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Paolo Zamboni inspects the brain scan of an MS patient in his office at the University Hospital of Ferrara, Italy, on Nov. 19, 2010. (Alessandro Vincenzi/Alessandro Vincenzi for The Globe and Mail)
Paolo Zamboni inspects the brain scan of an MS patient in his office at the University Hospital of Ferrara, Italy, on Nov. 19, 2010. (Alessandro Vincenzi/Alessandro Vincenzi for The Globe and Mail)

Ottawa to fund clinical trials for controversial MS treatment Add to ...

The federal government is looking to put the debate over a controversial multiple sclerosis treatment to rest once and for all.

Faced with sharply divided opinions among medical experts and intense lobbying efforts from politicians and patients - many of whom have gone abroad for the treatment - Health Minister Leona Aglukkaq announced Wednesday that the government will fund clinical trials of a vein-widening procedure that's being used to treat the symptoms of MS.

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The move comes as a surprise, given mounting scientific evidence that has cast doubt on the theory developed by Italian doctor Paolo Zamboni: that MS is not an autoimmune disorder, as experts have long believed, but a vascular condition caused by blocked or malformed neck veins, which can be treated with simple surgery.

Many studies, including one by a close ally of Dr. Zamboni, have failed to find blocked veins in a high number of MS patients. Last year, the Canadian Institutes of Health Research determined that the federal government should not fund trials of the vein-widening procedure because there were too many unanswered questions about the treatment.

But the CIHR recommended that a panel of scientific experts further review the literature, and that panel unanimously agreed Tuesday there is enough evidence of venous abnormalities in MS patients to warrant a clinical trial of the procedure used to widen the veins.

"It's certainly a step, but I think it's a big step," Alain Beaudet, president of the CIHR, said of the government's decision.

That decision comes after months of political rallies and online campaigns led by patients and advocates to get the treatment funded here. Highly mobilized patient advocates used Facebook groups and online forums to accuse the CIHR of acting in the interests of drug companies and needlessly denying them a potentially life-saving treatment.

The new scientific panel assembled by the CIHR studied the research, including seven trials being conducted in Canada and the U.S. with funding from the national MS societies in both countries.

Although the evidence from existing research is "heterogeneous" with "lots of differences between the studies," Dr. Beaudet said that if the caveats and limitations are taken into consideration, it appears more MS patients have venous abnormalities than people without the disease.

"Whether it's a cause or the consequence, nobody knows and the causality we really can't decide," he said. "But there appears to be a link."

Dr. Beaudet said preliminary results from the seven studies being conducted also show some promise. The panel decided to push for clinical treatment trials before those studies are complete because they don't want to deny patients a potentially beneficial treatment.

"Finally the idea that we may be saving a year for the patients is what prevailed," Dr. Beaudet said.

But he also offered a word of caution: "Clearly, the evidence is still weak. The number of patients [involved in the research trials]is not sufficient."

The new trials will be conducted at the Phase I and II levels, which typically involve a small number of people. They are used to determine whether a new drug or procedure is safe and whether there is any evidence it could work.

That was welcome news to MS patients who have been urging the government to fund treatment trials for months. Many used Facebook and Twitter to celebrate the decision Wednesday, while some criticized the government for taking too long to reach it.

"I think there is some disappointment that it's taken the government so long to move on this," said Libby Davies, NDP health critic.

Steve Garvie, a Barrie, Ont. resident, said the government shouldn't waste time and money doing small trials for a procedure many MS patients already know works. Only a small number of patients will be involved in the government-funded trials, which is unfair, according to Mr. Garvie.

"You might as well buy a lottery ticket, you have better chances," said Mr. Garvie, who had the vein-widening procedure in January, 2010 and felt substantially better after it.

The MS Society of Canada and the Canadian Medical Association both commended the government's decision, noting the importance of basing health decisions on scientific evidence.

"While Canada has one of the highest rates of MS sufferers in the world, we also have leading research and medical minds that can be mobilized to gather more evidence and conduct the necessary trials and studies to ensure efficacious, evidence-based treatment is available for all Canadians battling MS," CMA president Jeff Turnbull said in a statement.

Thousands of Canadians unwilling to wait for the treatment to be approved here have travelled as far as Costa Rica, Poland and Kuwait to get the procedure at private medical clinics, which typically costs thousands. That has led to controversy about whether patients should have access to follow-up care in Canada once they return home. At least two patients have died following the procedure and many have had serious side effects.

Several provinces with particularly high rates of MS, such as Saskatchewan and Newfoundland and Labrador, have committed millions toward clinical trials to study the vein-widening treatment. While some medical experts support the move to quickly determine whether the treatment is safe and effective, others criticized the provinces for acting in the interests of mobilized advocates and interest groups.

Dr. Beaudet said many details regarding the new trials have yet to be determined, including the cost. But even if they move as quickly as possible, the trials likely won't get under way until the beginning of next year at the earliest, he said.

"Science takes time," he said. "We will not drag our feet."



Stages of clinical trials

The federal government announced Wednesday it will provide funding for Phase 1 and Phase 2 trials of a treatment for multiple sclerosis. What happens during the various stages of clinical trials?

Phase 1: These trials, which are the first step toward studying a drug or procedure in humans, is used to determine whether the treatment in question is safe. Only a small number of people - a few dozen or even up to 100 - are involved at this stage

Phase 2: These trials are slightly larger, involving anywhere from a few dozen to a few hundred people, and look to determine the safety and efficacy of a particular treatment. If a certain number of people are found to have a marked benefit, the trial will move to the next stage

Phase 3: Typically the largest and most expensive, these trials compare the treatment in question to an existing treatment or placebo to see if it has any added benefit. The studies involve a large number of people who are randomly assigned to receive an existing treatment, a placebo or the new treatment. This is the last step treatments go through before receiving regulatory approval.

Phase 4: These trials involve post-marketing surveillance to see if the new treatment has any unknown side effects, or if the drug has any other uses or benefits that were previously unknown.

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