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?
Gee I liked that tag “traditional evidence”. I am goin to nick it and use it when the CAM folk start off at parties etc.
What do you do when things have ground down this far. The craze that’s developed over the last 20 years is astounding. Being a scientist i am sometimes thought of as the person to ask all sorts. Ive been bailed up by chiropractors, mortally offended naturopaths and acupunturists.
I think a far more dangerous thing is self diagnosing and then self medicating because labels do not give the warning “you should see a real doctor before you even think of buying this”.
Can you imagine the scenario where a mother prescribes St Johns wort to her labile teenager? who would be responsible for that? Its natural and safe… St Johns wort must be healthy and appropriate to dish out to someone who is being different. Its what 51% of the population seems to think.
As far as useless product.. there is no such thing.. purchasing it means retail therapy. Thats enough for some.
Finally, I still do not see why we should accept listed product endorsements from people who are great at sport or just downright gorgeous for things that do not work (except retail therapy of course). I cant even watch the tv when Deeks or the Punter are being interviewed. That is sad, i respect them for what they are.
There is a theory that short very intense exercise, with a good break between, can trigger fat loss due to factors that I believe the Murdoch Uni or UWA were looking into last year. I recall seing the 20 sec news clips on the box and became interested. Recently a BBC report showed a small experiment that may be linked to this , as it concentrated on diabetes and reducing its risk.
http://news.bbc.co.uk/2/hi/uk_news/scotland/edinburgh_and_east/7852987.stm
Yes , the claims that some products used by the “complimentary” industry for weight loss are something to be looked at, I think overall in these products ,Dr Stantons view is correct. BUYER BEWARE.
The basics though are the alternative/complimentary industry has been attacked on an ongoing basis by the pharma industry. It wants that money…..that 2 billion!!!
“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.”
Yes Ken , your friends in the pharma want that money. You talk about “clinical trials” and want to ignore “traditional ” EVIDENCE. Typically lets look at VIOXX….trials that said it was safe but how many Australians are DEAD because of the “trials” that are done by the pharma industry themselves, with no oversight. You are right that the TGA does not have the resources to check out companies and their products, especially the multi national drug firms that push their artificial drugs on human hosts. The FDA is in the same boat.
Herbs and vitamins are not in this class. I spent 20 years with the drugs of the pharma in me for my ulcer. What it has done I dont know, but after the antibiotics to clear the pain, I decided I WILL start to oversee my health. I will take what I deem fit. Not the artcificial patented products for pure profit .
Losing body fat is quite difficult and takes much more time than most people realise. Claims that you can lose 1kg or more a week are unrealistic except for those who are extremely large, but that’s not the impression you get from the names, labels, sales blurbs and advertisements for weight loss products. Many imply that all you need do is buy the product and the weight will miraculously ‘fall off’. Fast weight loss products ‘work’ by causing a loss of weight from water, lean tissue and the body’s stores of glycogen. Rapid weight loss is not fat loss.
Choice (February 2009) has an article titled Losing weight on a ‘program’. It examines weight loss meal replacement products sold as a package through pharmacies with findings that the training for the sellers of these weight loss ‘solutions’ is way below par. “Evidence” for their efficacy comes as testimonials from untraceable people. Pharmacies that sell these products need to take a good look at themselves, but I doubt they will see a problem. After all, many have been sucked into using some of their shops for fridges stocked with very expensive cordials with a few vitamins thrown in known as ‘vitamin waters’ . The Therapeutic Goods Administration should take a good hard look at many products sold in pharmacies. Even though they took a drubbing on vitamins and other supplements a few years ago, they need some kind of labelling guide where potential customers can see whether the product has or has not been evaluated. The average shopper has no idea that listed products are different from those that have been registered with TGA. How about a simple statement that says ‘Buyer beware: there is no proof that this product works’.
It seems to me ironic that one of the few weight loss products available to consumers without prescription truly subjugated by the consumer movement in this area has been Xenical. From what I can gather, at the behest of consumer groups, this product was stripped of its ability to advertise to the public. Astonishingly enough this product appears to be one of the only with solid science to support its claims, and appropriate controls governing supply (via a Pharmacist)!
Now I know that this was a ‘pharma’ product of differing registration status to these often offending ‘listed’ products, and other factors may be at play, but the removal of such a fundamentally important aspect of a products ability to reach its market seems extremely severe, particularly considering that it has effectively curtailed consumer choice to the smorgasbord of rubbish that continues to advertise freely.
As consumers shouldn’t we be encouraging products that hold sufficient evidence and have appropriate controls around supply with carrots such as the right to advertise? Isn’t that the intention of these guidelines?