Subcommittee on Neurological Disease Committee on Dec. 7th, 2010

[The Chair, Conservative, Joy Smith]

Good morning, everybody, and welcome. Everybody looks wide awake, so this is a good sign.

Pursuant to Standing Order 108(2), we are doing our study on neurological diseases.

Dr. Beaudet, we want to welcome you.

Dr. Beaudet, as you all know, is from the Canadian Institutes of Health Research.

Doctor, I will give you as long as you need to make your presentation this morning.

[Dr. Alain Beaudet, President, Canadian Institutes of Health Research]

Thank you, Madam Chair.

I'm pleased to appear before you today in my role as president of the Canadian Institutes of Health Research to provide you with an update on recent activities related to multiple sclerosis research in Canada. This devastating disease affects, as you know, thousands of Canadians. CIHR is committed to fund research that will alleviate the suffering of Canadians with MS and their loved ones.

First, I would like to share with you what CIHR has been doing on the issue of chronic cerebrospinal venous insufficiency and MS during the last three months.

As you may remember, in early September 2010, the Honourable Leona Aglukkaq, Minister of Health, accepted my recommendation that this issue be investigated in a standard scientific step-wise manner, first by determining whether or not there is an increased prevalence of venous malformations and impaired brain venous drainage in patients with MS as compared with healthy controls, and second, should this association be proven to exist, by proceeding with a clinical trial to evaluate the safety and efficacy of Dr. Zamboni's procedure. This position was endorsed by all provincial and territorial ministers at their September meeting in St. John's.

Already, seven studies sponsored by the Canadian and U.S. MS societies have been launched to determine whether there's a link between chronic cerebrospinal venous insufficiency and MS. To monitor the results from these studies, as well as from related studies from around the world on venous anatomy and MS, CIHR has set up a scientific expert working group.

This group is made up of the principal investigators of the seven MS Society-sponsored studies, the scientific leadership of CIHR and U.S., Canadian, and Italian MS societies, and a representative from the provinces and territories. The working group held its first meeting on November 23 in Toronto.

At this meeting, members of the Working Group reported on the progress they were making on their initiative, funding for which was provided in June 2010. Six of seven studies have been approved by the ethics committee and the seventh is in the approval stage.

The patient selection process for the trials is going very well, with two studies having already met their patient quota. Judging from the reports I have received, Madam Chair, I can say that stringent protocols are being followed and committee members can be assured of the quality and serious nature of the studies now under way. I am confident that these studies will determine whether or not there is a link between cerebrospinal venous insufficiency and MS and thus help us to decide if clinical trials on the procedure itself should be funded.

The experts did stress, however, that it was important to give researchers all the time they needed to conduct these trials, without putting any undue pressure on them. The Working Group also noted that Dr. Zamboni's proposed treatment wasn't without risk, as evidenced by the growing number of complications reported by Canadian patients after they were treated abroad and following the recent tragic death of one such patient.

Consequently, the experts recommend that all future therapeutic clinical trials include a treatment safety assessment.

The seven projects are progressing at an appropriate pace to meet their targets. The members of the working group agreed to meet next June to review preliminary results, and the MS Society of Canada will be posting summaries of these seven research projects on its website in the new year.

In the meantime, CIHR will continue to work closely with the MS Society of Canada and other stakeholders, such as physician associations, to share research evidence as it becomes available to build greater understanding of this devastating disease.

Patients should be discouraged, however, from seeking treatment abroad until more is known on the safety and efficacy of this treatment. But they should also be made aware that no physician will refuse to see and treat them for complications of a treatment received abroad.

I would also like to inform your committee that I will be providing an update of the working group's first meeting to provincial and territorial deputy ministers of health at their meeting on Thursday of this week in Toronto. This meeting will be a good opportunity for all participants to share information on any new developments with regard to this issue.

In conclusion, I would like to highlight the fact that CIHR is currently funding numerous research projects aimed at better understanding and at eventually developing a treatment for MS. In fact, CIHR has funded approximately $49 million in MS-related research since its inception.

Madam Chair, in closing, let me assure you that CIHR and all researchers involved are working as fast as possible to investigate this issue and provide the best science-based advice possible to patients and their families.

I will be pleased to keep the members of this committee apprised of our progress.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Beaudet.

Now we'll go into our seven-minute Q and A, beginning with Dr. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Madam Chair.

Thank you for coming, Dr. Beaudet.

