Roy Jobson
Roy Jobson

The Medicines Control Council and a decade of deliberate deception

The South African Association for Responsible Health Information and Advertising (ARHIA) – of which I am a founding member – has called on the Medicines Control Council (MCC) to remedy the untenable situation in which over 155 000 medicines on the market have not had quality tests verified by the MCC. This creates a serious public health risk (in the words of the Department of Health), and if anything is being done, it is too little, too late.

This information has also been made available on the TAC’s Quackdown website and Dr Harris Steinman’s CAMcheck website.

The Decade
Wednesday, February 22 2012 marks the tenth anniversary of the call-up of “medicines frequently referred to as complementary medicines”. This “call-up” initiated by the Medicines Control Council (MCC) ten years ago was intended to be an audit of the complementary medicines market over a six-month period, but its unintended consequences have resulted in a ten-year deluge of dubious and unproven products to the detriment of people living in South Africa.

The Deception
The Minister of Health stated in a written answer to a parliamentary question dated October 29 2010 that “approximately 155 000 submissions for complementary medicines have been received since the publication of the call up notice of February 2002″ and “[n]one of these complementary medicines were evaluated for safety, quality and efficacy as the process, procedures and guidelines are not yet in place.” [1]

What this means is that for ten years people making and marketing complementary medicines have done so with relative impunity, profiting off all in South Africa who have been convinced that they should use these products to improve their health and quality of life.

On his website pharmacist and advocate René Doms defines deception in the context of medicines as: “… a representation, omission or practice that is likely to mislead the consumer [who is] acting reasonably in the circumstances, to the consumer’s detriment.”

How the deception is deliberate
Using this definition, many of the 155 000+ medicines misrepresent themselves as being legitimate products through mimicking the formulations (tablets, capsules, creams and gels), packaging, package inserts and patient information leaflets of registered medicines. Some makers and marketers even misrepresent themselves as being “holders of certificates of registration” in their package inserts. Others claim to be “registered” by falsely referring to an MCC acknowledgment of receipt number as a registration number. This misleads consumers into “acting reasonably in the circumstances” and buying products which may not contain what they claim to contain, may not be safe and may not work. This deception does not only mislead consumers. Pharmacists, health store owners, supermarkets and “consumers-selling-to-consumers” have all been misled and deceived by these practices. Only pharmacists can be held accountable however because they are directly responsible, in terms of the Pharmacy Act, Good Pharmacy Practice and their Code of Conduct, for selling only products for which they can in effect guarantee the “quality, safety and efficacy”.

For registered medicines, the guarantee comes from the MCC. But for unregistered medicines where there is no such guarantee from the MCC, pharmacists have to personally make the decisions as to what to sell based only on information provided by the manufacturers of the products. The Department of Health itself has previously stated: “Complementary medicines are currently not well regulated and this poses a serious public health risk.”[2] This means that the Department of Health is well aware of this serious public health risk but has not yet reduced the risk. In our view the state is obligated, both by Section 39 of the Medicines Act, which “binds the state” to the Act, and by Section 12(2) of the South African Constitution which says that everyone has the right to bodily and psychological integrity, to remedy this risk without further delay.

The Minister of Health stated in 2010 that the “process, procedures and guidelines” were not yet in place to regulate these medicines. But they could have been adequately and appropriately regulated using the procedures and guidelines that have been in place since the May 2003 amendment of the Medicines Act and its Regulations. The Department of Health needed to allocate further resources to implementing this task. However what was then manageable has now become a gargantuan task which will require much greater effort and resources.

As no definitive changes to incorporate complementary medicines into the 2003 amendment of the Medicines Act were made just over one year after the complementary medicines call-up, it could be argued that, at that time, the regulators did not perceive a need to have separate legislation to deal with complementary medicines. And indeed there has been no prohibition for any complementary medicine to apply for registration based on its use and its claims. The manufacturers and marketers of these medicines have been at liberty all along to provide the evidence needed to prove the quality, safety and therapeutic efficacy of their products for the purposes of registration. We believe that for the majority of these 155 000 medicines the evidence cannot be provided, and concur with the Department of Health that unregistered products presently pose a serious public health risk to those who live in South Africa.

