On the risks of CCSVI treatment: where’s the beef?

The latest study into the controversial MS treatment sheds no light on its effectiveness

As a piece of scientific research, the much-discussed University of Calgary report by eight neurologists published in the September issue of the Canadian Journal of Neurological Sciences is a strange little document indeed. “Complications in MS Patients after CCSVI Procedures Abroad” reviews the cases of five Canadian multiple-sclerosis patients who experienced complications ranging “from moderate to severe” after they traveled for treatment pioneered by Italian vascular specialist Paolo Zamboni—possible stent migration, venous thrombosis, possible cranial nerve injury, abdominal hematoma. These cases, they conclude, “represent the beginning of a wave of complications for which standardized care guidelines do not exist.”

Clearly the folks at the journal want the study to be widely read: they recently began offering it as “Editor’s choice article FREE!” on the journal’s website, allowing readers to sidestep the usual US$120 subscription fee. My colleague Colby Cosh went to town about the study’s findings in a recent blog post that dismissed CCSVI treatment as “trendy” and Zamboni’s science as “junk.” An August 31 Calgary Herald editorial took a different tack, concluding that the spectre of a patient tsunami arising from offshore CCSVI treatment offers “one more reason for the province to conduct full clinical trials. Good science is needed before an informed verdict can be reached.”

Alas, good science is not in abundant supply in this report. Even its basic facts are a little dodgy, beginning with the assertion CCSVI has been “a dominant topic” for 12 months (it’s closer to 24 months). The researchers also shoot down the credibility of Zamboni’s hypothesis claiming “more rigorous studies” have “not found an association between MS and anomalous or pathological venous flow.” That will come as a surprise to the Canadian Institute of Health Research. In June, in a reversal of a year-old decision, it gave CCSVI clinical treatment trials the green light after its CCSVI advisory committee heard a review of research that supports a MS-CCSVI link (the summary will be published in an upcoming Canadian Medical Association Journal). Oddly, two of the researchers behind the University of Calgary report (Drs. Fiona Costello and Michael D. Hill) sit on the CIHR’s CCSVI advisory panel.

The five case histories are cursorily reviewed and lack any follow-up post-emerg, making one wonder why eight neurologists were required for the effort. The five patients observed had differing forms of MS, at various stages of progression and were treated in disparate locations (Eastern Europe, Mexico and India). The Calgary researchers admit they don’t have a clue what treatments or quality of care the patients experienced: “We are unable to comment in detail on the exact procedures or protocols employed by those centres because it is not clear standardized procedures are employed across centres.”

Actually, it’s as clear as crystal that CCSVI practices have not been standardized across centres, either for diagnosis or treatment, a dire situation which explains why research is all over the map, as Dr Robert Fox, an MS specialist at the Cleveland Clinic (and CIHR CCSVI panel member), explains in this video.

A new study from the University of Buffalo that reviewed CCSVI research over the past two years also backs this up: it concludes that because CCSVI diagnosis relies on highly specific “operator-dependent” scanning criteria, results have been wildly inconsistent; it concludes there’s “an urgent need” “to establish reliable, diagnostic gold-standard test(s).”

Unsurprisingly, the U of Calgary study lacks the sort of context that would make it useful: What percentage of total CCSVI post-procedure complications in Calgary did these five cases represent? What percentage of the total number of Alberta residents who’ve traveled abroad for CCSVI do these five patients represent? And how do these outcomes compare with the risks from routine angioplasty and venoplasty performed everyday in Canadian hospitals? Of course, the researchers couldn’t know: nobody has kept track, a situation that should improve with the implementation of CCSVI treatment tracking registries.

It has been guesstimated that anywhere from 12,000 to 15,000 people have received CCSVI treatment worldwide—hundreds, if not thousands, have been Canadian. And they’re not dropping upwards of $20,000 to travel to offshore clinics to be “trendy.” We’re not talking about jetting off for a weekend in Mystique or buying the latest Balenciaga bag. These people are desperately seeking relief from a devastating degenerative disease for which there is no cure, only outrageously expensive “disease-modifying” drugs that come with a host of side effects, including death.

According to anecdotal reports, CCSVI treatment has offered dramatic improvements for many—in mobility, balance, circulation, bladder control, cognitive function and decreased fatigue. Other patients, however, have not experienced such benefits; a few, including one patient in the Calgary study, report their MS symptoms worsened after treatment.

Studies indicate CCSVI treatment—a routine angioplasty—is safe. But all medical intervention involves risk. And in the case of offshore CCSVI treatment, you have to factor in plane travel and clinics of varying quality. Over the two and a half years CCSVI treatment has been available, three related deaths have been reported (two Canadians and one American), all related to blood thinner or anticoagulant use. And at least one patient suffered stent migration so serious that emergency surgery was required.

Stents, used to prevent restenosis of the veins, are commonly used in CCSVI treatment, though they’re not part of the Zamboni protocol and he warns against using them—and of traveling offshore for treatment until conclusive CCSVI clinical trials have been concluded. As Colby points out, stents haven’t been designed for use in veins, which are far less robust than arteries, though researchers are busy working on it now. That isn’t because stents can’t be put in veins (doctors have been doing so for decades), but rather that the venous system has received such stunningly little study there has been limited call for it.

Again, context is useful: George Christakis, a scientist and vascular specialist at Toronto’s Sunnybrook Hospital told advocacy group CCSVI Ontario complications also arise from arterial stents: “You have to realize that there are complications with stents no matter where they are used. People drop dead of heart attacks when their stents in their hearts suddenly block off. You don’t see cardiologists stop doing the procedure.”

Sandy McDonald, a Barrie, Ont. vascular surgeon, who performed six CCSVI procedures in a small, approved trial last year, dismisses the University of Calgary report as “fear-mongering.” But it is significant in that it’s the first time neurologists, traditional MS caregivers, have looked at MS patients who’ve traveled for CCSVI treatment in a peer-reviewed study. Not that neurologists will have to deal with any such complications. That will be up to vascular specialists, the experts in this area.

What struck me about the study—aside from its gaps and its ultimate pointlessness—was the lack of interest in CCSVI patient outcomes. There’s no mention whether these patients experienced any improvements or betterment of their quality of life. Did they feel, despite the complications, it was worth it? Granted, that was beyond the purview of this study, one that chose to focus on burdens to the system not the health of the patient. But isn’t that what really matters?




