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Seven fat years

Sunday February 22 2009 marked the seventh anniversary of the well-intentioned but ultimately misguided call-up of medicines frequently referred to as complementary medicines. Officially the call-up ended on August 22 2002, but the Medicines Regulatory Affairs Cluster of the Department of Health continues to accept documentation for these products. The Medicines Control Council (MCC) seems to have turned a blind eye to this practice, even though it -– and not the Medicines Regulatory Affairs Cluster, carries the statutory responsibility for ensuring that all medicines meet acceptable standards of quality, safety and efficacy.

In a nutshell what this means dear reader, is that

    not one

of the unregistered complementary medicines that you may so trustingly have spent your hard-earned disposable income on has been independently validated in South Africa to ensure that what is said/claimed to be in that medicine, is actually in that medicine. For the last seven years at least. Or perhaps longer.

Seven fat years for the manufacturers, distributors and sellers of these products.

Whether the products work or not, whether they are safe or not, is irrelevant when the ingredients of the products are not scientifically validated. Next time you buy a product that does not have an MCC registration number in terms of Act 101 of 1965, you should be aware that you cannot be sure that any independent testing of that product has ever been done or is presently being done. You may be buying a product that contains certain active ingredients in unknown amounts. You may be buying a product that contains no active ingredients at all. You may be buying a product that possibly contains heavy metal toxins or other poisonous components. But this is seemingly your choice and your right. (Unfortunately, as you are not provided with all the information to make a fully informed choice, it is a somewhat flawed right.)

However, the MCC does not have the choice nor the right to allow such medications to be made freely available to the public of South Africa. It is their statutory duty to assess the data provided by the manufacturers, distributors and sellers. These data are mostly unavailable, insufficient or inappropriate for assessing whether complementary medicines (so-called dietary supplements, etc.) are quality controlled, effective or safe. It’s the proverbial catch-22 situation. The MCC is responsible for assessing the data. The manufacturers are responsible for providing the data to be assessed. The manufacturers claim that they cannot afford to pay for adequate scientific testing of their products (despite the explosion in the industry to an estimated R4-billion a year). In the end, no data are submitted to the MCC. The MCC does not make a decision. The industry continues to market their products without any controls.

The attempts in 2004 and 2008 to introduce regulations to the Act that would control complementary medicines have so far been quite inadequate. The 2004 regulations were not accepted after vigorous opposition by the complementary medicines industry. They found them too restrictive. It would not serve them to have to actually prove that their products were of satisfactory quality, effectiveness and safety. The 2008 regulations are still in limbo, but do not even include a reasonable definition of complementary medicines that is substantively different from prescription or conventional medicines. It’s frankly a mess.

If this is all a bit confusing, let me re-state it in simple terms: you, the consumer, have been ripped off by a R4-billion a year industry over the past seven years that cares nothing for you, and everything for its profits. Do not be misled by the “natural” jargon. The marketers are not naturally or sympathetically inclined to your health problems. They are only in it for their profits. The profit that comes from your money. The irony of their accusations against the conventional pharmaceutical industry only being interested in protecting their markets and their profits is breathtaking.

The MCC has failed in its statutory obligation to ensure that the availability of any medicine is in the public interest in terms of its quality, safety and therapeutic effectiveness. The public is consequently at risk of poor quality, unsafe and ineffective medicines as far as unregistered complementary medicines are concerned.

Disclaimer: Although Prof Jobson was formerly a member of the MCC, this is written in his personal capacity.

Author

  • Roy Jobson is a specialist medical doctor in clinical pharmacology. He is employed as a specialist clinical pharmacologist at the Dr George Mukhari Academic Hospital / Associate Professor of Pharmacology at the Sefako Makgatho Health Sciences University. He is a Council member of the Allied Health Professions Council of South Africa. In his non-medical life, he is a vicarious observer of South African society through his association with the Khulumani Support Group, where his wife is the director. He has done extensive research in the last few years on the advertising and marketing of medicines in South Africa - with an emphasis on complementary medicines.

