Debunking the latest study ‘debunking’ CCSVI

On the quest for clarity on MS theory

by Anne Kingston

Beatrice de Gea/The New York Times

Anyone following the latest CCSVI research can be forgiven for experiencing whiplash-induced confusion. On Wednesday, McMaster University released a scanning study in the journal PLOS ONE that found virtually zero relationship between multiple sclerosis and CCSVI, a condition characterized by narrowed neck and chest veins identified by Italian venous specialist Paolo Zamboni.

The research assessed 200 people—100 diagnosed with MS, 100 who had no history of the condition, or  “normals,” using Doppler ultrasound and MRI. Only one participant, a man with primary progressive MS, met Zamboni’s ultrasound criteria for CCSVI.  The finding represents a 180-degree swing from Zamboni’s contentious preliminary 2009 research that found a 100 per cent correlation between MS and CCSVI in 65 people with MS. The McMaster research contradicts other research (two examples here and here) that found most people with MS also had CCSVI — and also detected it in people not diagnosed with MS. It also eclipsed new research out of Italy investigating the safety and efficacy of angioplasty to treat CCSVI that found blockages in 98 per cent of 1,200 study subjects using ultrasound with venograms.

Certainly the McMaster findings are not without precedent: other studies, two here and here, found zero correlation. Yet the press release announcing the McMaster study framed it as the definitive take-down: “McMaster University study debunks controversial MS theory.”  As with everything else surrounding “controversial” CCSVI, opinion on this one is divided.  Zamboni, unsurprisingly, countered with a letter to the journal critiquing the study’s screening methodology as outdated and for replacing his protocols with those of researchers who’d  reported negative results.

On the Facebook page CCSVI in Multiple Sclerosis,  Joan Beal, a high-profile champion of CCSVI research and treatment, issued a more  blistering rebuttal. People with MS who have benefitted from the CCSVI procedure, which does not benefit all who’ve had it, are speaking out. Another critic, surprisingly, is neurologist Anthony Traboulsee, the director of the MS Clinic at the University of British Columbia and  principal investigator of the recently commenced Canadian CCSVI clinical trial. “We have seen the extremes—Zamboni’s 100 per cent is too good to be true, now the Hamilton’s results are too negative to be true,”  he tells Maclean’s.  ”It doesn’t make sense when you think about all of these folks travelling around the world to have something done; the radiologists must be seeing something.”

Ultrasound, the method pioneered and used by Zamboni,  is problematic identifying CCSVI, says Traboulsee, who is not a vascular specialist. He prefers venography, a more intrusive scan conducted inside the veins using dye. “The ultrasound isn’t capturing what the catheter venography sees—that’s direct visualization. It’s going to be more accurate and sensitive for finding narrowings. In the study out of Hamilton, the ultrasound couldn’t detect what catheter venogram can detect. And why that is I really don’t know.” His research team at UBC is publishing a scanning study comparing ultrasound, MRI and venography in The Lancet within weeks. Employing venography, his team found most people with MS also exhibit CCSVI.  Exactly how many is unclear. In an interview with the Ottawa Citizen earlier this week Traboulsee is quoted saying “maybe about 70 per cent have the narrowing.” Speaking to CTV yesterday, he said it was 60 per cent. “Both numbers are correct,” Traboulsee told Maclean’s but he declined to elaborate because of publication restrictions. “It will become much more clear when I can discuss my findings with you,” he says.

Ian Rodger, lead author of the McMaster study, admits the 100 per cent finding surprised him. Rodger, professor emeritus in the Michael G. DeGroote School of Medicine, invited Zamboni in February 2010 to participate in a two-day CCSVI seminar, the first in Canada. He stands by the research. “We have no axe to grind,” he says. “We went in completely open-minded and conducted it as authoritatively as we could.” They detected variations in the venous architecture and blood flow between normal and MS populations but nothing pathophysiological, he says.  The study yielded a huge amount of data to be mined, says Rodger, whose group is preparing three more studies, including one evaluating  Zamboni’s hypothesis that blood reflux created iron deposition in the brains of people diagnosed with MS.  Rodger is critical of Zamboni research: “It seemed too good to be true.  Now we can see the rigour early on was highly questionable.” He agrees ultrasound delivers inconsistent results: “It is operator-dependent. Pressing too hard can create compression that restricts the vein.”  Rodger sees a “pendulum swing over the past 18 months”–from Zamboni’s 100 per cent correlation, to 56 per cent in a 2010 University of Buffalo, to his new study and others showing zero correlation. He’s trying to stay out of the politics that have underlined CCSVI for the past four years. But he does express surprise there hasn’t rethinking of the current Canadian clinical trial, in light of his research and a 2012 editorial in the Journal of Neurology that recommended MS patients not be treated for CCSVI.

Traboulsee says the McMaster trial hasn’t affected his thinking: “I don’t see it as even a hiccup.”  He speaks of  the more than 100 patients who’ve travelled out of country for CCSVI treatment interviewed for a UBC patient registry. ”There’s less perception of [CCSVI treatment] being a cure but interest in how it can help with quality of life and managing MS,” he says. The clinical trial design was based on patient responses, he says: “We were using that information for improvements we should measure. And these are things not measured on classic MS scales: hands feeling warmer, heads feeling clearer–the sort of responses that people report experiencing.” He expects results by 2015, at the earliest. Meanwhile, the quest for clarity continues.




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Debunking the latest study ‘debunking’ CCSVI

  1. omg how much time do they think we have………….it gives you back your life in many cases and I’m one of them. I got back 7.5 months it was me again like wow……….no I wasn’t on Placebo for 7.5 months it was reality. This unblocking of the veins works and to say it’s a Placebo effect is WRONG. There is a way to make us feel better or totally better but this time they have to find a way to make it last. I am a believer in CCSVI it does work, it’s the time that it’s taking to make it happen that is sad. The longer we wait the worst we get……………..please wake up! diane

    • Only 7.5 months Diane? 2 1/2 years for me and still better then before I went to New Jersey. Way too long for the placebo effect. :)

    • Same here, I had CCSVI treatment done almost 3 years ago this coming November and I’ve had nothing but immediate and steady improvements from day one. In fact this summer I was able to ride my e-bike for the first time in 5 years! There’s no placebo effect that lasts that long…trust me!

