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.