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Giving the right teeth to the tiger: creating an effective TGA

Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry…

Some complementary medicines fill a medical need while others are of no value whatsoever. nicholaslaughlin

Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry must have real powers to promote useful products and inform the public of the effectiveness and safety of both types.

Discussions of regulatory requirements for complementary medicines often proceed as though they are a homogenous group. They are not. Some fill a medical need while others are of no value whatsoever.

A number of supplements – such as iodine for pregnant and breastfeeding women and, vitamin B12 for pernicious anaemia sufferers and for vegetarians – are known to be efficacious and this use is endorsed by the National Health and Medical Research Council (NHMRC).

But that’s not to say that all vitamin and mineral supplements are of medical value. For healthy normal adults with no special needs, a balanced diet is the best source of vitamins and minerals.

St Johns Wort Anne Burgess

Then, there are complementary medicines that are never likely to have a scientific basis, such as homeopathic remedies. In 2010, the UK House of Commons Science and Technology Committee concluded that the principle underlying homeopathy was weak and that it should not be funded by the National Health Service.

Some herbal medicines have been investigated by reputable clinicians, but such studies are of little value without standardisation of the products. A 2009 review of St John’s Wort, for instance, concluded that the evidence for its efficacy varied according to different research trials. It concluded that “country of origin and precision with effects size complicates the interpretation”. Other influencing factors include country of origin, harvest time, method of processing, part of the plant used, and how long the harvested plant was stored before use in manufacture.

St John’s Wort contains numerous chemical components, some of which have been identified and many of which have not. It’s not known which of these components contribute to antidepresssant activity so they haven’t been tested as a mainstream medicine would be and standardisation of products is next to impossible.

What’s more, it’s highly likely that different batches of a complementary product will contain different chemicals in different ratios and have different profiles for effectiveness, adverse reactions and interactions with other medicines. To suggest, as some do, that numerous minor ingredients have subtle effects that are beyond conventional medicine to define is to indulge in witchcraft.

If the major active ingredient(s) could be identified and formulated as a standardised medicine, and safety and efficacy demonstrated in controlled studies, then St John’s Wort could make a real contribution to human medicine. The same has been done with other substances of vegetable origin, like digoxin from foxglove, morphine from poppies and and artemisinin, the life-saving drug for malaria from Chinese Sweet Wormwood, all of which became medically reliable when standardised and appropriately developed.

But the ethically dubious promotion of some complementary medicines and their extravagant claims must be restrained. So what is it that regulatory government bodies, such as the Therapeutic Goods Administration (TGA), can do about complementary products?

Regulatory options for the TGA include:

  • Publishing its own reviews of the efficacy of complementary medicines in layman’s terms. There’s already a mechanism for doing this via Medicines Talk, a part of the National Prescribing Service. More publicity and perhaps a sexier title would enhance use of this facility.
  • Monitoring advertising more rigorously. While some companies may advertise appropriately, the notorious case of Sensaslim, described by The Age as a “shonky diet nasal spray”, illustrates the depths to which advertising can fall.
  • Banning payment for items that are represented as “news” in current affairs programs.
  • Abandoning the requirement that sponsors of complementary medicines must hold data to support their claims but need not submit it to the TGA, and instead adopting a universal standard for all medicinal products. Any product that falls short of this universal standard should not be marketed, except with written TGA approval.

This fax was sent to pharmacists.

Instituting such a standard would require compliance with a set of criteria along the lines of – unless otherwise approved by TGA in writing, no medicine may:

  • contain an active ingredient that’s scheduled as prescription-only, pharmacist-only, or pharmacy-only;
  • contain a substance that’s on a list of banned substances;
  • claim efficacy for preventing or treating a serious illness, as defined by TGA;
  • recommend administration other than via oral or topical routes;
  • be manufactured at premises that are not TGA-licensed for that type of manufacture;
  • fail to comply with an applicable official standard published by TGA;
  • claim to be sterile or free of microbes;
  • fail to comply with general limits on microbial load, and the absence of defined pathogens, such as pseudomonads (this is already the case for other oral and topical medicines);
  • fail to comply with general limits on the content of heavy metals and pesticides;
  • fail to include instructions for patients on the container label or in an enclosed consumer medicines information leaflet; and
  • possibly other requirements after consideration by TGA experts.

