Not any more

Defiant Saskatchewan refuses to bend on clinical trials for MS treatment

In Canada on September 2, 2010 at 07:47

Saskatchewan is not backing down from its plan to start clinical trials on a controversial new treatment for multiple sclerosis, even though the federal Health Minister, the Multiple Sclerosis Society of Canada and the health-research community insist it’s too risky and that the province lacks the capacity to forge ahead.

The province’s Health Minister, Don McMorris, said once Saskatchewan gets the green light from researchers conducting diagnostic tests on patients, it will move toward accepting clinical trial proposals for the so-called liberation therapy, which could be as early as the new year.

“We started down this road without needing the approval or disapproval of the federal government. Provinces do research in areas on a regular basis. We feel this is an area that we need to take the leadership role, and we’re not backing down from that position,” Mr. McMorris said in an interview on Wednesday.

Federal Health Minister Leona Aglukkaq has accepted the position of the Canadian Institutes of Health Research that it’s too soon to conduct clinical trials on the procedure pioneered by Italian doctor Paolo Zamboni. The MS Society added leverage to Ottawa’s position on Wednesday by saying Saskatchewan can’t conduct a meaningful clinical trial on its own.

Yves Savoie, president of the MS Society of Canada, said a true clinical trial must be conducted at more than one institution and in more than one province. Because MS is so variable, “it will require well over 1,000 participants that will be recruited through a number of centres,” he said. “A single province or a single site would simply not be a way to get to the definitive answers that we all want.”

Saskatchewan has the highest rate of MS in the country.

Officials in the province rejected the notion that their clinical trials, if approved by the necessary regulatory bodies, would be lacking in science or thorough research. A spokeswoman for Premier Brad Wall said the province is not opposed to a joint study with another province. Researchers in Saskatchewan are already about to start conducting diagnostic testing of Dr. Zamboni’s theory with their counterparts in British Columbia, one of the seven projects funded by MS Societies in Canada and the United States.

“We don’t accept the fact that a thousand individuals would be required for a clinical trial. There is a clinical trial right now in New York with a much smaller group – and have been for many other clinical trials for various medical research. We would take our lead from the specialists putting together proposals,” said Kathy Young, communications director for Mr. Wall.

Liberation therapy has not only pitted the federal government against one province, but it also has been hotly debated in the MS community since Dr. Zamboni published a study suggesting the disease is a vascular disorder caused by vein blockages that lead to a buildup of iron rather than an autoimmune disease. He said it could be treated with a simple surgical procedure – angioplasty.

Studies on his theory have had mixed results. Researchers in Germany and Sweden recently found no unusual blockages in the veins of multiple sclerosis patients compared with those of control groups.

What also remains unclear – and what the diagnostic studies in Canada and around the world may determine – is whether multiple sclerosis causes blocked veins or if blockage of the veins leading from the brain causes MS, as hypothesized by Dr. Zamboni. The CIHR recommended on Tuesday that therapeutic clinical trials be put on hold until the results come in from the seven research projects to determine if there is a link between vein blockages and the disease.

But the uncertainty hasn’t stopped multiple sclerosis patients from receiving treatment. While the procedure has yet to undergo clinical trials in Canada, many here have shelled out thousands of dollars for the unproven and experimental treatment in countries such as India and Poland.

Saskatchewan’s announcement in July that it would finance clinical trials put it at the forefront of Canadian efforts to introduce a treatment. Newfoundland and Labrador has told the CBC it is also willing to help fund clinical trials.

“When we look at the prevalency of MS within our population, when you look at the number of people that have gone overseas to have the procedure done and the anecdotal evidence that is coming back, it puts a strong case,” Mr. McMorris said. “What we want to do as a government is take a leadership role and either prove or dispel this so-called treatment.”


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