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On the risks of CCSVI treatment: where’s the beef?

  1. Excellent article, Anne Kingston.  This entire issue has has become about a  battle of egos between neurologists and vascular specialists.  Let’s do proper studies and gather info about whether or not the treatment is of benefit to a certain types of MS patients.  It might not be a cure but if it provides significant symptom relief than it is a valid treatment that should be explored.

    • Exactly. We don’t let diabetics suffer simply because insulin isn’t a cure, despite the obvious risks associated with self injection, and of course the hormone itself.

      Personally I expect vein blockage is a side-effect rather than a cause, but regardless, if it helps people with MS live a better life, then what’s the problem eh?

    • I don’t really think that the ego of the vascular community is very involved, except perhaps for the fact that our health system still refuses to allow them to deal with a vascular problem, whatever else the patients may suffer.  The MS neuros ( and I don’t put the other neuros in the same bag) on the other hand, claim loudly that they, and they alone know all there is to know about MS.  THAT is ego!  And, fool that I am, thought that medicine was an all inclusive team effort, where specialists of all branches are called upon when needed or are even thought to be needed.

  2. One of the definitions my dictionary has for ‘Study’ is - Consider in detail and subject to an analysis in order to discover essential features or meaning. This Calgary study would fail even a grade school science project for not adhering to even the basics. I am not surprised they are not trying to sell it. In fact, if they had their heads anywhere but that dark, smelly place they obviously have them, they would be ashamed to put their names to it at all. My Granny used to say that it takes a big person to admit when they are wrong. It appears that there are lots of little people hanging out at the MS Neurology Department at the Foothills Hospital and the U of C neurology classrooms! Sadly they are not alone. We have a similar group here in Ottawa.

  3. THANK YOU ANNE KINGSTON.  I was getting so frustrated on the way CCSVI is being portrayed.  It seems that there is a one sided version that we all get to see.  The  version of the Multiple Sclerosis Society of Canada (MSSC) and the neurologists who are part of this group. 
     
    OF COURSE you are a HUGE exception ANNE KINGSTON.  I am so proud that you say it as it is and have the knowledge too boot! 
     
    I just wish this back and forth with people who really have NO CLUE would step aside and let the PROPER EXPERTS do their job.  This all would have been over and maybe we would actually be having real trials right now.  Yet the MSSC are the ones who are causing all these conflicts.  They are doing, saying and writing about Venous Issues.  It’s like going to an electrician because your toilet is plugged.  Why do they not get this?  It truly is a turf war and the financial implications IN A NEGATIVE WAY are huge for the MSSC. 
     
    We need more ANNE KINGSTONs out there!  Thank you again.

  4. I agree with with the comments questioning why these non-experts, like the two doctors mentioned in the article, continue to be allowed to sit on “expert” panels when they and their fellow non-experts have absolutely no experience or knowlege of testing or treating CCSVI. Many of them still believe that CCSVI does not exist. It is outrageous that these same non-experts will be devising protocols for the CIHR/Government funded clinical trials. It is clear that these non-experts suffer from severe conflict of interest and should either withdraw voluntarily and let the real experts take over or be removed. 

    Thank you, Anne, for an excellent, balanced article.  You put your colleague Colby to shame to say nothing of your biased colleague’s writing for journals like the Globe and Mail and the Toronto Star. 

  5. Thank you so much Anne for staying on the ball about our plight.  I’ve had two stents in my left jugular vein since July 2010 and to my knowledge I am still alive, doing fine and will have them looked at to ensure all is well.  Of course I have to leave my country to do so and, even though my Neuro wanted to get a venogram done here, the hands that could write a script were tied.  Please keep up your good work and for being a truly honest reporter.  Seeing is believing and you have done just that!

  6. Anne is an example to all journalists that accurate unbiased reporting can properly lay an issue out for educating and informing the reader. So refreshing to see her articles with no hidden agendas slanting and distorting such an important issue. Important at least to us with M.S.

  7. Thank you Anne for another well written article regarding the MS/CCSVI issue.  I continue to be perplexed as to why the venous system should not be addressed if it is faulty, regardless of having MS or not.  This past winter my body was dying a slow insidious death, due to poor blood flow. I was unable to leave my bed due to weakness, fatigue, poor balance, no coordination, swollen extremities, navy blue feet. I was given no answers or real investigation by a number of physicians and I can only believe it was because I also happen to have MS.  It was only at the point that I was told, there was nothing ‘they’ could do for me that I took matters into my own hands. 

    In an informed, intelligent and aware manner, I made my decision to have intervention of CCSVI, yes I indeed had insufficiencies in my venous blood flow, found by very state of the art imaging that, yes I indeed paid for in a North American facility that exceeded anything I have experienced here in Canada.  The mighty dollar speaks in many ways, good and bad.  For me, it was in an exceptionally good way.  I paid and I would do it again. I am out of bed, back walking with a walker, out for lunch, going to festivals, fairs, enjoying a lovely Canadian summer. Sleeping better than I have in 20 years. No swollen, navy feet.  Improvements in numbness, bladder and bowel function, increased energy, reduced fatigue.  Not cured in any way, nor did I believe I would be. I continue to have secondary progressive MS. Critics will say, but you are not without your walker or scooter, and I may never be, but it took me 20 years of venous insufficiencies to get to the poor state I have been in, it certainly won’t be fixed in a few months or even a year. 

    I will continue to be an advocate for those that have the courage to challenge the status quo and investigate, ask questions, listen to patients and move treatments, methods, diagnostics and positive communication forward so that an improved life for so many can be the ultimate goal here.

  8. Thank you for finally giving a balanced perspective on the issue ofMS/CCSVI. If there seems to be any doubt as to whether or not it is effective, here is a medical review:
     http://www.ncbi.nlm.nih.gov/pubmed/21876515
    We need more Anne Kingston’s!

    • The study you linked to concludes their was no neurological benefit to CCSVI treatment. In other words, the treatment doesn’t work. This is an uncontrolled study so the incredibly modest benefit to quality of life scores can be entirely explained as placebo effect.

      • That is NOT what it says. Read it again.

        • To quote from the paper directly “The endovascular treatment in patients with MS and concomitant CCSVI did not have an influence on the patient’s neurological condition” It would be very difficult to interpret the results of this study differently.

      • CCSVI is a Vascular condition, not a neurological one–improving a vascular condition does not require neurological improvements to be beneficial.