Chinese Sweet Wormwood Ton Rulkens

The consequences for the TGA if it adopted these criteria would be:

  • a reduced commitment of resources to the existing “pretend” regulating;
  • a focus on random and targeted sampling and testing, including review of labelling;
  • a focus on review of advertising; and
  • no imprimatur for safety and efficacy of medicines that TGA hasn’t evaluated for these things (perhaps these medicines should be labelled as such).

But strong action, including publicity for recalls in the event of non-compliance, would be required to accompany such changes. The consequences of strong TGA action (even if not well handled at the time) for Pan Pharmaceuticals, which collapsed soon after a recall of a large number of products, were dire. It wouldn’t take many such events to have a salutary effect on the whole industry.

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30 Comments sorted by

  1. Doug Cotton

    IT Manager

    Here we go again citing the well worn cliché "a balanced diet is the best source of vitamins and minerals."

    What guarantee can you provide that modern agriculture does not lead to significant reductions in mineral content in the food supply, as evidence clearly indicates it does.

    And where do you get sufficient vitamin D from a "balanced diet" especially on cloudy winter days when you're probably in an office anyway?

    Are you going to include red wine in your balanced diet in order to get enough…

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    1. Stephen Prowse

      Research Advisor at Wound CRC

      In reply to Doug Cotton

      Surely this article is about basing the claims and use of complimentary medicines on evidence, not on untested assertions and anecdotes. Where people are paying for a product that purports to benefit their health, they have a reasonable expectation that there will be some benefit.It is clear that many products have no efficacy at all (except a placebo effect which can be important) and there is a place for stronger regulation that should be paid for by the industry. The establishment of NICM is a step in the right direction.
      As a consequence of modern agriculture and a balanced diet, on a population basis we are healthier and living longer than ever before. Most of our health problems are self inflicted lifestyle problem such as obesity, smoking, lack of exercise etc.

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    2. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Doug Cotton

      You may be surprised to know that people have actually done studies on the mineral and vitamins conetnet of modern foods, and that they are perfectly adequate.

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    3. Doug Cotton

      IT Manager

      In reply to Ian Musgrave

      Well you quote your evidence and I'll quote this for starters ...

      "Here are a few of the nutrients that were found in higher levels in the organic foods:

      * Chromium is a micronutrient that is low in Western diets. Its deficiency is associated with the onset of adult diabetes and atherosclerosis (hardening of the arteries). Chromium was found to be higher in organic foods by an average of 78%.

      * Selenium is one of the antioxidant nutrients that protects us from damage by environmental chemicals…

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  2. Robin Bell

    Research Academic Public Health, at University of Newcastle

    Yes, here we go again. If there is evidence supporting the use of vitamins, minerals, herbal remedies or other remedies sufficiently sound to validate the claims made on the bottle, what is the problem with a regulatory body requiring that evidence be produced and reviewed by an independent government body like the TGA prior to registration and marketing.
    All this would do is bring alternative medicines under the same scutiny as all other products generally for proof of advertising.
    At present, it is an offence to market a toaster that doesn't work as advertised, but its OK to market a herbal remedy that doesn't work. Every other medicinal product in Australia is subject atleast to that kind of scutiny. The only obvious question is, why not alternative medicines?

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    1. Doug Cotton

      IT Manager

      In reply to Robin Bell

      There is evidence such as I have posted regarding the US Government's National Eye institute's study on vitamins C and E etc - see the thread http://theconversation.edu.au/mondays-medical-myth-reading-in-dim-light-ruins-your-eyesight-3149

      You might as well say don't market red wine because it has resveratrol in it which is a nutrient available in supplements that have not yet been approved by the TGA.

