New MS Treatment?

[Villagemaid]

Thanks Peaceseeker....

I woke up this morning after a SOLID eight hours of sleep (and long nice dreams).

Amazing.....I could barely go two hours before waking up because of restlessness, pain, having to pee.....total broken sleep.

It isn't Rocket Science to know that deep sleep is restorative sleep and to finally have that is a GOD SEND!!!!! No wait, actually it's due to a simple procedure to open up my narrowed veins. Really. And I do believe we can attribute the endless drive and pursuit of everyone with MS and the people who love them that this will not let this fade into the shadows the GOD SEND.

[peaceseeker]

Thanks Peaceseeker....

I woke up this morning after a SOLID eight hours of sleep (and long nice dreams).

Amazing.....I could barely go two hours before waking up because of restlessness, pain, having to pee.....total broken sleep.

It isn't Rocket Science to know that deep sleep is restorative sleep and to finally have that is a GOD SEND!!!!! No wait, actually it's due to a simple procedure to open up my narrowed veins. Really. And I do believe we can attribute the endless drive and pursuit of everyone with MS and the people who love them that this will not let this fade into the shadows the GOD SEND.

I, too, experience nightly sleep deprivation due mainly to having to go to the bathroom - at least four times a night...and usually quite restless throughout the night - lol, never have to worry about my alarm waking me up!

Looking forward to dreaming again...haven't had one in years.

[peaceseeker]

Peaceseeker, Thanks for that. A well balanced letter and believe me, I know one person managing MS symptoms through diet who could read this and weep.

You're welcome QK...is the pwMS you refer to looking to be diagnosed and treated for CCSVI?

[peaceseeker]

Close-minded Negativity by MS Doctors Does Not Equate to Scientific Skepticism
Ashton Embry,
Sept 30th, 2010
https://docs.google.com/viewer?a=v&pid= ... MSoIJv7QHQ

Introduction
I read with great interest the Toronto Star article entitled “MS doctors attacked for their skepticism” which was published on September 24, 2010. I especially enjoyed the comments of the various MS doctors on their feelings and views on the reactions of persons with MS to CCSVI and to the doctors themselves. It would seem, by way of this article, the MS doctors (neurologists and researchers) are now trying to convince the media/public that they have been unfairly treated by some of their patients and that their only fault regarding CCSVI is to offer a “healthy” skeptical viewpoint.

In this essay, I would like to point out some of the information the MS doctors conveniently left out about their previous actions and why such actions were in a large part responsible for the hostility they have been experiencing. The main body of the text will be making the case that the MS doctors have reacted to the CCSVI concept and the potential value for MS of treating CCSVI, not with scientific skepticism, but with close- minded negativity. Finally, I’ll wrap-up with a few thoughts on why the discovery of CCSVI in persons with MS may have triggered such a reaction in the MS neurological community and how we might improve the situation.

Verbal Abuse of MS Neurologists
There is no doubt that Mark Freedman is the most reviled MS neurologist in the entire world and he has been trashed on numerous websites. I personally do not believe in ad hominem attacks and think there is no place in the world of science for such nasty, emotional responses. Mark has been subjected to many such attacks and a nice sampling is provided in the Star article. Mark naturally asks “What did I do — to warrant this kind of aggressiveness from their part?”. The answer to why he has been singled out for the most vicious attacks is rather straightforward.

In February, 2010, a few months after a CTV documentary brought the linkage of CCSVI and MS to the attention of the world, Mark publicly called CCSVI a hoax which is equivalent to saying that Dr Zamboni is a fraudster. This was the first mean-spirited, personal attack associated with CCSVI. So it is completely understandable that, once Mark opened the door to nasty name calling, he should not be surprised that persons with MS fired back at him with similar malicious taunts. I must admit I laughed out loud when I read Mark was called “The King of All Turds”. However, I don’t think any name that Mark has been called over the last 8 months is as outrageous or unethical as publicly implying that a fellow medical researcher is a fraudster. His lack of an apology to Dr Zamboni has only made matters worse.

It is worth noting that MS neurologists continue to bad mouth interventional radiologists who are doing venous angioplasty for persons with MS. Dr David Spence of the University of Western Ontario has been the most spiteful and has publicly referred to
IRs as unscrupulous charlatans, quacks and scoundrels. Recently Pat Coyle, a prominent neurologist from upstate New York, has called IRs “opportunists”. This ongoing bashing of interventional radiologists by neurologists, which started with Mark
Freedman inferring Dr Zamboni is a fraud, only encourages the hateful comments from both sides of the CCSVI debate. However, I find it very hypocritical of the neurologists and MS researchers to pretend they are victims in this ugly and unprofessional name-calling war when they are really active participants.