        • To claim that the etiology of MS is vascular and not neurological is one thing,  but to claim that the SYMPTOMS of MS are not neurological is absolutely absurd. If CCSVI cannot improve the neurological symptoms (numbness, paresthesias, muscle spasm, muscle weakness, loss of balance, loss of coordination etc. etc. etc.) then it is not treating MS.

    • Jennifer, your reference is in fact stating poor results after venoplasty,  No benefit on neurological condition, an improvement on quality of life limited to 3 months and not present after 6 months and a high level of restenosis (33%) after 6 months, 55% for those with stents.

      Thank you for this instructive report.

      • That is NOT what it says. Read it again.

        • What do you suppose it means when it says “the endovascular treatment of the CCSVI improved the quality of life according to the MSIS-29 scale but only up to 3 months after the procedure (with no differences in the 6 month follow-up assessment). ”

      • CCSVI is a Vascular condition, not a neurological one–improving a vascular condition does not require neurological improvements to be beneficial.

  9. One thing that I don’t understand is why aren’t people experimenting with taking blood thinners to obtain this type of relief.  My doctor has been treating me for some time regarding cario problems and has had me taking the proverbial  81mg aspirin for a decade.  One of the other benefits of aspirin is suppose to be memory improvement so obviously it increases blood flow to the brain.  If my cardio problems worsen significantly,  then surgery may become the only alternative.  For now I’m doing well.

    • I was on .81 aspirin for at least three years before my procedure and I’m sure it kept me from a quicker path down the rabbit hole.  I tell everyone who will listen to keep their blood thinner in this way to avoid additional build-up because of poor drainage.  I do not have a Cardio but believe that aspirin does relieve and help until you can get your veins widened. Speaking from mature experience.

    • Simply said: blood thinners will NOT correct stenosis, aphysical problem with the veins.  Blood thinners are for blood flow..

    • Aspirin is not a “blood thinner” and does not in any way increase blood flow to the brain. If “blood flow” to the brain is ever reduced to any significant degree, the result is sudden and immediate, i.e. a stroke. What the aspirin actually does is act as an anti-platelet agent – these are little particles in the blood that “stick” together and can form clots and plaques. As such it’s useful for the prevention of angina, heart attack, and stroke. For people at higher risk of clots, anti-coagulants like warfarin or heparin are used. None of these medications affect blood flow, just the risk of heart attack and stroke by the prevention of blood clots. 

  10. NO ccsvi trials till there is evidence , no evidence till there are trials,
    Makes sense Canada has the highest MS I pay attention in UK.Evidence is there worldwide now and we need to move forward .Positives is there

  11. I agree with the others who have said that we need more Anne Kingstons!  Thank you so much for bringing CCSVI truths to the forefront. 

    This travesty of a situation grows more disheartening as we continue to see the wrong parties, whose minds are steeped in bias, involved in studies where (as you pointed out) they do not even care about improvements to patients’ health, well-being and quality of life.

    For decades, the keepers of the MS gate have really known nothing about MS, and still they have continued to spew one falsehood after another under the guise of fact and truth.  Now they have the nerve to position themselves as keepers of the CCSVI gate for only one reason, to keep it firmly shut.  Why are they being allowed to do this?  Why is our goverment enabling this ongoing travesty? 

    Sorry for ranting.  I really only did want to thank Anne Kingston and Macleans for the high standards of journalism you uphold with your continued portrayal of unbiased facts and truths – it’s a shame other publications are not following your fine example.

  12. Thank you Anne, as we read so much of the world in turnoil these days, all we want is proper blood flow I know it works and I don’t need a neurologist to confirm it, go ahead if they want the studies but they’re not the specialists, we need vascular experts to correct our flow it will take a lot of people like you to make these people realise we deserve proper blood flow:-)

  13. They HAVE TO position themselves as keepers of the CCSVI gate. If they lose their hold on MSers they lose their their income, their reputations, their standing in the community but most of all they lose their other income, their usefulness to the legal drug cartel and their standing in THAT community. That is very hard on those over inflated egos. I suspect that the sham of a scam (or should that be scam of a sham??) will carry on as long as they can squeeze a buck out of some poor uninformed MSer. Since they haven’t planned for this eventuality, I expect the suicide rate among them will climb as their prospects decline.

    • Interesting that you attribute the position taken by MS experts (i.e. neurologists) as being entirely money-driven, yet do not seem to have a problem with vascular surgeons gouging patients for 10 to 20 thousand dollars for a treatment with no evidence of benefit….

      • One has to wonder, Mr. Grieves, what planet you live on. Evidence is everywhere if you just take off the blinders, you too would be able to see it.What is way more important than the visible changes, are the ones the patients can feel – most notably, the lack of fatigue. But as you can’t see it, it is not noticeable unless you know a person and how they were worn down by it before and are no longer. However, some of the signs are very visible – like being able to walk, being able to hold things and actually feel them. Some are audible. Without cog fog, we tend to speak clearly and more precisely. We do not get hung up on a word that we have always known but cannot bring it to the fore. People who have not walked for years can now run. One gal in NS can run backwards – now for an MSer, THAT is a huge feat. Some things you won’t see because they are private even for people without MS like being able to urinate without a catheter.
        Money spent on medical treatments that accomplish nothing positive and often accomplish negatives – a scam. Money spent on a treatment that gives months and sometimes beyond of quality to on’s life – priceless as they say on tv. To put it in terms that you might understand – it is the difference between the red stuff winos call wine and buy for 1.50 and the kind you savour that costs $50.00 or more a bottle. There is no comparison.
        You show up on all the papers and magazines who write about MS/CCSVI. And your comments are so uninformed. I’m curious. Are you a disgruntled neuro?

        • Mr. Grieves could be a professional hater, you know, one of those hired to dismiss the views of those expressing views counter to those endorsed by the government and its promoters/supporters.

        • Scientific evidence is scant. All of the alleged benefits you mention could be easily tested in a clinical trial. The problem with anecdotes is that there is no control group to compare too. Without a control you cannot differentiate between the natural fluctuation of the disease and any genuine improvement afforded by the treatment. In addition, patients undergoing ANY intervention (real or not) tend to report improvement in subjective symptoms. For this reason we must rely on scientific evidence to judge the efficacy of a procedure.
          Unfortunately CCSVI treatment has become almost a religion among proponents. Ask yourself this honestly – if a large-scale trial demonstrated that CCSVI did not in fact work any better than placebo, would you admit that it did not work and stop advocating for it? 

