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Call For Proposals In Study Of Experimental MS Therapy

Mon, 11/28/2011 - 8:42am

HALIFAX — The federal government is ready to accept research proposals for an early-phase patient trial of an experimental procedure that's been touted as a potential therapy for people with multiple sclerosis. Health Minister Leona Aglukkaq announced the call Friday for research proposals to study the so-called liberation therapy during the federal, provincial and territorial health ministers meeting in Halifax.

"We're moving forward with the clinical trial application process," she told a news conference at the close of the two-day meeting. She said she couldn't provide details on how much they would cost or how soon they would begin after the deadline for proposals closes at the end of February.

"It's a bit too early for us to respond now, but we are opening that process up to Canadians to submit to the clinical trial."

Nova Scotia Health Minister Maureen MacDonald said she would be closely watching the process since many people have come forward in her province to push the government to sanction trials on the controversial procedure.

"We will certainly look forward to seeing what the outcome of that process is because many people with MS are relying on this treatment as a potential hopeful treatment for them," she said.

The therapy involves opening up blocked neck veins — a condition called chronic cerebrospinal venous insufficiency, or CCSVI. It was first described two years ago by Italian vascular surgeon Paolo Zamboni, who suggests that using balloon angioplasty to clear the blood vessels can improve symptoms in people with MS.

Since then, thousands of Canadians with MS have travelled to clinics in the United States and overseas for the procedure, which has been deemed experimental and is not approved for MS patients in Canada. At least two Canadians have died as a result of the treatment.

The Saskatchewan government announced last year that it would put $5 million into clinical trials and pay for residents to take part in the research being done in Albany, N.Y.

Health Minister Don McMorris said about 80 people from Saskatchewan will take part in the trial, but he added his province will also participate in any future trials funded by the federal government.

"What this is all about is to help advance the science, to see the efficacy of liberation treatment as a symptom reliever," he said. The idea that blocked neck veins might be linked to the progressive neurological disease, in which the immune system attacks and destroys the myelin sheath around nerves, has divided the medical community and led to MS patient advocacy groups demanding that Canadians have access to the vein-clearing procedure.

Taking a go-slow approach, Ottawa announced in June that it had accepted a recommendation of an expert scientific panel to undertake a small-scale Phase I/II clinical trial on CCSVI, with the aim of determining the safety of venous angioplasty and to gather better evidence on patient outcomes.

Aglukkaq said the federal government's next step is to identify a proposed clinical trial that can undergo an ethical review. The request for research proposals will be available Wednesday on the website of the Canadian Institutes of Health Research, which developed the guidelines and will fund the trial. Applications will undergo a review by an international committee, which will be established in the coming weeks.

"Multiple sclerosis affects thousands of Canadians and their families," said CIHR president Dr. Alain Beaudet in a statement. "It is imperative, given the uncertainties related to CCSVI and its potential relationship to MS, that CIHR support ethical research based on international standards of excellence to help us better understand what impact venous angioplasty procedures have on the clinical outcomes and quality of life of MS patients.

"The research evidence to date is so mixed that the only way to get to the bottom of this is to conduct a well-designed clinical trial with appropriate stringent patient safety considerations factored in." CIHR will announce the successful research team in March. The CEO of the MS Society of Canada said he was looking forward to getting closer to definitive answers on the efficacy of liberation therapy.

"People with MS deserve clarity about the hope that CCSVI offers as a potential treatment for MS," Yves Savoie said in a statement. "It is only through rigorous research that we can get these answers."

THE CANADIAN PRESS@ ___

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