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?


Update 2: The second reading of Bill C-280 is now scheduled for Thursday, December 8 at 6:30.

Update: The second reading and debate for Bill C-280 was pushed off the House of Commons schedule on Nov. 30 due to other business. It hasn’t been rescheduled. Stay tuned.

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.

“Disease-modifying” 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.


Hurry up and wait for a CCSVI strategy

  1. There are other trials underway as well.  The University at Buffalo Neurosurgery department has completed a Phase 1 safety study, and is at least 6 months into their Phase II efficacy study “Prospective Randomized Endovascular therapy in Multiple Sclerosis”.  I got fed up waiting for some action in Canada and enrolled in this study myself.

    Why we don’t just expand upon one (or more) of the studies already underway is beyond me.

    It has taken five months since the announcement just to release the RFP. It will take many more to review the propsals and award grants.  Then the long trial period.

    We need to speed things up.  Those of us with MS lose ability every day.  Waiting for years is not a viable option. 

    • Despite what the author is saying, it is very typical in Canada that we repeat studies to make sure that medications are safe before okaying them for use in Canada….remember the H1N1 vaccine?
      As I pointed out to an earlier blogger, we have neurologists who do not believe that this treatment is valid and they are the so-called experts on MS.  They have gone so far as to call the treatment unsafe.  The vascular surgeons are arguing that the treatment is valid and safe…who knows best? 
      It is good that so many studies are taking place in the US and once those studies are completed, Canada likely will have no choice but to do its own studies…if the outcomes are positive and the treatment has a good safety profile.  Meanwhile, people can still go to the US for the treatment.

      • Dear Healthcare Insider,

        If a person has a problem with a particular organ, wouldn’t it make sense to evaluate and treat any dysfunction pertaining to the very basic health of that organ, namely, oxygenation and waste removal? These functions are compromised in CCSVI patients and their target organ is their brain. As a healthcare insider can you seriously sit idly by and say it’s alright to ignore compromised circulation just because so-called MS experts have decided to ignore it for the past 100 years? You ask who knows best when it comes to a vascular condition, a neurologist or vascular surgeon. Do you call an electrician when your toilet backs up? Go back to your basic anatomy books.

        • Therein lies the problem….the “backup’ is in the brain….the neurologist is the brain specialist….no anatomy text-book needed.
          Further, CCSVI does not work for every person with MS so the illness is more complex than just sluggish blood return from the brain.  I am ON YOUR SIDE.  If it were up to me, I would get you a study in Canada.  I think the bickering between the specialities is ridiculous and even if CCSVI only provides symptom relief for a portion of people with MS, I think it is a valid treatment.  I am only explaining that this is not new in Canada.  Canada has always been wary of new medications and is late licensing them here.  I am just explaining that the neurologists are a powerful group and therein lies the problem with getting CCSVI trials off the ground.

      • Dear HealthCare Insider. Clearly your study of Canadian medical history only starts somewhere in the 1960’s. Canada used to do it’s own research and in several areas we were world leaders.
        Pop over to my place and I will lend you a towel to dry off with because I think you are all wet – Big Time all wet!

  2. Gosh, I hope a loved one of Harper and or a loved one of his health minister doesn’t have some tragic illness befall them, an illness like MS or ALS-only then will they get it.

    • This isn’t about high level politicians it is about powerful figures in medicine who disagree strongly over the efficacy and safety of this treatment.  If the neurologists who are the “experts” in MS and typically treat MS were on board, there is no question that the studies would have gone ahead but with them actively lobbying against the treatment, it is a very difficult situation for politicians.  They don’t know who to listen to – the vascular surgeons or the neurologists.

      • this is about powerful figures in medicine who receive millions of dollars from pharmaceutical companies for biased research, speaking engagements, and participation on advisory boards. this about money, MS is a billion dollar industry, over 15 billion in sales last I checked. There is serious conflict of interest from these experts, so much so there should be jailtime.

  3. A phase III trial in Poland?  Even Dr Zamboni didn’t mention a trial in Poland in a review of CCSVI trials he did 2 weeks ago in New York City

    From a journalist like you, we expect to be at least accurate with the presentation of the facts!