          • He IS a neuro stool.

          • Scientific evidence is scant about MS and your fancy drugs. It hasn’t stopped one MS neuros from injecting people with them and you do that on the basis of anecdotal evidence supplied by drug companies, not on scientific evidence. Very few doctors take the extra years required to understand drugs, In fact, they get relatively no real education about drugs. They do get the sales pitch though. For some strange reason, you would not buy a used car on that type of sales pitch but you will inject patients based on it?? Shades of Josef Mengele and Nazi Germany! He did it because he was a sadistic power monger. MS neuros do it because they are money hungry and uncaring. Same difference!! Different century.  

            The sun rises in the east. I do not need scientific trials to know that. I can see it. Just like I can see my neighbour who was wheelchair dependent for years out planting her garden, weeding it, harvesting it and standing at the stove cooking it when she has not been able to do this for years.

            You really need to check out the dictionary – a real one, not Wikipedia – about the meaning of “placebo”. Since it’s inception, it has always been associated with drugs until about 50 years ago or so when Neuros studying the ‘autoimmune’ hypothesis decided to attach it to surgeries and procedures.

            That brings us back to ‘scientific evidence is scant’. Indeed it is when 21st century doctors use ANECDOTAL evidence to diagnose MS and call it an ‘autoimmune’ disease based on the unproven hypothesis that there is even such a thing as ‘autoimmune’. and try to pump us full of drugs based on the sales pitch of a drug pusher.

          • Well, it certainly didn’t take you long to start the comparisons to Nazism – always a good sign that the poster lacks a cogent argument. 

            The evidence for MS drugs is robust. That does not mean they are magic bullets capable of curing the disease, but their efficacy and safety are clearly defined which allows physicians and patients to make informed decisions about their use. 

            Your comments concerning placebos and autoimmunity are puzzling. A more accurate term for non-drug placebo interventions would be ‘sham’ interventions. Sham surgeries have been used for decades to properly control surgical trials (arguably the most famous being the seminal 1959 paper by Cobb demonstrating no difference between Internal Mammary Artery ligation and sham ligation in the treatment of angina). I am unclear how the use of the word ‘placebo’ in this context has any bearing on the issue. Does saying that CCSVI needs to be compared to sham surgery strengthen your argument in some way? Your dismissal of auto-immunity is an interesting statement, The thousands of scientists studying, and millions of patients suffering from conditions such as rheumatoid arthritis, lupus, crohns disease and literally dozens of other conditions may take issue with it.

      • $10,000 US for the venous angioplasty day surgery – less than the cost of a year’s supply of very expensive immunomodulator drugs of questionable and sometimes fatal result to be taken indefinitely. Who exactly is gouging whom here?

        • BINGO.

          My brother-in-law has MS, and the money he has generated for the drug companies over his lifetime would buy a house… in Vancouver.

          If this treatment works to seriously relieve symptoms over extended periods of time, then there is no comparison to the daily drugs and weekly shots, even if they weren’t many many times more expensive, which they are.

          • Isn’t it interesting though that the MS drugs are very quickly approved by insurance companies (at upwards of $30,000 per year) , yet the liberation treatment, even at $10,000, is not covered by insurance companies or provincial medical plans, yet have the potential of saving hundreds of dollars per patient ??

      • The MS neuros do nothing but collect.  The vascular surgeons do something effective and efficient and they have to pay for their assistants, their offices and their supplies, and many do NOT charge $10 000.

  14. From the bottom of my “liberated” heart I thank you!  Finally someone gets it!

  15. THANK YOU ANNE KINGSTON, we need more like you.  I can relate to many points in your article as I have SPMS and have been treated with venoplasty twice.

    My first procedure was done in Egypt by Dr. Tariq Sinan in Oct. 2010.  There are few if any protocols their and communications with the Dr.s for after care is virtually impossible once back in Canada for linguistic and logistic reasons.  The trip was excrutiatingly long for someone wheelchair bound with spastic legs.  The journey home in pain, with no pain medication was even worse.  Even having said all of that, the benefits, well short lived were undeniable. 

    I had my second procedure in Newport Beach CA by Dr. Arata in April of 2011.  Yes, I had a stent placed in my azygous vein to keep it open.  I wanted to feel like I did after my first procedure, who wouldn’t. 

    We need more people like you willing to step outside the “politically correct” box so that those of us suffering with this debillitating condition can have this simple procedure at home.  Should some of the nay sayers roll a mile in my chair they may get their head out of the sand!  Kudos to you and Maclean’s!

  16. I am amazed to see how Mrs Kingston is again writing a bias report on CCSVI.  This paper published by University of Calgary neurologists is not a study but just a case-report paper explaining complications they saw from patients treated outside of the country.  This week, a similar article from UK written by vascular surgeons in a non neurological journal is reporting a similar complication http://phleb.rsmjournals.com/cgi/content/abstract/26/6/254 .  Colby Cosh did some serious research in his blog to describe some of the different scientific studies published in the last few months that are revealing problems with Zamboni’s hypothesis.  Just in the last 2 months, 5 studies coming from 4 different countries disapprove Zamboni’s conclusions on the presence of CCSVI on MSers compared to controls.

    Unfortunately, Mrs Kingston has limited again her research for this blog to the pro-CCSVI Facebook sites showing her obvious bias. 

    • Studies by MS neurologists, JH712, are like statistics – you can get them to say anything you want. Real patients who have really had the treatment are a much more reliable source than studies done on a condition with no known cause, no real idea of what the symptoms are really like, no cure and where all the info neuros are using is based on a still unproven hypothesis they like to call autoimmune. Just a thought but since they have been working on this hypothesis for decades and still have nothing concrete to show for it (unless you are talking about the ill gotten money made by selling useless, often deadly drugs), do you think they just might be wrong? I would think they could come up with something more concrete and useful than name calling other doctors who HAVE accomplished something for MSers.

  17. If any of you are interested in seeing what many CCSVI-patients are saying about the results of their CCSVI-procedure – go to http://www.ccsvi-tracking.com

    So far almost 700 CCSVI-patients have reported here.

