The Zamboni Myth: Why “CCSVI” is Surreal

“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

“Fraud and false­hood only dread ex­am­i­na­tion. Truth in­vites it.”
– Samuel Johnson

The plural of anecdote is not data.
– Joe Schwarcz

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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 miracle 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.

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.

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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 affected would be 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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The MS Society of Canada has now been intimidated by desperate patients into funding a trial of the Zamboni procedure. I will be surprised if any of these grant applications are approved by a scientific review committee.

Zamboni’s myth is not science; it’s a surreal artistic creation in that this process can never be reproduced by other investigators. But all this is really irrelevant anyway because such flow patterns can never damage the brain without causing an increase in cerebral capillary pressure.  Any MS patient with a large enough increase in venous pressure to cause red cells to leak out of  small veins would have a head that looked like a leg with severe varicose veins; his eyes and tongue would protrude and his face would be very swollen and blue. So, there is no point in even funding a trial of the “liberation treatment” because it is impossible to know what Zamboni actually did and the basic science says that there no point in even trying to figure out what he did. When one doesn’t even know how to reproduce a test, how can one do a clinical trial of it? No more money should be wasted on the Zamboni myth.

We will keep our readers updated on the expansion of the Zamboni myth and it’s inevitable implosion. When it does implode, I would hope Dr. Zamboni will compensate all patients, MS societies, governments and insurance plans who wasted time money on imaging for “CCSVI” or “liberation.”

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Nov. 25, 2009

A patient has reported that Dr. Michael Dake a professor of cardiothoracic surgery at Stanford University, is performing the Zamboni procedure in MS patients who ask for it. How he determines where the venous “blockages” are is a mystery. At any rate, it is unethical and contrary to the Hippocratic Oath, to perform a procedure, not yet proven to be safe or effective, outside of a blinded, randomized controlled trial of that procedure. Modern medicine is supposed to be evidence-based and  there is no scientific evidence that the Zamboni procedure, however one wants to interpret it, has any utility in MS patients.

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February 10, 2010

A private clinic in the UK has announced that it will offer diagnosis of CCSVI.

“Glasgow Health Solutions actively seeking to offer scanning for CCSVI in the UK in 2010 in both London and Glasgow. The Doppler ultrasound scan required to show the CCSVI abnormalities has been specially adapted and requires specialist training from Prof Zamboni and his team. It is vital to work with the recognised specialists in this field and we hope to have ultrasound technician trained by Dr Zamboni later this year. The cost of the scans in the UK is still to be finalized but should be around 250 to 300 pounds.”

Why does diagnosing “CCSVI” require special training from Zamboni? Why can`t he describe in words what he is doing? Can CCSVI be quantified? Is there a number for degree of CCSVI or is it an all or none quantity? Who are these specialsts and by whom are they recognized? Why would anyone spend 300 pounds on a test that can be interpreted only after being trained by a master of this occult art?

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February 7, 2010

From facebook group ms-ccsvi-uk

“John Whitaker Hi Gang, I have just sent an email to AHMED in Warsaw who have started the CCSVI procedure at @5000 eu after being told by Dr Simca that their list is pretty full till 2011 at a future cost of $10,000 to $15000 ! These private medical companies are jumping on the band wagon me thinks !”

Dr. Marian Simka in Poland is charging at least $10,000 for inserting stents in what look like normal jugular veins and claiming that MS patients are now “liberated” from their disease. That’s chutzpah!

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Jan 4, 2010

Want money for “CCSVI” without having to show that it has some scientific validity? No problem. Just start a foundation, like the Fondazione Hilarescere, appoint yourself to its “Scientific Committee” and give yourself a grant.

