Why "CCSVI" is Surreal

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Why "CCSVI" is Surreal

Postby griff » Thu May 05, 2011 3:00 am

It is an interesting article from the other side to initiate discussions:

http://medicalmyths.wordpress.com/2009/ ... i-surreal/

The Zamboni Myth: Why “CCSVI” is Surreal
Posted by Colin Rose on November 24, 2009

“Sorcery, astrology, acupuncture, and many other moonshine notions do not require research to be discarded – only clear thinking.”
– Heinz Klatt, prof. emeritus of psychopathology, London, Ont.

Extraordinary claims require extraordinary evidence.
– Carl Sagan

The plural of anecdote is not data.
– Joe Schwarcz

————————————————————————

This story has nothing to do with lifestyle diseases but it is valuable in showing the creation of a medical myth in real time. Usually the sort of papers published by Dr. Paolo Zamboni would have been rapidly relegated to the dumpster of science but this myth received a huge boost when two reporters working for CTVglobemedia, André Picard and Avis Favaro, usually quite rational, published a story and did a short documentary on it, calling it a “breakthrough” and related breathless anecdotal stories of dramatic “cures”. Thousands of MS patients and their relatives in Canada became convinced that Zamboni’s “treatment” was the cure they had been waiting for. Blogs were full of conspiracy theories and indignation that drug companies had suppressed this surgical cure and many demanded funding from MS charities and government to make the “liberation treatment” available to all MS patients. Even Brother André, of St. Joseph’s Oratory fame, the miracle worker canonized in 2010, who cured with holy oil, imbued with the healing power of St. Joseph, would have been impressed. The Vatican’s Theological Commission for the Causes of Saints has declared “scientifically unexplainable” at least one of the thousands of healing miracles attributed to Brother André. I hereby nominate Paolo Zamboni for consideration for canonization based on the hundreds scientifically unexplainable miracles attributed to him and his acolytes.


Brother André, canonized on October 17, 2010. The Vatican has determined that two of his miracle cures have no scientific explanation. Has the Vatican heard of Dr. Zamboni?

Dr. Zamboni has also performed miracles with no scientific explanation.

The Zamboni myth is also a good example of a surgical procedure that is “tested” on a few patients, proclaimed as a cure with no controlled trial, and then gets done on thousands of patients at great cost. Every few years the same thing happens. We have written about coronary bypass, coronary angioplasty and bariatric surgery. Why do surgeons have this power to ignore science? If one wants to sell a drug for treating a disease, one has to test the drug in controlled trials in animals and humans, testing that takes years and many millions of dollars, to prove it is safe and effective. Not for surgical procedures touted to be a cure for whatever disease. As long as a new procedure is not obviously killing most of the patients it is used on, surgeons can do as many as they want with no restriction. Why the difference between drug treatments and surgical treatments? Maybe because surgical treatments, like blood-letting of the past that killed thousands of patients, maintain a special mystique, an approach to disease that superficially seems so obvious it couldn’t be wrong. For an extreme example of surgical impunity see the history of Dr. Walter Freeman, the ice pick lobotomist.

Dr. Zamboni, a varicose vein surgeon at the University of Ferrara in Italy, was distressed that his wife developed multiple sclerosis, one of the more miserable of chronic, incurable diseases. He was determined to find the cause and the cure. Naturally, he focussed on veins, those vessels he had been operating on for years. As Mark Twain apocryphally said, to a man with a hammer everything looks like a nail.

However, in order for some abnormality in hemodynamics (blood flow and pressure) to cause damage to the brain there must be either or both of an increase in pressure in the small vessels of the brain or a reduction in cerebral blood flow. Neither have ever been shown to be a primary cause of MS. Undeterred by the principles of cardiovascular physiology, Dr. Zamboni hypothesized that MS might be analogous to varicose veins in the leg in which there is very high venous pressure that can lead to red cell leakage and iron deposition in the skin, known as stasis dermatitis. He imagined that some abnormality in the flow patterns of veins draining the brain, he calls “reflux”, caused by possible venous constrictions which somehow causes a leakage of blood from the small veins and an accumulation of iron in the brain, which somehow causes an autoimmune response which somehow damages the myelin sheaths of nerve axons, the basic pathology of MS. But, high venous pressure in the entire brain can only be caused by blockage of the superior vena cava which drains all the blood from the head and arms and not just a blockage in one or both internal jugular veins because of extensive collateral veins (see below). Superior vena cava syndrome causes swelling of the face and arms but has never been associated with MS. Carotid-cavernous sinus fistula can cause localized high venous pressure which is obvious from proptosis and congestion of eyeballs but, also, is never associated with MS.