Neurologists have undoubtedly been the target of verbal abuse by their patients (muttered or otherwise). This has occurred most often when they have not provided balanced, objective information on CCSVI and MS and have curtly dismissed the
concept with a flippant remark. It is not hard to understand a negative reaction by the patients in such a scenario. I can readily imagine the frustration a person, who is spiraling into disability, must feel when their neurologist refuses to provide objective, non-judgmental information on a potential treatment which has seemingly helped many others. Such frustration and anger are magnified by the fact that the drug treatments strongly promoted by the neurologists have little, if any effect, on disease progression.

In summary, if neurologists want to have a positive reaction from their patients, they should consider providing solid, thorough, science-based information on CCSVI and MS. It would also help if they kept personal judgements and negativity to a minimum. I know for a fact that persons with MS who have experienced this relatively rare, yet reasonable, approach have not left their neurologist’s office in a huff.

Close-Minded Negativity or Healthy Skepticism

What is “healthy skepticism?
The main theme of the Star article is that the MS doctors feel they have been maligned and misunderstood when they told their patients there is nothing to CCSVI and to not bother being tested, and definitely not treated, for the condition. They seem to think such a viewpoint represents “healthy” skepticism which is a key part of the scientificprocess.

I agree that a scientist must, above all, be a skeptical empiricist which means, when a hypothesis is made, the scientist should doubt its validity until enough scientific data are gathered to provide solid support for the hypothesis. The first ingredient of such skepticism is to consider the theoretical likelihood of the hypothesis (rational criticism) and to actively pursue the compilation of available data so as to quickly assess its merits and to see if it meets the minimum requirement for further attention. If it appears that the hypothesis is reasonable from a theoretical point of view, and there are some solid data which support it, the next step is to promote the gathering of new data which will provide “acid tests” of the hypothesis’ validity.

I would stress that scientific skepticism of a new hypothesis does not entail a firm and unflinching belief that it is wrong until the acid tests eventually show otherwise. Skepticism involves open-mindedness which sees the hypothesis as possibly being
valid. As part of this open-mindedness, it is essential to keep examining the available data in an objective fashion until the answer is clear.

My final remark is that science can never say anything is absolutely true or is absolutely wrong. It only provides probabilities such as the hypothesis is very likely correct or it is almost assuredly wrong. It is worth gathering data and keeping an open mind until either of these two end members is reached. Even then, new data may cause the question of validity to be reopened at any time.

Close-minded negativity
In sharp contrast to healthy skepticism, close-minded negativity is not useful in science. It basically entails a refusal to objectively appraise both the theoretical appeal and the available empirical data for a new hypothesis. In this approach the hypothesis is seen as definitely being wrong or perhaps even a hoax. You can usually recognize close-minded negativity by general comments like “everyone’s knows it is wrong”, “it’s simply impossible” and “there are no data which support it”.

Those who practice this approach also are against research which might properly test the hypothesis and will often focus on minor bits of information which are not in perfect accord with the hypothesis. Such data are then construed as “disproving” the hypothesis. One of the biggest giveaways is the studious avoidance by those practicing close-minded negativity of any data which support the hypothesis.

The current science of CCSVI and MS
The concept of a vascular component as part of the MS disease process has been considered for about 150 years because it is theoretically reasonable and there were indications that veins were involved in MS from the time it was recognized as a disease. However, the hypothesis was never taken seriously by most because only a small amount of circumstantial data was available. The new findings of Paolo Zamboni and others that significant vascular problems are highly associated with MS have caused the vascular hypothesis to be seriously re-examined. At this time it has not been proven beyond any reasonable doubt one way or the other if CCSVI is an important factor in the MS disease process and that treating it will be of value. However, some aspects of the relationship between CCSVI and MS have been well established beyond a reasonable doubt and thus open-mindedness and continued data gathering and analysis must rule the day from a skeptical point of view

CCSVI was shown to be highly associated with MS by Zamboni’s original work and, importantly, this was confirmed by the very large and reliable University of Buffalo study (500 subjects blinded to evaluators) which found CCSVI was three times more common in persons with MS than in healthy controls. Any lingering doubt regarding this high association has been removed by the 5000 + CCSVI treatments which have been done worldwide in various centres throughout the world over the last 10 months. All published reports have found 90%+ of MS patients had CCSVI as demonstrated by selective venography, the gold standard for CCSVI detection. Notably, no treatment centre has ever found that more than a small percentage of persons with MS do not have CCSVI.

