Subcommittee on Neurological Disease Committee on June 15th, 2010

[The Vice-Chair, Liberal, Kirsty Duncan]

Dr. Zamboni, be very quick, please, as we have to get to Mr. Brown.

[Dr. Paolo Zamboni]

Okay. Very, very quickly, I want to underline that the gold standard in medicine to detect a stenosis or a narrowing in a vessel is gold standard angiography. I formally invite members of the committee to visit us, and I will be pleased to show you, in the computer system of our university hospital, 130 consecutive cases of this narrowing.

So this proof is completely undebatable, and probably if you follow other paths to demonstrate that this does not exist, it will certainly be the wrong way of confronting the problem, because the consensus conference on venous malformations inserted CCSVI in the official guidelines of the medical vascular society.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you very much, Dr. Zamboni.

I will now go to Mr. Brown for seven minutes.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Madam Chair.

Thank you for all the excellent testimony and information today.

Dr. Zamboni, thank you in particular for training Dr. Sandy McDonald. He has told me and members of this committee, I know, that your techniques are what allowed him to successfully treat the patients he has in Barrie, Ontario.

I hail from Barrie, Ontario, and I know that everyone in Barrie views Sandy as a physician who is of unquestioned integrity. That's one of the reasons why I'm a big believer in your work: because I know that Sandy would never do anything that he didn't unequivocally believe in. I know that in our community he has put himself at exposure, at risk, and he spent his own money to help treat patients because he believes in your work so much.

We all talk about evidence. What I'm curious about is how we can move this yardstick forward and what evidence is required. I was quite disheartened when the Royal Victoria Hospital had to discontinue Dr. McDonald's work.

I had a conversation with the CEO of RVH. She said that there was a variety of reasons that this treatment couldn't take place at RVH. One was that there were certain protocols with the College of Physicians and Surgeons. There's also the Ontario health technical advisory committee. And RVH wasn't going to be the lone wolf in the province of Ontario.

Here's what I wanted to know. The MS Society talked about providing evidence to provincial governments and I've heard mention of the treatment arm. What do we need to provide? Has anyone had conversations with various provincial bodies?

I think we all have the same end goal. If we believe in this, the end goal would be to see this in provincial health plans, so that someone doesn't have to spend $10,000 to go to Bulgaria. What is it going to take to get it to that point, to see this on OHIP, for example, in Ontario, so that Doctor Sandy McDonald and others wouldn't be putting themselves in tremendous legal exposure simply to help patients? I spoke to him this morning. That's what he asked me: how do we find a way through this minefield?

This is my question for the MS Society. Have you been given any information from provincial health ministries and what is required to have it added to the list of treatments?

For Mr. Beaudet, in the research that the minister talked about last night, the minister said that they are eagerly looking for applications for MS and specifically this new CCSVI. Is there going to be clinical research that involves treatment in that? What are the restrictions on the research that is being currently asked for?

[Dr. Karen Lee]

I'll start first.

So what we do understand in the scientific world is that you do need to provide further evidence. So right now, Dr. Zamboni's group has provided evidence in terms of CCSVI in MS; however, it's a very small group of people, so it's a pilot study, as Dr. Zamboni has stated, and it was not randomized. Many of the provincial governments will look and analyze for those data, so unfortunately, therefore, they don't have enough data right now.

They need bigger populations. They need more randomized controls. That is why the MS Society is funding the initial phase of these, basically almost replicating what Dr. Zamboni has done, in order to further understand if there is a relationship between CCSVI and MS and to do randomized and controlled studies in larger populations. So that's the first step.

[Patrick Brown, Conservative, Barrie, ON]

How can the CIHR complement that in the expeditious fashion that we all hope for?

[Dr. Alain Beaudet]

Well, as I said already, and I'm sorry that I'm repeating myself, we're really anxious to receive a proposal for a randomized clinical trial, with treatment, to look at the possibility of funding a study, if it's deemed scientifically acceptable and methodologically sound, to look in a unbiased fashion and in a larger number of patients across the country at the efficiency of the treatment.

This being said, we do not make decisions as to the accessibility of treatment. What we do is fund the best possible research that we believe will provide solid scientifically sound evidence that the treatment is safe and efficacious. That's our goal.

[Patrick Brown, Conservative, Barrie, ON]

Now there's one thing that has been repeated. I'm sorry to make you repeat yourself, but I think it's important to get it out. One thing that has been said is that there is no treatment arm of this research. So in this clinical research, randomized treatment would be part of it--

[Dr. Alain Beaudet]

There would be a treatment arm.

[Patrick Brown, Conservative, Barrie, ON]

Okay. So that's very important to state, because obviously that's going to be something that's required to convince provincial governments that it's high time to have this as part of health insurance. So it's very encouraging to hear that.