Proptosis and congestion of the eyeballs caused by a carotid-cavernous sinus fistula. Venous pressure is very high, but patients do not get MS.



Undaunted, Dr. Zamboni set about looking for abnormal venous flow patterns in patients with MS. Download a PDF of his only major publication on his investigation to date.


Stasis dermatitis in a leg caused by high venous pressures secondary to defective venous valves in the large veins of the leg. Dr. Zamboni claims that the same process in the brain is causing MS. But in order to do so ALL of the veins draining the head would have to be obstructed as happens in the superior vena cava syndrome. One or two blocked veins cannot raise venous pressure because of the many collateral veins draining the cranial circulation.

Colour Doppler imaging is able to visualize structures and direction of blood flow within them. But instantaneous flow patterns in large veins about the heart are highly variable, being dependent upon patient position and breathing pattern, like breath holding or forced expiration. Looking for presumed abnormal patterns of venous flow, Dr. Zamboni used colour Doppler to image the veins in the neck and upper chest of some MS patients and some normal subjects in various positions and breathing status. These studies were blinded as to the diagnosis of the patient, he says. Even so, a variety of patterns could be produced in each subject and a selection made after. Then Dr. Zamboni made an unblinded selection of the MS patients who had the ”abnormal” flow pattern and did venous angiography to look for obstructions in the large veins. Now, when one is looking for a certain result of an action be it in science or any other field, unless one is extremely careful to isolate one’s action from the effect, one can even subconsciously alter to action to achieve the effect. Medical studies are particularly prone to this type of manipulation. That is why good journals will only publish rigorously blinded, randomized controlled trials of drugs or procedures. In this case, the person injecting the dye knew the diagnosis. The dye can be injected faster or slower or in different locations to give a picture that one predicts; the MS patients “should” have blockages, so the dye is injected at various places and speeds to find one. But one doesn’t likely look so carefully in the normal subjects. This is not necessarily conscious, fraudulent behaviour, but more often a subconsciously motivated action. Then Dr. Zamboni took these potentially biased venograms and made an unblinded selection of the ultrasound images that seemed to correspond to the “blockages” on the venograms, nullifying whatever randomization he had done initially. Then these patterns were classified in four “abnormal” patterns of flow which Zamboni calls “CCSVI, chronic cerebrospinal venous insufficiency” and which he claims is only present in MS patients are making an unblinded selection of images. “CCSVI” is presumably present from birth but only causes MS after 20 or 30 years. Possible MS causation by venous obstruction would be easy to test in an animal model but Dr Zamboni is not a “mouse doctor”, as he says. Doctors like William Harvey who discovered the circulation of the blood by animal experimentation and gave vascular surgeons, like Zamboni, employment are presumably just inferior “mouse doctors”.


“Abnormal” patterns of flow and obstructions in veins draining the head in patients with MS as divined by Dr. Zamboni from ultrasound images and venography. All of these patterns can be perfectly NORMAL, have no effect in raising intracranial pressure and, therefore cannot cause damage to the brain. “CCSVI” is just another name for normal variation in head and neck venous anatomy.
Veins, the capacitors of the circulatory system, are normally tortuous with bulbous dilations which store blood in case of sudden hemorrhage. It’s easy to show relative “obstructions” in normal veins needing “liberation”. Note the connections between the intra- and extra- cranial veins allowing diversion of venous flow in the case of occlusion of a jugular vein. Only blockage of the superior vena cava (the large vein at the bottom, leading directly to the heart) can raise intracranial pressure and potentially damage to brain and would be obvious from swelling of the face and arms.