The question of whether or not CCSVI is part of the MS disease process is not as well established. However, the high association in combination with both the congenital origin of most of the vascular anomalies and the biologically plausible mechanisms that link the effects of CCSVI to the MS disease process (e.g. iron deposition, venocentricity of lesions, hypoperfusion, upregulation of endothelial adhesion molecules) indicate it is much more likely than not that CCSVI is a key part of the MS disease process. The reasoning behind this is that the accepted three main ingredients for strongly suspecting
a “causal” relationship between a pathology and a disease are: 1) high association, 2) appearance of pathology before the disease process begins and 3) biological plausible mechanisms linking the two. The CCSVI/MS relationship fulfills all three. Clinical trial research, which demonstrates the relief of CCSVI also lessens the MS disease process, is required if this very probable causal relationship between CCSVI and MS is to be established beyond a reasonable doubt.

Finally, the question of whether or not CCSVI treatment is of value for persons with MS remains very open. The current data, which consist of positive results from the Zamboni pilot trial and many hundreds of documented positive experiences from persons who have had CCSVI treatment, indicate that the treatment may well have efficacy but such data, although very encouraging, are far from convincing for a skeptical scientist.

These data, in combination with the established high association of CCSVI and MS, and the probable role of CCSVI as part the MS disease process, are sufficient to dictate that a proper clinical trial to test the effectiveness of CCSVI treatment is urgently required so that the hypothesis can be either accepted and used to guide actions or rejected and forgotten. Robert Maggisano, a vascular sugeon, said it best at a recent Parliamentary Subcommittee Hearing when he testified that “we need to get going on this, so that within a year or two we can let our MS population know the answer.” And there is no doubt persons with MS need to know the answer as soon as possible given the unrelenting progression of MS and the accompanying increase in serious disabilities.

With the above background on where the science now stands in regards to CCSVI and MS, we can now look at the remarks and actions of the MS doctors interviewed in the Star article to see if they are truly “healthy skeptics” or are better seen as “nattering nabobs of negativity”.

MS Doctors and Negativity
The question of whether or not Mark Freedman has exhibited healthy skepticism or close-minded negativity is not hard to answer. When one publicly declares CCSVI, which has a great deal of empirical data and theoretical reasoning to support it, a hoax, there is no question about this being a quintessential example of close-minded negativity. Mark has never offered any criticism of the CCSVI science and does not appear to know much about it. Mark also is quoted as claiming that “breathless
reporting fed the outcry for liberation treatment, overpowering their reasoned caution”. Actually it was not the reporting but the impressive science that was the foundation of the great interest in CCSVI. Furthermore, Mark has never offered any “reasoned” caution and, I doubt if it would be possible, given the very safe nature of venous angioplasty. Finally, Mark has never tried to find out for himself if CCSVI is a real phenomenon or not. A quick visit to a CCSVI treatment centre, or even a CCSVI research centre like the University of Buffalo, would provide him with a clear view of the reality of CCSVI in persons with MS. Such avoidance again demonstrates Mark’s close-minded negativity.

Anthony Traboulsee is the head of the MS clinic at UBC and is quoted in the Star article as “feeling that he and others are being penalized for being honest about skepticism, to let people know that yes, this is interesting, but gosh, there isn‟t a heck of a lot of evidence”. If Anthony was truly skeptical, he would have been reading the 100+ articles related to CCSVI and MS and would have realized there actually is “a heck of a lot of evidence” regarding CCSVI and MS. Furthermore, he would not have voted against the need for a CCSVI treatment trial as part of the CIHR/MSSC committee (Beaudet Committee) because a skeptical person wants to get the “acid test” done as soon as possible because that is the only way to remove lingering doubts.

Anthony is also quoted as saying that “Maybe it‟s not the cure and people don‟t want to hear that messaging”. This statement has no substance to it and Anthony should realize that that very few, if any, persons with MS see CCSVI treatment as the fabled “cure” for MS. Persons with MS see CCSVI treatment as a therapy which has the potential to reduce symptoms of MS. I suspect this is a message that Anthony does not want to hear. I have no doubt he had his hands over his ears when vascular doctors, who are doing CCSVI treatment, publicly stated that 1/3 of their patients have had significant improvement and 1/3 have had moderate improvements. Anthony prefers to use absurd extremes (people with MS do not want to hear CCSVI is not the cure) to avoid the main issue at hand. Again, this is another classic tactic of close-minded negativity.

