E-drug: Australia shaken by complementary medicines recall
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[E-druggers, please note the 5th par of the text below. It explains that
complementary medicines are LISTED by TGA but not scrutinised in
the same way as registered pharmaceuticals. TGA does conduct spot
audits and encourages reports by doctors, pharmacists and patients
about even suspicions of adverse reactions to complementary as well
as formal pharmaceutical preparations. Consumer representatives
have called for better government resourcing of TGA so they can ade-
quately scrutinise complementary medicines. Copied as fair use. BS]
Australia shaken by complementary medicines recall
Lancet 361, 9370, 17 May 2003
[copied as fair use]
Confidence in Australia's complementary medicines industry has been
shaken after the Therapeutic Goods Administration (TGA) suspended
the production licence of Pan Pharmaceuticals--Australia's leading
manufacturer of complementary medicines.
After a 3-month audit, the TGA suspended Pan's licence for 6 months
on April 28. The audit found evidence of manipulation of test results,
substandard manufacturing processes, and substitution of ingredients.
The TGA also ordered an urgent recall of 1546 products made by
Pan.
The TGA first became aware of Pan Pharmaceuticals after reports of
adverse reactions to its anti-travel sickness product, Travacalm, in
January. Faulty batches of the product were responsible for 19 people
being admitted to hospital and 68 people having serious adverse
reactions. The TGA subsequently found that some batches of the
tablets contained up to seven times the amount of the active
ingredient--hyoscine hydrobromide.
On May 8, Pan terminated the services of its general manager, John
Brennan, after share register records revealed that Brennan, his wife,
and other members of his family sold their shares in Pan just over a
week after an audit by the TGA in February.
The debate has now shifted to focus on the efficacy of complementary
medicines. "These products are simply listed for risk management,
assessed on an audit basis, and included on an adverse-event
register. It is not the same level of scrutiny as registered
pharmaceuticals", Mitch Messer, Chairperson of the Consumers'
Health Forum of Australia, told The Lancet. "People have made
assumptions about what they are buying. At least now they are better
informed and they can make better choices."
Martyn Goddard, Health Policy Officer at the Australian Consumers
Association, criticised the government's failure to properly resource
the TGA. "There is now a proper challenge to the regulators and the
complementary medicine industry to prove products work and are
safe. This is an industry that has existed on faith rather than science",
he said. "Unfortunately, most consumers believe that when a health
claim is made for a product, there is solid scientific evidence behind
it--but there is more snake oil and quackery than in the 19th century.
We need more data. If a product works, we need to know that, if a
product doesn't work, we need to know that as well--to a high level of
scientific certainty. And on top of that, consumers need to be sure of
manufacturing quality. This is an industry at the crossroads. What
happens next could be seen to be the good that comes of the Pan
Pharmaceuticals recall."
Bebe Loff, Helen McKelvie
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