In many ways the Advertising Standards Authority of South Africa (ASA) has had to act as an informal surrogate medicines regulatory authority as far as ruling against false or misleading claims is concerned. Some of these medicines have as a result disappeared off the market even though the ASA does not have the authority to have products removed from the market. Unfortunately, various role players have recently started challenging the decisions of the ASA, and some media do not adhere to the ASA’s rulings.

ARHIA calls on the MCC, the Minister of Health, the Pharmacy Council, the Allied Health Professions Council and the Director General of Health to collaborate in remedying this situation as soon as possible. We note that draft complementary medicines regulations were published for comment in 2011, and although they clarify to some extent how these substances might be controlled, they are silent on implementation and a time frame for their implementation. We also note that the Minister of Health stated that there is no intention to introduce any grandfather clause with regard to the registration of any medicines.

The effect of the 2002 call-up has been to undermine the scientific governance of medicines. It is time to act and not allow another decade of deception and inertia pass.

Additional Notes

  • ARHIA is a voluntary association of individuals who have agreed to the objectives of the association as stated on its website.
  • The Complementary Medicines call up was gazetted in Notice No R204, Regulation GazetteNo 7282, Gazette No 23128, Date 20020222.
  • The quality of a medicines means that it contains only what is stated on the label and nothing else. Many complementary medicines have been shown to not contain what they claim to contain (e.g. hoodia is absent from some products tested); or contain adulterants (e.g. Simply Slim contained a Schedule 5 medicine, sibutramine); or may contain toxic heavy metals such as lead or arsenic (e.g. a product claiming to enhance stem cell production contains arsenic); or may be contaminated with micro-organisms such as E. coli, which can cause diarrhoea.
  • The safety of a medicine is usually proven in laboratory tests, cell lines, animal models and systematic controlled exposure of scientifically determined doses firstly in healthy human volunteers and then in humans with the particular conditions for which the medicine is intended to be used. Manufacturers and marketers are required to monitor the safety of a medicine after registration. This makes it possible to “de-register” a medicine if it proves unsafe when larger numbers of people are exposed to it (e.g. Vioxx®). There is no systematic monitoring in South Africa of the safety of complementary medicines and this is a major shortcoming and consequence of inadequate regulation.
  • The therapeutic efficacy of a medicine means that it actually does what it’s claimed to do.
  • Regulators are required to determine the the harms-benefits profiles of medicines and only register those medicines in which the benefits clearly outweigh any potential harms. Complementary medicines are no different, and only those where the benefits clearly outweigh any harms should be available to the public. It must be noted that a medicine which “does nothing” can cause various kinds of harm – including delays in the diagnosis and treatment of serious diseases; a worsened prognosis due to delays; and financial harm; among others.

Footnotes

  1. Question 3057, Internal Question Paper No 34, 29 October 2010.  
  2. Department of Health Strategic Plan 2009/10-2011/12, page 18.

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    • http://www.cindynel.co.za peter

      We all should be fully aware that the big drug companies are not interested in healing. They are profit motivated entirely and market drugs on an ongoing basis in order to create profits for the shareholders. This has nothing to do with the effectiveness or otherwise of the drug concerned. It is widely accepted that there are many doctors who are paid handsomely in order to market drugs that are not approved. It is sad that something called money can annihilate all morality and good sense.

    • IMPEDIMENTA

      “Gargantuan task” clearly describes what is ahead of the MCC if it is to regulate complimentary medicines.

      If many of these remedies are for all intents and purposes harmless (e.g. potentised homeopathic remedies that are 10 million dilutions of the original material), can they not be quickly eliminated from the list?

      Maybe a label that states “Health claims and safety have not been verified by national standards bodies. Use at your own risk.” would deal with a whole lot more.

      Sometimes it is just easier to do nothing. Consumers beware and exercise common sense.

    • Zach de Beer

      My guess is, that this is not such much a health risk as just a waste of money. What about all the “supplements” that you find at Dischem. It is a joke, I have family members that spend a small fortune on all sorts of quack potions packaged by Dischem.

