Got a cure for AIDS? Maybe you're convinced that large doses of vitamins can do the trick or that you have found the answer scores of scientists over the last 25 years could not. If you live in South Africa there is little to prevent you from packaging your "wonder product" in an old coke bottle or a fancy pill container, depending on your means, and selling it for whatever price you can get.
Pharmacies in Johannesburg's chaotic inner city stack their shelves high with immune boosters, herbal remedies and health tonics. Most items are not explicitly advertised as effective against HIV, but street hawkers outside are less shy about making such claims.
They offer products with names like "Life Extension" and "Ozone Rectal Treatment" for prices that equate to a sizeable chunk of the average South African's monthly income. Despite selling untested concoctions that make unproven claims about their effectiveness in treating AIDS, they are rarely disturbed by the authorities.
A lack of enforcement of the regulations that cover all medicines, and the delay in adopting new legislation that would focus specifically on complementary medicines, has allowed the growth of a rampant industry in untested remedies for AIDS and other serious illnesses.
According to Nathan Geffen of the AIDS lobby group, Treatment Action Campaign (TAC), the government's reluctance to crack down on the sale of untested remedies is in line with Health Minister Manto Tshabalala-Msimang's history of endorsing such products. "All of this sends a signal to people that it's open season to sell untested medicines," he said. "There's no enforcement, and even active support of quackery."
In theory, any substance purporting to treat a disease or its symptoms is covered by South Africa's Medicines Control Act and subject to a rigorous registration process that includes providing proof of properly conducted clinical trials.
In practice, labelling a medicine "complementary" appears to exempt it from this process: registration simply involves submitting a dossier listing the product's contents and the claims for its efficacy to the Medicines Control Council (MCC), the regulatory authority.
According to Alan Tomlinson, chairman of the Health Products Association of South Africa (HPA), an umbrella body for the complementary medicines industry, once the dossier has been submitted, a receipt from the MCC is sufficient to begin trading.
The MCC's registrar, Mandisa Hela, denied this, explaining that a dossier had to be evaluated first, but Andy Gray, of the University of KwaZulu-Natal's Department of Pharmacology, pointed out that none of 15,000 dossiers for complementary medicines submitted to the MCC since 2004 had received the results of their evaluation.
Gray argued that taking a dossier at face value "makes a mockery of the whole system" and in the absence of historical evidence confirming a complementary medicine's safety, it should go through the same registration process as any other medication.
Europe and Australia have taken this approach to complementary medicines but under the leadership of Tshabalala-Msimang the MCC appears determined to put alternative remedies in a separate category from conventional medicines.
In 2004, the government released draft regulations for the control of complementary and alternative medicines. According to Hela, a second draft of the regulations will be ready in November this year.
Tshabalala-Msimang referred to the draft legislation in a 2005 editorial published in The Star, a local newspaper: "We cannot transplant models designed for scientific validation of allopathic [conventional] medicine and apply it to other remedies. There is a need for creativity to come up with relevant and pragmatic models to prove safety, quality and efficacy of complementary, alternative and African traditional medicines."
Until the legislation is passed and with limited resources at its disposal, the MCC has been unable to control the mushrooming industry. "No product has been withdrawn from the market and there have been no prosecutions," said Gray, "and there's no test for what is or isn't complementary."
In response to the vacuum in regulation, the HPA has set up a self-monitoring committee. "If we see there are people in the marketplace making extravagant claims or including bad substances, we engage with them immediately and ask them to make adjustments," said Tomlinson.
The committee itself has no power to enforce compliance, but reports cases to the Advertising Standards Authority and the legal unit of the health department.
But Gray is not convinced the committee has had any impact. "All a company has to do to avoid self-regulation by the HPA is resign from the association," he said.
ARVs - no big deal
A recent World Health Organisation report noted that if South Africa is to meet its AIDS treatment goals, "It is necessary to address issues related to stigma, the fear of treatment side-effects, and quackery."
Despite what the government describes as the largest antiretroviral (ARV) treatment programme in the world, at some public health facilities there are still long waiting lists to begin treatment; at others, especially in rural areas, people do not come for treatment because they lack knowledge about ARVs or faith in their safety or efficacy.
A study conducted a year into South Africa's ARV rollout found a general lack of excitement about the drugs, and much higher levels of knowledge about alternative remedies. "We were very surprised," Dr Mickey Chopra of the Medical Research Council, one of the study's principal investigators, told IRIN/PlusNews. "Most people knew about the ARVs, but just didn't think they were a big deal."
The respondents tended to view ARV treatment as nothing new, but rather as one of many alternative therapies for HIV/AIDS, with the drawback of being more difficult to access and potentially more stigmatising.
Chopra believed the popularity of alternative remedies in South Africa stemmed in part from a belief in traditional methods and a distrust of Western medicines.
"There's an assumption that anything that's natural is safer," Gray commented. "Also, in this country a lot of faith is put in something that appears to be consistent with an African approach to healthcare."
While the manufacturers and sellers of alternative treatments have adopted aggressive marketing strategies that often exploit people's fears about ARVs, according to Chopra, the government has done little to promote the benefits of ARV treatment or reassure people of its safety.
Even worse, said the TAC's Geffen, by failing to crack down on and even supporting alternative remedies - such as Tine van der Maas's "Africa's Solution" and Dr Matthias Rath's multivitamins, both marketed as "AIDS treatments" - the government had sent out "mixed messages" about the value of ARV treatment.
"Government has recently changed its rhetoric, but the damage is done and there hasn't been enough damage control, or a concerted policy to promote ARVs and testing," Geffen said.
In a statement responding to questions about the lack of legislation on complementary medicines, the health department noted that it did not support any alternative products.
"The Minister of Health recognises the need for restructuring of the medicines registration process and appointed a ministerial task team in 2006 to investigate and advise her on the most appropriate structure, taking into consideration the unique South African situation and international models."
The task team was due to brief parliament last week, but the findings of its investigation have yet to be made public.
This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions
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