Finally, CCSVI clinical trials. So why is everyone so pissed off?

Anne Kingston takes a closer look at the federal government’s approval of $6-million, four-centre, three-province trials


Beatrice de Gea/The New York Times

On Friday, the Canadian government announced  approval of clinical trials into the safety and efficacy of treatment for cerebrospinal venous insufficiency, better known as CCSVI. Health Minister Leona Aglukkaq broke the news at a health ministers’ meeting more than five months after her April non-announcement announcement  that a research proposal had been selected. Back then she said she couldn’t say more until the proposal passed through ethical review boards’ approvals. Now she’s sharing details of the $6-million, four-centre, three-province trials—even though some ethical review board approvals still have to be cleared.

Anyone following the tortuous saga of CCSVI research in Canada will be forgiven if they hear the Peggy Lee chestnut Is That All There Is?  thrumming in the background. The announcement comes almost three years after Italian vascular specialist Paolo Zamboni made sensational headlines with his research linking multiple sclerosis to CCSVI, a vascular condition he identified that’s characterized by blockage in the blood flow of  neck and chest veins.  Zamboni’s claim that balloon angioplasty (or venoplasty) could improve or even arrest MS symptoms had Canadian MS patients clamouring for scanning and treatment, only to find themselves in a bizarro medical apartheid.

And it has been more than two and a half years since the Canadian Institute of Health Research (CIHR) teamed with the MS Society of Canada with the stated intent of expediting CCSVI research; together they’ve kept the issue in stasis with more flip-flopping than a bass on a boat deck.  In the interim, studies into the safety of CCSVI treatment have been published along with research linking it to other neurological conditions such as Alzheimer’s. And somehow neurologists, long-time MS caregivers, have become the go-to experts for a vascular condition—while actual vascular experts who’ve treated CCSVI have been shut out of the loop. Meanwhile, an estimated 30,000 MS patients, many of them Canadians, have travelled offshore to various clinics of varying quality for a procedure covered by provincial health plans, though not for MS. CCSVI treatment has proven effective relieving MS symptoms for some, though not all. Three people, two of them Canadians, have died following the procedure. Seeking answers, and fed up with federal inaction, Saskatchewan and the Yukon have gone rogue with a $2.2-million trial in which 86 MS patients were shipped to a phase II trial in Albany, NY.

Now we officially have “pan-Canadian” trials—provided your Canada only includes Quebec, BC and Manitoba. (Or maybe we should see this model as the test-case of Health Minister Aglukkaq’s signal August announcement about the future of Canadian health care.)  Manitoba’s presence on the list suggests last-minute scrambling. On Thursday night, the Manitoba Health Research Council (MHRC)  announced it wouldn’t sponsor in-province CCSVI trials, for which it had earmarked $5-million, because the one proposal submitted didn’t meet its criteria for a safe, ethical trial.  MHRC chairman Dr. Brian Postl also noted “other research into potential MS treatments is being identified and should be explored as well.” The next day, the province was part of the national trial, pending ethical review board approval. MHRC executive director Christina Weise told Maclean’s that approval is expected within 10 weeks, but that they don’t yet know how much they’ll be contributing to the trial. (The “potential MS treatments” Postl was referring to was stem-cell research, she said.)

The MS Society is boasting of being “partners” in the trial but the CIHR will provide $4-million of the $6 million cost, CIHR spokesman David Coloumbe told Maclean’s. How the remaining $2 million will be divvied is unclear (the MS Society of Canada didn’t respond to emails).  The randomized-controlled trial is small:  a total of 100 MS patients will be recruited for the Vancouver and Montreal centres beginning Nov. 1 (later in Quebec City and Winnipeg when those centres clear ethical review boards). At the outset, MS patients with CCSVI will be randomly selected to have either venoplasty or a “sham” procedure.  After a year, the groups will switch so everyone will receive treatment and be assessed.

At the helm is an CCSVI naysayer: neurologist Anthony Traboulsee, director of the UBC Hospital MS Clinic, who has voiced skepticism about CCSVI in the past. On the 2012 CBC’s MS Wars: Hope, Science and the Internet, Traboulsee expressed disappointment that CCSVI research has pushed funding for stem cell research, which he called “one of the greatest futures of treating all neurological diseases,” back by five years.  Traboulsee was also a member of the CIHR’s  Scientific Expert Working Group formed to oversee research into CCSVI clinical trials. CIHR spokesman Coloumbe says there’s no conflict of interest in Traboulsee now overseeing the shebang, and promised a full explanation as to why on Monday. (This post will be updated when it arrives.)

In an email, Traboulsee confirmed each site will have a “vascular specialist and MS specialist” though it’s unclear who the vascular specialist are. He’ll be working with interventional radiologist Lindsay Machan. The Montreal tranche will be run by doctors Marc Girard, president of the Québec Association of Neurologists, and Jean Raymond, an interventional neuro-radiologist who sat on the the August 2010 CIHR panel that decided against funding clinical trials into CCSVI treatment. The fact Quebec’s on board  is surprising given the province’s resistance to CCSVI. As Maclean’s reported in in 2010, the Collège des médecins du Québec, which polices the province’s doctors,  demanded Montreal’s Westmount Square Medical Imaging, one of  two private clinics then agreeing to scan MS patients for CCSVI, stop doing so.