  2. “We have seen the extremes—Zamboni’s 100 per cent is too good to be
    true, now the Hamilton’s results are too negative to be true,”

    If it’s “too good to be true”, then it isn’t.

    Thus “Too negative to be true” makes no sense. If the original study was BS, then a study refuting it 100% can, in fact, be accurate.

    This article is working from the base assumption that the original research was legitimate. A faulty premise for any science column about an unproven theory.

    • If you knew anything about the history of the “science” related to the study of MS, you might know that vascular issues have been seen to be extremely relevant for over a century. Unfortunately, a minimally invasive, PROVEN procedure to restore proper blood flow, doesn’t have the same money-making potential for neurologists and pharmaceutical companies as drugs based on the UNPROVEN autoimmune theory–causing the vascular issues to be ignored!

      • That’s very interesting. However, it has nothing to do with what I’ve said above.

        You can’t counter my argument, so you accuse me of scientific ignorance. You then talk about “unproven theories” which shows your complete lack of understanding of the scientific method.

        Try again.

        • The key issue is that eminent researchers are proving precise answers to (almost) irrelevant questions. Zamboni postulated that the lack of blood flow was the cause of MS. That theory has been proven false many times over, most recently by the McMaster study. (If CCSVI causes MS, then it ought to present in all or at least most MS patients).

          Zamboni’s theory led him to try an invasive procedure, which has led to many, many anecdotal reports of improvements in symptoms. Not a cure, but perhaps an effective treatment.

          The surgical insertion of a stent is not like a sugar pill or a homeopath, there is a real and substantive physical change. The validity of the original hypothesis that led to the treatment says nothing about the efficiency of the treatment wrt symptoms. Studies to answer the second question are more difficult, expensive and unfortunately less definitive than those such as the McMaster study but ultimately they are the only ones that matter.

          • “The surgical insertion of a stent is not like a sugar pill or a homeopath”

            Of course, if the blood flow issue isn’t actually causing the problem, then that’s exactly what it is.

          • No,

            1) with the stent blood flow is increased to the brain. This increase in blood flow will occur even if blood flow was not “restricted” prior to the insertion of the stent.

            2) veins have a complex structure including a layer of vascular muscle. Under control of the sympathetic nervous system these muscles can constrict or dilate to influence the local blood pressure and flow of blood. Introducing a stent, removes this functionality.

            My point is these are real changes and it is possible these changes have an impact on MS symptoms.

  3. Thank you, Anne Kingston. I am one of the “more than 100 patients who’ve travelled out of country for CCSVI treatment interviewed for a UBC patient registry”. I not only had MANY “invisible” improvements, including ELIMINATION of extreme heat intolerance, weekly headaches, erratic, emotions, and more, but I also had some improvements that were “measured on classic MS scales”, including restored equilibrium and increased Right leg strength. My quality of life has sky-rocketed, with the improvements having now lasted for 29 months! I have been classified as “Secondary/Progressive” since the mid-90′s, before any so-called disease-modifying drugs came on the market and since they’re only for Relapsing/Remitting cases, I had absolutely no treatment available. I was informed I would just continue to deteriorate until I die. This made my risk/benefit analysis pretty easy.

    When I was refused the chance to try “something” in Canada, I went to the U.S. for the simple procedure of venous angioplasty and, literally overnight, saw improvements in symptoms that I thought I was stuck with forever. I was grateful to Dr. Traboulsee back in May, 2010, for honestly stating that it would be “several years” before they could get any solid answers about this procedure and its relationship to MS which helped my decision to save some money to get this procedure out of the country. Best decision I ever made–degeneration doesn’t “just wait” several years!

    • Lori, when you say “more than 100 patients who’ve traveled out of country for CCSVI treatment”, you mean just in BC, correct? There are thousands of Canadians who have gone for treatment; I know of at least 100 in Alberta!

      • Yes, BC only–Dr. Traboulsie was referring to the BC CCSVI Registry that he is in charge of at UBC and I am one of the BC residents involved. There have actually been a lot more BC residents who have gone outside Canada for this treatment but MANY did not want to even bother with the registry because it was being run by the MS Clinic at UBC with a neurologist in charge and they didn’t think any of their invisible symptom improvements would be taken into account. As a participant, I KNOW that is true–most invisible symptoms were not addressed, but they did ask about fatigue and did allow you to make your own comments at the end of the questioning. I hope I am correct when I interpret that the clinical treatment trial will now use more “improvements we should measure” (like warm feet and hands…etc.) because they are extremely important to quality of life!

  4. It amazes me that any one will put any value in the the McMaster study. It means very little. The Pan Canadian trial, if done correctly will give the answers. If they felt the need to study CCSVI why are they not a part of the Canadian trial? It seems to me they just wasted time and money.
    Many people including Canadians have had the procedure with good results. Explain that! Placebo effect? After 3 years, I don’t think so.

  5. The percentage association circus must stop. The battle lines are drawn up and the amount of evidence to satisfy both sides will not be seen in our lifetime. The question that matters, the one that needs to be answered is, does central venous ballooning improve symptoms?

    • It did for me and many people I know.

    • The whole CCSVI issue is being beaten beyond belief. If people, including the media, would look at it for what it is: a condition with it’s own symptoms, and the treatment is consistent with the treatment for other vein-related ailments; it’s not that big a deal, and a mountain has really been made from a molehill.

    • No, it didn’t improve my symptoms, it GOT RID OF THEM COMPLETELY! When I went to my doctor to get a note to okay me to return to work, I had to see a doctor I’ve never seen before because my GP is away for a month. She had to read my file because she didn’t believe I had MS!

    • So why Dr Arata you and your colleagues at Synergy Health Concepts are not addressing this question by doing a real randomized double blind study to have the final answer? As a doctor, do you find ethical to continue to perform this treatment and asking money for it considering all the controversies surrounding CCSVI?

      • That is my point. The controversy is it’s association with MS. What has been published on symptom relief and quality of life indicates the treatment helps. That is why I do what I do.