Here is the committee,

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Gary Cutter
Professor of Biostatistics and Head of the Section on Research Methods and Clinical Trials, Birmingham, University of Alabama. Gary Cutter developed an outcome measure for motor and cognitive efficiency in multiple sclerosis known as MSFC. He is Professor of Biostatistics at the University of Alabama

Michael Dake
Chief of Cardiovascular and Interventional Radiology, Stanford University School Of Medicine, Stanford.  He was the first surgeon to accept  Prof. Paolo Zamboni’s suggestion to operate on stenosis associated with CCSVI

Claude Franceschi
Head of Vascular Laboratories, Saint Joseph Hospital,Paris (FRA). No doubt  the greatest venous haemodynamics expert in the world

Giulio Gabbiani
Head of the Department of Pathology and Immunology, Centre Médical Universitaire, Genève. One of the greatest world experts  in vessel wall structure

Roberto Galeotti
Head of the Interventional Radiology Section, University Hospital of Ferrara, Ferrara.

E. Mark Haacke
Director of the The Magnetic Resonance Imaging Institute for Biomedical Research, Detroit. Inventor of the  SWI system, i.e. the most sophisticated and advanced system for the diagnosis of  multiple sclerosis

Byung-Boong Lee
Chairman Georgetown University School of Medicine,Washington. Chairman of the International  Consensus Conference on congenital venous malformations

Francesco Mascoli
Director of the Vascular Surgery B.U., University Hospital of Ferrara, Ferrara (ITA)

Fabrizio Salvi
Head of the Centre for Rare and Neuroimmune Diseases, Bellaria Hospital, Bologna. He was the first neurologist to work with  Prof. Zamboni in the clinical experimentation  of  “removing the venous  obstruction” from MS patients

Franz Schelling
Author of several Hypothesis Papers in the 80’s on the etiologic role of the venous system in MS

Andrea Stella
Professor of Vascular Surgery, University of Bologna,Bologna (ITA)

Bianca Weinstock-Guttman
Jacobs Neurological Institute, Buffalo. One of the greatest experts of multiple sclerosis in the pediatric age

Paolo Zamboni
Director of the Centre for Vascular Diseases, University of Ferrara, Ferrara. He discovered and described  CCSVI in MS patients

Robert Zivadinov
Director of the Buffalo Neuroimaging Analysis Center, New York State University, Buffalo. One of the greatest experts in pharmacological trials for multiple sclerosis and efficacy measures using MRI

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And here is the grant.

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The Emilia-Romagna Region has approved a Clinical Governance Project which is co-financed by the Hilarescere Foundation. The 180,000 Euro grant will be used to provide evidence on the diagnostic accuracy of cerebro-venous echo-colour-doppler vs. advanced magnetic resonance in the diagnosis of  CCSVI, either alone or in association with Multiple Sclerosis. The Project will be conducted in the years 2010-2011 and will involve the Centre for Vascular Diseases of the University of Ferrara, the il Be.Ne Centre and the Neuroradiology Unit of the Bellaria Hospital in Bologna.

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Running a charitable organization to direct money to the directors of the charity would be highly illegal in most of the rest of the world. But this is typical of the Italian approach. Help your friends and they will help you even if the help is taxpayer funded. Ask for any disinterested opinion and risk having the money go to someone outside of the “family” doing real science? Why would anyone want to complicate their lives?

Five of the 14 committee members belong to the institutions in Bologna and Ferrara that are receiving the grant. And the others, most obviously sympathetic to “CCSVI”, get nice trips to Italy, no doubt funded by the Fondazione. Who’s to complain? Perhaps this sort of foundational incest has something to do with the fact that the last Nobel Prize in Medicine to be awarded to an Italian who did the Nobel recognized work in Italy was to Rita Levy-Montalcini in 1986. Her pivotal research was done in her own bedroom during WWII.

Below is a response to a post to the above effect on the Facebook group CCSVI in Multiple Sclerosis from it’s moderator, Joan Beal.

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I’m so glad my husband got MS, so I could go to Italy without him, pay for my flight, get no sleep and spend hours transcribing the lectures of the guest doctors. May you never have to watch your spouse suffer, writhe in pain or wish to end it all.

