Subcommittee on Neurological Disease of the Standing Committee on Health
Sous-comité sur les maladies neurologiques du Comité permanent de la Santé
EVIDENCE number 04,
Témoignages du comité numéro 04
UNEDITED COPY - COPIE NON ÉDITÉE
Tuesday, May 11, 2010 - Le mardi 11 mai 2010
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The Chair (Mrs. Joy Smith (Kildonan—St. Paul, CPC)): Order, please.
If I could call the subcommittee together.
Could ask everyone, if you have your conversations, can you take them outside, please? Thank you very much.
I just want the Subcommittee on Neurological Diseases. Dr. Bennett, are you sitting on the subcommittee today?
Hon. Carolyn Bennett (St. Paul's, Lib.): I haven't decided yet, Madam.
The Chair: Would you go outside with your conversations, then, Madam? Thank you. I would like to get the committee started. Thank you.
So we're all already.
Could we shut the door at the back, please? 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 done this committee, this whole committee, which is Dr. Duncan, Monsieur Malo, and Mr. Brown, done an exceptional job of trying to get all of this together so we can have our presentations today.
Is there a problem?
Hon. Carolyn Bennett: Yes.
The Chair: Yes.
Hon. Carolyn Bennett: 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.
The Chair: Really.
Mr. Brown, would you like to take the chair?
Mr. Patrick Brown (Barrie, CPC): I'd be happy to.
The Chair: Okay, Mr. Brown, takes the chair.
Having said that, we're going to talk to some people from Kingston, Ontario, by teleconference, an individual, Samuel Ludwin.
We're hoping that these teleconferences will work out. There's been a few technical difficulties, so they're not quite set up yet, I understand, but I'm just going to check and see.
Mr. Ludwin, can you hear me?
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.
The Chair: Oh, wonderful. So it's working well, then. Good for you. That's great.
So welcome, Mr. Ludwin. He's a Professor of Pathology, ladies and gentlemen, from Queen's University.
We have another teleconference from Montreal, the Multiple Sclerosis Society of Canada, Nadine Prévost, Director.
Nadine, can you hear me?
Ms. Nadine Prévost (Director, Services and Outreach, Quebec Division, Multiple Sclerosis Society of Canada): Yes, I'm hearing you very well.
The Chair: Oh, great. Well, these are working well now, then.
In Calgary, University of Calgary, we have Samuel Weiss, Professor and Director of the Hotchkiss Brain Institute.
Professor, are you there?
Dr. Samuel Weiss (Professor and Director, Hotchkiss Brain Institute, University of Calgary): I'm here, and I can hear you loud and clear.
The Chair: Wonderful.
Well, we're very pleased that you three could join us, from the teleconference aspect.
As individuals, we have Dr. Sandy McDonald, a medical doctor— welcome—we have, Dr. Jock Murray; we have Professor Emeritus from Dalhousie—welcome—and we have Janet Salloum.
Are you a medical doctor, as well?
Ms. Janet Salloum (As an Individual): I'm here to testify as a witness.
The Chair: As a witness. Thank you so much.
And I think we have, from MS Liberation, Rebecca Cooney.
Rebecca, are you a medical person or a witness, in terms of an individual?
Ms. Rebecca Cooney (Co-founder, MS Liberation): Yes.
The Chair: Okay. Thank you.
Well, you know, this subcommittee has been very involved in trying to set up a subcommittee because we don't have time to do it on the main health committee for this term. Perhaps next term, hopefully, 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. I have a huge school here, and they've flown all the way in from Manitoba, and they want to see me for a few minutes, so Mr. Brown will be taking the chair.
What we're going to do is we're going to have, I think, five-minute presentations so we can get to the Qs and As, the questions and answers.
We will start, as an individual, with Dr. Sandy McDonald, medical doctor.
Could you please give us your presentation, sir?
Dr. Sandy McDonald (Medical Doctor, As an Individual): Madam Chair, Madam Vice-Chair, honourable members, we are here today to speak on CCSVI, 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, that is, every Canadian 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. 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 azygos veins. It is a simple two-hour to three-hour out-patient visit done under local anesthesia with minimal risk.
I am a cardiovascular surgeon. I fix blood flow. I'm in that sense 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.
Just 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 where 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 just 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 the results, then it will harm MS patients, and they will simply wait longer for treatment.
