My Rebuttal to Paula Simon's Ridiculously Ignorant Article on Provincial Funding for CCSVI Studies and Treatment
by Ginger MacQueen on Thursday, August 12, 2010 at 2:21pm

Multiple sclerosis is a terrifying, debilitating, mysterious disease. Alberta and Saskatchewan have some of the highest MS rates in Canada -- and Canada has one of the highest rates in the world.

So it's understandable that many Canadians were filled with hope and excitement when Italian physician Paolo Zamboni announced last fall he had found a revolutionary new treatment for MS.

Although scientists have, for years, accepted that MS is an autoimmune disease that attacks the central nervous system, Zamboni, a vascular surgeon, declared he'd discovered an entirely new cause, which he creatively dubbed "chronic cerebrospinal venous insufficiency" or CCSVI.

Zamboni claims MS is caused by a buildup of iron deposits in the veins leading to the brain. He further claims that unblocking the veins, using balloon angioplasty and stents, improved cranial blood flow and improved the range of movement in MS patients.

Now, provincial politicians, besieged by phone calls and e-mails from desperate patients who see Zamboni's so-called "liberation" therapy as their only hope, are under pressure, either to fund so-called liberation surgery here or to fund expensive clinical trials for the procedure.

But no matter how much sympathy we all feel for desperate MS patients who see Zamboni as their saviour, it would be an enormous error in judgment for the Alberta government to sanction or fund this surgery -- or to divert any of the province's limited research and public health dollars toward clinical trials of a technique both dangerous and deeply dubious.

Since Zamboni's explosive news broke, independent scientists have tried to find some confirmation of his theory. Separate groups of medical researchers in Germany, Sweden, and Buffalo, New York, have used MRI and ultrasounds to examine the cerebral and jugular veins of patients with multiple sclerosis and those without.

The Buffalo study found that just over half the MS patients it screened had some vascular blockages -- but that about one-quarter of people without MS had the same blockages. The more recent German and Swedish studies, published this month in the journal Annals of Neurology, found no relationship between blocked veins, blood flow and MS symptoms.

No matter. Over the last few months, trusting, vulnerable patients have been flocking to clinics in places like India, Poland and Bulgaria, paying up to $30,000 to undergo Zamboni's risky and unproven "liberation" therapy.

Some have come home saying they have more energy and range of movement.

Such testimonials, however inspiring, are not proof. In the first place, "liberation" therapy is used to treat a form of multiple sclerosis known as "relapsing-remitting MS." It is a roller-coaster disease, where people can often experience remissions or lessenings of symptoms, sometimes for no apparent reason.

And don't discount the power of the human mind, of hope itself. Patients who truly believe a treatment will help them to walk better or grip better will likely feel more confident and better able to complete such tests. And the more invasive or expensive a treatment is, the greater the placebo effect is likely to be. Call it high-tech faith healing -- if you fiercely believe something is going to make you feel better, if you've invested all your dreams and energies in that conviction, you're likely to report that you do feel better.

Yet according to an Alberta Health Services bulletin issued on Friday, "As of today, no Canadian neurologist has found significant or sustained improvement upon examination of patients who had venous angioplasty performed, despite the fact that most returning patients report feeling better and sometimes note improvements in sensation or walking."

Still, Saskatchewan Premier Brad Wall has vowed Saskatchewan would fund clinical trials of liberation therapy. And Alberta's premier, Ed Stelmach, told reporters Alberta had "no problem" with participating in similar trials.

A spokesman for Stelmach says the province will only fund research if it's supported and carried out by the Alberta medical community.

Even with that proviso, the government needs to take a big step back. There are many world-class medical researchers working on promising treatments for all kinds of conditions.

Provinces only have so many medical research dollars to spend -- and a full-fledged clinical trial of Zamboni's surgery would be both extremely expensive and ethically complicated, given the inherent dangers of cranial venous angioplasty.

We mustn't politicize or sentimentalize the independent grant process, allowing elected officials to decide which pet project to fund. Money needs to be channelled to the most promising research, research that meets every rigorous, peer-reviewed scientific standard.

To deny funding to legitimate local research, the better to chase Zamboni's unicorn, would be grossly irresponsible -- to MS sufferers most of all.

