Evidence of meeting #31 for Health in the 41st Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was research.
A recording is available from Parliament.
Conservative
Colin Carrie Conservative Oshawa, ON
Is there anywhere in the world, that you know of, that has attempted to legislate the research process? I was wondering what you thought of that as a precedent. What would it do to researchers?
President, Canadian Institutes of Health Research
I am not aware of any precedent. Irrespective of MS now—and I think I've been very clear on this topic, publicly—I think it would be a dangerous precedent to legislate the type and the object of research that we carry out and that the federal government would be supporting in this country. The federal government—I'm sure you're aware, after a number of very serious issues that arose with the use of some drugs like thalidomide and laetrile, where there were major complications, when trials were not as tightly regulated as they are now—set up some very stringent regulatory mechanisms to ensure that trials carried out on patients are scientifically based and ethically approved.
They have set up principles to do that. That have set up organizations such as ours to do that. I would think it would not be a good idea to bypass the process you've already set up to protect the safety of the population and to start legislating on very specific objects of research. I understand very well, on humane grounds, how tempting this may be.
Conservative
The Chair Conservative Joy Smith
Dr. Beaudet, I'm just going to say we're over time now. We need to go on. Thank you so much.
Dr. Duncan, go ahead.
Conservative
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you. Thank you to the witnesses.
Dr. Beaudet, you and I have known each other a long time. You know we don't agree on this. I'm going to point out that this has been done in 60 countries. There have been 30,000 procedures and three major safety studies involving over 1,000 patients. We just heard a discussion about how we don't know how to do the imaging. I was at the International Society for Neurovascular Disease conference a week ago, where I gave two talks. You will see the positive and negative studies linking CCSVI in my rebuttal to the Health Minister of her letter of February 17 and her reminder of February 23. I show who, in those studies, did multimodal, non-invasive imaging, and who did non-invasive and invasive imaging. The studies that involve many modes are the studies that, of course, have the better results. I think the consensus is that we need to do multimodal, non-invasive and invasive imaging. On the ISNVD, there has been a consensus statement about how imaging should be done.
I think it's important for people to understand that this is not a new theory. This goes back to 1839. There was a division between the vascular surgeons and the neurologists back in the 1980s. We're having this debate again. I should also point out there are three FDA phase two studies approved in the United States, which are being undertaken right now.
One of the first questions I'll ask is, will the CIHR roster all the Canadian patients who have been treated for CCSVI to date? Yes or no? I'm just looking for a yes or a no.
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
As you know, the government is supporting the development of a monitoring system for all MS patients.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Ms. Elmslie, I know this. Yes or no; are we going to track those we have—
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
I'm not getting an answer, Madam Chair. I have a right to—
Conservative
The Chair Conservative Joy Smith
She's going to give you an answer. Can you give her one minute, please? You interrupted her.
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
I want to say this. The Canadian Institute for Health Information, our premier health information agency in Canada, is developing a monitoring system that will, over time, include all MS patients in Canada, provided that those patients and the clinics they are attending agree to be part of that monitoring system.
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
The answer—
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
—is yes, provided that—
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
—they agree.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
We will have lost 33 months by the time we start collecting data this September from the time that patients went overseas. We have lost the opportunity to track them at one, three, six, 12, and 24 months.
Will the follow-up include an MS quality of life-54 score, yes or no?
Director General, Centre for Chronic Disease Prevention and Control, Health Promotion and Chronic Disease Prevention Branch, Public Health Agency of Canada
The process to determine exactly what the monitoring system will include is under way now. We're in the developmental phase of the system. We have the country's experts involved in that. The question of exactly what the monitoring system will collect will be known in the next few months.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you.
Dr. Beaudet, this is a hard question. You know I'm not a combative person; this is difficult. In light of there being an absolutely robust anti-CCSVI campaign, how is CIHR going to guarantee a non-biased study? That's of real concern to the patients.
President, Canadian Institutes of Health Research
Actually, that's a very good question. The way we're going to do this is by ensuring that all—and that's really rare for us—all the members of the scientific evaluation panel will be from outside Canada.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you. I appreciate that.
Dr. Beaudet, have you personally read all the positive studies, as well as all the negative studies, that I mentioned in my rebuttal to the health minister's letter of February 17?
President, Canadian Institutes of Health Research
Actually, I have. I've seen your letter and I've read the articles.
In fact, I'd like to quote perhaps just one sentence from the latest one I've read, which was published in February 2012 in a reputable peer-reviewed journal, by Diaconu and colleagues:
Beyond the limited published reports on CCSVI intervention, much of the support for endovascular interventions in CCSVI currently comes from anecdotal patient self-reports posted on web sites, blogs, and chat rooms. Prospective randomized control trials will be necessary to fully understand the impact of endovascular treatment of CCSVI due to significant potential placebo effects, blinding will be of major importance in the randomized trials.
This is what we're doing.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
And I can say that we absolutely agree on the need for evidence-based medicine; you know that.
I'll point out three FDA phase two trials currently being undertaken in the U.S. I'm now going to quote Michael Shannon, former deputy surgeon general for Canada and director general of the laboratory for disease control:
It would seem that we have learned nothing from The Krever Commission which very clearly placed the blame for both the HIV and Hepatitis C misadventures of the 80's on the shoulders of the Red Cross and Health Canada. Their inability and unwillingness to protect the Canadian public was at least in part driven by financial considerations and tragically cost thousands of Canadian lives and ultimately the Canadian taxpayer billions in health care costs and law suits. Is CCSVI any different? Having lived through the restructuring of the Canadian Blood System in the late 90's—
He helped to enhance both the regulatory and public health concepts. He continues:
—I consider the lack of definitive action on the part of Governments, Government agencies such as the CIHR and NGO's such as the Canadian MS Society extremely disappointing.
How do you respond to that?