We cannot tell MS patients just to wait. We must tell all MS patients to obtain, and 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 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.
The Chair: Thank you very much, Dr. McDonald.
Now we'll go to Dr. Murray, please.
Dr. T. Jock Murray (Professor Emeritus, Dalhousie University, As an Individual): 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 that's the basis of how we're going to find answers to important questions about diseases that affect 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 that 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, has 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 randomised 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 randomised 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 hypothesis 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, first to 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 un common 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, if there is strong evidence, then a design of a standardized randomised clinical trial to show benefit and safety.
One of the things about getting to the age that I am is that you tend to become a historian. I have written a book on the history of multiple sclerosis and there's 100 pages in the book on the history of therapies that have been said to have been cures for the disease. If they are not studied in reasonable trials - 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 then we will not get the answers. We have had in recent years pressure in our clinics, not just for CCSVI, for dorsal column stimulation, many patients around the world because it got into the media, had implanted electrodes on their spinal cords until that was turned out to be unsuccessful and abandoned, and the media never went back to this story of that failure.
We've had snake-venom therapy, and --- therapy, ---, 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 the stories about sending people for stem cell and that 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 cured. All we ask is that there be a reasonable approach to the assessment of first the nickname problem and later the therapy itself.
The Chair: Thank you very much, Dr. Murray.
Now we'll go to Janet Salloum.
Ms. Janet Salloum: 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 December 8, 2008. Within seven months, she was confined to a wheelchair. Her disease is both progressive and aggressive.
Studies are currently underway 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 those who do not have time to wait for two years for the results of a study to 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 or not she has CCSVI. The test showed that she has diagnosis in both her jugular veins and needs to have her veins unblocked. 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 waitlist 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.
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 $1200 to $1500 versus $25,000 to $40,000 per year for standard MS drug treatments. From a financial point, 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 question 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. Also a drug called Tysabri, which has been known to cause fatal brain disease.
Yet some neurologists--
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 in losing research dollars to CCSVI studies and have 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 underway may be 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 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 care giver 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.
The Chair: I thank you for your courage in coming to witness on committee. I know a lot 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 from 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 so you do have five minutes, sir.
Dr. Samuel Ludwin: 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 I have been particularly interested, although I look at all brain diseases in my clinical job, my research work has been in the study of multiple sclerosis brains and 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 very unique discipline which 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 mylan 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 which provide for guidelines for ethical procedures in human research.
Doctor, you'll forgive me, 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 very unique country in the world of multiple sclerosis and admired throughout the world for the quality of both its clinical 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 out, of course, from necessity because of our large patient load.
But, in addition, there have been two very good reasons why our scientists and our clinicians have achieved this very enviable position in the world. The first is an extremely well organized clinic network which really looks after most multiple sclerosis patients in the country which is very different to the situation in most other countries and also to a very dedicated Multiple Sclerosis Society that 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 clinic 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 are generally, whether they're on trial arms or not, have a much more favourable outcome than patients who are not treated on this.
But this is a side effect to providing a rational basis for therapy. Any time that one looks at a therapeutic process, one has to have some sort of a 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 how our knowledge about what coronary angiography has derived from and it's derived from a decade and maybe even centuries of observable pathological changes in the actual heart that have shown blockages in the vessels and have led to techniques for diagnosing this, fortunately, before the patients die.
So these have been established over many decades before the advent of some of the treatment. With new technology, this observable time can be greatly shortened and 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--
The Chair: Dr. Ludwin, I have to interrupt you. Could you wrap up now, please.
Dr. Samuel Ludwin: Certainly. What I would like to do is just add up what is the importance of the CCSVI.
The CCSVI is an extraordinary, interesting, novel idea, and in fact the Canadian Multiple Sclerosis Foundation, some time ago, took a lead in the world in calling for a research proposal request, for which we were considered to be very great forerunners. It offers many new ideas in terms of pathology, and Dr. McDonald has mentioned some, such as the iron, but this has to be really proven. There are many flaws in this argument. It may turn out to be right, but it needs good study over a clinical and experimental ground.
The Chair: Thank you, Dr. Ludwin, and if we could, I know you were asked to come here, but could you please provide documentation and send it to the clerk of the House of Commons here, just so we can distribute your paper to all the committee members? Could you do that for me, please, Dr. Ludwin?
