Why Australia's Alternative Medicine Regulations Need Fixing

Australia's complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM -- which includes therapies such as chiropractic and naturopathy, traditional Chinese medicine, vitamins, minerals, nutritional supplements, as well as homoeopathic and aromatherapy products -- and there appears to be no sign of this declining. In many cases, the evidence for CAMs having significant beneficial effects is scant. And recent studies have even found that some supplements can be harmful.

Pills picture from Shutterstock

Though this is not true for all CAMs and, as a critic, I must be careful not make sweeping generalisations about efficacy -- each CAM modality must be examined at face value. It is now well accepted, for example, that folic acid can prevent some birth defects and St John's Wort is effective for mild to moderate depression.

But, as a consumer, how can you tell what products might be of use and which ones will only lighten your wallet? The task of sorting the wheat from the chaff is not made easy by unscrupulous pharmacies selling what is essentially snake oil alongside drugs for which efficacy is well established.

Can you trust the government to regulate products and only license those that work? You'd think so, but you'd be wrong. Indeed, the government is largely to blame for misleading consumers when it comes to CAMs.

How Are Medicines Registered?

In Australia more than 10,000 drugs and medical devices are listed on the Australian Therapeutics Goods Register (ATRG). There are two arms to the ARTG:

  1. Listed products. These products are considered low risk and include complementary medicines such as herbs, minerals, vitamins and sunscreens. Listed products are identified with an "AustL" number.
  2. Registered products. These products are high risk because they have a known effect and include prescription drugs and painkillers. Registered products are identified with an "AustR" number.

The degree of assessment and regulation required to gain registration (AustR) is rigorous -- sponsors are required to provide comprehensive safety, quality and efficacy data.

This is not the case for AustL. Under the current system, you can get your CAM product stamped with an official-looking number by simply applying online. You should hold evidence that your product works as described and you can explain this in a "free text" box which is provided when you apply for listing.

And therein lies the problem. Back in 2010, TGA auditors conducted a spot check on about 400 AustL products and found nine out of ten breached regulations.

The breaches were largely relating to false claims of curative powers on labels and as a result, a "significant number" of products were removed from the ARTG. Which products were removed and precisely why, was not revealed by the TGA.

Time For Change

Recently, the TGA announced it was finally putting a stop to the "free text" option when applying to list a product. As TGA manager Dr John Skerritt told a Senate estimates committee, this is supposed to be part of "the most sweeping reforms of complementary medicines regulations for many years in this country". The proposed changes mean sponsors will have to select from a list of indications, the aim being to prevent spurious claims of cures or miracle treatments.

But this is not the first time the TGA has announced an overhaul of the CAM listing system. In 2012, it proposed the introduction of an Expert Report that would require sponsors to conduct a review of the scientific literature in support of their product's claims.

Following a call for public consultations, this proposal was quietly scrapped, apparently as a result of pressure from the CAM industry which protested it was prohibitively expensive and would force many small suppliers to close down. Or maybe it was the lack of published evidence for their claims that was worrying them. Curiously, it appears this idea was recently resurrected with a second round of consultations on the same issue closing on February 18, 2013.

The removal of the free text option is also not new, being first proposed following a transparency review commissioned in 2010 by the Honourable Catherine King.

But even if these changes are implemented (and there's some suggestion that in an election year, there may not be enough time to modify the relevant legislation) they miss the point, in my opinion. What consumers should be made aware of is that the TGA does not check any AustL products to see if they work or even if they are safe. This needs to be stamped on the side of all AustL products in great big letters.

And while consumers are free to make complaints about what they believe to be false or misleading claims made by AustL products, don't expect anything to happen, even if the TGA rules in your favour. In approximately 30 per cent of cases, orders to publish disclaimers or remove misleading material are ignored by sponsors and the TGA has never in its history prosecuted a sponsor for non-compliance. Ever.

Adding a warning to a product may not change consumer behaviour, but it at least increases transparency, thus enabling consumers to make an informed decision about what they purchase. Although homoeopathy doesn't always come under the ARTG (because some preparations are too dilute to be considered of any risk), a sticker saying "this is not medicine" or "there is no evidence this works better than placebo" would make me think twice about handing over my 20 bucks.

So, the TGA can jump up and down all it likes and make announcements about proposed changes and new legislation, but until it actually instigates meaningful change, then it's just lip service. While I was encouraged to see the removal of several products from the ARTG recently, much more needs to be done.

Rachael Dunlop is a Post-doctoral fellow at University of Technology, Sydney. She receives funding from The Institute for Ethnomedicine, WY. She is a Vice President of Australian Skeptics Inc. The ConversationThis article was originally published at The Conversation. Read the original article.


Comments

    This is an article with an agenda against alternative medicine.

    Should you use alternative medicine when you have cancer? Probably not.

    Should you pop panadol which is proven to be one of the most toxic substances on an ongoing basis that the largest percentage of the worlds population often take daily? Probably not.

