Arguing Liberation in the Sherbrooke Record

Below is a copy of an article published in The Sherbrooke Record that suggests MSers should not be rushing into being tested for CCSVI and liberated, followed by a letter to the editor (from my friend who lives in the area) who was very distressed by the tone and factual inaccuracies in the article.  Here is the article itself:

Lamenting Liberation E-mail
By Stephen Black

With the decidedly upbeat headline, “Miracles will happen”, Corrinna Pole reports (The Record, April 1) on a breakthrough treatment for multiple sclerosis (MS). She writes that Dr. Paolo Zamboni has discovered that this debilitating disease is caused by blocked jugular veins draining blood from the brain. He claims that unblocking them can produce rapid and remarkable improvement in symptoms. Locally, a fund-raising campaign has been started to raise the $15,000 needed to send a Townships sufferer of MS to a hospital in India for this operation.
In the Zamboni procedure, a tube carrying a balloon is threaded into the neck veins and inflated. Then a wire mesh stent is placed inside the vein to hold it open. This is an expensive procedure. It is not risk-free. The hypothesized explanation of blocked veins differs radically from what is known about theThat such a fund-raising effort exists does not surprise me. Dr. Zamboni’s achievement has received wide coverage in the media. In particular, CTV news and its reporter Avis Favaro are actively promoting it. Given the publicity and the cruel nature of the disease, it is to be expected that MS patients would be intensely interested in receiving the treatment. Dr. Zamboni provides hope in a field in which there has been little good news.
Yet while the claimed success of this radical “liberation” treatment is not an April Fool’s joke, it might well be, because the evidence for it is disturbingly weak. A responsible medical researcher, no matter how passionately he believes in his treatment, would never allow his work to be promoted in the media as Dr. Zamboni has done. At least not before providing solid evidence of its effectiveness through publication in scientific journals where the procedures and results can be scrutinized by medical experts. cause of MS as an auto-immune disease. These drawbacks might be acceptable if the procedure had established effectiveness. But based on the limited evidence currently available, the dramatic claims may turn out to be a mirage. There are good reasons why the operation is currently neither funded nor carried out in Canada.
Dr. Zamboni’s confidence is based on testimonials of the effectiveness of his treatment and on two published papers. To a scientist, testimonials are the weakest form of evidence, because positive reports are all too easily the result of self-delusion, placebo effects, exaggeration, and occasionally even fraud. Yet they are often the most convincing for a non-scientist. A scientist requires something more rigorous: a randomized, placebo-controlled, double-blind trial (an RCT), such as those routinely carried out in the development of new drugs.
Dr. Zamboni’s 2008 publication is not an RCT but a correlational study. It found that a large proportion of individuals with MS have the abnormalities in the veins which he identifies as the cause, while no abnormalities were found in individuals without MS. But while the abnormality may cause MS, as Dr. Zamboni claims, it is also possible that MS causes the abnormality, or that the individual’s genes are responsible for both MS and the abnormality, but one does not cause the other. In the latter two circumstances, treating the abnormality would have no effect on the disease.
A more recent study of the same kind as Dr. Zamboni’s was carried out by a group in Buffalo but, as it has not been published, few details are available. It is said to support Dr. Zamboni’s findings, but at the same time reports fewer cases of the abnormalities in MS patients than Dr. Zamboni found, and some of the same abnormalities in individuals without MS. This result is not encouraging, because if blockage causes MS, every individual with the abnormality should have MS.
In 2009, Dr. Zamboni published a study of his treatment showing improvement in symptoms. However, the study was not an RCT, and its restrained conclusion was merely that, “The results of this pilot study warrant a subsequent randomized control study”, indicating Dr. Zamboni’s acceptance of the need to validate his claims with an RCT. No one has yet published such a study.
Also, in the 2008 article Dr. Zamboni urges caution, noting, “The hypothesis…seems to be plausible. Nevertheless, additional longitudinal studies are necessary to confirm this hypothesis”. Others are blunt. Dr. Mark Freedman of the MS unit of the Ottawa General Hospital is reported in the Ottawa Citizen as saying, “We need to have the supporting evidence before we start reaming out blood vessels and pretending that this is going to cure the disease”.
Dr. Colin Rose, a cardiologist and associate professor of medicine at McGill, asks on his blog, “The Zamboni myth is… 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…Why do surgeons have this power to ignore science?” Dr. Paul O’Conner, a neurologist and specialist in MS at St. Michael’s Hospital in Toronto, comments in the Edmonton Journal that “the theory…is held by a very small group of people only”.
What about the dramatic improvement claimed for the treatment? Researchers in Poland and in Jordan have reported positive results, which remain unpublished and therefore unavailable for scrutiny. But even so, they are hardly dramatic, consisting of “remembering dreams again…reductions in fatigue, and an end to ringing in the ears”.
Most disturbingly, a trial of the therapy at Stanford University was cancelled when one of the patients died of a brain hemorrhage on the way home after treatment, while another required emergency life-saving surgery when a stent became loose and lodged in the heart.
There is a sad history of quackery in medical practice, of desperate patients deluded into believing they can be saved by untested treatments which in reality impoverish them and shorten their lives. Surely, all sufferers of dread diseases deserve a cure. But “faith and hope” alone will not accomplish this. The enormous success of modern medicine is due to its insistence on scientifically-acceptable evidence. Such evidence is not yet available for Dr. Zamboni’s treatment.
The only way in which anyone should contemplate submitting themselves to such an operation is within a carefully-planned and monitored clinical trial, where the patient has at least some protection against harmful outcomes, and where the results can provide critical information for everyone about the value of the treatment. This, as it happens, is also the recommendation of the Multiple Sclerosis Society of Canada (see http://tinyurl.com/Zamboni-treatment). The Society also provides a responsible and thoughtful analysis of Dr. Zamboni’s work and its implications. It does not include a recommendation for expensive treatment at a hospital in India.