Dr. Samuel Ludwin: Certainly. It would take a few days though.
The Chair: Thank you. That would be just fine, and thank you for your presentation.
We'll now go the Multiple Sclerosis Society of Canada, Nadine Prévost. Five minutes, Nadine.
Mme Nadine Prévost: Je vous remercie de me permettre de parler des préoccupations des personnes qui ont la sclérose en plaques au Québec.
La Division du Québec de la Société canadienne de la sclérose en plaques compte plus de 8 000 membres au Québec et oeuvre depuis plus d'une décennie à faire connaître les besoins des personnes atteintes de sclérose en plaques.
Notre bureau est situé à Montréal et il y a aussi 25 sections locales qui couvrent la presque totalité du territoire québécois. Il y aurait de 13 000 à 18 000 personnes atteintes de sclérose en plaques dans la province. Le Québec a la chance de pouvoir compter sur un solide réseau de 16 cliniques de sclérose en plaques qui assurent leur suivi médical et cinq cliniques font aussi de la recherche.
Au Québec, nous offrons plusieurs services, la division du Québec offre plusieurs services. Nous sommes une source d'informations fiable sur la sclérose en plaques, les traitements, la recherche et les ressources sous différentes formes, soit des publications, site Internet, revue trimestrielle, sessions d'information pour les personnes venant de recevoir un diagnostic, conférence, congrès annuel et un colloque pour les professionnels de la santé. On offre également du support sous différentes formes, soit des groupes d'entraide, l'écoute active, référence à d'autres services dans la communauté et défense des droits. On a aussi un volet jeunesse, donc une revue trimestrielle, un site Internet et un camp pour les jeunes dont un parent a la sclérose en plaques. On a également des activités physiques et récréatives pour favoriser le mieux-être et briser l'isolement, ainsi que du prêt d'équipement.
J'aimerais vous parler aujourd'hui principalement des besoins liés au continuum de soins ainsi que ceux des proches aidants. La sclérose en plaques touche le plus souvent des jeunes adultes et on sait que la vie avec cette maladie épisodique et évolutive demande des ajustements fréquents. Les besoins résidentiels des personnes qui ont la sclérose en plaques sont variés puisque la maladie est elle-même différente d'une personne à l'autre. Il y a celles qui devront faire appel à leur CLSC pour des services de soutien à domicile sur une base ponctuelle ou permanente. Certaines autres personnes devront aussi faire adapter leur domicile pour le rendre accessible.
Quand il n'est plus possible de rester chez-soi de façon sécuritaire, il y a des choix difficiles à faire. Il existe pour le moment très peu de ressources résidentielles alternatives avec services et le CHSLD est trop souvent la seule option. Certaines personnes n'auront donc d'autre choix que d'aller vivre en CHSLD. On connaît des couples qui ont dû se séparer après quelques décennies de vie commune parce qu'ils n'avaient pas d'autres choix.
Il y a plusieurs pistes de solutions, notamment une hausse du financement des soins à domicile et un accès au programme d'adaptation de domicile dans un délai raisonnable. Nous souhaiterions que l'institutionnalisation ne soit considérée qu'en tout dernier recours et que soit privilégié le soutien des personnes dans leur milieu naturel. La majorité des personnes atteintes de sclérose en plaques préféreraient vivre dans un milieu qui se rapproche d'un logement traditionnel avec services et soins.
De plus, nous souhaiterions que soit soutenu le développement de ressources résidentielles alternatives spécifiquement pour les jeunes adultes qui ne peuvent plus demeurer dans leur milieu de vie et ainsi libérer des places en CHSLD pour les personnes en fin de vie.
Enfin, on aimerait que l'approche milieu de vie soit instaurée en CHSLD afin de créer un environnement stimulant qui respecte les besoins spécifiques des personnes.
Nous connaissons des jeunes adultes en CHSLD qui se perdent dans une masse de personnes âgées et ne reçoivent donc pas les services appropriés à leur âge et à leur condition.
The Chair: Ms. Prévost, I'm going to have to stop you now.
We're very tight on time, and there's been so many witnesses that were put forward today, that we might run out of time for everyone to have equal time to ask questions. So I'm going to have to downsize the question and answer time to three minutes each, because we have the University of Calgary and Rebecca Cooney yet.
We're going to go to Samuel Weiss.