      For many years the TGA prevented sales of supplements containing effective quantities of selenium, even though Australian soils are very deficient in selenium. I suggest many people died of cancer as a result.

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    2. Grendelus Malleolus

      Senior Nerd

      In reply to Doug Cotton

      The shorter Doug Cotton

      "Buy supplements, take selenium, I look young. Human induced climate change is a myth. Take selenium again"

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  3. Susan Walters

    Adjunct Associate Professor at UNSW Australia

    Yes there is one additional point I should have made. Having worked at the TGA for many years, I am well aware of the financial and political pressures that it faces. There is simply not enough money for the resources that would be necessary to evaluate complementary medicines to the same level as prescription medicines, and there never will be because of their vast numbers. TGA therefore has to take a risk management approach that commits its professional resources to the highest risk products…

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  4. Susan Walters

    Adjunct Associate Professor at UNSW Australia

    There is another point.
    It would be impossibly expensive to undertake the necessary studies of quality, safety and efficacy that would bring the standard of evidence for all complementaries up to that for prescription medicines, in either the public or private sectors. And even if you could persuade reputable scientists and clinicians to undertake such studies, it would be a waste of their time. They should focusing on remedies that have a real chance of being useful.

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    1. Doug Cotton

      IT Manager

      In reply to Susan Walters

      Your first point is indeed valid, but we don't have to do the studies in Australia. Having studied natural medicine for over 35 years, and taken dozens of capsules a day experimenting with my own body (putting my money where my mouth is - and into my mouth) I have seen numerous studies done in Australia years after very similar ones had already been published overseas. There seems to be a philosophy of distrust regarding studies done elsewhere, such as by the US Government sponsored National Eye Institute http://www.nei.nih.gov/news/statements/vitamine.asp

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    2. Robin Bell

      Research Academic Public Health, at University of Newcastle

      In reply to Susan Walters

      Accepted Susan. But at least if the evidence had to be produced prior to registration and could pass the "it exists and is some kind of evidence" test, that would avoid events like the recent sensaslim scandal.
      The selling of the worst of these products from Pharmacies implies a level of quality and elisits trust from the community independent of the imprimatur implied in the TGA listing.

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    3. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Doug Cotton

      Yes, we do need to do studies in Australia, as our populations and circumstances can be very different,

      Did you actually read that report you link to. It has now been found in several studies that high dose vitamins not only don't help in most cases, but can actually be slightly harmful.

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    4. Doug Cotton

      IT Manager

      In reply to Ian Musgrave

      I am very much aware of the quantities of various nutrients that may be harmful. So what? Just don't take that much. After all, the same goes for many medications. Being in Pharmacology you might, for example, suggest sleeping pills of one form or another, whereas I might suggest (and do in fact take) 10mg of the natural sleep hormone, melatonin which is found in abundance in babies and has other preventive benefits. There are something in excess of 5,000 studies on melatonin I understand…

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    5. Doug Cotton

      IT Manager

      In reply to Ian Musgrave

      If you care to actually quote your "several studies" i probably know about them and would be happy to point out the errors in their methods or conclusions. The vast majority of such negative studies (which are probably less than 2% of the number of positive studies that go "unnoticed" by the press) either use inadequate doses or investigate only one supplement at a time, thus ignoring the potential synergy of mixes such as vitamins C & E and selenium. They also use only the alpha tocopheryl form of vitamin E, whereas gamma and delta forms should be included.

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    6. Grendelus Malleolus

      Senior Nerd

      In reply to Doug Cotton

      "I might suggest (and do in fact take) 10mg of the natural sleep hormone, melatonin which is found in abundance in babies"

      I had to laugh at this statement - It seems to suggest a natural resource to be harvested from babies. Not your intent I am sure.

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  5. Doug Cotton

    IT Manager

    Here is a relevant excerpt from the US Government's National Eye Institute's website.* It is based on their government-sponsored 10 year study on the use of vitamin E and C, zinc etc for those at risk of developing Age-related Macular Degeneration.