Dr. Michael Shannon, head of the scientific advisory board for advocacy group  CCSVI Coalition,  applauds the CIHR and MS Society for taking this first step. “I think it has the potential of providing very useful information that can be integrated into the bigger CCSVI research picture,” he says.  Shannon, a former deputy surgeon general of Canada with expertise setting up clinical trials, says the study’s design must be bulletproof to be credible. “If the phase II trial is properly designed so the data is unassailable and compelling in terms of benefits over risks, CCSVI treatment should be be adopted as a standard of care,” he says, pointing out Health Canada has already approved balloon angioplasty to treat other venous blockages. But he also raises a big concern: that doctors performing CCSVI treatment in the Canadian clinical trial won’t have prior hands-on experience. Interventional radiologists say it takes upwards of 60 procedures to achieve proficiency; Salvatore Scalfani, a veteran interventional radiologist in Brooklyn NY, has reported it took him 200 procedures to feel comfortable.  Traloubsee told Maclean’s the technologist and radiologist involved in the trial spent a week with Zamboni and his team in Italy.  The vascular team has had “extensive conversations with many international colleagues who’ve performed the procedure,” he says, including Dr. Gary Siskin who’s running the Albany trials.

Linda Hume-Sastre, president of patient advocacy group  CCSVI Ontario, criticizes Friday’s announcement for what was left out: no mention of where the interventional radiologists performing the procedure have been trained or who trained them; no mention of how clinical improvement will be measured or by whom; no mention of the participation of vascular specialists, especially those with experience treating CCSVI. Hume-Sastre wants CCSVI to be unbundled from MS. Though diagnosed with MS, when she was treated for CCSVI 14 months ago it was for a a venous abnormality, she says:  “I had a vascular conditon that, when treated, meant that certain symptoms that MS neurologists define as MS symptoms were eliminated and remain at bay.”

Hume-Sastre questions of the timing of the clinical trials announcement only days before an Oct. 4 Senate committee begins consideration of (Lib.) Senator Jane Cordy’s Bill S-204 calling for a national CCSVI strategy: clinical trials, providing aftercare Canadians who travel out of country for treatment and a system to track patients.  It won’t be the first time politics reared its head in this issue.

For her part, Cordy is pleased clinical trials are finally happening, but maintains her bill remains relevant. She too has concerns about the annoucement, including the failure to mention vascular specialists and Traboulsee’s opposition to CCSVI treatment: “One has to question whether or not Health Canada and CIHR are truly interested in fair and objective trials,” Cordy says. It’s a damning indictment, one that rests with the feds to prove wrong.

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Finally, CCSVI clinical trials. So why is everyone so pissed off?

  1. Regarding the title of this piece: Can you not find a writer with a better vocabulary, or is the education system really that bad?

    • What’s wrong with it? It is very accurate – I know I for one, am royally pissed off about it!

    • No it is what it is ms patients pissed of with traboulsee being given this trial …

    • I know I am very PISSED off! I cannot express it any better via the media. I find this ‘Title” is very appropriate.

  2. I am confused. If people have so many doubts about the competence and integrity of Canadian physicians and Canadian universities to perform “fair and objective trials”, why press for them in the first place? Also, what does it mean when someone says, that it is up to them to prove your suspicions of their lack of objectivity wrong? Does that mean that unless the findings come out in a way that they want, they will accuse them of running corrupt trials or of being incapable of doing the procedures correctly? I am sorry Anne, I agree that these trials are way overdue but to now give voice to criticisms regarding how they will be run so as to call into question the “real reasons” for any undesirable outcomes is beneath your integrity as a journalist. There will obviously be BIG questions if the results of the Canadians trials differ from trials done in other countries. It is unfair to question the integrity of any research done in Canada when it is so closely monitored by eithics commitees at universities. These trials will be published in peer-reviewed medical journals. What possible pressure can the government exert on the outcome? The only way for the trials to be corrupted would be if all the medical personnel are corrupt and incompetent.

    • …and they are! most of the doctors who are involved in any government-led studies or surveys are outspoken opponents of CCSVI and/or have numerous ties to pharmaceutical companies! Not one doctor who has researched and learned this procedure from those who have done it and/or any of the few doctors in Canada who have actually done it are involved in any way! The CIHR won’t permit anyone who is a proponent of CCSVI treatment because they are biased and yet they are perfectly fine with any doctor who is an opponent of it! These phase one and two trials are a pointless waste of time – the studies have already been done, in the US and elsewhere, to prove the safety of the procedure (and they overwhelmingly have proven it safe!). We are pissed off because it should be phase 2 and 3 clinical trials, just as Kirsty Duncan proposed, and the time to start them isn’t now, it was over a year ago! 400 Canadians with MS die per year, but there is apparently no rush! The government blocks any and all access to this simple, safe procedure; but they are perfectly okay with killer drugs! Tysabri has caused 271 cases of PML; 59 of whom have died. 11 people taking Gilenya have died – that’s the new ‘miracle pill’ for MS that was announced when CCSVI started getting alot of press. Of over 30,000 CCSVI procedures done worldwide, I have only ever heard of 3 deaths, and at least two of those involved stents, something that is not done very often anymore. Canada should not waste time doing what has already been done – we should be working on perfecting the procedure and becoming the best place to be treated (we DO have the highest incidence of MS, after all)! Instead, it’s doing a whole lot of NOTHING!!!