      It is the white’s man’s version of traditional medicine. An when will traditional medicine be regulated lol?

    • MLH

      I once went to a neurologist who warned me off the joint supplement I was taking by telling me he had a patient dying in the same hospital because he had been taking it. I learnt a hard lesson about the Internet: you may be able to find the answer to any question there, but be extremely wary of any and all promotional websites. Always remember that the information people put up about their own products has not been vetted.

    • Anthony

      If one considers that properly prescribed pharma drugs are the official 4th leading cause of death in western countries, where prescribing standards are highest, one wonders where all the fuss about a few supplements comes from suddenly. I am not aware of any deaths in SA over the last 20 years from nutritional products or western herbal products. These are in most cases generally regarded as safe elsewhere. If Jobson could point out the dead bodies of those who died from use of nutritional supplements or western herbal products consumed in SA I’d be most pleased.

      On the other hand, Jobson and his allies in the new natural health bashing lobby fail to lobby or raise awareness against the real quacks in the natural health industry, namely the purveyors of homoeopathic products, flower remedies, tissue salts and some African Traditional Medicines, of which the latter kill +/- 20,000 people per year and the former are nothing more than expensive placebo’s offering zero health giving properties or treatment above taking nothing at all. Why are the two worst offending modalities among Natural Health products being blatantly swept under the carpet by Roy and others?

      Is it because pharmacists will loose too many homoeopathic sales which make a large percentage of their income stream, or because highlighting the high risk of African Traditional Medicines is too hot a political potato? Why the blatant double standards?

    • Karney

      As a health care professional I always ask patients what other over the counter meds they take. I am surprised sometimes at what patients are prepared to pay for these supplements etc but baulk at paying a smaller amount for a prescription drug. Patients need to be aware of drug interactions. I knew of a man who died after taking St Johns Wort with an anti depressant ; wonder how many peolple know of this potential and well recognized danger.

    • HEAD LITE

      Forgive me for my lack of civility sir Roy but you have raised my individual ire. You admonish the complimentary health industry, calling out a complicit deception and advocate rather for that old & trusted pharmaceutical industry, renowned indeed for its high standards of both social responsibility & moral accountability. Well by this measure of normative integrity no single pharmacological compound with possible side effects would or should even exist! For the regulated inner pamphlet that you so highly proclaim (with its list of possible medical complications & physiological side effects) does not in fact espouse moral or social responsibility but rather a finely worded legal impunity.
      It is common knowledge that such literature is not there to protect the consumer but to protect the manufacturer from possible litigation. In fact it can be compared to the fine print in a rental agreement that forces the tenant to swallow a bitter pill should he wish to continue doing business. Furthermore, the typical patient always ingests such apothecary in good faith & assumes that those advocating a pharmacological solution would have the decency to “verbally” forewarn them of impending dangers – when this is patently not the case for practical & monetary reasons.
      No Roy! Your professionally biased argument would have us schedule vitamin C; would proscribe sickness & monopolise wellness, would (in draconian fashion) de-democratise one’s constitutional right to self-healing &…

    • HEAD LITE

      & replace it with a limited range of choices offered by overly wealthy drug companies who care nothing for people but only for profits.
      If you are so incensed why not sue Coke for not “adding life” or the Swiss derivative that funds your council and given the fact that diabetes & related heart diseases are fast becoming the number 1 natural killer of South Africans why not advocate for a scheduling of all food products containing sugar; or food products with so-called added vitamins. In fact, why not insist on registering the milk you consume; after all, it contains unspecified amounts calcium
      It is common knowledge that complimentary medicines (per se) have not accounted for a single known death directly, that their evident danger lies in when they are used together with chronic pharmacological medications & that broadly trusted natural health brands all require one to consult medically when such interactions occur.
      You would make destitute & kill a generally beneficial industry that provides both hope and health, not to mention the livelihoods of hundreds of thousands of people. Furthermore you require a natural vitamin or food derived complimentary medicine to undergo the exact same procedure of laboratory testing & registration required of an unnatural, synthesized and chemically modified compound. Why? To ensure that only historical or politic funding drug companies with unlimited funds dispense?

