Friday, January 13, 2012
Sask. MS patients to U.S. for 'liberation' trial
REGINA -- Saskatchewan says it will send multiple sclerosis patients to the U.S. for the clinical trial of a controversial treatment -- an announcement that prompted more than 100 applications within hours.
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 traveled 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.
More than 130 applications were submitted within five hours of Wall's announcement. People 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 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 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.
With a population of slightly more than one million, Saskatchewan has some of the highest rates of MS in the country. An estimated 3,500 Saskatchewan residents have MS. 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 spring 2011.
-- The Canadian Press
Trials seem delayed
Manitoba was slated to announce last month which researchers in this province will share $5 million earmarked for clinical trials of the "liberation" therapy.
But the government has apparently delayed the announcement. Also, it won't say how many research proposals it received, how many were chosen for peer review or how many made the short list.
Last spring, with significant fanfare, Manitoba earmarked $5 million and put out a call for proposals relating to the liberation-therapy treatment.
The province's deadline to receive proposals was Sept. 30, and scientific peer review was to be completed in November.
Despite at least two separate freedom-of-information requests, a spokesman for Manitoba Health said due to the Manitoba Health Research Council's protocol, the number of proposals, the names of applicants and individuals sitting on the review committee cannot be released to the public.