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Liberation Procedure for Multiple Sclerosis

It has been very instructive, from a science-based medicine perspective, to watch the story of alleged chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS) unfold over the last three years. In 2009 Dr. Paolo Zamboni, an Italian vascular surgeon, published a paper in which he claimed that 100% of MS patients he investigated showed signs of blockage in the veins that drain blood from the brain, a condition he named CCSVI. This paper sparked immediate controversy. This controversy has been in the news again recently with the making public of the results of an observational study of the liberation procedure to treat CCSVI.

Existing research over the last half century strongly indicate that MS is primarily a disease of immune dysfunction (an autoimmune disease), resulting in inflammation in the brain that causes damage, specifically to the myelin, the insulation around  nerve fibers that allows them to conduct signals efficiently.  Zamboni is suggesting that MS is primarily a vascular disease causing back pressure on the veins in the brain and iron deposition which secondarily results in inflammation. This would be a significant paradigm shift in MS. It would also not be the first time such a dramatic shift in MS science has been proposed but failed in replication.

The MS community did not give much credence to the notion of CCSVI, but despite this there has been an incredible amount of research on the idea over the last three years (a PubMed search on “CCSVI” gives 103 results). Most of the research has simply attempted to replicate Zamboni’s findings, with mixed but generally unimpressive results. No one has found the 100% results that Zamboni originally reported. The studies have found a range of venous insufficiency in MS patients, down to 0%, but many finding results in the range of 20-40%. However, patients with other neurological disease and healthy controls have also been found to have similar rates of venous insufficiency. Some studies have found a positive correlation with MS, others have not.

Systematic reviews of CCSVI have mostly concluded that, while there is a weak signal there, it is buried in the noise of variability of study results, which seem to be dominated by variability in the techniques used. There are several ways to assess venous function (MRI scan, doppler studies, venography) and these produce different results. At this time the consensus of reviews seems to be that: Zamboni’s results have not been replicated, there may or may not be any association between CCSVI and MS, if there is any association it is only in a subset of MS patients and much smaller than Zamboni suggests. Some have suggested that perhaps the inflammation in MS (and in some other conditions) can secondarily cause venous anomalies, but this is incidental and not pathogenic in MS.

One recent study tied off the jugular veins in mice, which would be functionally analogous to severe CCSVI, and found no inflammation, changes to the blood brain barrier, or clinical signs – in other words, no signs or markers for an MS like response to a reasonable clinical model of CCSVI. This seems to undercut the plausibility of the CCSVI hypothesis.

The bottom line is that CCSVI seems to be yet another failed hypothesis attempting to change everything we thought we knew about MS.

Yet, over the last three years there has been significant interest in treatment of CCSVI on the part of MS patients, especially those who are not responding to proven therapy. This is understandable – any potential for a new treatment or cure would be of interest to a patient with a chronic debilitating disease.  The treatment is called the liberation procedure, and is essentially angioplasty to open up the veins draining the brain and relieve the alleged back pressure. Clinics are already offering the treatment to patients, despite the fact that CCSVI remains controversial at best and there is no convincing scientific evidence that the liberation procedure works.

Part of the CCSVI phenomenon is that it has been happening in the post social media world. Perhaps that is why the controversy has exploded and seems to be playing itself out so quickly. Part of this social media phenomenon is the divisive venom with which believers in CCSVI have attacked the medical mainstream. Conspiracy theories to explain away mainstream skepticism seemed to have already been in place and were taken out, fully formed, at the first sign of scientific skepticism.

Every online article about CCSVI is full of comments from supporters claiming that neurologists are engaged in a conspiracy to suppress CCSVI, that the government is complicit, and “Big Pharma” (of course) is behind it all. It has been instructive to listen to conspiracy theories about various medical treatments. Believers simply invent villains as needed, without any consistency of logic. In the Chronic Lyme controversy, for example, the treatment is a pharmaceutical – antibiotics. So Big Pharma can’t be the villain in that story, therefore believers simply made the insurance companies wear the black hats. At other times proponents of alternative treatments rail against mainstream medicine’s over reliance on invasive procedures, but now the treatment they want is an invasive procedure, so neurologists (who treat MS medically) are the villains, and the surgeons are the heroes. Somehow evidence and scientific plausibility gets left behind in all the conspiracy mongering.

The evidence, however, is what ultimately drives mainstream thinking about a disease and its treatment. In the case of CCSVI we now have the results of a large observational study. Zamboni’s group has also published a study of the liberation procedure, with weakly positive results, but given his role in this controversy few find the results compelling.

Dr. William Pryse-Phillips, a Canadian neurologist, followed the results of patients from Newfoundland and Labrador who went overseas to have the liberation procedure done. This was not a randomized trial, although the assessments were blinded. They followed 30 patients who had the procedure and 10 controls who did not. They found no benefits from the procedure – there was no improvement in standard measures of MS severity and no difference between treated and untreated patients. Further several patients developed clots in their jugular veins after the procedure. If the underlying concept of CCSVI is correct then these patients should have become significantly worse – but they didn’t.

Reports of the study also indicate that two Canadians have died from the procedure, but it was not clear if they were in this study or not (probably not, considering how it was reported). In any case, the point is that the procedure is not risk free. A risk vs benefit analysis of the liberation procedure for MS does not justify the treatment, which has dubious plausibility in addition.

In the US the FDA has issued a warning that the liberation procedure is not safe and has no proven benefit. In addition to rare deaths, there are other serious complications reported. There is no reliable statistics, however, on what percentage of patients are having serious complications.

Conclusion

CCSVI is a radical proposal seeking to fundamentally change our understanding of MS. Proponents of this new hypothesis have failed to meet the burden of evidence for such a radical change. Results of the burst of research that has taken place over the last three years display the typical variability and noise for a null hypothesis –  that the notion is not true. There is no convincing evidence that CCSVI exists, and now there is no convincing evidence that treatments based upon the CCSVI theory are effective. Further, these treatments are invasive and pose serious risks.

Despite low (but not zero) prior plausibility, the medical community has dedicated a significant amount of time and effort to doing serious research into the question of CCSVI. If it has any legitimacy, they want to know about it. They also want to back up their opinions with reliable evidence. Despite this, believers in CCSVI are enthusiastically weaving conspiracy theories to explain away legitimate scientific skepticism toward this new hypothesis.

Posted in: Neuroscience/Mental Health

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90 thoughts on “Liberation Procedure for Multiple Sclerosis

  1. This reminds me, sadly, of the autism/mercury kerfuffle. Minor prior plausibility, one doctor, patients “seeing results”, no mainstream acceptance once testing proves the idea ineffective/useless/wrong, huge public outcry of “conspiracy” for a long time afterwards. It’s sad and, I think, a testament to the general public’s lack of understanding of how basic science works and is evaluated.

  2. Jimmylegs says:

    I like the part when you point out the inconsistency of the conspiracy theorist villains. The common one is “Big Pharma” keeping us sick by using drugs or suppressing treatments; yet if the most effective treatment is a drug (in your example you said antibiotics), they find someone else.

    In my opinion, if your going to have a crazy idea at least stick to your guns so you’re consistently crazy.

    A good read as always Dr. Novella.

  3. Xanthippe says:

    I noticed that the article has been picked up by the CCSVI supporters that follow a CCSVI FB page. Now watch them come here in droves and prove Dr. Novella right by attacking him for being one of the “evil, greedy” neuros who are in the pocket of “Big Pharma” and therefore wants nothing but to keep MSers sick.

    I have witnessed their venom spewed on several MS-related forums against other MSers who don’t instantly become converts to their cause. To the supporters, CCSVI and its treatment is like a religion instead of a theory.

    It’s because of these true believers that I have NO HOPE that there will be effective treatments around when I become progressive and that I will see MS cured in my lifetime.

  4. streeves1 says:

    I am a person with MS for whom there is no drug. I have PPMS. I have had the CCSVI treatment, and have seen some improvements. I have a friend who has had the treatment (over a year ago) and she is almost totally symptom free. Could it be that she was misdiagnosed with MS? Could it be that many people who have had the treatment and have seen dramatic results were misdiagnosed? If so, what is wrong with treating the blocked veins and seeing if it helps?

  5. mr. grieves says:

    What sort of oversight exists in the U.S. for these type of procedures? I live in Canada and surgeons are prohibited from performing this procedure for this particular indication (outside of a clinical trial). It seems odd to me that clinics can offer a procedure like this, charging exorbitant fees, with almost no evidence of efficacy and a poor understanding of risk.

  6. Jimmylegs says:

    As a big big big disclaimer, I am in no way any medical personnel or such, so take what I say with a grain of salt please.

    It’s possible to be misdiagnosed with MS or any disease, but I do not know the rates of misdiagnoses or how well it is reported.

    However, asking what is wrong with doing the procedure to see if it will help is a bit easier to answer. First off any surgical procedure (hell even giving low dose APAP to people) has risk. The risk for benefit is evaluated and the go ahead or no go is based (partly I would assume) on that. For example if a procedure is very risky (prime anecdote is my grandfather had colon cancer and cirrhosis, any surgery to attempt to treat his cancer had a high chance of killing him so high that the hospital would not do it) and the benefit is poor, why would you do it?

    What I’m getting at is the effectiveness of the treatment is unknown so why do an invasive procedure with unknown benefit but known possible risks.

  7. WilliamLawrenceUtridge says:

    Streeves1, how do you know the changes were due to the liberation procedure? Don’t the symptoms of MS wax and wane? If the average number of episodes is 1.5 per year, that means on average there are going to be people who are symptom-free for more than a year simply due to chance (or for that matter, given the diversity of symptoms, simply attribute MS symptoms to something other than MS)?

    As for what’s wrong, people have died due to the procedure. If the procedure has no benefits beyond placebo but can make you stroke out, that’s not a very good risk:benefit profile. There are myriad explanations why people with MS report more or less symptoms and accordingly require very careful control. I don’t have much problem with “treating” blocked veins within the context of a clinical trial, but anything outside that is unethical (because you’re paying for a treatment of uncertain benefit, and if the liberation procedure is genuinely curative, you’re delaying its adoption as a form of treatment. It’s a frustrating disease, I have sympathy for you and your desire for an effective intervention – but that doesn’t mean CCSVI is effective.

    Incidentally, if an idiot named rustichealthy shows up, please ignore their suggestions to gobble down vitamins like they’re candy.

  8. Streeves1,

    First off, I am glad that you have perceived some improvement in your condition, and that your friend is mostly symptom free, & I wish you both the best for further improvement. My sister has PPMS and I feel for anyone with MS.

    I also know that people can and do move in and out of the subtypes of MS since assignment to subtypes is based on the progression and course of the condition and not on any test.

    Note that, as you are likely already aware, MS is often variable and “some improvement” is not inconsistent with MS or even primary progressive MS, and continued/significant improvement would likely essentially remove you from the primary progressive category by definition.

    From Wikipedia (not for your benefit, but for others reading) “The primary progressive subtype describes the approximately 10–15% of individuals who never have remission after their initial MS symptoms. It is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements.”

    Being mostly symptom free for a year or more as a natural course is also not out of the realm of possibility or even atypical of many MS cases.

    Again from Wikipedia: “The relapsing-remitting subtype is characterized by unpredictable relapses followed by periods of months to years of relative quiet (remission) with no new signs of disease activity.”

    There’s really no way to tell if the changes in your and your friend’s conditions are a result of the CCSVI treatment or due to more conventional explanations like natural remissions and variations/fluctuations of MS (and possibly some confirmation bias). You have only uncontrolled observations, anecdotes, and correlations that seem compelling to you.

    The consensus of clinical research shows no benefit and not insignificant risk. Risk w/ no known benefit is the reason not to just try it and see what happens. What happens may be death.

    For your misdiagnosis hypothesis to hold water, you’d need a few things first.

    To name just a few… First, plausibility aside, you’d need a small enough relevant subgroup to not significantly affect the results of the CCSVI studies done so far. That’s not necessarily a problem, but if the misdiagnosed subgroup were so small, it would be a huge coincidence for both you and your friend to end up both in that subgroup.

    Additionally, you’d need some plausible physiology/anatomy.neurology/etc to support the hypothesis that CCSVI can cause MS like symptoms in some individuals even if it isn’t the cause of those symptoms in the majority of persons diagnosed with MS. Laboratory testing with mice has failed to support such a hypothesis.

    Next, you’d have to first establish some objective way of identifying the members of that relevant subgroup before rolling out treatment since the treatment carries risk, and the risk should only be applied to those that may benefit. Without the ability to identify who may benefit from the treatment that carries a not insignificant risk, you’d be unnecessarily putting most of the patients you treat at risk with no possibility of benefit. (Assuming you have reasonably established the possibility of benefit for some subgroup at all)

    You ask us to consider your misdiagnosis hypothesis. I have and find it wanting. You assume the treatment is responsible for the improvements you have observed and are trying to find a way to reconcile that belief with the known facts regarding the outcomes of the clinical trials. I ask you to reconsider your approach and start by questioning whether the treatment must be the only explanation for the improvements you have observed.

  9. Big Sleepy Mac says:

    This is a very interesting summary of the contra view of CCSVI and the so called “Liberation Treatment”, i.e., Dr. Zamboni’s diagnostic protocol and venous angioplasty treatment. Unfortunately, it does repeat some of the factual errors found in other papers and I would like to take a moment to correct one of them. Dr. Zamboni has personally stated that he did claim he found that there was a 100% correlationship.

    Meta analysis of many independent studies has confirmed that the correlation is significantly high (higher than the 20-40% noted in this summary) although the results are dependant on the diagnostic equipment and the training of the person doing the test. Given the current meta analysis, I think we can safely discount the study that found 0 correlation and a study that found 100% as coincidence or seriously flawed.

    A specific double blind study is currently underway to determine the best practices in diagnosing CCSVI using different technologies and techniques as well as Dr. Zamboni’s protocol. Of course a high correlation does not prove a causal effect but it does raise a number of questions for further study. The fact that CCSVI has shown up in independent blinded studies with fairly high correlations in patients diagnosed with several other neurological diseases was startling and is being looked at separately.

    One thing the social media has done is allow thousands of MS patients to compare notes. One or two patients noting improvements in their quality of life might be convinced that it was the result of the placebo effect. Reports of improvements in over 2/3 of the patients can’t be attributed to placebo. So the research goes on to find the truth. It may indeed be a paradigm shift in MS. In the meantime for all those MS patients who have improved their standard quality of life test scores and those who haven’t – God bless – you are the pioneers!

  10. Scott says:

    Meta analysis of many independent studies has confirmed that the correlation is significantly high (higher than the 20-40% noted in this summary) although the results are dependant on the diagnostic equipment and the training of the person doing the test. Given the current meta analysis, I think we can safely discount the study that found 0 correlation and a study that found 100% as coincidence or seriously flawed.

