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Consumer group sounds alarm over regulation of complementary medicines

The TGA is under pressure on a range of fronts, as you will know if you saw the recent Four Corners program on dodgy hip replacements (the TGA’s response notes that moves are underway to improve the evaluation of high-risk medical devices).

Then, there are the concerns that have been widely raised about the TGA’s lack of transparency in dealing with the public and the media. We should be hearing more on this soon, with the panel that is investigating these issues due to report back to the Parliamentary Secretary for Health and Ageing, Catherine King, by June 30.

Another issue drawing heat is the agency’s regulation of complementary medicines. The issue has featured the past two weeks on The Health Report on ABC Radio National (more on this in a forthcoming post), following the TGA’s recent release of audit data suggesting that a significant proportion of complementary medicines are making claims that are not backed by evidence.

Meanwhile, Carol Bennett, Chief Executive Officers of the Consumers Health Forum, writes below that it is time the TGA and the Government put the interests of the public ahead of those of the powerful complementary medicines sector.  The public needs to know that most complementary medicines have not been independently tested to prove that they do what they claim on the label, she says.

“It is a serious and consistent failure of successive Governments that a majority of Australians are not aware that we have a two-tiered system of medicines regulation of therapeutic products. What is needed is something successive governments have failed to demonstrate – a commitment to health consumers ahead of the interests of big business,” she writes.

***

It’s time for some public interest action on complementary medicines

Carol Bennett writes:

Governments are clearly reluctant to tackle the obvious lack of transparency in the labelling and marketing of the growing multi-billion dollar complementary medicines (CMs) industry.

There’s hardly a medicine cabinet or drawer in Australia that doesn’t contain either a nutritional or dietary supplement or some form of herbal medicine.  Australians are speaking with their wallets and they’re spending big on what they must believe are products that offer them health benefits.  There are over 10,000 of these products available in pharmacies, supermarkets and health stores.

A very limited number of these products have been thoroughly tested and have evidence about their efficacy. A large number of these products are little more than placebos.  I still find it remarkable that people actually purchase products claiming miracle weight loss based on magnetic fat sucking properties, or believe in the obesity and sexual function miracle pills being touted in the Sunday newspapers and on late night television.

It is a serious and consistent failure of successive Governments that a majority of Australians are not aware that we have a two-tiered system of medicines regulation of therapeutic products.  Prescription medicines that have been through clinical trials for safety and efficacy are stamped Aust R – meaning they are registered on the Australian Register of Therapeutic Goods (ARTG).

Aust R products are completely different from Aust L labelled products, even though both involve the ARTG.   Aust L simply means the products have been listed, not tested for efficacy.    Almost all complementary medicines are able to obtain the Aust L label, whether they work or not.

A report on complementary medicines by the National Prescribing Service found that 52% of those surveyed believed that these products were independently tested for efficacy by a regulator or an independent third party, such as the Therapeutic Goods Administration.

The TGA does some tests for safety of ingredients (there are some ingredients you cannot put in complementary medicines) and for manufacturing standards (if it says 5 mg it should be 5 mg) but no more.  Even then the level of auditing and compliance is somewhat limited to around 2% of the products on the market and the time taken to pursue complaints allows ample time to make a profit.  The bottom line here is that the TGA currently does not have the resources to spare for further testing of what are generally regarded as low risk products.  If people want to take placebos, what harm is there?

Packaging and labels are the frontline of product communication for consumers. The Australian Government can choose to improve and update the labelling to explain what testing is done on these products, it can run a campaign to explain what ‘Aust L’ means and doesn’t mean, or it can invest a great deal more money to properly test every product coming onto the market. At the very least, for CHF the first of these activities – changing the labels – should be an immediate priority.

The issue of exactly how much risk these complementary medicines pose also needs to be more carefully considered.

A study published in the International Journal of Pharmacy Practice last year, in which over 1,100 Australian pharmacy clients were interviewed (72% of whom used a complementary product in the previous 12 months) reported that 7% of this group or 55 people had experienced an adverse reaction at some time.

Some 71% reported the adverse reaction as mild and not requiring treatment, 22% as moderate and/or requiring advice and 7% (or four people) described as severe and requiring hospitalisation. The study adds that under-reporting of adverse reactions to pharmaceutical medicines is a well-know problem and long suspected to be a problem with CMs.

Of even greater concern is the official statistics on regulation and compliance of CMs released by the TGA recently.

Around 10,000 complementary medicines are currently listed and the TGA receives approximately 2,000 applications to list new complementary medicines each year. Random reviews are not conducted until six months after a product is listed on the Australian Register of Therapeutic Goods.

From mid-2009 to the end of 2010, only 236 desktop reviews were initiated, and of those, 201 were completed.

