Evidence of meeting #6 for Subcommittee on Neurological Disease in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was done.
A recording is available from Parliament.
11:15 a.m.
Director, MRI Institute for Biomedical Research, McMaster University
I understand.
Am I allowed to continue to finish reading this?
11:15 a.m.
Conservative
The Chair Conservative Joy Smith
Yes, you are. You're going to speak in English, which is just fine. If you have pictures that we could see without text, that would be helpful. I don't know whether you have that or not, Doctor.
11:15 a.m.
Director, MRI Institute for Biomedical Research, McMaster University
I do have some images to demonstrate a few of the points. I think it might be more appropriate at this point to finish the text and then go to the pictures, if that's allowed.
11:15 a.m.
Director, MRI Institute for Biomedical Research, McMaster University
In terms of making a commitment toward this concept of collecting as much data as possible, I would recommend that Canada consider creating some centres of excellence in multiple sclerosis. If you had a single centre of excellence dedicated to this, you could collect 4,000 MS cases a year. If you had five of these centres across Canada, you could collect 20,000 such cases a year. That would still take you three years to cover the total population in Canada, but it would be a significant progress.
This could fit within the centres of excellence program in the federal government. Within a month of starting such a program, you would have more than 300 cases for each of these sites, or 1,500 cases from across the country. Conventional funding for such a project takes a year to get started from inception to the beginning of the scanning, and no site that I know of in Canada or the United States would be prepared to collect the numbers that I have just mentioned to you. Their research will be ten times more expensive and ten times less the number of people that I have just quoted to you here, using conventional funding mechanisms. The approach I have proposed for you would be 100 times more efficient and cost-effective.
The current wait-and-see attitude to treat people is really something that is coming about by treating people as numbers and not as suffering individuals. This is not just a scientific issue; it is a moral issue. It is akin to watching someone drown while you are testing a new flotation device, while all previous ones only sink several hours later. Perhaps this device will not work perfectly at the beginning either, but if it helps keep people afloat rather than watch them drown, then this testing should be done to save someone's life.
Are double-blinded studies, then, the testing that should be done, as claimed by many people, to save someone's life? These double-blinded studies in fact have their own weaknesses associated with them. I will give you an example of this. There is an operation called vertebroplasty that's performed on 200,000 people a year throughout the world. There are two recent studies that have done 100 cases per study and have claimed they did not find an effect. However, according to the surgeons who performed this operation, they did not use the same criteria we would use when choosing a patient for surgery. Still, the vertebroplasty surgery continues today on a daily basis.
I think that demonstrates to you that if the scientists cannot carefully design the double-blinded study with the right criteria after years of following this process, who is to say that the naysayers today will design the right study for the MS population? We don't need to wait to get strong data to show, first, what types of abnormalities are present, and second, to begin following patients immediately. I would say that we should allow patients to have their data retrospectively reviewed, even if they follow a clinical route where data is not usually used for research. In fact, a retrospective analysis of clinical data is allowed when appropriately presented to human studies approval committees.
To date, I have reviewed, coincidentally, 65 cases—the same number as in Zamboni's pioneering study. I have seen a wide variety of venous abnormalities. Questions arise about the total cardiac input to the brain, about the arterial and venous flow patterns, about the structural changes in the veins, and about other issues related to valves and septums and other abnormalities. The imaging methods that we use today are ultrasound, MR imaging, and the gold standard is angiography itself, where the clinician, such as Sandy McDonald, goes in and actually evaluates what is present in the person's vessels.
All these need to be used as an important--
11:20 a.m.
Conservative
The Chair Conservative Joy Smith
Doctor, I'm sorry, can you wrap up? Your time is way over right now. Thank you.
11:20 a.m.
Director, MRI Institute for Biomedical Research, McMaster University
I'm sorry. I am almost done.
We're at a crossroads today, where I think we need to combine the clinical and research components associated with the research that is going on. In order to overcome the current inertia and move forward in this direction, I think it is extremely important that the Canadian government look at what has been acquired today and consider imaging MS patients and treating MS patients on a compassionate basis.
Thank you very much.
11:20 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you so much.
We'll now go to Dr. Sandy McDonald. Five minutes please, Dr. McDonald.
June 1st, 2010 / 11:20 a.m.
Medical Doctor, As an Individual
Madam Chair, members of the committee, thank you very much for having me back. I really appreciate the opportunity.