Thank you for clarifying that no patient will go without follow-up in this country, because they have been going without. I'm aware of one patient who was denied treatment by four different specialists. So thank you for that reassurance.

Before I begin, could I ask you to table with the committee an agenda from the August 26 meeting, all the papers reviewed and any presentation or notes from it? Thank you.

Could I also ask that you table with the committee the work plan from the expert working group, who the panellists are, the mandate, schedule of meetings, timeline, what evidence will be reviewed to reach a decision about clinical trials—hopefully, a registry—and how much evidence will be necessary to reach a decision to proceed with clinical trials?

[Dr. Alain Beaudet]

These are very good questions. Actually, they're all the questions that were discussed at the inaugural meeting that was held in November.

Certainly, I will be pleased to post the documents regarding the composition of the committee and a summary of the discussions at our meeting.

It's a very unusual situation. As you know, usually when researchers receive a grant, they do the research, and they're very silent about their progress because there's intellectual property involved, as you know, and there's also competition involved. Don't try to imagine that there's no competition between these groups. They publish the results, and it's only when the results are published that they start talking about it.

We're doing things very differently this time--very differently. We're asking them to share their results at every step along the way and to be totally open about them. I must say, the response has been fantastic. At the end of the meeting, they all agreed that they were a tad reluctant to proceed in that way, but it had been a fantastic day because they actually learned and shared and got ideas that will allow them to go faster.

They also agreed that they would—after what was, as you can imagine, a very long discussion—reveal their results in six months. Why six months? Why not faster? It was because they all felt that there would be so few results before the end of June that it could be misleading. But they felt that at the end of June they'd have a sufficient amount of preliminary data that it will be meaningful.

Now, we're talking about blinded studies that they will agree to “unblind”, so they can share. It's a very unusual situation, and we won't be able to share those results with the external world, for intellectual property reasons that you can understand.

[The Chair, Conservative, Joy Smith]

The time is limited.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I'm also concerned that the new expert panel website has been down for a week, and I'm wondering when it will be up and running again.

[Dr. Alain Beaudet]

I wasn't aware of that. I'll make sure that--

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

[Dr. Alain Beaudet]

It went up yesterday, I'm told.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

It didn't, because I checked at about midnight last night.

I would like to know who the Canadian neurologists are on that website, please.

[Dr. Alain Beaudet]

The Canadian neurologists are basically the researchers who received a grant from the MS Society.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Is Dr. Freedman on that list?

[Dr. Alain Beaudet]

Dr. Brenda Banwell is on that list. She's one of the recipients. They're all the grant recipients.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Is Dr. Freedman on the list?

[Dr. Alain Beaudet]

There's no Dr. Freedman on the list.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

I am wondering if you will require every member of the new expert panel to declare their conflicts of interest.

[Dr. Alain Beaudet]

That's a good point. It has been asked and it will be done.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

That's good, because just as ECTRIMS does, it eliminates the possibility of real or perceived conflicts of interest.

[Dr. Alain Beaudet]

You're absolutely right. It's an issue that was discussed, and we agreed they would all sign such a declaration of conflict.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I really appreciate that.

At the third international scientific conference on CCSVI that I attended—I've attended three of the four, and I didn't attend the fourth because it was a week after the third—we learned that neurologists are admitting that their patients are improving. This is the fundamental question we have.

I'd like to know if you can table with the committee whether we have heard from these neurologists. Have they followed their patients? How have they responded? What if any improvements have they tracked on EDSS scores?

A prominent Canadian neurologist has written that the veins of MS patients are no different from those of anyone else. I would like to know how Dr. Beaudet responds to this, when Dr. Mark Haacke of the U.S. has identified 48 different venous abnormalities of the chest, neck, and spine.

[Dr. Alain Beaudet]

That's the issue we're facing. There's a lot of anecdotal evidence.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

No, I've seen the MRI images.

[Dr. Alain Beaudet]

There's also a neurologist who last week asked me, “What do I tell my patient who says he's really feeling better after the procedure? I've actually seen the EDS score and the NMR, and both have worsened. It's going to be heartbreaking if I tell the patient the truth. What do I do?”

We have to be very careful about the subjective “feeling better” and the objective way.

But let's come back to the veins. The problem is exactly that. On the one hand you have people who say there's a huge difference between patients with MS and healthy subjects. On the other hand you have people who say they're exactly the same and there's no prevalence in MS patients. That's exactly what we're trying to solve. That's what we need to solve.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Beaudet.

We'll now go to Mrs. Hughes.