Standing Senate Committee on Social Affairs, Science and Technology

THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY

EVIDENCE


OTTAWA, Thursday, October 4, 2012

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:30 a.m. to study Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVI).

Senator Kelvin Kenneth Ogilvie (Chair) in the chair.

[Translation]

The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.

[English]

My name is Kelvin Ogilvie, I am a senator from Nova Scotia, chair of the committee. I will ask my colleagues to introduce themselves, starting on my right.

Senator Seidman: Judith Seidman, from Montreal, Quebec.

Senator Enverga: Tobias Enverga, from Ontario.

Senator Seth: Asha Seth, from Toronto, Ontario.

Senator Martin: Yonah Martin, Vancouver, B.C.

Senator Day: Joseph Day, from New Brunswick.

Senator Peterson: Rob Peterson, Saskatchewan.

Senator Merchant: Pana Merchant, Saskatchewan.

Senator Eggleton: Art Eggleton, Toronto, deputy chair of the committee.

The Chair: We also have Senator Percy Mockler, from New Brunswick.

Thank you, colleagues. Just before I welcome our witnesses and introduce them, I want to remind everyone that this is meeting 1 regarding Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency, or CCSVI. The purpose of today's meeting is to provide the committee with an overview of Bill S-204 and current federal initiatives related to multiple sclerosis.

We have two panels this morning, colleagues. I am certain this will be a topic of great interest to everyone on the committee. The first panel will end at 11:30. The second panel will end at 12:30. In the event that all senators on the list have not had their questions answered, I will get them on the record and ask the witnesses to provide written comments subsequently. All questions will be important and we want to have the answers available to the committee. That will ensure that no question goes unanswered, as long as the witnesses are willing to provide an answer.

In that case, then, I am very pleased at this stage to welcome our witnesses, one of whom is in two capacities with regard to this committee, the Honourable Senator Jane Cordy, who is the sponsor of this bill.

Welcome, Senator Cordy, in this capacity.

Hon. Jane Cordy, sponsor of the bill: It is unusual to be at this end of the table, chair. Thank you.

The Chair: I also want to welcome Kirsty Duncan, Member of Parliament for Etobicoke North. I will open the floor to you for your presentations and subsequently to the committee for questions.

Kirsty Duncan, Member of Parliament for Etobicoke North: Mr. Chair, I want to begin by making it clear that politics has been played with the lives of 55,000 to 75,000 Canadians living with MS for two and a half years. The government has grossly mishandled the CCSVI file and I would draw your attention to investigative journalist Anne Kingston's article The silent treatment and her most recent blog, Finally, CCSVI clinical trials. So why is everyone so pissed off?, for details.

I therefore have a motion on the Order Paper calling for the House of Commons Standing Committee on Health to investigate. In May 2010, the Minister of Health ignored my colleague, the Member of Parliament for St. Paul's, and me when we wrote an open letter asking for clinical trials for CCSVI and the registry. The minister then ignored the leading experts in the world on CCSVI, who asked for clinical trials at the Subcommittee on Neurological Diseases I founded. A registry was then denied in 2010 because it was "outside the mandate."

The government then failed to invite the leading international experts in CCSVI to the August 26, 2010 meeting. However, it did invite those who publicly criticized the validity of CCSVI despite their bias. The government failed to attend international scientific conferences, failed to undertake site visits to labs and operating theatres, and blindly accepted a handful of studies. The government failed to review a large body of research regarding vascular links to MS extending back to 1839.

By the time of the August 2010 meeting, eight provinces and territories were pushing for action on CCSVI, yet behind closed doors at the meeting there was a unanimous decision not to undertake clinical trials despite the fact that both the presidents of the CIHR and Multiple Sclerosis Society were present and had previously advocated for them. The process failed Canadians with MS and failed to meet the standards of the Canadian health system.

The government then put in place a scientific expert working group with no scientific expertise or experience in CCSVI, which did not even declare conflicts of interest until I pushed for it, which did not even undertake a comprehensive literature review until I pushed for it, and analyzed interim and final results from seven Canadian and U.S. MS societies’ funded studies, for which we already had answers.

In March 2011, 10 months after our initial request, the government reversed its position and announced a registry for MS. The registry was to start in July 2012, then September 2012, and still we have no registry.

Since when do scientists fail to collect data? It is wilful blindness.

Before my bill, C-280, had its second debate in the house, I again invited all MPs and senators from all parties to attend a breakfast on February 14 with leading doctors treating CCSVI. I do this because this is a non-partisan issue. It is a humanitarian issue.

