Harvey ‘s MIMS complaint
December 15, 2010
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IF MIMS continues to publish
information from Listed medicine
product sponsors that is “potentially
erroneous and harmful” then a
prominent disclaimer should be
attached to each information page,
according to Adjunct Senior
Lecturer, Dr Ken Harvey, from the
School of Public Health at La Trobe
University.
Speaking to PD Harvey tendered
his comments following a
complaint he made to the
Therapeutic Goods Administration
regarding the promotion of Ethical
Nutrients’ ‘Urinary Tract Support’
herbal supplement in a number of
publications.
According to Harvey, the product
claims made in the promotions had
a lack of verifiable evidential
support.
“Promoting this product for
urinary tract infections (an
infectious disease best treated with
antibiotics) is a breach of Section
42DL(1)(c) of the Therapeutic
Goods Act 1989,” Harvey said in
his complaint letter to the TGA.
In response to his complaint
Harvey was told that a portion of
the information cited in some of the
Urinary Tract Support promotions
was sourced from MIMS.
“MIMS then confirmed that their
product information (PI) on Listed
complementary medicines was
provided by the company
concerned and received no
independent validation,” Harvey
told PD.
A MIMS disclaimer also states
that it ‘reproduces information as
provided by pharmaceutical
companies and approved by the
Therapeutic Goods Administration’.
“I have pointed out to MIMS that
this statement does not accurately
reflect the difference between TGA
“approved prescribing information”
(provided for prescription products)
and information on Listed
medicines that is not routinely
checked by the TGA,” Harvey said.
“The TGA have admitted (after
an FOI request) that, the high level
of regulatory compliance
irregularities (found on monitoring
26% of newly listed medicines)
presents a major risk to confidence
in the Australian Government’s
regulatory framework for
complementary medicines and the
complementary industry itself,” he
added.
At the time of publication
representatives for MIMS had not
yet responded to PD’s questions
regarding their Listed medicine
product information.
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