Is it Dr. Samuel Weiss?
Dr. Samuel Weiss: Yes, it is.
The Chair: Yes.
Five minutes, please, and I'll be very tight on the time. Thank you.
Dr. Samuel Weiss: Thank you very much.
Thank you for the opportunity to speak today. I'll keep my comments brief.
I am a neuroscientist and a stem cell biologist, and Director of the Hotchkiss Brain Institute at the University of Calgary. The mission of the institute is to translate discoveries into innovative health care solutions for patients and families with neurological and mental health conditions.
My research in stems cells in particular has been relevant to the development of new novel therapeutics, and, over the past five years, some of the work that we have done in very fundamental, basic research is now being tested in patients, for stroke in particular, but we also have some of our work that is being proposed for testing in MS patients sometime in the next 12 to 24 months. All of this work revolves around using safe compounds to try to activate people's own stem cells to improve neurological function. I should say, however, that it takes somewhere between 12, 24 to 48 months before some of the very basic fundamental findings are tested in small numbers of patients to ensure two things: one, that they are safe; and second, to ensure that they have a prospect of improving people's lives.
All of the individuals that I know, including the patients that come to our clinics, the families of our patients, including individuals throughout our communities, are affected by neurological and mental health disorders, which is why it's absolutely critical that the federal government make important strategic, carefully thought-through investments in research, both basic, fundamental, and applied research. I applaud this committee and this subcommittee for tackling this very important issue.
I can't speak with great knowledge about CCSVI, and you've already heard from many experts about it. The only thing that I can say is that in many cases like this it is very important that there is careful research before patient populations are subject to new treatments that have not yet been proven to be effective.
I think that, from what I understand, from both the MS Society of Canada, and the U.S. MS Society, there had been a call for proposals and there will be announcements of funding for new studies imminently, there will be cooperative studies throughout North America to test the validity of this diagnosis as well as experimental treatments. I think it's also important to note that one of the leading MS centres in the United States, Stanford University, halted any further CCSVI treatment because of the unfortunate death of one patient, as well as the heart attack of one of the other patients. This speaks to the importance of very careful considered research, both at the basic and clinical level, to ensure the best for all individuals, patients, and families throughout Canada when there are new therapies such as CSSVI.
Thank you, Madam Chair.
The Chair: We'll now go to Rebecca.
Ms. Rebecca Cooney: Canada gave the world insulin, mobile blood transfusion and the Montreal procedure, a surgical treatment for epilepsy. Back then, the barriers were the frontiers of medicine. Today, they're between the specialities of medicine. We are up against myths and self-serving practices. Fortunately, there's a solution. Venograms and venoplasty are already insured services under the Canada Health Act, so let MS patients have access to them now.
Je m'appelle Rebecca, co-fondatrice de MS Libération, un regroupement de 350 personnes atteintes de sclérose en plaques. Merci de bien vouloir entendre nos préoccupations et nos propositions.
All Canadians with vascular problems can be tested and treated in Canada unless they have MS. Since I'm diagnosed with CCSVI my family doctor has recommended I see a vascular specialist but none will see me without a referral from my neurologist who just in turn won't do it. Why? Treatment of CCSVI is held to the myth of risk-free medicine. What's the reality?
In 2007 the British Medical Journal analyzed 2,500 common medical treatments and found that only one-third had proven benefits. The Montreal procedure for Epilepsy was implemented without double-blinded trials. Angioplasty was accepted as the safe and economical way to treat coronary disease, without clinical trials. If I had heart disease I could get angioplasty without a neurology referral. Why is CCSVI held to a different standard.
There is also the myth that the treatment of CCSVI is experimental. In fact venoplasty used for thrombosis of the jugular vein and sigmoid sinus. Another myth is that there are conventional drugs for people with progressive MS. There are no drugs. Still another myth is why fix something that is not proven to help MS. The plain answer is that better blood circulation improves health MS or no MS and the goal is to treat the patient not just research MS.
Je ne suis pas médecin, mais j'ai une MBA de l'UQAM et 15 ans d'expérience dans l'évaluation des risques. En décidant s'il vaut mieux attendre ou agir dès maintenant contre l'insuffisance veineuse, nous devons évaluer trois facteurs, les risques, les coûts et les bénéfices.