On February 9, the fair and balanced "MS Wars" aired on "The Nature of Things." It included testimony from Dr. Gianfranco Campalani, a vascular surgeon who has seen marked improvements in his MS symptoms following treatment and who said it is unethical for doctors to deny treatment to those with CCSVI.

The very next day, on Friday, February 10, the Minister of Health appeared to go into damage control and announced a briefing on MS at 5:30 on February 13 to pre-empt my breakfast on February 14 by a mere 14 hours with, according to a leader of one political party, the sole purpose of killing my bill, Bill C-280.

On February 17, the minister then sent a letter to all MPs attacking my bill. On February 27, just two days before the vote on my bill, the President of the Canadian Medical Association suddenly decided to oppose the bill in a letter. It was extremely odd, when Senator Cordy's bill had been in the Senate since June and my bill had been in the house since September.

Bill C-280 was defeated by a mere six votes on February 9. The Minister of Health used the letter to sway her Conservative colleagues and supporters of the bill at caucus on the morning of February 29. When I invited the President of the CMA to meet with Senator Cordy and me on March 6, he had no idea how he came to write the letter of February 27, had no idea three safety studies involving over a thousand patients had been done, had no idea regarding the challenges of follow-up care in this country, and admitted that lack of care was wrong and that CCSVI was being treated differently than other new medical treatments such as kidney denervation.

Today, all we have is an announcement for clinical trials and a registry, although as of last week we actually have a start date for recruitment for a small Canadian clinical study. Let us be clear: The reason for last week's announcement was more politics with the lives of Canadian MS patients to shut down debate on this bill.

I wish I could continue to detail the failures of this government regarding the CCSVI file, including not allowing those living with MS to present at this committee. It is appalling that if this country is committed to patient-centred care, those who suffer with MS are being denied the opportunity to orally testify in front of this committee and that you have given me only seven minutes to make my plea for science, not politics, in the lives of Canadians.

This bill calls for much more than the government has announced regarding clinical trials. Today there is no national strategy for CCSVI as this bill calls for. Today there is no proper health care for a person following treatment as this bill calls for. Patients are turned away from hospital, turned away from their doctors and told to return to the treating country. Patients are cancelled by their treating neurologists, have their appointments cancelled and have their driver's licence revoked should they dare pull out of drug trials.

Today, Canada is not at the forefront of research. Phase III trials are currently under way elsewhere. Today, the advisory panel is not composed of experts in diagnosis and treatment. Tragically, this debate was never based on the science it should have been, but rather wilful blindness, medical politics and collusion with special interest groups. This committee has the opportunity to finally do the right thing and act in the best interests of MS patients and ask tough questions, rather than read prepared questions meant to protect the government's position.

Canadians with MS are waiting. They are getting sicker and, in some cases, they are dying.

Senator Cordy: I am pleased to be here this morning with Dr. Kirsty Duncan, who is the MP for Etobicoke North and a passionate advocate for those living with multiple sclerosis.

About 75,000 Canadians live with the progressively debilitating disease multiple sclerosis. About 1,000 new patients are diagnosed every year. Canada's prevalence rate of MS is among the highest in the world.

The suicide rate for MS patients is a staggering seven times higher than the national average. This is a shocking statistic, and it is indicative of the hopelessness that many people with MS are feeling.

Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency, was brought forward to address the gaps in the treatment of MS patients in Canada. It would provide choices for MS/CCSVI patients. Chronic cerebrospinal venous insufficiency, or CCSVI, which is how I will refer to it in other parts of my speech, is a condition where the blood flow is restricted in the veins from the brain.

The bill calls on the Minister of Health to firstly convene a conference with provincial and territorial health ministers for the purpose of establishing a national strategy. The national strategy would ensure that all provinces and territories would provide similar support and resources to MS patients.

Currently, Saskatchewan and Yukon have clinical trials for those who have been diagnosed with CCSVI. The patients from Saskatchewan and Yukon travel outside the country for the procedure. New Brunswick provides funds to patients who travel outside the country for treatment. Sadly, we seem to be promoting medical tourism here in Canada. It is imperative that the federal government take a strong leadership role so that MS patients, no matter where they live in Canada, have access to the same level of care.

Bill S-204 also calls for tracking of individuals who have received the venous angioplasty treatment for CCSVI, whether or not that treatment was in Canada. In March of 2011, the government announced that a registry would be started in July 2012 to do just that. The date was then changed to September of 2012, and here it is October and still no registry.