Alexandre Prat is a young MS researcher who is quoted as saying “that there are a number of scientific truths that have been presented and that do not support the claims of these Italian scientists”. As discussed earlier, there is no such thing as “scientific truth” and it is shocking that a bona fide research scientist would make say such a thing. However, a baseless pronouncement of the existence of mythical scientific truth which disproves the CCSVI/MS relationship certainly fits very well with close-minded negativity. Regardless, I can only hope Alexandre will investigate the philosophy of science and I especially refer him to the works of David Hume, the 18th century Scottish philosopher.

Another MS researcher who is quoted in the Star article is Peter Stys of the University of Calgary. He has been researching methods of neuro-protection for about 25 years and only relatively recently has he concentrated on MS. All he can muster is the classic, negative generalization of "the science is just not there". I assume Peter has not taken the time to actually look at what is actually there or else he would not have made such a baseless statement. Perhaps he is avoiding all the data on CCSVI and MS so that he can escape having to agree that CCSVI research should be a higher priority than neuro-protection research which, after 25 years, has yielded no tangible benefits for persons with MS.

The last MS doctor quoted is Katherine Knox who is the head of the Saskatoon MS Clinic. She notes that “she takes the time to explain her concerns with the experimental treatment — including the risk of blood clots and that a stent in the jugular vein could travel to the heart as it did for one patient”. I doubt if Katherine also takes the time to mention that since the one serious adverse effect of a stent migration, 5000 treatments have been done with only a few very minor problems which were quickly addressed. Once again, a complete emphasis on one, very early, negative event out of 5000
treatments is not a skeptical response but is basically fear-mongering which is another component of close-minded negativity.

I could provide many examples of MS doctors exhibiting classic, close-minded negativity and I would be hard pressed to provide any examples of “healthy” skepticism. As mentioned previously, such skepticism requires open-mindedness and this is one quality that does not appear to exist in the fraternity of MS neurologists and researchers when it comes to CCSVI. The best example of such a lack of open-mindedness is the MS doctor-driven recommendation of the Beaudet Committee to not do any CCSVI treatment research. Healthy skeptics want to see the key research done so that a clear decision can be made on the validity of an important hypothesis whereas negativity mongers want to ensure there is no chance of a positive result being produced.

Another classic example of the close-minded negativity of the MS clinicians and researchers is their firm denial that the impressive and undeniable physical improvements enjoyed by thousands of persons with MS following CCSVI treatment are not real but are simply “placebo effect”. The absurdity of such a position is apparent to anyone who has watched a person who could barely walk before CCSVI treatment run 10 kilometres weeks after treatment. In fact, most of the reported improvements could not possibly be “placebo effect” and the use of this term to rationalize the documented improvements is yet another manifestation of the blind and inhumane negativity of the MS doctors. A scientific skeptic would be closely investigating the experiential accounts of persons with MS who have had had CCSVI treatment to determine their nature.

Why MS doctors have adopted close-minded negativity
Close-minded negativity is often adopted by an individual or group of individuals when it is apparent a hypothesis will result in problems for them if it proves to be acceptable and suited to guiding future actions. It is no secret that CCSVI treatment has the potential to replace current drug therapies which are very lucrative for many MS doctors by way of funding, honoraria, and gifts from drug companies. Furthermore, interventional radiologists rather than neurologists may become the primary care
providers for persons with MS with the advent of CCSVI treatment. This would result in a further loss of income and status for the MS doctors.

The MS researchers are very negative about CCSVI because it will command a huge amount of research money once it is accepted as a part of the MS disease process. This will result in far less money for the pet projects of the current researchers whose expertise resides in the immunological aspects of MS rather than the vascular ones. This fear of lost research money has been voiced on a number of occasions by MS researchers, including Mark Freedman.

Overall, the spectre of CCSVI being accepted as a key part of MS and as the primary target for MS treatment is not a happy one for the current MS doctors and researchers. Thus, it is somewhat natural, although a little discouraging, they have taken a close-minded, negative approach to it. In contrast, interventional radiologists, who are being smeared by neurologists as quacks, frauds and opportunities, are taking a healthy, skeptical approach. They are proceeding with open-minded caution and are starting to organize treatment trials so that a clear answer will be attained as soon as possible.

