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Part 2: Private member's bill C-280 for a "national CCSVI strategy" in Canada
(continued)....
"MS drugs to alleviate symptoms, a market estimated to hit $15 billion by 2015, are “fast-tracked” to market all the time. In Oct 2008 Health Canada fast-tracked Biogen Idec’s Tysabri, despite concerns it can cause a rare fatal brain infection called progressive multifocal leukoencephalopathy (PML). (The total worldwide total reported cases of Tysabri-linked PML stands at 181; the death count at 38.) This month, the FDA fast-tracked Tovaxin, a drug developed to treat secondary progressive MS on the grounds that no other therapies were available for this group. On its website, the MS Society of Canada expresses urgency that the newly approved oral drug, Gilenya, be covered by provincial health plans: “The MS Society of Canada is working closely with the provincial and territorial governments, urging them to make quick and positive decisions to include Gilenya in their list of drugs for reimbursement under their public drug plans.”
MS patient and CCSVI activist Christoper Alkenbrack of Wolfville, Nova Scotia expresses cynicism about the pace the process has played out. In August 2010, the CIHR, Canada’s scientific funding body, conducted a closed-door meeting that resulted in a decision that Canada adopt a wait-and-see attitude toward clinical trials. Ten months later, on June 28, 2011, it did an about-face after being presented with a meta-analysis of CCSVI research. Five months after that, the minister of health announced clinical trials, less than a week before Bill C-280 was to be debated. Alkenbrack, a former high school principal who says he has benefited markedly from CCSVI treatment, questions whether those with experience dealing with CCSVI experts will be involved in the trials: “I suppose that I could reconsider my position if they actually put the real experts in charge of the studies, but up to this point, it has not been the case,” he wrote on CCSVI Facebook page.
Sandra Birrell, president of the National CCSVI Society in Victoria, BC, is buoyed that steps are being taken: “At least the Canadian government is doing something,” she says. “It might be appallingly slow for those of us who are waiting but we actually have movement.” Birrell says she has faith in the system, though notes “there are aspects that obviously are not nimble enough to respond to something like this. It’s a model built to test new drugs.”
She expresses frustration, however, that a vascular condition has been sucked into the neurological/auto-immune MS research paradigm. A dangerous precedent is being set, she says: “Have they studied breast implants in relation to MS? Or interventions covered by the health system like laparoscopy? What this means is that every time something comes along that could affect a chronic illness, those with that chronic illness will be withheld that new treatment until the full effects of that treatment on their chronic illness are well understood.”
Meanwhile, as the politicians debate, Canadians already are participating in CCSVI clinical trials—only not in Canada. Many (their exact numbers are unknown due to the fact these are blinded studies) have been treated at one of the three FDA-, IRB-approved trials currently in phase II trials in the U.S. and a phase III trial underway in Poland. And more are scheduled. The Saskatchewan provincial government is spending $2 million for 80 to 90 MS patients to travel to Albany, N.Y., for CCSVI treatment after efforts to get an in-province treatment trial running by year-end failed. Provided that doesn’t hit a roadblock, we’ll have some science about CCSVI treatment far sooner. Until then, if you’re interested in a glimpse of how politics, medicine and business collide, tune into CPAC tonight."
"MS drugs to alleviate symptoms, a market estimated to hit $15 billion by 2015, are “fast-tracked” to market all the time. In Oct 2008 Health Canada fast-tracked Biogen Idec’s Tysabri, despite concerns it can cause a rare fatal brain infection called progressive multifocal leukoencephalopathy (PML). (The total worldwide total reported cases of Tysabri-linked PML stands at 181; the death count at 38.) This month, the FDA fast-tracked Tovaxin, a drug developed to treat secondary progressive MS on the grounds that no other therapies were available for this group. On its website, the MS Society of Canada expresses urgency that the newly approved oral drug, Gilenya, be covered by provincial health plans: “The MS Society of Canada is working closely with the provincial and territorial governments, urging them to make quick and positive decisions to include Gilenya in their list of drugs for reimbursement under their public drug plans.”
MS patient and CCSVI activist Christoper Alkenbrack of Wolfville, Nova Scotia expresses cynicism about the pace the process has played out. In August 2010, the CIHR, Canada’s scientific funding body, conducted a closed-door meeting that resulted in a decision that Canada adopt a wait-and-see attitude toward clinical trials. Ten months later, on June 28, 2011, it did an about-face after being presented with a meta-analysis of CCSVI research. Five months after that, the minister of health announced clinical trials, less than a week before Bill C-280 was to be debated. Alkenbrack, a former high school principal who says he has benefited markedly from CCSVI treatment, questions whether those with experience dealing with CCSVI experts will be involved in the trials: “I suppose that I could reconsider my position if they actually put the real experts in charge of the studies, but up to this point, it has not been the case,” he wrote on CCSVI Facebook page.
Sandra Birrell, president of the National CCSVI Society in Victoria, BC, is buoyed that steps are being taken: “At least the Canadian government is doing something,” she says. “It might be appallingly slow for those of us who are waiting but we actually have movement.” Birrell says she has faith in the system, though notes “there are aspects that obviously are not nimble enough to respond to something like this. It’s a model built to test new drugs.”
She expresses frustration, however, that a vascular condition has been sucked into the neurological/auto-immune MS research paradigm. A dangerous precedent is being set, she says: “Have they studied breast implants in relation to MS? Or interventions covered by the health system like laparoscopy? What this means is that every time something comes along that could affect a chronic illness, those with that chronic illness will be withheld that new treatment until the full effects of that treatment on their chronic illness are well understood.”
Meanwhile, as the politicians debate, Canadians already are participating in CCSVI clinical trials—only not in Canada. Many (their exact numbers are unknown due to the fact these are blinded studies) have been treated at one of the three FDA-, IRB-approved trials currently in phase II trials in the U.S. and a phase III trial underway in Poland. And more are scheduled. The Saskatchewan provincial government is spending $2 million for 80 to 90 MS patients to travel to Albany, N.Y., for CCSVI treatment after efforts to get an in-province treatment trial running by year-end failed. Provided that doesn’t hit a roadblock, we’ll have some science about CCSVI treatment far sooner. Until then, if you’re interested in a glimpse of how politics, medicine and business collide, tune into CPAC tonight."
Hi, for my illness studies are conducted internationally included cancer hospitals in Canada and the US collaborating, and thanks to major discoveries made in drug therapy in the last five years Multiple Myeloma is not a death sentence and they are hopeful of finding a possible cure in the new drugs that are being fastracked and studied, it's making a huge difference.
I think Canada doesn't need to start their own trials from scratch, that will take so long! Why can't the follow the data in the US and use that at a starting point! I pray this turns out to be an MS cure for at least some people that would be a miracle, and the fact it is not drug based is even more amazing.
Gilena is the pill MS drug right? I hate that pills are not covered but IV meds are, pills are easier to take but when it costs you thousands who can afford the meds?
It would be much less waiting!
I think Canada doesn't need to start their own trials from scratch, that will take so long! Why can't the follow the data in the US and use that at a starting point! I pray this turns out to be an MS cure for at least some people that would be a miracle, and the fact it is not drug based is even more amazing.
Gilena is the pill MS drug right? I hate that pills are not covered but IV meds are, pills are easier to take but when it costs you thousands who can afford the meds?
It would be much less waiting!
Yes, I'm watching with interest and curiosity, and patiently waiting to see how this plays out. I'm still skeptical, now knowing three people with MS who had venoplasty and are not doing well at all, in fact one is very seriously ill and hospitalized as a result of the procedure. Still, so many swear by it, so, we'll see.
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