  18. Thankyou Anne Kingston.
    First, this is a venous issue. Why are MS neurologists even looking at this? Mine has told me right to my face in his office, that he cant even read what the IRs gave him to look at post care as he does not have training in the study of veins. He studies the brain, the nerves of the body and how they affect us. As we wait for them to determine and allow us healthy circulation, how successful do you think their recommendations will be when they do not study in that field or even consider circulation to be essential? Why have the MS neurologists taken so much lead in this issue? If I had a broken leg, would I need approval from some neurologist because I have MS before an orthopedic surgeon can fix me? Why? How preposterous is that? The government of Canada is still allowing this to continue. Why? These 8 MS neurologists are an absolute disgrace to the medical profession and Canada, let alone the human race for letting so many needlessly suffer… They have done great disservice to the MS patients of Canada and to the Canadian people period and continue to try to do so. They should be ashamed and, IMO, they and the MS Society should be made accountable and liable to ALL the MS patients and their families in Canada for allowing this kind of gross negligence to transpire and continue. We are suffering a vascular disorder that we cannot get treatment for here due to these neurologists and due to being diagnosed with MS. If there is no previous MS diagnosis, you are free and clear in Canada to have this done for you if required. How can the MS neurologists now even confirm their diagnosis of MS is even accurate? Blood flow has previously been ignored. Bottom Line: This is a Vascular condition that is being ignored and neglected in a certain category of people. Nothing more. This is AGAINST HUMAN RIGHTS!!!There is proof of CCSVI and the damage associated with CVD associated diseases. There is NO proof on the auto immune theory – and it still is only a theory! It is audacious and preposterous to claim that venous drainage is not as important as arterial flow. With out circulation there is no life! How can they even consider any of the diagnoses that they have made, with a main physical “essential life sustaining” system that is already compromised, to even be accurate? How can they justify present treatments until they fix the known problem in the circulatory flow? These 8 MS neurologists feeding this “junk” science to Canadians should, by now, show without uncertainty where their agendas lie. It has nothing to do with the well being or quality of life for MS patients (or any others affected by CCSVI). Do they really and seriously think that reflux only happens in the lower extremities? How absolutely moronic! I am sickened at the fear mongering from this particular group of doctors when its not even their field. How Dare they! Treatment should proceed with study. simple,and improvements can be made as studies progress. They know the efficacy rate and the safety stats on this procedure in all the areas of the body as they have documentation that is 40 plus years old. Everything from stent removal to new tools for safely dealing with clot removal.  They are just snowing everyone with the “making sure its safe for MS patients” line. Why is it safe for every other Canadian that is not diagnosed with MS? Should we stop doing it for kidney dialysis patients who depend on  this treatment  to live and have quality of life?  THE Ms Neurologists DO NOT OWN MS!! Why are they given the last word as to what treatment the patients are allowed to choose? There is physical PROOF that there is a physical problem that needs fixing! FIX IT This whole controversy over healthy circulation and who is allowed to have it and who is not is absolutely pathetic. I hope every MS patient and/or their families in this country sues their butts off! Shameful. 

    • Who says you need a venoplasty for better perfusion? lots of the scientists are now clearly stateing exercise to naturally perfuse the brain. Lots of alternatives to choose from. don’t
      have to be a sheep.  By-the-way my stroke neurologist helped penn the paper and there
      is no better physician/human being anywhere, it’s an honor to be a patient of such a scientist/physician.

      • I wanted to reply to two things.

        First, the answer to the question :  How can the MS neurologists now even confirm their diagnosis of MS is even accurate? They can’t.  “MS” is misdiagnosed when some other condition is causing the symptoms. That happens so often that it is a large problem to put any faith in scientific research, even when it involves large numbers of these patients.

        Treatment for CCSVI does, however, relieve some of the symptoms blamed on “MS”, even when medical science has no more to offer, and the only other choice is to let nature take its course.  (That means letting a lot of them die.)

        The other thing I wanted to say is that it may be that the reason arteries are not involved, only veins, which are often neglected in current medicine, is that the problems involve reflux of venous (vein) blood, going in the wrong direction. Arteries are protected from this because between the arteries and the veins, where the good things in the arterial blood are consumed by the organs, are capillary beds. In the brain, they are specially constructed to prevent bad stuff from getting in.  Much of the damage of “MS” happens where the reflux is stopped by these capillaries, at the so-called Blood-Brain-Barrier.

        This “BBB” might be thought of as a metaphor, symbolically showing what is going on in these discussions of CCSVI and “MS”.  Only in the real world the barrier between the people in charge of brain medicine and the people who want their blood to flow properly, is money: a real blood-brain-barrier.  If the brain is not protected, people die.  But if the blood doesn’t get its oxygen and food renewed, they also die.  A little later, but still too soon, and they spend what remains of  their lives suffering, unable to function.

        In the legs (CVI), reflux is assisted by gravity.  In the brain it isn’t, but
        our posture changes when we lie down, and the way things work with vein
        problems, what comes down sometimes goes back up.  Reflux can still
        happen, and brains are much more vulnerable than legs.

        • Following your logic, can you explain me why capillaries will be able to protect the brain from bad stuff coming from arteries with high pressure but unable to do so from veins with blood traveling back on low pressure? 

          • Only capillaries in the brain, because the vaunted blood-brain-barrier is actually special brain-only veins, arteries and smaller vessels like capillaries, constructed with what are called ‘tight junctions’.  These filter anything large enough from crossing into the brain, while allowing dissolved oxygen and glucose to leave the blood.  Once capillary beds have been exposed to too much reflux they can’t filter anymore, and the barrier breaks down, allowing larger things in.

            Capillaries are like diodes; blood usually only goes one way.

            Veins under low pressure carry blood which is slower and more turbulent, sometimes refluxing, and contains what is left over after the oxygen and glucose is used up, which will include deoxygenated iron and many free radicals produced by the burning of oxygen.  Also, the pressure from arterial blood is enough to prevent reflux.

        • The diagnosis of MS requires a very specific set of *recurrent* or advancing symptoms, correlated with MS-specific lesions found on serial MRIs of the brain. In any case, there is little to nothing about MS pathophysiology or signs and symptoms that resembles that type of damage that can occur due to insufficient blood flow or to increased intravascular pressure inside the skull. 