      • I am sure that everyone would like to skip ahead to phase 2 and 3 clinical trials but that has NEVER been the way anything has been done in Canada. Think back to the H1N1 flu vaccine. Canada did its own trials despite the results of international trials. As for the physicians being biased. Are the interventional radiologists also biased because they are also working on the trials. Further the entire trials and results will be described in a peer-reviewed journal so the entire medical world will critique the results and any conclusions drawn by the physicians involved. Any inconsistencies in trial design or bias in reaching conclusions will be immediately evident.

        • And who controls the collection of the raw data and reviewing / filtering the results prior to preparing the final reporting? I have not seen any posts implying any issues with interventional radiologists. NEVER in Canada has one group of sufferers been denied a procedure that has been used to treat other conditions.

          • Who controls the collection of raw data? In most studies, raw data collecting is done by research assistants who contact the participants and ask them a certain set of questions at various times post procedure. Also, the participants will likely be examined. Again, all of the data will be presented in a peer-reviewed journal article. The authors cannot pick and choose. Data cannot be excluded.

      • Unless Dr. Bill Code and Dr. Sandy McDonald have had input in the selection of the research team and/or are part of the research team then those controlling this trial have shown their complete lack of impartiality.

    • Healthcare Insider- The issue is transparency and questions about the clinical-trial model and bias, not competence. There’s no question Canadian doctors and scientists are equipped to perform competent and ethical trials. I agree with Dr. Michael Shannon: trial design and training of those performing the procedure needs to be bulletproof going in.

      • Yes Anne, but in order for bias to be an issue, every physician involved in the study would have to be bias. Also, there will be transparency if the study is to be published in a peer-reviewed journal. These physicians are professionals with reputations they obviously care about. These studies must be bullet-proof so that the results will be accepted at face value. To suggest that an entire group of professionals would let bias taint the results of their research in the hopes that….hmmm…no one would pick up on it when they review the results….is really naive. As for their training…a week of training for a group of already experienced interventional radiologists who are experts in doing balloon angioplasties is likely considerable.

        • Your comment these professionals care about there reputations is laughable..what theory care about is the honorarium they get pushing useless drugs on ms patients…if they cared as a group they should not of shown there bias against ccsvi on national tv…they chose as a group to pressure other doctors including vascular to not do angioplasty because they were seen for what they are a group of doctors more interested in preserving there bottom line which is us ms patients as there cash cow…they have known for years there was a vascular component with ms and please…

          • I am going to ask you some questions Sandra. Does EVERY person with MS have a vascular component? Would EVERY person with MS benefit from this surgery?

          • We’re not saying that every person does. The ‘real’ medical scientists are still investigating that – but so far the odds are with the MS population. I suspect you’ve read the literature. But it is a lot less invasive than stem cell replacement. Rebuilding an immune system is MAJOR and requires many months of prep but balloning a vein takes less than an hour – and it works. Who pays your salary?

          • I love this Ann….you think I work for what…a pharmaceutical company? No, I have a brother with MS. He hasn’t had symptoms in 2 years either because he has the kind of MS where his symptoms flair up and then remit. He also doesn’t take any meds for it. You don’t have to discredit people just because they ask questions and point out that if you are going to question the reliability of one kind of research done in Canada, you are questioning the reliability of EVERY research study done in Canada.

          • It has been known since the 1800’s there is a vascular connection…the neurologists chose to not act on it because they pushed the auto immune theory which to date has not been proven…however all these drugs target that…some of them costing 5700 per month…no not all are benefiting as you well know..that needs further trials to see why…but many have been helped and it can’t be ignored …I have no problems with clinical trials we have wanted them since this started we just don’t want traboulsee leading this…it needs to be vascular since this is a vascular condition…there has been a lot of guess work on behalf of the neuros because they simply do not know, and somewhere along this road they decided the drugs and pushing these useless drugs to be there first priority …as a patient with ms I’m saddened and angered by this group of doctors and the mss who have been dishonest with us…they have no conscience or morals anymore. They made us distrust them with there actions…the minister of healths actions have been deplorable but understandable since she is just a puppet..that woman has no understanding of this what so ever…all we want is clinical trials done properly with no bias this is not to much to ask for…my symptoms have not returned and I’m coming up 2 yrs…

          • @Healthcare Insider: This treatment is so much better than these so called experts have ever come up with. I think their noses got out of joint because it was a Vascular specialist that brought it forward to the MS patient directly. Their drugs are not even close to what relief people get from Venoplasty. What should we do ignore CCSVI and let these non experts waste another six decades and millions upon millions? Come on, how idiotic is that?

          • Not everyone with MS has the same kind of MS. Some have a steady progressive worsening type while others have a type that goes through declines and remissions. Those people with remissions go two years without symptoms without ever having any treatment. Often they are on no medication. I have a brother who has the second type. He has never been on medication nor has he received any other kind of treatment and yet he has gone periods….as long as you have….without symptoms.
            Of course these trials are essential. Remember though, the neurologists are NOT the only physicians participating in the study. There are a group of physicians who will do the vascular interventions. They will have a stake in the outcome. They don’t prescribe pharmaceutical medications in their work.