    Use whatever works. You're in no position to judge or qualified to give any real advice.

      "In many cases, the evidence for CAMs having significant beneficial effects is scant."
      and then
      "Though this is not true for all CAMs and, as a critic, I must be careful not make sweeping generalisations about efficacy — each CAM modality must be examined at face value."

      No-one recommends popping Panadol every day, that's a straw man argument!
      I reckon the article has a very balanced view. It doesn't claim to be qualified to give any medical opinion but to say that there is little evidence to support the efficacy of Alternative Medicine.
      If you disagree, feel free to highlight scientifically relevant evidence (ie double blind trials).

        I didn't say they did recommend it, and yet it's what statistically speaking is more likely to happen than not. It's wayyy too early in the morning for me to find and cite sources though haha.

        And I don't necessarily disagree as I say, i'm not taking sides but that sentence is basically the argument equivalent of a disclaimer absolving responsibility.

        Last edited 08/03/13 11:28 am

      "Should you pop panadol which is proven to be one of the most toxic substances on an ongoing basis that the largest percentage of the worlds population often take daily? Probably not."

      First of all, Panadol can't be proven to be "one of the most toxic substances", because it's a brand name, not a substance. The word you're looking for is Paracetamol, and second, you're absolutely wrong. It's nowhere near one of the most toxic substances on earth(THE most toxic is Botulinum toxin, with a great deal of other substances between that and Paracetamol when it comes to toxicity) and it's not toxic in and of itself. Paracetamol's toxicity comes from an intermediate product produced when your body metabolizes it, called NAPQI. Which is only actually an issue if you're taking an absolute overdose, be it accidentally(hell of an accident) or intentionally.

      "Use whatever works. You're in no position to judge or qualified to give any real advice."

      Actually, Yes she is - It's literally part of her job - and yes she is, far more so than yourself, I'd wager.

      This article doesn't have an agenda against alternative medicine. It's advocating that we stop the TGA from being a paper tiger, whose strongest action is writing a very cross letter at you. At a stretch, it's advocating that Alternative medicine is given the same treatment as actual medicine - a term I use very particularly, since Alternative medicine that's been objectively proven to work is no longer alternative medicine, it's just medicine.

      And frankly, if one thinks that Alternative medicine works as advertised, then there's really nothing to complain about in that, since it's a measure that will make everyone safer, and take a hell of a lot of scam artists out of the equation. Actually, probably the same outcome if you don't think that alternative medicine works, too, you've just a different opinion on precisely who the scam artists are.

        "Panadol is a brand not a substance" pedantry at its finest sir. And I never said it's "one of the most toxic substances on earth" I said it was one of the most toxic substances people take on a regular benefit under the guise of it being good for their medical health at that time.

        Part of her job as a blogger? Upon researching her specifically it appears she COULD be a doctor - but there's no indication of this here. Apologies for not specifically researching each persons qualifications, i'm sure you have a very interesting time reading articles online and then researching all the authors, but for some of us it's 8am and this is breakfast reading. If she wants to express herself as a medical authority, she should atleast have half a sentence on why she is qualified.. "In my background as a.... I have observed/talked about/etc etc".

        And no, I don't have an opinion one way or the other. I make use of many alternative therapies (mostly physical, not chemical) combined with modern/western medicines where appropriate.

        I can however see upon rereading that she does speak more than I gave credit for on the certification process rather than the effects - however the overall tone is still very much "modern medicine is the standard to which all other systems should answer" in an age when both industries are at least in my understanding equally driven by profits.

          I think you've forgotten the golden rule of pharmacology - all drugs are toxic, at the right dose. And yes, she does appear to be qualified as she is a 'post-doctoral researcher' - ie she has a PhD.

      Eh? Paracetamol is one of the safest analgesias available (when used as directed).

    And there rightly should be an agenda against alternative medicine as it stands now. It's essentially an unregulated playground where people are getting scammed and being given false hope by all sorts of unscrupulous scumbags. I sincerely hope that more stringent regulations are put in place for alternative meds. That the goverment or practicioners band together and form an oversight board that actually requires some sort of higher degree to start practicing. I want alternative medicine to be legitimate, to actually deserve the word 'medicine' in the name.

    As it stands it is a farce and if it isn't fixed, needs to be abolished asap.

    I think a postdoc in the Dept. of Medical and Molecular Sciences, can be considered "qualified", as you put it, to offer advice, at least as much as anyone is.

    As for "whatever works", well, that's the point of research, isn't it? To find what works, using the best available scientific methods.

      Sure - and when the research is funded by the people trying to sell the drugs then claimed it's unbiased..

      How many drugs have been told they are fine, to be pulled off a year or even 10-20 years later? Thousands, if not significantly higher.

      I'm not saying either system is perfect, but I find it extremely narrow minded to assume that just because one industry has more money thrown at research doesn't mean it isn't at the very least AS biased as evidence to the contrary - which is also very frequently funded by big drug companies in the first place.