The man who started the foundation, Agosto Zeppi, was a young business man afflicted with MS. Dr. Zamboni treated him, and he has remained in remission for the three years since. He began the foundation with other business leaders with the sole purpose to help MS patients.

 

STOP WRITING ABOUT THINGS that are beyond your ken. That was your last post, I consider you abusive, Dr. Rose. Goodbye.
J

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For the true believer all criticism of their conviction elicits a censorship reflex.

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January 23, 2010

See stories in the National Post by Tom Blackwell and Terence Corcoran on the Zamboni hysteria.

“As science journalism goes, the Zamboni MS stories were typical manifestations of junk science — the abuse of science fact via oversimplification, distortion and exaggeration of risk, often to serve some political end.”

Here is Joan Beal’s response to Corcoran’s comment.

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Jan 2, 2009

FROM CTV.ca
“Meanwhile in Italy, one of the companies that manufactures the ultrasound machines used in the testing for CCSVI, is beginning to hold training sessions for doctors and technicians who want to learn the novel technique for scanning the neck and head. One training program is being held this week at the University of Ferrara with technicians who developed the tests, and with Zamboni. A second session is planned for March.”   Contact information for the course is available through: Claudio.Buffagni@esaote.com.

Zamboni is incapable of describing in print how he diagnoses pathological “CCSVI”, so he has to run courses (cost?) to transmit the secrets of his arcane ritual. This is not science.

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Dec. 2, 2009

The Journal of  Vascular Surgery has published another paper by Dr. Zamboni. Why it was accepted for publication is a mystery. The “study” is unblinded, unrandomized and unreproducible and is, therefore, unscientific and worthless. If anyone can figure out what Zamboni is actually doing and how he defines “CCSVI”, what is needed, before anyone rushes off to the neurologist demanding the “cure”, is a blinded randomized trial of the “liberation” procedure.

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MS expert downplays Italian surgeon’s treatment

Research head at The Ottawa Hospital questions validity of clogged veins theory during education session

BY LYNN SAXBERG, OTTAWA CITIZEN

OTTAWA — The “liberation procedure,” a controversial new surgical procedure that appears to cure multiple sclerosis, is based on circumstantial evidence and MS sufferers should not rush into getting it.

That was the message delivered by Dr. Mark Freedman, director of the MS research unit at The Ottawa Hospital, during an education session hosted by the MS Society of Ottawa on Tuesday night. For many in the audience, his words dashed much of their newfound hope.

One of a series of education events regularly presented by the society, this meeting attracted throngs of MS patients and their loved ones, all curious about the new theory proposed by Italian researcher Dr. Paolo Zamboni. A vascular surgeon by training, Zamboni believes MS is not an autoimmune condition, as widely believed, but rather a vascular disease that can be cured with surgery.

Zamboni’s theory is that MS is caused by clogged veins, a condition he calls “chronic cerebrospinal venous insufficiency” (CCSVI). Zamboni first performed the angioplasty-type surgery on his wife, who suffered from MS, and her symptoms disappeared. He then tested it on a group of 65 patients with remarkable results: 73 per cent had no symptoms two years after the surgery.

However, Freedman, like many neurologists, is skeptical. During his presentation, Freedman said he confronted Zamboni at a recent meeting in Lisbon.

“He was there presenting some of his data and had a hard time answering any of the questions from the MS guys,” Freedman said. Among their concerns was Zamboni’s claim that the clogged veins are present at birth, yet no studies had been done on children. Zamboni had not done animal studies, either.

“I said, ‘Why don’t you tie off a few of the blood vessels in animals and see if they develop MS?’ His answer was, ‘I’m not a mouse researcher’,” Freedman said.

“If his observation stands up to other people being able to reproduce it,” Freedman said, “I think we’re going to have something of interest to chase, but we need to have the supporting evidence before we start reaming out blood vessels and pretending that this is going to cure the disease.”