      • Thank you Anne for exposing more than others will not. The truth hurts many nay sayers but I am so happy that you confirm our plight and I sure appreciate someone who has no conflicts reporting on this. Otherwise we would all be silenced by those who do not want the truth exposed. You have shown the transparency other refuse to show. Thank you and I hope more will see what is really going on.

    • most Universites are not eithel

    • You must be ready to retire. Old-school nurses used to be this naive, not today’s breed of nurses. I feel sorry for you.

      • No, I am not an “old-school nurse”. I have infact worked on two national research studies. I have also worked in university-run medical programs that are heavily research based. Thus I know what it takes to get ethics board approval to launch a research study. I also know that research studies involve alot of staff, especially when they are run out of multiple sites. That is how I know that the chances that bias could affect the way a study is interpreted and that the bias would NOT be identified, is highly unlikely. There will be complete transparency in design and very tight controls because the ethics boards at the institutions in Canada demand it. I also know that even accepting a sandwich from a pharmaceutical company during a information session about a new medication is frowned on in the hospital and medical school setting. It is true that hospitals do medication trials but that is part of a commitment to research. How do you think better anti-hypertensives have evolved? I have also worked in programs where trials were done on brain teaser games as a way of sharpening a person’s memory. It doesn’t mean the video-game company “owned” the physicians.
        No…kindly don’t feel sorry for me. I unlike yourself have some confidence in the integrity of our system because I have some experience working in it.

        • And we, unfortunately, have to deal with the medical system! We know from experience that MS neurologists frequently ignore any symptoms that don’t fit into their little ‘MS box’ and endanger our health and perhaps our very lives by doing so! There are actually still neurologists out there who still try to say MS doesn’t cause pain! Some of the studies that neurologists say disprove the efficacy of CCSVI treatment actually prove it!! Why? Because what it helps is fatigue levels and quality of life and other things that only the person who experiences them can possibly measure, so they completely discount them! It is stupid arrogance on there part that will skew their results! It’s understandably hard for them to accept that they have wasted their entire career chasing the wrong theory of MS, but in the end that is what will have to happen for treatment to advance….I’m not holding my breath; I’m going to find some way to raise money to go someplace the government doesn’t have a stranglehold on health care. In Canada we have sick care, and with a damn poor bedside manner to boot!

    • You are confusing specific “experts” involved with these trials and all Canadian physicians. It is your integrity that really is in question.

      • Say what? Is this really what it comes down to? Anyone who reminds you that the Canadian system will not allow for bias in its research studies is lacking in integrity?

        • The coolection of information for the study itself may not be biased, except for the fact that they will likely not involve anyone who has been properly trained in the procedure for testing for CCSVI nor anyone who has experience performing the procedure. What WILL be biased is the interpretation of the data that is collected because it is going to be interpreted by ‘doctors’ who have been very outspoken in their bias against CCSVI!

          • Anne said in her article that the interventional radiologists have gone and studied for a week under a vascular specialist who does CCSVI regularily. Therefore, they will have been trained in how to perform the necessary tests and perform the procedure. As I said earlier, the raw data will be collected by several different physicians and research assistants at the different sites. It will then be compiled and interpreted. The entire contents will have to be submitted for peer review, meaning that if there is a problem with the design of the study, the collection of the raw data OR the intrepretation of that data, the peer review at the medical journal where the study is to be published will uncover the errors. The study will be turned away by the editors of the journal because it is not valid….meaning its findings cannot be replicated. The authors of the study are for a better word, held in disdain by the medical academic world. Canada does not exist in a vacuum. It is part of a global, medical community. The question you have to ask yourself, is what has happened in studies done in other parts of the world? Have these studies shown conclusively that CCSVI works? You can expect that the results of the Canadian studies will be inline with the results of other studies done around the world. If the results differ greatly, the crap will hit the fan.

      • There’s no need to get personal, sosad. Healthcare is doing a wonderful job of demonstrating the problems with the so-called ‘experts’ involved in the study.

  3. Thank you Anne Kingston! We can always count on you for an honest story about CCSVI! I was never cynical and foolishly believed that the government and my doctors would do what was best for me until I started fighting for CCSVI testing and treatment. Now I wonder how I could have been so naive….with people like you around, more and more people will learn the truth of the matter and if enough people learn the truth, maybe we’ll finally be able to push to get something done! If I ever meet you in person, I will give you a big hug!

  4. Thank you for doing what CBC and CTV chose not to do which is report and investigate a huge conflict of interest..Dr Traboulsee has always shown his bias towards CCSVI so for the CIHR and the minister of health to do this shows there is more going on that needs answers…it is a sad day when ms patients are once again being duped for special interests who have a vested interest in never having this see the light of day…

    The minister of health needs to resign…

    The CIHR needs an independent body to investigate them..

    Traboulsee needs to be removed as head of this trial to show this will be done fairly and without bias…

    The neurologists only agenda is to say CCSVI does not exist and opening of the veins does not help ms patients. For vascular surgeons to not be leading this is very suspicious…

    Neurologists have been nothing but pimps for big pharma and this practice needs to end..with the help of the mss, government, and CIHR they have placed ms patients in harm for self profit…this should be a criminal offence..