    [citation needed]

    Reports of improvements in over 2/3 of the patients can’t be attributed to placebo.

    Due to selection effects, recall bias, etc. it most certainly can.

  11. streeves1 says:

    I am in no way a medical professional either, however, it is very strange to me that my improvements and the improvements of my friend started immediately after CCSVI treatment. I had had no improvement whatsoever before the treatment. In my simple, non-medical mind, if veins are clogged, then they are not working properly, so why not fix it? The reason I chose to have a treatment with “unknown benefit and known possible risk” is very simple! Any benefit I received or if I received no benefit at all would be better than knowing that there was no other treatment available for me and wondering for the rest of my life, “What if”!

    By the way, WilliamLawrenceUtridge, I do not have “episodes”. My MS is constantly progressing. I was diagnosed 4 years ago, and have gone from being an active, white water rafting, outdoors person who loved to play the piano, to being one who has no balance, walks with a walker for short periods, and is in a wheelchair for grocery shopping. That is why I chose CCSVI. Would I do it again knowing what little benefit I received? ABSOLUTELY!

  12. crljenak1 says:

    @Big Sleepy Mac

    When you say “Meta analysis of many independent studies has confirmed that the correlation is significantly high” I wonder if you are referring to This study:

    Association between chronic cerebrospinal venous
    insufficiency and multiple sclerosis: a meta-analysis

    Andreas Laupacis MD MSc, Erin Lillie MSc, Andrew Dueck MD MSc, Sharon Straus MD MSc,
    Laure Perrier MEd MLIS, Jodie M. Burton MD MSc, Richard Aviv MBChB, Kevin Thorpe MMath,
    Thomas Feasby MD, Julian Spears MD SM published in 2011 in CMAJ.

    This has been thoroughly discussed and elegantly discredited by Steven Novella in the Neurologica Blog (http://theness.com/neurologicablog/index.php/a-ccsvi-meta-analysis/). To summarize Dr. Novella’s thoughts, I will quote one line, “In other words – the data are all over the place, making a meta-analysis all but worthless.” Please refer to the complete blog post for a detailed and excellent dismemberment of this study.

    So I guess I’m waiting to see what “factual errors found in other papers” you refer to.

    In reality, CCSVI and its treatment became a huge deal because there are thousands, possibly hundreds of thousands of physicians who have the technical skills to perform the angioplasty of the veins that is the treatment for CCSVI. Many of them want to do something, that will help these patients. I happen to be one of them. Others, are driven by the big dollars to be made by angioplasty procedures which often have to be repeated in a condition known to have many years as its natural course. In addition, we have a patient population desperate to try something, anything, because they suffer from a debilitating disorder that often progresses in spite of their own efforts and best efforts of the physicians treating them.

    Unfortunately, there is no real science behind using venous angioplasty to treat CCSVI in patients with Multiple Sclerosis. No-one has been able to duplicate Dr. Zamboni’s results, or even come close. You state, “Reports of improvements in over 2/3 of the patients can’t be attributed to placebo.” I would love to see the properly designed controlled study in which those results occurred. It doesn’t exist. You also mentioned social media. There has never been a more efficient method of disseminating complete nonsense to so many people in the history of mankind. You might ask, why not offer it to patients who have no other options? I answer because we as a society cannot afford the many millions of dollars in payments to angioplasty balloon manufacturers, hospitals, and physicians that would ensue for this procedure that has no data to support it. In addition, and probably more importantly, the procedure is not risk free and deaths have been described related to it.

    I don’t think anyone can summarize the data available on this better than William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health when he said, “Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm

    I would love to be wrong on this. I would love for this to be a real treatment for this devastating disease. I don’t think angioplasty for CCSVI is going to be that treatment, however. I am perfectly willing to be persuaded, indeed, I want to be persuaded by well designed controlled studies. Until that study or those studies appear, we need to maintain vigilance against well meaning, or cynical woo being passed off as hope for desperate patients.

  13. steeves:

    “In my simple, non-medical mind, if veins are clogged, then they are not working properly, so why not fix it? The reason I chose to have a treatment with “unknown benefit and known possible risk” is very simple! Any benefit I received or if I received no benefit at all would be better than knowing that there was no other treatment available for me and wondering for the rest of my life, “What if”!”

    Along with “If it ain’t broke, don’t fix it”, I will be add “If it’s not currently known to be causing problems (and fixing it carries any significant risk), consider it not broke & see previous rule.”

    There’s also the whole risk of death thing. Non benefit with death as the outcome seems less desirable to me than wondering for the rest of my life if an implausible and unproven treatment might have made a difference. That’s a gamble I’m not inclined to make without better scientific support.

    If the benefit you perceived from the treatment was so little, why advocate a procedure with a not insignificant risk of death as an outcome, and how can you be sure that little benefit was from the treatment or was even an actual, objective improvement? You seem to have gone from “Hey it worked for me” to “It didn’t really make much difference to me, but it was worth trying and something is better than nothing.”

    Regarding the timing of the improvements, I can’t even speculate specifically about your cases since I have next to no actual information regarding the before and after, but immediate improvement after treatment is often more consistent with placebo responses/factors that objective improvements. Effective medical treatment often takes a while to to take full effect.

  14. >”Effective medical treatment often takes a while to to take full effect.”

    For instance eliminating that which is causing damage usually does not immediately reverse the damage already done, despite what may have been shown on House, MD.

  15. fledarmus1 says:

    @ Big Sleepy Mac – a lot of people saying “It helped me” does not make a study. It makes an interesting hypothesis on which to base a study. Now you need to find a reliable, objective measure of a person’s disease state before treatment, carry out a test of the procedure on a sufficiently large population, and determine for the population as a whole whether the objective measure has improved more than it has for the untreated population. THAT would be a study. Not a definitive study, but at least a start.

    There are ways of quantifying even such things as “quality of life”. They don’t usually involve things as nebulous as tweeting, ‘oh yeah, I feel way better than I did before the surgery,’ even if a lot of people are doing it.

  16. Big Sleepy Mac says:

    mr. grieveson said on 13 Jun 2012 at 12:03 pm

    “What sort of oversight exists in the U.S. for these type of procedures? I live in Canada and surgeons are prohibited from performing this procedure for this particular indication (outside of a clinical trial). It seems odd to me that clinics can offer a procedure like this, charging exorbitant fees, with almost no evidence of efficacy and a poor understanding of risk.”

    The US FDA recently notified physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption. Health Canada has announced funding for a stage I/II trial in Canada. Risk levels for venous angioplasty, which is done routinely for other conditions and based on an estimated 30,000 CCSVI procedures that have been done world wide have been compared to the risk of a gall bladder operation.

    The double blind placebo controlled study underway in Albany, New York has FDA IDE approval. The province of Saskatchewan is sending 86 of their MS patients to take part in that study and Yukon residents diagnosed with multiple sclerosis (MS) are being invited to apply for spots available in the “liberation treatment” clinical trials in Albany, New York. Several spots in the clinical trial have been secured for Yukon residents who are found to be eligible, based on criteria set by the clinical trial hosts. Also, the province of New Brunswick may reimburse MS patients up to $2500 if they have the procedure outside the province (caution if you live in New Brunswick – check the rules very carefully before making a final decision).

  17. VinceD says:

    I’ve been following this topic for ~2 years. This is how I came upon SBM. A great resource. Some brief background, since I’m a lurker and not a poster: I had a family member diagnosed with MS ~10 years ago. Since then, I’ve been following developments in treatments. I come to this site a lot to vet reports I see on line. The initial reports of CCSVI and the venoplasty treatment seemed unbelievable… I agree with Dr. Novella, the unbelievable reports are still unbelievable.

    That said… @ Dr. Novella… Don’t skirt around the role Neurologists and Big Pharma have played in this situation getting out of control…. http://seattletimes.nwsource.com/html/businesstechnology/2014957268_apusmerckseronosettlement.html?syndication=rss
    This story broke at the height of the CCSVI discussion. Big Pharma and Neurology certainly didn’t help themselves. Behavior like this doesn’t make the conspiracy theorists jump too far to arrive a their conclusion.

    @Karl… Regarding risk of death, keep in mind, the latest and greatest MS treatment, Natalizumab, comes with this risk as well. As of March, there were 212 cases of PML and 46 confirmed deaths. Certainly more than reported for venoplasty. I’m not thinking those 46 people got to see much of the benefit from the product with the best results out of double blind testing.

    In general, MSers don’t have the best prognosis. You simply follow the course of treatment prescribed by your Neuro and hope it works. Each case is different and each patient has their own individual set of issues. Insurance companies don’t like to foot the bill for MRIs, so you need to hope your Neuro does an accurate EDSS assessment, so you know what kind of progression the disease has. Symptom management is difficult and every pill has a myriad of side effects. There are MSers who have eschewed treatment altogether as the side effects of treatments were more debilitating than the disease itself. Where we are today with CCSVI is neither difficult believe nor understand. Much of this is guided by emotion, and a feeling of hopelessness against a disease for which there is no known cause or cure.

  18. Harriet Hall says:

    “it is very strange to me that my improvements and the improvements of my friend started immediately after CCSVI treatment.”

    Correlation doesn’t equal causation. That is a difficult lesson that history has taught us over and over but that still is hard to accept in cases like this.

    It’s easy to understand your desperation and your willingness to try anything. I don’t blame you for trying it or for believing it helped you; but experiences like yours don’t constitute credible evidence that CCSVI works, and they are not a basis for recommending it to others. At this point, you are too involved to consider the facts and the evidence objectively. I’m glad you’re doing better, but as an outsider able to look more objectively at the evidence, I see no reason to give CCSVI the credit.

  19. Big Sleepy Mac says:

    fledarmus1on said 13 Jun 2012 at 5:09 pm

    “@ Big Sleepy Mac – a lot of people saying “It helped me” does not make a study. It makes an interesting hypothesis on which to base a study. Now you need to find a reliable, objective measure of a person’s disease state before treatment, carry out a test of the procedure on a sufficiently large population, and determine for the population as a whole whether the objective measure has improved more than it has for the untreated population. THAT would be a study. Not a definitive study, but at least a start.”

    Your absolutely right! That probably triggered the initial studies. My understanding is that most if not all of the scientific studies currently underway in North America are using the MSQLI (MS Quality of Life Inventory) test before and after. The MSQLI is a battery consisting of 10 individual scales providing a quality of life measure that is both generic and MS-specific. These are the same tests that Neurologists use for their MS patients.

    @Scott I am trying to find the citation you requested. Initially I thought it was in the Systematic reviews of the evidence regarding chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis – Summary of the First Report for CIHR Expert Panel, September 23, 2011 to the Canadian Federal Minister of Health but it gave a more general conclusion “Ultrasound: 8 studies2-9 compared the frequency of CCSVI diagnosed with ultrasound in MS patients versus HC, and 4 studies compared MS patients with OND2,4,7,9. CCSVI was diagnosed more frequently in patients with MS than in HC [odds ratio (OR) 13.5, 95% confidence interval (CI): 2.6-71.4], but there was extensive heterogeneity. There continued to be a statistically significant association in the most conservative analysis, which involved removing Zamboni’s initial study and adding a study in which no CCSVI was found in any patient (OR 3.7, 95% CI: 1.2-11.0). The 4 studies that compared MS patients and OND patients found a higher frequency of CCSVI in MS patients, but this finding was not statistically significant (OR 32.5, 95% CI: 0.6-1775.7); removal of Zamboni’s study resulted in an OR of 3.5, 95% CI: 0.8-15.8). None of the studies that used ultrasound reported the success of blinding of the technicians or radiologists.” This report was the basis the Federal Government announcing funding for the Stage I/II clinical trials.

    The number I recall was a correlation of 55% and upwards between MS patients and patients diagnosed with CCSVI, I am still looking and will provide a link when I find it again.

    Interesting report published in the Functional Neurology Journal about “Venous angioplasty in multiple sclerosis: neurological outcome at two years in a cohort of relapsing-remitting patients” The report is a follow-up for two years on 29 of Dr. Zamboni’s patients. Significantly lower EDSS scores and relapse rates in 25 of the patients.

  20. Big Sleepy Mac says:

    Correction on my previous post, I believe the test reference should be to EDSS scores and not the MSQLI tests. Sorry for my confusion.

  21. George MAC says:

    Interesting that this article has no reasonable scientific backing mentioned. All are generalizations. Science is based on specifics. So, what are the negative studies against the theory of CCSVI? How were they conducted? On whom? By which methods? These are all part of the scientific methods. Maybe you have not heard that the use of ultrasound to identify CCSVI is operator dependent and most of the negative studies used this method and where not trained in vascular abnormalities. Conspiracy theory? Just the facts. From the article, it sounds like the conspiracy theories are on the other side, including, “How do we know that these people actually have MS?” So, lets stick to science. Do you know what the actual safety to benefit ratio is? Somewhere over 30,000 have had treatment for CCSVI. Two or three died, though not always a direct result of the procedure. So far, in the year that it was introduced, a new oral drug for MS has resulted in six deaths. I was almost one of them. Efficacy? Okay, the jury is still out as far as a blinded study, but there are many records and study that have shown improvements and this is data gathered from thousands. A scientific question is what are the measurements for improvement? No drugs have shown improvements in conditions yet. The only measure of success is the relapse rate, and yes the drugs have some success in this area. However, there is no proof that it actually slows progression. So, if you attack the CCSVI theory as not supported by facts, you have not done your research. I want to see truly scientific evidence from peer reviewed journals, where the methods and parameters can be examined. ‘Opinion pieces’ are not scientific. I have studied how to conduct research and have conducted research. The methods and structure of any study need to be sound and open for others to examine. This is part of any scientific journal.

  22. George MAC says:

    Interesting that this article has no reasonable scientific backing mentioned. All are generalizations. Science is based on specifics. So, what are the negative studies against the theory of CCSVI? How were they conducted? On whom? By which methods? These are all part of the scientific methods. Maybe you have not heard that the use of ultrasound to identify CCSVI is operator dependent and most of the negative studies used this method and where not trained in vascular abnormalities. Conspiracy theory? Just the facts. From the article, it sounds like the conspiracy theories are on the other side, including, “How do we know that these people actually have MS?” So, lets stick to science. Do you know what the actual safety to benefit ratio is? Somewhere over 30,000 have had treatment for CCSVI. Two or three died, though not always a direct result of the procedure. So far, in the year that it was introduced, a new oral drug for MS has resulted in six deaths. I was almost one of them. Efficacy of treatment for CCSVI? Okay, the jury is still out as far as a blinded study, but there are many records and study that have shown improvements and this is data gathered from thousands. A scientific question is what are the measurements for improvement? No drugs have shown improvements in conditions yet. The only measure of success is the relapse rate, and yes the drugs have some success in this area. However, there is no proof that it actually slows progression. So, if you attack the CCSVI theory as not supported by facts, you have not done your research. I want to see truly scientific evidence from peer reviewed journals, where the methods and parameters can be examined. ‘Opinion pieces’ are not scientific. I have studied how to conduct research and have conducted research. The methods and structure of any study need to be sound and open for others to examine. This is part of any scientific journal.