Then Dr. Zamboni had the idea to open the “blockages”, to “liberate” them, with a balloon-tipped catheter and insert a stent to keep them open in the same manner as is done in coronary angioplasty. He has done a small non-blinded, non-randomized, non-controlled trial of what he calls the “liberation procedure” on his wife and a group of patients who all claim immediate relief of symptoms like fatigue, “brain fog”, heat sensitivity, cold feet, and facial colour, highly non-specific symptom, very susceptible to the placebo effect. The “liberation procedure” is the modern equivalent of faith healing; the name evokes the same emotion, one is liberated from evil spirits. If he had called it the “jugular vein stenting” would it have had the same placebo effect? With the waning of organized religion, instead of prayer to a divinity, modern, sophisticated but desperate people now put their faith in technology. Self-promoting surgeons wielding high-tech tools are modern shamans; no disease should be resistant to their power. Because of the long duration and intermittent nature of their disease, MS patients are particularly prone to the siren song of con artists of all sorts.




Another diagram of "abnormal" venous flows in the head as imagined by Dr. Marian Simka, a Polish acolyte of Dr. Zamboni. Those nasty looking red chevrons are supposed to indicate high pressures damaging the brain. But even total occlusion of both internal jugular veins does not raise intracranial pressure because venous flow is directed through the extensive perivertebral venous plexus.




Intra- (grey) and extra- (black) cranial veins. Emissary veins allow communication between intra- and extra-cranial veins. The transient rise in venous pressure with occlusion of an internal jugular vein is rapidly relieved by diversion of venous flow into the other extra-cranial veins.






Venous adaption after occlusion of the internal jugular vein so that there is no increase in intracranial pressure and no damage to the brain including MS.

Digital subtraction angiography of the cranial circulation (venous phase) after removal of both internal jugular veins for cancer showing diversion of intracranial venous flow through the emissary veins at the base of the skull into the extracranial veins so that intracranial pressure is not increased. So, even total occlusion of both internal jugular veins cannot cause brain pathology including MS.

——————————————————————————————————————————————–

Why “CCSVI” is surreal:

1. Perhaps the most potent physiological argument against the Zamboni myth is that if, for whatever reason, brain blood flow were reduced, the first cells that would be affect are the high-oxygen consumption neurones in the grey matter, not the low oxygen-consuming, myelin-producing glial cells in the white matter, dysfunction of which is responsible for MS. Normally, blood flow to the white matter is very small compared to that to the grey matter. So, any theory of MS causation that invokes some aspect of blood flow is absurd. With any cause of reduced cerebral blood flow, one would lose consciousness long before there was any damage to glial cells in the white matter.

2. Chronically high central venous pressure (high pressure in all cerebral veins) does not cause MS. There are a number of cardiac conditions, such as tricuspid insufficiency and constrictive pericarditis, in which central venous pressure and jugular pressure are markedly elevated over long periods. Never has MS been described as a complication of these diseases.

I note that Pacific Interventionalists of Southern California who consider themselves experts in treating diseases of the veins and say they are doing treatment for “CCSVI” initially had the following on their patient info page:

“Currently the relationship between Multiple Sclerosis (MS) and CCSVI is still being defined and is debated among leading MS experts. However, many of the symptoms of central venous occlusion and stenosis seen in CCSVI are well understood and have been treated for many years. Central venous occlusion and stenosis may cause a variety of symptoms including swelling of the head, face, or neck, skin color changes within the head, face, or neck, swelling, heaviness, and throbbing of the arms, and occasionally light headedness.”

Note that they confound CENTRAL venous occlusion, (superior vena cava syndrome) with “CCSVI” (presumed or real blockage of jugular veins) which does not raise distal venous pressure because of collateral venous drainage. Central venous occlusion has never been associated with MS.

3. Chronic occlusion of one or both internal jugular veins does not increase intracranial venous pressure and, therefore cannot cause brain pathology. Intracranial pressure is increased transiently after internal jugular vein occlusion but quickly returns to normal as collateral veins open. Collateral perivertebral veins are adequate to handle venous drainage from the brain.