        • Lysolecithin aka lysophosphotidylcholine cause demylenation and vasoconstriction. So it causes demylenation which is sclerosis and also vasoconstriction which seems to be the cause of the symptoms of the disease Multiple Sclerosis. Lysolecithin is found in common everyday products like eyelash growth stimulator http://www.beautybridge.com/dslareeygrst.html and BB cream by Physician’s Formula http://www.specialchem4cosmetics.com/services/product-spotlight.aspx?id=1752. I give the second one because Physician’s Formula is sold almost everywhere and could be used by teenagers. That helps me figure out how a teenager could get MS. But you can also include Smashbox, Philosophy, Weleda, Lavera, and Dr. Hauschkas. I hope my explanation helps. It’s based on reverse thinking from the Journal of Neuroscience http://www.jneurosci.org/content/18/7/2498.full. The Lord led me to this through my friend’s prayers. God is good. He saved me so I don’t have to die spiritually and suffer eternal separation from him who is all goodness and truth, the Lord Jehova. He came to earth as Jesus and died in my place that I will have eternal life in him. God raised Jesus from the dead and he raised me too. Maybe he’ll free many from the effects of Multiple Sclerosis.

  6. Evidently,
    I believe Dr. Zamboni is going to need to come to North America and
    conduct/closely supervise these studies in the West, as his prediction
    of studies in the West being doomed to fail is materializing. There is
    nothing to prove regarding CCSVI treatment; it is a blockage, slowing of
    blood flow, or refluxing blood from the jugular and/or azygus veins
    resulting in hypoperfusion. It is a disease/condition with it’s own
    symptoms, such as headache, brain fog, cold extremeties. The treatment
    is venous angioplasty. End of story.

    • If there are problems with the design of Canadian studies, then that has
      to be drawn to the attention of the researchers, but having them supervised or conducted by a researcher who has already published results is problematic. If the design of trials or assessment of blockage is dependent on the involvement of that one researcher, and can’t be replicated reliably by others, then it isn’t scientific method.

        • I didn’t say it was. I’m not a scientist, just cautioning that replication can’t rely on the personal input of a single researcher. There are peer reviewers capable of ensuring appropriate methodology.

          • Point well taken. Thanks.

        • mcmaster did replicate his method (read the paper), they even trained at his centre prior to conducting the study, BUT he says he has changed his methods SINCE his original results were reported.

  7. Thank you Anne for keeping this very important issue in the forefront.  

    This is not a neurological issue but a Vascular one.  It is not just people with MS but includes other neurological conditions.  Unfortunately people with MS are the only ones who seem to have taken this on.  I wish the true experts would be allowed to report their findings.  These controversial and negative reports are done by neurologists and pharmacologists.  It is like my dentist or car mechanic doing these studies.  Why are the Vascular specialist not allowed to do the same?  They are the ones who know the proper protocol, the vascular system, know the  the proper equipment and how to use them.  Well I do know why … 

    The MS Societies worldwide have had a stranglehold on those that have so much to lose for over six decades.  They are the go to, so called authority that get approached whenever a question is asked.  Obviously they have had long enough time to come up with answers but, to this day the are still no further ahead.  Their words are not gospel.  Should that not tell us volumes?  Should we not ask the Vascular specialist instead and move forward instead of trying to reinvent that wheel over and over?  

    The battle has become a war and Big Pharma is striking us down at every turn.  We are on our knees fighting this meaningless war.  They have that market and know they will never lose.  Anecdotal evidence and reports seem to work very well for their drugs being pushed.  I have no faith in their drug studies either.  To much controversy in falsifying their findings.   

    Dr. Robert Fox a neurologist in Cincinnati, Ohio is trying to develop a drug to do the same thing that we are fighting for but, with a huge price tag and side effects galore.  Imagine that?  So let’s see …  a couple of years down the road billions wasted again and where will all those suffering be?  No further ahead.  Sound familiar?  It’s a game and we all know who will win.  Please prove me wrong.  Please,  I want to be wrong, so we can at least if nothing else, have a better quality of life.  And, we can get this NOW.   That is all, until the powers to be decide to find a cure.

  8. I was treated in July 2011 and I am still enjoying the benefits of the treatment. Treatment for CCSVI is not a cure for MS and, frankly, it doesn’t matter to me if it is related to MS, if it causes MS, if it is caused by MS, etc. CCSVI is a vascular condition; the treatment for it improves the quality of life for 2/3 of those people with MS who are treated. Proper blood flow is important to overall health and Canadians should have access to the treatment. It is unfortunate that CCSVI has been so strongly linked to MS where vested interests seem to prevail rather than science. The self-styled MS experts continue to chase the unproven autoimmune theory and refuse to look at anything else; drug manufacturers support the unproven MS theory by developing drugs to suppress the immune system and we have to remember that there is no financial advantage to them to CCSVI treatment becoming a treatment readily accessible to Canadians; the MS Society of Canada is not a supporter of CCSVI treatment for whatever reason – I have my own views but suffice to say that the MSSC is one of the biggest obstacles we have to achieving access to CCSVI treatment in Canada. We need to consider CCSVI on its own and remove the study of it from the vested MS interests who have so skewed the science that it will take years to untangle the mess that has been created.

    • Well said. Thank you Linda!

    • Point well taken. CCSVI really should be treated on it’s own as a condition regardless of it’s association with MS. This is something a lot of us have suggested for over a year now.

    • I find your accusation of the Canadian Society ironic given they are funding the clinical trial in Canada that Traboulsee is doing. You can’t have your cake and eat it to you know (yes I’ve seen you in all the forums and boards with your venomous accusations of this organization). Their funding may in fact end up being the funding needed to make this the treatment we need in Canada.

      • The MSSC is only putting in a pittance of $500,000 and only because they were trying to appease the thousands of members who are so angry with them so that they would appear to be taking an interest. They should have completely paid for clinical trials IMMEDIATELY, when this issue first became public, instead of putting up roadblocks to access. They have more than enough money stockpiled away!

