Evidence of meeting #4 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 patients.
A recording is available from Parliament.
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Order, please.
I call the subcommittee together.
Dr. Bennett, are you sitting on the subcommittee today?
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Would you go outside with your conversations then, Madam? Thank you.
Today we have a lot of witnesses, and I think it's going to be an extremely interesting study.
I welcome the witnesses today.
I'm going to have to leave at 11:30, and Dr. Duncan will be taking the chair following that. She's done very good work, as has this whole committee--Dr. Duncan, Monsieur Malo, and Mr. Brown--which has done an exceptional job of trying to get all of this together so we can have our presentations today.
Is there a problem?
11:05 a.m.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Madam Chair, I don't know if there's another way of doing this, but I think Dr. Duncan is so knowledgeable on this topic that it would be inappropriate for her to be in the chair.
11:05 a.m.
Conservative
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Okay, Mr. Brown will take the chair.
Having said that, we're going to talk to Dr. Samuel Ludwin, from Kingston, Ontario by teleconference.
Mr. Ludwin, can you hear me?
11:05 a.m.
Dr. Samuel Ludwin Professor of Pathology (Neuropathology), Queen's University, As an Individual
Yes. It's Dr. Ludwin. I'm hearing you loud and clear.
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Oh, wonderful. Welcome, Mr. Ludwin.
He's a professor of pathology, ladies and gentlemen, from Queen's University.
We have another teleconference, from Montreal, with the Multiple Sclerosis Society of Canada, with Nadine Prévost, director.
Nadine, can you hear me?
11:05 a.m.
Nadine Prévost Director, Services and Outreach, Quebec Division, Multiple Sclerosis Society of Canada
Yes, I'm hearing you very well.
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
That's great.
From the University of Calgary, we have Samuel Weiss, professor and director of the Hotchkiss Brain Institute.
Professor, are you there?
11:05 a.m.
Dr. Samuel Weiss Professor and Director, Hotchkiss Brain Institute, University of Calgary
I'm here, and I can hear you loud and clear.
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Wonderful.
Well, we're very pleased that you three could join us by teleconference.
As individuals, we have Dr. Sandy McDonald, a medical doctor; Dr. Jock Murray, professor emeritus from Dalhousie; and Janet Salloum. Welcome.
Are you a medical doctor, as well?
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you so much.
From MS Liberation, we have Rebecca Cooney.
Rebecca, are you a medical person?
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Okay. You're here, then, as an individual. Thank you.
This subcommittee has been very involved in trying to set up a subcommittee, because we don't have time to look at this issue on the main health committee for this term. Next term we hope we'll be able to do something more. But it's such an important issue that we have formed this subcommittee.
This is the first time I've had to leave. There is a huge school group here. They've flown in all the way from Manitoba, and they want to see me for a few minutes, so Mr. Brown will be taking the chair.
We're going to have five-minute presentations so we can get to the questions and answers. We will start with Dr. Sandy McDonald, medical doctor, as an individual.
Could you please give us your presentation, sir?
May 11th, 2010 / 11:05 a.m.
Dr. Sandy McDonald Medical Doctor, As an Individual
Madam Chair, Madam Vice-Chair, honourable members, we are here today to speak on CCSVI, chronic cerebrospinal venous insufficiency, a serious vascular problem. I am a vascular surgeon. Thank you for the opportunity to address this subcommittee on a matter of great importance and, in my opinion, great urgency.
You have the chance to help put an end to an enormously troubling situation in which thousands of innocent victims of multiple sclerosis are condemned to deterioration of every aspect of their lives and are deprived of a simple procedure available to every other Canadian without a second thought--every Canadian, that is, who suffers from a venous anomaly of any organ other than the brain, every single Canadian except those with MS. I am here to ask you to help remove the obstacles that make it impossible for MS sufferers to obtain treatment for CCSVI and make it impossible for doctors to give treatment, even as a matter of compassion.
I am a cardiovascular surgeon. One day not long ago, my lab suddenly experienced a flood of requests for imaging to diagnose CCSVI. We were receiving and continue to receive 1,000 requests a week for this service. I found news about Dr. Zamboni's research with the diagnosis of CCSVI. We did some research. We started to do the same imaging, as requested by the physicians referring the patients. To our astonishment, we found a large number of cases that had verifiable, diagnosable abnormalities seen in the veins draining the brain and the spinal cord.
At first we found these abnormalities in about 75% of the cases. I realized that this was an abnormality I did not understand. I chose to travel to Italy. I spent several days with Dr. Zamboni and his crew. I acquired training that was required to adequately detect these abnormalities and I am now sticking to a very rigid protocol, designed by Dr. Zamboni, to diagnose CCSVI. BVI is now finding abnormalities sufficient to diagnose CCSVI in upwards of 90% of patients with MS referred to us by neurologists.