Still, the fact that most of Freedman’s presentation was devoted to explaining the new drugs that are being developed to treat MS did not satisfy many members of the audience on Tuesday night.

“The problem I have is that you take Dr. Zamboni’s work very lightly, and, quite frankly, you haven’t done any better,” Mike Sastre said during the question-and-answer session. His wife, Linda Hume-Sastre, has lived with MS for almost seven years.

“All I want to say is give the man a chance, give the people here a chance who haven’t been helped very much by what you’re promoting,” Sastre said. “If they get better using something very simple, you lose a lot of research money, and so does the MS Society.”

Zamboni’s research has given hope to MS patients such as Dayle Baich, who uses a walker to get around.

“This I would do,” Baich said. “It’s a very simple surgery, compared to two years of chemotherapy. In three years, I have gone from being normal to now. So where am I going to be in two or three more years? I don’t have the time. Neither do most of the people here.”

The MS Society of Canada has issued an invitation for research operating grant proposals on CCSVI related to multiple sclerosis from qualified investigators based in Canadian institutions. The competition opens Dec. 9. The deadline for applications is Jan. 22.

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Nov. 28, 2009

Comments from an Australian MS support blog

The recent news presented in Researcher’s labour of love leads to MS breakthrough, appears to give hope. I’m wondering what’s the back-story? What sort of hope is it?  Real or false?

Colin Rose, Cardiologist and Associate Professor of Medicine, at McGill University in Montreal, Canada advises great caution. As he explains:

“Any MS patient with a large enough increase in venous pressure to cause red cells to leak out of  small veins would have a head that looked like a leg with severe varicose veins; his eyes and tongue would protrude and his face would be very swollen and blue.

You can read Dr Rose’s assessment for yourself and make up your own mind.

In the absence of blinded randomised controlled multiple trials, as Colin points out the scientist is subject to “subconsciously motivated action”. If MS could be halted by such a simple procedure, it would be lovely wouldn’t it?
In that case, I’m lining up for it.

However, I suspect this is not the breakthrough we’re hoping for.

At this point in time, this case is more likely to be an educated man who desperately wants to help his wife (who has MS herself), grabbing-at-straws and two internet-savvy  journalists who made a deadline

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Here is the original report in the Globe and Mail

November 20, 2009

Researcher’s labour of love leads to MS breakthrough

By André Picard and Avis Favaro
From Saturday’s Globe and Mail

Elena Ravalli was a seemingly healthy 37-year-old when she began to experience strange attacks of vertigo, numbness, temporary vision loss and crushing fatigue. They were classic signs of multiple sclerosis, a potentially debilitating neurological disease.

It was 1995 and her husband, Paolo Zamboni, a professor of medicine at the University of Ferrara in Italy, set out to help. He was determined to solve the mystery of MS – an illness that strikes people in the prime of their lives but whose causes are unknown and whose effective treatments are few.

What he learned in his medical detective work, scouring dusty old books and using ultra-modern imaging techniques, could well turn what we know about MS on its head: Dr. Zamboni’s research suggests that MS is not, as widely believed, an autoimmune condition, but a vascular disease.

Share your stories Tell us what this potential breakthrough in multiple sclerosis treatment means to you

More radical still, the experimental surgery he performed on his wife offers hope that MS, which afflicts 2.5 million people worldwide, can be cured and even largely prevented.

“I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis,” Dr. Zamboni said in an interview.

Not everyone is so bullish: Skeptics warn the evidence is too scant and speculative to start rewriting medical textbooks. Even those intrigued by the theory caution that MS sufferers should not rush off to get the surgery – nicknamed the “liberation procedure” – until more research is done.

U.S. and Canadian researchers are trying to test Dr. Zamboni’s premise.

For the Italian professor, however, the quest was both personal and professional and the results were stunning.

