The Therapeutic Goods Administration has called for submissions in a consultation paper titled “Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss.”

In promoting the paper, the TGA stated on its website that: “This guideline will … give consumers confidence in the medicines they choose for self-care.”

I don’t think so!

In my opinion, this document provides yet another example of how the Therapeutic Goods Administration (TGA) is focused on industry, not consumer, protection.

This document was first conceived in 2007, stimulated by the increasing number of complaints about complementary medicines promoted for weight loss. These products included Cat Media’s “Xantrax High Potency Weight Loss Formula”, “Fat Blaster” and “Fat Magnet” and Blackmores “Weight Loss Accelerate” and “Sugar Balance”.

My colleagues and I found more than 1000 of these products had been listed on the Australian Register of Therapeutic Goods (ARTG), their numbers were increasing exponentially, no evidence of their efficacy was required by the TGA, and the complaint system was ineffective, being overloaded, under-resourced and lacking effective sanctions.

Initially, it was my understanding that the TGA was to review the evidence about the limited number of herbal and other ingredients used in listed weight loss products; none of which have convincing evidence of efficacy, either alone or in combination. It was hoped that such up-stream evaluation would reduce the need for down-stream complaints (and better protect consumers) by proscribing the use of ingredients that lacked evidence of efficacy.

However, allegedly in response to industry concerns, the topic of the TGA review was changed to the current, “Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss”. In addition, although a consultant’s report was received in November 2007, the release of the draft Guidelines was delayed for 14 months; this procrastination is hard to understand given the anodyne nature of what has just been released.

The “Guidelines” state that, “Clinical trials, particularly randomised and blinded trials provide the most robust information regarding the potential effects of an intervention”. They go on to provide useful information about how such trials should be conducted, including the number and types of patients needed to achieve statistical power, outcome measures and the study duration.

Ironically, the “Guidelines” then allow “medium” level (non-randomised trials) or “traditional” evidence to be used in making claims. They also say nothing about the acceptability of product names making their own implicit claims, such as “Fat Magnet” and “Weight loss Accelerate”.

In my opinion, refining “Guidelines for evidence to support claims for weight loss” merely perpetuates the current situation where the onus remains on the public and health professionals to submit complaints about individual products to an already overloaded and ineffectual system.

This has led sponsors such as Blackmores to challenge complaint resolution panel findings and draw out proceedings for months and years through appeals to the TGA. Whereupon the complaints disappear into the TGA black hole! Although the TGA, say they sometimes take action, the details are “commercial-in-confidence”. Months or years may elapse, complainants are told nothing and the TGA publicises nothing, all very convenient for industry!

The only way that these “Guidelines” might have some impact would be if the TGA used them to undertake a post-market review of ALL listed weight-loss product; in short insisting that ALL sponsors of these products submit the evidence (according to the new Guidelines) that substantiates their efficacy.

Is the TGA likely to do this; on their current form?

In August 2008, Parliamentary secretary Jan McLucas said there was a real sense of urgency about reforming the complaints process and available information on weight-loss pills, vitamins, herbal remedies and other complementary medicines on which Australians spend more than $2 billion a year.

I believe that it’s time that Senator McLucas held the TGA to account! Or perhaps others might do so at the forthcoming Senate Estimates Committee?

Peter Fray

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