Healthy Skepticism Library item: 14984

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.
Anger at delay on fat drug guideline by the Therapeutic Goods Administration
The Australian 2009 Jan 23
http://www.theaustralian.news.com.au/story/0,25197,24950524-2702,00.html

Full text:

AUSTRALIA’S drug regulator is facing claims it is protecting the companies it is supposed to keep in line, with consumer groups angered by an apparent failure by the Therapeutic Goods Administration to act on concerns about herbal weight-loss products.

The TGA has taken 14 months to prepare draft guidelines to tighten controls on the complementary medicine industry.

The guidelines, which are expected to be put out for consultation next month, aim to clarify the scientific evidence that complementary medicine makers must hold to justify claims being made for their products.

But even sections of the complementary medicine industry are exasperated by the delay, after an unpublished consultant’s report on the issue was handed to the regulator in November 2007.

Critics of the industry say that while existing lax standards persist, companies are “laughing all the way to the bank” by making questionable advertising claims.

A review last year of such over-the-counter products, which are sold freely in pharmacies and supermarkets at up to $50 a pack, found more than 1000 had been listed by the TGA between 1996 to 2006, most containing differing permutations of herbs, minerals and vitamins.

The review, published in the Medical Journal of Australia, found the claims for the products were “often not in accord with the limited scientific evidence available”. The concerns are shared by some complementary products makers, who fear aggressive marketing claims give the industry a bad name.

One product, called FatBlaster, contains herbs such as brindleberry, guarana and bitter orange, which critics say lack credible evidence of aiding in weight loss. The product’s website features before-and-after photos of a bikini-clad woman, who is quoted saying: “I looked like a pregnant Teletubbie — now I’m happy and healthy thanks to FatBlaster.”

The joint government-industry run complaints body, the Complaints Resolution Panel, is overloaded and can only “request” companies to remove advertising claims that it deems unjustified. The complaints process can take months and the CRP’s only sanction for companies that refuse to comply is to refer the matter to the TGA for action.

However, companies can seek an internal review against any sanction the TGA proposes.

Ken Harvey, adjunct senior research fellow at La Trobe University’s School of Public Health, and a campaigner for tighter regulation of complementary medicines, said the long-awaited guidelines should reduce the number of complaints, but still fell short of the full review of weight loss products called for in last year’s Medical Journal paper.

Dr Harvey said it had been estimated that the TGA reaped about $800,000 a year in licensing and administrative income from complementary weight-loss products and one “unkind conclusion” was that this was linked to the TGA’s slow pace.

“They take on board the industry’s concerns about the need to be profitable and make these products available, and don’t seem to balance that with consumer protection.”

A TGA spokeswoman said the $800,000 figure was “considerably overstated” and it was “entirely improper to suggest that fees charged by the TGA … put the TGA in the pockets of the pharmaceutical or complementary medicine companies”.

Choice senior health policy officer Michael Johnston backed Dr Harvey’s concerns.

“Our concern’s always been that these products are reasonably expensive, but also people are looking for a quick fix for weight loss. That’s not the right attitude,” he said.

Wendy Morrow, executive director of the Complementary Healthcare Council, defended the products. “Just because there’s a lack of clinical evidence, doesn’t mean that the product doesn’t work,” she said.