Healthy Skepticism Library item: 8701

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cresswell A.
Beware the hype if going alternative
The Australian 2007 Mar 3
http://www.theaustralian.news.com.au/story/0,20867,21314498-23289,00.html

Full text:

Australia’s drugs regulators are under fire over the freer rein given to the advertising of alternative products. Health editor Adam Cresswell reports
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OBESITY is a growth industry in Australia, but if it affects you – or you just need to shed a few extra pounds – don’t despair: you are positively spoiled for choice over what to do.
Why not try the herbal preparation Xantrax? As its promotional blurb shouts from every second pharmacy window, it’s “recommended by a doctor” and contains “potent botanical extracts” that can reduce fatigue, suppress the appetite and “enhance the body’s ability to cope with stress”.
A snip at $50 a bottle, you might think, although it would be only fair to point out that the contents of these pills are extracts of bitter orange, guarana, ginseng and green tea, and the (very) small print reveals that the doctor who so enthusiastically recommends it is a paid consultant for the makers.

Never mind – you can move on to “new and improved” FatBlaster Max, which has tantalising photos of svelte, semi-clad models on its packaging.

Perhaps you could be fit like them, too, if only you would lie on the couch and take your herbal medicine – which in FatBlaster’s case will also set you back $50 for 60 tablets. FatBlaster Max leaves Xantrax’s contents box in the dust by adding to the herbal cocktail brindleberry, gymnema, kelp, yerba mate and cayenne, and at least a dozen other ingredients. Bargain!

Well, maybe not.

A trip to the website of the advertising regulator reveals that in December 2005 the company behind FatBlaster was found to have run advertisements “likely to arouse unwarranted and unrealistic expectations of product effectiveness”.

The ads also glossed over the important detail that to expect good results, anyone shelling out hard-earned cash for FatBlaster still has to eat healthily and exercise – in other words, just like everybody else.

Cat Media, the company that developed and markets both FatBlaster and Xantrax, as well as about 20 other complementary medicines, rejects criticisms of the products. A spokesman told Weekend Health that natural weight loss products “are fully backed with scientific, clinical and traditional evidence” to support their claims. “They provide an important low-risk alternative to the potential health risks of pharmaceutical drugs.”

Wherever the truth lies on that question, Xantrax and FatBlaster seem positively respectable when you look at some of the other things officially “listed” by the Therapeutic Goods Administration, Australia’s official medicines watchdog, including treatments for menopause, and “liver tonic pills” that claim to help “strengthen kidney organ meridian energy to supply healthy liver Qi”.

It’s an all-too-familiar story for Queensland scientist Loretta Marron, one of a growing band of sceptics who say it’s time to blow the whistle over what they regard as the TGA’s failure to police complementary medicines.

A tireless advocate for a tougher line, Marron’s latest media turn was in the pages of this week’s GP newspaper Medical Observer, where she accused the TGA of “failing both the public and the pharmacies badly because it’s listing products that simply don’t work”.

Marron told Weekend Health she has “identified 3000 totally useless products” that have been listed by the TGA.

She says the number of weight-loss treatments has grown from 1.5 per cent of total TGA listed products in 1996 to 5.5 per cent last year – “and most are based on caffeine or green tea, and all are useless”.

Fed up with what she sees as the TGA’s inaction, each month for the past six months Marron has taken to researching the evidence (or more usually the lack of) for a specific treatment, and posting the resulting dossier to the TGA.

“I did sex products last month, which was great fun,” Marron confides. “There’s one amazing device that clamps around the crown jewels – it costs $606 and claims to work by inducing a ‘galvanic current’. It’s the same load of claptrap . . . but a lot of erectile problems are in the head, and the placebo is a powerful force.

“It’s really easy to make money with the current rules – just find any garden weed that has a traditional use, put it in a box with flowers or a has-been athlete, list it with the TGA and go on a marketing blitz – and rake in the money.”

