[e-drug] Australian court suppresses complementary medicines report

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Australian court suppresses complementary medicine report
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BMJ Australian court suppresses report questioning effectiveness of
complementary remedy

http://bmj.bmjjournals.com/cgi/content/full/333/7559/116-a
[copied as fair use]

Canberra, Bob Burton

A Federal Court of Australia judge has granted an injunction sought by a
complementary health company to temporarily suppress a report by a
consumer watchdog group.

The report challenges claims that Tebonin, a product containing an
extract of Ginkgo biloba, is an effective treatment for tinnitus.

In April 2006 Schwabe Pharma (Australia) launched a major marketing
campaign in pharmacies, newspapers, and magazines promoting Tebonin
for tinnitus and vertigo relief.

Tebonin contains an extract of Ginkgo biloba leaves called EGB761 and
is made by the German company Dr Willmar Schwabe. On its website and in
other promotional material the Australian subsidiary of the company
claims that Tebonin has been shown through clinical research to be an
effective treatment for a range of conditions related to impaired
micro-circulation.

AusPharm Consumer Health Watch, an informal group of mostly pharmacists
but also including a doctor, reviewed several studies, including those
the distributors cited as supporting its promotional claims. In a draft
report the group raised doubts about Tebonin's effectiveness.

Schwabe Pharma and its distributor, Natural Health Products, sought an
injunction to suppress the report, claiming that its publication would
constitute misleading or deceptive conduct under the provisions of the
Trade Practices Act.

The companies argued that the report could cause significant financial
damage, and they also sought to restrain the consumer group from
otherwise engaging in criticism of the product Tebonin whether orally
or in writing.

In his decision granting the injunction the Federal Court judge Justice
Greenwood said that the Therapeutic Goods Administration could
investigate the complaint over the promotion of the product.

Commentators point out, however, that a regulation under the act
specifically prevents the administration from investigating a
complaint if a proceeding has begun in a court about the subject matter
of the complaint and the proceeding has not been finally disposed of.

The administration can now only review evidence submitted at the time of
the application for Tebonin to be included on the register of
therapeutic products. Any adverse findings are not made public.

Justice Greenwood rejected the applicability of public interest
protections available under the legislation on the grounds that several
of the report's authors were also involved in profit making websites and
that one of the 10 internet links given on the groups website was to
one of those sites. He also said that clinical trial data on Ginkgo
biloba in the group's report should be distinguished from data on the
company's product.

[Snip]

Advocacy groups are pressing Australian state governments to reform
legislation to prevent similar suits in the future.

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Comment: This case raises interesting questions about the regulation of
complementary medicines in Australia. It also highlights the need for
independent information about such medicines in order to assist informed
decision-making by consumers.

Sponsors of complementary medicines who wish to supply products in
Australia must apply to the Therapeutic Goods Administration (TGA) and
have their product included on the Australian Register of Therapeutic
Goods (ARTG) as either a "Listed" or "Registered" medicine. All "Listed"
and "Registered" medicines must be manufactured in accordance with the
principles of Good Manufacturing Practice (GMP).

"Registered" medicines are assessed as having a higher level of risk,
and are individually assessed by the TGA for quality, safety and
efficacy prior to market entry. "Listed" medicines are considered to be
of lower risk as they may only contain ingredients approved by the TGA
as being of low risk and may only make certain therapeutic claims. Most,
but not all, complementary medicines are "Listed" medicines (designated
AUST-L on the packet).

Initially, the TGA did not require evidence to support manufacturers'
claims for AUST-L products, provided the products were not for the
treatment of serious illnesses. A concern that multiple and at times
improbable claims were being made about such products led to the
introduction in April 1999 of a requirement that sponsors of AUST-L
products must hold evidence to substantiate their claims. This evidence
may be called for and evaluated by the TGA, should a concern or
complaint arise at any time during the life of a product. If the
evidence is inadequate, the TGA may cancel the listing for the product.

In 2003, an expert committee recommended that sponsors of AUST L
medicines should submit summaries of the evidence they hold to support
the efficacy of their products and that the TGA should randomly audit
this information. See:

http://www.australianprescriber.com/magazine/27/6/156/8/

A random sample of approximately 20% of new listings is now assessed in
detail each year for compliance with the listing requirements but
details of this process are not made public. This is just one of many 
concerns about the lack of transparency by the Australian regulator.

See: http://www.australianprescriber.com/magazine/28/4/artid/704/

In addition, in contrast to "registered" medicines the TGA does not 
require the sponsors of complementary medicines to provide "approved" 
product information or consumer medicine information.

Tebonin is categorised as a "Listed" product on the ARTG (No: 125310)
and the indication, "For the symptomatic relief of tinnitus" (and many
other claims) are contained on the ARTG. However, the TGA has yet to
make any assessment of the scientific validity of these claims.

Australia has an excellent quality use of medicines policy which
advocates the importance of independent information (and ethical
promotion) to assist decision making about medicines use. However,
despite extensive use of complementary medicines by the general public,
national therapeutic information providers such as Therapeutic
Guidelines, the Australian Medicines Handbook and the National
Prescribing Service do not yet provide independent information about 
these products.