Feds OK funding for MS 'liberation therapy' trials
Published Wednesday, June 29, 2011 10:28PM EDT
Last Updated Saturday, May 19, 2012 5:12AM EDT
The federal government says it will fund clinical trials into the controversial multiple sclerosis treatment known as the "liberation therapy."
Federal Health Minister Leona Aglukkaq made the announcement Wednesday afternoon during a news conference on Parliament Hill.
Aglukkaq told reporters the government came to its decision after a scientific working group it convened last summer determined during a meeting on Tuesday that a Phase 1 and Phase 2 clinical trial should proceed.
"I have asked CIHR, the Canadian Institutes of Health Research, to establish the terms of reference for this clinical trial," Aglukkaq said. "And we are committed to launching an open and transparent call for proposals, and process applications, as quickly as possible."
The liberation treatment was developed by Italian physician Dr. Paolo Zamboni and is based on his theory that narrowed neck veins are behind MS symptoms.
The condition, chronic cerebrospinal venous insufficiency, or CCSVI, reduces blood flow and allows iron deposits to build up in the brain, Zamboni says.
The treatment he developed uses balloon angioplasty to unblock the veins in the hope of alleviating symptoms.
In an interview with CTV News, Zamboni called the government's announcement "fantastic news," saying Canadian MS patients "waited for this for a long time."
While Zamboni's research has demonstrated success with the treatment, recent clinical trials have concluded that CCSVI is not a primary cause of MS.
The controversy surrounding both the condition and the treatment has not deterred Canadian MS patients from rallying across the country over the last several months to call on both Ottawa and provincial governments to fund the treatment, which is not available in Canada. Many Canadians have had the procedure at medical clinics overseas.
Aglukkaq said the working group was established last August and tasked with reviewing the latest research and making its recommendation to government. The group met in November and again on Tuesday.
Dr. Alain Beaudet, president of the CIHR, said Wednesday that an analysis of all the research done on CCSVI so far suggested "a trend to an association between the greater prevalence of CCSVI in patients with MS than in healthy controls."
Beaudet said more results are needed, particularly from seven current studies, to strengthen the committee's conclusion.
"But, nonetheless, the committee felt that, on the basis of this preliminary evidence and what's published so far, that we should in parallel start already with a Phase 1-2 trial," he said.
Barrie, Ont. vascular surgeon Dr. Sandy McDonald has treated six patients with the liberation therapy, three of whom experienced a dramatic improvement in symptoms and two who experienced a moderate improvement.
McDonald said Zamboni's theory represents a "paradigm shift" in how MS is viewed. For decades, neurologists have approached MS as an autoimmune disorder, but the liberation treatment suggests that it is in fact a vascular disease.
McDonald said he was "ecstatic" when he heard the government's announcement, saying a randomized, controlled, double-armed trial -- during which doctors follow a group receiving the treatment and a group that does not -- will conclusively determine the treatment's effectiveness, as well as risks.
"We already know from trials done in the United States that the risks are very low, and we already know also from the trials out of the U.S. that it seems to be effective in improving the quality of life in many people," McDonald told CTV News Channel.
"But we shouldn't expect that it will be the panacea for all patients with MS. It may be a part of MS, and that's why we need the trials to prove it either is or isn't, and hopefully it proves it is and we can actually help patients have a better quality of life."
During her Wednesday news conference, Aglukkaq hailed MS patients and their families for their struggle with a disease that can lead to symptoms that include difficulty walking, vision problems, fatigue and weakness.
"It has been a moving experience to meet many of you and to hear from so many MS patients and their families who have shown tremendous courage in the face of such difficult illness," she said.
With reports from CTV medical specialist Avis Favaro and producer Elizabeth St. Philip