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February 12, 2010 08:55  by Dr. Lorne Brandes

The headline over the Feb. 10, 2010 news release from the University of Buffalo, “First blinded study of venous insufficiency prevalence in MS shows promising results” seemed straightforward and encouraging. The statement went on to explain that, in the initial phase of the 500-patient trial, ultrasound (Doppler) examinations unequivocally showed narrowed neck or chest veins in 62% of patients with MS compared to 26% of normal volunteers. Complete data on these subjects will be presented at the American Academy of Neurology meeting in April.

Describing himself as “cautiously optimistic and excited”, the study’s principle investigator, Dr. Robert Zivadinov, went on to say “[the data] show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.”

To most observers, Zivadinov’s preliminary results lend a significant degree of credence to Dr. Paolo Zamboni’s as-yet unproven hypothesis that multiple sclerosis is primarily a vascular, rather than an auto-immune disease. Zamboni has coined the term CCSVI (chronic cerebrospinal venous insufficiency) to describe the toxic backup and leakage of iron-containing blood into the brain resulting from obstructive vein abnormalities in the neck or chest, that he believes is at the root of MS lesions or “plaques”.

Yet, the “spin” on the significance of Zivadinov’s findings depends on which news source reported them. For example, The Globe and Mail story header read, “Second MS study finds high rate of blocked veins”, while that in the National Post stated, “Research casts doubt on new MS theory”.

Like other major news media, including the BBC , London’s Daily Telegraph, and the Canadian Press , The Globe and Mail report, written by Caroline Alphonso, limited itself to a factual report on the Buffalo results, and included comments on the inherent weaknesses in the studies to date.

On the other hand, the National Post story, by Tom Blackwell seemed to display a distinctly negative tone. Yet, that should not come as a total surprise as it was consistent with a previous piece Blackwell wrote in the NP, entitled, “Is new MS research the real thing, or a media-driven frenzy?” It was accompanied by an article, “A cure in sight? Not so fast”, with the sub-heading “Media coverage reeks of typical hope-mongering”, authored by Financial Post editor, Terence Corcoran.

What is going on here?

All journalists have their expert “sources”. For example, over the years, I have advised CTV’s Avis Favaro, among others. Similarly, readers of Tom Blackwell may conclude that one of his expert sources is Dr. Mark Freedman, head of U. of Ottawa’s MS program. Dr. Freedman’s mainstream orthodoxy in the immunological treatment of MS, and his negative opinion of Dr. Zamboni and CCSVI is well documented. "I think there are going to be millions of dollars spent now to follow a hoax.... If I thought for one instant there was substance to this, I'd be all over it,” Freedman told Blackwell in January, before the interim results came out of Buffalo.

And what did Dr. Freedman think of Zivadinov’s new findings? Commenting in Blackwell’s latest NP story on the Buffalo data showing that abnormal veins were between 2 and 3 times more common in MS patients as compared to the nine-to-one ratio reported by Dr. Zamboni, he stated, "The whole notion of cause and effect is out the window."

Now, this is a free country where Mark Freedman, Tom Blackwell and Terence Corcoran, are entitled to their opinions. But, should not everyone, especially physicians and scientists, maintain an open mind to new and provocative information? As I noted in a previous posting, history provides us with some very sad examples attendant on the reflexive rejection of new ideas without any thought or inquiry as to their validity. Should we not learn from the past? And if we do not, how will progress be made, especially in science and the treatment of disease?

Before giving you my personal thoughts on where we currently stand with CCSVI, it is important to remember that I am an oncologist, not a neurologist, and certainly not an MS expert like Dr. Freedman. However, especially when judging the merit of new theories, sometimes outsiders to a specialty can see the “big picture” with more clarity (and perhaps less bias) than those who are “up close and personal”. And as one who, for over 35 years, has been heavily involved in laboratory and clinical research, I believe I know a thing or two about science and (sadly) the politics of science.

First, I continue to believe that the CCSVI theory of MS proposed by Dr. Zamboni is scientifically plausible and deserving of serious and intensive investigation. Those health professionals, and others who, for whatever reason, remain in denial should get over it and commit to finding the answer rather than obstructing progress.

Second, I believe that the preliminary findings of Dr. Zivadinov and his colleagues in Buffalo are significant and support a link between MS and CCSVI. However, their early data are not as robust as Dr. Zamboni’s and their study raises many new questions. For example, what is the true incidence of vein abnormalities in MS patients and normal controls?  Does MS only occur or progress in people with more severe types of venous obstruction?

While we do not yet know, it is important to understand that Dr. Zamboni used both ultrasound and the direct injection of dye into veins (called venography) to obtain his results. The first phase of the Buffalo study employed only ultrasound. Of the two tests, venography is more sensitive and definitive in demonstrating anatomical abnormalities and blockage in veins, akin to angiograms being the “gold standard” in diagnosing coronary artery disease in the heart. In acknowledging this important difference, Dr. Zivadinov has stated that more “advanced diagnostic tools” (including, I suspect, venography) will be used to test the next 500 subjects in his study.

Finally, taking into account Dr. Zamboni’s preliminary results, there is no “level 1” evidence that unblocking veins is an effective treatment for any type of MS. As Paolo Zamboni himself has stated, the answer to that most important question will require further independent assessment and will take time, probably 3 to 5 years at a minimum, to answer. Until then, I strongly advise that patients wishing to have their veins tested, and an unblocking procedure performed, should do so only in approved clinical trials that are properly designed to insure their safety and provide an accurate assessment of efficacy.

In this respect, Canadian MS patients are especially fortunate that centres at McMaster and UBC already have teams of neurologists, radiologists and vascular surgeons who are committed to carrying out these complex studies. While they have our thanks and best wishes for success, they also desperately need our donations. Please be generous and help if you can.

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Dr. Marla Shapiroclose [x]

Dr. Marla Shapiro, MDCM CCFP MHSc FRCP(C) FCFP, is a family physician and the Health and Medical Contributor for CTV's Canada AM as well as the editor of Parents Canada magazine, launched in March 2007.

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