Subcommittee on Neurological Disease Committee on May 11th, 2010

[Dr. Sandy McDonald]

I don't understand the resistance of the group treating MS patients and not addressing it as a problem. I understand there must be science, and I understand that science is important, but the cost of doing science can't be the cost of wasted lives at this point. People who have MS with no other treatment must be considered on a compassionate basis for treatment. The data can be captured. A registry can be formulated, and all the people who will be treated will not be lost to science. We can formulate the controlled double-blind study and take as much time as we need to do it, but in the meantime we absolutely have to treat these patients on compassionate grounds; otherwise they're going to die with their disease, with a possible treatment at hand.

[The Acting Chair, Conservative, Patrick Brown]

Thank you, Ms. Duncan.

Mr. Malo.

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

After the testimony we have heard, I would just like to add a comment about CCSVI.

Patients, a doctor and specialists have told us that we should focus on treating CCSVI. Others have said that the current state of science is not advanced enough to do that. Both sides are turning to Health Canada. However, no Health Canada representatives could join us today to explain why the treatment is not currently offered.

Even so, I have a question for Ms. Prévost. In her presentation, she listed two points she wanted to add to the discussion, but she only had time to present one of them.

Ms. Prévost, could you please go back to the second point you wanted to present to the committee?

[Nadine Prévost]

Very well, thank you very much.

I would also like to say something about caregivers. We know that caregivers make it possible for many people with multiple sclerosis to remain in their homes and their communities.

I would just like to mention that caregivers who stop working to take care of someone close to them are currently being penalized. When they quit their job, they lose their income, and quite possibly some of their future pension benefits.

That is why we would like at least the spouse to be eligible for the Quebec government's caregiver tax credit. This is the last point I wanted to raise.

Thank you.

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

In essence, Ms. Prévost, the demands you make in your presentation would fall under the jurisdiction of the Government of Quebec. Am I wrong?

[Nadine Prévost]

No, you are not wrong.

In fact, some of the demands are in line with federal recommendations, but the issues I brought up also come under provincial jurisdiction. You are right.

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

Thank you very much.

I would like to propose something to our witnesses. I know that your presentations were perhaps cut short. If you would like to present to the committee additional or complementary elements, I am prepared to share my time with you so that you can continue or finish your presentations.

[The Acting Chair, Conservative, Patrick Brown]

Thank you, Mr. Malo.

Is there anyone who requires additional time? They finished their testimony, but as Mr. Malo has suggested, they might have been cut off.

[Rebecca Cooney]

One of the things I would like to say is that people often say if we start testing and treating MS patients right now, it will take away from doing clinical trials. This is totally false. First of all, trials are usually very small, 100 to 200 people, so what happens to the rest of the 74,000 MS patients? The second thing is trials don't include people usually in the progressive forms of MS very often. Sometimes they do, but usually they don't.

Third, a lot of people with MS who have had MS for more than a certain number of years are excluded, as are people with other chronic conditions. I have Crohn's disease as well, and I would never be even eligible for a clinical trial. So people very often will use that myth, that if we don't do a clinical trial, if we start testing people, we won't have people for clinical trials. That's not true.

That's the only thing I wanted to add.

[Janet Salloum]

I would just like to say my sister has had it for about 18 months, so she's gone from an able-bodied functioning person to someone who is barely able to sit up in her wheelchair now. She's going to die without this treatment. She has to get this treatment immediately. So the studies are wonderful, but she needs action now. We have the technology, thanks to Dr. McDonald. He's doing wonderful work. I'm sure that there are facilities available that could take on patients right now and start treating them while the studies continue.

[Dr. Samuel Ludwin]

If I could just add, to continue, I actually am a great believer in spending money to do the studies as we requested the federal government do and as the National MS Society in the United States has done. I would make a plea, however, that these studies do get carried out before. It may be very counterproductive to what Dr. McDonald would like to do. If they are allowed to go without the studies, we will have a proliferation of many people who, unlike Dr. McDonald, may have not been properly trained and will be doing them willy-nilly. So I would encourage Dr. McDonald to publish his findings, to share his research findings so far and his studies, and all of these colleagues who do it, so that we have more people than just a few reports that have come out from Dr. Zamboni, and from Buffalo as well.

A study that we are proposing would include many, many more centres, which would really strengthen the case and protect patients as well from people who may not be qualified to do it.

[The Acting Chair, Conservative, Patrick Brown]

Okay. Thank you, Mr. Ludwin.

We need to move on to Ms. Hughes now.

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

Thank you. This is turning out to be a very controversial treatment, and I don't think it needs to be that.

I have friends who suffer from MS, and a friend whose son passed away very quickly from MS, I think within a year. So we do know how important it is.

Dr. McDonald, I know how passionate you were during your speech, and I think it speaks volumes on what needs to get done right now.

Because of the way the treatment is currently being issued for other reasons—the heart, the liver—with the blockage itself or the narrowing, what is the percentage of complications right now of the procedure itself, for what it is being used for, and what are the risk factors?

[Dr. Sandy McDonald]

Worldwide, we believe there have been about 750 procedures. The only death encountered was that in Dr. Dake's series in Stanford. He is using stents.

Zamboni says not to use stents. I know that, because I talked to him about two weeks ago.