21 Comments

  1. Lyndall Beddy Lyndall Beddy 7 March 2009

    Never mind that when pharmacies got together to try and get cheaper drugs to the public, the Competitions Board threatened them with legal action for forming a cartel.

    As they did when a group got together, which could have halved the price of bottled gas – also threatened by the Competitions Board.

    It does not strike anyone that “cartels” done openly,if there was a method of legalising them, to reduce prices, would be a GOOD thing!

  2. Roy Roy 7 March 2009

    Clarification: it could be claimed that products imported from other countries *have* been independently validated for their contents. The issue is that this is not being done *in* South Africa and the results submitted to the Regulatory Authorities here. Unfortunately, even if they were submitted, it seems that the infrastructure and resources of the Regulators could not deal with this additional information.

  3. john Bond john Bond 9 March 2009

    Thought provoking and well articulated piece Prof Jobson – Thanks

    Surely we already have effective legislation for conventional medicine, let’s just apply that to Complimentary medications, crystals, magnets, feathers, dream catchers and medicinal herbs. Either a product works and can be verified by trials or it doesn’t and all the user experiences is the placebo effect.

    As you also point out, added to efficacy is the quality issue. Six years ago, a doctor in Gauteng found a patients suffering from Mercury Poisoning. The mercury was eventually traced to her Spirulina tablets. Spirulina has an affinity for heavy metals and absorbes them easily. This product had been grown on an old tanner’s pond in the Cape.

    Then there is outright danger. For years, I took Comfry for a variety of ailments. I later discovered that the dealer selling me the Comfry was aware that it had been banned in the EU, UK and the US because of its toxicity. It was band in South Africa shortly after that.

    And these Alternative villains tell us how dishonest doctors are…

    The old South African (Roman Dutch) rule applies when dealing with alternative health – LET THE BUYER BEWARE –

  4. Foom Foom 9 March 2009

    ‘It does not strike anyone that “cartels” done openly,if there was a method of legalising them, to reduce prices, would be a GOOD thing!’

    …that’s because Cartel’s exist to keep prices artificially high, distorting the free market’s tendency to drive things to their ‘natural’ price. IE, cartel’s don’t reduce prices. They have no incentive to do so.

  5. roy roy 9 March 2009

    subscribe comments

  6. Lyndall Beddy Lyndall Beddy 9 March 2009

    John Bond

    Comfy is a very strong herb and should only be applied externally – for healing wounds.

    Foom

    Cartels trying to keep prices DOWN are also stopped – no discrimination at all. When we had the energy crisis all the gas suppliers got together to keep prices down by agreeing a price and not to compete – which would have HALVED the price of gas to the poor. The Competitions Board threatened them with legal action and broke up the cartel.

    The same thing happened when pharmacies tried to get together to keep DOWN the price of medicines.

  7. Chris Chris 9 March 2009

    But isn’t the definition of ‘complementary’ (aka ‘alternative’) medicine precisely that it hasn’t been tested and validated for efficacy? When it has been confirmed effective, doesn’t the label simply change to ‘medicine’ (aka ‘mainstream’)?

  8. Muffy Koch Muffy Koch 9 March 2009

    Bravo! We need to hear this.

  9. Perry Curling-Hope Perry Curling-Hope 9 March 2009

    We do not require further legislation.

    There is no such thing as a ‘complementary medicine’
    It hence demands no separate consideration in terms of law and further tedious, costly, wasteful lawmaking and administration which must be thrust upon society at our general expense and potential infringement upon civil liberty.

    Either something is a medicine or it is not.
    Medicines must be submitted to the registrar for registration as such in terms of the Medicines and Related Substances Control Act 101 of 1965 with amendments.

