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Ms. Kirsty Duncan (Etobicoke North, Lib.): Mr. Speaker, I have four petitions regarding mercury, one of the most toxic substances. Mercury used in dentistry may contaminate the environment by the disposal of solid waste products and contaminate air from dental clinics. Burial, cremation and human waste may also contribute mercury to the environment.
The petitioners request that the government recognize that the World Health Organization recommends the phasing out of dental amalgam and recognize the work of the Intergovernmental Negotiating Committee. The petitioners request the government assume leadership in recommending the phase-out of dental mercury and the phase-in of non-mercury alternatives within Canada.
Dear Minister Ambrose,
I am writing to you in order to express the frustration of Canadians living with multiple sclerosis who were looking for real answers regarding the clinical trials for chronic cerebrospinal venous insufficiency (CCSVI).
Health Canada (HC) previously told me that the Canadian Institutes for Health Research (CIHR) could answer my detailed questions regarding diagnosis, treatment and follow-up care for the CCSVI trial; but when I contacted CIHR, I was told HC should answer my questions.
However, when I then contacted HC again, I was told ministerial permission would be required to answer any of my questions. As a result, I put all my questions in the form of an order paper question for the Canadian public to see, and for Canadians with MS to receive the answers they need to make informed choices about the trial and their health care.
You can imagine their disappointment when I was informed “specific questions regarding the protocol of this independent research project or the cost of the clinical procedures should be addressed directly to the principal investigator of the study.” That means, no answers were provided for: (b), (c), (d), (e i-iii), (f i-iii), (g i-ii), (h), (i i-ii), (j), (k), (l), (n), (p), (q i-ii), and (r); the order paper question only included parts (a-r).
Canadians living with MS want to know how the trial will be undertaken, whether or not they appreciate the methodology of the trial, and whether or not they will be able to judge the results against what has been presented in the international literature.
But yet again, Canadians living with MS have been disappointed by a government that refuses to answer their questions, and continually stonewalls, as is the case with the Canadian MS Monitoring System, which was announced in March 2011, and for which they are awaiting an update.
I hope the government appreciates that Canadians living with MS are not fooled by non-answers; and just laughed when the answer to my order paper question revealed that the trial led by Dr. Anthony Traboulsee started on November 1st, 2012. They understand that the trial actually begins with ethical approvals and with recruitment of patients; and know that the previous Minister was reluctant to answer my questions regarding the dates of each, and actually provided several different answers for the same question.
Finally, I hope you and I can work together to provide some real answers for Canadians living with MS, and I would be pleased to meet with you at your convenience.
Kirsty Duncan MP
Question No. 53–
Ms. Kirsty Duncan:
With respect to the chronic cerebrospinal venous insufficiency (CCSVI) clinical trial being undertaken by Dr. Traboulse: (a) what milestones are reportable to the government, (i) on what date(s) is reporting expected to occur, (ii) how will this information be communicated to patients, the medical community, and the general public; (b) on what date did each of the trial sites pass ethical review; (c) on what date did recruitment of patients begin for each of the trial sites; (d) how many patients with multiple sclerosis (MS) are being recruited for each site, and how is consistency in diagnosis and treatment being ensured across sites; (e) who is performing the diagnoses for CCSVI for each site, (i) how is the diagnosis being performed, including, but not limited to, ultrasound and venogram, (ii) how many diagnoses has each person undertaking the diagnosis at each site performed prior to the study, and by whom was each person trained; (f) who is performing the procedures for each site, (i) how is the procedure being performed, including, but not limited to, anesthetic, balloon size, (ii) how many procedures has each person undertaking the procedure at each site performed prior to the study, and by whom was each person trained; (g) what are the selection criteria for the trial, including, but not limited to, type of MS, Expanded Disability Status Scale (EDSS) score, venous abnormality/malformed valve/stenosis, mobility, (i) how do these criteria compare with the international literature, (ii) with how many international studies to date will the selection criteria be analytically comparable; (h) if both progressive and relapsing-remitting forms of MS are to be examined in the trial, how will statistical significance be ensured given that 50 of 100 patients will undergo a “sham” procedure, 25 patients will have a progressive form of the disease, and 25 will have a relapsing-remitting form of the disease, and will people with both primary progressive and secondary progressive forms of the disease be included, and if so, how will statistical significance be ensured; (i) given that research has shown numerous venous abnormalities in the head, neck, and chest of MS patients, (i) how will statistical significance be ensured if there are only a limited number of patients, but multiple types of venous or valvular abnormality, (ii) how will a venous stenosis be measured (e.g. diameter, size); (j) what outcomes will be measured, including, but not limited to, EDSS, Modified Fatigue Impact Scale, Multiple Sclerosis Impact Scale, and Multiple Sclerosis Quality of Life Inventory, and at what time scales; (k) will patient-reported quality of life scores be included, and if so, what is the specific methodology; (l) what specific follow-up care will patients undergoing the “sham” procedure and treatment receive, and at what specific time periods; (m) if patients received the “sham” procedure, within what time period will they receive treatment; (n) how will the results of this study be interpreted within the growing international body of research, (i) to how many studies will this study be compared, (ii) to how many studies will this study be directly comparable; (o) what long-term follow-up will those enrolled in the trial receive and for what time period; (p) what is the cost of the trial, and what are each of the partners contributing, including, but not limited to funding, equipment, expertise, pharmaceutical products; (q) what is the cost of each diagnosis, (i) what is the cost of each “sham” procedure, (ii) what is the cost of each procedure; and (r) who is overseeing the trial, (i) the safety of the patients, (ii) the integrity of the results?