    • BigPharma donates a lot of money to the Conservative coffers – so I don’t expect this government will do much to help MS patients whose drugs cost $40,000/year. In some provinces, the taxpayer pays for this, not private insurance companies. But BigPharma always comes out on top – especially with MS patients in Canada.
      Thanks Anne Kingston.

      • Added thought – and the taxpayers should be ‘ANGRY’.

    • Dear Sandra,

      There is no researcher or clinician who is not biased. You and I are biased about something in everyday life, i.e. I prefer bright coloured clothing, versus another person likes darker colours. It is the way that trials are designed, that are used to minimize bias and uncertainty.

      Was Zamboni not biased when he first stepped out confidently to state that he has nearly found a cure to MS?

      That’s also what ethics review boards are for. And if in the event of a biased study, Health Canada and CADTH are the ones reviewing the quality of the evidence after it is all done. Perhaps you can come up with some evidence of harm done by the “mss, government, and CIHR” before you say they have made a criminal offence.

  5. Of course we’re still angry. This procedure is about proper blood flow to and from the brain. Relatively straight forward angioplasty given anyone, without delay, unless they’ve been labelled ms. Figuring out the motive doesn’t require a GENIOUS!

    • It seems to be that being a GENIUS means they do not get it! They have their way and as long as drugs are involved all is good. Pursuing a non drug route even if it helps to give relief to many is obviously not lucrative enough for these so called experts.

    • NOT relatively straightforward angioplasty. Normal cardiac angioplasty (or even Carotid artery endarderectomy) is done on the arteries, which are typically much thicker and more muscular than the veins. This procedure would be to perform angioplasty on the large veins of the head, which are much flimsier and more prone to rupture.

      Moreover, the question remains whether there is truly a blockage of blood flow from the brain in all patients with MS, or whether perhaps there is simply a subset that has this particular abnormality.

      • Which, of course, is what ‘good’ scientists are trying to figure out. We just don’t happen to have any of them in Canada.

      • There are many proper studies that conclude venous
        angioplasty used in CCSVI treatment is safe. The vein treatment sites are in
        the neck and chest, not in the head. So the facts of your post are quite weak.

        The basic question
        about the way the Feds and the CIHR are proceeding is that if you really wanted
        to prove if something is true, why do you hire someone with a negative bias to
        do the study? The only answer is that you don’t really want to prove it. The
        club of researchers that think they own the disease and research process want
        to continue the path they want, and damn any sick patients that don’t blindly
        follow along in suffering.

      • @ae7136e30aab8c016ba8463329ff7766:disqus , get your facts straight….the procedure is a venoplasty, which is always done on the veins. They don’t go near the head – the major veins in the neck and chest is what they treat. They do this exact procedure (the jugular portion of it that is) on people who are receiving kidney dialysis – it’s not quite routine, but it is a commonly accepted procedure. The vascular component of MS has been known for a hundred years; it has just been largely ignored while the medical dogs were chasing their tails trying to prove the wrong theory (the autoimmune theory) – you would think that after over 50 years of going nowhere fast they would finally figure out they’ve been going the wrong way! It would not be present in everyone with MS, for the simple reason that many of the people who have been diagnosed with MS do NOT have MS. There are more than 100 illnesses that are often misdiagnosed as MS, and MS itself doesn’t even meet the criteria to be called a disease. (they can’t even prove what causes it and have know way of predicting the course of the illness).

  6. Words can be so telling.

    At the original presentation of the CCSVI procedure, some leader within the MS Society replied, ” this is not the kind of research we do, we have to spend millions of dollars testing drugs…”

    I guess if you read between the lines, you can understand the ‘paradigm’ that has created the ‘box’ that we exist in. The current medical system in the USA, a fee for service paid for by insurance companies or patients, or the Canadian publically funded private systems where fees are still paid for visits and services, there is no great and direct financial system to find a cure, or prevent the disease; prevention the simplest and best of cures.

    Caesar J. B. Squitti
    H. B. Comm, (discovered anti+truths in 1989 – and i am guessing ‘they’ have not told you about this either )

  7. What? Never heard of the Disease, and I’m a cardiovascular nurse. Must be very rare.

    • It’s not as rare as a smug comment. Only upwards of 100,000 people. Are you interested in some peer reviewed medical journal links to read, or are you full? You would be shocked to realize you missed some stuff at school.

      • Nurses like you we could all live without. A good, interested nurse reads widely across all medical specialities.

    • @Tony_SFO_YUL:disqus Where have you been??? Cerebral Venous Insufficiency is very common in people who have a tumour that impairs the venous outflow from the head; you certainly should have heard of THAT before! Chronic Cerebrospinal Venous Insufficiency is caused by malformations of the Jugular, Azygos and/or hemiazygos veins – whether caused by injury, infection, illness or deformity has yet to be determined. I think you either are not actually what you profess to be, or you are so ignorant, you shouldn’t be!

      • CCSVI is a sham diagnosis that is based on spurious tests that lack validation.

        And someone with hemodynamically significant downstream venous stasis/obstruction would be critically ill. Veins normally deform and collapse – it’s what they do and I do it to them everyday when I place peripheral IVs.