I would like to point out that Rebecca Cooney is back with us today, and this time she walked in without a wheelchair. She had her venoplasty done in Albany, in the United States, a little over a week ago, and she's doing just great.
[Applause]
My goal today is to actually show you images of jugular veins in people who have CCSVI. The abnormalities that we see are real. You don't need to be a physician to see them. Correction sometimes makes a difference in the lifestyle of these people. I believe the problem they have is easily treatable, safely treatable, treatable at low cost and at low risk to the patient. I don't believe that people should be forced, as Rebecca Cooney was, to travel to the United States, Poland, or anywhere else in the world to have it done at significant expense, when they can have it done at home at much less cost.
I'd like to show you some images we made in Barrie of two patients who have waived their rights to patient confidentiality. They are Lianne and Steven. We're going to show you the images. This takes a minute to load, and I apologize for that. The other ones have a little bit of English on them, and these have nothing on them.
This was the venogram that was done in Barrie on Lianne's left neck vein. As soon as it's loaded, I'll show you. I also have images of Steve Garvie, and these images are equally as dramatic. This is dye being injected into the left internal jugular vein. At the bottom portion, where the catheter takes critical angle from going up in the chest in this direction, the left internal jugular vein meets the brachiocephalic vein. At that point, flow is abnormal compared to what one normally sees. At that point we put a balloon inside the vessel, and we stretch up the vessel with the balloon. Once we've done that you get a different image, and it looks a bit like this.
The net effect is we can change the function of the vein. This is going to be the appearance of the azygos vein, which is a different vein inside the chest. What it does is it functionally returns the vein from being a very abnormal structure to being a normal structure.
This is the actual procedure being done. It's a balloon inside the junction of where the vessel is abnormal. This balloon is dilated to 10 millimetres. We subsequently dilated the vein to 14 millimetres.
What you need to understand is the volume of blood going through the vein. This looks like it's a little bit bigger than it was before. Before, if you assume the vein was measured at 2 millimetres, then if we dilate it to 10 millimetres, we have 25 times as much flow in a 10-millimetre vein as we do in a 2-millimetre vein. That's simply math. The net effect is, this was done, and she'll speak to her results herself.
We're just going to put up Mr. Garvie's as well, and it will take a second to load. I must apologize for that, because the other one has some English on it, and we don't want to offend anyone.
The results are actually going to speak for themselves. I think Lianne's results will certainly speak for themselves.
Some people have actually expressed some angst or some fear about having the procedure done. I think if the question were asked of me, if I would have the procedure done and if I have significant confidence in it being done, I would defer that to my interventional radiologist, Chris Guest, who spoke on W5. On W5 he was asked that very specific question. His answer was in essence that the procedure is done at very low risk, and he would have no qualms himself about having the procedure done. That comes from the guy who actually does the procedure. I don't do the procedure; it's done by an interventional radiologist.
I'd really like to take time to show you the images of Mr. Garvie, because the images of Mr. Garvie are even more dramatic than the images of Lianne.
11:25 a.m.
Conservative
The Chair Conservative Joy Smith
As long as the committee understands that your questioning time will be cut down. I just want to make sure. We really want to see the images, so I'm going to say show the images and I will have to watch the time with the questions. It's very interesting. Thank you, Doctor.
11:25 a.m.
Medical Doctor, As an Individual
Would it be possible to move and let Lianne give her testimony while I pull up the images on Steven? That would save some time.
11:25 a.m.
Lianne Webb As an Individual
Thank you.
My name is Lianne Webb. I'm 48 years old and I live in Hillsdale, Ontario.
In my mid-twenties I began experiencing severe migraine headaches, and by August 1991 I began having very unusual symptoms. I basically lost all control of my right arm and leg. This was accompanied by great fatigue, and after several tests and months of wondering what was happening to me, I was diagnosed with MS in May 1992. That was18 years ago.
MS affects a patient's life and the lives of our family and friends in so many ways, so many profound ways. By 2009, after 18 years of living with this disease, the daily episodes and fatigue, I was naturally intrigued by the news coming from Dr. Zamboni in Italy. I wanted to know if I had a venous insufficiency.
Dr. McDonald diagnosed that I did, and you have seen the images of my jugulars. Unquestionably I did. Naturally I wanted to have the blockage flow corrected, and I wanted this correction even though Dr. McDonald clearly told me that he would be treating my vascular problem and not my MS. Dr. McDonald treated my CCSVI with balloon angioplasty on February 11 of this year. It was such a simple, painless procedure and it was only a few hours—and that included recovery time.