      Countless physicians & doctors now embrace complimentary health…

    • HEAD LITE

      Countless physicians & doctors now embrace complimentary health treatments as a useful tool for not only treating sickness but fostering wellness. Such practitioners are the vanguard of their industry & represent those that embrace new medicine & a new & democratised society.

      Hopefully, there are enough of them to balance the underlying $ based bias offered by you.

    • Louis Sweidan

      HEADLITE “Countless physicians & doctors now embrace complimentary health treatments as a useful tool for not only treating sickness but fostering wellness. Such practitioners are the vanguard of their industry & represent those that embrace new medicine & a new & democratised society”.
      What the hell has a democratsied society got to do with medicine and healing. The above comment may be slightly plausiible if doctors didnt dispense these produicts themselves for a tidy profit and left dispensing to pharmacists.
      It is disgraceful to visit websites of some of these products to see package inserts which are made to look like the real thing and the absurd pharmcological claims they make with no clinical studies,. Their prices are every bit as expensive or even more than that of registered allopathic medicines eg thyroid treatments (from an anti aging company). Wellness hardly comes from a bottle but needs people to make voluntary behaviour changes and take actions that reduce their health risks or enhance their ability to perform (sorry for you it isn’t in the bottle) Wellness programs address physical activity, nutrition and dietary practices, stress managment, smioking cessation, safety practices and hypertension screening. You can’t pop a pill and get wellness..
      By the way natural products such as comfrey, ephedra, cascara and kava kava cause liver damage and deaths. Dont believe the tripe that they are natural and therefore safe .

    • Reggie

      In April 2010, the American Journal of Preventive Medicine published a study which proved that hospitalizations for poisoning by prescription medication (prescribed by doctors) had increased by 65 percent from 1999 to 2006. The rates of unintentional poisoning from prescription medicines in the U.S. had surpassed motor vehicle crashes as a leading cause of unintentional injury and death. The researchers concluded that Adverse Drug Reactions (ADR’s) are the fourth leading cause of death in the United States after heart disease, cancer, and stroke. The situation in South Africa isn’t that dissimilar.

      The public seems to genuinely believe that medicines advertised or prescribed by doctors are safe, despite of the plethora of side effects and contra-indications to other medicines.

      It is estimated that between 65,000 and 80,000 people die each year in SA, due to ADR’s. There is not one recorded incidence of death caused by nutritional supplements and other locally produced health products over the last decade in SA. Where a handful of deaths have been attributed to a few isolated contra indications to St. John’s Wort internationally (not in South Africa), it was the pharmaceutical drugs which were to blame, as they were prescribed after the use of the herb.

      These ad hominem attacks on complimentary medicine by Jobson and others are nothing more than the last kicks of a dying pharmaceutical market place, as people wake up and take care of their own health.

    • Robin Grant

      The pharmaceutical industry has no real interest in people being healthy. There are many complimentary medicines and foods that have healing properties, but if they can’t be patented, they will not be promoted.

      For instance, peer-reviewed research has found that a spice known as turmeric can reduce tumors by 81% naturally. Researchers found that curcumin (a derivative of turmeric) dramatically decreased brain tumors in 9 out of the 11 studies examined by 81 percent.
      Furthermore, there was no evidence of toxicity. Widely used as a spice in South Asian and Middle Eastern countries, turmeric is continually being pinpointed as an extremely potent anti-cancer solution. What’s more is the fact that turmeric is extremely inexpensive, and can be found around the globe

      What you are in fact doing is promoting the demise of this cultural knowledge that has kept humans healthy through the ages for the sake of making money.

    • Pingback: Claim that traditional medicines will be tested is churnalism not journalism | ByMelis()

    • Mavie

      Where does all of this leave Hoodia gordonii-containing products, since the Blom et al (2011) findings that they are neither safe nor efficaceous? I’m not sure that consumers have enough information upon which to base their ‘buy’ decisions with regard to Hoodia. MCC should really step in. I’m interested that the MCC now has a backlog of thousands of products for vetting – I guess Hoodia will continue to be available. It won’t kill you, but you’ll only think you’ll lose weight, but you will definitely lose money.l