  19. Thank you for this sensible rejoinder to the fear-mongering that is going on in Canada with respect to CCSVI day surgery performed by qualified, certified, and experienced OVERSEAS surgeons. I would say to Canadian neurologists who seem determined to block this treatment without serious study, why have you forgotten scientific method? If you have no interest in truly investigating the positive outcomes for many of this promising surgery, would you at least stop trying so hard to block it? Your and the Canadian government’s approach to this seems rather medieval, and definitely lacking in compassion for the many Canadians seriously disabled by MS. What happened to “Do no harm” ??? #cdnfail

  20. Thank you Anne Kingston.  We believe in angioplasty and we believe in YOU.

  21. “There’s no mention whether these patients experienced any improvements or betterment of their quality of life. Did they feel, despite the complications, it was worth it? ”

    That’s the problem, isn’t it? This emergency room study is bad science, but so too is asking patients how they feel.

    And this study is junk science. So was the original Zamboni trial. So is any “observational” trial that takes into account multiple clinics, different standards and surgical technicques, varying conditions of those undergoing the therapy and almost impossible to measure results in a disease that fluctuates wildly.

    There are actual studies going on right now. Can all sides wait until the real science arrives?

    • No. We can’t wait. MS is killing me and I am not feeling too terribly CIVIL about that. And only a mental midget would ask such a stupid question.

      • My wife, the scientist with MS, does not share your opinion. And insulting me neither improves the quality of the data nor hurries the approval of the Zambono procedure. If you’d like the government to pay, you need to provide actual science.

        • We have already waited for over 50 years. I stand by my answer.

          • And we’ve been waiting for a cure for diabetes for 85 years. but we don’t fund every “cure’ brought forward based on crappy evidence, or we’d be broke by now.

          • You are off topic. There are viable treatments for diabetes. We were not talking about cure, just treatment.  And I still stand by my answer and would add the advice to stop digging a hole you won’t be able to get out of. 

    • What do you consider real science?  The studies funded by the MS Society and conducted by MS neurologists?

      • For a start. Also the varied studies currently underway in the states.

    • Yes, we’ll all be waiting – in our graves, if this travesty continues.

      • Life’s not fair. If you have MS, you already know that.

        So yes, you have to wait for hard science to prove that something works if you want the government to fund it. That’s HOW we have more-or-less universal health care. Because that’s how we can afford it.

        Travesty, no. Reality, yes.

        • You’re right, life is not fair.  And since you don’t have MS, you have
          absolutely no idea about the reality that so many of us with MS have lived
          through within the health care system.   THE
          REALITY IS A TRAVESTY.  You may have the
          luxury of enjoying “ more-or-less
          universal health care”, but so many of those living with MS have been suffering
          with below-standard care for far too long at the hands of one group of
          physicians.

          The CCSVI
          situation is just more arsenic on an already-poisoned cake.  Our government will rush
          to fast-track harmful drug treatments, but a non-drug procedure performed on
          those without MS has the government and advocates of drug treatments holding up
          red flags and spouting cautions about safety and efficacy.

          Don’t
          expect us to accept such trivializing statements as “life’s not fair…” and sit
          quietly.  We will not stop fighting for
          an end to this travesty. For the record, “hard science” from biased non-experts with major conflicts of interest = more travesty.  Even physicians who have MS agree on this.

  22. Anne Kingston has the courage to do the necessary research and report on the truth, even in the midst of a major paradigm shift that is not being acknowledged by the gate keepers of the disease.  The vascular problem will no longer be buried as it has been for many generations. The truth is out! Thank-you, Anne Kingston.

  23. In case anybody out there cares about the pedigree of the authors of the Calgary study, one of them is Dr. Fiona Costello, who is a principal on a research team for a CCSVI study that is one of the infamous 7 funded by the “MS” Society.  These studies are being pursued by people with, as we now can see, obvious biases against the theories of CCVSI and the procedure to treat it.  The studies pre-date the decision by the CIHR, to support the Canadian government holding Canada-wide clinical trials of the procedure. Trials which, incidentally, are very slow getting started, for some reason.

    The other thing one might want to know is that Dr. Costello formerly held a position at the Ottawa Hospital’s “MS” Clinic, which is run by one of the most vocal opponents of CCSVI, a neurologist, Dr. Mark Freedman.  One can imagine the kinds of things he had to say on the subject to Dr. Costello.  He is the doctor who called the CCSVI syndrome a hoax, in a Canadian national newspaper.

    Dr. Freedman is also very heavily involved in the Canadian “MS” Society, both as a fund raiser and a neurology consultant.

    He is also said to be Director of Membership of the Consortium of MS Centers (CMSC). This group was reported to be involved in the recent bribery scandal involving several doctors and a manufacturer of an “MS” drug, Serono.  They settled the matter by paying the US government over $40M US.  The drug costs  tens of thousands of dollars a year for each patient, and Dr. Freedman was involved in the research that led to its approval by the Canadian government’s Health Ministry.  He also prescribes this drug for “MS” patients.

    Dr. Zamboni, the theorist behind CCSVI, advises “MS” patients not to stop taking their prescribed “MS” treatments.  He has not spoken against traditional auto-immune disorder treatments.  His qualification is as an expert on the venous circulation.

    Some of the people doing Canadian CCSVI research, and assessments of CCSVI treatment, should be qualified to perform the procedure, not just peripherally involved due to their interests in “MS”.

    Would any of this controversy have even happened if we were talking about leg veins (CVI?), or is it just that the venous insufficiency is cerebro-spinal, which means it is someone else’s ‘property’?

    • Many of your points raise interesting points but Dr Freedman has also saved many
      a mser’s lives because of his groundbreaking work in Ottawa. I have a personal
      friend, and she is alive because of him and only because of his work. She was
      an epilepsy researcher and was on deaths door. She is very alive 5 years latter
      and works very hard in Ontario at a MS chapter office as a volunteer.

      As for Dr Costello, she is a worldwide expert neurology opthalmologist with support
      from many different disease foundations, especially alzheimer groups. She is the
      only scientist in the world to have developed a model of the human brains nervous
      system to trial tissue repair. It’s truly groundbreaking and she is to be highly
      commended.

      As for your comments that CCSVI experts should be included of course and they
      have been. Surgeons have been consulted all around the world. In fact some
      have even come to Canada. But an interesting tidbet is one particular surgeon (US)
      that performed the venoplasty on 45 patients on a pilot project told the health
      ministers in Canada everyone of the patients restenosed. He is not continueing
      with the work as far as a understand.

      And further given the recent revelations by California IR’s about stents in certain
      vessels and the massive radiation patients are being exposed too I would caution
      anyone to reconsider venoplasty until all the research is completed and the
      data assessed.

