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Friday, July 1, 2011 6:09 PM | Ken Torbert Volg link

Canada has at last decided to be a full participant, not a bystander, in testing a potentially revolutionary treatment for multiple sclerosis devised by the Italian doctor Paolo Zamboni. It will set up clinical trials of the treatment, which until this week had been dismissed by many experts. Full participation in clinical trials is the right thing – the ethical thing – to do in a country with 75,000 people who suffer from the disease. Canada needs to see this treatment through, till the truth is uncovered.


Much has been said, of late, of a University of Buffalo study that casts doubt on Dr. Zamboni’s theory that vein blockages contribute to the disease and can be eased by surgery. But the authors of that study went on to say: “It behooves the clinical research community to carefully pursue [the theory] to its end. We should neither jump on the bandwagon as it passes through town, nor assiduously miss the parade.”


The Canadian Institutes of Health Research – this country’s main medical research funding body – has been true to its word. When it rejected clinical trials for the vein-unblocking treatment last year, it said that an expert panel would watch preliminary studies carefully. Now the expert panel has jumped in and said that early evidence of vein abnormalities is enough reason for proceeding to clinical trials.


And Health Minister Leona Aglukkaq has been true to her word, too. She said the government would support clinical trials if the CIHR gave its support.


There was always an irony in Canada’s rejection of clinical trials. The CIHR’s creation of an expert panel on the treatment was itself a recognition that Dr. Zamboni’s ideas were novel and powerful. Yet the panel rejected trials as premature and went so far as to say that they might not even win approval from ethics boards in hospitals because of the treatment’s risks. That seemed a narrow view of ethics, given the suffering of many people with the disease, which is marked by weakness, loss of muscle co-ordination and vision problems.


The CIHR says the evidence from new research isn’t clear on whether vein blockages are a cause of MS or a consequence. But there does appear to be a link between the blockages and MS, says CIHR president Alain Beaudet. That is enough to launch the first two phases of four-phase clinical trials. And so it is game on. This is not bandwagon-jumping. It is an attempt to test a new idea about an old disease, and it is in keeping with the best traditions of scientific inquiry.


http://www.theglobeandmail.com/news/opinions/editorials/aglukkaq-is-right-to-authorize-zamboni-trials/article2082943/