. South Africa has the world's highest number of people living with HIV/AIDS, with around 5·4 million of its 48 million population infected. After a slow start, the country now boasts the biggest ARV programme in the world, with 450 000 people started on to therapy by the end of February. Many health professionals say that this success is despite—rather than because of—Tshabalala-Msimang. Rath started his operations in Cape Town around 2004, and forged a partnership with a prominent community group, the South African National Civic Organization. Rath claimed that ARVs are highly toxic and are pushed on an unsuspecting public by multinational drug cartels. In full-page newspaper adverts, leaflets, and at public meetings, he claimed that vitamins and micronutrient compounds cured HIV/AIDS. He found a receptive audience in poor townships where many people rely heavily on traditional healers and consult medical doctors as a last resort. Rath and his associates bragged about the success of a “clinical pilot study” to study the effect of vitamins and micronutrients on people presenting with AIDS symptoms. WHO and UNAIDS condemned Rath's activities, and South Africa's Advertising Standards Association ruled that his adverts were misleading and defamatory. But the Medicines Control Council and the health department's law enforcement unit failed to take action even after the death in October, 2005, of one of Rath's patients, who appeared with him at a press conference to publicly renounce ARVs. TAC said at least five of his patients died. In November, 2005, SAMA and TAC launched their legal action against Rath and his associates—Tshabalala-Msimang and her department's director general Thami Mseleku. Cape Town's High Court Judge Dumisani Zondi banned Rath from doing further tests. He dismissed Rath's claims that he was not doing clinical trials, saying that Rath's newspaper advertisments had declared them as such. “In my view, the Rath respondents' activity…constituted a clinical trial.…Their conduct was unlawful in that they did not have permission to run clinical trials.” The judge dismissed Rath's claims that his micronutrients were nutritional supplements and said that they fell under the Medicines Control Act. He barred Rath from promoting VitaCell—the compound distributed in South Africa—pending a review by the Medicines Control Council of its medicinal claims. The ruling also ordered the department of health to “take reasonable measures” to investigate Rath and to prevent him from doing unauthorised clinical trials and advertising the medicinal effects of VitaCell on people with HIV/AIDS. Judge Zondi said Rath and his associates should pay 90% of the costs and Tshabalala-Msimang and Mseleku 10%. The department of health said it would not appeal the ruling. Even before the judgment, Rath's Cape Town operations had fizzled out. But on his website he remained unrepentant. “The purpose of this legal attack by two ARV promoting organisations is to discredit life-saving vitamins as unwanted competition to the multi-billion business with toxic ARV drugs.”