It is too early to say whether CCSVI is actually causing MS. However, it is not too early to say that the logic of such connections is very plausible and makes scientific sense. Indeed, anecdotal evidence today is very compelling.
We know that patients with MS have a buildup of iron in deep-brain tissue, an area close to draining veins. It is plausible that the compromised venous drainage causes red blood cells laden with iron to leak from the thin-walled veins into brain tissue. As the leaked red blood cells break down, iron is deposited, an immune response follows, neurological damage subsequently develops. The experience of Zamboni and Simka is that virtually all CCSVI sufferers with MS who undergo corrective angioplasty experienced some improvement in their symptoms. I have proceeded to refer six patients to treatment for angioplasty: all six have seen significant improvement, four of them dramatic.
Angioplasty is a well-known, universally practised procedure. It is not experimental. Interventional radiologists do it virtually every day. It is very low-risk. There is nothing special about venous angioplasty. The angioplasty we speak of with Dr. Zamboni is for jugular and azygous veins. It is a simple two-hour to three-hour outpatient visit done under local anesthesia with minimal risk.
I am a cardiovascular surgeon. I fix blood flow. In that sense, I'm a plumber. When I see a serious plumbing problem, I want to fix it. When I see the whole house is suffering, I want to fix the pipes. I can do that without harming the wiring in any way and do not see why we condemn the family to misery while we wait for an electrician to give his permission.
Only this past week, I had to tell a young patient whose young life is being expropriated by MS that I had found a clear obstruction in the blood flow from her brain. I could tell her that technology exists to treat this abnormality quite easily, quite cheaply, and with undue risk. But I had to tell her that this procedure is not available in Canada. She is not the only one. She is one of tens of thousands of MS patients in Canada who simply do not understand how it is possible to justify discriminating against them in this way. They are right not to understand. You should not understand.
Unless we put an end to this Kafkaesque and perfectly discriminatory situation in which we will predictably see MS sufferers seek diagnosis and treatment elsewhere, MS sufferers will litigate and a disproportionately large percentage of MS sufferers will commit suicide.
Yes, more study is needed. The recently requested $10 million for study by the MS Society is a good start, but only that. It will not help any MS sufferer in the meantime. It is fatally flawed if it does not include a treatment arm for CCSVI.
We will only learn the efficiency of treatment with CCSVI if we do the procedure. If this study is done as an excuse to do nothing while we wait for results, then it will harm MS patients. They will simply wait longer for treatment.
We cannot tell MS patients just to wait. We must keep the door open for doctors to deliver on a compassionate basis, if necessary, correction of CCSVI and MS. If universal health care is not accessible for treating patients with CCSVI and MS, then we must, as a minimum, allow these MS patients to purchase their services in Canada from qualified physicians.
Please report to the Standing Committee on Health and advise the minister that there are unconscionable and unacceptably discriminatory obstacles in the way of corrective angioplasty for CCSVI sufferers who also happen to be diagnosed with MS.
Physicians are sworn to help their patients. Please let me help mine.
11:15 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you very much, Dr. McDonald.
Now we'll go to Dr. Murray, please.
11:15 a.m.
Dr. T. Jock Murray Professor Emeritus, Dalhousie University, As an Individual
Thank you very much.
When I was originally asked to come to this committee, I thought the discussion initially was going to be about the need for neurological research in general, and I was quite prepared to do that, because I still think that's the basis of how we're going to find answers to important questions about diseases that afflict so many Canadians.
There is a very strong research community in neuroscience in Canada. Particularly in the area of neuroscience many of our universities have some of their greatest strength. In MS, we have a group of clinicians and researchers who have been part of most of the advances that have been made in the disease in the last 50 years. There has been a network of clinics across the country, which now can put together a study like the genetics study, which can put 32,000 MS patients into a study to answer questions about the genetics of the disease. So the ability and the power is there, but it has to be understood that most advances that have come in MS as well as other diseases have come from basic science.
The importance, I think, is to make sure that we have adequate funding for all important questions, all peer-reviewed good research involving the neurosciences. In MS, we learn from other research and other fields, and so much of what we're beginning to understand about neuro-protection, about the recovery from damage to the brain, is coming from studies in stroke and is coming from studies in trauma, and all of that will reflect on our ability to manage patients with MS in the future.
We are now within a therapeutic era of MS. I started taking care of MS patients 40 years ago, and initially we had no therapies that altered the outcome of the disease. We now have six therapies that are approved in this country for MS patients that do alter the outcome of the disease, but unfortunately not for all. We have a number that are in the wings waiting to be approved, that have randomized clinical trials that show proof of benefit. We also have some that are now approved in the United States that are soon to come for approval in Canada. It's interesting that there's no media attention at all to these, which have randomized clinical trials to show efficacy.