Just as a friendly suggestion, I understand from Dr. Maggisano, who is from Sunnybrook.... I know that Sunnybrook has done partnerships before with the Royal Victoria Hospital in Barrie on cancer care. When I spoke to the CEO at RVH, I know that she mentioned they'd be eager to do partnerships with a senior hospital, a teaching hospital, and possibly on this MS. So maybe that's a possible application.

We heard from the Minister of Health last night that she's eager to see applications. We've heard from Mr. Beaudet that he's eager to see applications. So let's start seeing those applications roll in, because that's going to be a key step in this.

Is that something you might be interested in? I'm sorry to prod you on something that's obviously Sunnybrook's decision, but I thought I would mention RVH as a suggestion.

[Dr. Robert Maggisano]

Yes. We have been very interested in putting forth a proposal. It would require gathering a team, which obviously involves neurologists or MSologists. The barrier we've had to date is getting that team to collaborate to put forth a proposal. Perhaps after today, and if I go back to my neurological colleagues after being a witness here, they might reconsider and will consider putting together a proper randomized protocol study that hopefully will be funded, and we'll definitely get working on that as soon as possible with Sandy.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you, Mr. Brown.

Would the committee allow me to ask a few questions before we move to the five-minute round?

[Patrick Brown, Conservative, Barrie, ON]

It's 12:52. We're not going to have time for any five-minute rounds, are we? Maybe we could just have four quick questions.

[The Vice-Chair, Liberal, Kirsty Duncan]

Would the committee be willing to allow me to ask some questions?

[An hon. member]

Oui.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you.

I guess what I'm struggling with this morning is that we've heard that it's a small number of people who have actually had diagnosis and treatment and it was referred to just Dr. Zamboni's work. The number is upward of a thousand people now. I think Dr. Maggisano was clear in saying that let's not just do an interesting academic exercise, that we do have to test.

Why did the MS Society's announcement of research spending a few days ago aim exclusively at finding a statistical association of CCSVI in MS patients and not at allocating a single cent to actual treatment of CCSVI when all studies done to date have found that association?

[Dr. Karen Lee]

The MS Society heard from our clients in November when Dr. Zamboni's work was on the public stage. We expedited a process for a research grant, which we normally don't do at the MS Society, because we heard the need for CCSVI and MS research. At that stage, we crafted a request for operating grants specifically to look at the relevance to MS, so CCSVI and MS, so we invited those applications in. At this time, we are announcing funding for $2.4 million to further understand that evidence, that initial work that Dr. Zamboni has done.

[The Vice-Chair, Liberal, Kirsty Duncan]

I think we have to be clear that there is more than Dr. Zamboni's work that has been done. We've heard today that Dr. Simka alone has done 400 patients.

Dr. Beaudet, I tried to ask this earlier today in the health committee. We have heard from the government that $16 million is going to be available to CIHR. The MS Society has asked for $10 million for research. What I asked for before was that the research occur with diagnosis and treatment. Let's diagnose and treat the people. Then you can follow them.

Of that $16 million, I'd like to know not how much is related to MS, but how much is actually allocated to CCSVI.

[Dr. Alain Beaudet]

Out of that $16 million, which, as you know, was money provided to us by the federal government as an increase over our base budget to address a number of priorities, one of these priorities was to increase the funding for clinical trials. That's exactly what we're talking about today. It's not to increase clinical trials specifically on that topic, but clearly if we receive a solid application to look at this very important issue, it will be considered and hopefully found acceptable for funding. That's all I can tell you.

[The Vice-Chair, Liberal, Kirsty Duncan]

Will the people who—

[Dr. Alain Beaudet]

If you're asking whether the $16 million will be entirely devoted to MS research, the answer is no.

[The Vice-Chair, Liberal, Kirsty Duncan]

Do we have any idea how much will? The MS Society has asked for $10 million and I have yet to hear if that money is going to be forthcoming to do diagnosis and treatment and follow the people.

[Dr. Alain Beaudet]

What I'm telling you is that we haven't yet received formal approval from Treasury Board as to how we're going to spend this money, so I cannot give you exact figures. But we have asked for a significant portion of that money to be put in our open grants competition so we can fund clinical trials, and I do hope we will have a successful application in that area.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you, Dr. Beaudet.

I would like to ask one last question. Then I'll ask if any of the other committee members would like to ask questions.

It's going to be really important going forward, if we're going to have review of these grant applications, that we have vascular surgeons as part of the review committee. These are the experts in the area. Can we be assured there will be vascular surgeons as part of the review committee?

[Dr. Alain Beaudet]

We always make sure that every aspect of an application has an expert reviewer to look at it. If the application looks like what I think it will look like, there will be vascular aspects, so we'll have an expert in vascular surgery involved. We need them. We'll also have an expert on MS. We'll need them as well.