Healthy Skepticism Library item: 5797

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

Catch 22 stymies ad complaint
Pharma in Focus (Australia) 2006 Jul 31
http://www.pharmainfocus.com.au/news.asp?newsid=1252

Notes:

Ralph Faggotter’s Comments:

In a bizarre legal decision, a judge has cast the issue of whether Schwabe’s Tebonin should be permitted to be advertised to as an effective treatment for tinnitus, into an insoluble legal dilema- a Catch 22 from which it cannot be extricated. The judge has declared that the TGA must rule on the issue before the Court can consider it further, but the TGA cannot do so while the matter is before the Court.
Consequently, unless a thrid party ( government or a higher court) intervenes, the judge has guaranteed that the matter can never be resolved!

see http://www.austlii.edu.au/au/cases/cth/federal_ct/2006/868.html for Court details

Full text:

A little known aspect of the Therapeutic Goods Act has stymied an
advertising complaint against the complementary health product Tebonin
(gingko biloba) which claims to be “an effective treatment” for tinnitus.

The complaint was lodged with the Therapeutic Goods Administration
(TGA), and the complaints resolution bodies of the Therapeutic Goods
Advertising Code Council and the Complementary Healthcare Council on
June 9 by the operators of the website AusPharm Consumer Health Watch
(www.consumerhealthwatch.net.au). They alleged the product pack, packet
insert and current promotional material for Tebonin makes claims that
are not supported by the full body of evidence.

However, because Tebonin’s sponsor the local arm of the German-based
Schwabe Pharma and one of its local distributors Natural Healthcare have
won a temporary injunction in the Federal Court preventing the website
from publishing an investigation of the medicine, the complaint remains
in limbo and cannot be heard.

While declining to comment on the details of the case, Therapeutic Goods
Advertising Code Council Execituve Officer Judith Brimer said, “The
Regulations specifically prohibit the CRP from adjudicating a complaint
that is the subject of ongoing court action where the subject matter is
the same. While the CRP has the power to make its own procedures in some
respects, it must comply with this regulation.”

The effect of the regulation is that so long as the Federal Court case
remains unresolved, the complaint cannot be heard.

CHC Executive Director Tony Lewis also said his organisation would wait
for the case to be resolved before hearing the complaint. The TGA said
it was appropriate for the co-regulatory committees to consider issues
relating to the advertising of Tebonin.

Mark Dunn, one of the principals of AusPharm Consumer Health Watch said
he had been advised advised that it would cost around $50,000 to contest
the injunction and a larger amount again to take the matter to trial.
The principals have offered Schwabe the opportunity to make the
injunction permanent, Dr Harvey said.

However, solicitor for Schwabe Pharma, John Sweep, said the matter was
still on foot and both parties would need to appear in court again
before it could be discontinued.

The case centres on a critical review of Tebonin originally scheduled
for publication on AusPharm Consumer Health Watch on May 18.

Schwabe and Natural Healthcare alleged the site’s principals had
breached the misleading conduct provisions of the Trade Practices Act in
so far as the way they – especially Dr Harvey – had obtained information
and used it in preparing the review did not adhere to procedural
commitments made on the site. The site’s principals said their activity
was not commercial and so did not fall under the act.

They also said their review was a genuinely held opinion and was
properly founded so publishing it could not be misleading conduct.

Justice Andrew Greenwood disagreed with both these assertions, concluded
there was an issue to be tried and a “reasonably strong prima facie
case”, and placed an interlocutory injunction on publication of the
review pending further hearing of the case.

However, he also said the public interest would be served by enabling
the website principals to articulate their criticisms to “the relevant
officers of the regulatory authorities” which would also give Schwabe an
opportunity to respond.