  23. Big Sleepy Mac says:

    Really George we are not related but I agree with you and unfortunately good research takes time. The frustration comes from the patients and the caring doctors who worry about the 400 MS patients that die each year in Canada and the proportionally larger number that die in the US. For them time is running out.

  24. Scott says:

    So, what are the negative studies against the theory of CCSVI? How were they conducted? On whom? By which methods?

    Did you follow the links in the post? They lead to the citations for the statements made.

  25. WilliamLawrenceUtridge says:

    That said… @ Dr. Novella… Don’t skirt around the role Neurologists and Big Pharma have played in this situation getting out of control…. http://seattletimes.nwsource.com/html/businesstechnology/2014957268_apusmerckseronosettlement.html?syndication=rss

    This story broke at the height of the CCSVI discussion. Big Pharma and Neurology certainly didn’t help themselves. Behavior like this doesn’t make the conspiracy theorists jump too far to arrive a their conclusion.

    The fact that a drug company bribed some doctors to promote one of their drugs does not mean CCSVI works. Drug companies are often bastards, but that fact is completely independent of the effectiveness of a surgical intervention. This news story is evidence of Merck inappropriately promoting a drug, it is not evidence that CCSVI works, or that Big Pharma is suppressing it. Find me documents or a news story showing Big Pharma bribing doctors to criticize a procedure that has been proven to work, then you’ve got a smoking gun. This is a dirty butterknife.

    @Karl… Regarding risk of death, keep in mind, the latest and greatest MS treatment, Natalizumab, comes with this risk as well. As of March, there were 212 cases of PML and 46 confirmed deaths. Certainly more than reported for venoplasty. I’m not thinking those 46 people got to see much of the benefit from the product with the best results out of double blind testing.

    What’s the denominator though? How many people were on the drug, and how many benefited without developing PML or dying? Drugs have risks, but they also have benefits. CCSVI, to date, appears to have only risks.

    There are MSers who have eschewed treatment altogether as the side effects of treatments were more debilitating than the disease itself. Where we are today with CCSVI is neither difficult believe nor understand. Much of this is guided by emotion, and a feeling of hopelessness against a disease for which there is no known cause or cure.

    Yes, this is the tragedy – there is no cure, and the treatments are far from perfect. But throwing a lot of money (public or personal) at an unproven procedure just exacerbates the problem rather than helping anyone. I see Zamboni as behaving more than a little unethically in this situation by publicizing it before proving it. I know why he did it – his own wife has MS and he is also desperate for a cure. But desperation and emotional involvement makes for bad science. The road to hell is paved with the best intentions, particularly when you intend to help someone you love.

    Really George we are not related but I agree with you and unfortunately good research takes time. The frustration comes from the patients and the caring doctors who worry about the 400 MS patients that die each year in Canada and the proportionally larger number that die in the US. For them time is running out.

    And having them undergo an unproven treatment with no demonstrated benefits but a risk of stroke will just add to that number, for no good reason. It’s unfortunate, but desperate patients (and doctors, families, etc.) does not make a cure any more likely.

    Hope is good, but false hope is poison.

  26. VinceD,

    “Regarding risk of death, keep in mind, the latest and greatest MS treatment, Natalizumab, comes with this risk as well. As of March, there were 212 cases of PML and 46 confirmed deaths. Certainly more than reported for venoplasty. I’m not thinking those 46 people got to see much of the benefit from the product with the best results out of double blind testing. ”

    Yes, but medicine is about the balance of risk and reward. Presumably those 46 people do not represent the majority of people who used Natalizumab.

    You seem to miss my point entirely. I’m not saying any treatment with a potential risk of death should be discarded. The key is Natalizumab has some compelling, significant demonstrated benefits to weight the risks against. The liberation treatment has no demonstrated benefit. If 46 people had died as a result of taking a drug, and there was no demonstrated benefit of taking the drug, then its use should be probably be discontinued.

  27. lifeback says:

    As someone who, in July 2010, was mere months away from a wheelchair due to the onset of aggressive secondary progressive MS, I am happy to report that CCSVI balloon therapy WITHOUT STENTS, gave me my life back! I did the DMD route for over 15 years whilst continuing to deteriorate consistently until the aggressive downfall in 2009/10 and found immediate and long-lasting results on the table while undergoing the CCSVI procedure in July 2010. I had many more autonomic functions return post-procedure as well.

    I am happy to report that almost 2 years later, I am still 95% better than I was when I entered the OR for the CCSVI procedure! It may not be a cure, but it is the best treatment for autonomic symptoms of MS I’ve seen in my over 26 years of struggling with them.

    Stop the turf wars & allow this to be studied properly and allow those for whom this treatment makes sense get on with their fulfilling lives!

  28. Xanthippe says:

    @George MAC: “From the article, it sounds like the conspiracy theories are on the other side, including, “How do we know that these people actually have MS?” So, lets stick to science.” Where in his article is Dr. Novella questioning the diagnoses of MSers? And operator bias also has been noted in the positive studies as well as the negative ones. The amount of pressure the operator uses seems to influence whether or not vein narrowing is found. This is why there are a number of CSSVI studies focused primarily on finding a more objective and reliable technique of detection than ultrasound. For a while, it was venography that was the gold standard, but I don’t see it mentioned as much nowadays.

    @Big Sleepy Mac: “The frustration comes from the patients and the caring doctors who worry about the 400 MS patients that die each year in Canada and the proportionally larger number that die in the US. For them time is running out.” Are you implying that venoplasty will actually save the lives of MSers?

    @WilliamLawrenceUtridge: “I see Zamboni as behaving more than a little unethically in this situation by publicizing it before proving it. I know why he did it – his own wife has MS and he is also desperate for a cure.” His wife is not his only conflict of interest. Zamboni also submitted a patent for an ultrasound machine made specifically for CCSVI detection years before he announced its discovery. Furthermore, he failed to declare this CoI in any of his published CCSVI studies: http://news.nationalpost.com/2011/04/02/zamboni-says-no-con%EF%AC%82ict-in-applying-for-ms-patents/

    The most interesting thing I find about Zamboni’s recent study is that he only focused on relapsing-remitting MSers. Is there a reason why he did this as Zamboni has included progressive MSers in his past studies (ie, “Chronic Cerebrospinal Venous Insufficiency in Patients with Multiple Sclerosis”)? Also, in a 2011 pilot study, Zamboni had the relapsing-remitting participants stay on their DMTs after the surgery (if they were on one already). Did he require the same with the 29 relapsing-remitting MSers in his recent study?

  29. WilliamLawrenceUtridge says:

    @lifeback

    Stop the turf wars & allow this to be studied properly and allow those for whom this treatment makes sense get on with their fulfilling lives!

    Criticizing the lack of evidence base for CCSVI isn’t a turf war, and medical procedures should be based on what is proven, not on what “makes sense”. CCSVI doesn’t really “make sense” within the context of MS. The whole point of the objections to Zamboni’s “press release” medicine is that it didn’t allow the treatment to be studied, it just went public. If Zamboni has actually found a new etiology and treatment, going to patients first muddied the waters. If it’s not, if it’s just a placebo procedure, then Zamboni has blood on his hands from everyone who tried the “liberation procedure” and ended up dead of a stroke.

    Keep in mind that science test things, it does not “prove” them. If CCSVI is real, science will find out. But if a serious scientific study of a phenomena always includes the null hypothesis – the possibility that there may not be a real effect. If you approach CCSVI with the idea that it’s true, an absolute cure, and refuse to accept any negative evidence – you’re not doing science. You’re pretending to do science to justify a conclusion you already hold.

  30. deniseb says:

    The problem is not with wanting to look at CCSVI scientifically….the problem is with want to pick and choose and only look at things that CCSVI treatment has no impact on. Restoring proper blood flow will help, but it certainly willnot undo cerebral damage that has already been done…and those who want this treatment don’t expect that. It has a 60% chance of offering some improvement in Heat Intolerance and Fatigue (which in my case are my most debilitating symptoms – thankfully not much neurological damage has been done yet) and half of those will experience significant improvement. The traditional drugs (CRABs) can only offer at best about a 30% chance of MAYBE slowing the progression of the illness and little to no hope of any improvement. The newer MS drugs can kill – more than 50 of the 95000 on one have died and nearly 250 have developed a severe and debilitating braing infection. 35000 on the new MS pill and 15 deaths within 24 hours of the first dose; I have only ever heard of 3 or 4 deaths of the approximately 30000 people who have been treated for CCSVI and at least one of those may have not happened if he had been given treatment for the blood clots that formed in Canada instead of having to fly when he knew he had a clotting problem. Any doctor can tell you he should not have flown in his condition. Another of the deaths may have been due to a pre-existing condition rather than to CCSVI treatment. Balloon angioplasty is a decades-old routine and SAFE procedure (it is safer than liposuction which has no medical benefit but IS allowed in Canada). Dr Modato, et. al. published a study in January of this year that found only a 1.6% risk of any serious complication and more than half of those involved stents, which is obviously going to increase the risk of complications. That study followed 257 procedures. Another year-old study by a group of neurologists in Poland found “clinically significant improvement” in heat intolerance and fatigue remained six months after CCSVI venoplasty as well as improved quality of life – here is the link: http://www.ncbi.nlm.nih.gov/pubmed/21876515 (this is just the abstract for the study). I personally know more than ten people who have been treated and some are still experiencing benefits more than a year post-procedure. Some have been treated more than once and some who were treated have gone back to close to where they were before treatment…but many more experience some lasting results than don’t and not one of them says they regret having the procedure done. I know of at least one person who no longer has MS. Before CCSVI treatment they had the MS label and now the neurologist can find no evidence of MS. There are over 100 illnesses that are mis-diagnosed as MS, so that may well be the case in her situation. What if that is the case with nearly 30% of the people who have the MS label? The placebo effect can only influence the outcome for a relatively short period of time and I know it cannot explain any of the benefits that have lasted for a year for some people. There is something to this that needs to be looked at and maybe if nothing else, it will be able to remove some symptoms that have been erroneously attributed to MS. I desperately want to get this treatment, even if I have to pay for it. I was just diagnosed with MS in 2007; but I believe I have had CCSVI since my mid-teens, which is when my heat intolerance started. I have been unable to work for more than 2 years because of my fatigue and heat intolerance – 20 degrees is now getting too hot for me! If CCSVI treatment could allow me to go for a walk with my daughter on a nice summer day that would be more than enough for me; if it gave me more I could have a life again! Why are so many so against us wanting that? Why do so many doctors completely disregard the symptoms that CCSVI treatment helps? As many as 95% of people with MS experience fatigue as a symptom and heat intolerance is so prevalent that at one time they used a ‘hot bath test’ to diagnose MS. I would love to hear a logical, acceptable explanation why then a treatment that can alleviate these symptoms is dismissed by the medical community before it is even considered? I don’t like to talk about ‘Big Pharma’ and medical ‘turf wars’ and as a result sound like a conspiracy theorist; but I have yet to find any other explanations that make sense. If I am one of the lucky ones for whom CCSVI treatment can give significant improvement in my quality of life I want to find out, and incidentally I would love for an open-minded medical community to poke and prod all they want to figure out how it helps and why; but I am being denied even the possibility of getting treated and benefiting other Canadians with MS. I have researched this in depth and thoroughly support this treatment. The potential benefits of this treatment almost completely negate any possible dangers and ARE completely negated by the risks of doing nothing-steadily spiraling into increasing disability and finally death, most likely from aspirational pneumonia. Angioplasty is no more dangerous than having a wisdom tooth pulled, and far safer than breast augmentation or liposuction which require anesthesia. Why are we not allowed access to it even as an elective procedure? I would happily pay the $2-5000 it would cost to have it done here in Canada, but instead I have to pay more that $10,000 to go to the US to get treated! And all of that valuable data that could be collected by Canadian doctors will be lost!

  31. VinceD says:

    William, I agree that drug companies allegedly bribing neurologists does not prove that CCSVI works. I think I was pretty clear in stating that I’m in agreement with Dr. Novella on his position. My point in bringing this up the scandal (alleged, as all court docs are sealed with the settlement) to Dr. Novella is that neurologists and pharmaceutical companies are not doing themselves any favors. When an MS patient reads this story they might think, “hmmm, maybe there is something to it… maybe those guys are right about big Pharma and neurologists not having my best interests in mind.” Seriously, if you want people to believe you (and your evidence), don’t give them reasons not to trust you. It is that simple. Whether the two things are related or not doesn’t really matter for many… For someone who doesn’t have the time or ability to investigate, the train has left the station, their mind has been made up. If you are dealing with an emotional issue, this may even be magnified. I’ve worked for years in sales and marketing (I’ll freely admit my bias)… Many people don’t look at the data (unfortunately), and appearance, while not everything, is something. We sales guys have data on that… trust me ;)

    Karl / William, I agree there are risks with all of these treatments and that the risk and reward must be looked at objectively. I learned this first hand from sitting with neurologists, and my family memember, discussing the course of treatment. Karl, I did miss your point, and would agree that Natalizumab does have significant demonstrated benefits. That said, I’m not sure that all the data is in on the risk of death. They seem to still be trying to get their arms around the PML thing.

  32. Big Sleepy Mac says:

    Unfortunately Michele Findlay was unable to log into this site and register so, with her permission, I am posting this for her as I believe she makes some very valid points:

    “An open letter to Steven Novella of Science Based Medicine 13/06/2012
    by ms-ccsvi-uk on Thursday, 14 June 2012 at 07:15 ·

    If you want to read what Steven has said in criticism of CCSVI treatment you need to click here

    I would have made a comment on the site, unfortunately it is preventing me from registering, so my comments appear here.

    An answer to the criticism of what Steven Novella calls the Liberation Procedure

    Open minded dialogue is what is needed.

    Re: Mouse model experiment. From what I understand in humans the jugular veins are the veins that drain the brain when we are supine… as mice are supine most of the time you would imagine that their system would function somewhat differently to ours. So is it not difficult to compare one with the other? What other draining veins do mice have? Were alternative ligations done to see what would result?

