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ONCE again I have been threatened with a defamation suit by a complementary medicines sponsor.
This time, it is alleged that statements I made on the ABC radio program PM defamed Undoit.com.au Pty Ltd and its director Michael Romm.
Last year, it was SensaSlim Pty Ltd. When the first case was struck out, a second was initiated by a SensaSlim director. Eventually, that was also struck out.
So why complain about the promotion of therapeutic goods if it can be such a hassle?
Ethical promotion is a crucial component of National Medicines Policy. In 1988, I was a member of a team of experts who put together the WHO Ethical Criteria for Medicinal Drug Promotion. Since then, I’ve felt an obligation to be an occasional complainant.
In 2007, the World Health Assembly urged governments to: “enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines” and to monitor drug promotion. This increased my interest in testing the Australian system by submitting complaints, documenting problems, suggesting reform and participating in government working parties.
The Australian system consists of self-regulation by numerous industry associations (promotion to health professionals), co-regulation involving an independent Complaints Resolution Panel (CRP) administering the Therapeutic Goods Advertising Code (promotion to consumers), and its underpinning legislation, the Therapeutic Goods Act administered by the Therapeutic Goods Administration (TGA).
Complaints have had some impact. In 2011, the federal government set up a Working Group on Promotion of Therapeutic Products to address the inconsistencies of nine self-regulatory industry codes and the problem that such codes do not apply to non-members ― often the worst offenders.
The Working Group recommended that the various industry groups create greater consistency in their operations and governance, and that the government make marketing approval conditional upon compliance with industry codes. The latter recommendation was rejected, as the government first wanted to evaluate the effectiveness of voluntary sign-up.
More encouragingly, this year the government has allocated $1.4 million over 4 years to assist both industry and the health professions in developing and implementing clear enforceable codes of conduct.
An important function of complaints is that they help to expose flaws in the co-regulatory system, especially with respect to complementary medicines.
The CRP has been found to be overloaded, underresourced and lacking the power to impose sanctions. Cases of non-compliance are sent to the TGA, which can “order” compliance, but this can be easily ignored. Underpinning legislation contains only criminal penalties and has never been invoked.
Another way in which companies have evaded the TGA is to delist products under review while re-listing similar or identical products. The end result is a multitude of complementary medicines that make extravagant claims without supporting evidence and evade regulatory controls for substantial periods.
Practices such as these bring the entire complementary medicine industry into disrepute. They also make it difficult for consumers to separate the evidence-based wheat from the hype-driven chaff.
Nevertheless, complaints about these matters have stimulated a number of government inquiries which culminated in the 2011 document, TGA reforms: a blueprint for TGA’s future. This sets out a package of reforms which, if properly implemented, could substantially improve the complementary medicines sector.
The federal government has also recently amended its therapeutic goods regulation to remove the incentive it contained to initiate legal action against complainants.
My experience shows that submitting complaints, documenting problems, suggesting reform and participating in government working parties can produce regulatory reform. But you have to be persistent, work with allies and not be deterred by minor annoyances such as defamation suits.
I encourage others to join the action.
Dr Ken Harvey is adjunct associate professor at the School of Public Health, La Trobe University. He can be contacted via http://medreach.com.au
Posted 30 July 2012
Michael Romm (the sponsor of Undoit) claims there has been no critique against the published, randomised, placebo-controlled clinical studies used to support his product. I submitted evidence to the independent Complaint Resolution Panel (CRP). My concerns about the promotion of Undoit were upheld. See: http://www.tgacrp.com.au/index.cfm?pageID=13.
In addition, non-compliance by Undoit.com.au Pty Ltd with the CRP’s determination has now been sent to the TGA for a regulation 9 order.
None of the above has been personal; its merely that I don’t like to see promotion that breaches the Therapeutic Goods Advertising Code.
The product “undoit” is promoted as a product that lets you eat whatever you want without absorbing the fat or carbohydrate. From the promotional website: “It binds the fat and carbs after you’ve eaten them and stops them from being absorbed. That’s right! It grabs all the calories so they don’t get absorbed.”
The formulation consists of senna (aperient), Chitosan (an extract of crustacean shells that apparently forms a gel and binds lipids) and a plant extract “phaseolus vulgaris” which is actually the common bean – and is claimed to stop the breakdown of carbohydrates into simple sugars. The website states “Both the fat and carbs pass through your system without being absorbed until they exit.” (http://www.undoit.com.au/how_it_works_2). The study referenced on the site was published in “Journal of the American Nutraceutical Association” in 2001 (available via a link on the site). The results are dubious – the control group apparently gained weight (on their normal caloric intake) while the treatment group lost weight but had no significant increase in faecal fats.
It appears that this product is a purgative that could likely cause malabsorption of nutrients. The senna was apparently added after the complaint on the original product was upheld by the TGA. Purging is an unhealthy and potentially hazardous way to lose weight. The supporting citations appears flawed, as described above.
Ken, I support your right to complain to the TGA. It’s when you move away from commenting on the product and get personal that you let yourself down. Based on absolutely nothing, you said that we were avoiding the TGAs rules and were being dishonest to customers – neither of which are true. So please keep it professional and confine your comments to the product. And by the way, I am still waiting for someone to bring even one piece of good evidence or critique against our published, randomised, placebo-controlled clinical studies. It’s nice to throw an allegation at a product, but how about you justify yourself and support it with some evidence? I am happy to debate the clinical evidence with you any time.
All strength to your campaign Ken. As you implied, self-regulation does not work; it is an unsatisfactory compromise that suits only those being “regulated”. It is time that all complementary medicines were subject to TGA strict requirements for licencing as are conventional therapeutic agents viz scientifically demonstrated efficacy and safety.
Congratulations on your dedication to the public good, Dr Ken. It would help the campaign to eliminate frauds and charlatans if government departments and ministers implemented the legislation they have available, instead of hiding behind “monitoring.”
See http://tinyurl.com/d3zvtsn
Ken
Many of us are grateful for the wonderful job you do. It takes much effort, time and bravery.
Sadly, laws about claims made on food labels seem to have learned nothing from TGA – or maybe they have learned that objection to shonky claims is easily bypassed.
Keep up your good work!