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COMPLEMENTARY medicines are currently subject to an expert review of medicines and medical devices regulation, prompting a submission from Complementary Medicines Australia.
In its submission, made earlier this month, Complementary Medicines Australia (CMA) called for a “light touch — right-touch” approach to regulation, including the simplification of the existing regulatory framework, abolishing advertising pre-approvals for low-risk products, and disbanding of the Complaints Resolution Panel.
My submission agrees — in part.
I agree that the complementary medicine industry’s regulatory burden could be reduced by abolishing the current inconsistent and incomplete advertising pre-approval system, which is delegated to industry associations.
Under my proposal, the Therapeutic Goods Administration (TGA) advertising code would still apply, but all complaints would be sent to a strengthened TGA complementary medicines branch — eliminating the Complaints Resolution Panel — and the TGA would be given the power to apply timely and meaningful sanctions capable of deterring repeated regulatory violations.
A similar proposal was put forward in a 2013 TGA impact statement on regulating advertising to the public — recommendations to government that have been ignored for far too long.
In addition to these changes, post-marketing reviews by the TGA need to be at least doubled. The TGA’s information on 2014 complementary medicines compliance review outcomes showed 190 reviews were initiated in 2014, which represented 1.5% of all 12 300 listed medicines. This information also showed substantial levels of non-compliance continue to be detected (61% of the 181 targeted reviews; 27% of 41 the random reviews).
However, these figures do not include the many reviews that were aborted when sponsors delisted their products when notified of a TGA review — products that were often then relisted.
It’s doubtful that the current TGA post-marketing regime is achieving its aim of minimising consumers’ exposure to non-compliant complementary medicines. So, as well as more post-marketing reviews, the TGA needs to impose substantial penalties for non-compliance.
If increased fees paid by the complementary medicine industry are needed to achieve these aims, then so be it.
Complementary medicines are relatively low-risk products, but that does not mean they are without risk — particularly in relation to causing adverse effects from drug interactions.
Without independent assessment of the effectiveness of these products (and their side effects and interactions), how can consumers and health professionals make appropriate assessments of risk and benefit? Approved and consistent consumer medicine information (CMI) for complementary medicines is needed.
Complementary medicine sponsors should provide a summary of the evidence they use to self-certify the indications and claims for their product to the Australian Register of Therapeutic Goods. This public summary document should also be available on the sponsor’s website with the CMI for the product. This would help the TGA to conduct post-marketing reviews, allow third parties such as consumer organisations and health activists to more readily check the information provided, and educate consumers about the product’s risks and benefits.
Consumer organisations have suggested in many submissions that Australian product labels and promotions should be required to show a disclaimer similar to that used in the US. For example: “The claims made for this product have not been evaluated by Australian health authorities”.
A similar large sign should also be compulsory in pharmacies and health food shops selling these products.
The CMA has also proposed that regulatory duplication be cut through recognition of approvals by overseas regulators to provide faster access to new products. I do not agree. Why? One example is from Canada, where homeopathic vaccines purported to prevent polio, measles and pertussis are licenced.
Incentives are needed to stimulate more research on complementary medicines. Currently, sponsors get a much greater return on investing in hype and celebrity endorsement than on research.
Some research that has been conducted on complementary medicines and dietary supplements has mostly concluded there is inadequate evidence to support routine supplementation for primary prevention of chronic diseases. Variability in the composition of complementary medicines also makes extrapolating results from controlled clinical trials challenging.
For example, an Access Economics report on complementary medicine noted that it is unlikely that all St John’s wort products are equally effective. The report suggested that the standardisation of St John’s wort products would be required before these products could be recommended as an alternative to pharmaceutical antidepressants for mild to moderate depression.
Without appropriate regulation to ensure product quality, safety and effectiveness, these products lack validity, despite the substantial amount of money consumers spend on them.
In short, a touch more regulation is required so Australian consumers and health professionals can have confidence in complementary medicines.
Dr Ken Harvey is adjunct associate professor at the School of Public Health and Preventive Medicine, Monash University www.medreach.com.au
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It is a pity that those that are making the most outrageous claims are receiving very little attention, the phamaceutical industry.Drugs are responsible for approximately a third of elderly Australians being taken to hospital, let alone all of the false data that led us to believe that the new anti-inflammatory drugs are safer,statins which can increase diabetes by nearly 50%, overuse of antibiotics apart from other problems etc.