Fighting for his wife’s health, Dr. Zamboni looked for answers in the medical literature. He found repeated references, dating back a century, to excess iron as a possible cause of MS. The heavy metal can cause inflammation and cell death, hallmarks of the disease. The vascular surgeon was intrigued – coincidentally, he had been researching how iron buildup damages blood vessels in the legs, and wondered if there could be a similar problem in the blood vessels of the brain.

Using ultrasound to examine the vessels leading in and out of the brain, Dr. Zamboni made a startling find: In more than 90 per cent of people with multiple sclerosis, including his spouse, the veins draining blood from the brain were malformed or blocked. In people without MS, they were not.

He hypothesized that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial brain-blood barrier. (The barrier keeps blood and cerebrospinal fluid separate. In MS, immune cells cross the blood-brain barrier, where they destroy myelin, a crucial sheathing on nerves.)

More striking still was that, when Dr. Zamboni performed a simple operation to unclog veins and get blood flowing normally again, many of the symptoms of MS disappeared. The procedure is similar to angioplasty, in which a catheter is threaded into the groin and up into the arteries, where a balloon is inflated to clear the blockages. His wife, who had the surgery three years ago, has not had an attack since.

The researcher’s theory is simple: that the underlying cause of MS is a condition he has dubbed “chronic cerebrospinal venous insufficiency.” If you tackle CCSVI by repairing the drainage problems from the brain, you can successfully treat, or better still prevent, the disease.

“If this is proven correct, it will be a very, very big discovery because we’ll completely change the way we think about MS, and how we’ll treat it,” said Bianca Weinstock-Guttman, an associate professor of neurology at the State University of New York at Buffalo.

The initial studies done in Italy were small but the outcomes were dramatic. In a group of 65 patients with relapsing-remitting MS (the most common form) who underwent surgery, the number of active lesions in the brain fell sharply, to 12 per cent from 50 per cent; in the two years after surgery, 73 per cent of patients had no symptoms.

I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis Dr. Paolo Zamboni

Augusto Zeppi, a 40-year-old resident of the northern Italian city of Ferrara, was one of those patients. Diagnosed with MS nine years ago, he suffered severe attacks every four months that lasted weeks at a time – leaving him unable to use his arms and legs and with debilitating fatigue. “Everything I was dreaming for my future adult life, it was game over,” he said.

Scans showed that his two jugular veins were blocked, 60 and 80 per cent respectively. In 2007, he was one of the first to undergo the experimental surgery to unblock the veins. He had a second operation a year later, when one of his jugular veins was blocked anew.

After the procedures, Mr. Zeppi said he was reborn. “I don’t remember what it’s like to have MS,” he said. “It gave me a second life.”

Buffalo researchers are now recruiting 1,700 adults and children from the United States and Canada. They plan to test MS sufferers and non-sufferers alike and, using ultrasound and magnetic resonance imaging, do detailed analyses of blood flow in and out of the brain and examine iron deposits.

Another researcher, Mark Haacke, an adjunct professor at McMaster University in Hamilton, is urging patients to send him MRI scans of their heads and necks so he can probe the Zamboni theory further. Dr. Haacke is a world-renowned expert in imaging who has developed a method of measuring iron buildup in the brain.

“Patients need to speak up and say they want something like this investigated … to see if there’s credence to the theory,” he said.

MS societies in Canada and the United States, however, have reacted far more cautiously to Dr. Zamboni’s conclusion. “Many questions remain about how and when this phenomenon might play a role in nervous system damage seen in MS, and at the present time there is insufficient evidence to suggest that this phenomenon is the cause of MS,” said the Multiple Sclerosis Society of Canada.

The U.S. society goes further, discouraging patients from getting tested or seeking surgical treatment. Rather, it continues to promote drug treatments used to alleviate symptoms, which include corticosteroids, chemotherapy agents and pain medication.

Many people with multiple sclerosis, though, are impatient for results. Chatter about CCSVI is frequent in online MS support groups, and patients are scrambling to be part of the research, particularly when they hear the testimonials.

