This week the Canadian medical Establishment put the brakes on as far as fast tracking the CCSVI "Liberation Treatment" is concerned.
Little proof to back MS procedure, agency says
Tom Blackwell, National Post · Wednesday, Sept. 1, 2010
The federal government's premier research organization has concluded it is impossible to justify a major trial of an experimental new treatment of MS, despite intense pressure from some patients to embrace the therapy, the agency's head said yesterday.
Doctors and scientists called to a meeting last week by the Canadian Institutes of Health Research concluded unanimously that there was an "overwhelming lack of evidence" to support study of the operation developed by an Italian vascular surgeon, said Dr. Alain Beaudet.
The agency is recommending the government set up a working group that will monitor research already under way on the theory behind Dr. Paolo Zamboni's procedure: that the disease is caused by a blockage in blood flow from the brain.
When results from those trials come in, the group will advise whether more study is necessary, possibly including a Canada-wide trial of the operation itself, Dr. Beaudet told a news conference.
Until then, a study that saw patients undergo the operation would be unethical, he said.
"Quite simply, the experts agreed that there is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure," he said. "There could be little justification for taking a patient off medications that are known to be efficacious in order to subject them to a treatment for which there is so little evidence."
Leona Aglukkaq, the federal Health Minister, had asked the institutes for advice on the issue and is to hold a news conference today to announce whether she will accept the recommendations.
The prevailing scientific theory is that multiple sclerosis results from an auto-immune response -- the body's immune system turning on itself.
But Dr. Zamboni hypothesized that narrowed veins in the neck cause backups of blood, triggering inflammation of the brain's myelin coating that is believed to be behind the disease.
He has argued that the problem can be treated through angioplasty -- inflating a tiny balloon in the constricted vein to improve drainage.
Results from a handful of small, preliminary studies have produced widely mixed evidence about whether the vein problem might be a cause of MS, and whether the operation is an effective treatment.
The CCSVI concept, though, has touched off an intensive lobbying campaign by patients eager to see the ideas adopted. Supporters point to patients who have undergone the procedure in places like Bulgaria and India and report significant improvement in their condition.
Linda Molyneux, who heads a group raising money to research CCSVI and whose 23-year-old son recently had the Zamboni treatment in Bulgaria, said she was "appalled" by the CIHR's wait-and-see approach.
"I am absolutely dumfounded," Ms. Molyneux said. "They're stalling.... To get these trials up and running, we're looking at a few years anyway. Even if it only takes five years, that's 5,000 more Canadians diagnosed with MS."
Zamboni supporters have complained that the neurologists who treat most MS patients are biased against the idea.
Dr. Beaudet said the panel convened by his agency included neurologists, vascular surgeons and radiologists, as well as basic research scientists. They were unanimous in calling on the government to wait for results of seven studies on CCSVI being funded by the MS societies of Canada and the U.S.
Read more: http://www.nationalpost.com/news/canada/Little+proof+back+procedure+agency+says/3467095/story.html#ixzz0yOz6wQj
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