Saskatchewan Clinical Trials "Up In The Air"

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

Saskatchewan Clinical Trials "Up In The Air"

Postby Blaze » Thu Jun 30, 2011 9:58 am

Well, Canadians, yesterday's announcement is now yesterday's news. Today's news may be a bit of a setback. The Saskatoon Star Phoneix is reporting the Saskatchewan trials are up in the air and will not be proceeding until there is more scientific research. This is a huge disappointment because Saskatchewan hs been a leader in this.C

The Star Phoenix is also reporting the first people to be tested in Phase 1 of Canadian trials will be healthy people to determine if the procedure is safe for people with MS. How crazy is that?!?

Here's the article:

REGINA — Saskatchewan’s big plans for clinical trials of the controversial “liberation” therapy for multiple sclerosis have run into a scientific roadblock even as Ottawa abruptly reversed course Wednesday to announce federal funding of more limited clinical trials for the treatment.

The Saskatchewan Party government has been in the lead on the issue nationally, with Premier Brad Wall last year announcing $5 million for clinical trials of the therapy, which involves angioplasty to widen neck veins. In December, the Saskatchewan Health Research Foundation (SHRF) issued a call for proposals and the province had said clinical trials should begin later this year.

But on Wednesday both the foundation and the Saskatoon-based research team that had made the single proposal to the SHRF said more scientific research is needed before a broad trial like the one proposed in Saskatchewan could move ahead.

It was Health Minister Don McMorris, responding to the announcement by Conservative Health Minister Leona Aglukkaq, who revealed that the SHRF had received only one proposal that did not meet the criteria set out by the foundation’s expert panel.

“There was no proposal that would be moving ahead in the short term,” said McMorris, who described the situation as a “setback.”

That means clinical trials will almost certainly not happen in Saskatchewan this year.

With the federal decision, which came as a surprise to the government, the province is now interested in whether its activities can be linked to the federal plan for clinical trials, said McMorris. Ottawa is likely to issue a request for proposals by the end of 2011, with clinical trials in the new year.

However, what the federal government is proposing is a smaller-scale, two-phase trial than what was proposed by Saskatchewan. Phase 1 will involve a small number of healthy people to test the safety of the procedure while Phase 2 will involve between 20 and 300 patients to look at the effectiveness of the treatment on a limited number of people.

Saskatchewan had been looking for a larger trial that “would really show definitively that the liberation procedure does improve quality of life for MS patients,” said June Bold, CEO of the health research foundation, in an interview Wednesday.

“When we first put out the call, we were looking for that really powerful study to show definitively the answer to the question. But it’s just become clearer to us ... that really, there needs to be some of that early work done,” she said

Liberation therapy is based on the theory of Italian surgeon Dr. Paolo Zamboni that MS is linked to narrowed or blocked veins in the neck or spine, a condition for which he coined the term, chronic cerebrospinal venous insufficiency (CCSVI). Likely dozens of Saskatchewan patients have travelled outside the country to undergo the treatment, which is not allowed in Canada.

Dr. Katherine Knox, head of the Multiple Sclerosis clinic in Saskatoon and one of the leaders of the research team, said the team had put forward a conditional plan for treatment trials, to be based on the results of ongoing research, such as her team’s current study into vein abnormality that will be completed in 2012.

Knox said the criteria put forward by the foundation did not meet the research team’s criteria either.

“We did not feel a treatment trial could move forward with the current level of evidence required. The type of treatment trial that the SHRF proposal called for, which is a large trial to prove whether or not angioplasty improves quality of life in MS (patients) did not have enough preliminary information to be able to design and execute a trial to prove that at this time. We essentially stated that in our proposal and the reviewers agreed with that. The scientific evidence is not at the stage to prove whether or not the treatment works,” said Knox, who thinks it unlikely that any researcher would have been able to meet the SHRF criteria at this point.

Asked whether the health research foundation had been too ambitious because of the provincial government’s enthusiasm for the issue, Bold said it had been “very willing” to work on the province’s behalf to move research forward and that it had learned a great deal from the process.

McMorris said his primary concern now is ensuring that Saskatchewan patients can take part in clinical trials, whether under provincial or federal auspices. The province has one of the highest rates of the disease in the country.

But while the government is committed to “moving the science ahead,” McMorris acknowledged the uncertain timeframe will frustrate some MS patients anxious to take part in clinical trials.

“We’re going to have to say, ‘be patient,’ because this is about not just doing a procedure quickly but making sure the science is behind us.” ... n+treatm...
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