With respect to the full process currently being undertaken by the Canadian Institutes of Health Research (CIHR) regarding chronic cerebrospinal venous insufficiency (CCSVI), including the August 26, 2010, meeting of the Scientific Expert Working Group (SEWG) and the CIHR’s “knowledge synthesis review”: (a) what is the accepted operating definition of “conflict of interest” for the CIHR, (i) why was no disclosure statement made by all participants who attended the August 26, 2010, joint meeting of the CIHR and the Multiple Sclerosis Society of Canada (MSSC), (ii) are there plans to provide an opportunity to declare possible conflicts of interest subsequent to the meeting; (b) what are the details of all information produced and circulated by the CIHR in January 2011 regarding follow-up care for multiple sclerosis (MS) patients and to which organizations was the information sent; (c) will the disclosure statement to be signed by members of the SEWG at its next meeting in June 2011 include specific reference to any (i) consultancy, (ii) grant support, (iii) membership on advisory councils, (iv) speaker’s bureau, (v) other sources of funding a member might have; (d) how does the CIHR plan to ensure that all members of the SEWG have the same understanding of private or personal interests that could influence decision-making; (e) will all disclosure statements in (c) be made publicly available and, if so, when, and, if not, why not; (f) which, if any, of the SEWG’s members have been trained in Dr. Zamboni’s methods and by whom were these members trained; (g) which, if any, of the SEWG’s members have watched diagnosis and treatment of CCSVI and, for each member identified (i) where did this observation take place, (ii) under what guidance, (iii) how many images and treatments were studied by the member; (h) which, if any, of the SEWG’s members have undertaken diagnosis and treatment of CCSVI and, for each member identified, (i) where were these actions performed, (ii) under what guidance, (iii) how many images and treatments were performed by the member;
(i) does the CIHR recognize the emerging scientific discipline of neurovascular disease; (j) does the SEWG include any members of the International Society for NeuroVascular Disease (ISNVD) and, if so, who are these members, and, if not, why not; (k) which, if any, members of the SEWG have attended any of the ISNVD’s conferences, specifying for each such member the conferences that he or she attended; (l) does the inclusion of investigators of the seven MS Society-funded studies in the SEWG comply with the CIHR’s operating definition of “conflict of interest” and, if so, what are the reasons that explain this compliance; (m) regarding the “knowledge synthesis review”, (i) what is the protocol for the review, (ii) how is research deemed to be, or not to be, pertinent, (iii) who specifically is undertaking the review, how were they chosen, and what expertise do they have to undertake the review, (iv) why has the CIHR decided to have them undertake the review, (v) what are the CIHR’s reasons for not having the SEWG undertake the review, (vi) what is the cost of the review, (vii) what is a comprehensive list of abstracts to be reviewed, (viii) what additional material, people, or other sources will be consulted, (ix) will the review include scientific evidence presented at all the major scientific conferences on CCSVI to date, namely, Hamilton (February 2010), New York (July 2010), Washington (October 2010), Katowice (March 2011), Bologna (March 2011), Chicago (April 2011), and San Diego (May 2011), (x) will the review include contacting the leading experts in the field, asking for their unpublished data, visiting their laboratories and operating theatres, (xi) if the answer to (m)(x) is in the affirmative, what, if any, protocol has been established for each contact, and what, if any, weighting will be applied to this evidence; (n) how does the CIHR plan to weigh or asses the seven MS Society-funded studies and the “knowledge synthesis review” in its establishment of any future policy, particularly in its deliberations on whether to undertake clinical trials for CCSVI in Canada; (o) which , if any, members of the SEWG have attended any CCSVI conferences, specifying for each such member (i) what conferences he or she attended, (ii) in what capacity, (iii) who paid for the trip or attendance at the conference, (iv) what written evidence did he or she report to either the CIHR or SEWG, (v) if no written evidence was reported, why not; (p) which members of the CIHR have attended any CCSVI conferences, specifying for each such member (i) what conferences he or she attended, (ii) in what capacity, (iii) who paid for the trip or attendance at the conference, (iv) what written evidence he/she reported to either the CIHR or SEWG, (v) if no written evidence was reported, why not; (q) why has the CIHR decided not to further investigate CCSVI through clinical trials; (r) why has the CIHR decided not to follow recommendations made by the Ontario Association of Neurologists, the Canadian Society of Radiologists, the Canadian Society of Vascular Surgery, the American Society of Interventional Radiology, and the International Union of Phlebology regarding CCSVI;
(s) what does the CIHR consider an “appropriate pace”, a term used in its May 18, 2011, e-mail to Dr. Kirsty Duncan, Member of Parliament for Etobicoke North, for the introduction to Canada of any potential new medical treatment for any medical condition, and how much evidence does the CIHR consider is required before a treatment should undergo clinical trials in Canada in terms of (i) the number of procedures undertaken, (ii) the number of countries undertaking the procedure, (iii) scientific evidence presented in academic peer-reviewed journals, (iv) scientific evidence presented at academic conferences, (v) scientific evidence presented at academic conferences for conditions that are progressive diseases, especially progressive diseases for which there are limited or no options for treatment; (t) what is the CIHR’s accepted protocol, including all necessary steps, for bringing a new treatment to clinical trials in Canada, (i) when was the protocol established, (ii) what treatments have undergone clinical trials as a result of the protocol, (iii) which treatments have been rejected to date; (u) is the creation of a SEWG a standard step in the CIHR’s protocol for bringing a new treatment to clinical trials in Canada, and, (i) if so, since the creation of the protocol, what are all new treatments and their associated SEWGs, (ii) if not, why was this step deemed necessary for approval of clinical trials for CCSVI; (v) what are the last five medical treatments for any medical condition accepted by the CIHR for use in Canada and, for each treatment, what are the details of all evidence required by the CIHR in its decision to have the treatment undergo clinical trials, including, but not limited to, the number of procedures undertaken, the countries undertaking the procedure, and scientific evidence presented in both peer-reviewed journals and academic conferences; and (w) with regard to the MS registry announced March 23, 2011, (i) who specifically is collecting the information, (ii) what precise information is being collected, (iii) what consent will be necessary from patients for any data collection, (iv) when will information begin to be collected, (v) what specific information is being collected regarding the treatment of CCSVI, (vi) what information is being gathered or tracking is being done of individuals who have chosen to have the liberation procedure outside Canada?