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Friday, October 29, 2010 8:25 PM
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Ken Torbert
Q-3622 — September 16, 2010 — Ms. Duncan (Etobicoke North) — With
respect to chronic cerebrospinal venous insufficiency (CCSVI): (a) do
the Canadian Institutes of Health Research (CIHR) or Health Canada
recognize the Consensus Document of the International Union of
Phlebology (IUP) on the diagnosis and treatment of venous malformations,
in which CCSVI is recognized as venous truncular lesions obstructing
the main outflow routes from the central nervous system; (b) does CIHR
or Health Canada recognize the recommendations by the IUP expert panel
for therapeutic interventions, including angioplasty, stenting, or open
surgical repair of the lesions, in proven CCSVI cases; (c) did anyone
from CIHR or Health Canada attend the July 26, 2010 CCSVI Professional
Symposium and, if not, (i) was there a review of the findings of the
Symposium, (ii) was the review included in the process for the August
26, 2010 meeting between CIHR and the Multiple Sclerosis Society of
Canada (MSSC); (d) what were the terms of reference for the August 26,
2010 meeting between CIHR and the MSSC; (e) in detail, what were the
steps taken in the review of the current state of CCSVI science for the
August 26 meeting and, specifically, (i) were international experts
outside of the United States consulted, (ii) what process was undertaken
to ensure fair and unbiased reviewers, (iii) what check of reviewers’
backgrounds was undertaken regarding links to specific organizations,
review panels and grants obtained, (iv) which, if any, of the reviewers
had previously spoken for or against the CCSVI theory or liberation
procedure, (v) were reviewers who had experience or expertise with CCSVI
selected and, if not, why not, (vi) which, if any, of the reviewers
declared a conflict of interest, (vii) what, if any, action was taken to
address any identified conflict of interest; (f) did the Health
Minister review the biographies of the committee members for the August
26 meeting (i) if not, why, (ii) if so, were any problems identified and
any action taken; (g) what published papers were reviewed by panel
members, broken down by (i) those that confirm venous malformations in
Multiple Sclerosis (MS) patients, (ii) those that deny venous
malformations in MS patients, (iii) those that neither confirm nor deny
venous malformations in MS patients; (h) were international
practitioners, such as those in Bulgaria, Italy, Kuwait and the United
States, consulted to learn (i) how many liberation procedures they had
undertaken, (ii) what, if any, improvements their patients experienced,
particularly in relation to fatigue, "brain fog", motor skills, and
Expanded Disability Status Score; (i) what were the details of the
agenda for the August 26, 2010 meeting; (j) what will be the process for
establishing the CCSVI working group, announced August 31, 2010, and
(i) will it be an open or closed process, (ii) will it include CCSVI and
liberation procedure experts from Canada, such as Dr. Sandy MacDonald,
and around the world, (iii) who will Chair the group, (iv) how often
will it meet, (v) how often will it report and to whom; (k) what are
CIHR and Health Canada’s responses to the Society of Interventional
Radiology’s September 2010 position statement, particularly its
statement that it “strongly supports the urgent performance of
high-quality clinical research to determine the safety and efficacy of
interventional MS therapies, and is actively working to promote and
expedite the completion of the needed studies”; (l) prior to the CIHR’s
announcement on August 31, 2010 that pan-Canadian clinical trials on the
liberation procedure would not go forward at this time, how many
provinces or territories requested that the federal government undertake
national clinical trials; (m) since the beginning of 2010, how many
Canadians have travelled abroad for the liberation procedure and what,
if any, tracking has CIHR or Health Canada undertaken regarding each
patient’s procedure, progress and related expenses; (n) will Health
Canada be undertaking a review of the liberation procedure at each
location it is performed worldwide, including an examination of (i) the
cost, (ii) the number of procedures performed, (iii) the data collected,
(iv) the safety and efficacy of the procedure, (v) the follow-up, (vi)
the ranking of the sites for Canadians wishing to pursue this treatment;
(o) what consideration has CIHR or Health Canada given to how the
August 31 recommendation not to proceed with national clinical trials
will impact the number of Canadians travelling outside of Canada for the
liberation procedure and what, if any, studies have been undertaken to
address the possible impacts; (p) will CIHR or Health Canada undertake
any studies relating to any challenges MS patients face on returning to
Canada after receiving the liberation procedure abroad, including
medical complications, the refusal of treatment by neurologists or
practitioners and the refusal of care by long-term health facilities;
(q) will the government grant the $10 million the MSSC has requested for
research and, if so, when; (r) how much of the $16 million the
government allocated to CIHR will be available for (i) MS research, (ii)
CCSVI research; (s) will CIHR funds be made available to assist in the
creation of a registry that collates data regarding the progress of MS
patients who undergo the liberation procedure and, if so, (i) who will
be involved in its development, (ii) what is the timeline for
development and roll-out; and (t) what research is CIHR or Health Canada
undertaking or funding regarding (i) an atlas of anatomical venous
variations in the neck and chest, (ii) treatment for venous
inflammation, iron storage and hydrocephaly, (iii) possible linkages
among CCSVI, MS and other unidentified factors, (iv) treatment and
follow-up protocols, (v) design of safe apparatuses and procedures to
keep liberated veins open?
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