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Friday, October 29, 2010 8:25 PM | Ken Torbert Volg link
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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