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No Evidence That Glatiramer Acetate Slows Multiple Sclerosis (MS) Progression

London, Ontario, November 1 (ots/PRNewswire)

In this week's
issue of the Lancet Neurology, glatiramer acetate, known as
Copaxone(R), was subjected to an independent review. The systematic
review, called a Cochrane Review, performed by Dr. Luca Munari and
colleagues, challenges the claims of benefit from previous
industry-based publications.
A convincing benefit on disability and an effect on the proportion
of patients free from acute flare-ups of the disease during treatment
could not be demonstrated, "Glatiramer acetate is now routinely
prescribed for MS and it is the fastest-growing product in its
market. However our systematic review of all randomized controlled
trials of glatiramer acetate found little support for use of the drug
in patients with MS," notes Dr. Luca Munari of Italy's Azienda
Ospedaliera Niguarda Ca' Granda.
These efficacy-challenging observations might come as a surprise
for many Copaxone users. Most Canadian MS patients and prescribers
are unaware of these early concerns about Copaxone's efficacy even
though the FDA, the U.S. government agency which reviewed the product
license application in 1996, was concerned about "data dredging" in
the sponsor's own data analysis. The agency conceded then that the
treatment had a very slim treatment effect, but approved the drug.
Cochrane Reviews are now being applied to the new drugs being used
to treat multiple sclerosis. Given that Canadian neurologists
prescribed $150 million worth of these new treatments last year, it
is imperative that those without a financial stake scrutinize
treatment claims.
"Canadian health care dollars are precious. We must continue to
scrutinize treatment claims from the pharmaceutical industry and
continue to design clinical studies, which improve upon from the
missteps of previous studies," says Dr. George Rice, Neurologist and
Director of the MS Clinic at London Health Sciences Hospital in
London, Ontario.
The Cochrane Collaboration attempts to distill a true sense of
worth from all published and unpublished clinical trials of a given
agent or intervention, despite industry claims. The approach is
simply to obtain all published observations, to adjudicate trial
methodology and quality and to perform statistical analyses of
aggregate outcomes. The Cochrane organization is not-for-profit and
is designed to provide realistic expectations of what drugs might do,
for patients, prescribers and payers. Application of rigid
methodology in Cochrane views generally leads to more sobering
interpretation of treatment claims.
Beta-Interferons are widely used in the treatment of early,
relapsing forms of multiple sclerosis. The Cochrane Collaboration
scrutinized these clinical trials in a publication in Lancet last
year. A consistent benefit on attacks and disability progression was
identified for two years for which data were available. Concerns were
raised about the relatively short duration of clinical
experimentation justifying use of this kind of treatment in a
disease, which is 40 or 50 years for most patients. Concerns were
also raised about methodological problems across most of the studies
reviewed, particularly the application of rigid intention to treat
analyses.
(R) Copaxone is a registered trademark of Teva Neurosciences
Canada Inc.

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