Uebersetzung von Why "CCSVI" is Surreal

Version vom 23. Februar 2010, 20:25 Uhr

Von: http://medicalmyths.wordpress.com/2009/11/24/the-zamboni-myth-ccsvi-surreal/

The Zamboni Myth: Why “CCSVI” is Surreal/Der Zamboni-Mythos: Warum "CCSVI" surreal ist

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.”

"Hexerei, Astrologie, Akupunktur und viele andere Mondschein-Begriffe benötigen keine Forschung um verworfen zu werden - nur klares Denken."

– Heinz Klatt, prof. emeritus of psychopathology, London, Ont.

This story has nothing to do with lifestyle diseases but it is valuable in showing the creation of a medical myth in real time.

Diese Geschichte hat nichts mit einer Lifestyle-Krankheiten zu tun, aber sie zeigt in Echtzeit die Schaffung eines medizinischen Mythos.

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”.

Normalerweise wandern die Art der Arbeiten, die Dr. Paolo Zamboni veröffentlicht hat, rasch in den Müll Wissenschaft, aber dieser Mythos erhielt einen enormen Schub, als zwei Reporter von CTVglobemedia, André Picard und Avis Favaro, meist recht vernünftig, eine Geschichte veröffentlichten und hat eine kurze Dokumentation darüber, die es einen "Durchbruch" nannte und pausenlos anekdotischen Geschichten von dramatischen Heilungen.

Thousands of MS patients and their relatives in Canada became convinced that Zamboni’s “treatment” was the cure they had been waiting for.

Tausende von MS-Patienten und ihre Angehörigen in Kanada wurden überzeugt, daß Zamboni's "Behandlung" die Heilung war, auf die sie gewartet wurde.

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.

Blogs waren voll von Verschwörungstheorie und Empörung, daß Pharmaunternehmen diese chirurgische Heilung unterdrückt hatten und viele forderten die Finanzierung von MS-Wohltätigkeitsorganisationen und der Regierung, um die "Befreiungs"-Behandlung "für alle MS-Patienten zu ermöglichen.

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.

Selbst Bruder André von der St. Joseph's Oratorium Ruhmeshalle, der Wundertäter des Jahr 2010, der heilte mit heiligem Öl, heilig gesprochen mit der Heilkraft des St. Joseph, wäre beeindruckt gewesen.

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.

Die Vatikanische Theologische Kommission für die Selig-und Heiligsprechung erklärte als "wissenschaftlich unerklärlich" mindestens eine der Tausenden von Wunderheilungen, die Bruder André zugeschrieben werden.

I hereby nominate Paolo Zamboni for consideration for canonization based on the hundreds scientifically unexplainable miracles attributed to him and his acolytes.

Ich nominiere hiermit Paolo Zamboni für die Prüfung der Heiligsprechung auf der Grundlage von hunderte wissenschaftlich unerklärliche Wundern, die ihm und seinen Gefolgsleute zugeschrieben werden.

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?

Bruder André, wurde am 17. Oktober 2010 heiliggesprochen. Der Vatikan hatte festgestellt, daß zwei seiner Wunderheilungen keine wissenschaftliche Erklärung haben. Hat der Vatikan von Dr. Zamboni gehört?

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

Dr. Zamboni vollbrachte auch Wunder, für die es keine wissenschaftliche Erklärung gibt.

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.

Der Zamboni-Mythos ist auch ein gutes Beispiel für ein chirurgisches Verfahren, das an einigen wenigen Patienten "geprüft" wurde, und dann als Therapie - ohne kontrollierten Studie - bei Tausenden von Patienten mit großem Aufwand durchgeführt wurde.

Every few years the same thing happens. We have written about coronary bypass, coronary angioplasty and bariatric surgery.

Alle paar Jahren passiert das gleiche. Wir haben über Bypass, koronare Angioplastie und bariatric surgery geschrieben.

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.

Venous circulation of the head. Note that the facial veins drain into the upper internal jugular veins. An obstruction in the lower internal jugular vein, substantially increasing venous pressure would affect the face as well as the brain.

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, caused by possible venous constrictions somehow causes a leakage of blood from the small veins and an accumulation of iron in the brain, which somehow caused an autoimmune response which somehow damages the myelin sheaths of nerve axons, the basic pathology of MS. But, if there were severe enough blockages in the lower internal jugular veins draining the head to cause such a high venous pressure, and because the same pressure would be present in the veins draining the face, the heads of MS patients would look like the legs of patients with varicose veins, swollen, and blue with protruding tongue and eyes.

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. This is what the head of MS patients would resemble if their disease were caused by obstructions in the veins draining the head. The dark spots are caused by red cell extravasation and iron deposition in the skin. Dr. Zamboni claims that the same process is causing MS.

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. We are particularly intrigued by patterns B and C in which venous blood in the internal jugular veins (IJV) is flowing upwards towards the head. If this ever happened for more than a second one's eyes would pop out of one's head.

A more realistic reconstruction of the veins of the head and neck. 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" needing "liberation".

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” and heat sensitivity , 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.

Another diagram of "abnormal" venous flows in the head as imagined by Dr. Marian Simka, a Polish acolyte of Dr. Zamboni. Like Dr. Zamboni he claims that flow can be upward in the IJV because of an occlusion in the proximal IJV. All blood from the head seems to be flowing through the small spinal veins which have nowhere near the capacity to accommodate such a large flow. We guess that those red arrows pointing up imply blood is pushing against the brain causing MS.

Bilateral congenital complete occlusion of the internal jugular veins as purported to exist by Drs Zamboni and Simka is incompatible with life. Blood could not flow back from the brain. Fetuses with this abnormality, if at all, are presumably spontaneously aborted.

The faces of people with bilateral internal jugular vein occlusion would like like the faces of people who had been strangled.

“In strangulation cases, the following post-mortem appearances could be seen: Face swollen and blue, lips blue, eyes opened, eyeballs bulging out, pupils dilated, tongue swollen and between the teeth” ref.

During strangulation the trachea is occluded along with the internal jugular veins which lie beside it but the carotid arteries can only be occluded with much higher compressive force. Before the strangulation victim dies from asphyxiation the IJV’s have been occluded for at least 30 seconds while the carotid artery continues to pump blood to the face.

Unilateral jugular vein occlusion is caused by thrombosis (blood clot) secondary to various conditions and has serious complications which do not include MS.

“Thrombosis of the internal jugular (IJ) vein is an underdiagnosed condition that may occur as a complication of head and neck infections, surgery, central venous access, local malignancy, polycythemia, hyperhomocysteinemia, neck massage, and intravenous drug abuse. It is also reported to occur spontaneously. IJ thrombosis itself can have serious potentially life-threatening complications that include systemic sepsis, chylothorax, papilledema, airway edema, and pulmonary embolism.”

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.

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.

But 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 indemnify all patients and insurance plans who wasted 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.

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.