      Give any researcher $200,000 and a truckload of an alternative medicine and tell them "we want to know the side effects of this drug" and see how unbiased the results come out.

        There is no 'other system', because contemporary medicine does not constitute a system at all: it's just the accumulation of empirically-derived theory, with treatments that have been established as working.

        So-called CAM is just as heavily promoted by big companies as evidence-based treatments are, as it's poorly regulated in most countries, so is a corporate joy. Indeed, it's often the *very same* companies that sell so-called 'conventional' drugs. Because of the resistance by many of its advocates to empirical research, CAM offers *no* resistance to bias. To put it another way, without empirical research, bias is all you're left with.

        Much of the point of scientific research is to reduce bias. When and if commercial bias creeps into empirical research, the solution is to do the research better, tighten up disclosure and other controls, etc. It's not perfect, but it's far and away the best we have ever had.

    "Around two thirds of Australians use CAM — which includes therapies such as chiropractic and naturopathy, traditional Chinese medicine, vitamins, minerals, nutritional supplements, as well as homoeopathic and aromatherapy products — and there appears to be no sign of this declining. In many cases, the evidence for CAMs having significant beneficial effects is scant."

    From this statement which products are the scams and which have viable therapeutic value, or are they all a scam?

      'From this statement which products are the scams and which have viable therapeutic value, or are they all a scam?'

      Some are some aren't. To be a scam there needs to be an element of dishonesty. You get everything from total dishonesty, to elements of dishonesty to no dishonesty.

      It's why you need proper regulation based on science.

      End of the day whether someone is selling a product they full believe in that doesn't work, or someone knowingly selling one that doesn't work. The end result for the consumer is exactly the same.

      Although personally, when it often comes to labeling, the way claims are phrased, there's dishonesty that's deliberate in most of them at some level. Even if just mental dishonesty.

      You also need to get these out of pharmacies. There's an expectation that your local pharmacy isn't selling products that claim health benefits which aren't backed up by science. Many which are well known to be bogus and some which are literally based on principles of magic. Often in an aisle across from actual medicine.

      It's worth reading up about some of these products. Inform yourself. Things like how homeopathy is meant to work are ridiculous. From my experience people assume there must be something to do these things, that there is a layer of protection in consumer law stopping people from selling magic beans.

      What are scams? Some are easy to call out:

      Homeopathy: This whole area is just one big scam. It has failed every well designed trial, and the underlying theories contradict the way the universe works. Sugar pills with a high price and a genuinely nasty selling push.

      Naturopathy: Most is rubbish. Those smalls bits that aren't are hard to identify due to the high noise factor from the fake stuff.

      Really, the old saying is true. What do you call alternative treatments that work? Medicine.

    for example, that folic acid can prevent some birth defects

    This quote is exactly why I have little faith in government regulation of health.

    Folic acid is an oxidised and synthetic analogue of folate. Whereas the natural form of folate( tetrahydrofolate – THF ) can enter the folate cycle, folic acid requires to pass through the liver, which is a slow process, and thus supplementing folic acid can lead to high levels of folic acid in circulation. Studies [1][2][3] have shown that high levels of folic acid in the blood have shown increased prevalence of cancers.

    I don’t want the government regulate what I have researched and consider OK to put in my body. (Especially when they having conflicting interests – I personally don’t care if the grain industry is affected about me not eating flour based products, but I would like to see a politician make it a health policy).

    Companies should not be allowed to make outrageous claims without some scientific basis, but people should be able to make their own decisions on what is ok.

    [1] https://www.ncbi.nlm.nih.gov/pubmed/17697404
    [2] https://www.ncbi.nlm.nih.gov/pubmed/17697404
    [3] http://jnci.oxfordjournals.org/content/101/6/432.full

      folic acid supplementation during pregnancy has been well researched and has proven benefits, http://ajcn.nutrition.org/content/71/5/1295s.short

    I don't care what the agenda is, the crux of government spending on public health should be one of science-based medicine.

    If a CAM had therapeutic value then show the proof and apply to have it listed for funding.

    In the meantime, of course the TGA should be limiting the claims of CAM providers to that of proof.

    I, for one am very upset at not being able to buy private health coverage without supporting hundreds of thousands of people on medically unproven therapies.

      Indeed; if a CAM is shown to have therapeutic benefit, it then becomes a medicine. (Eg: aspirin, botox etc).

    Put simply, alternative medicine is by definition unproven. There is an agenda against such unproven therapies and this should be heartily promoted. Anything that is proven (and pretty much every therapy deserves a shot at being proven via a process of scientific enquiry) becomes conventional medicine. This, by the way, includes drugs, surgery, etc which should be subjected to the same rigourous tests.

    If there were less restrictions stopping people from accessing conventional medicines there wouldn't be so much demand for complimentary medicines. I'm not suggesting a free-for-all but if people could get direct access to more medications without going through a GP or a pharmacist we wouldn't be having this conversation.

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