How MS doctors can become healthy skeptics
If the MS doctors, who are bemoaning the fact that their patients and the public don’t understand them, want to really become respected, healthy skeptics, I would suggest they actively start trying to see for themselves if CCSVI is a real phenomenon in MS and if CCSVI treatment is a safe, straightforward procedure. This can be achieved by simply spending a few days at an established CCSVI treatment facility such as the prestigious Arizona Heart Institute in Phoenix, Gary Siskin’s Clinic in Albany, NY or Marian Simka’s Clinic in Poland. There are many others to choose from and most are doing three to six CCSVI treatments a day.

At a clinic, the MS doctors could examine the venography for each patient and clearly see whether or not the venous anomalies which constitute CCSVI are present. Following this, they could watch the restoration of venous flow by way of venous angioplasty. Finally, they might well also see the positive effects of the treatment on the symptoms of the patients. Right now the situation is similar to doctors in Canada debating if a heart transplant was possible, while at the same time 100 heart transplants were being done throughout the world every day. This disconnect from reality by the MS doctors due to their close-minded negativity is definitely a problem.

To help alleviate this unfortunate situation, Direct-MS is prepared to help fund trips to CCSVI clinics by the five doctors interviewed in the Star article. Our charity sees such an initiative as being an effective way to help reverse the close-minded negativity which pervades the MS neurological community. We also call on the other main MS charity in Canada, the MS Society of Canada, to join us in this initiative and to share the funding costs. MSSC has repeatedly claimed they want to do everything possible to help persons with MS but their past actions on CCSVI have made many persons with MS skeptical of the veracity of such a statement. Their participation in this initiative, of helping some prominent, Canadian, MS doctors and researchers see for themselves if CCSVI is real or not, will go a long way to demonstrate that MSSC really has the best interests of persons with MS as their # 1 priority when it comes to CCSVI.

Summary
The claim by MS doctors and researchers that they are simply skeptical of CCSVI and the value of CCSVI treatment has no support. The statements and actions of the MS doctors and researchers demonstrate that they have taken a close-minded, negative approach and that they are studiously avoiding examining the available data and the results of ongoing clinical treatments for CCSVI. Furthermore, their claim that they are the innocent targets of malicious slander is also at odds with reality. Neurologists actively continue to slander interventional radiologists doing venous angioplasty. The latest public slur was delivered by a clinical neurologist during a CCSVI debate in Ireland (24/09/10) in which he called IRs charlatans, a favourite insult of neurologists in regards to IRs.

It is clear that ongoing, widespread, and sometime voracious, criticism of MS doctors is due mainly to their blind negativity in regards to CCSVI and to their unprofessional name calling in regards to interventional radiologists who are doing venous angioplasty. It has nothing to do with falsely perceived and completely absent scientific skepticism.

To help rectify the serious problem of the close-minded negativity of the MS neurological community, Direct-MS is offering to help fund five MS doctors to visit CCSVI treatment centres. This will provide an opportunity for the doctors to see for themselves the reality of CCSVI, the safety and ease of CCSVI treatment, and the types of improvements enjoyed by some after the treatment. MSSC is invited to join this necessary and potentially game-changing initiative.

[Queen K]

Peaceseeker, Thanks for that. A well balanced letter and believe me, I know one person managing MS symptoms through diet who could read this and weep.

You're welcome QK...is the pwMS you refer to looking to be diagnosed and treated for CCSVI?

I don't know yet, I'll direct her to this thread but, "you can lead a horse to water but you can't...."

[peaceseeker]

Peaceseeker, Thanks for that. A well balanced letter and believe me, I know one person managing MS symptoms through diet who could read this and weep.

You're welcome QK...is the pwMS you refer to looking to be diagnosed and treated for CCSVI?

I don't know yet, I'll direct her to this thread but, "you can lead a horse to water but you can't...."

I hear ya...wow, I thought trying to be diagnosed and treated for CCSVI was a no-brainer for a pwMS.

[peaceseeker]

Check out this Globe and Mail article "Globe Opinion poll" at http://www.theglobeandmail.com/news/opi ... icle+Links.

Do you think the controversial multiple sclerosis treatment, 'liberation therapy', should be made available in Canada?

Results at time of posting...