    "Can diet alone provide the same high levels of antioxidants and zinc as the AREDS formulation?

    No. The high levels of vitamins and minerals are difficult to achieve from diet alone. However, previous studies have suggested that people who have diets rich in green leafy vegetables have a lower risk of developing AMD.

    Can a daily multivitamin alone provide the same high levels of antioxidants and zinc as the AREDS formulation?

    No. The formulation's levels of antioxidants and zinc are considerably higher than the amounts in any daily multivitamin."

    * http://www.nei.nih.gov/health/maculardegen/armd_facts.asp

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    1. Ken Harvey

      Adjunct Associate Professor, School of Public Health and Preventive Medicine at Monash University

      In reply to Doug Cotton

      On Monday December 12, 2011 the Government will announce a blueprint for the TGA's future when it finally reveals its response to a number of key regulatory reviews conducted over the last 18-months. These include:

      • The Health Technology Assessment (HTA) Review (2010);

      • Public consultations on the medical devices regulatory framework (2010);

      • Public consultations on the regulatory framework for advertising therapeutic goods (2010);

      • The TGA Transparency Review (2011);

      • The Australian National Audit Office Report on Therapeutic Goods Regulation: Complementary Medicines (2011);

      • Industry-led Working Group on Promotion of Therapeutic Goods (2011);

      • The TGA informal working group on regulation of complementary medicines (2011).

      It will be interesting to see which of the many recommendations put forward in the above reviews will get up.

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  6. John Wright

    Director

    Doug, I am not sure red wine is being actively marketed for it's health benefits, although resveratrol or otherwise. Next you will be suggesting that we stop selling cruciferous veg.

    Having spent a lifetime involved with mainstream pharma, I have developed a healthy skepticism for what passes as evidence based medicine and regulatory approval.

    But at least with the drug industry there is data to critique, it seems to me perfectly reasonable the complementary sector should be required to do the same.

    As for Vitamin D - here, in Australia, really. A more balanced assessment of the Cancer Council concerns would help here not a supplement.

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  7. Russell Hamilton

    Librarian

    "For healthy normal adults with no special needs, a balanced diet is the best source of vitamins and minerals"

    Do you think that "eat a balanced diet" is sufficient advice for many of the older people, living alone, who just aren't motivated to provide, day after day, a balanced diet for themselves? Maybe a multi-vitamin tablet is a sensible addition to a less than perfect diet.

    But my main question is, why did you bother to write this? Before you elaborate grand schemes for how complementary…

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    1. Doug Cotton

      IT Manager

      In reply to Russell Hamilton

      Yes Russell. I have quoted examples of how food (other than organic) is very deficient in minerals. Vitamins in the food are also partly destroyed by pesticides.

      Then ,the quantities of some vitamins that are needed to reduce the risk of things like dementia and macular degeneration, are far more than those found even in organic foods. And, of course vitamin D needs sunlight rather than food.

      The only thing I would say is, beware of so-called "multi-vitamin" pills because, when you compare quantities, they have next to nothing compared with typical antioxidant supplements.

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    2. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      Complementary medicine can does a lot of harm, many complementary medicines have severe and life threatening side effects or interactions with standard drugs (St. John's Wort, ginger, ginkgo and even garlic Are examples).

      Then there is the issue of people spending money they can I'll afford on substances that will do them no good at all. Not to mention the issue of people substituting effective therapies for ineffective therapies.

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    3. Doug Cotton

      IT Manager

      In reply to Ian Musgrave

      Ian - Yes, no doubt that's why the US Government spends funds on research into vitamins etc through its National Health Institutes, such as the National Eye Institute which, in a 10 year published study, found vitamins E & C, with zinc etc reduced the risk of Age related macular degeneration by 25%. (See my other posts for links.)

      Now it's up to you whether you want to pay for something like that, but you are not in a position to say people are wasting their money on such protection which, by…

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  8. Russell Hamilton

    Librarian

    Ian Musgrave wrote "Complementary medicine can does a lot of harm, many complementary medicines have severe and life threatening side effects ..."

