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Wednesday, November 24, 2010 11:15 PM | Helen Cosburn Volg link

The CCSVI Liberation procedure has been out in the open for one year now, thank you to the works of Dr. Zamboni. However, the Canadian government continues to show a lack of support to bring this treatment to Canada. The views remain divided; some say the treatment is “new”, ground breaking and controversial, and must go through the approval process like all new procedures in Canada, while others say this is only a simple modification of a common procedure, practiced everyday and for over 30 years, the angioplasty. If the later is true, why have we not accepted this is Canada? I do not have the answer. If the former is true, we must examine what it takes to get a new procedure approved in Canada.



CBCNews.ca contacted biomedical ethicist and McGill University Prof. Jonathan Kimmelman, to discuss some of the ethical issues surrounding the procedure. One of the questions asked was ” Could you explain the process of how a surgical procedure becomes a recognized treatment, why the steps are necessary and how long it could take?”



“Controlled clinical trials are only ethical if there are good reasons to believe a new treatment is as good as — and perhaps better than — a standard of care. That way, doctors performing these studies do not violate their duty to advance the best interests of patients who enrol. So in the case of venous angioplasty, trials would be ethical if there is solid evidence that venous insufficiency is a plausible hypothesis. We might get this from large, well-designed observational studies of MS patients. Animal experiments could also be informative. I am not a neurologist, but my understanding is the CCSVI theory is not nailed down, and cannot account for a number of features about the course of MS.



Without a doubt, good science — and protecting patients who volunteer for clinical trials — takes time. Controlled trials are also expensive. But it would take far longer to establish the value of these treatments if we made them available outside of trials. There are many examples in medicine where risky procedures were offered to patients before their value had been established. One example in the 1990s was the use of autologous bone marrow transplantation for the treatment of breast cancer. Many women were seriously harmed before trials made clear that the very burdensome procedure was useless for treating breast cancer.” Reports biomedical ethicist and McGill University Prof. Jonathan Kimmelman.



But the CCSVI Liberation procedure is clearly not “useless for treating symptoms of MS”, so how many patients will be treated overseas bringing home positive anecdotal evidence that CCSVI Liberation does help alievate symptoms of MS, before the govemernmet will allow this treatment in Canada?



Until a significant change is made, Canadian MS patients continue to do their research online through sites such as CCSVI Locator, CCSVI.mx and through social networking groups, to learn about various treatment providers, potential benefits and risks of the procedure and to network with those facing the same decisions. For now, Canadians suffering from MS are looking to the world for hope.