Multiple sclerosis is a national scourge we must fight with all the best science available. But we won't find cures by running down blind alleys -- or validating false hopes

Dear Editor,

Clearly Paula did not do her research! Zamboni’s theory is not based on veins blocked by iron as she states in her article. CCSVI is chronic cerebro spinal insufficiency and is theorized to be caused by blocked internal jugulars and/or azygos veins that drain the blood from the brain back down to the heart. The iron deposits are believed to be the lesions on the brain and spine that have always been classic signs of multiple sclerosis. Multiple sclerosis by definition means “many scars”.

To call Zamboni’s theory a “unicorn” is so grossly childish it boggles my mind. CCSVI is not a fairy tale creature, a blind alley or a false hope. CCSVI is a real medical phenomenon that has been scientifically validated and published in medical journals. Veins are made to move blood. Blocked veins are therefore bad. Regardless if there is a link between CCSVI and MS any person with dangerously blocked veins should be able to have them fixed whether they have a pre-existing condition of MS or not.

I am appalled at Paula’s cynical and heartless view of not following Saskatchewan’s lead in funding research and clinical trials. If we all thought this way we would have never had such surgical breakthroughs like heart bypass and brain surgery! So essentially, Ms. Simons is telling the roughly 75,000 Canadians afflicted with MS is that they are not important enough for our government to risk funding studies that could potentially rid them of suffering and consequent death? Simons says “…it would be an enormous error in judgment for the Alberta government to sanction or fund this surgery -- or to divert any of the province's limited research and public health dollars toward clinical trials of a technique both dangerous and deeply dubious.”

The fact that she uses terms like “dangerous and deeply dubious technique” only intensify the overall ignorance of this story. Angioplasty has been performed for many, many years and the risk of death is rated at 1 in 1000 and that is for ALL types of angioplasties. The benefits from angioplasty far outweigh the 1 in 1000 risk or it would not be performed in our country. These studies and clinical trials will put to rest any doubts whether this treatment is beneficial or merely placebo effect.

Of course Paula could not help but grab hold of the two recent studies by the Swedes and Germans that did not find any correlation between MS and CCSVI. The truth of both those studies has been out for awhile now. (maybe Paula didn’t get the memo) Neither of those groups followed the Zamboni scanning protocols so to try and compare them is ridiculous. She goes on to state that the angioplasty referred to as the Liberation treatment is only used to treat relapsing remitting MS. How she ever came up with that tid bit is beyond me. Thousands of patients with ALL types of MS have been reaping the benefits of this procedure! I know many PPMS and SPMS patients who are now out of their beds and wheelchairs! There has never, ever been any treatment for PPMS or SPMS before this. There has never been any treatment that has made so many MS patients feel this good!

So naturally, it must be placebo effect right? Placebo effect can account for a number of positive effects but cannot be given credit for bladder and bowels spasms going away, balance returning and gait improvement and eye sight improving. She also cites in her article that Alberta Health has stated that “"As of today, no Canadian neurologist has found significant or sustained improvement upon examination of patients who had venous angioplasty performed, despite the fact that most returning patients report feeling better and sometimes note improvements in sensation or walking."

I would like to know who these neurologists are that are examining the returning “liberated” patients? My neuro wont even see me anymore since I have had the angioplasty! He is not interested! Why would they be? If this angioplasty works then it is proof positive that MS is vascular and all these years the neuros have been treating us with ineffective and often dangerous drugs. If I were a neuro I would be very worried right now.

Another statement by Paula: “Provinces only have so many medical research dollars to spend -- and a full-fledged clinical trial of Zamboni's surgery would be both extremely expensive and ethically complicated, given the inherent dangers of cranial venous angioplasty.” I agree about the expense part but when you compare it dollar for dollar to the millions per year that we as patients are spending on ineffective drug therapies there is no contest! I am glad she brought up ethics! How ethical is it that medical professionals and members of MS Societies can own stock in pharmaceutical companies and be paid to do research and clinical studies by these pharma companies? That is a HUGE conflict of interest! When Alberta does go ahead with trials and studies the ratio of neuros to vascular specialists should be even at the least.

Another profound statement by Simons: “We mustn't politicize or sentimentalize the independent grant process, allowing elected officials to decide which pet project to fund. Money needs to be channeled to the most promising research, research that meets every rigorous, peer-reviewed scientific standard.”
Brad Wall of Sask. And Ed Stelmach of Alberta did not independently decide to fund trials and research. Hundreds of thousands of Canadian voters have been inundating our politicians with their desire for help in this matter. Anecdotal or not, thousands of MS patients are better after the angioplasty and Stelmach and Wall listened and, thankfully, are doing their jobs!