Ottawa to fund trials of controversial MS treatment
Dr. Alain Beaudet looks on as federal Health Minister Leona Aglukkaq announces funding for MS treatment in the foyer of the House of Commons on Wednesday in Ottawa. Beaudet said clinical trials cannot realistically be expected to begin until early next year. (June 29, 2011)
ADRIAN WYLD/THE CANADIAN PRESSOTTAWA—The Conservative government has decided to go ahead with clinical trials of a controversial new treatment for multiple sclerosis.
“Patients and their families have been calling for 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 proceeding safely,” federal Health Minister Leona Aglukkaq told reporters in Ottawa on Wednesday.
“There is (now) unanimous agreement that a clinical trial should proceed,” she said.
The Canadian Institutes for Health Research advised Aglukkaq to begin the process of setting up therapeutic clinical trials for the so-called “liberation” treatment pioneered by Italian researcher Dr. Paolo Zamboni after a scientific working group set up by the federal government decided on Tuesday there was enough evidence out there to support such a move.
Ottawa had decided to hold off financing clinical trials last fall on the advice of an expert panel convened by the CIHR and the MS Society of Canada, which said that clinical trials would not be scientifically or ethically advisable at that time.
Patients, who have been shelling out thousands of dollars to have balloons inserted into their apparently narrowed or irregular veins in the United States or overseas since Zamboni unveiled the therapy in 2009, were disappointed by the decision and some held rallies to pressure the government into acting more quickly.
The federal government also said it would support the tests if a scientific expert working group monitoring $2.4 million worth of research into the theory put forward by Zamboni — that the debilitating disease is linked to narrowed veins — decided they are worth it.
The group of neurologists, radiologists, vascular surgeons and other researchers met in Toronto on Tuesday and concluded that a meta-analysis of preliminary results of those seven ongoing diagnostic studies as well as the latest published research showed enough of a link between what Zamboni called Chronic Cerebro-Spinal Venous Insufficiency (CCSVI) and MS that further studying the liberation treatment is warranted.
“It permits us not to lose any more time,” said Dr. Alain Beaudet, president of the CIHR.
Still, Beaudet noted that clinical trials cannot realistically be expected to begin until early next year and it could take much longer before MS patients can begin receiving the treatment in Canada.
“Clinical research takes time,” Beaudet told reporters on Wednesday. “You don’t want to subject patients to treatment that has not been proven and you don’t want to carry out a trial in patients without having the necessary scientific evidence to do so.”
The CIHR expects to issue a call for applications by the end of the year, at which point the Conservative government will specify the amount of money it expects to commit to clinical trials.
“I can’t come up with a figure until (Beaudet) has done the proposal guidelines,” said Aglukkaq.
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