"Hurry up and wait for a CCSVI strategy: MS drugs get fast-tracked all the time. Why can’t a clinical trial get the same treatment?"
by Anne Kingston on Wednesday, November 30, 2011
"CPAC is not always recommended viewing but tonight’s programming is must-see-TV. At 5:30 pm EST (and later in endless loop) Liberal MP Kirsty Duncan’s private member’s Bill C-280 calling for a national CCSVI strategy is set for second reading and debate. (If the House of Commons vote scheduled to begin at 6:15 pm goes past 7:01 pm, private member’s business will be cancelled and rescheduled for another time at the discretion of the Speaker.)
Duncan, a Ph.D. and adjunct professor at the University of Toronto, was the Liberals’ public health critic when she initiated the 2010 sub-committee on neurological diseases, which called upon Italian vascular specialist Paolo’s Zamboni to answer questions about his hypothesis that venous malfunctions in the neck and chest are linked to multiple sclerosis—and that venous angioplasty can relieve MS symptoms dramatically. The member for Etobicoke North is calling for CCSVI clinical treatment trials as well as a national tracking program for the estimated thousands of Canadians who’ve traveled offshore for treatment—and have been denied after-care upon return.
Canadians might think they’re watching a re-run. It’s not, though the Conservatives have been all over CCSVI in the past week. Leon Benoit, MP for Vegreville-Wainwright, proposed a private member’s motion calling for a national tracking system and to increase patient awareness of CCSVI treatment. And on Friday, Health Minister Leona Aglukkaq announced that the Canadian Institute of Health Research (CIHR) was calling for proposals for a “small scale” phase I and phase II clinical trials into CCSVI.
Duncan’s bill is expected to create schisms within party caucuses as CCSVI supporters take on the skeptics. It already has support among CCSVI advocates, the same groups that expressed frustration and anger with the minister’s CIHR announcement. Response to that was fast—and for the most part furious—particularly to the news actual trials wouldn’t commence for another year, which would mean CCSVI screening and treatment for MS patients would be in lock-down for a decade. That’s a typical timeline for clinical trials—but devastatingly slow-moving to those with MS, a degenerative disease for which a year can make the difference between walking and being bedridden. Some 55,000 to 75,000 Canadians are estimated to be afflicted with the condition—though those are old numbers in need of updating says the MS Society of Canada, which estimates multiple sclerosis costs the Canadian economy more than $1 billion a year.
In a press release, the advocacy group CCSVI Ontario blasted “the waste of time and money on unnecessary safety [phase I] and efficacy [phase II] trials” into venous angioplasty, which is accepted practice and already used in neck veins to improve blood flow in kidney dialysis patients. CCSVI Alberta was even more impassioned: “To allow people to suffer and die while a potential life-saving treatment is at hand is unethical, bordering on criminal.” Like other groups, it advocates a large scale phase II/III [treatment] trial in multiple centres immediately.
Michael Shannon, a medical doctor with extensive experience designing and running large clinical trials, says that a phase I safety trial, which could take at least 18 months, is “a 100 per cent total waste of time and money.” CCSVI clinical trials are already well underway in the U.S.,” he notes. “The fact the FDA has approved three double-blinded clinical trials at phase II level should convey to anyone who understands the regulatory process that the FDA is satisfied with the general safety of this procedure which is routinely used throughout North America for all kinds of medical conditions requiring arterial or venous intervention.”
Dr Shannon, who has held several high-level federal government positions, including Director General of The Laboratory Centres for Disease Control, heads the Scientific Advisory Board of the CCSVI Coalition. He estimates that a phase I clinical trial would take at least 18 months to complete, cost more than $1 million and contribute absolutely nothing in the way of new information to the large body of safety information already available for this procedure. His group is advocating for an “adaptive phase II, phase III” trial, which can expedite the regulatory process without compromising its scientific rigor and which could save an additional half year of time."
......continued in "Part 2."