Sask. plan to fund MS treatment trials raises debate across Canada

SASKATOON — Saskatchewan's decision to go it alone with clinical trials of a controversial and unproven multiple-sclerosis therapy is a worthy one — even if the trials do nothing more than prove that the so-called "liberation" procedure doesn't work, says an expert.

Saskatchewan Premier Brad Wall has raised hopes across the country by confirming his government will fund Canada's first clinical trials of the contentious procedure. Liberation therapy is based on the theory of Italian neurologist Dr. Paolo Zamboni that a narrowing or blockage of veins in the neck that drain blood from the brain may cause MS symptoms.

Internationally recognized stroke researcher Dr. David Spence said the hype for the procedure is misplaced and doesn't warrant such a large investment — but trials might serve to put the highly emotional debate over the procedure to rest, he said.

"I think the hype has been so tremendous that the study needs to be done," said Spence, director of the Stroke Prevention and Atherosclerosis Research Centre at the Robarts Research Institute in London, Ont.

"But it's extremely unlikely they'd find anything. Everything we know about (multiple sclerosis) suggests that blocked veins don't have anything to do with it. It would be wonderful if it turned out to be true.

"But (the procedure) is taking advantage of people by offering false hope. People should only have this kind of therapy when it's shown to be effective, not when it's done by unscrupulous charlatans."

The Saskatchewan clinical trials should be done on more than 1,000 patients, Spence said, in a randomized, controlled trial to minimize the placebo effect.

"The findings have to be objective findings — not just reports of feeling better or feeling less depressed or less tired," he said. "Belief does not qualify as evidence. The plural of anecdote is not data. No matter how strongly people believe this works, it doesn't qualify as evidence."

Zamboni contends a procedure similar to balloon angioplasty, which unblocks coronary and other arteries, dilates narrowed or blocked veins in MS patients, improving blood flow and, with it, balance and walking, while reducing dizziness, fatigue, muscle spasms and incontinence.

His study results gained favour among MS patients and led to fervent lobby campaigns of government health agencies.

While Bulgaria, Mexico, Hungary, Poland and others now offer the surgery at roughly $10,000 per angioplasty, many members of the medical community insist it's still too soon to warrant full-blown clinical trials.

To date, no other Canadian province has offered to follow Saskatchewan's lead.

Alberta Health Minister Gene Zwozdesky said he would raise CCSVI treatment for discussion at the next inter-provincial meeting of health ministers in September.

"Every province, every minister is well aware of CCSVI because we're all treating people with Multiple Sclerosis," he said.

It is a promising treatment, but many questions still surround it, he said.

"I'm excited Saskatchewan is looking more deeply into this. We are already doing some research here in Alberta and waiting for clinical evidence."

Research in Alberta has not yet proceeded past the paper-study stage.

Many MS sufferers who paid out of pocket to have the treatment abroad say they don't need clinical trials to convince them it works.

Darrell Derksen, a 49-year-old MS patient in Saskatoon, recently returned from Sofia, Bulgaria, where he had the surgery performed 2 1/2 weeks ago.

"They can call it a placebo, and they can call it what they want," he said. "I'm not skipping rope yet but I can climb up stairs better and I have a better stride in my walk.

"My energy level has gone up. I'm sleeping better and some of the tension I was carrying in my neck has greatly improved.

"I don't want people to think it's a cure. This is a step forward. It's a treatment and people should have the ability to access it."

Kelly Terry, a 36-year-old MS patient from Melfort, Sask., had the liberation procedure two weeks ago in Bulgaria and spent $10,500 on the trip. His mother died from MS and told him he needed to be part of the cure, he said.

"My experience so far has been phenomenal," Terry said. "My vision has improved. I couldn't put five words together before and now my speech is better. It's not a placebo effect, it's something within your body that's improved. I can finally play with my daughter again. I can walk without a cane."

Wall said he isn't concerned other provinces aren't lining up with help. With the highest incidence of MS in the country, Saskatchewan should take a leadership role, he said.

Helping fund the trials is "not about politics. . . this is about research," Wall said.

The MS Society of Canada welcomed Wall's "commitment to advancing the (liberation procedure) and MS research."

During recent Multiple Sclerosis Society of Canada board elections, there were factions split over what percentage of resources should be put toward research into the Zamboni procedure.

"We are hopeful that additional research approaches to this important issue will allow us to advance the speed of research and allow scientists to discover the definitive answers to the questions relating to (the liberation procedure) at an even faster pace," the organization said in a statement.

With files from Calgary Herald