      I would really like to see the Cochrane Library group of scientists brought in at
      this point to help. The back and forth is just an endless fight and evidence is
      what is really needed. I have no doubt problems exist in the vascular, I have them, but
      they exist in many disease states and certainly only play a role in MS I believe.

  24. Once again Anne Kingston you write a very good article because its the narrow minded and bruised egos from Neurologists( like Mr Grieves on here commenting) that have this Venous angioplasty held hostage when it should be done here right now in Canada to correct bloodflow whether we have MS or not. Keep the truth coming Anne it needs to be told even more as to why this is being blocked so much by the Neurologists.

  25. The comparison, Mr. Grieves, to Nazism comes from having
    studied it from the cradle. My Father fought it and our home was a haven for
    war vets and war refugees for a good many years after the war and they lived it
    – something we in this country until now have managed to avoid. The comparison
    was made because there IS a comparison to be made regarding the attitude of MS
    neuros pumping useless at best and lethal at worst drugs into unsuspecting,
    disabled patients and the attitude of Dr. Mengele et al. History used to be
    compulsory in school and the intent was that we learn from it so as not to
    repeat it. Doesn’t look like you learned much though. Sad!

     

    You say the evidence for the drugs is robust. Funny!
    Everything I have seen on them is anything but robust. The news of late has
    seen many articles on the deceitfulness of drug companies and their drugs. Here
    is just one example. http://theamericanscholar.org/flacking-for-big-pharma/?key=50601046

     

    I did not bring the term ‘Placebo’ into the fray. An MS
    neuro did. It may very well have its place in drug research but there is no
    sane reason to subject patients undergoing surgery or any procedure not
    involving drugs to a sham, as you call it, procedure. It is cruel and unusual. More
    serious and risky operations and procedures have been carried out without such
    an ill conceived control. Of course They are carried out by REAL doctors trying
    to really help their patients, not by sham artists.

     

    About ‘autoimmune’ – I don’t care if one scientist or one
    million scientists are studying it. It is only a theory. An unproven theory. An
    unproven theory for all these many decades. And I have yet to hear of one
    patient  with “rheumatoid
    arthritis, lupus, crohns disease and literally dozens of other conditions” that
    have been cured or even received any noteworthy treatment that has had any definitive
    affect on their conditions. Hmmmm Sounds familiar! 
    Time for you  to move on!

    • Karen your comments regarding other auto disease is very wrong. Many of the
      new drugs have had a tremendous impact on Lupus and RA. Of course some
      of the drugs don’t work and in fact can kill, it’s not easy for any patient these
      decisions. Walk into a RA patient office today and look at peoples hands, you
      won’t see the horrific disabilities you saw 20 years ago. I used to take my
      mom to her arthritis specialist and wait for her to see her doctor. I could never get
      over how much harm RA could do to a person. I opened the doors, sat people
      down, got their canes into the stands etc. Today meet a RA patient and see
      for yourself. A university professor of history at the UofC has RA and you
      would never know it.

      As for perfusion can you try exercise. A 66 year old woman from Scotland has
      some very famous youtube videos on the net proving that after 3 years of rehab,
      4x a week she has regained alot of her walking abilities – very inspiring to watch,
      - Promethus Foundation UK. I encourage anyone to try rehab very diligently
      as it has worked wonders for me also.

      • Finding treatments for something does not make it ‘autoimmune’ which is still just a theory. I am very happy for anyone with any disease who finds a treatment that relieves any of their symptoms. However, this is about MS and CCSVI, not RA or any of those others conditions. Let’s keep this on topic.  Rehab works fine when you are not suffering from MS fatigue and if you have not experienced it, you have no idea what it is like.

        When doctors lie to patients over and over again, do not be surprised that we stop believing anything they say. That’s where things lie right now and that is true in Canada where I am and in the UK where they get the same non treatment that we get here. If you do not have MS or CCSVI, you are an onlooker. Until and unless you start to listen to what MSers are saying, you will always be an on looker.

    • You don’t have the slightest idea what you’re talking about. The hallmark of diagnosis of autoimmune diseases like RA or Lupus is the measurement of auto-antibodies (Rheumatoid Factor, anti-dsDNA, anti-Ro, anti-La, anti-cardiolipin, antiphospholipid, etc… there are many). In the case of Lupus, dsDNA antibody levels correlate with flares of the disease. Immuno-modulating drugs are the standard of care in these cases, including various steroids, methotrexate, and newer “biologics” which target specific inflammatory cytokines (especially TNF-alpha). 

      • Standard of care?? More like  ’care has no standard above minus 2′. Your  various steroids, methotrexate, and newer “biologics”  have not cured one person. They don’t even address the symptoms. Oh Oh! Silly me. They do make the pharmaceutical companies rich. When you get Lupus or RA or MS or any of them, you come back because until then, you are the one who doesn’t have the slightest idea what you are talking about. In the meantime, be sure to pay all your taxes – in the end, from a strictly financial point of view, the taxpayer is the one taking the biggest hit.

        2 weeks to come up with this answer! I know! It was the spelling that slowed you down, eh? Next time try to mix comprehension of topic with proper spelling.

  26. Dr. Costello is a fine ophthalmologist.  I know this because I was her patient.  I do not understand  what you mean by “a model of the human brains nervous system to trial tissue repair” but there are a lot of things I don’t understand.  So I will commend her.  But not for this publication.

    I was also Dr. Freedman’s patient at one time.  I am sure he has saved lives, which is one of the very good things that doctors do.  There are many neurological problems besides “MS”, some also caused by venous insufficiency.  The vascular and interventional surgeons must be part of the evaluation of this vascular therapy, which does not belong to any specialty or area of science.  In addition, I think the unwarranted tendency to believe everything neurologists say in the press, is dangerous, sometimes to human lives.

    As for radiation, many like me have already been exposed to too much radiation in hospital X-rays, and are not in more danger from that than they are from their “MS”.  It is a small price to pay for “massive” symptom relief.  People who do CCSVI procedures are very aware of the levels of radiation from the X-rays.  At least they are not like the “MS” Society, telling people that they should not even be tested with ultrasound, which is cheap and does not use any radiation.  The Society probably prefers the expensive MRI, with dangerous gadolinium dye injected into the patient’s blood.