4. Zamboni’s paper says there was NO INCREASE in jugular venous pressure, the only parameter that matters if “CCSVI” is to damage the brain. The small gradients observed across presumed “stenoses” are not pathologically significant. So there is no way that whatever Zamboni is seeing could possible cause pathology. If “CCSVI” is causing brain pathology, it must do so via some mysterious, unmeasurable, un-disprovable “reflux”, not amenable to the scientific method.

5. Here are venograms of the internal jugular vein of an MS patient done in Poland before and after presumed cure of a stenosis which is presumably causing the MS. There is no way that slight indentation of the vein, which may even be just an artifact of how the dye was injected or catheter placement in a very thin-walled vessel, could cause a significant increase in upstream pressure enough to cause damage to the brain and cause MS. It is highly unethical to insert such a stent without hemodynamic proof of the importance of the “obstruction” by measuring a significant pressure gradient across it.


Left: a presumed stenosis in the IJV. Right; presumed cure of the stenosis with a stent. This is a perfectly normal IJV. Inserting rigid stents into large, thin-walled veins is potentially disastrous. Rupture of a large vein in the chest would be very hard to repair. Pressure cannot be applied to stop bleeding and patients could bleed to death internally before repair could even be attempted.
Here is a video from the same Polish lab doing “liberation”. Note the streaming of the dye along the wall giving the appearance of a severe stenosis. Injecting dye slowly into a large volume vein with laminar flow will result in streaming along the lamina. This internal jugular vein is perfectly normal. As one can see in the reconstruction above there is a normal relative constriction in the normal IJV as it enter the larger innominate vein. It appears that these doctors are doing stenting of normal veins and telling MS patients they have been “liberated.” High tech, dangerous snake oil.
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Postby griff » Thu May 05, 2011 3:27 am

I have already gone through a CCSVI procedure. The article does not reflect my opinion about CCSVI, but I would like to see both sides of the coin.
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Re: Why “CCSVI” is Surreal

Postby frodo » Thu May 05, 2011 7:39 am

griff wrote:Why “CCSVI” is Surreal

Exactly in which paragraph of this text is justify that “CCSVI” is surreal? All I have read here is the opinion of a person, and with a very biased vocabulary.
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Postby WeWillBeatMS » Thu May 05, 2011 8:51 am

Hi griff. Welcome to TIMS. I see you joined a little over a month ago now and your posts always seem to have a consistent theme.

Just wondering if you might be so kind as to tell us a few things such as...

1) if you or a loved one has MS and when the diagnosis was
2) when and where you had the procedure to correct CCSVI

Thanks,

WeWillBeatMS
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Postby ikulo » Thu May 05, 2011 9:01 am

Most of Rose's statements also have no basis in fact. I would absolutely love if he could provide references for most of his conclusions (e.g., "first cells that would be affect are the high-oxygen consumption neurones in the grey matter").
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Postby Cece » Thu May 05, 2011 9:07 am

Dr. Trapp presented on this at ISNVD. There has been shown to be axonal gray matter damage very early in the disease process due to a "hypoxia-like" process.

http://ccsvism.xoom.it/ISNVD/Abstract-Trapp.pdf
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Re: Why “CCSVI” is Surreal

Postby NHE » Thu May 05, 2011 9:28 am

frodo wrote:
griff wrote:Why “CCSVI” is Surreal

Exactly in which paragraph of this text is justify that “CCSVI” is surreal? All I have read here is the opinion of a person, and with a very biased vocabulary.


There are also insults...

Usually the sort of papers published by Dr. Paolo Zamboni would have been rapidly relegated to the dumpster of science


...and blatant inaccuracies...

Then Dr. Zamboni had the idea to open the “blockages”, to “liberate” them, with a balloon-tipped catheter and insert a stent to keep them open in the same manner as is done in coronary angioplasty.


Which makes Mr. Rose's own writing worthy of recarpeting a parakeet's cage.


