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Australia shaken by complementary medicines recall

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					MEDICINE AND HEALTH POLICY




   MEDICINE AND HEALTH POLICY

Australia shaken by complementary medicines recall
      onfidence in Australia’s
C     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.                                 Rights were not granted to include this image in electronic
   After a 3-month audit, the
TGA suspended Pan’s licence                                      media. Please refer to the printed journal.
for 6 months on April 28.
The audit found evidence of
manipulation of test results,
substandard manufacturing
processes, and substitution of
                                  PA Photos/AFP




ingredients. The TGA also
ordered an urgent recall of
1546 products made by Pan.
   The TGA first became
aware of Pan Pharmaceuticals                      Pharmacists have been ordered to remove Pan Pharmaceutical’s products from their shelves
after reports of adverse
reactions to its anti-travel                      are better informed and they
sickness product, Travacalm,                      can make better choices.”        Coordination centre for UK
in January. Faulty batches of                        Martyn Goddard, Health
the product were responsible                      Policy Officer at the            Biobank project announced
for 19 people being admitted                      Australian Consumers
to hospital and 68 people                                                                he University of Manchester has been selected to host
having serious adverse
reactions. The TGA
                                                  Association, criticised the
                                                  government’s failure to
                                                  properly resource the TGA.
                                                                                   T     the coordination centre for the UK Biobank project, the
                                                                                   Medical Research Council, Wellcome Trust, and the
subsequently found that some                      “There is now a proper           Department of Health announced in a joint statement on
batches of the tablets                            challenge to the regulators      May 7.
contained up to seven times                       and the complementary               The controversial project aims to link DNA samples and
the amount of the active                          medicine industry to prove       lifestyle data with the medical records of up to 500 000
ingredient—hyoscine                               products work and are safe.      individuals aged 45–69 years, who are then tracked for
hydrobromide.                                     This is an industry that has     30 years, to explore the role of genes and environment on
   On May 8, Pan terminated                       existed on faith rather than     health. Experts hope the national database, which has
the services of its general                       science”, he said.               received initial funding of £45 million (US$ 72 million), will
manager, John Brennan, after                      “Unfortunately, most             enable scientists to determine which factors are responsible
share register records revealed                   consumers believe that when      for disorders such as heart disease, cancer, Parkinson’s
that Brennan, his wife, and                       a health claim is made for a     disease, and diabetes (see http://www.biobank.ac.uk).
other members of his family                       product, there is solid             The Manchester headquarters will have overall
sold their shares in Pan just                     scientific evidence behind       responsibility for delivering the project and will be
over a week after an audit by                     it—but there is more snake oil   responsible for participant recruitment, initial data and
the TGA in February.                              and quackery than in the 19th    sample collection, and coordinating the activities of six
   The debate has now shifted                     century. We need more data.      regional collaborating centres.
to focus on the efficacy of                       If a product works, we need         “Manchester welcomes the opportunity to host this
complementary medicines.                          to know that, if a product       landmark project to determine the contributions of both
“These products are simply                        doesn’t work, we need to         nature and nurture to human health”, commented Bill
listed for risk management,                       know that as well—to a high      Ollier, professor in immunogenetics at the university.
assessed on an audit basis,                       level of scientific certainty.   “Hosting the coordinating centre for Biobank UK
and included on an adverse-                       And on top of that,              consolidates Manchester’s position as an international centre
event register. It is not the                     consumers need to be sure of     of excellence in genetics.”
same level of scrutiny as                         manufacturing quality. This is      Biobank’s chief executive, John Newton, said: “This
registered pharmaceuticals”,                      an industry at the crossroads.   announcement heralds the next phase of UK Biobank.
Mitch Messer, Chairperson                         What happens next could be       Setting up the coordinating centre in Manchester and
of the Consumers’ Health                          seen to be the good that         developing capacity in the regional collaborating centres will
Forum of Australia, told The                      comes of the Pan                 drive the project forward in an exciting way.”
Lancet. “People have made                         Pharmaceuticals recall.”
assumptions about what they                                                        Helen Frankish
are buying. At least now they                     Bebe Loff, Helen McKelvie


1710                                                                                        THE LANCET • Vol 361 • May 17, 2003 • www.thelancet.com

  For personal use. Only reproduce with permission from The Lancet Publishing Group.

				
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