Perhaps this is can be explaind by the pharmaceutical industry funding most of clinical research ,funding many medical journals and conferences etc
If people do their own research, and find a product works for them, is it necessarily less valid than a thousand poor Indians paid by a “research” company?
There is currently an over-the-counter group of complementary medicines with all sorts of delightfully vague promises ( “may help support” thyroid / prostate /skin / heart /bone health etc) often with a “money back guarantee”—how can a customer possibly disprove these claims, and who is going to go through the long process of getting their money back for a $20 product ? Where is there any kind of the regulation of these products, and who actually attempts to verify the claims? Often they are promoted in pharmacies, which should have some kind of evidence base. Pharmacists want increasing responsibilities in treating illness and dispensing medication but have a financial conflict of interest and also not a good record in evidenced-based products.
Ken Harvey is being generous in his description of the Canadian system for regulating natural health products. Recently the consumer affairs show Marketplace showed how a totally fictitious product for pain and inflammation in children could be registered simply by photocopying a few pages from an old naturopathy book, filling out a form and presto a few months later Health Canada issued a licence to sell the product. Those who are interested in seeing the segment of the show can find it at https://sciencebasedpharmacy.wordpress.com/2015/03/15/bogus-childrens-remedy-invented-by-cbc-marketplace-approved-by-health-canada/.
I agree that a sign saying that many alternative medicines “have not been evaluated by Australian health authorities” would clarify some issuses, Ken. But, there seems to be a reticence to actually examine some of the products. Take the use of homeopathy for disease prevention which you refer to. The NHMRC assessment of homeopathy specifcally excludes the use of homeopathy for disease prevention, and the Access Economics Cost Effectiveness of Complementary Medicine Report 2010 didn’t address its use for disease prevention (or anythig else) either. As this aspect of homeopathy seems to be gainng ground, it should be investigated.
Our health authorities should be getttng on with evaluating CAM, so they can then regulate it for the safety of all Australians. This needs to be done transparently, and with much greater attention to avoiding bias than in the aforesaid NHMRC report.
Great article but here is another idea. At present the registration of CAM products with the TGA gives these products a figleaf of respectabilty and a tool for marketing. It will never be possible to educate the community about the difference in level of assessement of CAM and orthodox medicines. Rather than continuing this sham why not advocate for total deregulation of CAM or a single TGA category of registration? It might prove to be better than what we have now as the public might then start thinking about the issues when they learn that what they are buying has not been “officially approved”.
I congratulate Dr Harvey on his continuing sensible and ethical stance for better regulation of complementary medicines in Australia where unsubstantiated claims can be made for alternative therapies that could not be made for audited medicines that have been registered (Aust R) by the TGA. It is time for a level playing field with a requirement that all medicines and supplements sold to the public are subject to proof of their efficacy and their long-term safety.
The questions that needs to be asked is how much does the huge alterative medicine industry invest in Australia’s political parties and in intensive lobbying to try to keep the double and very weak standards for the sales of complementary medicines? And how much does this influence governments to keep “a light touch” on their regulation?
The large increase in sales of alternative medicines and supplements is not proof of their efficacy but rather more likely in the effectiveness of massive advertising campaigns and paid endorsements by sporting and media personalities. The morality of such dubious endorsements of unproven heath products is questionable.
Emeritus Professor Alastair MacLennan, Co- Vice President, Friends of Science Medicine, wwwscienceinmedicine.org.au
the flood of advertising and claims of benefits for these products, particularly vitamins, with endorsements by sporting identities and sporting teams has to stop. In general they are harmless but the huge con, especially by the pharmacists who are shamelessly making a financial killing on these products, as evidenced by double-paged advertising spreads in the newspapers needs to be addressed. It is time the pharmacies develops some ethics and stopped peddling snake oils, wrinkle removers and potency improvers. The same applies to the various magnetic mattresses that sell for thousands of dollars and “circulation booster” massagers promoted by our greatest swimming legend who must at this stage of her life be short of a quid.