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Postby bluesky63 » Thu May 05, 2011 9:42 am

Since this exact piece has already been discussed here, and reposting it is just going round the same stuff, do we need to do it again? I can't find the posting terms of service (I am really bad at searching) but it doesn't feel like re-posting a very old piece we've discussed ad nauseum is advancing us much. :-)

Perhaps anyone interested can just look for the old discussions?

Feel free to disagree! As though I have to say that! :-)
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Buy the Book !

Postby MegansMom » Thu May 05, 2011 12:42 pm

Dear Griff,

It is my sincere suggestion to you that you buy Marie A Rhodes new book on CCSVI.

Its called " CCSVI as the Cause of Multiple Sclerosis: The Science behind the Controversial Theory".

This book is well worth the money and explains so much. In fact it clarifies and verifies what is theory and what has been proven so far.

I read that you already had CCSVI treatment ? what were the findings? What was the treatment ? Where did you have it done and when?

You seem ( and I don't want to sound condescending) that you are just starting to understand the theory, not someone post-procedure. Forgive me but that is the impression I got from your posts.

My daughter was treated for her CCSVI 1 month after her MS diagnosis and she had relief of many (12) symptoms. But not before she ( and I ) had a solid understanding of the theory and the risks of treatment, weighed against the risks of MS progression and/or the risks of DMDs ( which she doesn't take)
She works full time, dances, works out, bikes, hikes, kayaks, and is a great mom (without her 12 symptoms).

The research showed us that:

Each patient must know that 30% see marked improvement, 30% see minimal improvement and 30% see no change.

It also showed the earlier you get treated the better the outcome.

It's too late to call it "SURREAL" for anecdotal reports might not count for research but those anecdotal patients ( like my daughter) are very REAL pwMS.
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My 35 yo daughter is newly dx 8/19/10 (had 12 symptoms)
Dx with Type A CCSVI- 1 IJV & double "candy wrapper" appearance of her Azygos
Venoplasty done Sept 21, 2010
Doing extremely well-
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Re: Buy the Book !

Postby 1eye » Thu May 05, 2011 2:00 pm

MegansMom wrote:Dear Griff,
It's too late to call it "SURREAL" for anecdotal reports might not count for research but those anecdotal patients ( like my daughter) are very REAL pwMS.


I saw and met quite a few of us on the hill today. We were all there, from the miraculous well to the stubborn plodders to the still waiting. I walked with the Nordic Ski poles down from the top where the speeches were, back to the eternal flame, where we had started. Used my walker the rest of the time. I stood for a lot of it. I had been there one year ago, pushed in a wheelchair. That's right. It's too late to call it a lot of things.

There were those who could not be there because of their CCSVI symptoms. I think there were also more than a few who missed the parliament hill event, because they suddenly had energy to devote to something besides being sick or getting well. There were also probably a bunch (I know Dr. Kirsty Duncan was one of these) who went to the Queen's Park demonstration, so their attendance at the Ottawa one couldn't happen.

It is a provincial issue, and Conservative politician Gord Brown reminded us that a previous federal government cut the agreed-on funding formula. From Wikipedia:
The amount of transfer payments from the federal to the provincial governments is always controversial, particularly in the area of health care, which is of particular importance to Canadians. The premiers of Canadian provinces allege that federal funding has decreased markedly since the beginning of publicly-funded health care, from fifty to sixteen cents of every dollar. The federal government denies this, saying that the provincial numbers ignore tax transfers and that federal funding never amounted to 50% of the cost of health care. The complexity of the funding formula means that each position depends on one's perspective.

Critics of the CHST, CHT and CST note that the programs have allowed the federal government to interfere in areas of provincial jurisdiction by giving Ottawa a powerful hammer (the threat of withdrawing the transfers to any province that displeases the federal government). With the possible exception of Alberta, any province which lost the CHT and CST would quickly face the collapse of its health care system, fiscal impoverishment or perhaps both. Penalties for violation of conditions for receiving the health and social transfers have so far been restricted to cash deductions, as opposed to what would likely be a far more controversial penalty of actually attempting to charge differential federal tax rates in the offending province.