And here is Shelley's letter to the editor:

Mrs. McCully,

I don’t know if you personally know anyone with Multiple Sclerosis – if you do, being the editor of The Sherbrooke Record, I can only imagine that you felt heartsick after reading (and allowing to be published!) Stephen Black’s article entitled, Lamenting Liberation. If you don’t know anyone with MS, you should feel heartsick and you should also feel ashamed for allowing such rubbish to be published, not just because of its cruel and sarcastic tone towards a sick woman hoping for help after years of suffering with one of the most frightening diseases known to mankind, but because it is beyond flawed and inaccurate. I am sick to my stomach from reading such self-indulgent, inaccurate, misinformed, and biased rhetoric that Mr. Black considers journalism. I don’t know where he was schooled in journalism, but perhaps he missed the lecture on accuracy and fact checking >Dr. Zamboni does NOT yet endorse the use of stents in regards to the Liberation procedure. He believes balloon angioplasty is the best way to proceed with caution in treating blocked/narrowed veins at this time. And the complication with the patient in the US who died of a brain hemorrhage shortly after being treated was due NOT to having been liberated, but rather, her death was instead a result of an adverse reaction to the prescribed blood thinners, due to a genetic condition. Her family spoke out in support of the Liberation Treatment after her death for God’s sake! Mr. Black should focus his time and attention on learning what the true facts are, rather than disparaging a local woman’s hope to be helped from a most debilitating illness. He should be aware that her hope of being treated happens to be shared by over 2.5 million people with MS worldwide, over 70,000 of whom happen to live in the same country as Mr. Black. There will be a march on Parliament Hill May 5th to get the message out to ignorant Canadian naysayers like Mr. Black that it is time to say NO to drugs and YES to medical interventions that actually cure and/or halt the disease process of MS. Canadians will be marching in major cities across the country in support of CCSVI testing and the Liberation Treatment. What an education Mr. Black will get if he watches the news that day – I’m assuming he isn’t a religious follower of the news.

This article can certainly help to educate him on the subject of CCSVI/MS/Liberation since he took it upon himself to speak with authority on a subject he clearly knows little about.  It is from Macleans- surely he has heard of this publication. http://www2.macleans.ca/2010/04/19/the-%E2%80%98miracle-cure%E2%80%99/print/

I wonder if Mr. Black had blocked veins in his neck, if he would like to have them opened up to allow better blood flow to his brain? Would he scoff at an angioplasty procedure on narrowed/blocked veins if it could spare him his sight, his continence, his intellect, and his mobility? He appears to suffer with vein blockages in his heart and in his brain – no compassion or open-mindedness seems to flow through them. Too bad there is no “liberation” for this ailment.

I welcome this letter to be published in your newspaper. You may use my name.

Shelley Black

P.S. Since I don’t have his email address, kindly forward this email to Mr. Black.