E-DRUG: Australian row over regulation of alternative drugs deepens
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[copied as fair use; WB]
http://www.theaustralian.news.com.au/story/0,20867,19858386-23289,00.html
A court battle has drawn renewed attention to whether there is enough
policing of the promotional claims made for complementary medicines.
Adam Cresswell reports
July 22, 2006
SO worried was the professional body for pharmacists earlier this year
about the proliferation of dodgy products on pharmacy shelves, it made a
statement warning its own members of the dangers in no uncertain terms.
In a media release dated February 1, 2006, the national president of the
Pharmaceutical Society of Australia, Brian Grogan, noted that by selling
"'miracle' products that offer no evidence for their quasi-therapeutic
claims, some pharmacies are undermining the very basis for the
profession's trusted position in the Australian community".
The product singled out for criticism was a so-called "oxygen therapy in
a bottle" called Oxygen4Life, which the PSA castigated as "just the
latest in a long line of dubious offerings" to have hit the shelves.
It was that statement that precipitated the formation of AusPharm
Consumer Health Watch, which was set up in April by about 10
pharmacists, academics and others with an interest in assessing the
evidence behind the promotional claims.
Aiming to "help consumers make informed choices about these
(non-prescription health-related) products", the website's founders
worked out a process for gathering evidence on a product's effectiveness
both from the product's makers and independently. They would then assess
the strength of the evidence, and seek further comments before coming to
a conclusion about the extent to which the claims made by the makers
could be substantiated.
But the website now faces an uncertain future after Schwabe Australia
successfully took it to the Federal Court to suppress a report being
prepared on the firm's herbal remedy for tinnitus, Tebonin.
The site's 10 backers had already shrunk to three in the face of the
growing legal threat, and the remaining trio are now preparing to
capitulate after paying $15,000 out of their own pockets in an
unsuccessful bid to oppose the temporary injunction banning publication
of their report.
It is understood the three are willing to agree on the injunction being
made permanent in exchange for Schwabe dropping the case. The company
had objected to the process by which the report was drawn up, as well as
to its assumptions and conclusions.
The final outcome of the case remained unclear this week. But one of the
three remaining backers of the website, La Trobe University academic Ken
Harvey, says whatever the outcome the episode illustrates a wider point
about the regulation of OTC products in Australia.
"Most people don't realise that this stuff is just not looked at by the
regulators," he says.
Plenty of others share his concerns.
Although Australia's regulation of prescription-only medicines is
considered among the best in the world, the rules are different for
over-the-counter and complementary medicines, particularly those which
are deemed to pose no safety risk.
Higher-risk medicines, which include the prescription-only drugs and
some OTC ones, are "registered" on the Australian Register of
Therapeutic Goods (ARTG), which is administered by the industry
regulator, the Therapeutic Goods Administration. Registered medicines
are evaluated by the TGA for quality, safety and effectiveness.
According to the TGA, "most, but not all" complementary medicines are
considered lower risk - meaning they only have to be "listed" on the
register. While they still have to meet quality and safety requirements,
they are not evaluated for effectiveness before they go on sale - in
other words, there is no independent test to check if they are any good
for whatever complaint the manufacturers are selling them for.
All the makers are supposed to do is have "evidence to support the
claims made for their product and to make such evidence available to the
TGA if requested".
How often they are requested to do this is a moot point. Harvey says
only 20 per cent of new applications have their claims examined, while
the thousands of products already on the register continue to escape
scrutiny.
Listed medicines must also comply with limitations on promotional
messages. They must generally only carry claims for "health maintenance
and health enhancement" - not promise a miracle cure - and must not
refer to serious diseases, disorders or conditions. They must also "not
indicate that they are for the treatment, management, cure or prevention
of any condition or disease".
The TGA says it "is aware of concerns raised by AusPharm regarding the
product Tebonin" and has monitored the court proceedings.
"Being a Listed medicine, Tebonin is subjected to the normal regulatory
processes applicable to Listed medicines, which may include reviews of
the product labelling, manufacturing processes and evidence held by the
company in support of their product claims," the agency said in a statement.
"Complaints concerning advertisements are dealt with through a
co-regulatory committee, the Complaints Resolution Committee (CRC),
which is representative of all peak stakeholder groups including consumers.
"The TGA is an observer on the CRC and, in the absence of any public
health and safety concerns, it is appropriate for the CRC to consider
issues relating to the advertising of Tebonin."
The consumer magazine Choice is firmly behind Harvey and the AusPharm
team, as it has long advocated a tougher stance on non-prescription
drugs. Choice media spokeswoman Indira Naidoo said consumers "definitely
want the TGA to crack down" on the sale of complementary medicines.
"A lot of consumers do not realise that a lot of complementary medicines
sold on the market do not have enough evidence, we believe, to support
the claims made for them," she says. "They are very rarely asked to
produce evidence and research material to support the claims they make
about their products. Many consumers assume that because a product is
available, that it does what it says. That's not the case."
Currently the TGA is wholly funded by contributions from the drug
industry it is supposed to be regulating - something the ACA says has to
change.
"We think that (industry funding) compromises its independence and
transparency," Naidoo says. "We want that changed so it can be a truly
independent body."
Another expert who thinks it's time for a bit more rigour is Ric Day,
professor of clinical pharmacology at the University of NSW and Sydney's
St Vincent's Hospital.
Day says for prescription medicines, there's "pretty good information"
freely available to patients and doctors in the form of Consumer
Medicine Information, the contents of which are regulated.
"Our regulatory system for complementary medicines is very good compared
to most places in the world," Day says. "But one area where the whole
field could be improved is access to good information about the veracity
of the claims."
He cites the example of the National Prescribing Service, which
evaluates and publishes assessments of the evidence for prescription
drugs, and says we "need the same sort of information" for complementary
medicines.
Ken Harvey says in his view the solution lies in empowering the TGA to
"immediately require the sponsor of each complementary medicine to list
the key evidence for each claim on the ARTG, and make this information
publicly available on the TGA website".
Under the current rules, the only information publicly available is the
product name and the name of the company that applied to put it on the
register.
"Claims could range from 'may relieve XYZ' (supported by traditional
use) to 'clinically proven to improve ABC' (based on a reputable
analysis of several studies, such as a Cochrane Collaboration review).
"I also believe the sponsor should be required to make a statement on
the ARTCG (supported by evidence) about side effects,
contra-indications, interactions, etc.
"In the longer term I believe that complementary and alternative
medicines should have TGA approved Consumer Medicines Information
available as packet leaflets from health professionals and via the TGA
and NPS websites."