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Thursday, September 02, 2010
Government of Canada Rejects "Liberation Treatment" Trials
posted by Larry Chen at
Liberation TreatmentOpposition critics say the decision by the Government of Canada not to fund Canada-wide clinical trials of a controversial multiple sclerosis treatment is a huge setback for the thousands of patients suffering from the debilitating neurological disorder.

"I think it's devastating for MS patients," said Liberal public health critic Kirsty Duncan. "This is a body blow to a lot of people that think this treatment really works."

Duncan said the hundreds of Canadians already travelling to get the surgical treatment in Bulgaria, Poland and India should be tracked to determine if the Italian-developed procedure works.

"If Canada wants to know if this works, why are we not tracking the patients that go overseas?" she said. "We have to have evidence-based medicine and we're not collecting the evidence."

On Wednesday, Federal Health Minister Leona Aglukkaq announced that the Government of Canada has decided to accept the recommendations of its premier health research organization that there be no pan-Canadian clinical trials of the controversial new therapy because of the overwhelming lack of scientific evidence on the procedure's safety.

"I feel the most prudent course of action at this time is to accept the recommendation of the country's leading researchers," Aglukkaq told a news conference in Ottawa.

Backed by experts from the Canadian Institutes of Health Research and the MS Society of Canada, she said the government would wait for the results of seven Canadian research projects looking into the efficacy of the so-called liberation treatment before clinical trials proceed.

The procedure, developed by Italian researcher Dr. Paolo Zamboni, involves using balloon angioplasty to inflate the veins in a patient's neck to help blood flow from the brain to the heart. The theory is that the brain and spine can be damaged when blocked veins do not allow blood to freely flow.

Zamboni calls the condition chronic cerebrospinal venous insufficiency, or CCSVI.

Speaking in Baddeck, N.S., from a party caucus meeting, Liberal Leader Michael Ignatieff said he had spoken directly with Aglukkaq, and he was urging the government to sponsor clinical trials that would allow the controversial procedure to be tested.

"It's not appropriate for a politician like me to pronounce which treatment's going to work," he said. "It's for medicine, for scientists, assisted by the federal government, to prove this thing up or down once and for all."

Ignatieff said the Liberal party has for months supported clinical trials of the new treatment.

Saskatchewan Health Minister Don McMorris said Tuesday his provincial government still plans to fund clinical trials for the treatment.

Currently, very little research has been conducted into Dr. Zamboni's work, but the MS Society of Canada and its U.S. counterpart are providing $2.4 million for diagnostic studies aimed at testing whether the theory behind the treatment is correct.

The studies, conducted over two years, will compare blood flow in the veins of healthy people to those with MS using several diagnostic tools, including ultrasound and MRIs.

Aglukkaq said if the studies show a clear link between Zamboni's theory and MS, then pan-Canadian trials involving the surgical procedure will be started quickly.

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