Saskatchewan starts to fill trial spots for controversial MS liberation therapy

REGINA - Saskatchewan multiple sclerosis patients hoping to take part in a clinical trial of a controversial treatment may soon get a call from the ministry of health.

But only around 10 per cent of those who applied will actually get that call.

Deb Jordan, a ministry spokeswoman, said 670 people had signed up as of Thursday.

The deadline to apply for the two-year, double-blind trial of liberation therapy was midnight Friday.

Jordan said names will be randomly drawn starting next week to determine who will fill 86 spots in the test taking place in Albany, N.Y.

A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment.

"Once we verify that information, then the applicant will be forwarded to the folks who are involved in the clinical trial," said Jordan.

"I want to also emphasize that the fact that a patient may be drawn does not necessarily mean that they will move on to the clinical trial.

"There's the medical assessment that has to take place by the team and it is the ... clinical team that is operating the clinical trial that will ultimately make the decisions about the patients who will be participating in the trial."

Jordan said the process could take several months.

The treatment is based on a hypothesis by Italian vascular surgeon Dr. Paolo Zamboni that a condition he dubbed chronic cerebrospinal venous insufficiency, or CCSVI, may be linked to multiple sclerosis. The theory suggests that narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation.

Liberation therapy involves opening up blocked neck veins.

The idea that the condition might be linked to the progressive neurological disease has divided the medical community.

Some patients have reported substantial improvements in their symptoms after the therapy. Other studies have raised doubts about its effectiveness and questioned the benefits when weighed against the risks of complications from the operation.

The procedure is not offered in Canada and some patients have travelled around the world to seek it out.

At least two Canadians have died after having the treatment.

With a population slightly more than one million, Saskatchewan has some of the highest rates of MS in the country. An estimated 3,500 Saskatchewan residents have the illness. Canada's rate of MS is among the highest in the world at 240 per 100,000 people. On the Prairies, the rate is 340 per 100,000 people.

Saskatchewan was the first province to pledge clinical trials when it put up $5 million and issued a call for proposals in October 2010. The goal was to proceed with clinical trials by the spring of 2011.

But last June, the government said only one proposal had been received and it didn't meet criteria set by an expert panel.

That's when the province looked to New York.

The double-blind aspect of the study means only half of the patients will actually receive the treatment. Patients and physicians who do the followup will not know who got the treatment.

Jordan said the number of applications is in an expected range. Not everyone would be interested, she said.

"People have to take the information and assess it and decide for themselves whether they want to participate in a clinical trial or not," she said.

"Very clearly, while 86 Saskatchewan patients will participate in the trial, half will receive the procedure and half will not, so how that may factor into an individual patient's decision making can only be determined by them."

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Saskatchewan starts to fill trial spots for controversial MS liberation therapy