    Otherwise it may not be sold as a medicine and is a foodstuff, whatever the sellers’ claims may be about its alternative, complimentary or holistic ‘medicinal’ or ‘therapeutic’ properties. Such claims are expressly prohibited in terms of Subsection 20 of the act.

    Supplements are foodstuffs, period.
    They are already regulated in terms of The Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) and The Health Act, 1977 (Act 63 of 1977) with amendments.

    Making more laws does not produce more ‘protection’ especially if the are already failing to effectively administer the thousands of laws already in existence and at their disposal to effect such protection.

  10. Winkie Winkie 9 March 2009

    Comfy? What a pity, I rather liked my comfy.
    One thing Prof Seftel says I subscribe to: all medicines are just poisons which happen to have a beneficial side-effect.
    Occasionally, irresponsibly used complementary medicines may have some less-than-happy results. Comfrey is useful topically, not orally – and by the way, it has only been banned ORALLY in the UK, Germany and a couple of other places. It is sensible to do your research on ANY substance which lays claim to therapeutic effects.
    GPs hand out antidepressants like sweeties, and patients meekly comply, not even asking simple questions about side effects. Drugs are prescribed for off-label uses (see http://www.alternet.org/story/124266/ for one interesting story), for which the evidence is lacking, is indeed usually as anecdotal as any for complementary meds, and patients utter not a murmur.
    Yes, let’s have regulation of all therapeutic agents – but for heaven’s sake, don’t talk about people being “ripped off by a R4 billion a year industry”. Instead, let’s talk about how to make people responsible users of all therapeutic agents – and how to rein in Big Pharma’s more irresponsible marketing, to promote R&D into orphan diseases, and to make effective treatment, whether allo or not, accessible to everyone.

  11. Roy Roy 9 March 2009

    @Perry
    In the Matthias Rath judgment last year it was clearly stated by the judge that any so-called supplements which make any kind of medicinal claim are *not* foodstuffs. Most “supplements” make unsubstantiated medicinal claims and are therefore medicines and not foodstuffs. Check out the definition of a medicine in Act 101 of 1965 to see the extent to which it specifies the “purported uses” of substances.

    @Winkie
    The whole point of this blog was the quality of the products. If the quality has not been guaranteed through independent Regulatory validation in South Africa, it is not feasible to “make people responsible users” of such products. Because no one knows for sure what’s in them, least of all the “ripped off” consumer.

  12. Terryh Terryh 10 March 2009

    In conferring Pope-like infallibility on Statutory Regulatory bodies such as the FDA/MHRA/MCCm, you open yourself up to accusations of cultish unquestioning idolatry. Regulated medicines from big Pharma have, to put it mildly, been subject to much negative publicity with regard to concealing side effects, faking research and ghost writing of endorsements. Many of these side effects have been disabling or fatal and drugs have only been recalled well after first reports of adverse drug reactions have come to light. The patients are unlikely to succeed in suing big Pharma because the legal concept of pre-emption, which indemnifies the drug company from litigation once FDA approved of the drug and wording of package leaflet.

    Pharmacists have become the unwitting zombie foot soldiers of allopathic Pharma and are now subject to disciplinary action should they sell unregistered medicines. This means that a pharmacist must refuse to dispense a prescription for Probiotics like Lp229v, most vitamins, homeopathic and herbal formulae, even when prescribed by specialists. This, despite the medical aids being happy to pay for them and the MRA/MCC unwillingness to regulate or engage with the complimentary or traditional medicine industry.

    There are many doctors now engaged in the “Wellness” craze sweeping the world, prescribing and dispensing CAM’s to grateful and happy patients.

  13. Lyndall Beddy Lyndall Beddy 10 March 2009

    Rhubarb and potatoes are food.

    I would not suggest you eat the leaves!

  14. Perry Curling-Hope Perry Curling-Hope 10 March 2009

    Roy,

    The legal merits of wrangling surrounding the activities of Mattias Rath were obfuscated by official AIDS denial and obstructive posturing by the health ministry.