    • metro10- Categorization is tricky here. Dr. Marian Simka confirmed that his research group in Katowice, Poland is currently evaluating data and following up patients, some 200 of them Canadian, enrolled in an open-label design treatment trial, which has been referred to as Phase III. Today he clarified in an email that it’s being grouped as Phase II, but as he points out: ”
      since it is the trial evaluating procedure and not a drug, the criteria regarding phases, which are used to classify pharmacological trials, cannot be easily applied.”

      • Mrs Kingston,

        In Wikipedia, a Phase 3 trial is described as a randomized control multicenter trials with a large group of patients (300-600) .  Dr Simka project has no other centers involved and it is not a randomized control trial.   By including Canadians who live far away from his center, he depends mostly from self-report data coming from treated MSers with no objective observations usually obtained by regular follow-ups visits.  His report will be at the most a weak Phase 2 study.

        There are only 2 real randomized controlled study for CCSVI available in the world: the PreMise study run by Dr Zivadinov in Buffalo and the BRAVE DREAMS study by Dr Zamboni.  The PreMise study is a small Phase 2 trial and BRAVE DREAMS is a real Phase 3 trial.  The actual proposition by the CIHR of having a group of 100 patients half treated and the other half not treated is going exactly in the same direction than the other studies .

        From the answer you wrote to me, I understand that you recognized implicitly your error and I thank you for that.

  4. I was liberated in Febraury 2010 and no longer drag my leg when I walk.  Thank god for Albany.  I am impatient and certainly not able to wait like the masses.  While the ‘loan’ required to have the surgery was not optimal…it changed the quality of my life.  A foot note, I stopped taking Copaxone sometime ago as well.  My health did not change for the worse or for the better.  What is in Copaxone?  Hyped up vitamin C?  Wake up folks…the government and the MS Society are sleeping with the pharmeceticul companys.  They are not coming up with cures, certainly not drugless health improvements anyway, anytime soon, if ever! 

  5. I have had MS since 1977 and frankly I am getting too tired to “Hurry up and wait!”
    But I can go to Albany NY in the spring, but I would like to get my angioplasty here in Canada!

  6. I wonder what Harper would do if his wife, daughter, son got the diagnosis of MS or were stricken with some other type of debilitating disease, just what would he DO then???

    • PWK, can you have other arguments? You just repeat what you already said!

      • Stephen and Leona are both slow learners where health care is concerned. Things have to be repeated to them or they will never get it. As of this morning, they still have not got it so here is that comment again, “I wonder what Harper would do if his wife, daughter, son got the
        diagnosis of MS or were stricken with some other type of debilitating
        disease, just what would he DO then???”

    • He would likely take them to the US to get the therapy ….afterall Danny Williams went to Florida to get heart surgery.

  7. None of the foreign trials of` “liberation” have been peer-reviewed by scientific committees and are funded only by fees charged to patients, not by government or charitable agencies. They have no scientifcally acceptable way of defining “CCSVI”, are not well-blinded and any data obtained will be uninterpretable. These “trials” are basically infomercials to attract paying patients under the guise of doing science.

    Saskatchewan discovered that it is impossible to find any real scientist to do a trial simply because no real scientist wants be go down in history as another food who believed Zamboni`s myth.

    Governments throw money at the Zamboni cult to appease it. There is no political advantage in opposing zealots with miserable disease and a high tech religious faith in a saviour. Science takes a back seat to emotion.

    “CCSVI” is junk science and its treatment by “liberation” is a dangerous hoax. No more time or money should be wasted on it. See blog for details:

    • Colin has OCD

    • Colin, You are a cardiologist, right? How does that make you any more an expert in the subject of MS and CCSVI than say a proctologist or a podiatrist? Oh! It doesn’t. So why do you not go back to your heart patients – oh! I guess you don’t have ant – you seem to spend all your time in chat rooms and in sites like this pontificating about things you know nothing about. Perhaps you should spend your time staying up with your own area of medicine just in case you ever get a real patient with a real heart problem. Of course, if you would rather keep up with this, then keep up!  Here is a starting place:

      When you have read it, call your buddy in Ottawa and tell him too. Apparently he is too busy reading sales pitches for drug companies to read medical papers and articles.

      In any case, I want a part of this hoax. Several of my friends who have had it are walking again and some are back at work. Gotta love a good hoax like that!!

  8. clinical trials are NOT always done for other procedures yet given its doesnt make sense.
    CANADA deserve help NOW
    Lynne Heal UK (Lynnie)