No Evidence That Glatiramer Acetate Slows Multiple Sclerosis (MS)

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No Evidence That Glatiramer Acetate Slows Multiple Sclerosis (MS)

Progression

(PRNewswire)

LONDON, ON, Nov. 1 /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unpublished clinical trials of a given agent or intervention, despite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,