      • lorimayb is correct regarding MSSC funding – $500,000 with the rest of the $6 million coming from the government. For your information, I comment on some articles in the press and I comment in some CCSVI groups but I am personally not in “all the forums and boards” although what I have written for CCSVI Ontario may have been published in those forums and board. As to “venomous accusations” if the shoe fits I guess it has to be worn.

        • What part of this 6 million that you state has CCSVI Ontario contributed? Ante up if you’re so mad at other orgs…

      • And I find your accusation of “venomous accusations” extremely offensive. The MSSC deserves to be shown to be as hypocritical as it is. Even though they say their mission is to “enable people affected by MS to enhance their quality of life”, they have actively fought against the ONLY treatment to show any actual relief of symptoms. I used to think they’d be all over investigating such a chance to really make a difference, but I was wrong–I have now seen them for what they are–a BUSINESS! (and not one that cares about its primary shareholders!)

      • CButcher, I have never seen anything positive on a Canadian ms society page about balloon angioplasty. How come they do not mention any of the success stories from the people posting here? Kind of strange, isn’t it? I am told that they spend 7 cents of every dollar received on “research”. which seems to be mostly drug trials for extremely profitable companies. Where the rest of the money goes, nobody knows. The Canadian MS society reminds me of Burke and Hare. Remember them? But at least the ms society does not rob graves. (Because the drug trials require live victims).

  9. Thanks again Anne Kingston. I am a 3 year CCSVI treatment patient doing very well and enhancing my experience with other treatments to help my health. This is not a placebo (they last up to 9 months at the most) I have been told. Please, could the media stop reporting negative studies and ignoring positive ones so that the general public is not being biased. Doctors, listen to the patients and look at this as a chance to increase blood flow to and from one of the two the most important organs of the body. Patients want help with symptoms and in large numbers (60% +) this is what happens following treatment. This should never have become a turf war but unfortunately it has, and we the patients, are right in the middle of it with our lives.

  10. Really the ultimate truth is that blocked veins just need to be unblocked. Why this has been such a controversial issue defies logical thinking. I invited the Ontario ombudsman panel who denied Judy Butcher’s appeal to tie off their jugular veins for however long it took them to realize proper blood flow is essential, not experimental. This whole 4-year long battle has left me disillusioned, extremely disappointed in the medical community, and shaking my head at how absolutely stupid the politicians in power both federally and provincially really are.And, with the exception of a few individuals, how shallow and sensationalistic the Canadian media is. It is like watching/listening to the Enquirer.

  11. We are going to the states with my wife’s mystery illness to get the treatment. The interesting thing is that she has had symptoms since she was a teenager and they came out in force since her “stroke” 4 years ago. She was in hospital for weeks on a blast of steroids to save her life and the lesions went away. So now based on no visible lesions, she definitely does not have MS! But based on symptoms, (and the old pre-2001 protocol), she would definitely have it. Maybe the lesions are just one of the symptoms, not related to the cause at all?

    • That seems to be what I think too Brian! Wish doctors would have more inquisitive minds. I wish your wife all the best and continued healing.

  12. Thank you Anne, for again pointing out the shortcomings of these negative studies and the media that reports them (and seemingly ONLY them). For them to give so much power to a study done using the wrong testing method that was run by a pharmacologist who used to be the Medical Director at Merck for this vascular condition that is present in neurological patients. I had been unable to work since Spring 2009 as my relapsing-remitting MS became secondary-progressive. By spring this year I was ready for a wheelchair, but I went to the US to try CCSVI treatment first as a sort-of ‘Hail-Mary’ play. Well, it paid off in spades! I hobbled in to my treatment with a walker and the day after I was walking in the sand and surf on the beach without even a cane! During the procedure I asked if someone had turned on another light because the room got brighter and shortly thereafter I broke down in tears as the headache I’d had since about 15 ‘dissolved’ for the first time in my adult life! I am right now looking at the letter I got from my doctor’s office giving me the all-clear to return to work after being on CPP Disability. The cause and effect argument of the condition known as CCSVI is a moot point. The fact that it can save and/or restore lives is the only thing that really matters – in my case, since I am a couple of decades away from retirement age, it will save the government hundreds of thousands of dollars to not have to pay me to live with a disability and pay for MS drugs that MIGHT only more effective than a placebo by 2 or 3 percent (if they don’t kill me first) that would cost tens of thousands of dollars per year.

  13. Those that favour this treatment as always talking about the need for research, but then when research is delivered they pan it.

    And the MSM should be taken to task – for the most part the MSM is totally ignorant on how research is conducted – it is a slow process that picks away at little bits of a mystery with every study. Like real science (not climate science science), nothing is ever conclusive but with each study you get a slightly clearer picture of what the solution might be. And unfortunately, in the case of MS, which is complex set of symptoms not one definitive test, the picture was very unclear to start with. I’m sure there are some people that benefit from the treatment and it is entirely possible they never actually had MS to begin with (but only fit the symptoms). And that may be the conclusion – that many people are deemed to have MS because they fit most of the symptoms, but in reality they had blocked veins which needed to be unblocked. BUT that doesn’t mean that the treatment should be provided wholesale to EVERY person that has been diagnosed with MS because they fit many or some of the symptoms. The treatment may have no effect on them whatsoever (but will cost alot to an already stressed public health care system). If patients want to go outside of Canada for the treatment and pay for it – be my guest. BUT if the expectation is that the public system should pay for it, then it has to be based on research which is beginning to slowly emerge and it may turn out that only a very small percentage of MS patients will be treated.

    • We are willing to pay for treatment in Canada. That is not the issue what so ever. It is the after care we need. I would pay for that too. It is so illogical to go out of country but on returning we are not allowed follow up care. So that is a mute topic. And please note this is not a MS thing it is a vascular thing. It just happens that those with MS are the ones who are trying their darnedest to have this available for all those with neurological conditions. If I did not have that MS label I would not be discriminated against this treatment and would be taken care of pronto. That is the bottom line. MS like cancer is a huge industry that refuses to close their doors.