    Re Immune system theory. There is no doubt that there is immune system involvement in MS but the point is that it is doing the job it is meant to do and that is to clear up dead or dying cells. The auto-immune theory has not been proved and there is convincing recent evidence to suggest that the immune system does not get involved in the lesion formation until after oligodendrocytes have died as the result of some as yet uncertain activity in the newly forming lesion. See the research done by Prineas and Barnett. There is also significant, long historical evidence of lesions being venocentric. This evidence goes back 150 years and should not be dismissed because it does not sit comfortably with the modern theory. Recent research supports the idea that circulation in the brain may contribute to the problem. Marcello Mancini et al, recently measured the cerebral circulation time in a number of patients and controls and found: The longest and average CCTs were substantially prolonged in patients with MS compared with those in control subjects…’

    Miracle cures: It was quite clear to me that there were no promises of miracle cures. We all take a chance whenever we accept treatment for our condition. If you go down the drug route you are vulnerable to serious side effects, even death at a much higher rate than the side effects of CCSVI treatment. And the cost to the country is actually between three and four times the cost of angioplasty. True the individual does not pay, but everyone else does. And as with CCSVI treatment, drug treatment is not uniformly beneficial, some would say that the benefits are not significant enough to warrant the cost or the risks (see risk sharing schemes evaluation).

    If some advocates of CCSVI treatment sound like zealots then maybe we should examine the reasons why that might be. The long history of pathological evidence for venous involvement in MS should be re-examined with the technology available now. And yet it is vilified, ignored and side lined. The frustration of the people who cannot have a dialogue with specialists who are in a position to do this research is what drives them to extremes of emotion and rhetoric.

    The role of the media and bloggers in escalating the heat in these exchanges through the use of words such as Liberation, miracle, controversial, dangerous, snake oil; this is detrimental to serious research and enquiry into this theory. Comparing it to bee sting therapy or goat serum is neither fair not helpful. Look into the evidence, there is a lot of it around and then design a science based study before dismissing this theory as invalid.

    The role of Pharmaceutical industry: at the recent MS Life conference in Manchester a parmaceutical representative addressing the audience of people with MS referred to them as the ‘market’. This is what pwMS are seen as, the sad thing that transpires from a little research is that in this day and age the cost of marketing the drugs they produce actually exceeds the cost of developing them… This industry has a lot to answer for and a lot to lose. Marc-Andre Gagnon recently spoke about this at a recent business conference in Toronto: Veblenian Analysis of Big Pharma’s Intangible Assets: Capitalizing Medical Bias

    So let us try to look at the alternatives to the auto-immune theory which to be quite honest, has not delivered substantial improvements in 50 years of trying, with an open mind and a serious aim of understanding Multiple Sclerosis better.”

  33. Jimmylegs says:

    “use of words such as Liberation,…”

    It should be noted that Dr. Novella did not make up this term, it is the name of the procedure so people that write or talk about it will use that name.

    “addressing the audience of people with MS referred to them as the ‘market’.”

    This taken at face value seems like a negative or mean way to say patient or person. However, we are all considered the “market” for gas, food, water, electricity, etc. All the wording meant was the MS drugs are marketed to people with MS, which makes sense. Why would someone with out MS buy MS drugs?

  34. @streeves, with all due respect, you come here advocating a procedure with no scientific credibility, and you claim you benefited from it, and yet you say your symptoms are progressing. … … … …

    It sounds like you are in denial, and don’t want to admit to yourself that you spent money on and underwent an unnecessary procedure. I can understand this, considering the fact your MS is progressing and your quality of life is simultaneously becoming worse. That’s got to be a horrible and difficult reality to cope with.

  35. @”Michele Findlay”, the “alternative” to the very well understood autoimmune basis of MS has been looked at, and we have found no convincing evidence to establish chronic cerebrospinal venous insufficiency as a major factor in the disease. Likewise, we don’t find that people who undergo the dubious and dangerous treatment benefit from it.

    So… At what point do you say “Ok, I was completely wrong, it was worth a shot, let’s move on.” ?

  36. WilliamLawrenceUtridge says:

    Re: Mouse model experiment

    Researchers aren’t stupid, they realize mice and humans are different (and since thalidomide, for drug trials at least there must be multiple animal models before moving to humans). Had this worked or not, it would be a single point in favour or against, not a final death knell.

    Miracle cures…We all take a chance whenever we accept treatment for our condition.

    At this point, CCSVI is a proposed treatment, that has yet to demonstrate a clear and consistent benefit.

    If you go down the drug route you are vulnerable to serious side effects, even death at a much higher rate than the side effects of CCSVI treatment. And the cost to the country is actually between three and four times the cost of angioplasty. True the individual does not pay, but everyone else does.

    The drugs, however, have been through multiple models and randomized controlled trials to demonstrate benefits, which the liberation procedure has not. Those side effects come with recognized benefits, while the benefits for CCSVI are still merely asserted, not demonstrated. If it works, then five years from now we should know and the treatment should become standard. If, however, it does not work, then every single person who died due to the procedure died for absolutely no benefit. This goes for the cost as well – if it’s $1000 for angioplasty or $5000 for drugs, right now one of those is demonstrated effective. The other, thankfully, isn’t paid for by most of the Canadian provinces or (I believe) health insurance providers. Again, five years from now we’ll either be paying for CCSVI procedures out of the public wallet, or we’ll recognize we might as well be burning the money.

    And as with CCSVI treatment, drug treatment is not uniformly beneficial, some would say that the benefits are not significant enough to warrant the cost or the risks (see risk sharing schemes evaluation).

    But again, and I know I’m repeating myself – drug treatment is not uniformly beneficial but at least in aggregate there is evidence of benefit (PML for natalizumab for instance, is a relatively uncommon side effect but still caused the drug to be pulled from the market once it became apparent it was not a one-off). CCSVI, again, has not yet been proven to work. Patient testimonials are suggestive, they are not definitive; they are not proof. If the procedure is as effective as everyone claims it to be, the signal should emerge from the noise relatively quickly.

    The long history of pathological evidence for venous involvement in MS should be re-examined with the technology available now. And yet it is vilified, ignored and side lined.

    Not really, doctors and related agencies are merely waiting for the results of clinical trials before embracing it. Except for the unscrupulous assholes offering the treatment, for a pretty penny, in Caribbean and Eastern European hospitals.

    Anyway, the active involvement and careful research – which to patients may look like equivocation – is necessary to avoid wasted time and conservation of scarce resources (money, researchers and even patients as subjects in the myriad trials run to test interventions). The research is being examined, carefully and methodically. And it might be negative. Patients may see conspiracy, I’m more inclined to see it as false hope being squashed. The regular problems of research, hope and despair are exacerbated by the involvement of social media – they are excellent resources when genuine results are available, but as we often see with CAM interventions, they are easily turned towards conspiracy mongering and rhetoric against Big Pharma.

    The role of Pharmaceutical industry: at the recent MS Life conference in Manchester a parmaceutical representative addressing the audience of people with MS referred to them as the ‘market’.

    Um…yeah…they’re a company, not a charity.

    So let us try to look at the alternatives to the auto-immune theory which to be quite honest, has not delivered substantial improvements in 50 years of trying, with an open mind and a serious aim of understanding Multiple Sclerosis better.”

    Yup, that’s what’s happening now – but just because autoimmune theories haven’t produced results in 50 years doesn’t mean that CCSVI works, that’s a false dilemma. Far from there being a conspiracy against CCSVI, there is an active research effort – despite many researchers thinking it’s not a promising avenue. Doctors may not know the cause or cure of MS, but that doesn’t mean they are completely ignorant either. It’s possible that a promising avenue of research has been overlooked; it’s also possible people are chasing down a blind alley just like they did with vaccines and autism.

    Time will tell; I have relatives with MS, I wish results were available and promising. But as of right now, they don’t seem to be. Hopefully that will change. But if this is false hope, Zamboni has a lot to answer for.

  37. streeves1 says:

    SkepticalHealth, I did benefit from the CCSVI treatment. I did not say that all symptoms had improved. I have some symptoms that have improved, such as my feet are no longer so cold that they hurt. My hands are no longer so cold that they feel like they are freezing from the inside out. I now sleep at least 7 hours per night instead of 2 or 3 which had been the case for several years. I can now lift my left arm above my head which I had not been able to do for over a year before the treatment. I can put my coat on unassisted, which I had not been able to do for over a year. There are other, more personal improvements that I will not go into here.

    Some of my symptoms are still progressing. I can no longer play the piano, I can only type with one hand, I am still heat intolerant, and that is worsening. My ability to walk is steadily declining, and the length of time that I can stand is steadily decreasing.

    I am in denial? I think not.

  38. “I am in denial? I think not.”

    I’m sorry, but I have to add this to the random quotes page of my blog.

  39. WilliamLawrenceUtridge says:

    Streeves1, were your symptoms uniform before this point? Were they always steadily progressing with no waxing and waning? Were they the same year-round, irrespective weather, temperature, pressure, location, humidity and the like? How many of your symptoms are subjective? How many signs or subjective symptoms have you systematically tested or recorded? Did you write down “markers” of your symptoms at different points (i.e. I can only raise my arm six inches today; the fingers of my left hand are numb from the second knuckle down; I can make a partial fist but can not touch my palm)?

    Whenever I take an Advil, my headache eases as I swallow. This has nothing to do with the Advil. I know this. It still happens. Placebo effects don’t just influence the easily fooled, and it’s quite easy to forget that. I have had various injuries which got better gradually; at times I was unable to sneeze without agony, climb stairs without a railing, or do a push-up at all. If I hadn’t made a specific point of remembering how severe my symptoms have been, in the months it took each injury to heal I may have forgotten how bad they initially were and therefore assumed they were not getting better.

    I’m not saying the liberation procedure absolutely didn’t help you, or that it’s impossible it didn’t help you. I will note, however, that MS is known for unpredictable relapses and varying symptoms, and that sham surgery is one of the most effective placebos we know of – more so than sham injections or pills.

    I support the judicious study of CCSVI, to a reasonable degree. I do not support unscrupulous doctors taking advantage of the desperate.

    Incidentally, I take the generic version of whatever Advil is. Cheaper, and since the knock-off bottles and pills have similar colours, I know I’m getting the same thing. Take THAT Big Pharma!

  40. BillyJoe says:

    The bottom line here is that Zamboni has not taken the scientific approach to proving his hypothesis that CCSVI causes MS and, if turns out that time and money has been wasted needlessly and that people have died needlessly as a result, he should stand condemned.
    The underflying problem, however, is that most medical professionals are ignorant of the scientific method.

  41. lifeback says:

    Why are neurologist based CCSVI studies not using the same protocols or better than the Zamboni study was following? (note that the treatment has come light-years forward at the current time thanks to doctors like Dr. Scalfani in Brooklyn amongst others) The neurological sect seem focused on disproving Zamboni rather than moving forward to help patients which it seems many of the interventional radiologist-run studies seem to be achieving.

    I support proper research! I know anecdotal and post-procedure studies do not meet current research standards, but the observational studies must shed some light on supporting going forward with “proper” studies. I asked my neurologist why he doesn’t want to study me and my success with CCSVI treatment as opposed to some of his other MS patients who have not had the success I have had. His reply to me was frightening… “Why should I care?” oh my, this is what I am up against! Perhaps that is why so many MSers are flocking to doctors who actually want to help them!

    The safety of angioplasty/venoplasty has already been proven time & time again. Kidney dialysis patients undergo jugular ballooning on a regular basis yet there is not hue & cry from the neurological community… hmm… methinks kidney patients do not affect their bottom line. The hypocrisy of the situation is glaringly apparent.

    Tysabri and Gilenya have killed more people than CCSVI treatment and will continue to do so, yet the neurologists are pushing patients to take them.

    I’m just glad I went for the procedure and found such phenomenal long-term results. My neurologist told me he never needs to see me again unless I want to go on a DMD, tysabri or gilenya… sad that he’s not interested in monitoring my success.

  42. WilliamLawrenceUtridge says:

    Lifeback, referring to neurologists as a “sect” is, in addition to being insulting due to it’s implications of faith in an evidence-based profession, simply wrong. As far as I know, neurologists don’t think CCSVI is particularly promising because it doesn’t match up with the immunological basis of MS. Again, just because an idea provides hope for a cure doesn’t actually make it a cure, and objecting to an intervention or theory because it doesn’t mesh with the existing body of knowledge on a condition doesn’t make someone mean.

    The rest of your post is a relatively standard set of talking points – doctors are heartless, doctors are greedy, the procedure is harmless, drugs have risks. What your points miss out on, presumably because you’ve already made up your mind, is that medicine is frustrating, procedures carry risks and drugs carry benefits. The doctors providing CCSVI procedures outside the context of an actual clinical trial – they are either greedy or overly soft-hearted. They’re either taking your money (greedy) or willing to try anything to help their patients (softhearted). There’s a reason doctors and other experts are gatekeepers in health, because they have some (imperfect) training in assessing risks, benefits and standard practices.

    As for why your doctor doesn’t want to see you again, it sounds like you’ve ceased seeing him as a partner in your health and now see him as a member of an opposing faith-based movement. I could understand why your doctor might not want to be associated with your ongoing care – you’ve already made it evident that you care more about rumours on the internet than you do about evidence.

    I hope your symptoms do not return, but I really wish you had had a chance to participate in a clinical trial rather than undertaking your own, scientifically useless medical anecdote. A clinical trial helps everyone, an anecdote helps only you – and possibly not even that.

  43. Shirley R says:

    “Proponents of this new hypothesis have failed to meet the burden of evidence for such a radical change.”

    If this is so … Then the auto-immune theory is in the same boat.  I have yet to see this theory proved.  Even though it has been touted for many years.  The ONLY reason it has been accepted by all is because if it is said enough times it seems to become true.  Every item written … (about MS  or other conditions that neurologists have been approached on and are not interested in truly finding the cause but yet are quite willing to medicate are put under this umbrella of “auto-immune”) … begins or is embedded in the article, brings this bogus theory into play.

    Also … why are neurologists even voicing opinions that they have no knowledge about anyway?  This is a Vascular issue.  Like Dr. Sandy McDonald from Barrie Vascular Imaging has said … 

    “When I see a plumbing problem, particularly one which deprives the whole house of good clean water, I want to fix it. When I see the whole house suffering, I want to fix the pipes. I can do that without harming the 
    wiring in any way and do not see why we condemn the family to misery 
    while we wait for the electrician.” 

    Sure looks like a turf war and the wrong experts refuse to get off the field.

  44. Shirley R says:

    “Proponents of this new hypothesis have failed to meet the burden of evidence for such a radical change.”