Too late to call it placebo. Too late to call it a hoax. Too late to say it doesn't work. Too late to say it kills. Too late to say it is not well-tolerated. Too late to say it does not have a better chance against both inconvenient symptoms and disabling ones than any drug ever sold to people diagnosed with 'MS'. I think it's way too late for the newspapers, TV news, and insurance companies to still be calling it "experimental". When I was taught the Scientific Method, experiments had a Purpose and a Method. I think many people have seen Results and drawn their own Conclusions. Too late to bury the truth. It smells too bad.

Too soon to lose hope, too late to die young (for some of us :-))
Last edited by 1eye on Fri May 06, 2011 7:52 pm, edited 1 time in total.
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Postby cheerleader » Thu May 05, 2011 3:43 pm

Dr. Rose has not published in any peer-review journals. He is a blogger. He posts comments on other doctors' research...but does not research himself. Here are his reviews from patients on a medical review site, they are quite amusing....

reviews of Dr. Rose from patients

For peer-reviewed, published research on CCSVI, go to CCSVI Alliance
www.ccsvi.org

cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby HappyPoet » Thu May 05, 2011 6:19 pm

Cheer, with all due respect, yes more research is needed, BUT people need help NOW fighting their insurance companies for coverage, and your CCSVI Alliance could easily be VERY helpful in this area (despite your mission). While flying around the country talking about CCSVI, couldn't at least some of your paid employees (and volunteers) start working on a webpage that would contain information to help people appeal their denials of insurance coverage?

I've been an advocate for the Alliance, have donated money, and have even asked others to donate their money, too, but if the association stays silent and does not come up with some creative ways to help people on this issue, I'll have to reconsider my support I'm sorry to say. But maybe you feel there are enough desperate pwMS that this issue doesn't have to matter to you. Sorry if my anger is seeping into this post, but I'm very upset.

And it's not like this issue hasn't been talked about before -- CCSVI associations should be ahead of the curve on anticipating this huge storm brewing and on having strategies to help us to combat the storm.

Johnnymac wrote a post you should read if you haven't already; in fact, you should read the entire thread: http://www.thisisms.com/ftopict-16471.html A comment would be appreciated. Thank you.
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Reduced cerebral blood flow

Postby colros » Thu May 05, 2011 8:18 pm

ikulo wrote:Most of Rose's statements also have no basis in fact. I would absolutely love if he could provide references for most of his conclusions (e.g., "first cells that would be affect are the high-oxygen consumption neurones in the grey matter").

---------
http://rad.usuhs.edu/synapse/radpix.htm ... m=1005#pic

Normal cerebral blood flow (CBF):
> 40-67 ml/100 gms/minute (usually around 50-55)
> Gray matter 3-4X greater than white matter
> Autoregulation requires pressures 60 - 180 mm HG
> Below 60 mm, perfusion becomes "pressure dependent"
> Above 180 mm, perfusion may increase or decrease depending on vasospasm, etc.
> CBF below 22 ml/gm/min causes reversible injury
> CBF below 18 ml/gm/min neuronal depolarization
> CBF below 12 for more than 120 minutes causes infarction
> Neurons are most sensitive, oligodendrocytes somewhat sensitive, and astrocytes the most resistant to ischemia
------------------------
In other words, a significant reduction in cerebral blood flow shuts down neurons in the gray matter long before cells in the white matter are affected. If Zamboni's hypothesis were real, all MS patients would be unconscious.
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Postby Cece » Thu May 05, 2011 8:25 pm

Does anyone know, what does it mean for perfusion to be 'pressure dependent' when it's below 60 mm?
What are the figures for what the cerebral perfusion in MS patients is? This has been studied, perfusion is lowered in MS patients, although the cause is/was not known.

The new line of thinking with MS has been that gray matter is affected very early in the disease. The doctor I mentioned above, Dr. Trapp, has done some critical research.
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Postby CureIous » Thu May 05, 2011 8:29 pm

Yes, we should be wary of any and all information contained in blogs, as it pertains to CCSVI or any medical condition. It is a one-way broadcast medium, similiar to an op-ed page in a newspaper, and as such is easily manipulated to present as much one sided reporting as is necessary to bolster whatever particular bent is in the mind of the author.
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