E-drug: Challenging complementary medicines claims in Australia
---------------------------------------------------------------
[Copied as fair use - DB]
Disputed remedy in the dock: an Australian defamation case highlights the
need to tighten regulation of complementary medicines.
Leigh Dayton | The Weekend Australian | June 18, 2011
LAST Tuesday, Dr 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reports and an apparently unpublished abstract merely stating the nasal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."
[For the latest news on "The SensaSlim Affair" see Dr Harvey's blog at:
http://www.medreach.com.au/?page_id=115]