    If this is so … Then the auto-immune theory is in the same boat.  I have yet to see this theory proved.  Even though it has been touted for many years.  The ONLY reason it has been accepted by all is because if it is said enough times it seems to become true.  Every item written … (about MS  or other conditions that neurologists have been approached on and are not interested in truly finding the cause but yet are quite willing to medicate are put under this umbrella of “auto-immune”) … begins or is embedded in the article, brings this bogus theory into play.

    Also … why are neurologists even voicing opinions that they have no knowledge about anyway?  This is a Vascular issue.  Like Dr. Sandy McDonald from Barrie Vascular Imaging has said … 

    “When I see a plumbing problem, particularly one which deprives the whole house of good clean water, I want to fix it. When I see the whole house suffering, I want to fix the pipes. I can do that without harming the wiring in any way and do not see why we condemn the family to misery while we wait for the electrician.” 

    Sure looks like a turf war and the wrong experts refuse to get off the field.

  45. streeves1 says:

    Hey, Lifeback, Congratulations on your success with CCSVI! While some neurologists may have years of training, instruction, and experience behind them, when something goes against their beliefs or training, then they want nothing else to do with you. It is sad. Keep on spreading the word about your success! I believe that people with MS need to hear the success stories like yours and the somewhat lesser success stories like mine. They need to do the research as I did, and probably you did too and make up their own minds as we did. I am probably less than a year away from a wheelchair, and as I stated before…knowing the small improvements I have seen for myself, I would do it again in a heartbeat! I would have loved to have been in a clinical trial, but in Ontario, there are none. Time to wait was not on my side!

  46. mdstudent says:

    The justification of effort effect??

    http://en.wikipedia.org/wiki/Effort_justification

  47. @Shirley, please leave your ignorance at the door before you start posting here. Perhaps you can get away with ridiculous statements like that on your Facebook pages or whatever, but over here, we know better. Neurologists shouldn’t touch “vascular issues”? Have you ever heard of a stroke? Get lost. Your statement that we don’t know that MS is auto-immune, or that neurologists don’t care about the cause of the disease, and just want money treating it? Get f-cked. Take your anti-medicine rhetoric elsewhere.

    @Streeves, I tried being polite to you because I didn’t see the point in ridiculing or otherwise embarrassing someone who is stricken with a horrible autoimmune disease like MS. It’s really rather sad that you put so much faith in CCSVI, when you did not benefit from it whatsoever. Your disease is still progressing and your quality of life is decreasing. What’s disgusting is your promotion of the useless procedure and your advocating it to other MS patients. I guess misery loves company.

  48. BillyJoe says:

    “The justification of effort effect??”

    It could be. Or it could actually be effective.
    The point is that clinical trials proving benefit must preceed widespread application.

  49. mdstudent says:

    “The point is that clinical trials proving benefit must preceed widespread application.”

    Three years have passed during which numerous studies have been performed without success in consistently replicating Zamboni’s results. At which point do researchers admit they’ve been chasing unicorns and return to more promising avenues of research grounded in evidence that is actually compelling? There’s a lot of hype surrounding ccsvi (“maverick md revolutionizes understanding of ms while saving wife” makes for a great headline) so I’m assuming it won’t be anytime soon. Sad.

  50. WilliamLawrenceUtridge says:

    deniseb:

    If CCSVI treatment could allow me to go for a walk with my daughter on a nice summer day that would be more than enough for me; if it gave me more I could have a life again! Why are so many so against us wanting that? Why do so many doctors completely disregard the symptoms that CCSVI treatment helps? As many as 95% of people with MS experience fatigue as a symptom and heat intolerance is so prevalent that at one time they used a ‘hot bath test’ to diagnose MS. I would love to hear a logical, acceptable explanation why then a treatment that can alleviate these symptoms is dismissed by the medical community before it is even considered?

    Nobody is against effective treatment or cure. It simply takes time. Everyone, doctors, patients, family and friends would dearly love it if we could test CCSVI in a week or less – but science takes time, particularly when working with a condition as variable as MS.

    It’s frustrating to me that people proclaim the medical community as dismissing CCSVI before it is considered. It’s currently being tested in a variety of ways, including clinical trials. Imagine this scenario – Pfizer announces it has developed a drug to treat MS. It announces that the drug has very few side effects. It hasn’t been tested, but Pfizer thinks tests are unnecessary and goes straight to the public instead of the FDA. The drug costs only $100 per month. The press officer at Pfizer is the only person who answers inquiries, and assures every inquirer that he has personally seen every single person who has taken the drug, and every single one of them says it helped them immensely.

    Would you take it? Or does that thought skeeve you out?

  51. Shirley R says:

    @ SkepticalHealth

    Ignorance seems to be coming fom you buddy. Your tone shows it quite well. On that note … I hope you read your comment and reveal who you really are. Your comment means squat coming from some who hides behind fictitiousus name.

  52. @Shirley,

    “Proponents of this new hypothesis have failed to meet the burden of evidence for such a radical change.” If this is so … Then the auto-immune theory is in the same boat. I have yet to see this theory proved. Even though it has been touted for many years. The ONLY reason it has been accepted by all is because if it is said enough times it seems to become true.

    In this paragraph you reveal that you in fact do not know anything about the pathological basis of multiple sclerosis. The inflammation, demyelination, and axonal degeneration seen in MS is believed to be mediated by immune system cells. We think this because we see inflammatory cells such as B-cells, T-cells, and macrophages on tissue slides of MS lesions and many of those cells we find are reactive to myelin. We also see elevations in certain IgM and IgG immunoglobulins in the CSF of MS patients, and many other auto-reactive cells. Not to mention the fact that MS responds well to drugs that inhibit the immune system. It has all the markers of an immune system condition, but we do not yet know for sure.

    When you actually read the literature on MS, this “chronic cerebrospinal venous insufficiency” is not even in the top 3 possible causes of MS.

    Every item written … (about MS or other conditions that neurologists have been approached on and are not interested in truly finding the cause but yet are quite willing to medicate are put under this umbrella of “auto-immune”) … begins or is embedded in the article, brings this bogus theory into play.

    This is nonsense. Millions and millions of dollars are spent each year researching MS. Medicine is actively trying to find better cures and to learn more about the disease process. To suggest that no one cares about the cause and only wants to sell a cure is completely dishonest and frankly a rather embarrassing claim.

    Also … why are neurologists even voicing opinions that they have no knowledge about anyway? This is a Vascular issue. Like Dr. Sandy McDonald from Barrie Vascular Imaging has said …
    “When I see a plumbing problem, particularly one which deprives the whole house of good clean water, I want to fix it. When I see the whole house suffering, I want to fix the pipes. I can do that without harming the wiring in any way and do not see why we condemn the family to misery while we wait for the electrician.”
    Sure looks like a turf war and the wrong experts refuse to get off the field.

    Again, you are completely wrong. First of all, there is no good evidence to suggest that MS is a “vascular issue.” The best evidence shows it is an immune issue, with an auto-immune disease being the absolute most likely cause. The evidence supporting a vascular etiology is slim if not non-existant.

    Furthermore, to say that a neurologist can’t deal with a vascular issue is ignorant. Have you heard of stroke? It’s a “vascular issue” that is treated by neurologists. (Well, any doctor can treat an acute stroke, unless it comes to pushing tPA.)

    I’m not surprised you don’t know these things. Your post is full of anti-medicine rhetoric. You are not interested in educating yourself on MS. You are only interested in advertising/publicizing this useless treatment for MS.

    Ignorance seems to be coming fom you buddy. Your tone shows it quite well. On that note … I hope you read your comment and reveal who you really are. Your comment means squat coming from some who hides behind fictitiousus name.

    You have not shown that you are informed on anything that you have written about. You do not know the basic pathophysiology behind MS. You do not understand the realm of neurology, and you do not understand the lack of evidence supporting CCSVI.

    Regarding my “fictitiousus” name, please feel free to leave your full name, address, and phone number.

    -

    Reekers JA, Lee MJ, Belli AM, Barkhof F. Cardiovascular and Interventional Radiological Society of Europe commentary on the treatment of chronic cerebrospinal venous insufficiency. Cardiovasc Intervent Radiol. 2011 Feb;34(1):1-2. Epub 2010 Dec 7.
    PMID – 21136256

    Chronic cerebrospinal venous insufficiency (CCSVI) is a putative new theory that has been suggested by some to have a direct causative relation with the symptomatology associated with multiple sclerosis (MS) [1]. The core foundation of this theory is that there is abnormal venous drainage from the brain due to outflow obstruction in the draining jugular vein and/or azygos veins. This abnormal venous drainage, which is characterised by special ultrasound criteria, called the “venous hemodynamic insufficiency severity score” (VHISS), is said to cause intracerebral flow disturbance or outflow problems that lead to periventricular deposits [2]. In the CCSVI theory, these deposits have a great similarity to the iron deposits seen around the veins in the legs in patients with chronic deep vein thrombosis. Zamboni, who first described this new theory, has promoted balloon dilatation to treat the outflow problems, thereby curing CCSVI and by the same token alleviating MS complaints. However, this theory does not fit into the existing bulk of scientific data concerning the pathophysiology of MS. In contrast, there is increasing worldwide acceptance of CCSVI and the associated balloon dilatation treatment, even though there is no supporting scientific evidence. Furthermore, most of the information we have comes from one source only. The treatment is called “liberation treatment,” and the results of the treatment can be watched on YouTube. There are well-documented testimonies by MS patients who have gained improvement in their personal quality of life (QOL) after treatment. However, there are no data available from patients who underwent unsuccessful treatments with which to obtain a more balanced view. The current forum for the reporting of success in treating CCSVI and thus MS seems to be the Internet. At the CIRCE office and the MS Centre in Amsterdam, we receive approximately 10 to 20 inquiries a month about this treatment. In addition, many interventional radiologists, who are directly approached by MS patients, contact the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) for advice. Worldwide, several centres are actively promoting and performing balloon dilatation, with or without stenting, for CCSVI. Thus far, no trial data are available, and there is currently no randomized controlled trial (RCT) in progress Therefore, the basis for this new treatment rests on anecdotal evidence and successful testimonies by patients on the Internet. CIRSE believes that this is not a sound basis on which to offer a new treatment, which could have possible procedure-related complications, to an often desperate patient population.

    ^ The only “evidence” for this supposed treatment is YouTube videos and internet testimonials. lol. To anybody who has seen the website of user @rustichealthy, we know exactly how much weight that carries.

  53. MSdragonslayer says:

    This site claims, “Our only goal is to promote high standards of science in medicine.”So I have these questions. Why are you so adamantly against venoplasty as a viable treatment for some of the worst symptoms of MS? I cold understand it if anyone in the medical community could give us all a cause but you cannot and based on the way the medical community diagnoses MS, you never will know what causes it. There seem to be several diseases that get lumped into MS but do not belong there. Lyme Disease comes to ind as one.

    How do you recreate a disease like MS in mice? Everything I have read about the mouse connection is very UNscientific. This goes back to cause. If you do not know what causes something, how can you possibly replicate it mice? You cannot! At best, you can replicate a few of the symptoms and as a grade 12 biology student can tell you, pain is a symptom of many different things; balance problems are symptoms of many different things; fatigue is a symptom of many different things; vision problems are not MS specific and on and on and on. Still you keep using mice that do not have MS to prove all your drug answers for MS. Sorry but that is neither logical nor scientific.

    How do those of you in the medical profession explain how anything you have done with drugs ‘slows relapses’? Many MSers have decades pass without a relapse. Others have relapses quite frequently. I have heard that it prevents them but I have yet to hear from any doctor anywhere, how the devil you know that the drug rather than the naturally unnatural behaviour of the disease is causing the progression to slow down? Sorry but that is not logical.

    And then there is that word – autoimmune. Where did that come from? Are you aware that a good number of MSers appear to have very good immune systems. Some of us never get the flu, a cold, whatever bug is running rampant at any particular time. I am 66 years old. I have never had the flu though I have been surrounded by it. I have never had a cold. In fact I have never had anything much. How does that mean my immune system is out of whack?? I agree that the myelin where the lesions are screwing the works up may be compromised but there have,of late,been a couple of other theories about that and they are a good deal more logical than this ‘autoimmune one’.

    And about these drugs that are commonly prescribed – how do you justify the cost – I have seen $1,500.00 per person per month all the way up to $4,000.00 per person per month. Are they laced with gold dust? The companies who make them are not starving and simply trying to make a reasonable profit. In fact, they seem to be raking in billion – not millions but BILLIONS and that is after they have paid my former MS neuro and others for prescribing their drug.

    Why are you so fanatically opposed to venoplasty? If you have a good and logical reason, please inform us all. And please do not use a couple of deaths – there have been a good many more deaths attributable to the various drugs prescribed to MSers.

    Why is it impossible that people who say they have had some good results might actually and truly have good results? Throwing names around is not an answer though it appears to be the most used method among other commentators.

    Some sensible answers to my questions would be appreciated. Do not bother calling me ignorant – I’m not. I have not had the venoplasty for CCSVI – I have not even been tested for CCSVI, so please save those insults too. For those who read this and respond without the name calling, thank you.

  54. weing says:

    This smacks of internal mammary artery ligation for coronary artery disease. You need a nice study to settle the issue.

  55. Big Sleepy Mac says:

    @Scott – I am still unable to find the specific meta analysis I recalled but I did find the University of Buffalo News Release July 10, 2010 at http://www.bnac.net/wp-content/uploads/2010/02/first_blinded_study_of_ccsvi.pdf which found “More than 55 percent of multiple sclerosis patients participating in the initial phase of the first randomized clinical study to determine if persons with MS exhibit narrowing of the extracranial veins, causing restriction of normal outflow
    of blood from the brain, were found to have the abnormality.” “When the 10.2 percent of subjects in which results were border line were excluded, the percentage of affected MS patients rose to 62.5 percent, preliminary results show, compared to 25.9 percent of healthy controls.” The first phase of this study involved 500 people and I believe that the results were presented by neurologist Robert Zivadinov at the American Academy of Neurology meeting in April 2010. Like many research projects at this stage the early results answer some questions but also raise many other questions that need to be explored. CCSVI research is ongoing currently in many countries.

    I would suggest that the growing number of “anecdotes”, now in the thousands, some of which have been documented using before and after EDSS scores is becoming rather compelling. It is very difficult to ignore and argue against measured success. The research has to go on.

    Canada needs a more compassionate flexible health care system to allow terminally ill people to obtain prompt access to promising treatments.