Hon. Rona Ambrose (Minister of Health, CPC):
Mr. Speaker, with regard to milestones and the reporting process in the Canadian MS clinical trial supported by the Canadian Institutes of Health Research as queried in questions (a), (b), (c), (d), (n), and (r), the Canadian MS clinical trial supported by the Government of Canada is taking place in four sites across the country: Vancouver, Winnipeg, Montreal, and Quebec City. The trial led by Dr. Anthony Traboulsee from the University of British Columbia started on November 1, 2012; two sites, Vancouver and Montreal, received ethics approval in 2012, and the other two sites received ethics approval from their research institutions by February 2013.
The four teams have met on a regular basis to ensure harmonization of the protocol among the sites. Protocol training, ultrasound technician training, and interventional radiologist training took place at the four sites over the course of 2013 and were completed by September 2013.
The recruitment of patients has started at the four sites and is expected to be completed over the next year. In all, 100 patients are expected to participate in the trial.
In August 2013, Dr. Traboulsee announced that researchers had been able to assess approximately 50 patients to determine whether they have the CCSVI condition and that procedures had been done on fewer than 10 patients.
It is important to note that the study is a double-blind study. In other words, neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment. This process is important, as it guards against both experimenter bias and placebo effects. In this context, the researcher team will be unable to analyze and share preliminary data before the study is completed.
Dr. Traboulsee expects to reach final conclusions on the safety and efficacy of the CCSVI procedure by 2016. It is expected that the results of this study will be published in peer-reviewed journals. Under CIHR’s open access policy, researchers awarded CIHR funding are required to ensure that all research papers generated from CIHR-funded projects are freely accessible through the publisher’s website or an online repository within 12 months of publication.
As indicated in the request for applications, the principal investigator will have to submit a final report to CIHR. He is also required to submit annual progress reports.
With regard to the protocol and funding of the MS clinical trial as queried in questions (e), (f), (g), (h), (i), (j), (k), (l), (m), (o), (p), and (q), funding of the $6 million study over four years is a collaborative effort of CIHR, the MS Society of Canada, and the provinces in which the trial will take place. The Provinces of British Columbia, Manitoba, and Québec and the MS Society of Canada have each pledged $500,000 towards this clinical trial.
Details regarding the funding opportunity developed by CIHR to support a phase I/II MS clinical trial, including the selection criteria, are available on CIHR’s website.
The proposals submitted to CIHR for the funding opportunity were rigorously evaluated by a panel of international experts. The panel recommended supporting the application submitted by Dr. Anthony Traboulsee, which ranked first in the competition.
It is important to note that all of the 100 MS patients participating in the trial will receive the CCSVI procedure at some point. During the first year of the trial, half of the patients will receive the CCSVI procedure, while the other half will undergo a placebo procedure. In the second year, MS patients who received the placebo procedure in the first year will undergo the CCSVI procedure, while those that received the CCSVI procedure in the first year will undergo the placebo procedure. MS patients participating in the double-blind clinical trial will be monitored over a two-year period. Specific questions regarding the protocol of this independent research project or the cost of the clinical procedures should be addressed directly to the principal investigator of the study
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