      • your right Shirley.if Canada was a company it would read Canada corporation owned and operated by big pharma.unless we can convince our fellow Canadians of that fact we’ll continue to be under the control of these godless people.i had the ccsvi procedure done in florida my vein was injured so bad it closed off completely now my symptoms are gone through the roof,i can’t get any help in this country.if Canadians put themselves in my shoes they would realize there government are in bed with these godless drug lords

    • People with MS would happily pay for a venogram, in Canada, to determine if their veins were blocked BUT THE MS SOCIETY, ALONG WITH THE COLLEGES OF PHYSICIANS AND SURGEONS, PUT UP ROADBLOCKS, DENYING PEOPLE WITH A DIAGNOSIS OF MS ANY CONSULTATION WITH A VASCULAR SPECIALIST!

      If you don’t have MS you can get a venogram. This is DISCRIMINATION and should not be tolerated in a supposed first-world country–can you give me a valid reason why this is happening?

      • I’ll believe you, but not really since I suspect that as soon as such was allowed there would be a campaign to have the public health system pay for it – but as I said I’ll believe you.

        But it is moot since under our public health system lots of people can’t pay for services that they think they need. I can’t pay for a diagnostic exam because it would ‘jump’ me ahead of the line for those waiting for services so I get the special joy of waiting of close to 8 months for an MRI to determine a problem in my knee.

        THAT is the tradeoff of having a ‘free’ public health system. The control does not rest with patients to spend money on whatever procedure they think will help them. We have ceded that control to a system of bureaucrats and that system demands that proof of results be provided before a procedure approved to be funded by the PUBLIC system.

        Now if you want to advocate for a parallel system, fine, but you will not get very far with that (particularly with the Council of Canadians and the NDP) but you should try anyway!!! Might be fun to watch.

        • OK then … all Venoplasty must be stopped for everyone. You can get it no matter what. But, I cannot because I have that label of MS. I get to wait at the very end of the line. You get to move forward. Since when has it been that I am not allowed to see a Vascular Specialist? I repeat I am not allowed. You … can. So let’s talk about how fair is that? I do not expect special treatment. I expect the same treatment you are allowed. You do expect the system to pay it for you. Why not me? Just to be clear I would rather pay the 2K in Canada than go out of country and fork out 10 K. So that issue is moot.
          By the way … what is MSM? Maybe you are responding to a different article?

        • Maureen, Kristi Duncan MP did follow up on hundreds of Canadians who had it done, she found that 1/3 get no improvement, 1/3 get some improvement and 1/3 get life changing improvement. The procedure costs $10,000 in the USA + about $5000 accommodation and flight. So even if the government of Canada paid to send everyone who wanted it to the USA for treatment, the taxpayer is better off. 1 year of MS drugs for 1 person costs about $40,000 which we taxpayers fund. Also note that the USA is a for profit medical system, My friend MS sufferer Kerri Cassidy in Australia says it costs $1400 there. I have been told it would cost about $4000 here in Canada. By the way, Canadian vascular surgeons are good at the procedure. 7 were done in Canada before it was Banned, 6 patients reported improvement including at least 1 who got bladder control back. Put a cost on a year’s worth of diapers for a 40 year old mother of 3. Would you take her place?

          • Sorry, but all of this irrelevant. In Canada, for better or worse, we have handed off the decisions regarding our health care to a system of bureaucrats and in return we get ‘free’ health care. But that ‘freeness’ comes with restrictions – and one of those restrictions is that the health care system will fund procedures that have been proven – through research – to be effective. One of the other restrictions is that you are not allowed to go outside of the system to get service. That’s sad, but the options would be the dreaded two tier system (I personally don’t think it is a problem, but as I have mentioned before you would need to take on the NDP and the Council of Canadians – be my guest).

            Research processes are long and involved and many times only answer a small part of the overall question and the results only apply to a specific number of individuals. But that is the nature of research. I’m sure there are many people that feel they have improved as a result of the treatment – but what are the standards involved to quantify that improvement? If you have spent thousands on a treatment, you are going to believe a lot of stuff. And what about the people who did not improve – do we hear from them? Probably not because they have just wasted thousands of dollars – who wants to own up to that?

            I suspect at the end of all this (I will be dead by then), it will be discovered that the people who benefit from this procedure, probably never should have been classed as having MS to begin with. MS is not a definitive diagnosis, but rather a collection of symptoms and if you have enough of those symptoms you are deemed to have MS (or some form of it). You know – that would probably be a good finding because it would clarify the scope of symptoms of MS and it probably would lead to funding for the procedure for individuals who have problems but do not have MS. THAT is the nature of research.

          • Wouldn’t it be nice if MS wasn’t a degenerative condition and everybody had all the time in the world to wait? MS is a differential diagnosis and several conditions are supposed to be ruled out before diagnosis, including vascular malformations. I know a lot of people labelled wit “MS” that NEVER had that ruled out, or even mentioned. Neurologists just seem to be in big hurry to grasp at the MS diagnosis so they can get people on the so-called disease modifying drugs as quickly as possible. I see this as MALPRACTICE.

            http://www.ncbi.nlm.nih.gov/pubmed/11794488
            The differential diagnosis of multiple sclerosis: classification and
            clinical features of relapsing and progressive neurological syndromes.
            Trojano M, Paolicelli D.
            Source Department of Neurological and Psychiatric Sciences, University of Bari, Italy.
            Abstract
            In the absence of pathognomonic clinical features or a definitive
            laboratory test, multiple sclerosis (MS) remains ultimately a diagnosis of exclusion. Accurate diagnosis is increasingly important with available disease modifying therapy. Unfortunately the rate of misdiagnosis remains around 5%-10%, indicating that 1 in 20 patients thought to have MS has, instead, a condition resembling MS. In this review we describe conditions that may be confused with MS because they can present as lesions disseminated in time, space, or both. Conditions
            often confused with MS may be inflammatory (systemic lupus
            erythematosus, Sjögren’s syndrome, vasculitis, sarcoidosis, Behçet’s disease), infectious (Lyme disease, syphilis, progressive multifocal leukoencephalopathy, HTLV-1 infection, herpes zoster), genetic (lysosomal disorders, adrenoleukodystrophy, mitochondrial disorders, CADASIL), metabolic (vitamin B12 deficiency), neoplastic (CNS lymphoma)
            and spinal (degenerative and vascular malformations) diseases. The key to the accurate diagnosis of MS is vigilance for atypical features, suggesting the possibility of an alternative diagnosis.