  56. gretemike says:

    Big Sleepy Mac,

    The doctors who post here are repeatedly reminding us non doctors that the absence of a cause is NOT necessarily a cure. Thus if you have lung cancer you cannot treat it by throwing your cigarettes in the trash. Likewise, demonstrating that people who get MS tend to have vascular problems does not mean that treating vascular problems = treating MS. In fact, I suspect it doesn’t even mean that MS is caused by vascular problems . . . lots of Americans tend to develop vascular problems by the time they are the age at which MS tends to rear it’s ugly head.

    I work as a nurse at a nursing home and unfortunately we have a number of advanced MS patients. Every one of them is taking something that they read about on the internet that will cure their MS, and in each case they claim subjective improvement of their symptoms despite objective evidence of deterioration.

  57. PJLandis says:

    “It is very difficult to ignore and argue against measured success. The research has to go on.”

    I certainly wouldn’t argue for a stop to research, but “measured success” is a wildly optimistic interpretation of the data. Usually it’s best to determine if something has any relationship, and preferably as a cause not an effect, with the diseas your seeking to treat. The correlation between CCSVI and MS is unclear, and the idea that CCSVI is causing or exacerbating MS is wild speculation. Weighing that against two known deaths from this procedure and I think the unbounded optimism for this treatment is becoming irrational and dangerous.

    Using a little Wikipedia magic, here is the “…92% of the MS patients showed abnormal findings and 84% of them showed evidence of CCSVI, however; only 24% of controls showed abnormal findings, but none of them showed evidence of CCSVI…” trial (http://www.ncbi.nlm.nih.gov/pubmed/20351667). So that’s one study for the CCSVI is correlated with MS (no mention on whether it causes or is caused by MS).

    The largest study I found involved 499 patients, using the Doppler method of the first study I cited, and found CCSVI was higher in MS patients, but also in patients with other neurological disorders and concluded: “Our findings are consistent with an increased prevalence of CCSVI in MS but with modest sensitivity/specificity. Our findings point against CCSVI having a primary causative role in the development of MS.

    I’m excluding Zamboni because his results are so contrary to even the most optimistic studies by others, it’s reasonable to assume his lack of controls likely influenced his results (perhaps innocently, but all the same).

    Those two positive studies both used “Doppler and B-mode ultrasound” (Wikipedia notes this method may be Operator-dependent [i.e., unreliable] but I don’t see an explanation for why) which as far as I can tell was not the method used for these 5 other studies (some form of magnetic resonance is listed under results in most of them) which found no or little correlation between CCSVI and MS:

    1. This one’s in German I believe, but the Springer translation reads “The authors conclude that the “chronic cerebrospinal venous insufficiency (CCSVI)“ cannot represent the exclusive pathogenetic factor in the pathogenesis of MS. In our cohort, only 20% of the patients fulfilled the required neurosonological features of CCSVI. So far, the pathogenetic relevance of these findings remains speculative. Thus, based on the current scientific position we cannot justify invasive „therapeutic“ approaches, especially if they are performed outside of clinical trials. (http://www.springerlink.com/content/u492178480r30984/)

    2. This one was only MS patients, but found only 9/43 patients with “[e]xtracranial venous stenosis (EVS).” “We conclude that EVS is an unlikely cause of MS since it is not present in most patients early in the disease and rarely involves more than one extracranial vein. It is likely to be a late secondary phenomenon.” (http://www.ncbi.nlm.nih.gov/pubmed/21041329)

    3. Here we have 21 MS patients and 20 controls with no correlation found at all. “The prevailing view on multiple sclerosis etiopathogenesis has been challenged by the suggested new entity chronic cerebrospinal venous insufficiency. To test this hypothesis, we studied 21 relapsing-remitting multiple sclerosis cases and 20 healthy controls with phase-contrast magnetic resonance imaging…In conclusion, we found no evidence confirming the suggested vascular multiple sclerosis hypothesis.” (http://www.ncbi.nlm.nih.gov/pubmed/20695018)

    4. “Fifty-six MS patients and 20 controls were studied….Except for 1 patient, blood flow direction in the IJVs and VVs was normal in all subjects. In none of the subjects was IJV stenosis detected….Our results challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS. Future studies should elucidate the difference between patients and healthy subjects in BVF regulation. (http://www.ncbi.nlm.nih.gov/pubmed/20695010)

    5. This one used 20 age and gender matched controls. “A completely normal venous anatomy was observed in 10 MS patients and 12 controls. Anomalies of the venous system were found in 10 MS patients and eight healthy controls. An anomalous venous system in combination with associated alternative venous drainage was observed in six MS patients and five healthy controls. Flow quantification showed no venous backflow in any MS patient or control….CONCLUSIONS: Findings suggestive of anomalies of the cranial venous outflow anatomy were frequently observed in both MS patients and healthy controls. Given the normal intracranial venous flow quantification results, it is likely that these findings reflect anatomical variants of venous drainage rather than clinically relevant venous outflow obstructions.” (http://www.ncbi.nlm.nih.gov/pubmed/20980483)

  58. gretemike says:

    Big Sleepy Mac,

    Regarding your comment that “One thing the social media has done is allow thousands of MS patients to compare notes,” I’m reminded of a coworker who “met” a man online from England who eventually wanted her to mail him money (as I had predicted). The point I tried to make with her is that she had no idea whether this individual was a man, woman or even whether it WAS an individual . . . it might have been a group of scammers. Scammers are not confined to the realm of online dating, there are tons of scammers pushing bogus cures of various types. In the same way that my coworker had no idea who she was really chatting with online, those who participate in they sorts of social media you’re referencing have no idea whether the people with whom they are communicating are in fact who they say they are (or even if they are in fact multiple people). In my opinion the internet has given us quantity of information while sacrificing the quality of information. The quality information regarding healthcare is still to be obtained by medical professionals . . . as Steve Jobs evidently learned the hardest way.

  59. gretemike says:

    Regarding the “Big Pharma” claim in general, aside from the general weakness of such claims as often discussed by the regular bloggers, I note that in this case the argument cuts both ways. This procedure, if it worked, would be a whole lot less expensive for the various governments in Canada than standard MS treatment. And apparently that really recent study was commissioned by the governments of Newfoundland and Labrador to determine whether they would pay for this sort of therapy. So if you want to believe that financial motive is what ultimately drove the study’s result, then the actual result of the study is the opposite of what you predicted.

    http://www.vancouversun.com/health/Canadian+study+casts+doubt+liberation+treatment+patients/6750345/story.html

  60. BillyJoe says:

    MSdragonslayer,

    Well, that was a long post and a lot of questions.
    But you could have saved your time by reading the comments. ;)

  61. @gretemike,

    Scammers are not confined to the realm of online dating, there are tons of scammers pushing bogus cures of various types. In the same way that my coworker had no idea who she was really chatting with online, those who participate in they sorts of social media you’re referencing have no idea whether the people with whom they are communicating are in fact who they say they are (or even if they are in fact multiple people). In my opinion the internet has given us quantity of information while sacrificing the quality of information. The quality information regarding healthcare is still to be obtained by medical professionals . . . as Steve Jobs evidently learned the hardest way.

    This is fantastically worded. Anybody with $10 and a credit card can open up a website and make any claim they want. Honestly, your post should be a disclaimer on Google anytime anyone searches helth care related topics.

    -

    The posts by the CCVSI supporters in this thread would be a great case study of people downright ignoring facts. They want to believe in a “vascular cause” for MS. However, almost all of our data says MS has an immune etiology. So what do they do? They just say neurologist don’t know anything, or they just flatly state “we (as in science) don’t know anything about MS”.” Neither statement is true, but it doesn’t matter, because they need to “clean the slate” to allow for their likely false idea to have equal footing.

    Sadly, this isn’t a bunch of hippies treating their sadness of only having one Mercedes with homeopathy. These are people with a severely morbid progressive disease.

  62. @MSdragonslayer, I’m sorry, but as soon as someone says they’ve never had the flu or a cold, they lose all credibility.

    @PJlandis, thank you for reviewing all those articles. Good info!

  63. Big Sleepy Mac says:

    MR Venography of Multiple Sclerosis report published in the AJNR Am J Neuroradiol 21:1039–1042, June/July 2000. CONCLUSION: With MR venography, the perivenous distribution of MS lesions in the brain can be visualized in vivo. The venous anatomy defines the typical form and orientation of these lesions.

    Actually the involvement of the venous system with MS has been explored in the literature and pathological studies for over 140 years. It took Dr. Zamboni’s hypothesis and someone’s fortuitious choice of the term “Liberation Treatment” to capture the attention of the media and MS patients around the world.

    BTW people, I notice that some of the comments are getting a bit personal. Please remember that this is a debate on Dr. Novella’s opinion and obviously some posters agree with him and others do not but everyone has the right to their own opinion. The debate is important so lets try to keep it polite please!

  64. WilliamLawrenceUtridge says:

    So I have these questions. Why are you so adamantly against venoplasty as a viable treatment for some of the worst symptoms of MS?

    Because the balance of the evidence supports immune involvement for MS, not cardiovascular. Because the treatment has yet to be tested appropriately. Because the treatment puts people at risk and uses up scarce health care dollars.

    I cold understand it if anyone in the medical community could give us all a cause but you cannot and based on the way the medical community diagnoses MS, you never will know what causes it. There seem to be several diseases that get lumped into MS but do not belong there. Lyme Disease comes to ind as one.

    Just because the exact cause of MS is not yet known does not mean that CCSVI is that cause. This is the problem with Zamboni’s press-release science, it created massive amounts of publicity and buzz before other scientists could confirm the results. There is a distinct possiblity Zamboni’s results are due to conscious or unconscious bias, and he didn’t use the many tools required in science to reduce bias. It’s bad science, and far too early to proclaim a cure.

    How do you recreate a disease like MS in mice? Everything I have read about the mouse connection is very UNscientific. This goes back to cause. If you do not know what causes something, how can you possibly replicate it mice? You cannot! At best, you can replicate a few of the symptoms and as a grade 12 biology student can tell you, pain is a symptom of many different things; balance problems are symptoms of many different things; fatigue is a symptom of many different things; vision problems are not MS specific and on and on and on. Still you keep using mice that do not have MS to prove all your drug answers for MS. Sorry but that is neither logical nor scientific.

    Mice are used because there are ethical implications in using people. Mice are very similar to humans, grow to maturity quickly and there are numerous strains that are genetically essentially identical – which helps when isolating individual factors. Mice aren’t a “best case” model for MS, they’re a “best substitute”. Would you rather we used people?

    You’ve also hit on one of the very problems with MS research – it’s an extremely variable condition. Symptoms come and go, and vary in expression, making it more difficult than, say, diabetes, to establish causes and effective treatments.

    Your comment makes it evident that you don’t understand science or the ethics behind experimental procedures. Science is simple in conception but complicated in practice; scientists aren’t idiots, they’d love to have a simple answer to the issue – but they don’t. But that doesn’t mean Zamboni’s ideas are correct by default.

    How do those of you in the medical profession explain how anything you have done with drugs ‘slows relapses’? Many MSers have decades pass without a relapse. Others have relapses quite frequently. I have heard that it prevents them but I have yet to hear from any doctor anywhere, how the devil you know that the drug rather than the naturally unnatural behaviour of the disease is causing the progression to slow down? Sorry but that is not logical.

    Again, you are asking questions about a complicated disease, with multiple, variable symptoms, that wax and wane unpredictably. Knowledge is imperfect, which is why people keep doing research. If we had a cure, if it was as simple as insulin for diabetics, they’d stop. Instead of being able to prevent or attack the root cause of MS, scientists are left trying to find drugs that reduce symptoms in aggregate groups. Everybody wants there to be a cure, or low-risk treatment. Doctors aren’t criticizing or failing to support CCSVI because they’re mean – they do it because it seems a very unlikely treatment that fails to mesh with the existing body of knowledge. Fortunately, if the liberation procedure has a beneficial effect – we’ll be able to show it with clinical trials. Even if it is not understood how or why it works. Unfortunately, clinical trials take time.

    And then there is that word – autoimmune. Where did that come from? Are you aware that a good number of MSers appear to have very good immune systems. Some of us never get the flu, a cold, whatever bug is running rampant at any particular time. I am 66 years old. I have never had the flu though I have been surrounded by it. I have never had a cold. In fact I have never had anything much. How does that mean my immune system is out of whack?? I agree that the myelin where the lesions are screwing the works up may be compromised but there have,of late,been a couple of other theories about that and they are a good deal more logical than this ‘autoimmune one’.

    In autoimmune conditions, having a “good” immune system is worse. Autoimmunity means the body attacks itself; a strong immune system may be excellent at attacking invading antigens – but that may also make it excellent at attacking itself. Within biology, “logic” is often a terrible way to deal with broad-strokes issues. Biological systems are cobbled together over millions of generations through the blind system of natural selection. You may be correct that MS patients rarely get sick due to very strong immune systems – but the cost of that enhanced immunity may be autoimmunity.

    And about these drugs that are commonly prescribed – how do you justify the cost – I have seen $1,500.00 per person per month all the way up to $4,000.00 per person per month. Are they laced with gold dust? The companies who make them are not starving and simply trying to make a reasonable profit. In fact, they seem to be raking in billion – not millions but BILLIONS and that is after they have paid my former MS neuro and others for prescribing their drug.

    Because training doctors takes years, and in order to get people to enter the profession, remuneration must be high – so your doctor charges a higher price than a shoeshiner would to shine shoes.

    In addition, a molecule might be cheap to produce, but figuring out which molecule to produce can take a lot of time and money. Drugs take decades to research, and often millions of dollars. That initial high price is used to subsidize the cost of all that research, since once the patent runs out anybody can produce a generic knock-off. In addition, those costs are used to subsidize further research into new drugs. And a portion goes towards executive bonuses, pharmaceutical reps, class action law suits and a whole lot of costs unrelated to the production of the drug. So yes, drug companies make a profit; some of those profits are used “well” (research and development) and some are used “badly” (advertising and executive bonuses). But drug companies are companies, and profit-motivated. It’s a flawed system, perhaps you could convince Congress to extend the duration of patent rights for drugs, allowing the companies to charge a lower price for longer in order to recoup their costs. But overall – it’s complicated.

    Why are you so fanatically opposed to venoplasty? If you have a good and logical reason, please inform us all. And please do not use a couple of deaths – there have been a good many more deaths attributable to the various drugs prescribed to MSers.

    A good, logical reason in my mind is that it’s unproven. A less logical but more empirical one is that it doesn’t seem to match up to the causes of MS as we know them.

    Why is it impossible that people who say they have had some good results might actually and truly have good results?

    Because MS has a variety of symptoms that wax and wane unpredictably. Because symptoms are subjective, and thus can be influenced by mood, sleep, desire for a benefit and expectations.

    It’s not that the good results are impossible, it’s that without careful, controlled studies you don’t know what is causing the results.

