Healthy Skepticism Library item: 14056

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Publication type: news

Cresswell A.
Alternative medicine's lax rules attacked
The Australian 2008 Aug 2
http://www.theaustralian.news.com.au/story/0,25197,24108440-23289,00.html

Full text:

A HUGE increase in fines against pharmaceutical companies for breaching drug promotion rules is increasing pressure on the federal Government to clamp down on lax practices in the alternative medicine sector.

Critics say that while fines of up to $200,000 hang over the heads of conventional drug makers who break the rules, the complaints mechanism for complementary medicines lacks any effective sanction.

They say there is also insufficient assessment of products at the time of listing them with the TGA, which allows complementary and alternative medicines (CAM) makers to get away with claiming benefits for products that are, at the very least, highly dubious.

The push is being resisted by the complementary industry’s main umbrella group, the Complementary Healthcare Council, which has long argued that the lower risk profile of most complementary medicines means a tougher line is unwarranted.

The CHC’s new executive director, Wendy Morrow, argues that the existing regulation of CAM is sufficient, and while complaints handling is slow, that is a “resourcing issue, not a system issue”. “We don’t believe that throwing out the existing system and bringing in a new one makes it any better for consumers,” she said.

However, part of the push for a tougher line is now coming from some elements of the CAM industry itself. Earlier this month, a group called the Naturopathy Foundation submitted a paper to Parliamentary Secretary for Health and Ageing Jan McLucas, arguing that stricter regulation on a number of fronts would “lift the quality of (alternative) practitioners, improve patient safety, promote research and allow for greater collaboration between complementary and conventional medicine”.

Naturopath Jon Wardle, a research student at the University of Queensland and who wrote the report, said existing regulation of CAM was “completely inadequate” and what was needed was better assessment of the quality of herbal medicines as well as regulation of promotional claims and practitioners themselves.

Although many naturopaths were now being trained in four-year university courses, some practitioners were calling themselves naturopaths with far less training — or sometimes no training at all, Wardle said.

He said a lot of Australian companies chose the cheapest ingredients for their products, but this often resulted in inferior or even ineffective products. One example was echinacea, a herb often used in cold remedies. “A lot of products use the (echinacea) leaf, which is nowhere near as effective as the root, but a lot cheaper.” Also of variable quality was the arthritis remedy glucosamine.

Health academic Ken Harvey, a longstanding critic of unbridled drug promotion, said evidence of efficacy was largely restricted to glucosamine sulphate — whereas many products contained a different variant, glucosamine hydrochloride, which did not work as well.

Harvey contrasts the “slow and ineffective” CRP system with the sanctions available for pharmaceutical giants.

Medicines Australia, the peak industry group for pharmaceutical giants, is currently working out how to spend a record $1.8 million in fines announced in its recent code of conduct annual report. This year’s 34 fines dwarf the 16 fines worth a combined $695,000 imposed in 2006-07. In previous years the fee income was used to defray the $600,000 cost of administering the MA code of conduct process, but the size of this year’s fine income creates a substantial excess.

Medicines Australia says options are being considered, such as programs to promote compliance with the code. “Under no circumstances” would the cash be used for the “direct or indirect benefit of (MA) member companies”.

No financial penalties at all are available to the parallel scheme for CAM, administered by the Complaints Resolution Panel of the Therapeutic Goods Advertising Code Council. The CRP can merely “request” companies withdraw the offending material, and refer them to the Therapeutic Goods Administration if they fail to comply.

A complaint by Harvey against nine separate ginkgo products has just been referred by the CRP to the TGA, after the CRP decided the complaint was less about advertising claims and more about the quality of supporting evidence.

In one case, Harvey noted a claim that ginkgo “has been found to be clinically effective in improving working memory in healthy individuals”. The product also claimed that “clinical efficacy has also been established for cerebral insufficiency in the elderly; difficulties of concentration and memory, absent-mindedness, confusion, tiredness, decreased physical performance, lack of energy, dizziness, aches, (and) disorders of circulation”. Harvey’s complaint cited two systematic reviews that found negligible evidence of beneficial effect on brain or memory function from ginkgo.

In January Senator McLucas asked the TGA to investigate claims that herbal medicines claiming to cause weight loss were ineffective and misleading. The minister’s office this week referred enquiries on progress to the federal health department, which said the National Prescribing Service was currently studying the “information and skills needs of consumers and health professionals in relation to complementary medicines”.