          • We hear about all 3, the 1/3 who show no improvement, the 1/3 that show minor improvement and the 1/3 who show amazing improvement. (Kristie Duncan followed up and compiled those figures.) By the way, I was in research once upon a time and Kristie Duncan’s methodology is way more appropriate in a situation where thousands of Canadians are travelling abroad (they ARE the data) than the methods of the weirdos who are doing “studies” and ignoring the evidence of their own eyes and neurological tests on people who had it done. You are simply out of order about the travelling abroad for treatment. You know why? Every politician who ever had a heart palpitation here runs off to the Mayo Clinic. Why? Because they get the job done. In the real world, “its results that count” And when they come back, if they get complications, they are not left in the waiting room to die like that poor lady in Saskatchewan. Yes indeed, doctors refused to treat a lady who had complications (not from balloon angioplasty but normal ms complications) and she died! O, and by the way, that is one reason people are scared to talk when they come back. If you withdraw treatment, apparently in Canada it is not murder. (As long as it is a ms patient and not a politician). Brian

          • What exactly is your point Bill? My point is that the Canadian medical system has no problem whatsoever treating returning POLITICIANS who went abroad to get better health care but if a Canadian MS patient does the same thing, and get any random sickness, they might leave them in the emergency waiting room to die. (Least they did in Saskatchewan). Roxane Garland, 37, died July 22 2012 from a BLADDER INFECTION). How hard is is to treat a bladder infection? I mean, lets face it, Canadians go abroad ALL THE TIME, and get treated abroad all the time. Why single out MS patients for systematic cruelty?

    • I stopped taking the so-called treatment drugs for MS after I was treated in 2011. Dr. David Hubbard (a neurologist) has said that the MS drugs have an efficacy rate of about 30% – no better than a placebo. One of the newest drugs, Tysabri, can cause permanent brain infection and so far 89 people have died; Gilenya, also a new drug, has (as I understand it) 11 deaths to its credit. These drugs and others are intended to suppress the immune system and they cost governments from $25,000.00 to $55,000.00 per person per year. The autoimmune theory that the drugs are based on has never been proven. So the public system is paying millions of dollars a year to support a drug “treatment” that is not based on research or science. MS neurologists have been chasing the autoimmune theory for decades and do not appear to be looking for the cause of the MS symptoms but are quick to prescribe drugs based on an unproven theory. I think what we need in Canada is a regulation requiring drug manufacturers to list on a public website any financial recompense they give to doctors, reseachers, etc. The U.S (Sunshine Act) and Australia are way ahead of Canada in this type of transparency. Canadians as a whole would benefit as would the medical treatment they receive.

      • Sorry Linda but interferons and Copaxone are in fact 30% better than placebo to reduce the risk of relapses, Gilenya about 50% and Tysabri around 60% better than placebo. You can’t say they have the same efficacy than a placebo.

        • I’m citing David Hubbard – but there are studies that have been done on the interferons and Copaxone that show they are ineffective in slowing progression and only slightly better than a placebo at reducing relapses – again about 30%. Check Ashton Embry’s page (direct-ms.org) where he posted the studies a year or so ago. Gilenya and Tysabri are, for me anyway, way too risky and I understand that Tysabri should only be taken for 2 years. So what happens after 2 years? I stand by what I’ve said about these drugs. The MS experts do not know what causes MS symptoms but they have latched on to an unproven theory – autoimmune – and prescribe drugs that suppress the immune system. Seems to me there is a disconnect.

        • How do you rate the negative effects of more than 1 in 500 taking Tysabri getting PML? PML is pretty much a type of Brain Cancer. Given that the brain cancer rates are notably lower when taking a placebo, wouldn’t it give many MS patients a bit more peace of mind if they were prescribed a big pill bottle named “placebo”, instead of “might cause brain cancer”.

  14. Pleased Anne has written this and also agrees with what Michael Arata has said in his comments also . Lots of GOOD LUCK to CANADIANS with MS for CCSVI which they all deserve

  15. Excellent explanation and new reporting, as always, Ms Kingston.

  16. Open debate can be productive or merely a head butting contest. An honest, well written article is refreshing and unexpected. I appreciate the opportunity to express my opinion and read those of other people interested in CCSVI and its treatment.This study,however is more smoke and mirrors.

  17. I don’t care if they right off the improvements to placebo effect or reality. If the procedure even helps 10% of MS patients and 40% of stroke patients it should be allowed and covered under provincial health plans!

    There was another study in the US this week that showed the opposite, that it did work in 60% of MS patients in the trial. Seems every other week there is someone else doing a study/trial and releasing results, someone do a study without big pharma or gov’t money and I’ll go with those results as the true answer.

    Comes down to Big phara is going to lose money on the high cost of drug treatments, mostly that only maintain the patient and don’t improve their situations, and the provincial gov’t will have to pay out more for the operation.

    It’s a shame that only MS patients with money and who can afford to go to the US or other countries for the treatment, are getting it! What about the poor person on disability only, they can’t afford to go to the States or anywhere for the treatment. I think we should raise money for them to get the treatment seeing as the MS Society isn’t doing it!

    • “I don’t care if they right off the improvements to placebo effect or
      reality. If the procedure even helps [...] it should be covered under provincial health plans!”

      Do you understand that in the case of the placebo effect, the procedure did not help, merely enabled the patient to imagine it?

      • If I’m “imagining” that I can stand up without hanging onto anything for the first time in almost 20 years, I’ll take it! My “placebo” effect has lasted over 29 months now! Funny that my neurologist was able to measure improvements in my walking ability and increased strength in my right leg with the same neurological tests he’s used on me since 1990–guess his imagination is really powerful, too! You can see some of my neurological exam in my 1-year angioversary video on youtube on Lori Batchelor’s channel.

        Even though my neurologist didn’t want me to have this treatment, I’ll give him credit for being happy for me when he saw my improvements and had to admit that I am “significantly better”.