  65. @BigSleepyMac, there isn’t a debate going on. There are a few people who believe in, without evidence, the utility of CCSVI coming to this forum and spouting off a bunch of nonsense. You ignore all contrary evidence, and only support a scientifically-unspported viewpoint.

  66. MSdragonslayer says:

    @ SkepticalHealth – I am sorry you do not believe me when I say I have not had the flu or a cold. It might surprise you to know that I am not the only MSer who has not suffered the flu or a cold. Perhaps, if you are a doctor and have MS patients, you might try listening to your patients. It is something that doctors did when I was younger. When I was younger though, doctors also had a reputation for helping their patients get better. I must say we don’t hear that much anymore.

    You toss the word “evidence” around a lot. Have you ever looked the word up in a dictionary? Try it some day. Evidence is not necessarily the same as ‘fact’. In fact, it might serve you well to discuss ‘evidence’ with a lawyer if you know one. “Evidence” has put men in prison. ‘Fact’ has been setting them free. Something you might be well advised to think about as there are doctors out there who have used ‘evidence’ to commit crimes (and not always deliberately or with malice, but out of a lack of knowledge). They end up in court looking at malpractice suits and sometimes in prison. Might be an unhappy situation doctors could avoid if they just listened to their patients. In the end, people living with MS know more about it than doctors who only know what they have read and what you read about it in your med school studies is just some other doctors choice of the truth. If you really want to offer those ‘High Standards’, you may want to see vision doctor and have those blinders removed.

  67. WilliamLawrenceUtridge says:

    Regarding the “Big Pharma” claim in general, aside from the general weakness of such claims as often discussed by the regular bloggers, I note that in this case the argument cuts both ways. This procedure, if it worked, would be a whole lot less expensive for the various governments in Canada than standard MS treatment. And apparently that really recent study was commissioned by the governments of Newfoundland and Labrador to determine whether they would pay for this sort of therapy. So if you want to believe that financial motive is what ultimately drove the study’s result, then the actual result of the study is the opposite of what you predicted.

    I’ve bolded the crucial portion of your comment. If it doesn’t work, every single dollar you put into treatment was wasted. Each dollar could have been used to fund more research, pay for more drugs, address symptoms, etc. If CCSVI treatments actually work, it’ll be a tremendous boon for MS patients, health care systems and doctors.

    If.

    Everybody* wants a cheap, safe cure for MS. Everybody* wants to find out that apple juice curse cancer/MS/Huntington’s disease/whatever. But wanting a cure is not the same thing as having a cure. In five years we should know if CCSVI treatments are effective in demonstrating objective improvements in symptoms. If so – it will be adopted very quickly since the skills and materials are already out there. But until the studies are done we can’t be sure. If they’re the miracle many commentors appear to believe they are, it should be easy to demonstrate and we should know quickly. It’s a relatively easy test – knock 50 people out, give half of them stents and the other half dummy procedures. But it takes time to gather the subjects, do the procedures, gather the results, analyze them and write up the publication. It would be great if we could do it all in a day or less – but we can’t. It’s not spite that keeps people from embracing CCSVI, it’s a combination of lack of prior probability and lack of results. If results come in supporting it – opinions will change, as will our understanding of MS. But nobody is going to revolutionize an entire field on the basis of one guy’s word and some ambiguous, poorly-controlled results.

    As I’m fond of analogies, imagine someone says they can reduce car accident fatalities by using apple juice instead of radiator fluid. He’s tested it, and got some excellent results, 100% reduction in fatalities! Would you fill your rad with apple juice and start tailgating?

    *Probably not the drug companies in aggregate, but certainly the individual people working for them.

  68. PJLandis says:

    Also, that large 499 patient study was retrospective and performed by a colleague who worked closely with Zamboni. I forgot the link before: http://www.ncbi.nlm.nih.gov/pubmed/21490322

    It’s also interesting that Zamboni’s results are so divergent from all other independent studies, to the point where he has claimed others are incompetent to diagnose.

    (http://www.medscape.com/viewarticle/732683)
    “Dr. Baracchini noted that he went to Ferrara to view Dr, Zamboni’s methods. ‘To me it was a must to go see how he worked,” he said. Ultrasonography is not only operator dependent but is machine dependent, and Dr. Baracchini said he believes most of the discrepancies between Dr. Zamboni’s findings and others’ are due to the suboptimal machinery that Dr. Zamboni is using.’”

    One interesting point, even Zamboni the biggest supporter of this treatment doesn’t think it should be performed outside of a research environment because of the risks and lack of reason to think it will be effective.

  69. PJLandis says:

    “When I was younger though, doctors also had a reputation for helping their patients get better. I must say we don’t hear that much anymore.”

    This type of casual dig at doctors or pharmaceutical companies gets very tiring. Doctors continue to help patients get better, and they do so more effectively today than ever before. If you’re complaining that your doctor isn’t holding your hand, then say so don’t insinuate that they aren’t helping people because you probably would’ve died from some other disease before you even progressed to MS if it weren’t for modern medicine.

    Also…just because you know what it’s like to have MS doesn’t give you any special expertise in treating the disease…evidence and facts are the same thing, only evidence is marshaled in favor of some conclusion (e.g., innocent and guilt, both require evidence)…malpractice is listening to your patients instead of good evidence, you can still sue a doctor if he does what you ask him to do because the responsibility is to do what is right not what your patients demand.

  70. DavidRLogan says:

    @WilliamLawrenceUtridge

    Sorry to jump on you, but medical costs are a real sore point with me (and millions of Americans…but FWIW I agree with you and Skeptical on the non-cost related points, and I think you’re a clever poster around here). Anyway, you say:

    “Because training doctors takes years, and in order to get people to enter the profession, remuneration must be high – so your doctor charges a higher price than a shoeshiner would to shine shoes.”

    It’d be awesome if good MD’s (or good scientists of any stripe) were the most compensated people in the current system, and existing costs were required to entice them into medicine, but I’m dubious. MD’s don’t “charge” a price to their patients…medical costs are a combination of insurance forces, market forces, the necessity for certain procedures given a climate of malpractice lawsuits, and, as you acknowledge later, what companies want to charge for their product! I bet there are THOUSANDS of American MD’s who would like to see medical costs lower, and do not feel the current costs were necessary for them to spend their life in medicine. But even if every doctor determined every price individually (which, of course, they don’t), your analogy is pretty weak. Surely there’s more to the difference between the costs of a shoeshine and a modern medical procedure than what you say?

    “In addition, a molecule might be cheap to produce, but figuring out which molecule to produce….”

    Some of what you say is true…though you’re making an empirical claim and supporting it with a sort of economic textbook rationale…the only really convincing thing would be EVIDENCE that current costs (do you want to say you’re right for every procedure, or just the ones to which you’re replying?) are in fact just what’s required to support R and D and etc. (not saying you’re wrong…only saying it’s empirical). And it’s not as easy to run on a patent as you say, because a wily chemist will be able to extend them, or have unreported steps in the synthesis (whoops I’m not supposed to type that…delete all the harddrives and meet me in blue quadrant!!!!!)

    Best,
    -David

  71. bluedevilRA says:

    Never had a cold or the flu or other sort of infection? I love it when people make absurd claims such as this. Even if you seem to get fewer infections than others, this anecdotal evidence does automatically mean you have a superhuman immune system. Might as well add in that you have a skeleton made of adamantium :)

  72. WilliamLawrenceUtridge says:

    Sorry to jump on you, but medical costs are a real sore point with me (and millions of Americans…but FWIW I agree with you and Skeptical on the non-cost related points, and I think you’re a clever poster around here).

    I live in Canada. The US needs a real health care system, desperately. The fact that I don’t have to pay for my health care has a significant effect on my posts (and in my opinion, ensures a modicum of evidence-base for most of the medicine paid for in Canada). I have tremendous sympathy for people in the US, because you always have that terrifying spectre of illness looming over your heads.

    It’d be awesome if good MD’s (or good scientists of any stripe) were the most compensated people in the current system, and existing costs were required to entice them into medicine, but I’m dubious. MD’s don’t “charge” a price to their patients…medical costs are a combination of insurance forces, market forces, the necessity for certain procedures given a climate of malpractice lawsuits, and, as you acknowledge later, what companies want to charge for their product! I bet there are THOUSANDS of American MD’s who would like to see medical costs lower, and do not feel the current costs were necessary for them to spend their life in medicine. But even if every doctor determined every price individually (which, of course, they don’t), your analogy is pretty weak. Surely there’s more to the difference between the costs of a shoeshine and a modern medical procedure than what you say?

    One defence of universal health care I read was that it actually drove down costs by spreading them out across more people. Instead of having to pay $1000 out of pocket, I pay $100 in taxes. Again, a health care system is a wonderful thing.

    Sure, many things determine the charges for health care costs. But one reason it is expensive is because doctors are expensive. And re-reading the initial comment leading to my post, they were mostly complaining about the cost of drugs rather than the cost of paying their neurologist. So yeah, determining the cost of health care, particularly in the US where there’s much less of a system than nearly any other first-world nation, is complicated. IMO it will no matter what be a costly service to provide because of the cost of training providers. But yeah, I agree – my post is part charicature and I don’t claim anywhere near the expertise to determine why docs charge what they do.

    Some of what you say is true…though you’re making an empirical claim and supporting it with a sort of economic textbook rationale…the only really convincing thing would be EVIDENCE that current costs (do you want to say you’re right for every procedure, or just the ones to which you’re replying?) are in fact just what’s required to support R and D and etc. (not saying you’re wrong…only saying it’s empirical). And it’s not as easy to run on a patent as you say, because a wily chemist will be able to extend them, or have unreported steps in the synthesis (whoops I’m not supposed to type that…delete all the harddrives and meet me in blue quadrant!!!!!)

    Of course it’s not a perfect point, and it does underestimate the assholeness of drug companies in a lot of ways – but the reality is medication is going to be expensive. I read once that for every drug produced there are thousands of potential molecules discarded. It needs to be effective, with minimal adverse effects, survive passage into the body, arrive at the targeted cells, have its effect, then be broken down into metabolites that are nontoxic. That’s a pretty specific list of requirements, so it’s no wonder that the process is expensive.

    Plus drug companies are, even post-R&D costs, extremely profitable – among the best investments in the stock market. They’re very good at making a profit and paying out dividends. I’m not saying the price charged for new meds is fair – just that drug companies can’t simply charge the cost to manufacture a molecule. They could, but they’d go out of business very quickly. But someone has to pay for drug R&D as well as manufacturing. It could be the government with your tax dollars, but in the US, Canada and most of the world it’s private industry.

    Pretty much everything I’ve said is a charicature of the process, in terms of the development process, patenting, ethics of drug companies, how prices are set and more. My overall point I still stand by – medicine is going to be expensive, and not simply out of greed. If people are interested in knowing why, here are some basic starting points. Medicine isn’t expensive because CCSVI works or “the man” wants to keep effective treatments out of circulation.

  73. MSdragonslayer says:

    @ bluedevilRA What is absurd today often becomes tomorrows reality – like people – the vast majority of them- used to think the earth was flat. Just because you do not know something, does not make it absurd. It makes you close minded. Flying used to be considered absurd but today not only is the world spherical but we can and often do fly around it. The only thing absurd here is that you think you are the be all, end all where knowledge is concerned and that because you have a knee jerk reaction to what I have said, that it is illogical. Blanket statements are dangerous playthings. There are always exceptions and to ignore them is foolish. And do not read your own illogical thoughts into what I have written. I never said I had a “superhuman immune system”. I don’t. I get bladder infections quite often. But I do not get the flu and colds. The point I was making was that there is not a whole heap of logic to the autoimmune hypothesis. Hypothesis is another word you might like to check out in the dictionary. It is not a law; it is a theory and one that does not have a lot of basis in fact. But you will never know that unless and until you talk to those who suffer MS.

  74. WilliamLawrenceUtridge says:

    @ bluedevilRA What is absurd today often becomes tomorrows reality – like people – the vast majority of them- used to think the earth was flat.

    But unlike that point in time, nearly all knowledge in the world is based on empiricism, which is to say reality. You can’t compare MS research today with flat earth beliefs a thousand years ago. You appear to be alluding to a paradigm shift, which could occur in MS research. But a new empirical paradigm must explain all the observations made under the previous paradigm, as well as any outlying, new or contradictory data. Don’t know if CCSVI does that.

    Just because you do not know something, does not make it absurd. It makes you close minded.

    It’s not closed-minded to ask for evidence before making up one’s mind. Would you buy a car from a dealer who accused you of being closed-minded when you asked about the gas mileage?

    I never said I had a “superhuman immune system”. I don’t. I get bladder infections quite often. But I do not get the flu and colds.

    You mean you don’t get signs or symptoms you attribute to influenza or rhinoviruses. Pretty much the only way to establish actual infection would be lab tests.

    The point I was making was that there is not a whole heap of logic to the autoimmune hypothesis. Hypothesis is another word you might like to check out in the dictionary. It is not a law; it is a theory and one that does not have a lot of basis in fact. But you will never know that unless and until you talk to those who suffer MS.

    If experiencing the disesase was all that was necessary to treat a condition, we would have cured every disease in existence by now. Experiencing a disease isn’t necessary to treat or diagnose a condition, but empirical research is. Theories stand or fall based on how well they integrate facts and allow accurate predictions. There are several possiblities here:

    - CCSVI is not the etiology for MS
    - CCSVI is the sole etiology for MS
    - CCSVI is the etiology for some types of MS

    The only way to tell which is which is through research. It’s possible CCSVI will explain all MS through some hitherto-unappreciated mechanism. It’s possible CCSVI will explain the symptoms of some MS patients. It’s possible CCSVI is an erroneous hypothesis, and explains nothing.

    A truly open mind accepts all three might be true, and waits for the evidence to verify or disconfirm the theory. If you refuse to believe CCSVI could be wrong, no matter what the evidence, you’re being as closed-minded as someone who refuses to believe it could possibly explain MS.

  75. DavidRLogan says:

    @WilliamLawrenceUtlidge

    Thanks for the thoughtful and detailed response…good points. Two hours later, I can say I had no good reason to post a response like I did to your flippant comment…obviously you knew it was a more complicated issue. But for whatever reason I can’t stop posting on the internet and trying to sound smart…I always regret it immediately. I have a personal beef with medical costs and so I was reactionary about it online instead of doing something constructive this morning ie I’m a total waste of space haha (I’m only half joking).

    Have a nice day…thanks again for your perspective.

    -David

  76. @MSdragonslayer

    The point I was making was that there is not a whole heap of logic to the autoimmune hypothesis. Hypothesis is another word you might like to check out in the dictionary. It is not a law; it is a theory and one that does not have a lot of basis in fact. But you will never know that unless and until you talk to those who suffer MS.

