Experts urge rejection of MS therapy trial

Canada should not fund a clinical trial of the so-called liberation therapy for multiple sclerosis now, an expert group has recommended.

The Canadian Institutes of Health Research and the MS Society of Canada said Tuesday in Ottawa that a group of international experts they brought together met last week to discuss the latest findings on the theory proposed by Italian doctor Paolo Zamboni.

The group unanimously recommended against supporting a clinical trial in Canada at this time, CIHR president Dr. Alain Beaudet said.

"There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is any link between blocked veins and MS," Beaudet said.

Beaudet informed Health Minister Leona Aglukkaq about the group's recommendations. She plans a news conference on the subject on Wednesday, and is expected to accept the recommendations.

Research to test theory by monitoring abnormal blood flow

Liberation therapy is based on an unproven theory of chronic cerebrospinal venous insufficiency (CCSVI) — put forward by Zamboni — that MS is caused by a narrowing or "stenosis" in the veins that drain the brain. Zamboni proposed treating multiple sclerosis by inflating small balloons to open up veins.

Some Canadians are spending thousands of dollars overseas to seek the experimental treatment.

In June, the national MS societies in Canada and the U.S. awarded a combined $2.4 million in research grants aimed at testing if Zamboni's theory is correct, by checking for abnormal blood flow in the veins in people with MS and healthy controls using ultrasound, MRI or catheters with dye.

"We do not put all of our eggs in one basket," said Yves Savoie, head of the MS Society of Canada.

The society is looking at many avenues to treat MS, including CCSVI, Savoie said, adding the group respects the rights of patients who've weighed the risks and sought the vein-opening procedure.

Zamboni's original research was not blinded, which makes it difficult to draw conclusions about its scientific validity, said Dr. Barry Rubin, a vascular surgeon at Toronto General Hospital, who spoke to reporters from Stockholm.

Beaudet made three recommendations to Aglukkaq:

• Establish a scientific expert working group made up of four investigators from Canada and three from the U.S. funded by the MS societies in both countries, and a representative of the provinces and territories, to monitor and analyze results from studies investigating CCSVI worldwide. The group should hold its first meeting this calendar year.
• Based on the outcomes of these studies, the scientific expert working group should reach conclusions regarding  the association (or lack thereof) between CCSVI and MS, and a common standard for reliably diagnosing the condition using imaging or other techniques.
• Depending on these conclusions, the scientific expert working group should make recommendations on further studies including, if appropriate, a pan-Canadian, interventional clinical trial.

Provincial calls for trial

In July, Saskatchewan Premier Brad Wall said his province would fund a clinical trial into liberation therapy, and he invited proposals from the scientific community for such a trial. Saskatchewan has Canada's highest incidence of multiple sclerosis, Wall says.

Manitoba Health Minister Theresa Oswald said Tuesday she believes it's important to listen to doctors, particularly on the issue of safety. Still, Oswald wants the issue discussed at next month's meeting of federal, provincial and territorial health ministers in St. John's.  

Newfoundland and Labrador Health Minister Jerome Kennedy said Tuesday that his province's pledge to help fund trials into the unproven treatment still stands, despite the experts' recommendations.

The publicly funded CIHR gives grants to researchers across the country working in health and medicine.