When a question suddenly arises like CCSVI, it is important that it be treated respectfully and be assessed like all the other hypotheses, of which there are many at the present time. What we have asked for is that there be an accepted, standardized approach to answering the questions, and most of the clinicians involved in this have asked for it to be in two stages. One is to first assess what the importance is of the neck vein problem, because although it has been said to occur in 100% of MS patients, a recent study showed it to be 50%. It was said to be zero in the non-MS patients, and now we find there have been studies over the last five years to show that it is not that uncommon in the normal population. There are questions about what the importance of this is. What we need is a rational approach to answering, first, the basic questions about the importance of this, and then, if it does appear that there is strong evidence, a design of a standardized, randomized clinical trial to show benefit and safety.
One of the things about getting to the age I am is that you tend to become an historian. I have written a book on the history of multiple sclerosis, and there are 100 pages in the book on the history of therapies that have been said to be cures for the disease. Some of these therapies were given to MS patients for as long as 20 years before they disappeared.
All we ask is that there be a reasonable approach to how this question is being answered. If all patients are given the therapy, no one will go in a trial. If that occurs, we will not get the answers. We have had, in recent years, pressure in our clinics, not just for CCSVI, but for dorsal column stimulation. Many patients around the world, because it got into the media, had implanted electrodes on their spinal cords until that turned out to be unsuccessful and it got abandoned. The media never went back to the story of that failure.
We've had snake-venom therapy, bee-venom therapy, Cari Loder diets, hyperbaric oxygen chamber therapy, and our patients were pressuring us to send them and pay for the cost of that in Florida. It's still available. Two years ago the press was raising stories about sending people to China for stem cells. It goes on and on.
Is there any harm in all of this? Yes, there is. Over the years we've had repeated disappointment to the MS community about things that were initially said to be cures. All we ask is that there be a reasonable approach to the assessment of the neck vein problem, and later the therapy itself.
11:20 a.m.
Conservative
11:20 a.m.
As an Individual
Good morning.
I wish to thank the committee for allowing me to testify today. I'll try to get through my points as quickly as possible, as I only have five minutes. This feels like the most important five minutes of my life.
I'm here to testify for my sister, Michelle. She is a young woman in her thirties with three small children, ages six, four, and the baby is not yet two. Two and a half months after the birth of her third child, she developed symptoms. She was diagnosed on December 8, 2008. Within seven months, she was confined to a wheelchair. Her disease is both progressive and aggressive.
Studies are currently under way at St. Joesph's and McMaster for CCSVI. As important as these studies are, many with MS, like my sister, don't have time to wait for the results. I'm here to ask the committee to take whatever steps, whatever action necessary, to ensure that those who do not have time to wait for two years for the results of a study get immediate treatment for CCSVI on compassionate grounds.
Like many people with MS, Michelle paid out of pocket to go to Buffalo to have the tests done to determine whether she has CCSVI. The tests showed she has diagnosis in both her jugular veins and needs to have her veins unblocked immediately. Some people with MS have been fortunate enough to pay for and travel to other countries, such as Poland, Kuwait, Italy, to get their veins unblocked and are returning to Canada feeling that they have been cured, liberated.
Even if one had the means to go outside of Canada, there is a waiting list of over one year to get the procedure done. Why isn't it being done right now in Canada?
Canada has an opportunity to be leaders in this breakthrough. Many of you have an opportunity to be heroes. I know for sure that there's at least one right here, right now. I'm asking the committee--no, I'm begging the committee--to take immediate action, whatever necessary, to unblock the veins of those suffering with CCSVI, even if they also happen to have MS, and particularly the ones whose conditions are galloping, like Michelle's.
Why should people with MS be discriminated against? Why should they not have the choice in getting their veins unblocked? Canadians are able to get their veins unblocked for any other organ in the body. Why not their brain? If nothing is done and patients are forced to wait for the results of the study, people like Michelle will die waiting. Knowing this and doing nothing is like watching someone drown while you test flotation devices.
It's manslaughter. It's unethical. It's immoral.
I'm sure this committee has heard the financial comparisons with respect to the cost of CCSVI treatment, which is approximately $1,200 to $1,500, versus $25,000 to $40,000 per year for standard MS drug treatments. From a financial point, then, clearing veins makes sense.
What about the right to choose treatment? Canadians are fortunate, in that they have choices: abortion, circumcision, cosmetic surgery. These can be controversial and rooted in religion, women's rights, or aesthetics. Shouldn't Canadians have the right to unblock their veins?
