Saskatchewan MS trials could go ahead without fees
September 8, 2010
Joanna Smith
OTTAWA BUREAU
OTTAWA—A Saskatchewan doctor researching an experimental treatment for multiple sclerosis says she will base any decision to go ahead with clinical trials on scientific evidence, even if a federal advisory group ultimately recommends another course.
The federal government announced last week that it will delay funding nationwide therapeutic clinical trials for the so-called “liberation” treatment for MS on the advice of an expert panel convened by the Canadian Institutes for Health Research (CIHR) and the MS Society of Canada that found going ahead without further study would be scientifically and ethically inadvisable.
Ottawa will instead set up a scientific working group to monitor and analyze $2.4 million worth of research sponsored by the MS Society of Canada and its American counterpart examining the link between blocked veins and MS, which is the theory behind the vein-clearing treatment pioneered by Italian researcher Dr. Paolo Zamboni.
One of those projects is being run by Dr. Katherine Knox at the University of Saskatchewan, where the provincial government is sticking by an earlier decision to fund clinical trials if it receives a proposal, even if it ends up conflicting with the federal approach.
Knox has finally made her intentions clear by saying that she will not base a decision to begin clinical trials on the results of her diagnostic study alone, but neither will she wait for the scientific working group if the case is strong enough.
“We will move forward when we believe there is a case for experimental intervention of possible blockages. This decision will not be solely based on our own data or solely on the (federal health research agency) recommendations,” Knox said in an email Wednesday through a spokeswoman at the College of Medicine at the University of Saskatchewan. “If other data is released (in addition to the six other funded studies) that supports or refutes a case to move forward, that data will be considered.”
This does not mean that Knox, who expects the diagnostic study to yield preliminary data “within a short time frame”, has any plans to go rogue and start testing the treatment on Canadian patients who have hitherto had to pay thousands of dollars and travel overseas for the treatment.
“The details of a possible treatment trial will be confirmed when we have further information, particularly with respect to safety and the reliability and accuracy of diagnosing obstructions,” Knox said, noting the expert panel identified the same priorities.
But it does mean Knox views the federal recommendations as just one factor, albeit an important one.
“This decision will depend on the strength of the evidence supporting or not supporting a case to move forward safely and on the timing of the of the next anticipated CIHR recommendations,” Knox said. “We value the expertise from CIHR in our decision-making process.”
While the scientific working group is going to look at all seven studies, the process could speed up if any one of them provides strong enough evidence to support clinical trials at any point.
“We do not necessarily need to wait until the studies are finished before making a recommendation on next steps,” said David Coulombe, a CIHR spokesman, adding that preliminary results should be available within the next year.
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