On Thursday, November 1st, the Senate Social Affairs, Science and Technology (SAST) committee had the third hearing on Senator Jane Cordy’s Bill S-204. The bill calls for a national strategy for chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). I had sponsored the same bill, Bill C-280, in the House of Commons.

Since Conservative senators refused over and over to hear from those who have MS (and from a well-known Canadian CCSVI expert, Dr. Sandy McDonald), Canadian MS patients are hoping that the government actually heard the November 1st testimony, and will act on the recommendations by internationally-renowned experts.

Dr. Andreas Laupacis, a physician who practices palliative care at St. Michael’s Hospital in Toronto, Dr. Robert Zivadinov, the Director of the Buffalo Neuroimaging Analysis Centre, and Dr. Paulo Zamboni, the founder of the CCSVI treatment, appeared before the SAST committee on November 1st.

Dr. Laupacis was funded to undertake a literature review by the Canadian Institutes of Health Research (CIHR) regarding CCSVI; the committee heard previously from Dr. Barry Rubin, who was indebted to CIHR for funding his research for 15 years. Dr. Laupacis’s group found 11 studies which showed that CCSVI was about eight times more likely to be found in people with MS than in healthy people. Dr. Zivadinov made reference to more than 25 studies, which is not surprising: Dr. Zivadinov has been investigating CCSVI since 2008. Dr. Laupacis is neither an expert in MS nor the vascular system.

Like Dr. Rubin before him, Dr. Laupacis focused disproportionately on adverse events, and said that “there have also been reports of major bleeding from the blood thinners the patients are prescribed around the time of the procedure, some of which have been fatal. There have been instances of clots in the neck, leaking of the veins where the balloon was blown up, and stroke. In some instances, stents have been inserted as part of the treatment and some have moved, sometimes into the heart, and this is why stents now tend not to be used when treating CCSVI.”

It was disturbing that Dr. Laupacis, a researcher, failed to mention that Dr. Mandato et al showed in a study that endovascular treatment of CCSVI is a safe procedure — with a 1.6 per cent risk of major complications — how many times a stroke is known to have occurred, how many times a stent migrated to the heart, and what the denominator was or the actual number of procedures undertaken. Over 30,000 procedures have been performed worldwide in sixty countries, with four deaths having been reported, along with one stroke, and one stent migrated to the heart.

In sharp distinction, the government fast-tracked the MS drug Tysabri, despite the fact that it was known to cause a fatal brain infection, progressive multifocal leukoencephalopathy (PML). As of October 5, 2012, there were 298 confirmed cases of PML worldwide; 63 of those with PML have died. The growing safety concerns over Tysabri remain unaddressed in this country, which I believe is unconscionable. Dr. Laupacis recognized that “the drugs cause serious side effects. However, we know what the benefits of the drugs are, from randomized trials.”

Dr. Zivadinov expanded the discussion of CCSVI treatment to discuss its relevance in possibly treating other neurological disorders. He also stressed the complexity of the venous system, and the different forms of imaging necessary to diagnose CCSVI.

Once again, there was a split between the expert recommendation and the government position. The government previously held a consensus workshop on ultrasound imaging that only looked at one type of imaging technology to diagnose blocked veins in September 2011, which was described in a CIHR briefing note of February 13th, 2012.

Disappointingly, my first ATIP request failed to generate any results on the ultrasound workshop; a second request is expected to yield results, but again requires an extension of the time period.

Canadian MS patients rightly question what imaging techniques will be undertaken regarding the clinical trials which were announced June 29th, 2011 (they were supposed to begin November 1st, and now we hear they’re starting in December. In one month, some 90 people will be diagnosed with MS, and over 30 will die of the disease.

Dr. Zamboni next discussed the importance of histology and pathology in medicine, and the fact that evidence shows there is a marker in the vein wall that is “more represented” in people with CCSVI, and that a significant number of inter-luminal obstacles are found in the jugular veins of those who die with MS. Moreover, specific environmental factors have been found to be linked to CCSVI, including heart disease, infection, and irritable bowel syndrome.

Dr. Zivadinov questioned whether there might be treatment outcomes specific to CCSVI, including a decrease of headaches, fatigue, and sleep disturbances, and whether or not these should be included in studies.

Dr. Zamboni told the committee that he pulled out of the Italian MS study examining CCSVI because those involved lacked training in the method he had pioneered, which compromised study outcomes. While the government is at last beginning clinical trials for CCSVI, MS patients, doctors, and researchers have concerns as the trial is not pan-Canadian, and involves only 100 patients. Doctors have been clear that it can take several hundred procedures to be practiced and competent in the procedure.

The government has shown a decided reluctance to confer with Dr. Zamboni on methodology and training. Dr. Zivadinov, on the other hand, explained that before beginning his work, “we felt that it was very important to contact Professor Zamboni. We went through numerous training sessions … I thought it was important to learn what other people know, and then go forward and create a large study to apply all these techniques in a multi-modal way.”

In concluding, I will speak for those who have been silenced by the government, namely voiceless and vulnerable MS patients, who were deeply concerned by the chair’s editorializing at the committee when he said “… I looked into the details of the drug. Tsyabri apparently is applied to MS, Crohn’s disease and some other areas. In all patients studied, for those who have all three conditions the risk ratio is 1.1 per cent. That falls within the range you were discussing. It was helpful to us that you made the point that it is the risk factor and not the number of events that is important. It is how you interpret those risks against the issue.”

People with MS are tired of being labelled “no-hope” by a government that doesn’t care, and they ask parliamentarians to ensure that they are not “mere collateral damage” of risk-benefit ratios.

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