This issue is not new, but hit the headlines again this week after an outburst by Fred Nadjarian, the head of Roche Products, maker of the weight-loss drug Xenical.

Xenical, also known by its chemical name orlistat, used to be a prescription-only drug, but was allowed to be sold over pharmacy counters last year. It was also reclassified to allow it to be advertised direct to consumers.

Last week Nadjarian slammed as “just plain nuts” a recent decision by the TGA’s National Drugs and Poisons Schedule Committee to scrap that advertising concession, after complaints by consumer group Choice over Xenical ads screened during the Australian Idol TV show.

Nadjarian said reimposing the advertising ban on Xenical left the field open to “hocus pocus” products “largely based on green tea extract, eye of newt, wing of bat and guinea pig tail”. And a number of others who are normally no friends of Big Pharma have lined up to agree.

Xenical promotes weight loss by blocking the absorption of fat in the gut. Even experts who disapproved of Roche’s TV ads say it is considered very safe and has a legitimate role in treating the patients for whom it is approved – obese patients with a body mass index over 30, or overweight patients who also have other diseases. Side-effects in patients who eat excessive fat while taking Xenical include oily stools and “rectal leakage”.

“To be fair to Roche, they do have a product that works, has been clearly validated by external people, and it does have a small place,” says Ken Harvey, adjunct senior research fellow at Victoria’s La Trobe University. “But by and large, a lot of the alternative products are crazy.”

Higher-risk drugs – usually prescription and pharmacy-only medicines – including Xenical are almost all “registered” by the TGA, a process requiring the manufacturer to pay the TGA a hefty fee in exchange for the TGA evaluating the product for quality, safety and effectiveness.

“Listing” a lower-risk product, on the other hand, is simpler. Most complementary products are listed.

Obtaining a listing is as simple as visiting the TGA’s website, entering some details about your product and paying a fee.

No evidence that the product does what it says it does has to be produced at the time of listing. Officially, sponsors of listed medicines are supposed to hold such evidence in case they are asked for it, which generally only happens after a complaint or when the TGA does random spot-checks.

Listed products cannot make claims about curing, treating, managing or preventing any condition or disease, and may instead only make claims related to symptoms and to “health maintenance and health enhancement”. The TGA says these measures “ensure that consumers will not inappropriately self-diagnose or self-treat potentially serious medical conditions with medications that have not been established as being effective by the TGA”. The agency defends the system as “robust and appropriate”, and Cat Media says all advertisements have to be pre-approved before publication, describing the process as “among the most rigorous and restrictive in the world”.

The TGA says it does take “regulatory action” when it finds evidence is wanting. But critics say the TGA only checks 20 per cent of listed products, so the chances of getting away with over-the-top claims are good.

In addition, critics like Harvey say members of the public do not understand there is any difference between registered medicines and those that are merely listed, and fears that a TGA “listing” simply gives questionable products a sheen of bogus respectability.

Marron also says the significant fee income the TGA derives under the existing system means the agency has little incentive to tighten procedures further.

It costs $950 for an initial application to list a product, and an annual fee of $850 thereafter. “In other words, 3000 dodgy products bring in over $2.5 million,” says Marron. “There’s a culture of denial in the TGA – they don’t want to know what I’m saying.”

Marron also blames some pharmacists for using TGA listing as carte blanche to promote products that as health professionals they ought to steer clear of. But other pharmacists are also just as critical of quick-fix cures.

“As pharmacists, we all know that, in the main, these (weight-loss) products don’t work,” says Tasmanian pharmacist Mark Dunn, publisher of the AusPharm suite of websites.

Dunn says the TGA should “formally assess the evidence for Aust-L (“listed”) weight-loss products and if product sponsors can’t produce good-quality evidence showing that their products work, they should not be allowed to put them on to the market.”

In the meantime, Dunn says products should be compelled to carry the warning: “The TGA has not assessed this product for efficacy”.