OTTAWA — The Conservative government will fund clinical trials of a controversial treatment for multiple sclerosis patients, Health Minister Leona Aglukkaq announced Wednesday.
Saying it has been a “moving experience” to hear from MS patients and their families, Aglukkaq said there is now enough preliminary scientific evidence to move ahead government-funded clinical trials into so-called liberation therapy.
“Patients and their families have been calling for the funding of a clinical trial on a treatment to unblock veins. Our government has been clear that we are prepared to fund a clinical trial, but only when there was sufficient medical and scientific information to support it proceeding safely,” Aglukkaq told reporters on Parliament Hill.
“I have always said that I would do everything I can to accelerate progress in this area, and I believe today’s announcement is another example of our government’s commitment to keep working tirelessly in the fight against MS.”
The procedure, developed by Italian neurologist Paolo Zamboni, involves opening up blocked veins. Zamboni’s theory is that stenosis, a narrowing or blockage of veins in the neck that drain blood from the brain, results in a medical condition known as CCSVI, or chronic cerebrospinal venous insufficiency, which may cause MS symptoms.
Dr. Alain Beaudet, president of the Canadian Institutes of Health Research (CIHR), who chaired a meeting Tuesday with the scientific working group that decided to recommend clinical trials, was on hand Wednesday to support the unanimous decision of the expert panel.
Last year, the group told the government that it would be premature to support national clinical trials, saying there was “an overwhelming lack of scientific evidence on the safety and efficacy of the procedure.” Following this move, some provinces stepped in to announce provincial funding.
On Wednesday, Beaudet said he expects a request for proposals to be issued by the end of the year, with trials set up by next year. Federal funding for the project has yet to be determined.
The Multiple Sclerosis Society of Canada has called on Ottawa and all provinces and territories to fund therapeutic clinical trials and has committed $1 million toward the financial cost of clinical trials.
Canada has among the highest MS rates in the world. There is no known cure, but symptoms can be managed.
Although many in the medical community remain skeptical of the therapy, hundreds of Canadians have spent thousands of dollars to travel to private clinics and hospitals in countries such as India, Poland and Costa Rica to have it done.
Beaudet told reporters this was one of the factors behind the expert panel’s recommendation to move ahead with clinical trials in Canada.
“It’s really the hypothesis of Zamboni that prompted this and the fact that so many patients were going outside the country to get the angioplasty treatment and the anecdotal report of success. So the next step, now that there seems indeed to be some relationship between venous abnormality of MS — which is to say nothing about what causes what, it could very well be MS that causes the venous abnormality — but the committee felt that there was enough to not waste time,” said Beaudet.
One trial, known as Phase 1, will involve a small number of healthy people to evaluate the safety of a trial. Phase 2 will involve between 20 and 300 patients to look at effectiveness of the treatment on a restricted number of people.
These two trials will “really ensure that we are set up to start evaluating the intervention itself,” said Beaudet.
Liberal MP Kirsty Duncan, who has been pressing the federal government to fund clinical trials for over a year, said it’s about time Ottawa is moving forward.
“I’m very pleased we’re finally going to see clinical trials,” said Duncan, pointing out the procedure is currently being done in 50 countries, including multi-centre clinical trials in the United States.
“If there’s a chance that this improves the quality of life for MS patients, we absolutely have to be doing clinical trials,” added Duncan, who has tracked about 300 Canadians who have travelled outside the country for the procedure and found that about two-thirds report either significant or some improvement, said trials are important
NDP health critic Libby Davies said MS patients have waited long enough for clinical trials.
“Clinical trials are an important step. People suffering from MS have waited and advocated for changes for a long time,” said Davies, insisting it be a national approach “so people aren’t left out, as some provinces were moving on it and some weren’t.”
Davies added: “We support an evidence based approach — something this government has had difficulty accepting. Just look at their refusal, for example, to look at the evidence on INSITE or asbestos.”
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