Subcommittee on Neurological Disease Committee on June 1st, 2010

[Lianne Webb]

I can't even imagine why not. It's criminal that we're not still doing it. I don't know why we're not doing it.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Steve.

[Steven Garvie]

I have the same answer. I have no idea why not. It's a simple, painless way of getting on with your life.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you all.

I'm going to finish again with the line from the doctor who had the treatment: “I hope you fight for the rights of Canadians to get treatment in Canada”.

Thank you all.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Duncan.

We'll now go to Mr. Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

I would like to thank all witnesses for coming to meet with us this morning. Mr. Garvie and Ms. Webb, I especially thank you for your very personal testimony. I know it is not easy to testify like that. Your lives are actually being discussed before us, before a parliamentary committee. I sincerely thank you for doing that. It is always very enlightening.

I will speak to you, Dr. Haacke...

[Dr. Ewart Mark Haacke]

Yes.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

During your presentation, you told us that, in your opinion, the only thing left to do was to sub-categorize the CCSVI patients. Could you expand a little more on that? In your view, what needs to be done and how long could a surgery like that take? Finally, why is it important to sub-categorize the patients?

[Dr. Ewart Mark Haacke]

Thank you.

I think you need to do the ultrasound imaging that Sandy has talked about, but you need to do the MR imagining as well. We have discovered that there are many different sources for CCSVI, and not just narrowed vessels. Sometimes there are bad valves, and sometimes extra material called septum inside the vessels causes a problem. In other cases bones have grown too big and have compressed the vessels. There are many things that can cause CCSVI, so to understand why this treatment might work for some people and not for others one needs to know what the problem is. In order to do that you have to get experience in imaging people.

This can be accomplished at almost any MR site or ultrasound site in Canada. My recommendation is to always do both. It gives you more information. Sometimes we see things better on MR than ultrasound, and sometimes it's the other way around. That can be done in Canada today. There are protocols out from Zamboni for ultrasound and from our group for MR that make this possible. So in order to really follow the surgical results and do a good double-blind study, you need to have an understanding of what the source itself is.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Have you already done studies to that effect? I know you did a presentation. Was that based on a study you already did?

[Dr. Ewart Mark Haacke]

That's an interesting point. Unfortunately, since most places have been stopped--that's true in both Canada and the United States--the experience we have is related to reviewing data that has been sent to us from around the world: from Australia, Germany, China, and many places in Canada. So this does come from direct experience of reviewing patients' data. In some cases these patients have been operated on by people such as Dr. McDonald and others. We do find that what we see in imaging is often corroborated by the surgical results.

I think the critical issue for Canada right now is to wrap your arms around how you're going to implement this in your system so that a conventional hospital, whether it's a community hospital or a research hospital, is allowed to collect the extra scans that are done on most MS patients anyway. Almost all MS patients get an MR scan. By adding an extra 30 or 40 minutes to that, you can get the necessary information to tell if that patient has a problem. So why wouldn't you do that when you have the opportunity? I think the technology is there for you to assess this very shortly.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

What is the next step in your efforts to shed light on that?

[Dr. Ewart Mark Haacke]

One thing we're trying to do at the moment, since it's tough for one site to collect a lot of data, is collaborate with sites across Canada--for example, with Saskatoon. I'm meeting with Quebec City people a week from now, and hopefully with other groups. We'll combine all of their data, so instead of having 50 patients from each site in a few months, we can do 1,000 patients in a few months by bringing this data together. Otherwise, the current rate of research, in both the U.S. and Canada, is so slow under conventional granting circumstances that it would be years before this data could be collected. But with a simple collaborative effort we can do in months what would otherwise take years to create a database.

[The Chair, Conservative, Joy Smith]

Thank you.

We'll now go to Ms. Hughes.

[Carol Hughes, NDP, Algoma—Manitoulin—Kapuskasing, ON]

Thank you very much for your presentations. I would like to thank Mr. McDonald. After suggesting to have witnesses who have undergone that surgery, I am very proud and happy that arrangements could be made to make it happen.

I actually spoke to a doctor about why there would be a need for more research on this. Maybe you can comment on this. The doctor from Manitoulin Island basically indicated that years ago there was a procedure for strokes called carotid endarterectomy. I'm assuming you know what the procedure is.

[Dr. Sandy McDonald]

Yes.

