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Wednesday, December 15, 2010 8:05 PM | Ken Torbert Volg link

The hype surrounding a possible breakthrough in treating multiple sclerosis is clouding the scientific issues, say two of Canada's leading neurologists.


The controversial therapy first proposed by Italian researcher Dr. Paolo Zamboni of the University of Ferrara in November 2009 involves an angioplasty to unblock veins in the neck. His studies indicated patients with MS suffered from blocked veins -chronic cerebrospinal venous insufficiency (CCSVI) - that resulted in a buildup of iron in the brain. The treatment has not been approved by Health Canada.


"This new hypothesis has gained significant attention and hype in the lay media, and needs to be investigated with scientific rigour and properly done studies," says Dr. Virender Bhan, director of the MS research unit at Dalhousie University. "We neurologists should not trash it but, at the same time, MS patients should not embrace it without further research. Results of current studies should be available in two years."


Ottawa resident Tracy Severin, who was diagnosed with MS nine years ago, was not prepared to wait. The mother of three crossed the border to a medical clinic in Albany, N.Y., in October. The improvement in her condition since being treated has been remarkable, she says.


"My biggest symptoms have been fatigue and vertigo," she says. "They're not visible, but my whole life is structured around my disease. The way I function is that I work until 1 p.m., then rest for two hours until the kids come home. Then I can function for the rest of the day, though on bad MS days, my whole left side is weak. Since the treatment, I haven't needed to rest in the afternoons.


"I just hope my improvement continues," says Severin. "I would be terribly disappointed if it turned out to be a placebo effect."


On Nov. 19, Federal Health Minister Leona Aglukkaq warned Canadians about travelling outside the country for the procedure (sometimes called "liberation therapy") after the death of a Canadian man who underwent surgery in Costa Rica.


Before even considering a therapeutic trial, Bhan says, "two key questions must be answered: whether CCSVI or abnormal veins are more common in MS patients than controls (healthy subjects or patients with other neurological


diseases) and how CCSVI can be tested most effectively."


"To ensure we realize the full potential of any new discovery, early results need to be replicated and validated in multiple, large, and well-designed studies," the MS Society of Canada states on its website.


Neurologist and multiple sclerosis specialist Dr. Brad Stewart, an assistant clinical professor at the University of Alberta, says, "there is no evidence linking problems with veins in the neck to MS.


"The notion that MS is caused by vascular problems is fundamentally wrong. I don't believe in Santa Claus, I don't believe in the Easter Bunny and I don't believe in this. I will accept hard data and good studies, but there aren't any."


Bhan says studies conducted by other researchers have not corroborated Zamboni's findings. "For example," he says, "Dr. Robert Zivadinov at the University of Buffalo, usingDr. Zamboni's methodology, found a smaller percentage of MS patients with CCSVI than did the Italian researcher (56 per cent versus 100 per cent). Similarly, studies in Germany and Sweden have failed to demonstrate CCSVI in MS. "



Bhan adds there are major risks in angioplasty on the veins in the neck. "I think that the most confusion for the public comes from the fact that angioplasty is commonly done for heart and stroke patients. But there are structural differences between arteries and veins, with arteries being thick-walled and, as such, can withstand balloon compression from inside, whereas veins are thin-walled and can rupture and lead to many complications."


Memorial University postdoctoral fellow and physiotherapist Michelle Ploughman, who has just completed a major study on how health and lifestyle affect MS patients, notes the dichotomy between doctors and patients.


"It seems that members of the scientific community are saying one thing -they are more skeptical about the results of the surgery -while the individuals returning from having it all seem to say they feel the difference," she says.


Seven research studies exploring the relationship between CCSVI and MS are underway in North America, four in Canada and three in the





Read more: http://www.montrealgazette.com/treatment+needs+study/3973183/story.html#ixzz18D0RLKbC