This Is MS Multiple Sclerosis Knowledge & Support Community

Context Multiple sclerosis (MS) is a chronic progressive neurological disease common in young adults.1 Canada has one of the highest prevalence rates of MS in the world.2 MS causes significant disability due to mobility and vision problems, fatigue, incontinence, and cognitive impairment.1 The Public Health Agency of Canada estimated that the total costs associated with MS in 2000-2001 for hospitalization, treatment, and lost productivity due to morbidity and premature mortality were $950.5 million.1 Treatments involve suppressing or modifying the immune response, but there is currently no cure for MS.3 Although MS is commonly believed to be an autoimmune disease, the evidence to support this concept has been questioned.4 An alternative hypothesis has been put forth by Dr. Paolo Zamboni, a former vascular surgeon and professor at the University of Ferrara in northern Italy. Dr. Zamboni believes a phenomenon termed chronic cerebrospinal venous insufficiency (CCSVI), an abnormality in blood drainage from the brain and spinal cord due to the narrowing of veins, may cause the buildup of iron deposits and contribute to inflammation and nervous system damage.5 Initial findings that CCSVI may be associated with MS were published in 2009 from a study of 65 patients with MS.6 Results from a second study suggested that treating CCSVI with endovascular angioplasty (the insertion of a tiny balloon or stent into blocked veins to improve blood flow), also referred to as the liberation procedure, is feasible and safe.7 Results from other studies have not supported the hypothesis that CCSVI is present in patients with MS.8-12 Findings from a clinical trial published in April 2011, involving 499 participants, indicate that CCSVI may be a consequence rather than a cause of MS.13 The results showed that only 56.1% of MS patients had CCSVI. Furthermore, 42.3% of participants had other neurological diseases and 22.7% of healthy controls also had CCSVI. It was also noted that CCSVI prevalence was significantly higher in patients with advanced progressive MS than those with non-progressive MS.
The CCSVI surgery for MS patients has not been approved by Health Canada and is not covered by provincial health insurance plans. In 2010, an estimated 3,000 Canadians travelled to clinics in the United States, Bulgaria, Poland, India, Costa Rica, and Mexico, each paying thousands of dollars for the procedure.14 Among them was an Ontario man who died in October 2010 from complications of the procedure, which he received in Costa Rica.15 Based on the risks associated with the CCSVI surgery and the inconclusive results of preliminary research, there have been recommendations that rigorous large-scale clinical trials are required to determine whether CCSVI is a clinically important factor in the development or progression of MS.16,17 In light of the high prevalence of MS in Canada, the CCSVI procedure has sparked unprecedented interest and generated considerable debate in the medical and scientific communities. Politicians have faced increasing pressure from the public to provide funding for clinical trials.
Objectives
The purpose of this report is to review recent developments in the investigation of CCSVI for the treatment of MS. This report will update information presented in a previous Environmental Scan, released in December 2010.18 The following questions will be addressed:
Which clinical trials in North America are currently studying the association of CCSVI with MS?
What is the status of funding for CCSVI research in Canada?
What other initiatives are taking place in Canada with regard to CCSVI?

Scientific and medical organizations and experts across Canada have uniformly urged caution and rigorous study before the CCSVI procedure is recommended for use outside of clinical trials in MS patients. The recent approval of fingolimod has provided a new treatment choice for patients who have not responded to other MS therapies. Several other technologies are currently in the pipeline for the management of MS.

Other health technologies currently being studied in clinical trials include monoclonal antibodies (such as rituximab, daclizumab, alemtuzumab, ocrelizumab, and ofatumumab), statins (such as atorvastatin and simvastatin), laquinimod, oral fumarate, teriflunomide, firategrast, and autologous hematopoietic stem cell transplantation.3,63,64

The federal government intends not to fund a pan-Canadian clinical trial until ongoing studies indicate that CCSVI is indeed a hallmark in the disease process of MS.

About CADTH
Decisions about which medical devices and drugs to use are crucial to the quality and sustainability of health care in Canada. Access to evidence-based information is key to making informed decisions that harness the benefits of technology while getting the best value from every health dollar.

The Canadian Agency for Drugs and Technologies in Health (CADTH) provides decision-makers with the evidence, analysis, advice, and recommendations they require to make informed decisions in health care.

Funded by Canada’s federal, provincial, and territorial governments, CADTH is an independent, not-for-profit agency that delivers timely, evidence-based information to health care leaders about the effectiveness and efficiency of health technologies.

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Cece wrote:

The federal government intends not to fund a pan-Canadian clinical trial until ongoing studies indicate that CCSVI is indeed a hallmark in the disease process of MS.

I wonder what they mean exactly by hallmark.

Neurofibrillary Tangles are a Hallmark of Alzheimer's Disease