REGINA — Multiple sclerosis patients in Saskatchewan can apply to take part in a clinical trial of a controversial treatment that has been touted as a potential therapy.
Premier Brad Wall said a New York state doctor is in the final stages of getting U.S. federal approval for what’s believed to be the largest liberation therapy trial of its type.
The province is providing $2.2 million so 86 MS patients can be included in the two-year, double-blind trial at the Albany Medical Center, said Wall.
The procedure is not currently offered in Canada and some patients have travelled around the world to seek it out despite it having not been proven to work.
“While we’re talking here, people are raising money and having bake sales and getting the support of neighbours and friends to try to go somewhere to have the treatment. Well, we should find some answers,” said Wall.
The double-blind aspect of the study means only half of the patients will actually receive the treatment. The patient and the physicians who do the followup will not know if they got the treatment.
“They’ll knowingly volunteer for the trials understanding that they may not get the treatment, which of course is probably what many would like to have. But they’re going to do it in the interest of science, in the interest of demonstrating the efficacy of this treatment or coming to some other conclusion, which would also be helpful,” said Wall.
Applicants have until Feb. 24 to apply either through the government’s website or a toll-free line.
The province says those selected will be contacted and the first patients can expect to travel to Albany, N.Y., in March.
“We know that there will be some applicants that will be disappointed, but I can assure you that all will be given an equal chance,” said Health Minister Don McMorris.
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. But the idea that the condition might be linked to the progressive neurological disease has divided the medical community.
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.
However, in June 2011, it was revealed that only one proposal had been received and it didn’t meet criteria set by an expert panel.
“There was some disappointment there ... because we did want to lead on this file and had allocated funding and resources to do it. And then we become more and more aware of what was happening in Albany,” said Wall.
Some patients have reported substantial improvements in their symptoms after the therapy. But studies have raised doubts about its effectiveness and questioned the benefits when weighed against the risks of complications from the operation.
At least two Canadians have died after having the treatment.
People who have already received liberation therapy, like Michelle Walsh, will not be eligible for the clinical trial.
The federal government plans to fund a preliminary clinical trial of liberation therapy, but has warned it could be years before it would be widely available in Canada. Federal Health Minister Leona Aglukkaq said in November that she couldn’t provide details on how much the trial would cost or how soon it would begin after the deadline for proposals closes at the end of February.
Wall said the province could consider funding the treatment if the results appear promising at the end of the trial in Albany.
“If it proves out that this is symptom relief, that it’s efficacious, that it’s safe, that it works for patients, then I think ... it’ll behoove this government to look very carefully at making that treatment available on a wide scale,” the premier said.