        • If it doesn’t exist, then why the hell has treating it helped so many thousands of people?? And don’t say ‘placebo’ – a placebo effect cannot last for years!

  8. Inflammatory tabloid style writing from Kingston as usual. Ironic that I see the ad for $20 subscriptions. Cheap as it may be, with writing like this, it’s not even worth $1.

    • Then don’t read it…Anne Kingston is a rarity she writes the truth and investigates..She has been the only journalist to keep reporting the facts and I thank her for doing that for us msers…so it’s simple if you don’t like it get off the site..

    • Is that all you can say to rebut Anne Kingston? A cheap smear. Not nearly good enough to counter the thousands of pwMS, family and friends that have witnessed the “system” try to prevent proper and quick investigation of this theory. If the status quo crowd was really so convinced of the lack of merit of this research avenue, they should have quickly allowed studies to proceed three years ago and be done with it. Ther is something here and we will eventually see the results.

  9. Why is it necessary to use potty words in your headlines? Surely you can use the thesaurus??

    • What do you have to say about this whole debate? Bet you couldn’t even start to keep up with Anne Kingston.

    • @451d3bca185c2b25a4582aa28ec3cde0:disqus It is necessary to use ‘potty words’ because the situation is so shitty for Canadians with MS!

  10. I do not know how many different ways it can be said bit here goes again … CCSVI IS A VASCULAR CONDITION. MS IS A NEUROLOGICAL DISEASE. For Pete’s sake let the proper experts do the studies/trials and science. It is all about the Turf War and claiming something that is NOT the neurologist turf. Pursuing a non drug route even if it helps to give relief to many is obviously not lucrative enough for these so called MS experts.

  11. CCSVI is a VASCULAR condition not neurological….we are angry because neuro’s are not the people that should be doing this study in the first place! I had treat mnet done almost 2 years ago and I an totally symptom free…now my neuro wants nothing to do with me! He didn’t even show for my last appt at the MS Clinic! Vascula community please stand up!

  12. The real question here is whether physicians/scientists who are skeptical of a certain theory can in the face of overwhelming evidence, change their minds about the validity of said treatment. Anne Kingston and a certain number of bloggers who are angry about Canada dragging its feet on CCSVI treatment doubt that physicians/scientists are capable of evolving their thinking and not only that, they believe these people of science will actually somehow taint the investigation process to ensure the results support their already pre-conceived ideas of what the outcome should be. Anyone who doubts this conspiracy theory based on past experiences in medicine (ie; the discovery of H.Pylori as one of the most common causes of the gastric ulcer – many, many, many physicians publically maligned the theory only to be proven wrong and then embrace the truth of the science), is targetted as being naive to the ways of the Conservative government and (gasp) BIG PHARMA.
    Since I have been a nurse, all sorts of advances have been made in medicine as the result of clinical trials. People are now allowed to drink clear fluids up to a few hours before a procedure when the past they had to drink nothing past midnight. You, Anne Kingston have been a championship of the right of Canadians to explore the efficacy of this procedure, even if it only provides temporary relief for those MS Suffers who have vascular pooling and can benefit from it. Just because a physician is skeptical about a procedure, it is wrong to imply that they are somehow dishonest and would manipulate the results. If you had someone running this study who championed this procedure, skeptics could make the exact same claim. We have Colleges that police the integrity and honesty of our physicians and surgeons and we have ethics boards in every hospital and every university in Canada. As for suggesting that any physician is getting a payoff from BIG PHARMA, file a complaint with the physician’s college if you have any proof.

    • Read Selling Sickness and/or Pharmageddon (written by MDs) Bias matters and “science” isn’t the objective thing you think it is when medicine is involved. Your jab at people for their concern about “BIG PHARMA” gives you away–you are uninformed about why it is a problem and ignorance such as this is why the fiction is maintained that medical research is some kind of objective science when it is in actuality marketing.

    • Are you serious, you do not think these MS Neuro’s are getting a payoff from Big Pharma…really. You do not think researchers influence the results of studies…really. Clearly you have not followed the MS Neuro’s shananigans over the last 3 years and their desperate attempts to discredit CCSVI via their clinics and the MS Society. I bet you think the Neuro’s don’t run the MS Society either. Big sigh

      • I think people eyes and minds became so opened in the past three years … I know mine has! Unfortunately until someone has health issues and have to deal with the system … Most are oblivious and cannot believe such corruption really happens. A big sigh from me too!

      • Like I said, physicians in Canada are not allowed to take payoffs from pharmaceutical companies. If you have proof that this is the case, file a complaint with the physician’s college. They will investigate.
        Also, you have maligned all of the neurologists. What about the radiologists who will be doing the vascular interventions in the studies? Are they corrupt too? Obviously they do alot of vascular interventions so they must believe in the validity of these treatments. What about the ethics communities that are overseeing the design of the studies? Are they all corrupt? Are the medical journals corrupted? Does BIG PHARMA own everybody?
        ….and then what happens if the results show that the procedure is valid and should be offered to patients to alleviate symptoms…then what? Suddenly this corrupt study is not so corrupt?

