new info on Copaxone

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No Evidence That Glatiramer Acetate Slows Multiple Sclerosis (MS)

Progression (PRNewswire)

LONDON, ON, Nov. 1, 2004 /PRNewswire/ – In this week's issue of the Lancet

Neurology, glatiramer acetate, known as Copaxone®, 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. 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distill a true sense of worth from all published and unpublished clinical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.

® Copaxone is a registered trademark of Teva Neurosciences Canada Inc.

Reference

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(1) Munari L., Lovati R., Boiko A., " Therapy with glatiramer acetate for

multiple sclerosis, " The Cochrane Library 2004, Issue 1.

(2) Luca M Munari and Graziella Filippini, " Lack of evidence for use of

glatiramer acetate in multiple sclerosis, " The Lancet, Neurology,