Meds and you

16 November 2009

No SA rules on cure-alls

With regulation virtually non-existent, South Africans are exposed to dangerous alternative health products marketed under unsubstantiated claims. We investigated.

You may have heard people talking or read on the internet about some new supplement that cures just about everything. And, thinking that, since it is “natural” it must be safe, you may well decide to try it out.

Rather than boosting your health, many of these complementary and alternative medicines may in fact be doing harm to your body. And due to the regulatory vacuum in South Africa, there would have been no way, apart from doing your own research, for you to know this.

In the United States, by contrast, what may or may not be sold, and with what label and advertising claims is carefully regulated. In fact, companies can be fined millions of dollars for making misleading claims. By comparison, South Africa has been described as a free-for-all.

The silver that can turn you blue
One of the many examples is the way colloidal silver is being marketed in South Africa.

According to the August 2007 edition of the Harvard Health Letter, “there’s no proof that taking colloidal silver by mouth has any benefits. As for harm, brain and nerve damage from silver exposure is rare, but colloidal silver can cause kidney damage, stomach distress, and headaches.”

And according to the US Food and Drug Administration, “the indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discolouration of the skin and deep tissues.”

Despite these authoritative claims, the local website claims that, “it has been proven effective against over 650 different infectious diseases,” and that, “medical tests indicate no known adverse effects.”

And according to, ““eCS (Electro Colloidal Silver) is 100% safe, non-toxic, non addictive and has no known side effects.”

Since information about the possible adverse effects of colloidal silver is freely available on the internet, it is hard to believe that the authors of the material on and are unaware of these risks.

It is much more likely that they are intentionally misrepresenting the safety profile of colloidal silver, something which may well have resulted in a hefty fine in a healthier regulatory environment.

Why not in SA?
The Medicines Control Council (MCC) of South Africa is responsible for the regulation of medicinal products, and as such are responsible for keeping dangerous and untested medicinal products off the local market.

Yet, they seem not to be taking the regulation of alternative medicines very seriously.

The Democratic Alliance alleges that, “in relation to alternative medicines, the MCC has almost completely ignored its responsibilities. … there are several avenues available to it to respond to misleading or false claims. The Medicines Act, for example, specifically prohibits the sale of any product as a medicine unless clear specifications are met, including meeting safety and efficacy standards. Yet contraventions of this law happen every day, with apparently little action.”

This notion is confirmed by the experiences of Dr Harris Steinman who is still waiting for a reply from the MCC to letters sent three years ago.

Turning to the ASA
In the absence of action from the MCC, concerns over misleading advertising are being taken to the Advertising Authority of South Africa (ASA).

Apart from ordering changes to the wording of advertisements, there is very little that the ASA can do. They can, for example, not order a product to be taken off the market and neither can they impose fines.

Furthermore, suspicious claims are only scrutinised once someone lodges a complaint, and even then, the ASA lacks the resources to do a proper analysis of the science. According to Steinman, all that it takes is for a company to convince one “expert,” through financial insentives or otherwise, to back up their claims and the ASA may be swayed.

There are some successes though: Following a complaint to the ASA, earlier this month a juice manufacturer withdrew unsubstantiated claims that their hoodia-containing juice could act as an appetite suppressant.

Regulating yourself?
In June 2006 the Health Products Association of South Africa (HPA) launched a self-regulatory programme with the stated aim of excluding manufacturers who are destroying the industry by means of unethical behaviour.

This is however not an ideal solution since a regulatory authority run by the people who it is intended to regulate would necessarily be exposed to vested interests.

The DA alleges that, “members of the organisation (HPA) include Glomail and many of the other companies that have been complained about to the ASA, and the newly established self-monitoring advertising advisory committee of the HPA appears to have done virtually nothing to take action against major offenders.”

The HPA however asserts that they are satisfied that their Self Monitoring Technical Committee(SMTC) “is playing a role in the control of irresponsible and misleading advertisements and the control of safe substances.”

“We have engaged with many companies and in general we have had an excellent response. The companies have changed their advertising material and have indicated their support of the process. … We believe that our activities in the SMTC are providing a valuable service to the public of South Africa while we await the introduction of Regulations for Complementary Medicine,” Dr Alan Tomlinson, chairman of the HPA, told Health24.

He also said that the HPA have long campaigned for an appropriate regulatory structure for Complementary Medicine.

There are an estimated 20 000 alternative health products available in South Africa and the market is valued at about R1.8 billion.

New regulations
Draft legislation to regulate the complementary and alternative medicines market in South Africa were announced in July 2004, but there has been hardly any progress since then.

In fact, as far back as September 2004 the registrar of medicine is quoted as saying, "The long-awaited regulations to control the availability and safety of complementary and African traditional medicines have been published for comment, and are likely to come into force before the end of the year (2004)."

Extreme delays such as these have caused the Democratic Alliance to accuse the government of dragging its feet.

In response to such allegations, the department of health in July released a statement saying that, “the draft regulations are now being reviewed taking into consideration the comments that have been received. They will soon be considered by the legal unit of the Department of Health before being submitted to the Minister of Health.”

The department also said that a “complementary medicine committee has been established within the Medicine Control Council and it is currently developing guidelines for registration and regulation of complementary medicines.”

No set deadlines have been provided though.

Lingering doubts
According to Dr Steinman it is unlikely that new regulations will be in place any time soon.

He suggests that the controversial appointment of the sociologist Herbert Vilakazi as chairman of the Presidential Council on Traditional Medicine indicates a lack of commitment to an independent regulatory authority.

Vilakazi was actively involved in the promotion of the untested “Aids cure” called 'Ubhejane'. According to media reports, Vilakazi was party to claims that research conducted at the University of Kwazulu-Natal supported the notion that Ubhejane can cure HIV/Aids. The claims were refuted by the university.

The former deputy minister of health, Nozizwe Madlala-Routledge, has also described Vilakazi’s appointment as a mistake.

A free-for-all
Vilakazi’s appointment and the general lack of urgency regarding the establishment of an active and independent regulatory framework have been linked with the government and the department of health’s apparent rejection of mainstream science.

The UN associated news service, PlusNews, quotes the Science and Governance' director of the AIDS and Society Research Unit at the University of Cape Town, Professor Nicoli Nattrass, as warning that "the most pernicious legacy of President Mbeki's dissident stance on AIDS has been the erosion of the authority of science and of scientific regulation of medicine in South Africa."

"Once science is discarded as the best yard-stick of efficacy, patients are at the mercy of charlatans selling unproven substances. Responsible governments should not place them in this position – especially in this age of AIDS when so many people's lives are at stake," Nattrass is quoted as writing. – (Marcus Low, Health24)

Harvard Health Letter -
FDA talk paper on colloidal silver- and were both accessed on August 31, 2007.

Department of Health press releases and DA documents on the regulation of alternative medicines.

Read more:
Hoodia claim withdrawn
DA – bogus meds flooding SA

September 2007


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