Subcommittee on Neurological Disease Committee on June 15th, 2010

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

Dr. Zamboni can answer, of course, but first, I would like to ask Ms. Lee a question.

Twice during his remarks, Dr. Maggisano clearly indicated that, in his opinion, the research process that the Multiple Sclerosis Society of Canada is undertaking is not adequate.

I would like her to respond, because I believe that what Dr. Maggisano said is quite important.

[Dr. Paolo Zamboni]

I'm sorry. Probably I don't understand very well, but the idea of Dr. Magissano is perfect, because any time you have new--

[The Vice-Chair, Liberal, Kirsty Duncan]

Sorry, Dr. Zamboni, but I am going to rudely interrupt you for a minute to allow Dr. Lee to respond to a question.

[Dr. Karen Lee]

Thank you.

We understand that there's an urgency today from our clients who are wanting the treatment right now and to be tested. At the MS Society, we want to be responsible, to ensure that this treatment is safe and effective. In order to do this, we need to ensure that there is enough data out there. Right now, I know that Dr. Zamboni has presented his work and is presenting data on this. Also, however, Dr. Zivadinov is showing some differing data. And right now a new paper has come out that shows people with MS have zero blood flow drainage issues.

So with those different data in mind, we have to ensure that first steps are correctly looked into. Therefore, we have funded, with our American counterparts, $2.4 million towards further understanding the relationship between CCSVI and multiple sclerosis.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you, Dr. Lee.

I will respectfully ask all our visitors to maintain decorum so that we can continue with the committee.

Thank you, Monsieur Malo.

Now we will go to seven minutes for Ms. Hughes.

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

Thank you very much.

I greatly appreciate your testimony and your comments today.

With the amount of procedures that you have done currently--and I'm asking this of the physicians who are with us today--I'm just wondering, have there been some negatives? I know that you've talked about some of the negative impacts, but how much of this has actually helped the patients?

People with MS have a condition. They get this procedure. How many of them have had zero....

[A voice]

Benefits.

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

Yes. Benefits: that's the word I'm looking for. Thank you.

How many of them have had zero benefits from it?

[The Vice-Chair, Liberal, Kirsty Duncan]

Is this question to...?

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

This is a question to the doctors: Dr. Zamboni, Dr. Simka, and Dr. Magissano.

[Dr. Marian Simka]

May I answer the question?

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

Yes.

[Dr. Marian Simka]

Our results are very preliminary because we began the treatments on the larger group of patients in January of this year, so we have only some months of experience on the bigger group of patients. I think we will have full data in the autumn, after the half-year, after the treatment.

But what I can say now about what we are seeing after one or two months of the treatment is that about 80%, 90%, of the patients experience improvement, and many of the patients are progressive multiple sclerosis patients with no options for treatment. Many of them have no possibility to have effective pharmacological treatment. For these patients, it's really a big thing, but of course, as I said, our data is very incomplete and primary.

[Dr. Robert Maggisano]

We have not done any angioplasties at our institution because we refuse to do them outside of a proper protocol. But Dr. Sandy McDonald, as I'm sure you're aware, has done seven cases, all of whom have shown improvement. I'm cautious here, in that the improvement was not identified by a blinded independent observer, which is what's necessary to do a proper study.

I have to comment on Dr. Lee's comment that they are evaluating the safety of the procedure. I beg to differ. What they are testing and funding testing of is not the procedure that is being advocated; rather, they're researching and funding research to see if venous disease is associated with MS. So if you're going to evaluate the efficacy and the safety of a procedure, you can't do it outside of actually doing the procedure and seeing whether it is safe.

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

Dr. Zamboni, do you have any comments with respect to the benefits for the patients, what the percentage has been?

[Dr. Paolo Zamboni]

Yes. I began this treatment in 2007. We had 50 relapsing-remitting patients who completed three years of follow-up. The result was that 75% of the relapsing-remitting patients did not have more relapses or more active lesions on the MRI and increased their quality of life. This was in three years.

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

I think the word is that the quality of life.... I mean, for these patients, for these people, this is the important part. They understand that this is not a cure, but it's an opportunity to relieve some of the symptoms they have and maybe prevent other medical problems from occurring.

