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
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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Director of Communications
Department of Health and Community Services
2010 09 13