The statistics show that 90% of those tested failed to meet compliance requirements, 55% required corrective action and 33% were cancelled by the TGA.  Also alarming is the fact that some 15% of the products were withdrawn by their sponsors when they were informed they were going to be reviewed.

The complementary medicines sector is a massive industry in Australia and internationally.  It has some very big players, including major pharmaceutical drug companies.  It also has a lot of fly-by-night operators who appear quickly in the market, make a killing with some ‘miracle’ new product then quickly disappear.

Governments are always reluctant to take on big industry or in any way threaten their profits, but with figures showing that some 70% of Australians will buy a complementary medicine in any given year, it is simply unacceptable to turn a blind eye for the sake of political expediency.  Powerful industries should not be the primary consideration in determining regulatory policies.

What is needed is something successive governments have failed to demonstrate – a commitment to health consumers ahead of the interests of big business.  The buying public have a right to know, clearly and simply, that the vast majority of the complementary medicines they are spending their hard earned cash on are not independently tested to prove that they do what they claim on the label.

Labels and other packaging should contain a simple and consistent message stating this and the TGA should be allowed to broadcast this fact far and wide.

I am sure there is a pill somewhere in my local pharmacy that will claim to ease my frustration at the way the political process seems to squeeze out the interests of health consumers.  And I would be in the majority if I believed that it will work because it is listed on the Australian Register of Therapeutic Goods and sold at my pharmacy.  I wonder how much it will cost?

• Stay tuned for more posts on the TGA

Comments 6

  1. Altakoi says:

    I agree that the complementary industry gets away with a fair bit in Australia. It has the protests-too-much approach to saying “look how terribly regulated we are, oh poor us this happens almost nowhere else in the world” but really what they get is a government endorsement with a very light regulatory touch.

    The debate from the pro-complementary side tends to focus on whether there should be a privileged standard of effiacy – the large clinical trials required for prescription medicines. The issue on which the industry is silent is that, whether you believe random herbs are therapeutic or not, there is a major problem with the product actually containing what it says it does. Complementary products are regularly adulterated with prescription medicines, plants known to be harmful or heavy metals. There is no argument for the efficacy of these products which justifies bad manufacturing standards.

    An issue with the governments courage on these matters is the actual legislative framework the organisation works with – the Therapeutic Goods Act. This is not, as people might expect it to be, a Public Health Act for pharmaceuticals. It contains no legislative basis for precautionary action, and hides most enforcement powers behind weasel words lie “safe and effective” which are almost un-dis-provable in administrative law. This means the organisation has no teeth in any but the most extreme cases of public risk, and even then the administrative lawyers have then tied up on proceedure.

    What would really help, I think, would be explicitly public health related enforcement powers in the TG Act, similar to those in most infectious disease clauses of Public Health Act which allow an officer to take, for example, action to alleviate a health hazard. No environmental health person has to prove cockroaches should not be in the pudding, or that this is a potential threat to public health, or provide 28 days to respond before taking action. Neither should the TGA have to.

  2. simon.chapman says:

    The complementary medicine industry should be called the “Expensive Urine Generating Industry” because that’s about the only outcome the great majority of it produces. Everyone should read Ben Goldacre’s “Bad Science” http://www.amazon.co.uk/Bad-Science-Ben-Goldacre/dp/000728487X/?tag=bs0b-21 for an excoriating critique of the worst of it.
    When I ws last in London, I herad about a marvellous demonstration by some sceptics outside the Homeopathic Hospital in Bloomsbury where they were sculling whole bottles of homeopathic medicine to the great amusement of the crowd.

  3. piggle says:

    Thankyou for raising this important issue and giving it some, “airtime”. I sincerely hope the TGA effects some changes – at the moment – utterly hopeless. And some of the comments made by TGA staff are bewildering.
    We need a level playing-field where all prospective medicines are treated the same.

  4. Bill Parker says:

    Never mind sculling whole bottles of homeopathic medicines, what about the plethora of osteoarthritis “treatment” products on the market?

    There are no guidelines as to dosage, no information about product sources, no information about possible contamination from animal (abattoir waste?) derived products and so on.

    Glucosamine. Good or bad or ineffectual? All three

    Chrondrotin. About the same. Both anecdotal.

    There is an absolute need for double blinded large trials on these products.

    I was made aware of one NZ produced product made from green lipped mussels that was about as safe as one could get considering the data supplied by the manufacturer. But when the video showing an “expert” was advising the consumption of 10 capsules a day for three months, I gave up.

    At the absolute very least we need dose response data. We live in a world where more is better. Swallowing 5 grams of glucosamine a day doesn’t not leave me with a confident feeling.

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