The risk of venoplasty is minimal. It has been performed very safely for many years on thousands of people. Conversely the medical risk of existing drugs for MS are well known.
The cost to test and treat CCSVI are minimal, estimated to be $1,500 per person, less than the costs of one month of drugs for a patient with Relapsing Remitting MS.
The benefits of venoplasty are the most encouraging yet for MS. Venoplasty actually improves the condition of some patients, something that MS drugs rarely do. It stops the progression of the disease in some patients. Something no MS drug does. For people with Progressive MS it is the only safe option available. There are no drugs for Progressive MS.
Resources must be deployed strategically. The MS Society has asked for $10 million. Since their competition does not cover researching the treatment of CCSVI only the testing I have serious concerns that I will leave unsaid.
What I will stress is that immediately the Government of Canada can:
1) declare CCSVI diagnosis and treatment insured services under the Canada Health Act.
2) require that all CCSVI data be documented in a national-wide clinical trial.
3) ensure that treatment of CCSVI and clinical studies be done in parallel not in sequence.
Il y a quatre ans, la sclérose en plaques a mis fin à ma carrière. Voici ce qui s'en vient. La chaise roulante, l'incontinence, des maux de tête débilitant, l'incapacité d'avaler, la démence. Mais les courriels que je reçois de partout me rappelle que je ne suis pas seule.
For every patient there are scores of friends, family and relatives deeply affected. One email from a mother stands out:
The only thing worse than not having a treatment for your child's MS, is knowing that there is a treatment out there, but you are denied access to it by your own government.
Ladies and gentlemen, you can change that. For that I thank you in advance.
The Acting Chair (Mr. Patrick Brown): Thank you for all of the witnesses today that took the time to share their presentations with us.
If I could ask the committee for some direction. We have 10 minutes left in our scheduled time which would only allot three minutes per round. If there is consensus would we be willing to stay 10 or 15 minutes longer so that we could have a 5 or 7 minute round?
M. Luc Malo (Verchères—Les Patriotes, BQ): Ce n'est pas vraiment [inaudible]
The Acting Chair (Mr. Patrick Brown): It's not possible for Mr. Malo.
Mme Carol Hughes (Algoma—Manitoulin—Kapuskasing, NPD): J'aimerais simplement dire qu'on pourrait passer à des tours de 3 minutes et si on a le temps pour en faire plus, on en fera plus.
The Acting Chair (Mr. Patrick Brown): A three-minute round would be very tight though. I'll just warn you. If Mr. Malo went first and we did five-minute rounds it would only take us to 12:10. Is that agreeable?
Is that okay, Ms. Duncan?
We will start off with Ms. Duncan, for five minutes.
Ms. Kirsty Duncan (Etobicoke North, Lib.): Thank you, Chair.
Thank you to all of you for coming.
I am concerned, as a former research scientist, about the uni-disciplinary thinking we've had around this today. This is being treated strictly as a neurological problem. I believe what Dr. McDonald is asking, what patients are asking, what my colleagues are asking, is that we take MS out of the equation. If you have a vein problem in your liver, in your leg, we image and we treat it, and since there was discussion about the science, Dr. McDonald, I'm wondering if you can talk to us about the science of CCSVI. Is it a recognized condition? By whom? What are the guidelines for diagnosis and treatment?
Dr. Sandy McDonald: There are 47 countries in the world that recognize CCSVI as a true entity. Concerning the science, Dr. Zamboni did a study. He looked at 65 patients and found that many patients with MS had significant venous anomalies. He treated 65 patients and many of them saw significant improvement in symptoms.
I read his paper. I realize what his paper says. I, however, also spent several days with Dr. Zamboni and he subsequently has done a total of 130 to 135 patients, finding there is significant improvement in the symptom complex in these patients.
The science is also supported by the work of Dr. Simka in Poland, who has done upwards of 300 patients, similarly finding improvement.
If you take the study to Stanford University, Dr. Dake did 40 patients. With those 40 patients he was doing a different procedure. He was actually stenting the veins in the patients, which is not supported by Dr. Zamboni or his work. He does not stent or believe in stenting. The problems that Dr. Dake encountered were stent problems. That is the stent migrated and resulted in a cardiotomy, and the other problem was a post-op stroke that the patient's family denies had anything to do with the procedure itself.
Ms. Kirsty Duncan: Thank you, Dr. McDonald.