    Rath’s Vita Cell was registered as a foodstuff, but contained a schedule 2 substance, (N-aceylesteine) which rendered it liable for registration as a medicine in South Africa.

    It was therefore a foodstuff which contained a scheduled substance, which is illegal, and simultaneously an unregistered medicine, the dispensing of which is also illegal.

    To put possibly too fine a technical point upon it, ‘purported uses’ does not make a substance a medicine under the act, legal registration does.

    The judgment correctly shut down Rath’s activities on the grounds of misleading advertising pertaining to his ‘trials’ and ‘therapies’, (illegal when applied to ‘medicinal’ claims in terms of the act) and quackery.

    I have no problem with the judgment, but question the logic behind calls for further costly, burdensome and essentially unnecessary bureaucratic regulation to be imposed upon an already overregulated society.

  15. john Bond john Bond 10 March 2009

    Lyndall

    Comfrey should not be used medicinally – either internally or externally. PERIOD.

    Liver damage is common, if used internally
    Cancer has been recorded in some skin tests of on animals

  16. Lyndall Beddy Lyndall Beddy 10 March 2009

    John Bond

    “Some” tests on “some” animals does not cut it for me.

    I eat butter not marge – butter is natural (and will give me a heart attack ), and marge is artificial ( and will give me cancer, but I can’t bear the taste).

  17. Lyndall Beddy Lyndall Beddy 11 March 2009

    John Bond

    The medical and pharmaceutical professions have been trying to badmouth herbs for centuries – no money to be made.

    An excess of almost anything can cause cancer. Comfy is one of the best wound healers there is.

  18. Terryh Terryh 11 March 2009

    Lyndall: Don’t get carried away with Comfrey. It used to be a useful fodder additive until it was universally banned for use in animal feed – much like melamine in fodder and milk powder. You dont want to go there??

    Keep it sensible.

    I’m watching you!

  19. Roy Roy 12 March 2009

    @Terryh

    “conferring Pope-like infallibility” and “cultish idolatory”??? I hope you aren’t referring to me. If so, I take exception. My whole blog was critical of the MCC/MRA.

    I would like to know how you as a pharmacist, determine the quality of unregistered complementary medicines before you sell them. (You would know that the quality of registered medicines will have been assessed during the process of registration, and the manufacturers are obliged to maintain that quality for the medicine to remain registered.)

    @Perry
    I’d refer you to paragraphs 45, 57 and 96 of Judge Zondi’s judgment. Only the issue of “registrability” was related to the Schedule 2 substance. In paragraphs 45 and 57, the Rath product was declared a medicine and not a foodstuff. Para 96 concludes “A substance which falls within the definition of ‘medicine’ cannot be classified as foodstuff in terms of the Foodstuffs Act.”

    As for “further costly, burdensome and essentially unnecessary bureaucratic regulation” — this is not the issue. We only have to *implement* the *existing* Medicines Act. I am astounded by the implication of your description of this as “unnecessary” — do you really think it’s OK to sell products where the quality has not been, and is not being independently validated? The Complementary medicines (including so-called food supplements making medicinal claims) industry is having a field day. No-one’s checking up on them at all. They’re free to sell products containing “nothing”, they’re free to sell scam products!

  20. Lyndall Beddy Lyndall Beddy 12 March 2009

    Terryn

    I said right in the beginning – external use only. They still use comfey leaves for poultices on horses legs if sprained.

  21. Pongoland Pongoland 16 May 2009

    While I agree with everything Roy says, the point that Big Pharma is no paragon of scientific virtue is equally valid. And many of the drugs they pedal are far more dangerous than homeopathic placebos.

    Misrepresenting the results of trials and bribing reputable journals to carry favourable reviews are just two of their tricks.

    This post by Ben Goldacre of the UK Guardian is essential reading. (Why is there no hyperlink function?)

    http://www.guardian.co.uk/commentisfree/2009/may/09/bad-science-medical-journals-companies

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