You've seen from Dr. McDonald's images that my unquestionable venous abnormality has been corrected. Dr. McDonald warned that me that this treatment or procedure could have no effect on my MS.
The fact is my MS is much easier to handle now. I have lived through a marked improvement. Some of this improvement I felt right away. The fatigue is gone. I have not had an attack or episode since the treatment, and so far that's four and a half months of true bliss.
Before the procedure I was taking my medication but I was still having attacks and episodes. Since the treatment I have not taken any medication. I stopped this on my own, since I was having no further symptoms. No one recommended that I stop.
I'm able to stay awake in the evenings past 7 p.m. I am living again.
In addition to working full-time, I go golfing two to three times a week, and I walk the course; I don't take a cart. I am enjoying one of my lifetime passions, horseback riding, at least twice a week, and I'm actually looking to buy my own horse. I'm able to go for bike rides and walks with my family after work now that I have the energy to do so. It's hard just to sit and relax. I want to do and try so many things now, whereas before I was just way too exhausted to even think about it.
I can't imagine asking anyone to simply put up with the blockage I had. I ask that this committee do everything possible to remove all possible obstacles for all Canadian patients diagnosed with CCSVI to receive this treatment.
Thank you.
[Applause]
11:30 a.m.
Steven Garvie As an Individual
My name is Steve Garvie. I'm 53 years old. I was diagnosed by Dr. Paul O'Connor, head of the MS Clinic in Toronto, at St. Mike's Hospital. He diagnosed me with secondary progressive MS. This was approximately ten years ago.
Before the procedure on January 29, 2010, I was in SCAPD housing. That's government-funded housing where the caregivers come in three times a day. They help me shower. At four o'clock in the afternoon I was so fatigued that I sat in a lift chair. I couldn't move. They came in and cooked my supper. They fed me. They did my dishes. Came back in. They washed me.
People have pride. I had none. My life was taken away from me. These people gave it back. I don't know how you can put a wait on that. I'm a human being.
They helped me shop for groceries. They cleaned my apartment. I'm a self-motivated person. Having these things done for me is worse than a jail sentence. I was unable to walk without the use of an aid, a rollator or an electric wheelchair. As a man, that part of me was no more. I couldn't share my love with the person I loved. That was taken away from me by MS. It made me totally dysfunctional.
I took anti-depressants. That helped me get through my life. I don't have this thought written down, but I'll tell you right now I tried to commit suicide twice in the early stages. It wasn't selfish—I was trying to make sure my girls, my three daughters, didn't have to go through this. Pride does that to people, and a lot of people die every year because of this. The time is so important.
I've been six months fixed. In that six months I'd like to know how many people have died needlessly, how many people have had more disability because of what happened with the MS. More disabled, more disabled, more disabled. There's no need. None.
I saw the W5 program online. I didn't see it originally. Someone told me about it. I printed off the protocols. I went to my family doctor, Dr. Kiss, out of Barrie, Ontario. We discussed the blocked Doppler that they were talking about. I wanted to find out if I had that venous insufficiency. She was good enough to book me immediately to Dr. McDonald's clinic, where they did the Doppler scan. There's no pain involved with that. A little goop on your neck and they can show you what's what along the way. And they know exactly what they're doing.
They were good enough to book me an appointment with Dr. McDonald. I went and saw him. My jugulars were unquestionably blocked. I'm sorry for calling it an operation; it's not. It's a 45-minute procedure. Painless. Life-giving. It gave me back what I lost, and I can't thank them enough for that. I really can't. They're my heroes. I think you should let them be heroes for everybody else.
My CCSVI was treated with a balloon angioplasty, a procedure that's done every day of the week. No tests necessary.
My left hand came back to me on the OR table. It was numb; I couldn't use it. I shook the nurse's hand. My head was turned when they did this. I said, “What have you done to me? You've done something.”
Dr. Kiss said, “Why?”
I said, “My hand works. I can lift my left leg.”
I couldn't believe it. I went into this procedure with the thought of stopping progression. I'd learned to deal with the other things. I got my mind straight on the suicide. I didn't feel that I was worth a whole lot, not with what I was going through. I was getting worse every day, every month, every minute. Secondary progressive MS does that to you, and so does primary. You don't get better, you get worse, and that's all you have to look forward to.