Why do you think that MS patients are being discriminated against, i.e. not receiving a venoplasty for a venous abnormality?
Dr. Sandy McDonald: At present a lot of institutions have adopted a wait-and-see protocol, wait and see what everybody else does. They don't want to go out on a limb and be the first doing a procedure even though it may be very beneficial for the patient. It is fear of being procrastinated against by the medical society as it exists at present.
Ms. Kirsty Duncan: Do you think it would be fair for every MS patient across this country to be imaged for CCSVI?
Dr. Sandy McDonald: I believe everybody with MS should be imaged. The cost of doing the procedure is small. The problem, however, is the number of people who are adequately trained to do the duplex imaging of patients with CCSVI is small. There are currently three technicians trained in Canada by Zamboni to do the procedure. There is a fourth who lives in Niagara Falls and works in Buffalo. That's it. That's all you have.
Unless they follow the very rigorous protocol set up by Dr. Zamboni they'll get spurious results. What needs to happen is people need to be trained by someone who is very good at it, as is Dr. Zamboni, and then they can proceed and do the studies and actually have reproducible, reliable data. If they just read the book and say “This is how you do it”, they will do a flawed study and the research will be useless.
Ms. Kirsty Duncan: Dr. McDonald, who will make the decision whether or not to image for CCSVI in Canada? What are the criteria which have to be met? What timeline are we looking at? What is stopping you from performing this procedure today?
Dr. Sandy McDonald: The difficulty with imaging is that it's not believed by all the people who look after MS that it is useful. Many people do not believe that treating the jugular vein or the azygous vein will actually improve the symptom complex, and on this basis, different bodies are actually telling us that we can't do it. For instance, in Quebec, the college said that they didn't think that we should be imaging for CCSVI in patients. Why, I don't know. Why the decision was made, I don't know but I believe that decision came down roughly a week ago.
Ms. Kirsty Duncan: I think it's outrageous that someone who has a venous abnormality, if it occurred anywhere but in the neck, it would be treated. How do you feel about that?
Dr. Sandy McDonald: I don't understand the resistance of the group treating MS patients not to address it as a problem. I understand there must be science and I understand the 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 that 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 a compassionate grounds, otherwise they're going to die with their disease with a possible treatment at hand.
The Acting Chair (Mr. Patrick Brown): Thank you, Ms. Duncan.
M. Luc Malo: Je voudrais simplement ajouter un commentaire à la suite de la liste de témoins qui nous a été présentée. Essentiellement à propos de l'IVCC, des patients, un médecin et des spécialistes nous disent qu'il faut aller de l'avant.
D'autres nous disent que l'état de la science actuelle ne nous permet pas d'aller de l'avant, mais tous s'adressent à Santé Canada et on n'a aucun représentant aujourd'hui de Santé Canada qui pourrait être en mesure de venir nous expliquer pour quelles raison pour l'instant ce traitement n'est pas disponible.
Tout de même, je vais adresser ma question à Mme Prévost parce que dans sa présentation elle a énuméré deux points auxquels elle souhaitait s'inscrire dans le débat, mais elle n'a eu le temps que d'en présenter un. Par conséquent, Mme Prévost, pouvez-vous s'il vous plaît revenir au deuxième point que vous vouliez soumettre au comité?
Mme Nadine Prévost: Parfait, merci beaucoup.
Je voulais dire un mot aussi sur les proches aidants. En fait, on sait que les proches aidants permettent à bon nombre de personnes ayant la sclérose en plaques de demeurer dans leur foyer et dans leur collectivité.
Je voulais simplement mentionner que les proches aidants qui arrêtent de travailler pour s'occuper d'un proche sont pénalisés actuellement et ils perdent leur revenu lorsqu'ils quittent leur emploi. Ils risquent aussi de voir diminuée leur future pension de retraite.
C'est pourquoi on souhaiterait à tout le moins que le conjoint soit admissible au Crédit d'impôt remboursable pour aidant naturel du gouvernement du Québec. C'est le dernier point dont je voulais parler.
M. Luc Malo: Sauf erreur, Mme Prévost, les revendications de votre présentation sont essentiellement liées aux responsabilités du gouvernement du Québec. Est-ce que je me trompe?
Mme Nadine Prévost: Non, vous ne vous trompez pas.