So I have a question for Ms. Lee and Mr. Beaudet. There is some talk about.... Dr. Maggisano talked about the evaluating of the technique. What appears to be lacking is testing hypothesis; that's also what he's mentioned.

So here's my question. We were at a time where people were actually getting the procedure in Canada and the testing, so while we're waiting for you to get yourselves organized in order to decide how the research is going to be done for this, there's an opportunity for all of these people to actually have access to a treatment that will provide them with some relief, even if it's just a little bit of relief—whether their feet will no longer be cold, whether they will be able to go to the washroom on their own, anything.... It would be something they don't have right now.

So my question is this: is it not possible? We talk about a blinded study. I don't think we need to be blind about the fact that we saw Mr. Garvie walk in here as opposed to being in his wheelchair.

[The Vice-Chair, Liberal, Kirsty Duncan]

Ms. Hughes, you have 30 seconds left, if you want to ask your question.

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

I'm just wondering, is it not possible to be able to do the study with respect to having the procedures done in conjunction with the doctors performing them to provide you with the information you need? It would save us a lot of money as well and your study would go a lot further and a lot longer.

[Applause]

[The Vice-Chair, Liberal, Kirsty Duncan]

Before we go to Dr. Beaudet, I'll just respectfully ask that we all.... This is emotional for everybody in the room.

We'll allow the witnesses to respond.

[Dr. Alain Beaudet]

So again, I think we agree here that our health care system is based on evidence-based practice. We do not submit patients to treatments for which we don't have proof that it works and that the benefits outweigh the risks. That's the first thing.

The second thing is what you're proposing actually is putting patients on protocols, i.e., to carry out proper randomized clinical trials to determine, in an unbiased fashion, whether or not the treatment works. What we are saying is that we urge researchers to come with a proposal to put patients on protocols to actually look at whether or not the procedure is actually efficient.

Now, I think this ties in very well with the studies that the MS Society has just started to fund, because you will agree with me that we could not really ethically carry out angioplasty on patients without first demonstrating that, indeed, there's insufficient or improper venous drainage in those patients; hence the importance of developing methods to determine whether or not there's proper venous drainage. Because you wouldn't do an angioplasty to improve venous drainage if there's no problem with the venous drainage, you would agree with me.

So that, I think, is a very important part of the puzzle: demonstrating that the hypothesis is right and justifying ethically the clinical studies using angioplasty.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you, Dr. Beaudet.

I think Dr. Maggisano wanted to get in on this. I'll allow him to answer before we go to Mr. Brown.

[Dr. Robert Maggisano]

I don't disagree with the proposal for randomized studies. I have an issue with what's currently being funded. It's lacking the treatment arm necessary to answer the question that you just said needs to be answered.

So of course it's important to know how to evaluate it and of course it's important to know how to image, but in the absence of a treatment arm in the protocols that the MS Society is funding for $2.4 million, we're not going to get an answer to the question. And the real issue is, will treatment of the lesions that we're going to learn how to identify...? And it's very easy to learn how to identify them. If one takes a trip to Ferrara, Dr. Zamboni will be more than happy to teach our techs and doctors how to properly evaluate for the hypertension and the decrease in blood flow. We're not used to these kinds of evaluations in Canada. I run vascular labs and my techs do not know how to do the study because we have not ever evaluated this in our country.

But what needs to happen is a change in paradigm. Let us go over to Ferrara. Let us learn what the proper technique is for evaluating MS, both by ultrasound and MR venography, and bring it back and then put to the test the hypothesis of whether or not treatment is efficacious.

If we don't do that, if we're going to focus on the evaluation of the disease process of the venous drainage over the next two years, we won't get to answer the question for four to five years. If we put the treatment arm with the studies concurrently to what is happening, then it's conceivable that we might have an answer within 18 months or 24 months, which will help the MS population a lot.

[The Vice-Chair, Liberal, Kirsty Duncan]

Thank you, Dr. Maggisano.

[Dr. Paolo Zamboni]

May I answer?