1273 votes Yes - 87%

191 votes No - 13%

[peaceseeker]

Buffaloed: The anti-CCSVI Bias of the University of Buffalo
Researchers and their Unsupported Interpretations
Ashton Embry, April 19th, 2011
https://docs.google.com/viewer?a=v&pid= ... 64GQ&pli=1

Introduction

Last week researchers from the University of Buffalo published the results of their 2009 research on the prevalence of CCSVI in various groups of people including 289 persons with MS, 21 persons who had experienced a clinically isolated syndrome (CIS) (often a precursor to MS), 163 healthy controls and 26 subjects who were suffering from other neurological diseases. The paper was made available online on the website of the medical journal Neurology (http://www.neurology.org/content/early/ ... 1.abstract ) and the University also issued a press release (http://www.buffalo.edu/news/12469) summarizing the main points in the paper. These same results were made public 14 months ago in February, 2010.

In this essay I will demonstrate that in reporting and interpreting these results, the researchers have displayed a clear and strong anti-CCSVI bias. I find this very disturbing because in the past the researchers have portrayed themselves as a neutral group wanting to only determine the “truth”. Because of this neutrality claim, the charity I am associated with (Direct-MS) has provided funding for CCSVI research at the University of Buffalo over the last 16 months. We would not have done so if we had known the researchers had a such a significant anti-CCSVI bias because such a bias cannot help but negatively affect their research effort and their publications as well as the public’s perception of CCSVI. Direct-MS is interested in funding only scientists who produce reliable results and who objectively interpret such results. Whether such results support or disprove
CCSVI is not a concern. We want the real story not a desired one. It is now painfully clear that the University of Buffalo CCSVI researchers are not capable of producing objective interpretations regarding CCSVI and MS and thus are not interested in the real story. The data they have produced are considered to be reliable but their interpretations of these data are so biased and
unsupported that they are inconsequential and have to be ignored.

Anti-CCSVI Bias in Data Reporting

The first obvious anti-CCSVI bias in the paper relates to how the percentage of persons having CCSVI was calculated for each group. For a diagnosis of CCSVI, two of five, blood flow parameters must be detected by Doppler technology. Unfortunately the Doppler technician had a problem with determining parameter 2 in a number of patients and, in 30 of these patients, one other parameter was positive. This created a problem of how to classify such patients (called borderlines) who tested positive for one of four parameters and may well have gotten a diagnosis of CCSVI if the last parameter could have been evaluated.

An anti-CCSVI bias would assign all borderlines to the negative CCSVI category despite the fact that the chance of all 30 borderline subjects being negative for parameter 2 is very remote. An unbiased approach would be either to exclude such borderline subjects from the statistics or to assume half of the borderlines were positive for parameter 2, and thus had CCSVI, and half were not.

The authors offer CCSVI percentages based on both a fair approach (borderlines excluded from the calculations) and an anti-CCSVI bias approach (assumed all borderlines were CCSVI negative). However, in their reporting of CCSVI prevalence throughout their Discussion section, they used only the anti-CCSVI biased numbers. This allowed them to unfairly downgrade CCSVI association percentages. For example, with an unbiased approach, 62% of those with MS have CCSVI whereas with the anti-CCSVI approach only 56% have CCSVI.

Overall, this is a minor point because the key ratio of persons with MS and CCSVI versus healthy controls with CCSVI is essentially unaffected and remains at ~2.5. However, by frequently quoting the biased and unrealistic, lower percentage for CCSVI prevalence in MS, the authors make it seem CCSVI is not as common in MS as it really is. This statistical trick provides the first indication that we are not dealing with objective researchers.

Anti-CCSVI Bias in Discussion of the Results

The largest and most blatant anti-CCSVI biases in the paper are found in the Discussion section. First of all, the authors completely downplay their key finding that CCSVI is far more common in MS patients (62%) than in the general population (26%). The one mention of this major result is at the start of the section where they say “Our findings are consistent with increased prevalence of CCSVI in MS” and then they downplay it even more by adding a “but” statement - “but substantially lower than the originally reported sensitivity/specificity rates in MS”. Given that the main question the research was designed to solve was whether or not CCSVI was significantly more prevalent in those with MS than the general population, such a lack of discussion and trumpeting of a very important, positive finding demonstrates the significant anti-CCSVI bias of the authors..

In the next paragraph of the Discussion, the authors report the percentages of CCSVI in the various groups using the biased percentages (“only 56.1%”) and then claim “These findings point against CCSVI as having a primary causative role in MS”. Such a claim is completely unsupportable. The fact that CCSVI has a much higher association in MS says it may have a causative role but not necessarily. However, association data for other categories cannot possibly be used to argue against (or for) causation.