    • Here is something you should read since not many take notice and denials are plenty …
      “Thanks to the academy’s increasing dependence on industry, that distance is a thing of the past. The major drug companies are now hugely profitable, with net incomes consistently several times the median for Fortune 500 companies. In fact, they make more in profits than they spend on research and development (R&D), despite their rhetoric about high prices being necessary to cover their research costs. (They also spend twice as much on marketing and administration as they do on R&D.) The reasons for the astonishing profitability of these companies aren’t relevant here, but suffice it to say that as a result the industry has acquired enormous power and influence. In contrast, medical centers have fallen on difficult times (or so they believe), mainly because of shrinking reimbursements for their educational and clinical missions. To a remarkable extent, then, medical centers have become supplicants to the drug companies, deferring to them in ways that would have been unthinkable even twenty years ago.”
      Big Pharma, Bad Medicine How corporate dollars corrupt research and education

    • The further irony is that the connection to H pylori helped facilitate the almost complete switch to medical from surgical management of peptic ulcer disease, including notably expensive PPIs.

      The problem with this whole condition is that veins are normally collapsable and even torturous – and absent atherosclerotic plaques, one wonders how angioplasty – I mean, venoplasty – will have any lasting effect. It only works on the arterial side because arteries are stiff-walled and not readily collapsable. What really gets me are the following two talking points:

      1) “Neurologists aren’t “vascular specialists” so they don’t have competence with a “vascular condition” like CCSVI.”

      First, this laughable ad hominem argument misses the point that neurologists are still *physicians* and hardly ignorant of, say, the anatomy of the vasculature of the head and neck. In fact, it’s fair to say they are experts in said anatomy, since expert knowledge thereof is intimately connected to the study, diagnosis, and management of cerebrovascular disease. Neurologists, after all, are usually the ones who see acute stroke patients in the Emergency Department and push the tPA.

      Second, if neurologists are *not* experts in the surgical or neuro-radiological management of vascular disease, it also follows that vascular surgeons are not remotely experts in neurological disease. In fact, apart from performing carotid endarterectomy for prevention of embolic stroke, they don’t encounter any neurology (or even neurosurgery frequently) in their residencies let alone as staff. But even for something like an endarterectomy, the risks of the surgery are enough that only a select group of patients are candidates.

      2) “Angioplasty is done all the time but it’s discriminatory that MS patients aren’t getting it too.”

      Well, no, it’s not discriminatory because angioplasty is not done for just any reason, and particularly not for as yet speculative and not yet rigorously demonstrated “disease” like CCSVI. But for renal artery stenosis or a 70% stenosed left circumflex? Sure. Under no circumstances should you start messing around in large vessels based on as poor research as Zamboni’s.

  13. Thanks to Anne Kingston for explaining the disappointment in the MS community. We question the independence of this proposed research because there are such obvious financial conflicts of interest. This clinical trial is headed up by neurological specialists compensated by pharmaceutical companies. These researchers receive speaking honoria, consulting fees, research grants and more- for maintaining the autoimmune/EAE murine model of MS. CCSVI is a vascular condition with neurological consequences. As Anne mentions, researchers are finding connections to other neurodegenerative diseases, like Parkinson’s and Alzheimer’s. Slowed cerebral spinal fluid clearance and venous blood flow may contribute to the oxidative stress and neurodegeneration, present in all neurodegenerative disease. The immune reaction in MS may well be secondary, as it is in ischemia and stroke. Are we to believe neurologists are willing to take the chance that their livlihoods and careers have been based on an incorrect theory–and investigate CCSVI in earnest? Let’s hope so.

  14. I do not have MS .and I think this study is doomed to faill because of the people runing it.If you think the MS experts will swallow their pride and addmit they were wrong you don’t live in the real world (I was going to say your dumb as a post but you might not understand )

    • Thank you for ‘getting it’ Joe! And oh so true. There will never be a time for them to admit they were barking up the wrong tree.

  15. My first reaction was concern as I have seen and heard negative comments concerning the viability of CCSVI treatment from Dr Traboulsee in the past. However, I do have some hope that we will see fair and honest trials, as there was an peer review committee established to assess the proposals from the investigating teams. I have utmost respect for some of the members of that peer review committee: Dr Zivadinov and Dr Siddiqui, both of the University at Buffalo. They are principal investigators in the PREMiSe study, which should be a model for the pan-Canadian study. I am hoping that with true experts (experts being persons with real hamds on experience) reviewing the propsals, that the studies will be valid.
    It’s at least two years late getting stated, but better late than never.

  16. This risk can have terrible procedures. When there’s the first death or serious complication the enthusiasm might change. Combined with the fact that this question seems to have been asked and answered in other countries and there is still no benefit demonstrated.
    The FDA has had serious warnings, but they get dismissed by conspiracy theorists as coming from shills trying to protect the drug industry who sell expensive treatments for MS.
    I’m worried about the risks and this is exactly why patients should not be the ones deciding – they are too close to this to be objective.

    • It seems strange and convenient any death related to compilcations AFTER the procedure are headlines for most neurologists and yet the deaths related to drugs currently approved for MS patients are very hard to obtain. As for the FDA, they approved the MS drugs that have been proven to be killing people and at least one drug that has no value in the treatment of MS.