They say that this does not help people with secondary progressive MS. I beg to differ. Please look at the evidence. I'm right here.
I have no need for the care any more. I left that apartment three months ago. I wash myself. I cook my own dinner. I can live my life. The housing is gone. I'll leave that apartment at the end of July. I left it three months ago, and I haven't been there except to move stuff.
Dr. McDonald called me and asked me to come here, along with you--
11:35 a.m.
Conservative
The Chair Conservative Joy Smith
Mr. Garvie, I'm not trying to be rude, but I've given you two extra minutes. What I'm trying to do is get presentations that are so important, and yours is very compelling. Could you please be so kind as to wrap it up now?
11:35 a.m.
As an Individual
I sure can.
Please take the obstacles out of the way. Everybody deserves to have a life, and with a simple angioplasty, that can be done.
I thank you very much for hearing me.
[Applause]
11:35 a.m.
Conservative
The Chair Conservative Joy Smith
If there are other things you'd like to say, when we go into the rounds of questions, please do it. Even though you're asked a question, if there's another thought that you have, please include it in that question.
We're just thrilled to have you here today. It is a subcommittee. We've added it on. Every person on this committee is your friend. This is why we're studying neurological disorders and learning more about them.
I will begin with a very strict five-minute round, starting with Dr. Duncan. Dr. Duncan, please.
11:40 a.m.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you, Madam Chair.
Thank you for your science, for your courage for doing this work.
To Lianne and Steve Garvie, thank you so much for having the courage to come and share your stories. They are overwhelming.
Before I ask my questions, I want to read a letter I got last night. It reads:
I am a Canadian medical doctor who's been practising since 1969. I also have had MS since 1990 and just got back from Poland, where I had balloon angioplasty to a stenotic right internal jugular vein. I have noticed improvements in several areas... I also met many Canadians in Ketowice who had been treated with positive results. They were ecstatic and so grateful for an improvement to their quality of life. Two-thirds of all the people treated there are Canadians. ... There are 2,000 people on their waiting list. The argument in Canada by neurologists is that we need more studies before we can do this in Canada. The only way you do a study is by treating people and a follow-up. Neurologists should have no input into this aspect of treating MS. They are not vascular surgeons.
He goes on to talk about what it costs per month. He says:
Improvement of quality of life has no price tag. We will only know if the positive changes resulting from this endovascular surgery will last after months and years of follow-up. There is no problem for paying for angioplasty for coronary artery stenosis or surgery for carotid artery stenosis. Why the discrimination to venous stenosis?
His last line is:
I hope you fight for the rights of Canadians to get treatment in Canada.
Dr. McDonald, how easy is it to correct these anomalies?
11:40 a.m.
Medical Doctor, As an Individual
In most cases the procedure itself is fairly easy. To say it's easy for the inexperienced hand would be foolish. For a very experienced intervention radiologist the angioplasty, as I showed on Mr. Garvie, was done very simply, very quickly, and very safely, with very low risk to the patient.
11:40 a.m.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you.
How dangerous is the diagnosis? Does the imaging present any risk?
11:40 a.m.
Medical Doctor, As an Individual
To the best of my knowledge, the imaging presents no risk whatsoever. It's done with ultrasound technique, and if it's done by a well-trained technician the results are significantly better than if it's done by someone who hasn't been trained in Zamboni's actual technique.
We started doing them without being trained by Zamboni, and some people with MS had negative studies. We thought that not everybody with MS was going to have CCSVI. I don't know if everybody with MS has CCSVI or not, but when we restudied the patients we had initially done prior to our Zamboni training, they all came back with criteria that met Zamboni's diagnosis of CCSVI after we had been properly trained by Zamboni.
11:40 a.m.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you.
Do you have any ethical dilemma in deciding to treat MS patients with CCSVI?
11:40 a.m.
Medical Doctor, As an Individual
I would answer that in a different way. I think I have an ethical dilemma as a physician not to treat people with CCSVI. I think there is good anecdotal evidence to suggest that people with CCSVI do well with treatment. Again, as a vascular surgeon I do not treat MS; I treat CCSVI.
11:40 a.m.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
To Lianne and Steve, thank you.
I know you had your angioplasty done in Barrie. Is that hospital still doing this? I'd like to ask both of you for your answers. Do you know why or why not?