For a factor to be considered a probable cause, one needs higher association (which the Buffalo data clearly and indisputably demonstrate), the presence of the factor before disease onset (no data presented in paper) and plausible biological mechanisms which link the factor to the disease process (no data presented in paper). The association data for the other groups have absolutely no bearing on whether CCSVI is a causal factor or not for MS. The fact that the authors try to spin the data and claim it argues against causation indicates an incredible anti-CCSVI bias on their part as well as a lack of understanding of how a causal relationship between MS and a given factor can be reasonably determined.

In the third paragraph, the authors claim that their association data argue against the published claim that lesions which cause CCSVI are congenital truncular venous malformations. This is false logic given the only way one can determine the origin of the lesions is to image the lesions with selective venography and intravascular ultrasound (IVUS). The association data have absolutely nothing to say about the nature of the lesions which are causing CCSVI in the various groups. Notably, selective venography and IVUS have clearly shown that many lesions causing CCSVI are indeed congenital malformations and the authors are well aware of this fact.

Given the above, the authors have exhibited both fervent anti-CCSVI bias and a tendency to ignore established data which do not fit their anti-CCSVI views. I assume the authors included their baseless attack on the existence of congenital lesions in CCSVI because, the established existence of such lesions which are formed before the MS disease process begins, in combination with the high association of CCSVI with MS (confirmed by the authors), and the well accepted, plausible biological mechanisms which link CCSVI to the MS disease process, leave little doubt that CCSVI is indeed a causal factor in many people with MS. It is not hard to understand why anyone with an anti-CCSVI bias wants to try to discredit a key aspect (e.g. lesions are congenital) of the well supported interpretation that CCSVI is very likely a causal factor for MS in many cases.

In paragraph four of the Discussion, the authors try to claim, on the basis of their data, that CCSVI is “a consequence of rather than cause of MS”. They do this on the basis of the data which show CCSVI prevalence becomes higher in more
progressive forms. On the basis of these data alone one could say either MS causes CCSVI or that the presence of CCSVI causes more severe MS. The clear anti-CCSVI bias of the authors is unmistakable given the fact they only mentioned the first possibility (argues against CCSVI) and not the second one (argues for CCSVI). Researchers with even a semblance of objectivity would have mentioned both obvious possibilities and perhaps indicated what observations might decide the question of which explanation is more likely.

Notably, available research on the nature of the some lesions involved in CCSVI demonstrates beyond a reasonable doubt that CCSVI is not caused by MS. Such lesions include webs, septa, inverted valves, malformed valves and external pressure from a bone or artery. It is impossible that such lesion types are caused by the MS disease process and thus any claim that the MS disease process is causing CCSVI has absolutely no support or validity. The fact that the authors completely ignore this obvious fact, which they are well aware of, is of great concern and leaves no doubt as to their complete lack of objectivity.

Press Release

The title and content of the press release which accompanied the publication of the paper were incredibly biased. This is an even more serious problem than the pervasive anti-CCSVI biases in the scientific paper because most public reporting of the research relies solely on the information in the press release.

The title of the press release is “Higher CCSVI Prevalence Confirmed in MS, but Meaning of Findings Remains Unclear”. An unbiased and honest title would have been “Higher CCSVI Prevalence Confirmed in MS”. The solid and indisputable confirmation of significantly increased prevalence of CCSVI in persons with MS is scientifically very important and is the big story.

The best they could say about the significantly increased prevalence of CCSVI in persons with MS is “While this may suggest an association between the MS and CCSVI”. Such a complete downplaying of their most important and uncontestable finding, and one which helps to establish CCSVI as a causal factor in MS, again indicates that the authors have a strong anti-CCSVI bias. An objective researcher would have said the results solidly confirm that CCSVI is associated with MS beyond a reasonable doubt and emphasized that this was by far the most important result of their research.

The authors also made sure they included in the press release the completely unsupported statements that “that chronic cerebral venous insufficiency may be the result of multiple sclerosis, not a cause” and that “These findings indicate that CCSVI does not have a primary role in causing MS". It was these inflammatory and entirely false, anti-CCSVI statements that made headlines in papers and on TV news channels in North America and Europe, thus completing a smear job on the concept that CCSVI may well play a key role in MS.