        • “My “placebo” effect has lasted over 29 months now!”

          Congratulations, but note that you are the only one labeling yours “placebo”.

          • Apparently you don’t grasp the idea of quotation marks for sarcasm!

          • Do you think the original poster (not you) was also sarcastic when he/she wrote that it doesn’t matter whether a treatment/effect is placebo or real in general, and that it should be publicly funded regardless? We weren’t talking about -you-.

          • I will tell you what I believe in the issue of CCSVI (I know it’s long-winded but I am passionate about this subject!). Chronic venous insufficiency has been a recognized medical condition for many years, with venous angioplasty being an accepted form of treatment. It was only when the cerebrospinal veins were specified, threatening the status quo of MS care, that, suddenly, this procedure has been deemed “experimental”. It cannot be stated strongly enough that venous angioplasty is used to treat venous insufficiency, and is NOT SPECIFICALLY A TREATMENT FOR MULTIPLE SCLEROSIS!

            Refusing a common treatment to a group of people, who happen to have been diagnosed with MS, seems discriminatory according to the “Universality” principle of the Canada Health Act which states: “The provincial and territorial plans must entitle all insured persons to health insurance coverage on uniform terms and conditions”. http://www.parl.gc.ca/content/sen/committee/372/soci/rep/repoct02vol6part7-e.htm
            It may not be a “typical” treatment for MS, but that doesn’t mean it should not be available to people with MS who have symptoms of a vascular nature.

            Also, Canada is a member of The World Medical Association and should be obligated to follow its ethical practices! http://www.wma.net/en/30publications/10policies/b3/ In their Declaration of Helsinki, section 35 states: “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized
            representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate,
            made publicly available.”

            A member of the Canadian Institutes of Health Research Canadian CCSVI Systematic Review informed me “Thanks
            for raising the Declaration of Helsinki. It is certainly true that
            physicians not infrequently try unproven treatments when they feel their
            patients have no other options.” I am waiting for an explanation why this is not being taken into consideration for people with Progressive forms of MS, who have no form of treatment options. A CHANCE is better than no hope at all!

          • I’ve been having trouble posting–probably because I included links. Please see (hopefully) a new posting from me, explaining how I feel about this issue.

  18. Could it be that big pharmaceutical has no interest in a surgical procedure that may eliminate many, and for some all MS symptoms. Who is actually paying for many of these “studies”? I lived in an area in Manitoba where iron content was extremely high in the drinking water. Many of the people who grew up there drank the water untreated all their lives. Six of our neighbors in this small farming community had MS. Before I moved there I had only known one person who had MS. I have no problem believing the relationship between iron and MS, as that was the common denominator in the area.

  19. It is a shame, that the guards of the right to poison patients- and Paolo Zamboni, didn’t just measure the arterial flow into the brain, and the pressure, at the same time, because this would surely have shown, if there is differences in bloodstream between healthy subject and patients with sclerosis.

    The brain demands a certain amount of oxygen and nutrients to stay healthy, appr. 1 ltr. pr. minute of blood.

    Multiple sclerosis have developed into the mysterious disease of unknown orign, because of years of maltreatment, performed by the neurologists, the ones who almost for certain have financial interests in making sure, plenty of MS-patients will continuesly arise and exist.

    The maltreatment, done by developing very expensive medication for just affect and block the immunesystem, have caused patients genes to mutate, in its continuesly fight to find ways of interfeer with the infection, and made the neurologists, repeadily claimed “autoimmunity”, a diagnosis never proven, because the situation is manmade..

    Epigenetic at it’s best, that will be inhereted for generations, so big success for The Big Pharma and its neurologists, and a very negative outcome for the patients, who in fact should have been treated with antibiotic!

    The origin of the disease is mostly because of malfunction of the bloodcirculation, caused by infection and biofouling i the veins.

    The nature of the infection can be viral, bacterial and due to spirochetes, and the more the bloodcirculation is blocked because of biofouling, the more the bloodpressure on the endothelium will rice, at the more the lining witt leak.

    Leak into the tissue of the brain, and viola, a mysterius illness has been created that generates 10 to 15 bill $ a year.

    Per West

  20. Debunk = to uncover while ridiculing. Well we certainly see the ridicule but uncover??? With 20 year old equipment?? A bit like performing heart surgery with a dull rusty scalpel don’t you think? I expect better from McMaster Univ. than that.
    Oh what a tangled web we weave. When first we practice to deceive.

    • The way I see it, the medical establishment feels they have too much to lose–it’s not only about pharmaceutical funding–a big part of the refusal to accept how important CCSVI is involves EGOS. Not only do neurologists not want to admit they’ve been barking up the wrong tree for so many years, they would also have to admit willful ignorance by ignoring the Declaration of Helsinki, section 35, which states: “In the treatment of a patient, where proven interventions do not exist
      or have been ineffective, the physician, after seeking expert advice,
      with informed consent from the patient or a legally authorized
      representative, may use an unproven intervention if in the physician’s
      judgement it offers hope of saving life, re-establishing health or
      alleviating suffering. Where possible, this intervention should be made
      the object of research, designed to evaluate its safety and efficacy. In
      all cases, new information should be recorded and, where appropriate,
      made publicly available.”

      I had no treatment available but when I asked for venous angioplasty, I was refused–I guess I should be talking to a lawyer!

  21. Dr. Zamboni’s response was, approximately, that the McMaster study

    a) didn’t follow guidelines recommended in 2011 by an international group of scientists specifically intended to clarify the debate about CCSVI,

    b) didn’t use M-mode ultrasound, and

    c) didn’t even look at the parts of veins where other studies have found the abnormalities.

    He included references and a statement of competing interest in his letter. He did not mention Merck, but he did mention a meta-study, which found that the research conducted since his 2009 study has come to unusually opposing conclusions. I have my own opinions on why that is. One doctor used a phrase “dogs are barking, but no-one’s home,”

    Time will tell. Some of us Canadians don’t have much left.