En fait, plusieurs sont liées aux recommandations nationales, mais ce sont aussi des dossiers de juridiction provinciale. Vous avez raison.
M. Luc Malo: Je vous remercie beaucoup.
Je lance la question à l'ensemble des témoins parce que je sais que leur présentation a peut-être été écourtée. S'ils veulent soumettre des éléments supplémentaires ou complémentaires au comité, je serais prêt à leur laisser le reste de mon temps pour qu'ils puissent poursuivre ou terminer leur présentation.
The Acting Chair (Mr. Patrick Brown): Thank you, Mr. Malo.
If there is anyone that requires additional time, they finished their testimony. As Mr. Malo has suggested, they might have been cut off.
Ms. 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, that it will take away from doing clinical trials which is totally false, because first of all trials are usually very small, up to 100-200 people, so what happens to the rest of the 74,000 other MS patients?
The second thing is trials don't include people usually in the progressive forms of MS very often, sometimes they do. But very few times they don't.
Third, a lot of people with MS who have had MS for more than a certain number of years are excluded. People with other chronic conditions, like I have Crohn's disease as well, I would never be even eligible for a clinical trial. So people very often will say 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.
Ms. 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. And 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: May I just add in, I was going to continue in, I am actually a great believer on spending money--
The Acting Chair (Mr. Patrick Brown): If you could please identify yourself for the benefit of the committee.
Dr. Samuel Ludwin: This is Dr. Ludwin from Kingston.
...On spending money to do the studies as we requested the federal government to do and as the National MS Society in the United States have done. I would make a plea however that these studies do get carried out before, it may be very counterproductive to what Dr. MacDonald would like to do, is that if they are studied, if they are allowed to go without the studies, we will have a proliferation of many people who unlike Dr. MacDonald may have not been properly trained and who will be doing them willy nilly. I would encourage Dr. MacDonald 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. Zambonie and from Buffalo as well.
A study that we are proposing will 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 (Mr. Patrick Brown): Okay, thank you Mr. Ludwin, we need to move on to Ms. Hughes now.
Mrs. Carol Hughes: Thank you. I think this is turning out to be a very controversial treatment and I don't think it needs to be that. I do have friends that suffer from MS and I do have a friend of mine whose son passed away very quickly from MS, I think within a year, so we do know how important it is and Dr. MacDonald, certainly I know how passionate you were during your speech and I think it speaks volumes on what needs to get done right now. I'm just wondering, because of the way the treatment is currently being issued for other reasons, you know the chart, the liver, the blockage itself, the narrowing, I'm just wondering with the procedure itself, what the percentage of complications right now 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. Diggs series in Stanford. He is using stents. Zamboni says don't use stents and I know that because I talked to him about two weeks ago.
Mrs. Carol Hughes: I'm actually talking about the other procedures that are being used for. There are thousands of times that this procedures been used, so what has been the risk factor in 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 that for possibly Budd-Chiari Syndrome. A venous angioplasty in a low pressure system carries with it very little risk of leak, because again, you are 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, and the walls of coronary arteries are no thinker in most instances in the walls of the veins we are treating with veno-plasty, so the risks are very, very small.
Mrs. Carol Hughes: Before I move on to the other questions, does anybody else want to jump in here, those who were on teleconference?
The other question or comment that I want to make is with respect to, I understand the difficulties with the MS, I don't particularly live it myself and I think it is easier for us who are not living it to say we need more research on this, but obviously what has transpired here and the urgency, I think there is a need for us to move forward and to do it in conjunction with a research study. I'm just wondering. This here, CCSVI, I believe would also assist in eliminating some of the stresses on the health care system and I am just wondering, 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 at you as well, just because we've had to deal with this at one of my offices and it happened to be with cancer, where a certain medication for a certain cancer could only be used for this here, 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 that unless we asked for ministerial discretion, which we got. So what is the difference with this here?
Mme Rebecca Cooney: En terme de coûts, j'ai fait une analyse financière des coûts des drogues pour la sclérose en plaques vis-à-vis si on avait cette procédure.
What we found is that if it basically halts the progression for even 20% of the people with MS, Canada would save millions of dollars, if that is the case. Now, that is a hypothesis and it has to stop.
However the people who have had the procedure, and I've talked to dozens of them, basically say that they have not progressed since they've 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 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. May I just add 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 in the relapsing-remitting disease.