Kevin Lipp, a 49-year-old resident of Buffalo, was diagnosed with MS a decade ago and has suffered increasingly severe attacks, especially in the heat. (Heat sensitivity is a common symptom of MS.) His symptoms were so bad that he was unable to work and closed his ice-cream shop.

Mr. Lipp was tested and doctors discovered blockages in both his jugular and azygos veins. In January of this year, he travelled to Italy for surgery, which cleared five blockages, and he began to feel better almost immediately.

“I felt good. I felt totally normal. I felt like I did years ago,” he said. He has not had an attack since.

As part of the research project, Mr. Lipp’s siblings have also been tested. His two sisters, both of whom have MS, have significant blockages and iron deposits, while his brother, who does not have MS, has neither iron buildup nor blocked arteries.

While it has long been known that there is a genetic component to multiple sclerosis, the new theory is that it is CCSVI that is hereditary – that people are born with malformed valves and strictures in the large veins of the neck and brain. These problems lead to poor blood drainage and even reversal of blood flow direction that can cause inflammation, iron buildup and the brain lesions characteristic of multiple sclerosis.

It is well-established that the symptoms of MS are caused by a breakdown of myelin, a fatty substance that coats nerve cells and plays a crucial role in transmitting messages to the central nervous system. When those messages are blurred, nerves malfunction, causing all manner of woes, including blurred eyesight, loss of sensation in the limbs and even paralysis.

However, it is unclear what triggers the breakdown of myelin. There are various theories, including exposure to a virus in childhood, vitamin D deficiency, hormones – and now, buildup of iron in the brain because of poor blood flow.

While he is convinced of the significance of his discovery, Dr. Zamboni recognizes that medicine is slow to accept new theories and even slower to act on them. Regardless, he can take satisfaction in knowing that the woman who inspired the quest, and perhaps a dramatic breakthrough, has benefited tremendously.

Dr. Zamboni’s wife, Elena, has undergone a battery of scans and neurological tests and her multiple sclerosis is, for all intents and purposes, gone.

“This is probably the best prize of the research,” he said.

André Picard is the public health reporter at The Globe and Mail. Avis Favaro is the medical correspondent at CTV News.

With reports from Elizabeth St. Philip, CTV News

W5 DOCUMENTARY

Watch W5‘s documentary on the groundbreaking new treatment for multiple sclerosis, which includes the first time the “liberation” surgery was filmed.

It is available on the Web at http://www.W5.ctv.ca, and will be replayed Sunday on CTV Newschannel.

MS IN CANADA

An estimated 55,000-75,000 Canadians have multiple sclerosis, and every day three more people in Canada are diagnosed with the disease. Canada has one of the highest rates of MS in the world. MS is the most common neurological disease affecting young adults in Canada.

• Women are more than three times as likely as men to develop MS.
• MS can cause loss of balance, heat sensitivity, impaired speech, extreme fatigue, double vision and paralysis. The disease is characterized by lesions on the brain, a result of the breakdown of myelin, the protective covering wrapped around the nerves of the central nervous system.
• The most common treatment for MS is corticosteroids. Steroids reduce inflammation at the site of new demyelination, lessening symptoms.
• MS was first identified and described by French neurologist Jean-Martin Charcot in 1868.
• MS is widely believed to be an autoimmune disorder, but the cause or causes are unknown. There are a number of theories about what might trigger the disease, including exposure to a virus in childhood; exposure to tobacco smoke; lack of the female sex hormone prolactin, which plays a role in the development of myelin; and vitamin D deficiency. Vitamin D may play a role in MS because it helps to construct the interior layer of blood vessels.
• Despite the long-held assumption that MS is an autoimmune disorder, new research suggests it is actually a vascular disease triggered by a buildup of iron in the brain due to problems in blood flow.

