Business boosters: The law that regulates medicines in South Africa is not enforced for complimentary and alternative medicines.
About 10 years ago “Ntombi” started taking an aloe vera juice immune booster her uncle bought from an agent. Explaining the circumstances, Ntombi said: “I’m HIV positive; there was no treatment back then.” She paused. “My uncle brought me the supplement because he was worried about my health. I was very ill at that stage.”
But she didn’t get stronger. Her condition worsened. “It didn’t help at all. In fact, I was hospitalised just days after I started taking the supplement. Doctors diagnosed me with both TB [tuberculosis] and pneumonia,” she said. She decided to stop taking the supplement.
About a year later, she started taking antiretroviral (ARV) drugs, which makes it difficult for the HI virus to replicate. “Now I don’t use anything else. I only take my ARVs. When I have a headache I just drink water.”
But Ntombi knows of several HIV-positive people who use immune booster supplements with their ARVs and she tries to dissuade them from doing so.
“I just share my experience and encourage them not to mix their medication. But it is difficult to change people. ARVs changed my life. The pills are available for free from government clinics. But these supplements you have to pay for.”
Ntombi tells people to use the money they spend on immune boosters to buy food instead.
Immune boosters are widely available and easily accessible. No prescription is needed and almost anyone can manufacture or sell immune boosters, because the law that regulates medicines in South Africa is not enforced when it comes to complementary and alternative medicines.
Immune boosters in your local pharmacy
After days of battling with flu-like symptoms, the idea of a pill that can alleviate aches and pains sounds appealing. With this in mind, I went in search of some products.
My first stop was a small pharmacy in downtown Pretoria. There, I found an entire section of tablets, capsules, drops and juices, including Ntombi’s aloe vera juice, all promising to help my body to fight the negative effects of everyday life.
Overwhelmed by the sheer number of products on offer, I asked the salesperson for guidance. She promptly pointed out her product of choice and assured me it would work. She also told me not to stop any medication I was already taking.
My next point of call was Clicks in the Rosebank Mall in Johannesburg. Once again I was confronted with endless supplies of multivitamins, relaxants and immune boosters on the open shelves.
The head of pharmacology at Rhodes University, Professor Roy Jobson, warns against immune boosters. “They are not any more effective than eating good food. Taking them does not translate into clinical improvement and there is nothing you can’t achieve through good nutrition and a healthy lifestyle.”
Jobson said that the majority of manufacturers of immune boosters did not follow the rules stipulated in the Medicines Act — for example, they were often sold without registration numbers. “The problem is that most of these products are not tested and not registered … We do not know for sure what’s in them.”
Labels are no source of truth
According to Jobson, the information pamphlets found in the packaging of these products are unreliable and are included to protect the marketer.
“It is people who are unscrupulous who are making a profit from relatively ignorant people. I say ‘relatively ignorant’ because people everywhere fall victim to these products because they think it will help them to be healthier.” Jobson said people who use immune boosters often ignore health problems that can arise because the products provide a false sense of security. “Others may even put off going to a doctor because they are trying to give the product a chance to work,” he said.
The HIV epidemic has fuelled the market for such supplements, he said. “Immune boosters were not around before HIV and Aids. It all started with HIV. Since then, everybody’s jumped on the bandwagon.”
A physician specialising in HIV, Dr Sindi van Zyl of the non-profit Anova Health Institute in Johannesburg, echoed Jobson’s sentiments and said that drug interaction was a big concern when dealing with patients on ARVs. “The real danger with these products is that we do not know what is in them. They could have adverse effects on people taking ARVs,” she said.
Based on anecdotal evidence, Van Zyl said blood tests revealed irregularities when her patients supplemented their treatment with immune boosters. “Sometimes we notice that the viral load [an indication of how much HIV is in someone’s blood] is not suppressed. Over time, we have learned to ask the right questions.”
Van Zyl said that, because of the counselling HIV-positive people received, most of her patients sought professional advice before taking immune boosters.
Immune boosters slip through the legislative cracks
Although complementary drugs are also subject to the Medicines Control Council’s (MCC) standards of quality, safety and efficacy, no one ensures that alternative medicine manufacturers adhere to them. In 2011, draft regulations on complementary drugs were published for public comment but the regulations have yet to be promulgated.
In a 2009 open letter to the council, “concerned academics and others” argued that the 2002 call on manufacturers of alternative medicines to register their products with the MCC “for the purposes of auditing the complementary medicines market over six months” was ineffective because no one regulated the process properly.
