The Canadian Press
Date: Wednesday Jun. 29, 2011 3:18 PM ET
OTTAWA — Health Minister Leona Aglukkaq is giving the go-ahead for clinical trials of a controversial treatment for multiple sclerosis patients.
Aglukkaq says the federal government will fund trials of the so-called liberation therapy in spite of some recent studies that have cast doubt on narrowed neck veins as the primary cause of multiple sclerosis.
The minister says a scientific working group established by the federal government last August has agreed unanimously that a clinical trial should proceed "at the Phase 1 and Phase 2 levels."
Narrowed neck veins -- or chronic cerebrospinal venous insufficiency -- became the subject of numerous studies after Dr. Paolo Zamboni of Italy theorized it could be a factor in the development of MS.
Zamboni has speculated that reduced blood flow leaves iron deposits in the brain, leading to the neural lesions typical of MS -- and he contends that reversing the condition by unblocking neck veins using balloon angioplasty could help alleviate symptoms.
Many hopeful Canadian MS patients have gone abroad seeking the procedure, which isn't offered in this country.
However, some clinical studies -- most recently by a team at the University of Buffalo -- have indicated that CCSVI does not have a primary role in causing MS.
Blaze wrote:Does anyone know what a Phase 1 and Phase 2 means? I don't like to be skeptical, but I would love to know why the panel which last August unanimously rejected clinical trials now "has agreed unanimously that a clinical trial should proceed to the Phase 1 and Phase 2 levels."
This is still a long way from treatment being widely available, but it's a step in the right direction (I hope!).
CTV.ca News Staff
Date: Wed. Jun. 29 2011 4:27 PM ET
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 Institute 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.
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 Canadian Institutes of Health Research, 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.
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.
MrSuccess wrote:Blaze .. don't look in the mouth of a gift horse ......
There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed "Liberation Procedure," said Dr. Beaudet. "There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is any link between blocked veins and MS.
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.
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