Discussion

There can be little doubt that the CCSVI researchers at the University of Buffalo have a significant, anti-CCSVI bias and want to discredit the concept. The entire neurological community shares the same anti-CCSVI bias. The simplest explanation for such a bias is the fact that if CCSVI treatment replaces drug therapy for MS, the neurologists stand to lose huge sums of money. Notably, the neurologists involved in the University of Buffalo research reported very extensive financial ties to pharmaceutical companies in the disclosure portion of the published article. Thus it is quite understandable that neurologists, including those at the University of Buffalo, are doing what they can to discredit the concept of CCSVI. Very few people would not fight against a concept that has the potential to greatly decrease their earning power.

So why would the University of Buffalo workers undertake such research in the first place. The most obvious and simplest answer to this question is that they were sure that the CCSVI concept had no merit and they wanted to be the researchers which proved there was no association of CCSVI with MS. There is nothing wrong with this motive and science progresses on the desire to falsify concepts. I would have liked to have been there when they realized their research effort clearly showed there was an undeniable association between MS and CCSVI. They must have been very surprised and dismayed that they did not achieve their goal of dispatching CCSVI to the garbage heap.

Notably, after the Buffalo researchers announced the positive results of their research in February, 2010, other research teams lead by neurologists immediately started to do research to prove CCSVI was not associated with MS. The University of Buffalo researchers had failed to get the job done so it was now up to others to save the neurological community from the potential devastation CCSVI might cause. Because of the urgency to discredit CCSVI as a factor in MS, these new studies were quick and dirty and a number of them were published in less than 6 months after the research was started, an unprecedented turnaround. This fact alone suggests a lack of scientific integrity of these studies which predictably found no association of CCSVI and MS. Few people outside of the neurological community have taken these studies seriously.

The University of Buffalo researchers had spent over a year and a great deal of money on their MS/CCSVI association study so they had to publish it. This put them in the dilemma of how to publish a study which was positive in terms of CCSVI and MS when their main goal was to falsify CCSVI. We now know how they solved that problem. In their formal publication and in the all-important press release which accompanied it, they greatly downplayed their main finding that CCSVI was indeed associated with MS. On top of this, they concocted completely unsupportable claims that their data suggested that CCSVI has no causal role in MS and CCSVI is likely an effect rather than a cause of MS.

The bottom line is that their data clearly show that CCSVI is indeed highly associated with MS and their data in no way indicate either that CCSVI is not a cause of MS or that it is an effect of MS. This is the real message their research has delivered.

Reconciling the Buffalo findings with CCSVI testing and treatment findings

About 20,000 persons with MS have been tested for the presence of venous blockages with selective venography and about 90% of them have been found to have significant blockages which required angioplasty to restore normal flow. Furthermore, MRV flow studies (very different from the MRV structural studies done at the University of Buffalo) of thousands of MS patients also indicate that about 90% have abnormal venous flow. Thus any question that CCSVI is not highly associated with MS has been put to rest.

An obvious question becomes why did the Buffalo researchers find only 62% of persons with MS have CCSVI whereas selective venography and MRV studies are finding venous blockages and flow problems in about 90% of persons with MS. I think the answer to this lies in the Buffalo data that are in the published paper. It was found that about 90% of persons with MS who were tested for all five parameters had at least one abnormal blood flow parameter. I suspect a single abnormal parameter as measured by Doppler may well indicate a significant blockage and associated flow problems which are imaged by MRV and selective venography.

The Future

It is now well established by large, well controlled association studies such as that of the University of Buffalo and by thousands of selective venographies and MRVs that CCSVI is highly associated with MS. We don’t need any more small, poorly done, association studies using non-invasive techniques administered by inexperienced technicians and supervised by anti-CCSVI neurologists. However, we will continue to see such studies as the neurologists continue to try to discredit CCSVI. I suspect that the seven association studies currently being funded by the MS societies and supervised by neurologists will be negative in regards to CCSVI. There are 10 billion reasons why this will happen.

Of course, the research that needs urgently to be done is an objective and comprehensive clinical trial which tests the effectiveness of venous angioplasty for MS. The thousands of reliable and well documented (video) reports of significant symptom improvement following venous angioplasty suggest such a trial will yield a positive result. Thus such a trial presents a huge threat to future cash flows of neurologists so I expect it will be quite a fight to get one funded and completed in a rigorous and objective manner. One can imagine the monumental efforts that will be made by some anti-CCSVI factions to try to ensure that any CCSVI clinical trial that gets off the ground will have a negative result.



Applicable song/video...

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[Queen K]

Anyone go to a clinic in New York lately and have good results with the Liberation Treatment?