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Health agency dampens MS patients' hopes by rejecting clinical trials

Italian doctor Paolo Zamboni made world news with his experimental treatment for MS, which immediately prompted calls for studies.

Alessandro Vincenzi/Alessandro Vincenzi/The Globe and Mail

The federal agency that funds health-care research says it is too soon to begin clinical trials on a contentious new treatment for multiple sclerosis, deflating the hopes of many patients who want to believe it will end their suffering.

The Canadian Institutes of Health Research on Tuesday recommended a wait-and-see approach to the so-called liberation therapy, citing "an overwhelming lack of scientific evidence" that it works, that it is safe, and that the theory behind it is sound. The recommendation is not binding, however, and Health Minister Leona Aglukkaq will announce Wednesday how the federal government intends to proceed.

That sets up the possibility of a troubling disconnect between Ottawa and some provinces on the MS treatment. The government of Saskatchewan has said that it will pay to test the procedure pioneered by Italian doctor Paolo Zamboni, and that it "remains committed to funding proposals for clinical trials, should the research community bring them forward," said Kathy Young, communications director for Premier Brad Wall.

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"There are clinical trials being done in the States; there are clinical trials being done all over the place, except in Canada," she said. "So we believe, since we have the highest per capita incidence [of the disease in Canada] we need to either rule out MS liberation as a tool that will help people with MS - or not."

Teresa Woo of McLennan, Alta., who has suffered with MS for 16 years, is frustrated that the federal agency wants to move slowly.

"People are desperate," she said. "Even if it doesn't help everybody, people will take anything. These doctors, if they had a family member with MS, I can almost 100-per-cent guarantee that they would want to give it a try for their family member."

Liberation therapy has been hotly contested among MS patients 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 argued that it could be treated with a simple surgical procedure - angioplasty.

But Alain Beaudet, president of the Canadian Institutes of Health Research, told a news conference on Tuesday that a gathering of North American experts convened by his agency last week agreed that there is "an overwhelming lack of scientific evidence on the safety and the efficacy of the procedure." Nor is there evidence of a link between vein drainage and MS, Dr. Beaudet said.

To test Dr. Zamboni's hypothesis, the Multiple Sclerosis Society of Canada has agreed to spend $2.4-million to fund seven research projects that will examine the relationship between the flow of blood through the veins and the nerve-wasting illness.

Dr. Beaudet has told Ms. Aglukkaq that she should ask a panel composed of the principal investigators of each of those studies funded by the MS Society to make recommendations about future clinical trials based on their findings.

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The experts brought together by the CIHR are dubious about the results of Dr. Zamboni's research.

"Dr. Zamboni submitted his work to a scientific journal," Dr. Beaudet said. "It's not a top-rated scientific journal. I think my colleagues will agree that it was a second-tier scientific journal."

There is no objective evidence to prove that the procedure is effective, said Dr. Beaudet. Patients who have received the treatment often say they feel better or less fatigued, he said. But no studies have proved that they have undergone physical changes such as increased muscle tone or reduced frequency of relapse, he said.

Diana Gordon, a multiple sclerosis patient who lives in Barrie, Ont., described the decision of the CIHR against immediate clinical trials as "maddening."

Ms. Gordon paid $7,000, plus her travel expenses, to have the procedure in June. Since then, she said, her symptoms have disappeared. "I have been feeling fantastic and I ride my bike every day," she said.

As for Ms. Woo, she said she would love to get sensation back in the bottom of her feet - something she has not felt for years. But she can't afford the cost of getting the liberation therapy abroad.

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"If I had the money, I would be so gone, it wouldn't be funny," Ms. Woo said. "If it doesn't work, that's fine. But what if it does? As far as I'm concerned, Dr. Zamboni has proved it works enough of the time to take the chance."

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About the Author
Parliamentary reporter

Gloria Galloway has been a journalist for almost 30 years. She worked at the Windsor Star, the Hamilton Spectator, the National Post, the Canadian Press and a number of small newspapers before being hired by The Globe and Mail as deputy national editor in 2001. Gloria returned to reporting two years later and joined the Ottawa bureau in 2004. More

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