How do the National Institute of Complementary Medicine deal with negative media reports? And what does the regulator, the TGA, have to do with it?

As soon as you read any negative media report describing people who got hurt or died using  complementary medicine (CM) you can expect a statement from the CM industry such as “Australia already has one of the most rigorous regulatory systems in the world for complementary medicines,” or “he said Australia had a world-class system for regulating complementary medicines” The NICM, an “independent” research institute, uses a very similar statement “with Australia having one of the highest (?) regulatory systems for complementary medicines in the world.” When you read the NICMs media releases you will come across this statement, and many other commonly shared statements, quite often.

It is almost as if the CM industry has met with the NICM where they decided together that this statement will cause the least damage to the CM industry. It will come as no surprise that this is exactly what happened. The NICM has developed, in partnership with the CM industry, a communication strategy to deal with negative media reports ( highlighted text page 3 and 4) and this full time position at the NICM is fully funded by industry (highlighted text page 3).  The first important question is if you are fully paid by industry will you really say anything negative regarding their products or will you defend it? The second issue; isn’t it maybe better to employ a scientist who can critically look at the media report and provide all the scientific evidence (risks and benefits) for that specific CM? Isn’t that what an “independent” institute such as the NICM should do? Their statement is designed so that the public should think that all CM products are rigorously tested by the Therapeutic and Goods Administration (TGA) and hence they should not worry too much. Trust the TGA!

The term CM encompasses such a huge number of different medical treatments and products, so surely the NICM should be able to say that a specific CM works or not, or that it carries a number of risks. The public need to get the full story! Unfortunately this does not seem to be the case so together with their industry partners and sponsors they devise strategies to undermine the much discussed NHMRC homeopathy report and any other negative media reports covering any CM such as chiropractic.  And of course they have devised a strategy to deal with their archenemies the Friends of Science in Medicine.

Does Australia have the best regulatory environment for CMs in the world? CM’s are regulated through the TGA and the current estimates of listed CM products range between 10 000 and 16 000.  Most members of the public believe that this mean that the TGA has tested the claims of all these products but this is simply not the case. It is not the responsibility of the TGA to perform these tests – it is up to the CM industry to provide information regarding efficacy and safety. But there is another very important aspect that is often overlooked. In my view there are actually two “levels” of regulations concerning CMs. The most important level of regulation concerns the safety and efficacy. Only when a product ticks this box does the second level of regulations (quality control, labelling, stability testing, packaging, advertising etc) become important. The TGA does a wonderful job when it comes to the second level of regulations – although some people might hold a different view on this – but it fails miserably at the first level of regulation. This means that the regulatory environment of CM’s in Australia is completely inadequate and the statement made by the CM industry/ NICM is simply misleading the public.

To prove my point. I can identify a plant growing in my garden, google the name of the plant and  download the “scientific evidence” that this particular species has been used somewhere in the world for at least three generations – which means it is safe – and then register a new product with the TGA.  I do not have to provide the evidence of efficacy I just have to say that I have it somewhere and that it is available on request. If the evidence is requested by the TGA, and this only happens in very few cases, I can simply withdraw my new product without facing any penalties. The fact that there are 10 000-16 000 CMs (and this number is growing fast) further strengthens my point. It is a very simple process and the NICM has spent a lot of effort lobbying the TGA to make this process so simple. For their hard work the NICM was also duly awarded a prize from the CM industry.

The main problem with this overreliance on scientific publications produced elsewhere as evidence of safety and efficacy, is that academics all over the world are under such pressure to publish that some scholars currently claim that “most published research findings are false”. This can again be seen by the interesting phenomenon that almost 100% of clinical trials of herbal traditional Chinese medicine gave positive results when the research is conducted in China.  Thus, in my view, the regulatory environment in Australia for CMs is most definitely inadequate.

When the NICM/CM industry refers to the TGA they refer to the second level of regulations regarding quality control, packaging, labelling etc. And they do this simply to mislead the public. It is like claiming that homeopathy (or acupuncture) is extremely cost-effective and hence should be promoted nationally but completely forgetting about the efficacy and/or safety issues. Yes water is very cost effective but does it work as a cancer treatment? When they claim that the quality control, labelling, stability etc is done according to TGA regulations (second level of regulations) they seem to be forgetting about the most important issue of safety and efficacy of CMs.

But then again if you look at the number of complaints that the TGA receives regarding misleading label claims then the NICMs approach becomes quite concerning. The CM industry are notorious for making massive claims without having much evidence to back this up and for breaching label laws without any real penalties from regulators. Any move from government to improve or strengthen regulations is fiercely opposed by industry/NICM and they will garner support from some high profile politicians in order to prevent tighter regulations. Currently industry and the NICM are lobbying for even further deregulation of CM products. They must simply make it easier for industry to sell their products. So is the NICM an independent research institute – no way!

Any comments welcome

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