Frequently asked questions on the CIHR recommendations for MS research priorities in CanadaCIHR and MS Society of Canada Joint Invitational Meeting on MS
August 26, 2010
Q1: Did CIHR recommend that no treatment trial on the proposed experimental CCSVI procedure be done?
A1: No. CIHR recognizes the importance of investigating the efficacy and safety of the proposed experimental CCSVI procedure by means of a pan-Canadian treatment clinical trial, but cannot do so ethically without more information about the definition and nature of venous insufficiency and potential relationship with MS. This is critical in determining who should be included in a trial so that the results are scientifically valid. Seven clinical diagnostic trials are currently underway, funded by the Canadian and US MS Societies. These first trials will help us determine how to proceed in a safe and ethical manner.
Q2: If we need to be gathering more evidence on the proposed experimental CCSVI procedure, can't we get that evidence by doing a treatment clinical trial?
A2: The proposed experimental CCSVI procedure is based on Dr Zamboni's (Italy) published reports that patients with MS have blockages in the veins that drain blood from the brain, and no patients without MS have similar blockages. He has therefore used angioplasty to open up the venous blockages in MS patients. Unfortunately, a number of reputable researchers have been unable to replicate his conclusions about the association of vein blockages with MS. This makes it very difficult to design a scientifically valid treatment clinical trial. Angioplasty of veins draining the brain is not a minor procedure. If we are testing the idea that venous blockages cause MS, and if some patients do not have clear-cut blockages, then it is not ethical to include them in a trial. Furthermore, including them could lead to very confusing results, actually biasing the trial to show no benefit from the proposed CCSVI procedure. This lack of clarity about the definition and nature of venous blockage is the major reason why we are delaying the launch of a trial and waiting for more information from the seven studies as well as other studies around the world.
Q3: Why don't researchers just gather the data from Canadians who got the treatment in other countries?
A3: For such data to be scientifically useful, we would need to have a full analysis with clinical data collected in a standardized way of the patient's condition both before and after the procedure. We would also need detailed clinical information related to the type of diagnostic and interventional procedures as well as other treatments that the patient received. We do not have access to this so any evidence we obtain would be anecdotal.
Q4: How long will it take to get the results from the seven MS Societies-sponsored studies?
A4: The studies are already underway. An expert working group comprised of the principal investigators and vascular researchers from the seven studies, scientific leadership from CIHR and the MS Society, and a representative from the provinces and territories, has been established to closely monitor the studies. The working group is also tasked with making recommendations on a proposed protocol for a pan-Canadian treatment clinical trial that would evaluate the safety and efficacy of venous angioplasty in patients with MS. A meeting is already planned for this fall.
Q5: Who was on the panel of experts that attended the August 26 meeting and how were they selected?
A5: The list of experts is published here. These experts were selected based on their clinician trial expertise, relevant research disciplines and research track record in scientifically credible peer-reviewed journals.
Q6: Will CIHR accept researchers' applications to study the proposed experimental CCSVI procedure?
A6: CIHR encourages researchers interested in better understanding the linkages between MS and venous insufficiency to apply to CIHR funding opportunities. Each research application will undergo a rigorous, independent peer review process. Only researchers whose projects meet the internationally accepted standards of scientific excellence in health will receive funding from CIHR. As for any studies involving human participants, funding will be predicated on protocol approval by Institutional Ethics Review Boards. All decisions are publicly posted on our website.
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