The letter stated: “In our view, the advertising claims of any medicine which has been submitted in terms of the 2002 call-up can be considered misleading. This is on the basis that, because the quality of the product is unknown and has not been independently assessed by the MCC or any independent body, no valid claims are possible.”
Nathan Geffen, from the activist organisation Treatment Action Campaign, said there was little recourse for the consumer. Marketers had to be barred from making medicinal claims about untested products.
In the absence of closer regulation by the MCC, the Advertising Standards Authority has been bombarded with complaints about elaborate medicinal assertions.
“Many complaints against these adverts have been upheld,” Geffen said. But the system was not sufficiently effective because many adverts that were contrary to the advertising code remained unchallenged.
“The most important thing is that people must be wary of anything that says ‘immune booster’. Not all these products are deadly but they’re potentially harmful. They result in behaviour that includes not seeking the best medical care or going to healthcare facilities.”
Dr Danny Pillay, from the professional board for homeopathy, naturopathy and phytotherapy, the Allied Health Professions Council of South Africa (AHPCSA), said that the trade in unregistered medicines in the country was estimated to be about R9-billion a year.
“But this problem is not unique to South Africa. There are similar problems with the Food and Drug Administration in the United States, for example,” he said.
Pillay said consumers should read the labels on products before buying them. Phrases such as “activate your immune system” or “protect your health” were not medicinal claims. “Manufacturers get away with it because they don’t make health claims,” said Pillay.
The AHPCSA does not have jurisdiction over alternative medicines. It only regulates registered alternative health practitioners.
“The people selling these products are not practitioners or clinicians but business people. It’s an easy business. As it stands, the law allows it,” Pillay said.
Consumers should “get professional advice” and “look for clinical trials to verify claims and not ask the sales reps for advice” — they would say anything to make a sale, he said.
Notorious quacks and their potions
South Africa has a history of untested, alternative drugs that claim to cure HIV or alleviate the side effects of other medication taken by people with HIV. Most of these drugs date back to the HIV-dissident period in the late 1990s and early 2000s, during which former president Thabo Mbeki and his health minister Manto Tshabalala-Msimang publicly doubted that HIV caused Aids.
One such product is ubhejane, which was notoriously supported by Tshabalala-Msimang and several Kwazulu-Natal political leaders. Surfacing in the province in the early 2000s, ubhejane, a brownish liquid made from a “secret recipe of herbs” and sold in two-litre plastic bottles, was promoted as a cure for HIV. It was manufactured by former truck driver Zeblon Gwala, who claimed his product was registered with the Medicines Control Council (MCC). Gwala’s claims were later dismissed by the MCC and the national and provincial health departments.
Ubhejane was available in some Kwazulu-Natal pharmacies and had tragic consequences for people with HIV. Consumers were explicitly told to stop using their HIV medication and had to pay about R200 for a bottle of the concoction.
An attempt in 2006 by the Democratic Alliance to have criminal charges brought against Gwala proved futile as a Pinetown prosecutor said there was not enough evidence to prove that fraud had been committed.
Although no formal research has been conducted on the effects of ubhejane on users, several studies have shown that when HIV-infected people stop taking their antiretroviral treatment their condition deteriorates considerably.
In 2008, the Advertising Standards Authority banned the advertising of ubhejane in the absence of any proof of its efficacy.
The infamous Matthias Rath and his ‘cure’ for Aids
Another notorious quack was German doctor Matthias Rath, who maintained that vitamins could cure Aids and cancer.
Rath arrived in South Africa in 2005 and claimed to be conducting a trial on a natural supplement in Khayelitsha, Cape Town. According to Rath, participants in his trial were suffering from advanced HIV infection, but were not using antiretroviral drugs.
In 2008 the Cape High Court ruled that Rath’s “so-called studies” were illegal after the advocacy organisation Treatment Action Campaign (TAC) took Rath to task. This judgment essentially barred Rath from advertising, selling or conducting unauthorised clinical trials in South Africa.
According to the TAC, at least five research participants died during Rath’s trials in 2005.
In a research report, the organisation detailed how some family members of deceased participants were instructed to call the Rath Foundation instead of an ambulance in cases where their loved one’s condition worsened.
The Rath Foundation still claims to be active in 12 countries including the United States and France.
HIV patients are advised not to take any supplements that have not been prescribed by their doctors.