Ken Harvey’s recent Crikey piece about the TGA’s draft guidelines for evidence on weight loss products has apparently ruffled a few industry feathers.
Pharma Focus recently reported the ASMI’s concerns about “mischievous misrepresentation” of the guidelines.
The discussion continues below. Read on…
From: Ken Harvey, Adjunct Senior Research Fellow
School of Public Health, La Trobe University
To: Deon Schoombie, Australian Self-Medication Industry
It has been reported (in Pharma Focus) that, “Negative media reaction to the new guidelines has irritated the Australian Self Medication Industry (ASMI)”.
In response to queries from a colleague the TGA has stated, “It has not yet been proposed that all products would be scientifically tested for the evidence. The [draft] guidelines simply outline scientific evidence considered acceptable to support claims so that sponsors are aware of the type of evidence they should hold”.
In short, the TGA will continue to rely on sponsors doing the right thing or consumers and health professionals challenging the claims made.
While I accept that members of your association may respect the revised guidelines, you are well aware that there are many other non-ASMI sponsors who have consistently ignored the previous TGA’s “Guidelines for Levels and Kinds of Evidence to Support Indications and Claims,2001.” Why would they change what is obviously a profitable approach?
In addition, industry personnel who “pre-approve” advertisements (only in specified media) do not have the time to routinely ask for, and checkclaims against the evidence, as shown by successful complaints against advertisements with CHC pre-clearance numbers.
Furthermore, you cannot expect consumers and health professionals to continue to submit complaints when the CRP now merely forwards these to the TGA whereupon they disappear into a black hole and are never heard of again!
I (and others) would be much more positive about responding to these draft guidelines if the TGA had announced any intention of implementing them!
With best wishes,
Thank you for your email.
In our view there are 2 aspects to the issue of supporting evidence for indications and claims – the first is setting the rules (through regulatory requirements and/or guidelines) and the second is ensuring compliance with those rules. The guidelines address the first aspect and we believe it to be a major step in clarifying the required standards.
On the issue of compliance (and bearing in mind that the draft is still subject to public consultation and amendment) I believe it won’t be too difficult to request sponsors (at the time of pre-approval of ads, or when dealing with complaints or at the time of post-market audit – which could perhaps be stepped up in specific areas like weight loss as ASMI has been advocating for some time) to submit the “piece of paper” which supports weight loss of 5% and 3% above placebo in 2 – 6 months in the intended target population – no less and no more. Issues arising from sample size and research methodology (outlined in the guidelinesdocument) will also become evident straightaway and should result in a simple pass/fail conclusion.
The message will get out soon enough and most sponsors will get their houses in order. The others will get caught through the complaints process and post-market audits (increased targeted audits). In addition penalties and sanctions should be heavy enough to act as effective deterrent.
Part 3: PostScript from Ken
While I accept that the draft guidelines COULD be implemented along the lines Deon suggests, the TGA has shown no inclination to do so. In addition, there are still loopholes in the draft for claiming “traditional use” and using non-randomised, non-placebo controlled trials.
Getting ‘caught up in the complaints process’ must be terrifying for these companies. They might be asked to explain their claims a year or so after they have moved on to claiming something else. That’s if anyone can be bothered going through the process of complaining with the knowledge that the complaint is extremely unlikely to have any impact on the company. But the company might be unlucky enough to be found guilty of a transgression. It might even be fined. Of course, the fine will be simply part of the profit/ loss statement. Any loss will be passed on to the consumer.
Let’s get real. Guidelines to protect the public need to be explicit. Adherence to guidelines needs to monitored closely by the TGA, with the capacity in the TGA to immediately force companies to justify claims, publish apologies, and pull incorrect advertising. Of course that would mean that an organisation which is funded by industry would have to control that industry’s excesses. Small conflicts of interest can undermine the best guidelines. Major conflicts of interest make them close to useless, but for one saving grace. It’s a little easier to see the problems.
Doctors Reform Society
As a consumer, I am disappointed in the new guidelines, which accept traditional products.
These guidelines will do little to stem the flow of garden weeds etc sold as weight loss products. I asked the TGA to comment on the following statement which continue to ignore
“It is the balance of evidence that is considered and if both traditional and scientific evidence were to be considered for a traditional claim then the quality and significance of each would need to be considered” (from Page 9 of their existing guidelines which also supposedly applies to traditional weight loss).
Their response was that “If they showed conflicting views then a judgement would need to be made as to what sort of claim could be made.”
Despite requesting a ‘judgement’ in the past on traditional remedies that are considered ineffective by scientific research (red clover and glucosamine hydrochloride are two examples) – to the best of my knowledge a judgement has never been made – and if it was it clearly wasn’t done by an independent 3rd party because no products have been removed for this reason . The TGA remains a black hole when it comes to this type of request.
While this issue is not resolved, no matter how much research is done on traditional weight loss products, they will undoubtedly keep their listing numbers, remain on pharmacy shelves and continue to undermine peoples attempts to lose weight.
In the fattest country in the world, unproven traditional weight loss products are not acceptable.