    Quite simply, you are wrong about MS. There *is* a “whole heap of logic” to the autoimmune theory of MS. If you actually read up on it, you’d see the types of immune system cells we find in MS lesions, that we find increased quantities of immune system cells in the CSF of MS patients, and a ridiculous number of other things. In fact, the vast majority of all of our understanding of MS points towards an auto-immune disease. There is some evidence that it may be an immune system disease but not auto-immune. There is very little, if any, evidence that it is related to a vascular cause.

    These are 100% facts. Everything I said is verifiable if you actually took the time to read the literature. Your statement that there isn’t much to the autoimmune hypothesis is purely ignorant. You simply don’t know what you are saying, and you are talking out of your rear. Just because you make something up and write it, does not make it true.

    By the way, you clearly do not understand science, because you completely fail at differentiating between hypothesis, law, and theory. A theory is a concise and coherent collection of facts that have been repeatedly confirmed that explain some aspect of the natural world (for example, we take all of our facts that we know about MS and compile them into the autoimmune theory of MS.) A law is a description of how nature works (ie, Laws of Thermodynamics.)

    A theory is *never* promoted to a law, because they describe different types of phenomena. So your statement of the autoimmune theory of MS not being a law is nonsensical. It’s like saying “You’re wrong, because a bird isn’t a truck.” Furthermore, your statement that the theory does not contain a lot of facts is also completely wrong, because a theory is nothing more than a collection of facts.

    This your 3rd or 4th post where you’ve said absolutely nothing of substance, and have only repeatedly said incorrect things. Do you have anything of value to contribute? Or do you only make stuff up randomly and type it into the little box and click Submit?

  77. WilliamLawrenceUtridge says:

    David, you actually underscored my point – it’s complicated :) I’ve read just enough on the topic to realize it’s not simply a matter of “Big Pharma is EVUL for the LULZ!!!”

    I dislike having to defend drug companies and the costs of medicine, but not as much as I like the lazy habit of assuming an entire industry is not just greedy, but evil. It’s absurd and it helps no-one.

  78. bluedevilRA says:

    I am not the one making the bold claim. You implied you are immune to influenza and colds. There are 100′s of possible causes of a upper respiratory tract infection. Over 200 different viruses, plus many more bacterial causes. There are over half a dozen different serotypes of influenza A. So you’re immune to all of them? I guess the H1N1 pandemic didn’t really scare you…

    “I have never had the flu though I have been surrounded by it. I have never had a cold. In fact I have never had anything much.” – direct quote. Your statement asserts that you have had hardly any infections in your life. I do not think I read too much into that. I may have mocked it a bit, but I think “superhuman” is a decent word for what you are describing. If everyone else is vulnerable to infection except for one man (or a dozen people or whatever) would that man not be considered to have a superhuman immune system? So yeah, you really are claiming to have a superhuman immune system (minus the backpedaling on the cystitis). Now at least put your Wolverine abilities to good use and spend some time around people with severe infections. Maybe dedicate your life to helping people who suffer from leprosy? I’m not being facetious either. Seriously, if I had an immune system that I believed was capable of withstanding all kinds of infections, I would put my money where my mouth is and volunteer my time to help people with severe infections that most other people wouldn’t want to go near for fear of infection (sadly, the stigma against leprosy sufferers still exists in some countries, like India, so you could do a lot of good). But I would never believe that I was immune to 100s of different infections. So when I treat patients, I will be sure to wear gloves, wash my hands, etc.

  79. MSdragonslayer says:

    @WilliamLawrenceUtridge
    “Because the balance of the evidence supports immune involvement for MS, not cardiovascular. Because the treatment has yet to be tested appropriately. Because the treatment puts people at risk and uses up scarce health care dollars.”

    That is not an answer to my question. I have already discussed the meaning of ‘evidence’ and all that what you have said is that what YOU believe is that the immune is involved. If the facts really supported that, you doctors and scientists would have found a cure or at least a viable treatment by now. And so far you have turned up nothing reliable. MS is so vague in fact and so all inclusive that how could you really? Have you not entertained the idea that because it is so vague that possibly more than organ has a hand in the total picture? No one has ever said that venoplasty was a cure – except folks like yourself. What about 60% of those who had venoplasty HAVE said is that venoplasty has alleviated one or more of the myriad of symptoms. Show me one person who has been relieved of all their symptoms and I think you might be looking at someone who was misdiagnosed with MS when, in all likelihood,they had a cardiovascular problem. Just a thought but perhaps people who appear to have MS should be tested for cardiovascular difficulties. While you are at it, you might check them out properly for Lyme Disease which is another disease that is misdiagnosed as MS. That would certainly be more thorough and save some people a good deal of grief and expense. If you are a doctor in the business of doctoring for the betterment of the patient, that is what you would do. If you are a doctor who is only interested in his/her own bank balance, you will carry on as usual.

    About symptom relief – If you have MS, chances are you have a lot of various and varying symptoms. Why some have different symptoms and to different degrees to mine is just a guess but my guess is the location of the lesions, the number of lesions and perhaps the age or depth of the lesions. Perhaps the chemical makeup of those lesions? I don’t know really but it seems a good possibility. In any case, if an MSer has, say 10 different symptoms that make daily life very unpleasant, then getting rid of just one of them is a high point. Getting rid of several is really great. Better yet would be to be able to specify which symptom we would be happiest to get rid of but at this time that is only a dream. If you do not understand the meaning of symptom relief in MSers, well at the risk of sounding like a broken record, start listening to your patients.

    Your final response to that particular question was that it put patients at risk and uses up scarce health dollars. Give your head a shake. Compared to treatment that have been accepted without a word of controversy like heart transplants, the risk is almost nil. Compared to the C.R.A.P. (error intentional :o) Drugs it is way less but you have no problem writing out those prescriptions. And about the health dollars. I’m not entirely sure which side of the border you are on but here in Canada those drugs I mentioned cost $1,500.00 per patient per month all the way up to $4,000.00 per patient per month and there has been no symptom relief or cure in any of them. The cost of venoplasty would be less than $4,000.00 per patient once or for some once a year. Some of us would be able to go back to work (some who have had the treatment already have) which means less tax money spent and more tax money available. Maybe your argument holds water in the States but I rather think it doesn’t. I will be back to respond to your other comments but I do have MS and it has destroyed my use of my right hand and arm so speed typing is no longer a part of my resume and writing this with only one hand leaves me fatigued.

  80. PJLandis says:

    So, can we agree that the evidence for MS having an auto-immune component is strong (I’m not even gonna cite that because a quick PubMed search will inundate you) while the evidence that vascular issues, e.g., CCSVI, contribute to MS is vanishingly small (so much so that every available study is likely already cited in these comments) for the moment?

  81. PJLandis says:

    We know that HIV causes AIDs but we still don’t have a cure, are you gonna deny that HIV causes AIDs now?

  82. PJLandis says:

    “What about 60% of those who had venoplasty HAVE said is that venoplasty has alleviated one or more of the myriad of symptoms.”

    Because there haven’t been any studies of people, as opposed to anecdotes, how can you know that 60% have had any symptom alleviation? 60% of how many people? Where were they treated? Was there a control group? Does that include the two people who died?

    Did you just make that number up?

  83. MSdragonslayer says:

    @ PJLandis – Better to remain silent and be thought a fool than to speak out and remove all doubt

  84. @MSdragonslayer,

    You can’t possibly believe that you have made any “ground”, can you? There is virtually no evidence supporting a vascular etiology for MS. I tell you what, why don’t you go find a slew of studies that supports your view point, and convince us that MS is vascular and not auto-immune in nature. After all, practically all evidence synthesized from around the world by researchers and doctors points towards auto-immune. But you know better, right? So, why don’t you enlighten all of us dumb doctors and show us the error of our ways?

    By the way, do you have an intelligent rebuttals of the slew of studies that PJlandis posted?

  85. WilliamLawrenceUtridge says:

    That is not an answer to my question. I have already discussed the meaning of ‘evidence’ and all that what you have said is that what YOU believe is that the immune is involved. If the facts really supported that, you doctors and scientists would have found a cure or at least a viable treatment by now.

    You appear to be under the impression that the immune system is easy to understand. It’s not. In cases where the immune system is known to be involved, such as lupus, there is still no cure (merely symptom control). Knowing a cause isn’t the same thing as being able to prevent or treat it. We know what causes cancer – still can’t prevent or treat it. To miss something as clear as vascular flow and mistake it for autoimmunity would be indeed quite a blunder. Perhaps it’s right, but I’m doubtful that so many researchers could be so wrong for so long. We’ll see. Belligerence does not speed the research process, nor does calling researchers stupid.

    And so far you have turned up nothing reliable. MS is so vague in fact and so all inclusive that how could you really? Have you not entertained the idea that because it is so vague that possibly more than organ has a hand in the total picture?

    I’m not an MS researcher, just a layperson. It’s possible MS is multiple conditions, some of which may be caused by CCSVI. I actually alluded to this possibility in my post.

    No one has ever said that venoplasty was a cure – except folks like yourself. What about 60% of those who had venoplasty HAVE said is that venoplasty has alleviated one or more of the myriad of symptoms. Show me one person who has been relieved of all their symptoms and I think you might be looking at someone who was misdiagnosed with MS when, in all likelihood,they had a cardiovascular problem.

    I’ve never said venoplasty was a cure, but others think do seem to think this.

    I can point to the thousands of years where people thought bloodletting was a cure for nearly everything and attributed their improved health to leeches. Yet now we don’t use leeches – because we tested the theory and it failed. Testing will bear this out, and proclaiming CCSVI a cure now is premature. If it’s genuinely helpful, we’ll find this out.

    Just a thought but perhaps people who appear to have MS should be tested for cardiovascular difficulties. While you are at it, you might check them out properly for Lyme Disease which is another disease that is misdiagnosed as MS. That would certainly be more thorough and save some people a good deal of grief and expense. If you are a doctor in the business of doctoring for the betterment of the patient, that is what you would do. If you are a doctor who is only interested in his/her own bank balance, you will carry on as usual.

    Perhaps, which would prove misdiagnosis is a problem (valuable to know, but not exactly revolutionary). MS doesn’t have an absolutely definitive test available before autopsy. Which is a shame – but doesn’t mean CCSVI is the cause.

    About symptom relief – If you have MS, chances are you have a lot of various and varying symptoms. Why some have different symptoms and to different degrees to mine is just a guess but my guess is the location of the lesions, the number of lesions and perhaps the age or depth of the lesions.

    It’s funny, you curse at doctors for being uncertain – yet you are uncertain about the causes of symptoms. Uncertainty is a fact of life and medicine, it’s no crime to admit it.

    If you do not understand the meaning of symptom relief in MSers, well at the risk of sounding like a broken record, start listening to your patients.

    I’m not a doctor, I don’t have patients. I am a taxpayer, and for ethical and fiscal reasons, I don’t want CCSVI offered as a treatment until it’s been tested properly.

    Compared to treatment that have been accepted without a word of controversy like heart transplants, the risk is almost nil. Compared to the C.R.A.P. (error intentional )

    Heart transplants and MS treatments are quite different, are they not? Designed to address different pathologies? Not to mention – it’s easy to see if a heart transplant works or not – the patient lives or dies. Comparing this to the protean symptoms of MS that treatment attempts to address is rather inapt in my mind.

    Drugs it is way less but you have no problem writing out those prescriptions. And about the health dollars. I’m not entirely sure which side of the border you are on but here in Canada those drugs I mentioned cost $1,500.00 per patient per month all the way up to $4,000.00 per patient per month and there has been no symptom relief or cure in any of them.

    I’m in Canada, and again I’m not a doctor so I write no prescriptions.

    So none of these drugs provide any symptom relief whatsoever? Or none of those drugs have helped you? Those are very different things.

    Also, symptom relief and cure are very different things, conflating them does not help. We may have drugs that can ease symptoms – and this is a good thing even if they don’t cure.

    The cost of venoplasty would be less than $4,000.00 per patient once or for some once a year. Some of us would be able to go back to work (some who have had the treatment already have) which means less tax money spent and more tax money available. Maybe your argument holds water in the States but I rather think it doesn’t. I will be back to respond to your other comments but I do have MS and it has destroyed my use of my right hand and arm so speed typing is no longer a part of my resume and writing this with only one hand leaves me fatigued.

    And that’s $4,000 wasted if venoplasty is ineffective, which we won’t know until the treatment has been tested with proper controls. Currently tax dollars are being spent on investigations – at this stage that is the best use of tax dollars, and patients paying for the treatment privately would be better off passing those funds off to researchers to conduct more research.

    I’m not arguing that venoplasty would be a good use of funds were it effective. I’m just pointing out that it is still not established whether it is effective.

  86. Big Sleepy Mac says:

    Breaking news: KIRSTY DUNCAN QUESTIONS THE GOVERNMENT DURING QUESTION PERIOD IN THE HOUSE TODAY, 21 JUNE 2012
    by C.C.S.V.I. Ontario on Thursday, 21 June 2012 at 16:03 ·

    In Question Period in the House today, 21 June, Kirsty Duncan served notice on the government that she intends to table a motion to instigate an investigation into the handling of CCSVI by CIHR.

    Kirsty Duncan, Etobicoke North: Today Maclean’s magazine published the article, “The Silent Treatment”, an expose of the government’s mishandling of CCSVI.

    It details explosive conflicts of interest, politics over science, and the Canadian Institutes of Health Research admitting “we hadn’t seen the crisis coming”.

    Today I intend to place a motion on notice calling on the government to ensure Health Committee investigate CIHR’s handling the development of a registry and clinical trials for CCSVI.

    Will the Minister of Health commit to an investigation?

  87. PJLandis says:

    Considering that MSdragonslayer has bee reduced to insults, I sincerely hope you will look into the studies I’ve cited. Real studies are always more interesting than the ones you make up yourself. MS isn’t dragon, it’s a real disease, and only real science is going to relieve the symptoms or cure it; false hope doesn’t help anyone.

    Here’s a good Medscape article that covers this issue: http://www.medscape.com/viewarticle/732683

    It’s interesting to note that Zamboni, the guy who started this craze, is strongly against the CCSVI procedure because he agrees that there isn’t enough evidence to justify it’s use. He explicitly calls it’s performance , outside of a controlled trial, “unethical.”

  88. PJLandis says:

    Just read a good book covering one researchers attempt to develop an MS treatment.

    Human Trials, by Susan Quinn

    It’s somewhat geared toward the business end, but it gives a really good overview of all that goes into trying to find real cures or even marginal benefits for a disease that can’t be reduced to one bug.

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