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Health and Community Services
September 13, 2010

Province to Fund Observational Study of MS Patients

The Provincial Government today announced plans to fund up to $320,000 (and more if required) for a Newfoundland and Labrador-based observational study of multiple sclerosis (MS) patients who have chosen to undergo the experimental liberation procedure proposed by Dr. P. Zamboni. The Honourable Jerome Kennedy, Minister of Health and Community Services, made the announcement today.

Multiple sclerosis is the most common disabling neurological disorder of young adults in Canada, with the average age at time of diagnosis being 28. Women are two to three times more likely than men to be diagnosed with the disease. It is estimated that approximately 1,100 residents in Newfoundland and Labrador have MS.

"Our government recognizes the significant impact that MS has on those who suffer from the disease as well as their families, and we are aware of the significant concern they have about the length of time it will likely take to complete research on the liberation procedure," said Minister Kennedy. "By funding this non-interventional clinical trial (observational study), we are attempting to do our part to add to, and perhaps expedite, the research that is currently being done in this area."

The Provincial Government will not be funding patients to have the liberation procedure done at this time; rather, patients from Newfoundland and Labrador, who have chosen to have the procedure done, will be invited to participate in the observational study. The purpose of the observational study will be to, as much as possible, objectively evaluate the impact of the liberation procedure on the symptoms and progression of MS in a patient. The Provincial Government will review next steps once the observational study is complete.

The proposed study will be organized and conducted by local neurologists in the province, specializing in multiple sclerosis. The study will be provincial in scope with the examiner travelling to clinical sites in the regional health authorities to examine the studyís participants. The study will involve multiple examinations, pre- and post-procedure (at one, six and 12 months) with standardized physical, functional and cognitive examinations being completed. Serial MRIs would also be performed. An MRI, which is a non-invasive diagnostic test, is one of the most important diagnostic tools for multiple sclerosis. Because it can show changes in the diseaseís activity, the MRI will be used to assess the effectiveness of the treatment and the impact on a patientís symptoms, in addition to the examinations being performed.

Each patient enrolled in the study, who has had the liberation procedure completed, will be "matched" with a comparable patient (i.e., age, sex and comparable disease-state scores). Both patients would then be reviewed on a regular basis by the same examiner, who will otherwise be "blinded" as to which patient had/did not have the procedure performed. By "blinding" the examiner, many of the criticisms directed at Zamboniís original research results will be minimized.

Further details regarding the study, including patient participation will be announced once the last few details of the trial are finalized.

In August 2010, the Canadian Institute for Health Research (CIHR) recommended to the federal minister of health that a pan-Canadian clinical trial on the treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in MS patients should not be considered for funding at this time, pending the results of research being undertaken by the MS Society of Canada and US to investigate the possible relationship between CCSVI and MS. The outcome of the research is expected to be available within two years.

"I want to reassure MS patients and their families that our government is committed to sponsoring the research necessary to expedite our understanding of the impact of the liberation procedure on MS," said Minister Kennedy. "We stand with MS patients and their families in looking forward to the results."

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Media contact:

Tansy Mundon
Director of Communications
Department of Health and Community Services
709-729-1377, 685-2646

2010 09 13                                                     11:30 a.m.

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