  22. I tried replying to someone but I can’t find my posting (I’ll try again with no links) so I thought I’d try making a bit of a statement here about how I feel about this issue–sorry it’s long-winded but it has been made more complex than necessary and I am very passionate about this subject:

    Chronic venous insufficiency has been a recognized medical condition
    for many years, with venous angioplasty being an accepted form of
    treatment. It was only when the cerebrospinal veins were specified,
    threatening the status quo of MS care, that, suddenly, this procedure
    has been deemed “experimental”. It cannot be stated strongly enough that
    venous angioplasty is used to treat venous insufficiency, and is NOT
    SPECIFICALLY A TREATMENT FOR MULTIPLE SCLEROSIS!

    Refusing a common treatment to a group of people, who happen to
    have been diagnosed with MS, seems discriminatory according to the
    “Universality” principle of the Canada Health Act which states: “The
    provincial and territorial plans must entitle all insured persons to
    health insurance coverage on uniform terms and conditions”.
    It may not be a “typical” treatment for MS, but that doesn’t mean it
    should not be available to people with MS who have symptoms of a
    vascular nature.

    Also, Canada is a member of The World Medical Association and should be obligated to follow its ethical practices! In their Declaration of Helsinki, section 35states: “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert
    advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate,
    made publicly available.”

    I, along with many others, was refused this treatment when I requested it. I have been secondary/progressive since before any of the so-called disease modifying drugs came on the market, and, therefore, did not qualify for any treatment. If I had known about this Declaration, I would have BEGGED for the chance to try this procedure, happily being a subject of research-I had participated in an experimental drug clinical trial in the past-but, oddly, there was no scientific curiosity displayed for this non-pharmaceutical treatment of venous angioplasty.

    A representative of the Canadian Institutes of Health Research advised me on their Canadian CCSVI Systematic Review website: “Thanks for raising the Declaration of Helsinki. It is certainly true that physicians not infrequently try unproven treatments when they feel their patients have no other options.”

    I have asked my provincial and federal Ministries of Health, the BC and Royal Colleges of Physicians and Surgeons, and the Canadian Medical Association, why the Declaration of Helsinki has not been taken into consideration for people with MS who have no form of treatment but I haven’t received any answers yet.

    Nerve degeneration doesn’t wait. People with Multiple Sclerosis shouldn’t have to!

  23. It’s hard to trust your life to those who can only do the bidding of drug manufacturers.

    I
    don’t want to limit my skepticism to those who say something can be
    done. Sometimes I am also skeptical of those who say it can’t. In
    some languages it’s easier to say no than yes, and vice versa in others.
    Whether you are right or not depends on the truth, not on who you are.

    Sometimes things that are not profitable to say are still true, and sometimes things that are profitable to say are still false.

    Dream big, even if , like many with “MS”, you are limited to daydreams. They come true, sometimes, too.

    Life, as they say, depends on the liver. 100%. :-)

  24. Science is designed to be disproven, not proven. Falsibiability gives science strength. With that in mind, I find it ignorant of people to use phrases like UNPROVEN autoimmune theory, when scientists are receiving backlash for disproving, or attempting to disprove, specific claims made by existing CCSVI studies. Attempts to disprove the autoimmune theory have helped to strengthen it. I don’t see this happening in CCSVI studies. Let me be clear that I am only speaking of the basic science, not the impressive testimonials. I am happy for anyone whose life has been positively affected by the liberation procedure. I have no interest in Canadian politics or Big Pharma. I truly care about the scientific process.

  25. What is so disheartening is that the McMasters study did not follow the Zamboni protocol. This was clearly stated in a letter written by Dr. Paulseth one of the co-investigators and co-authors of the study. It is such a betrayal of MS patients. They invented their own protocol changing the angle of the ultrasound probe among other things. Below is a verbatim quote from a letter written August 28, 2012 by Dr. Paulseth.

    “A group of us at McMaster lead by principal investigator Dr. I Rodger, have concluded a study into ultrasound and MRV in 100 MS patients and 100 age and sex matched healthy controls. We are in the process of applying to have this published. Our radiologists were blinded. Our technicians were not completely blinded but we did make an effort with less severely impaired patients to mask whether they were MS patients or controls. Our technicians went to Italy to learn the technique from Zamboni and his group. Our results are strikingly negative. We found CCSVI in only 1 of 100 MS patients and none of the controls, using the Zamboni ultrasound protocol. We did not find significant abnormalities in MRV either. Our results seem to be explained by technical considerations. The technicians and radiologists found that by changing the angle of ultrasound probe that apparent reversal of blood flow in ultrasound suddenly disappeared and changed direction. Zamboni had included ultrasound evidence of veins draining the CNS having flow in the opposite direction (back towards the brain) from what is normally seen as one of his criteria for CCSVI. Zamboni did not insist on having the ultrasound probe applied at more than one site on the vein. We required persistent evidence of reversal of flow at different probe angles before we accepted the result as abnormal. Basically we conclude that many of his observations, particularly on reversal of flow are artifact”. Written August 28, 2012 by J.E. Paulseth, MD, FRCP (C) JEP/fp

  26. I was diagnosed with MS in June 2011 and in March of this year I decided to change neurologists. He was very through in my work up and upon finding out my paternal grandfather died at the age of 47 with an anyuresm he ordered an MRA study. The study showed TWO anyuresms. One behind my left eye and one in the lateral aspect of the cavernous aspect of the left carotid artery. The report states the remainder of the intracranial arterial circulation APPEARS normal. No evidence of SIGNNIFICANT luminal irregularity. Now I don’t know what all this means and obviously I don’t know the right questions to find the answers. However I believe too much control is given to the radiologists who reads these reports. Who ARE they and what are their qualifications? Are they independent or are they employees of the hospital working by the hour.

    I was sent to an Atlanta top Neurosurgeon and he advised against any action at that time. Saying if they were to rupture; it would not kill me. I don’t understand all of this. I don’t understand how he could be fine with the loss of my vision in my left eye or what damage would be caused by the rupture of the one in my neck. I only know I had a normal life up until the MS symptoms began to show around April 2010. My brain feels like a complete fog and I have a hard time finding my words and staying on task. To the point that I can’t work any longer. I feel like I’m just waiting to die. I want my life back. If this procedure could do that I would be first in line! Connie

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