To improve the quality of their life, take MS out of the equation and treat CCSVI like any other venous insufficiency would be treated in the body. Each day that goes by, Michelle's condition worsens. Neurologists prescribe a host of drugs and drug treatments that carry great risks, such as chemotherapy, and also a drug called Tysabri, which has been known to cause fatal brain disease. Yet some neurologists have been vocal in expressing their concerns about a very low-risk procedure to unblock veins. Clearly, drugs such as these pose a much greater risk than in an angioplasty-type procedure.
One neurologist in particular has expressed fear of losing the research dollars to CCSVI studies and has even suggested that CCSVI and its relationship to MS may be a hoax. It may be like the chicken and the egg: it doesn't really matter at the moment if CCSVI causes MS or if MS causes CCSVI.
The studies under way may provide answers to these questions. What matters and what we do know now is that people have blocked veins and need to get them unblocked. Not doing so is wrong on so many levels, it's immoral.
Michelle is often confined to a bed, since there are times when she can't hold up her head or keep her balance in a wheelchair. She is too weak sometimes to speak and suffers unbearable headaches. Her children look shell-shocked as they watch their mother deteriorate before their eyes. And her husband looks thin, beaten down, frightened, and exhausted.
The only thing keeping her alive is a shred of hope that she may get treatment soon to unblock her veins and that she may one day be able to hold her baby again, change her diaper instead of watching a caregiver do it, and push her children on a swing in the park.
She deserves a chance. Please take whatever steps are necessary to give her this chance.
Thank you.
11:25 a.m.
Conservative
The Chair Conservative Joy Smith
I thank you for your courage in coming to be a witness at committee. I know that many of us have been touched by Parkinson's or MS, and we share your concerns. We really do.
We're now going to the teleconference with Kingston. We have Dr. Samuel Ludwin. I'm sorry to have to give you such a short time, but we want to hear from everybody. You have five minutes, sir.
11:25 a.m.
Professor of Pathology (Neuropathology), Queen's University, As an Individual
Thank you very much for inviting me to testify.
My name is Samuel Ludwin. I'm a physician, a neuropathologist, which is somebody who studies the brain. I have been studying neuropathology for the last 40 years. During this period, although I look at all brain diseases in my clinical job, my research work has been in the study of multiple sclerosis brains. I'm also an experimental researcher.
My whole academic life has been related to trying to understand the link between what we observe in the experimental situations and what we see in the clinic and what we see in the brains of patients with multiple sclerosis.
I might add that pathology is a unique discipline that gives the physician the privilege of being able to look at a patient from an objective point of view, and we take that responsibility very seriously. I'm also a teacher on both clinical and basic matters.
I have also served as an associate dean of research and the vice-president of research in the Kingston hospitals, and this has given me a unique perspective on research in general. I've served as a patient advocate on both multiple sclerosis and some other myelin-related diseases. Finally, and I will come back to this, I am currently the incoming chairman of the federal panel on research ethics set up by the three funding agencies that provide the guidelines for ethical procedures in human research.
Dr. Murray has mentioned some of the issues, but I think they bear repeating, because a lot of these I will have done. Canada is a unique country in the world of multiple sclerosis, admired throughout the world for the quality of both its clinical work and research. As they say, we punch far above our weight in terms of the number of people treating and publishing and doing research. This has come about, of course, from necessity, because of our large patient load.
But in addition, there have been two very good reasons that our scientists and our clinicians have achieved this very enviable position in the world. The first is an extremely well-organized clinical network, which really looks after most multiple sclerosis patients in the country—this is very different from the situation in most other countries—and also to a very dedicated Multiple Sclerosis Society, which has provided funding for many decades and has funded some of the most important advances in multiple sclerosis.
I can't emphasize too much the relationship between good clinical practice and research. I'll start off by making a general statement from all clinical research: that studies have shown that patients who are undergoing clinical trials generally, whether they're on trial arms or not, have a much more favourable outcome than patients who are not treated this way.
But this is a side effect to providing a rational basis for therapy. Any time one looks at a therapeutic process, one has to have some sort of justification. Sometimes the justification can come from clinical observation and sometimes it can come from experimental observation on animal and tissue culture models. For instance, we all know—and this has some analogies to CCSVI—that coronary angioplasty and coronary stenting is a routine, accepted procedure. But people forget to stop and think about what our knowledge about coronary angiography has derived from. It has derived from a decade and maybe even centuries of observable pathological changes in the actual heart, changes that have shown blockages in the vessels and have led to techniques for diagnosing them, fortunately, before the patients die.
These have been established over many decades before the advent of some of the treatments. With new technology, this observable time can be greatly shortened, so patients will not have to wait for the kinds of decades that they did for coronary angiography.
Research in Canada covers most fields. There are very many important fields—
11:30 a.m.
Conservative
The Chair Conservative Joy Smith
Dr. Ludwin, I have to interrupt you. Could you wrap up now, please?