[Carol Hughes, NDP, Algoma—Manitoulin—Kapuskasing, ON]

It used to be done automatically as soon as someone had a stroke. But stats eventually showed that there were worse outcomes than if they had taken an aspirin a day. Basically it was considered to be a bread-and-butter operation at the time. It is now only done when there is greater than 70% narrowing.

The other procedure she mentioned with regard to the research was on the tonsils. The perceived wisdom years ago was that half of those who came through the doctor's office would need to have their tonsils out. A study was done where if a group was sent to see a pediatrician, 50% would need to get them out. Then they would send the other 50% to another doctor, or the same 50%, and there would be second and third opinions. They would select different groups saying they needed them out.

I'm just wondering if you can put some perspective on this procedure and the fact that you don't feel there needs to be as much research, or we need to go into the procedure right away, given the fact that these procedures were thought to be safe, and then as they followed up they realized that people were having more strokes or were dying earlier because of the procedures.

[Dr. Sandy McDonald]

If I could go back to the studies that were done, in the early 1990s carotid endarterectomy was a common procedure in Canada. When we got into the mid-1990s, the neurology group thought the carotid did not need to be fixed surgically and it could be controlled by giving drugs. They subsequently did a trial called the NASCE trial—the North American symptomatic carotid endarterectomy trial—and they looked at several thousand patients.They were looking at the outcome of patients treated with carotid endarterectomy versus the outcome of patients treated with drugs. The trial was abandoned after it had gone on for several months because the patients who had carotid endarterectomy did significantly better statistically than patients who were treated with drugs.

You're right, the trial looked at a 70% stenosis, but more studies have been done since then, specifically the ACAS trial—asymptomatic carotid atherosclerosis study—and it suggested that there is significant benefit, though not as significant as the other study, in doing carotid endarterectomy on patients who are asymptomatic. More studies have been done, and there is good data now that supports doing a carotid endarterectomy on patients with greater than a 50% stenosis. That's current data.

To answer your other question, as to where we should go at this point, I agree with Mark Haacke totally. The amount of time it's going to take to get the answers to the question with each individual centre doing 40 or 50 studies a year will take a very long time, and will be done at the significant cost of patient lives. If we collaborate and put all the data together, the question will be answered fairly quickly.

Part of the problem is the cost of doing the studies. Patients need to be treated now because patients are dying. You can gain a lot of information by treating people now, putting them in a registry, having them as part of an ongoing, open-ended study in collecting the data. If you do that, you achieve two goals. You achieve the scientific goal, which is actually generating the science on it, determining who should be treated, and so on, as you collect the data. At the same time, you can treat people with significant disease now. If they have significant CCSVIs demonstrated on an MRV and on a duplex scan, then they should be treated.

[Applause]

[The Chair, Conservative, Joy Smith]

We'll now go to Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Madam Chair.

Let me say at the outset that it is with enormous pleasure that we have Sandy McDonald here again today. I take great pride, coming from the city of Barrie, that we have such a renowned vascular surgeon. Many people in our community refer to you as a local saint. As people around Canada are hearing about what you're doing, more and more people are coming to that conclusion.

I wanted to touch on a few of the things that have been mentioned today, one of them being obstacles to this treatment. I think it's important that we dissect them, so that it's very clear when this committee does a report that we can highlight what those obstacles are and what needs to be rectified.

The first obstacle that is mentioned is hospitals. The hospital you're at no longer permits you to provide this treatment. What is the status of other hospitals in Canada?

[Dr. Sandy McDonald]

I'm not aware of any hospital in Canada doing the procedure at this time.

[Patrick Brown, Conservative, Barrie, ON]

And initially they were allowing it--turning a blind eye?

[Dr. Sandy McDonald]

I wouldn't say a blind eye. I think there has been an incredible amount of pressure generated within the system that says you have to do a controlled double-blind study to see if it's effective, just as you would for a new drug coming out.

The difference is it's not a new drug. It's not a new procedure. It's not new anything. Hundreds of thousands of angioplasties have been done since Gruentzig introduced the procedure in 1984.

[Patrick Brown, Conservative, Barrie, ON]

Hospitals are administered provincially. Do you think there's been a directive from the provincial Ministry of Health not to allow this? Or are these locally based decisions? Is it a coincidence that every hospital in Ontario or around Canada—

[Dr. Sandy McDonald]

Your guess is as good as mine.