Wednesday, June 29, 2011

Feds approve controversial MS therapy trials in spite of latest studies

OTTAWA - Health Minister Leona Aglukkaq is bucking some of the latest research and giving the go-ahead for clinical trials of a controversial treatment for multiple sclerosis patients.

Aglukkaq says the federal government will fund trials of the so-called liberation therapy in spite of recent studies that have cast doubt on narrowed neck veins as the primary cause of multiple sclerosis.

The minister says a scientific working group established by the federal government last August has agreed unanimously that a clinical trial should proceed.

"Our government has been clear that we were prepared to fund a clinical trial, but only when there was sufficient medical scientific information to support proceeding safely," said Aglukkaq.

She said the team reviewed scientific reports on the procedure and deemed it safe enough to go ahead.

"There is unanimous agreement that a clinical trial should proceed at the Phase 1 and Phase 2 level."

Narrowed neck veins — or chronic cerebrospinal venous insufficiency — became the subject of numerous studies after Dr. Paolo Zamboni of Italy theorized it could be a factor in the development of MS.

Zamboni surmised that reduced blood flow leaves iron deposits in the brain, leading to the neural lesions typical of MS. He contends that reversing the condition by unblocking neck veins using balloon angioplasty could help alleviate symptoms.

Many hopeful Canadian MS patients have gone abroad seeking the procedure, which isn't offered in this country, while the MS community has been leaning on Ottawa to proceed with trials.

Some clinical studies — most recently by a team at the University of Buffalo — have indicated that the vascular condition does not have a primary role in causing MS.

But Dr. Alain Beaudet, president of the Canadian Institutes of Health Research, said some evidence brought forward to the panel suggests "a trend to an association between the greater prevalence of CCSVI in patients with MS than in healthy controls."

"More studies will be needed, particularly the results of the seven ongoing studies, to strengthen this conclusion. But, nonetheless, the committee felt that, on the basis of this preliminary evidence and what's published so far, that we should in parallel start already with a Phase 1-2 trial."

These a preliminary trials involving small sample groups. If they continue to show promise, a larger Phase 3 trial could go ahead at some point in the future.


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