I would like to address a second item missing from the budget: funding for clinical trials for chronic cerebrospinal venous insufficiency, or CCSVI.

After much resistance, the federal government announced this summer that it would fund clinical trials for CCSVI. This was welcome news for Canadians with MS and for their families. However, this decision took far too long to arrive at, and, since the announcement, no plan has been provided describing how the government plans to establish these trials.

I want to be very clear: right now, all we have is announcements; what we need is action. Canadians with MS cannot afford to wait, as any delay possibly means more damage.

Mr. Speaker, 30%-50% of MS patients who are untreated worsen by one EDSS score in one year, and 50% with relapsing-remitting MS later develop a progressive form of the disease for which there are no drugs. The reality is that one month can mean the difference between walking and not walking, or between living independently and living in care.

CIHR has recommended a phase I/II clinical trial, which is usually undertaken to assess safety. However, angioplasty is an accepted standard of care practice and routinely used for many conditions. The U.S. Food and Drug Administration has accepted the basic safety information for angioplasty, since it has already approved three double-blind phase II clinical trials, which are already being conducted in the United States. There is no need for a phase I trial in Canada. It will waste time and money and would provide nothing beyond what is already known worldwide about this procedure.

What is needed is an adaptive phase II/III trial, which would permit a rapid and seamless transition from the phase II trial--subject, of course, to interim assessments of safety and efficacy--to a full phase III trial. This approach would still address all the regulatory requirements and answer all the key safety and efficacy questions, but it would also save time and cost.

Moreover, we need experts who are actively engaged in diagnosis and treatment of CCSVI on the CIHR's expert working group.

Kirsty Duncan