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?
In the House of Commons on November 3rd, 2010. See this statement in context.