The second thing is many of the patients, my understanding is and I stand to be corrected, have been continued on their regular medical therapy, many of which have been shown to have an effect on relapsing-remitting, very similar to that as being described by CCSVI.
I think it clouds the picture a little bit, when we—
The Acting Chair (Mr. 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 to have 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 give 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 this is a safe procedure, you have to have a sample size of 1,500. I wanted to see what you think would be a fair sample size to have confidence in the safety of this procedure.
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 was looking 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, i.e. medical management, of carotid artery pathology resulted in strokes, and if we operated the patient seemed to have significantly less 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 regress just for a second, if I may, about cost. Now I'll allude specifically to one patient we treated. His name is Steve. He was virtually unemployable because he had so much fatigue. He got his angioplasty done. Since he 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 he is saving the taxpayer $4,000 a month.
The Acting Chair (Mr. Patrick Brown): What do you think the cost of the procedure would be, just to give us context?
Dr. Sandy McDonald: The cost to the hospital, without staffing and without paper costs, we tallied up the costs from the six patients we did, and a cost per patient for the study done was about $450. You then have to add the costs of the technicians, radiologist, paper costs, admitting costs and all that nonsense. On that basis, I've been quoted as saying the cost is $1,500 because I like to leave a margin. I've no idea what the costs of putting a patient through a hospital system is.
There's one caveat, though, where the cost can go up, and 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. A standard cost for the actual high-pressure angioplasty device is $189.
The Acting Chair (Mr. Patrick Brown): There's been some concern expressed by neurological doctors. If I could also give you the opportunity, what is your response to neurological doctors who may have expressed some concern?
Dr. Sandy McDonald: I've heard a lot of wait-and-see. If everybody takes the wait-and-see venue, we'll never go anywhere. Somehow we have to get, hopefully, this committee to say to the government, “This is a real disease. We really need to treat it because people are hurting.”
Physicians know how to treat it. Patients want to be treated. We're being blocked from treating it, and I have no idea why.
The Acting Chair (Mr. Patrick Brown): You're in a very unique position, Dr. McDonald, in the sense that you've actually treated patients with this procedure. And I understand that you've actually done it at your own expense. I understand you've treated six patients. Have there been any complications? And what have you learned from the treatment that you have engaged in so far?
Dr. Sandy McDonald: There have been no complications to treatment.
I'll give you a really nice example. A 23-year-old kid can't feel his left arm or left leg. He gets an angioplasty done, and he's gets feeling back in his left leg and his left arm. He's living in a house with an elevator because he can't go up and down the stairs. A week later he tells his mom and dad he's moving out of the house and into an apartment with his girlfriend because he doesn't have MS any more. The procedure works. We have to allow patients to have the procedure.
The Acting Chair (Mr. Patrick Brown): I've got one minute left on my time. So Dr. Murray, I know you wanted to say something, as well.
Dr. T. Jock Murray: I know that the neurological community is purveyed as being skeptical. Not that we object to the fact that this is an important issue to be addressed, but we recognize that anecdote is not strong evidence in medicine any longer. There are accepted ways to analyze benefit in any treatment.
One of the reasons neurologists have a concern--and they have a concern--is what Dr. Zamboni published, not what the media has been saying or the stories that we have heard. Dr. Zamboni published results in 65 cases. There were relapsing-remitting patients, secondary progressive patients, and primary progressive patients. His results, after 18 months.... He indicated in his paper that the relapsing-remitting patients, if their veins stayed open, got some benefit. But those patients whose veins collapsed did not get benefit. The secondary progressive patients did not get benefit. The primary progressive patients did not get benefit.
The Acting Chair (Mr. Patrick Brown): Unfortunately, Dr. Murray, we are out of time. I have to cut my round off; otherwise, I'll have taken longer than anyone else. I don't want to do that.
Thank you, everyone, for coming today. This has been very informative. Thank you so much for taking the time to share your experience with us.
Mrs. Carol Hughes: Can we just say that if they have anything to add, they should send it in.
The Acting Chair (Mr. Patrick Brown): That's a very good point, Ms. Hughes.
If you have any research that you could pass on to the committee as we develop this national strategy... on the brain, our study on neurological disorders, it would be much appreciated. And thank you again for your time.
The meeting is adjourned.