    Since this discussion is so much about evidence I hope, Ian, you can provide the evidence of harm being done, actually being done. After all, millions of us have been taking these things for decades - there should be plenty of evidence, where is your evidence?

    Where is your evidence that people who take vitamins can't afford them?

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  9. Ken Harvey

    Adjunct Associate Professor, School of Public Health and Preventive Medicine at Monash University

    Russell wanted evidence on harm:

    First, there is direct harm resulting in adverse patient outcomes, for example when a complementary medicine has its own adverse effects or interacts adversely with prescription medicines. See:

    http://www.tga.gov.au/safety/alerts-medicine-black-cohosh-070529.htm

    http://www.tga.gov.au/safety/alerts-medicine-stjwort-000313.htm

    http://www.tga.gov.au/hp/aadrb-0502.htm#a

    Second, there is indirect harm, resulting from a delay of appropriate treatment or from unreasonable…

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    1. Doug Cotton

      IT Manager

      In reply to Ken Harvey

      "But our current regulatory system has meant that it is very difficult for consumers (and health professionals) to sort out the small amount of wheat from the voluminous hype-driven chaff."

      You can't help placing a slant on it, can you? "small" v "voluminous" - try interchanging those two words and you might be closer to the truth. There are literally thousands of studies on some supplements, so, yes it may seem hard to sort out.

      That is why I like to make use of the research carried out by a reputable organisation which has been leading the world in this field since 1980, namely the Life Extension Foundation whose website http://lef.org and monthly magazines I consider second to none.

      But ultimately the onus should be on the medical profession, not just the TGA, to look into this research and put it into practice. If they don't, then have only themselves to blame if others jump the gun.

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    2. Doug Cotton

      IT Manager

      In reply to Ken Harvey

      In the "adverse effects" section your papers list about seven products (out of thousands) and the main problem seems to be reducing the efficacy of other medications.

      In my experience there are usually warning on the labels of such products (certainly any supplied by LEF) which advise of such effects and perhaps suggest not taking the product within two hours of medication. .

      This is yet another reason why far more in the medical profession need to get involved so that they know about the interactions and prescribe an appropriate mix, whether it be for treatment or prevention. This will only happen in Australia when the AMA starts endorsing proven products, for most practitioners do not have the courage to go it alone.

      You keep talking about waste of money, but the facts are more likely that widespread use of at least a basic antioxidant supplement (often costing less than $1 a day) could save far more in health costs. What price life?

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  10. Russell Hamilton

    Librarian

    Ken, thanks for taking my question seriously enough to do all that Googling .... but you haven't provided the evidence, in fact in your first links about some substance called 'black cohosh' we find:

    "The expert group concluded that there appears to be an association between the use of Black cohosh and liver damage, but that it is very rare.The expert group also determined that Black cohosh is still suitable for use in complementary medicines, but recommended that the current warning statement on…

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  11. Russell Hamilton

    Librarian

    Now this is worrying. When you ask academics for evidence that complementary medicine is harmful, as claimed, they provide you with 'evidence' which is no such thing.

    Ken Harvey's links were as much evidence for the contrary position - one of his links showed that the TGA considers complementary medicine 'low-risk'. And now Ian Musgrave also provides links which are not evidence that anyone has found complementary medicines to be causing significant harm. His first link has more 'may's than I've…

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  12. Russell Hamilton

    Librarian

    I have another question - Stephen Prowse wrote in his comment :
    "As a consequence of modern agriculture and a balanced diet, on a population basis we are healthier and living longer than ever before."

    Is this true, or rather, what is the evidence for this? If we are living longer I imagine there are many factors - reduction in infant mortality (childhood diseases etc) would bring up the average; better public health would contribute; safer workplaces; miracle drugs like antibiotics ... there must be many reasons for us living longer, but where is the evidence to say how much 'modern agriculture and a balanced diet' has contributed?

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