Medicandus

Medicandus

Trust me, I’m ‘clinically proven’!

The recent Swisse Vitamins flap has led to another round of discussions about advertising terminology for supplements and over-the-counter (OTC) health products.

To briefly summarise, for those up the back, Swisse have been ordered by the Complaints Resolution Panel of the Therapeutic Goods Administration (CRP) to stop using the terms “clinically proven” or “independently tested”, as well as its “Tired? Stressed? You’ll feel better on Swisse” tagline.

The order from the CRP has been contested by Swisse, who have published on their website a list of the evidence they rely on to support their claims. The case hinges in large part upon the scientific credibility of this evidence, which will no doubt be given a thorough going-over in other forums. It also raises the issue of what these commonly used advertising phrases actually mean.

‘Clinically Proven’ sounds like a very strong recommendation indeed, and clearly tests well with focus groups, as it is an industry favourite. The average punter would assume that it means something like ‘scientifically legit and definitely effective. Used all the time in medical practices.’ The TGA itself has gone as far as to publish guidelines back in 2008, for the benefit of advertisers and the general public. To quote them precisely:

the Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon.

This clearly implies that having one or two small studies with positive outcomes is not good enough to justify the term, and furthermore, that these couple of studies with Product X can’t be quoted without mentioning the more numerous or better-conducted studies which show it doesn’t work. The use of ‘Clinically Proven’ on a product ought to be a guarantee of rigorous testing and use in the clinic, but unfortunately it is so debased and frequently applied that it really is virtually meaningless. Hence why CRP put out a guideline about it. Like so many other warnings and directions the watchdog has put out, it has been ignored by many in the industry. A quick trawl through the CRP Complaints Register shows that the term has cropped up in misleading advertisements for everything from anti-snoring devices to stress-reliving herbal supplements and back pain devices.

‘Independently tested’ implies that there is some type of arm’s length arrangement between the company selling the product, and the people doing the research. In practice, this usually means a university team doing the research which may or may not be directly funded by the company concerned. Such arrangements are common with Big Pharma products, and high levels of integrity are fundamental to good science being carried out. Full disclosure of funding sources is expected all the way through the peer review process, and is also expected to be acknowledged at conferences or in journals where the data may be publicised.

Swisse’s cause was not helped by the disclosure 2 days ago that the current CEO’s father was one of the academics who oversaw some of the research at Swinburne University in Melbourne which was funded by Swisse and is also used by them to support their claims of effectiveness. Such as an obvious potential conflict of interest as is quoted in the Swisse case does not automatically invalidate the research, but full disclosure ought to have been made at all stages of handling that data so outsiders can judge for themselves the strength of the evidence with all the facts to hand. With no guidance from CRP as to exactly what constitutes a valid claim of ‘independent testing’, this phrase is going to be headache for consumers for some time yet.

Truth in advertising is a long-term societal principle which must balance commercial interest with the public good. Big Pharma are prevented in this country from advertising directly to the public but the performance of those in the healthcare industry who are allowed to advertise in this way must improve substantially if consumer protection is the goal.

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