    • The f’ing Canadian government is perfectly okay with Tysabri, a drug that has caused a serious debilitating brain infection (progressive multifocal leukoencephalopathy) in 271 people and killed 59 of them, and they are okay with the ‘new’ drug Gilenya, which has only killed 11 (so far!). But they are not okay with a simple out-patient procedure that has only been associated with 3 deaths, and at least one of those was a direct result of being refused follow-up care in Ontario (Mahir Mostic) and I believe all 3 had stents, which have become much less commonly used. As for the studies done in other countries, at least 3 of the ones that have been published so far found beyond a shadow of a doubt that the procedure is extremely safe if done properly, and several published studies have proven the efficacy of the treatment in reducing heat intolerance (a symptom so prevalent they used to diagnose MS with the ‘hot bath test’), fatigue (which approximately 70% of people with MS say is their most debilitating symptom), and percieved quality of life. I’d say that’s a pretty damned significant benfit! And those of with MS should absolutely be able to decide for ourselves, rather than being dictated to and denied the only treatment available that has been demonstrated to work!

  17. Yes, Canadians with MS are absolutely furious, and rightfully so. Traboulsee was quite clear with his disdain over CCSVI on the “MS Wars” documentary, and now we are supposed to believe that he and his cronies will perform clinical trials and be honest and objective with the results? Really? The fact that we are still fighting for this procedure in Canada is proof that there is something seriously wrong with our Medical system. The CIHR is so far behind on this issue they think they are first!

  18. Question: Do they normally do clinical trials on procedures?

    • Not usually, no.

  19. Thank you Anne for once again spelling all this out so that the reader who has not been following this carefully understands the possible problems with these trials. I commend all my “pioneer M.Sers ” for never giving up in our quest to push for this procedure for CCSVI to be preformed on people with M.S here in Canada.

    I too worry that the wrong doctors will be in charge of these trials and that vascular surgeons and interventional radiologists will lack training and skills in this country – however we have to start somewhere.
    It will be so good to see them work with us. Unfortunately they spend too much of their time trying to fix people with self inflicted ailments caused by smoking, obesity and alcoholism, this will be a very pleasant change.

  20. Questioning the training of the IRs who will be performing the CCSVI procedure when those experts will make sure that they will do ” NO HARM ” is ridiculous !! Who are those people in the MS community to be judging the IRs credentials ????

    • We are the patients and it is my right to question all services that I pay for and I do pay taxes

  21. How are we supposed to trust Traloubsee, Aglukkaq, and the CIHR now? They have done everything in their power to discredit CCSVI. Are we supposed to believe that now they have had an epiphany and will conduct a fair science based clinical trial to prove the efficacy of CCSVI? I have a great idea, how about, they all resign, we replace them with medical experts who do not have any ties to big pharma, and then conduct the clinical trials. Now that would be fair and believable!

  22. My concern with these trials is that the symptoms that improve are not measured by science. I had the procedure and my Neuro choose not to believe that I had no more headaches (that were daily & debilitating) my balance was better along with fatigue being normal again. I also saw great improvement with depression and thought processes these are things that are not measured by science. I had one improvement that was measured by science in the form of my Opthamologist, I had optic neuritis and 2 months after my procedure I went to see my MS eye specialist and his exact words were ” you have no MS in your eyes I no longer need to see you”. When I took those results to my Neuro she just looked at me and said you need glasses and my eye specialist had just told me the week before that I do NOT need glasses, so I am worried about the bias of the doctors involved and the way they will perceive the results. The biggest problem with this study is lack of experience in the procedure as it can take up to 200 procedures before the IR is proficient and of course the fact that the Neuro’s have twisted our symptoms to fit their box for decades.
    @57fc79f8528c0aa6c4b4330d53700334:disqus You say your brother has MS, I would think you would be happy that those of us who have followed this closely since 2009 are interested and concerned that this clinical trial for a medical procedure, are expressing the facts about the people involved. We have every right to be suspicious of Dr. Anthony Traboulsee considering he stated on national television that this was a waste of funding. (was upset that ccsvi would take away from Stem Cell research) I have noticed lately that CCSVI along with Stem Cells has been an enormous success and wonder what Dr. Traboulsee has up his sleeve. He may consider combining the two as well. I will always know it was a different group of professionals that discovered combining Stem Cells with CCSVI may well be an even better answer for MSers.
    I am very happy that this is finally moving forward but Dr. Traboulsee was one of the biggest obstacles in the trials to begin with. I rejoice and am trying to have faith.

    • Sorry the second half was intended for Healthcare Insider

  23. Being a US citizen and having PPMS I have found in my experience here that the doc’s involved only want to treat symptoms, not the cause.
    This of course is primarily because of profits (drug company’s), anyone who would say otherwise is fooling themselves.
    I have one doctor, only one, who actually believes in treating the cause. Unfortunately he is retiring next year, due to age as well as the BS that doc’s must contend with regarding drug company s and Federal regulations/restrictions.

    As for new treatments addressing the cause(s) of such diseases as MS, I would think ANY research would be welcomed by politicians as in the long run it would lower the overall cost of treatment of the patients, especially when the government is subsidizing said treatment either through Medicare in the US or the system in Canada.

    And regarding “specialists” running oversight boards or credentialing committees, Scientists and doctors are the most closed minded individuals I know, and I find this odd when they are there to advance our knowledge. Yes, scientists and doctors alike, the earth is round.

  24. thankyou from me in the UK