Healthy Skepticism Library item: 19590

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Publication type: news

Dayton L
Disputed remedy in the dock: a defamation case highlights the need to tighten regulation of complementary medicines
The Australian 2011 Jun 18
http://www.theaustralian.com.au/news/health-science/disputed-remedy-in-the-dock-a-defamation-case-highlights-the-need-to-tighten-regulation-of-complementary-medicines/story-e6frg8y6-1226076682759

Full text:

LAST Tuesday, Ken Harvey was stranded in Melbourne as airlines juggled volcanic ash. But the public health physician’s lawyers were able to attend the Supreme Court in Sydney on his behalf.

Harvey, an adjunct professor at La Trobe University, is being sued for defamation by SensaSlim Australia, the supplier of a nasal spray marketed as an effective weight-loss product. SensaSlim is seeking $800,000 in damages.

Harvey had challenged SensaSlim’s claim. In Sydney, the parties agreed to court orders over the further conduct of the claim, but the case goes on.

It all began in late April. That’s when Harvey lodged an official complaint with the regulator of complementary medicines, the Therapeutic Goods Administration, arguing that a spokesman for the company misled the public about the efficacy of its liquid spray.

“The nub of my complaint is it doesn’t do what is claimed,” alleges Harvey, who is a prominent advocate for the tighter regulation of complementary medicines.

SensaSlim legal adviser Terry Harrison tells Weekend Health the company has supplied the TGA with the evidence.

Weekend Health asked to see the evidence, preferably a trial report published in a peer-reviewed journal. Instead, the firm sent links to media reports and an apparently unpublished abstract merely stating the nasal spray works.

The Therapeutic Goods Act does not require a company or individual — a sponsor — to prove their product works, only to claim such evidence exists. Under the act, the TGA is required to consider whether a product is manufactured safely and contains an approved set of ingredients.

When a report about Harvey’s complaint was published on auspharmacist.net.au — Harvey claims he did not write it — SensaSlim launched defamation action, effectively halting the TGA’s investigation of the complaint until the case is complete.

“My view is it’s a delaying tactic,” suggests Harvey. But Harrison says, “I’m more than happy with the complaints resolution process.”

The merits of the case aside, there’s a twist in the tale. A very similar case concluded two weeks ago in the Federal Court — similar in that it involved claims made by providers of complementary products and services.

In that case, two companies and two individuals were hit with penalties totalling $185,000 for making false claims and misleading consumers about their ability to test for and treat allergies, using unproven complementary products and methods.

The difference between the two cases is that the Federal Court matter was brought and funded by the Australian Competition and Consumer Commission, based on allegations raised by Canberra immunologist Raymond Mullins, an allergy specialist in private practice.

In effect, the ACCC’s involvement sidestepped TGA complaints protocols. In contrast, Harvey claims he’s already about $17,000 out of pocket.

Although outgoing ACCC chairman Graeme Samuel declines to comment on whether the SensaSlim matter is the type of case the commission could take up, he tells Weekend Health that the ACCC’s Federal Court victory is a “major step forward” in its relationship with the TGA. “There’s been a change of approach at the TGA, which has been working a lot more in collaboration with us.

“In the past the processes of the TGA weren’t attuned to speed.”

Statistics posted online by the TGA’s independent Complaints Resolution Panel confirm Samuel’s statement. The average period between receiving a complaint and determining an outcome fell from 147 days in 2007 and 153 in 2008 to 113 days in 2009.

Clearly, as Samuel suggests, closer co-operation between the two bodies promises “beneficial changes” in areas where providers of complementary medicines and services engage in misleading and deceptive conduct. Although the TGA had not responded to queries by the time Weekend Health went to press, a spokesperson informally acknowledged the authority had been working with the ACCC for some time.

Harvey agrees the two organisations should work closely together to protect the public, but he’s not optimistic. “I’ve talked to the TGA over a few years about my concerns about the regulation of complementary products,” he says, adding that the existing situation “also discourages the sponsors of evidence-based, legitimate, proven complementary medicines. They have no traction in the marketplace. Consumers can’t distinguish between the good guys and the bad guys.”