    Besides, no matter how invasive and potentially destructive a treatment is, if an informed patient chooses it, it is no-one’s right to prevent it. I question the motives of people who resort to scare tactics.

    • Dr Costello is a neurological opthalmologist sciencist, that is why she has
      moved away from Ontario. The eye is part of the brain.

      Freedman’s work is not what normal doctors do, his work is absolutely groundbreaking
      and the only thing that has saved patients with progressive escalating ms. The patients
      would not be alive without the bone marrow treatment. They are all on deaths door, when
      being considered for the treatment,
      this is not for regular progressive MS patients. His treatment is for death door patients.

      As for the radiation, are you serious? You couldn’t possibly have any real med knowledge,
      MS patients have been exposed in the Cath labs to doses equivalent to 400 x-rays min
      and up. Why do you think the nurses and doctors are covered neck to toe in
      anti-radiation wear. Some patients have been through the procedure 3 or 4 times.
      This is a hugh risk for cancer down the road big time!

      Dr Machan is a IR in Vancouver and has been doing the UBC study, he is the lead
      speaker at many of the Neurovascular events with the other IR’s like Siskin etc.
      He is one of the lead advisors for some of the provinces.

      Alot more work has to be done and I hope the Cochrane scientists take up
      the challenge as it is so sorrily needed. Let’s see what they can recommend.

      • Perhaps patients have had the equivalent of 400 modern chest x-rays in the “cath lab”, or the place where the CCSVI procedures take place.  I am sure I had the equivalent of much more than that in my many X-rays when I was in hospital in 1966, when people weren’t so concerned about radiation, and when I was much younger and more vulnerable, when I was still growing.  Yes, I am serious.  But I am not so concerned as you claim to be, because I know I will die from my “MS” before I ever see any effects from that, or from my CCSVI procedure.  As I said, I question the motives of those who resort to scare tactics.  So I question yours as well.  People wear lead aprons in all x-ray labs, to make sure their children are not born deformed.   I have had a vasectomy, so I’m not as concerned as you claim to be. I have had many dental x-rays, some from a moving beam that circled my mouth.

        If anyone wants to read Cochrane they may see that placebo has never been shown to treat anything.  I think it is bad medicine to believe that it will. So use of randomized placebo in proving some drug or procedure betrays no “intention to treat”.

        Some kinds of bone marrow treatment, or Dr. Freedman’s ‘stem cell’ treatment, actually kill patients.  If one is at death’s door with “MS” they should be allowed the CCSVI procedure if they so choose, as many times as they wish. They are somehow allowed to take their chances on placebo. I had a heart attack while on placebo. Do cancer patients die from placebo treatments?

        Dr. Siskin whom you mention, performed my CCSVI procedure. I cannot walk yet but I am getting better at the piano, at my advanced age.

        I know of one lawyer and one other patient who were not at death’s door when they received the chemotherapy ‘reset’ and their own stem cells, from Dr. Freedman.

        I believe the CCSVI procedure has saved ‘death’s door’ patients, one of whom was bedridden, and could not sit up, eat, or talk. Now she can do all three. She had to be air-lifted out of Canada.

        Don’t tell me to try rehab. I just came back from using my walker to get around the machines at a fitness place. I might go there four times a week if the head of rehab had not been so unnecessarily keen on taking away my driving license.

      • Where on earth did you get all this?

        I will agree with you on one point - Freedman’s work is not what normal doctors do. 

  27. Venous backflow alias “Reflux in the brain” is a Bogeyman of CCSVI theory, monstrous imaginary figure used for threatening MS-patients. This legendary monster has no specific appearance, no evidence of existing, non explainable by any hemodynamic theory. He simply has no set appearance, but is just an amorphous embodiment of terror. Just endless repeating …. If you are not Liberated, the bogeyman will get you and eat your brain!

  28. … reviews the cases of five Canadian multiple-sclerosis patients who experienced complications ranging “from moderate to severe” after they traveled for treatment pioneered by Italian vascular specialist Paolo Zamboni—possible stent migration, venous thrombosis, possible cranial nerve injury, abdominal hematoma. ….
     
    There are four registrated death cases folowing Liberation treatment so far:

    Holly Shean, August 2009, Liberated by dr. Dake team, Stanford.
    Mahir Mostic, October 2010, Liberated by Dr Marcial Fallas CCSVI team, Costa Rica.
    Margo Larayne Oliver, March 2011, Liberated by Dr Marcial Fallas CCSVI team, Costa Rica.
    Maralyn Clarke, March 2011, Liberated in Newport Beach, CA

    and still counting….

    Are they counted in “from moderate to severe” cathegory?

    • Trying not to dignify this with a response of any kind, but why don’t you go and look up fatalities from cosmetic surgery and malign those doctors and disrespect the dead patients and their families and friends while you are at it?  And by the way, what is your name?

  29. I want to go on record protesting the misuse of this comments section by the user who calls himself “Malden Dj” using sarcastic language in the context of a pointless listing of the names of four deceased patients and two of their physicians.  If this magazine can reveal his identity to those doctors it should do so, and allow them to take appropriate action.

  30. Where are all the neuroogists with MS….Oh that’s right they’re off having CCSVI treatments as they can afford it after being paid all that money by the big pharmaceutical companies for prescribing poisons to us peasants.

  31. What a piece of sensational journalism! using words such as “unsurprisingly”, “little science”, and childish deflections that other drugs are expensive and can cause deaths too (ie. ok I wet my bed but big brother Johnny wet his bed 5 times last week). Few points here. That was a medical case report format, not a “study” per se. Most single-patient case report will have 2-3 credited authors who are involved in patient care and contribute to history gathering. Also Dr Hill is not a MS neurologist, he’s stroke neurologist who does not see MS patients. Stroke neurologists are vascular specialists of the brain. If you have a brain venous malformation, arterial stenosis, venous thrombosis, you’ll be seeing Dr Hill. And Dr Goyal is not even a neurologist. He’s an interventional radiologist who actually angioplasty/puts stents into carotid arteries and cerebral veins, and uses stents to retrieve clots in stroke. If CCSVI treatment is ever approved, Dr Goyal will see an exponential increase in his patients. The safety study you quoted is fine but it does not include followup of patients the next days after the procedure when they return to Canada. The point is to document any complications that develop after patients return home that are clearly related to the procedure but not included in prior short-term CCSVI safety studies. Patients have a right to know about these delayed complications.

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