Globe Editorial on Canadian Decision

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Globe Editorial on Canadian Decision

Postby Blaze » Fri Sep 03, 2010 5:23 am

The Globe (who along with CTV first brought the story about CCSVI to Canadian public attention last November) has an editorial in today's issue.

Here it is:

Clinical trials for the Zamboni treatment of MS would be a bold move – but the right one

Canada should fund medical trials of a revolutionary treatment for multiple sclerosis, and not act as if the rejection of those trials by an expert panel must be obeyed. This is a political question, not a purely scientific one.

No one should be surprised that a panel set up by the Canadian Institutes of Health Research, a government agency, was cautious about the call for research dollars for a new treatment for MS proposed by Paolo Zamboni of Italy. Caution is in the DNA of such panels, though it should be said that, in the circumstances, its caution was reasonable and fair. (The CIHR provided a useful explanation of the panel’s thinking on its website.) Health Minister Leona Aglukkaq said accepting its advice is prudent. She’s right, it is prudent. But who says prudence is what’s needed?

Canada should be bold because it has a high rate of affliction, and because Dr. Zamboni’s work, though far from definitive, was powerful enough to demand further exploration. As many as 75,000 people have this neurological condition, which affects movement, eyesight and thought. Saskatchewan has an especially high rate. The condition is more common in countries further from the equator.

It’s not up to scientific panels to tell government to be bold, or how to go about it. It’s for politicians to seize, as Saskatchewan Premier Brad Wall has done by insisting that his province will pay for clinical trials.

The work done by Dr. Zamboni suggests that vein blockages play a key role in multiple sclerosis, and that a simple dilation with a balloon catheter can relieve the worst symptoms. There is no definitive set of rules on when such work can be tested with clinical trials. It is in a grey zone. Can the CIHR honestly say that no early-phase clinical trials have ever been begun with less evidentiary support?

Dr. Zamboni’s researchers, using ultrasound technology, found abnormalities in 100 per cent of the multiple-sclerosis patients studied, and in none of the subjects without the condition. But the researchers were not “blinded”; they knew who the diseased patients were beforehand. It’s possible they found what they were looking for, as the CIHR’s panel said. Similarly, there were no control groups of MS sufferers given sham or phony treatments, alongside those whose veins in the neck and chest were dilated. So there is reason for the panel’s skepticism. Dr. Zamboni proved nothing.

Even so, the work was groundbreaking enough to launch studies of his theories in several countries. There are seven studies under way involving major Canadian hospitals. The CIHR’s creation of the expert panel is an extraordinary move that suggests the power of Dr. Zamboni’s ideas.

The expert panel said there is no evidence of safety or efficacy. But how to acquire such evidence without trials that provide treatment to some patients, risky though it might be? The panel had one, unnamed “person living with MS.” Was this person equipped to challenge the “wide range of internationally recognized participants”? This may be a case of scientists detached from the community they are meant to serve. Ms. Aglukkaq, and provincial health ministers, should take a close look at the option of clinical trials. Politicians, not expert panels, are accountable to the public for fighting disease. ... le1694507/

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