Subcommittee on Neurological Disease Committee on May 11th, 2010

[Dr. Samuel Ludwin]

Certainly. What I would like to do is end up with what the importance of the CCSVI is.

The CCSVI is an extraordinarily interesting, novel idea, and in fact the Multiple Sclerosis Society of Canada 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 on both a clinical and an experimental ground.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Ludwin.

I know you were asked to come here, but could you please provide documentation and send it to the House of Commons clerk here, so that 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, Conservative, Joy Smith]

Thank you. That would be just fine. And thank you for your presentation.

We'll now go to the Multiple Sclerosis Society of Canada, Nadine Prévost.

You'll have five minutes, Nadine.

[Nadine Prévost]

Thank you for giving me the opportunity to talk about the concerns of Quebeckers with multiple sclerosis.

The Quebec Division of the Multiple Sclerosis Society of Canada has over 8,000 members. For over a decade, it has been working on raising awareness of the needs of people with multiple sclerosis.

Our office is in Montreal. There are also 25 local chapters across Quebec. There are an estimated 13,000 to 18,000 people with multiple sclerosis in Quebec. Quebeckers are fortunate to have a strong network with 16 multiple sclerosis clinics that ensure medical follow-up. Five of the clinics also conduct research.

The Quebec division offers a number of services. We provide reliable information on multiple sclerosis, treatment options and research. We offer various types of resources, such as publications, a Web site, a quarterly newsletter, information sessions for recently diagnosed people, conferences, an annual congress and a seminar for health professionals. We also provide a range of support services, such as support groups, moral support, referrals to other resources in the community and advocacy. We also have a youth component, which includes a quarterly newsletter, a Web site and a camp for children with a parent with multiple sclerosis. In addition, we offer physical and recreational activities to promote wellness and break the isolation, and we lend equipment.

Today, I would primarily like to talk to you about the continuum of care and the needs of caregivers. Multiple sclerosis most often strikes young adults, and we know that living with this episodic and progressive disease requires frequent adjustments. The residential needs of those living with multiple sclerosis are varied, since the disease itself varies from one person to the next. Some people have to rely on their LCSC for in-home support services on an ad hoc or permanent basis. Others also have to modify their homes to make them accessible.

When people can no longer safely remain at home, they are faced with some difficult choices. At this time, there are very few residential options that include a service component. Nursing homes are the only available option all too often. Therefore, some people have no choice but to move to a nursing home. There are cases of couples that had to separate after a few decades of living together because they did not have any other choice.

There are several possible solutions, among which are increased funding for home care and access to home adaptation programs within a reasonable timeframe. We would like institutionalization to be considered as a last resort and priority to be given to supporting people in their natural environment. The majority of people with multiple sclerosis would prefer to live in an environment that is similar to a traditional home with services and care.

In addition, we would like the development of other home resources to be supported, especially for young adults who can no longer remain in their living environment. That way, we would free up space in nursing homes for people in the final stage of life.

Finally, we would like the living environment approach to be integrated into nursing homes in order to create living conditions that are stimulating and mindful of people's specific needs.

We know of young adults in nursing homes that get lost in a sea of elderly people and so do not receive services appropriate to their age and condition.

[The Chair, Conservative, Joy Smith]

Ms. Prévost, I'm going to have to stop you now.

We're very tight on time, and so many witnesses were put forward today that we might run out of time for everyone to have equal time to ask questions. 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, Conservative, Joy Smith]

You have 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 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 or 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, that they have a prospect of improving people's lives.

All of the individuals I know, including the patients who 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 I can say is that in many cases like this, it is very important that there be careful research before patient populations are subject to new treatments that have not yet been proven to be effective.

From what I understand from both the Multiple Sclerosis Society of Canada and the U.S. MS Society, there has 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 CCSVI.

Thank you, Madam Chair.

[The Chair, Conservative, Joy Smith]

We'll now go to Rebecca.

[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.

My name is Rebecca Cooney, co-founder of MS Liberation, a group of 350 MS patients. Thank you for hearing our concerns and solutions.

All Canadians with vascular problems can be tested and treated in Canada, unless they have MS. Since I've been diagnosed with CCSVI, my family doctor has recommended that I see a vascular specialist, but none will see me without a referral from my neurologist, who in turn won't do it. Why is that?

The 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. Without clinical trials, angioplasty was accepted as the safe and economical way to treat coronary disease. 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 is 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: Why fix something that is not proven to help MS? The plain answer is that better blood circulation improves health, whether there's MS or no MS, and the goal is to treat the patient, not to research MS.

I am not a medical doctor. But I do have an MBA and 15 years of experience in risk assessment. Before deciding whether to wait or act now regarding CCSVI, we need to assess three things: risks, costs and benefits.

The risk of venoplasty is minimal. It has been performed very safely for many years on thousands of people. Conversely, the medical risks of existing drugs for MS are well known.

The costs to test and treat CCSVI are minimal. It's estimated to be $1,500 per person, less than the cost 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, which is something that MS drugs rarely do. It stops the progression of the disease in some patients, which is something that 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 and only covers the testing, I have serious concerns that I will leave unsaid.

What I will stress is that immediately the Government of Canada can, one, declare CCSVI diagnosis and treatment to be insured services under the Canada Health Act, two, require that all CCSVI data be documented in a nation-wide clinical trial, and, three, ensure that treatment of CCSVI and clinical studies are done in parallel, not in sequence.

Four years ago, multiple sclerosis ended my career. Here are some of the things the future holds in store: a wheelchair, incontinence, debilitating headaches, the inability to swallow, dementia. However, the e-mails I receive from all over the world remind me that I am not alone.

For every patient, there are scores of friends, family, and relatives deeply affected. One e-mail 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, Conservative, Patrick Brown]

Thank you to all of the witnesses who took the time today to share their presentations with us.

I would ask the committee for some direction. We have ten minutes left in our scheduled time, which would only allot three minutes per round. If there is consensus, would we be willing to stay ten or fifteen minutes longer so that we could have a five-minute or seven-minute round?

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

That is not really possible.

[The Acting Chair, Conservative, Patrick Brown]

It's not possible for Mr. Malo.

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

I would just like to say that we could proceed with three-minute rounds. If there is still some time remaining after that, we can keep going.

[The Acting Chair, Conservative, 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.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Chair.

Thank you to all of you for coming.

As a former research scientist, I am concerned about the unidisciplinary 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.

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. In terms of 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. However, I 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. He was doing a different procedure with those 40 patients. He was 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.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Dr. McDonald.

Why do you think 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.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

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 do the studies and have reproducible, reliable data. If they just read the book and say this is how to do it, they will do a flawed study, and the research will be useless.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Dr. McDonald, who will make the decision whether or not to image for CCSVI in Canada? What criteria 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 improve the symptom complex, and on this basis, different bodies are telling us we can't do it. For instance, in Quebec, the college said they didn't think 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.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

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?