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

I'm actually talking about the other procedures it is being used for. There are thousands of times that this procedure has been used. So what has been the risk factor and the percentages of--

[Dr. Sandy McDonald]

The risk of an angioplasty is very small. We're talking about two different things, though. Venous angioplasty is different from an arterial angioplasty. Venous angioplasty is done in a structure with very low pressure, compared to the arterial status—save for possibly Budd-Chiari syndrome. A venous angioplasty in a low-pressure system carries with it very little risk of leak, because again, you're dealing with a low-pressure system.

I realize the vein wall is thin. However, we do coronary angioplasty, and I've seen thousands of coronary arteries myself when I was doing my residency and training. The walls of coronary arteries are no thicker, in most instances, than the walls of the veins we're treating with venoplasty. So the risks are very, very small.

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

Before I move on to the other questions, does anybody else want to jump in here, those who are on teleconference? No?

The other question or comment I want to make is that I understand the difficulties with MS. I don't particularly live it myself, and I think it's easier for us who are not living it to say that we need more research on this, but obviously with what has transpired here and the urgency, there is a need for us to move forward and do it in conjunction with a research study.

This CCSVI, I believe, would also assist in eliminating some of the stresses on the health care system. In the ones that have currently been done, has the study indicated that there has been less need for medication for those patients?

I'll throw one more question at you as well, just because we've had to deal with this at one of my offices. It happened to be with cancer, where a certain medication for a certain cancer could only be used for that. But someone had a different cancer and there was an opportunity to have that assist, but because it wasn't proven they couldn't have access to it unless we asked for ministerial discretion, which we got. So what is the difference with this?

[Rebecca Cooney]

Regarding costs, I have conducted a financial analysis to compare the costs of medications for multiple sclerosis with what the costs would be for this procedure.

What we found was that if it basically halts the progression for even 20% of the people with MS, Canada would save millions of dollars, if that were the case. Now, that is a hypothesis, and it has to stop it. But people who have had the procedure--and I've talked to dozens of them--basically say that they have not progressed since they had the procedure. Some of them were from Stanford, and that was six to eight months ago. They haven't progressed at all.

For example, for me, every three weeks I deteriorate. If I could just stop it and still be able to stand in six months, that would be great.

[Dr. Sandy McDonald]

We've referred six people for treatment.

[Dr. Samuel Ludwin]

If I may, Mr. Chairman, I will just add that there are a few wrinkles in some of the arguments. First of all, my understanding is that Dr. Zamboni has distinctly said that his procedure does not work for progressive disease; it must be done on relapsing-remitting disease.

The second thing is that many of the patients, in my understanding, and I stand to be corrected, have been continued on their regular medical therapies, many of which are being shown to have an effect on relapsing-remitting that is very similar to that being described for CCSVI. So I think it clouds the picture a little bit, when we....

[The Acting Chair, Conservative, Patrick Brown]

Thank you, Dr. Ludwin.

We need to move on to the next round. I'll take the Conservative round.

Thank you once again, everyone, for being here. It gives me particular pleasure to see Dr. McDonald. I represent the riding of Barrie, Ontario, and we take great pride in Barrie in having such a renowned vascular surgeon in our community.

I want to give you an opportunity to expand a little bit on some of the comments you made. I think it would be helpful if we gave you an opportunity to play devil's advocate. You can reference some of the concerns that have been raised.

I heard last week from a witness that to have an accurate sample size to make sure that this is a safe procedure you would have to have a sample size of 1,500. To have confidence in the safety of this procedure, what do you think would be a fair sample size?

[Dr. Sandy McDonald]

I'm not an analyst of data, but I am a good physician. I can go back historically and answer your question a little bit.

Several years ago, in the mid-1990s, there was a study done. It was called the NASCET trial. It looked at strokes in patients with blocked arteries in the neck. It was done in conjunction with neurology. The study was aborted, because we found that conservative management, that is, medical management, of carotid artery pathology resulted in strokes, and if we operated, the patient seemed to have significantly fewer strokes. From that perspective, there can be science that can be done that can be aborted in the interest of the patient.

I would like to go back just for a second, if I may, to cost. I'll allude specifically to one patient we treated. His name is Steve. He was virtually unemployable because he had so much fatigue. He had his angioplasty done. Since he's had his angioplasty done, he no longer has a caregiver, no longer lives in supported government housing, has stopped taking his drugs, much against my advice, and is going to send his wheelchair back. He says that he is saving the taxpayer $4,000 a month.

[The Acting Chair, Conservative, Patrick Brown]

What do you think the cost of the procedure would be, just to give us some context?

[Dr. Sandy McDonald]

The cost to the hospital for the study done, without staffing and without paper costs--we tallied up the costs for the six patients we did--was about $450 per patient. You then have to add the costs of the technicians and radiologists, the paper costs, and the admitting costs and all that nonsense. On that basis, I've been quoted as saying that the cost is $1,500, because I like to leave a margin. I've no idea what the cost of putting a patient through a hospital system is.

There's one caveat, though, where the cost can go up. Dr. Zamboni is saying that in some patients, a cutting catheter needs to be used to facilitate the angioplasty. A cutting catheter costs $1,200. The standard cost for the actual high-pressure angioplasty device is $189.

[The Acting Chair, Conservative, Patrick Brown]

There's been some concern expressed by neurological doctors. What is your response to neurological doctors who may have expressed some concern?