Source: MS Society of Canada

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Here is an example of the  someone caring for an MS patient enthralled by the Zamboni myth. Joan Beal’s story was later related by the Daily Mail. Joan has been the major online patient advocate for “CCSVI.” Her husband’s MS sounds somewhat atypical. MS never causes “abnormal blood numbers, high liver enzymes, [and] high SED rate”. It can cause fatigue. But all of these can be caused by hepatitis. One could hypothesize that during her husband’s trip to a high altitude he was infected with a hepatitis virus, the resolution of which was coincident with the “liberation” procedure for his MS. His fatigue improved but it had nothing to do with “liberation”. If high altitude caused MS everyone living above a certain altitude would have it. So here we have an opera singer determined to find the cure of her husband’s medical problems, getting into diagnosis and treatment of what was probably at least two diseases, attracted by facile, unproven, superficially attractive concepts and then promoting it over the social interaction sites on the Web. Thousands of MS patients are now bombarding neurologists and MS societies with demands for “liberation”. This is the first major medical fad of the Internet age; it will be a fascinating story when it eventually plays itself out.

Hi everyone-
It’s just one person. Joan Beal, wife of MS patient Jeff Beal. We were the American family featured in the CTV documentary in part 2. There’s been alot of comments and some anger expressed as to “who set us this page???”. I just want folks to know that I started this page over the summer. Because I wanted to get the word out. I’ve been writing about CCSVI research on ThisIsMS.com since last December. That’s where Ashton Embry found me as “Cheerleader.” Lots of folks have been discussing this treatment over the last year at ThisIsMS…we have an amazing online community. And that’s how Avis Favaro found me. Come visit us and learn more.

I’ve been searching for the vascular connection to my husband’s MS since his diagnosis. And I have worked many months, reading medical journals online and learning all I could about the history of MS. When a friend on ThisIsMS.com posted Dr. Zamboni’s CCSVI research, it made sense with everything I had noticed in my husband’s MS- his first flare occurred after an hypoxic event (lack of oxygen to the brain) at high altitude, and he had many abnormal blood numbers, high liver enzymes, high SED rate, and overwhelming fatigue. These appeared to me to be signs of hypoxic injury to his brain. And in Dr. Zamboni’s research he found iron deposition, slowed perfusion and hypoxic injury to gray matter were the real insult to MS brains. And this was caused by closed veins. The blood heading back to the heart couldn’t get there in a timely matter, and it injured brain tissue. The demyelination happened AFTER the gray matter injury. By allowing oxygen to flow and stopping iron deposition with the Liberation procedure, Dr. Zamboni found a way to halt the demyelinating lesions and slow MS progression. And to relieve many of the worst symptoms of MS, including fatigue, depression, spasms, sleep issues and more.

I am not a doctor. I was trained as an opera singer. But I can write like a doctor now, because I wanted to learn all I could. There is no ulterior motive to this page. I just wanted to help other MS patients. Once I saw my husband’s twisted jugular veins on MRV technology, and his improvement after having them corrected- I knew this was real.

I promise I will never write and sell and e-book. Really. The supplement/diet/lifestyle program I made up for Jeff is on here for free. Look for Endothelial Health program in the notes section.

We all need to be our OWN ADVOCATES. No one will do the heavy lifting for us. If you want someone to learn about CCSVI, print out the research, print out the press and mail or bring the packet of information to the doctors you hope to reach. That’s all I did. Really. I tell you how to do it. Read the notes for “dubious doctors.” Read all the notes I wrote up…I tried to explain all of this in plain english.

 

So, go start your own Facebook or web page!! Please!!! Lots of folks are organizing around the globe. There’s no trademark on CCSVI, and Dr. Zamboni would be thrilled to have his research tested by other doctors. He’s wanted to get the word of CCSVI out….and thanks to Avis Favaro and Elizabeth St. Philip, now it is!
I’m just one gal who loves someone with MS. Really.
My best to everyone fighting to cure this horrific disease,
Joan