Eighteen months have passed since the registry was announced. We have missed out on a year and a half of collecting data about Canadians who have MS/CCSVI and who have been treated. About 400 MS patients die every year. That is about 600 patients who have died since the registry was announced. Almost 1,500 new cases of MS have been diagnosed since March of 2011, when the announcement of the registry was made, and still no registry to collect data. It appears to be a case of wilful blindness — little data, so little action.

As the bill states, we should have the information:

. . . to ensure the accumulation of knowledge relating to the treatment’s efficacy, its effect on the individual’s quality of life, the duration of that effect, the need for any repeat treatment for CCSVI and whether there were any side effects or risks that should be considered in future decisions to provide that treatment;

Canadians with MS and CCSVI deserve this information to help them make informed choices about their care. Health Canada should also be eager to have this data.

Bill S-204 also wants to ensure that proper follow-up care is not refused to a person who has had the procedure for CCSVI outside of Canada. Unfortunately, the stories that Dr. Duncan and I have heard about MS patients who have received the procedure and who have been refused treatment is scary. You have heard the story of Roxane Garland, who died this past summer at the age of 37. Senator Jaffer spoke about her in the Senate chamber earlier this week. She was turned away for a specialized scan to determine her medical needs. She contracted a bladder infection and other complications and was later admitted to the hospital, where she died. Her obituary contains these words:

Rocky would want people to keep on trying to get CCSVI treatment available in Canada and, more importantly, the follow-up care that she so desperately needed but could not attain.

I attended a meeting of the national CCSVI society in Okotoks, Alberta, last weekend. Unfortunately, I heard too many stories about patients who were refused follow-up care. One specialist told his patient that he was disappointed in her. Why did she have the procedure done? He then told her that he would no longer treat her. Not getting follow-up care in Canada is deplorable.

A friend of my husband's had a heart attack in Florida. He was treated there and flown back in a medi-plane to Halifax for further care. He immediately was taken to the hospital from the airport. I fell in Romania last year and had a cast put on my wrist. When I returned to Canada, my doctor examined my wrist and sent me for further X-rays. Should it not be the same for MS patients?

There should be no discrimination. This is Canada. One of the pillars of the Canada Health Act is accessibility, which means reasonable and uniform access to insured health services and that no one may be discriminated against on the basis of income, age and health status. MS patients who have had the venous angioplasty treatment abroad are facing discrimination and lack of accessibility when they return to Canada.

I believe Bill S-204 will benefit the almost 75,000 people in Canada with MS.

On Friday, the government announced that recruitment for clinical trials would begin on November 1. This is a start. The first announcement for clinical trials was made on June 29, 2011, more than 15 months ago. Clinical trials will take place in British Columbia and Quebec, and perhaps later in Manitoba. The press release spoke of a "pan-Canadian controlled study." I am from Nova Scotia. Atlantic Canadians have been excluded from this clinical trial. Dr. Duncan is from Ontario. MS patients in Ontario have also been excluded. I do not think this is pan-Canadian. There will be 100 patients in the study, an average of less than 10 patients per province and territory. This is, I believe, a small sample for a country the size of Canada.

The clinical trials announced on Friday, September 28, are Phase 1, which is to determine the safety and efficacy of the procedure. There was a trial on the safety of the procedure done in Albany, New York, by Dr. Gary Sisken. Of the 257 procedures, half the patients were Canadians, so already over 100 Canadians have been part of a Phase I clinical trial on venous angioplasty. The scientific data is there. Why are we not starting at Phase II? We are repeating what has been done.

While we have to ensure that drugs and procedures are safe, it appears that the process in Canada has been extremely slow and that the government has made announcements and announcements followed by long delays. CIHR and the MS Society have spoken of lightning and accelerated speed for the process. I will let you decide on that one. The Phase I trial is expected to take about two years.

The federal government must take the lead to ensure that all Canadians are free to make choices about their health care. MS patients should be treated no differently. We need a national strategy on MS. We need the collection of data, and we need follow-up care for MS patients who have had venous angioplasty, whether performed in or outside of Canada.

Thank you. I look forward to any questions that that you may have.

The Chair: Thank you both very much. I will now open up the floor to my colleagues.

I remind my colleagues that the time is short, so if you could keep your preambles to a minimum and get right to the essence of the question, it would be greatly appreciated by your colleagues.

Senator Eggleton: Thank you very much, both of you, for being here. You have spoken passionately about the subject, and you are obviously very committed to this issue. Neither one of you are medical doctors, although Dr. Duncan has a lot of expertise that is world renowned. I wonder if you might tell us about the expertise that the two of you bring to this particular subject matter.

Senator Cordy: I am a regular person. I used to be a schoolteacher. I do not have a medical background. I have been in touch with hundreds of people who have MS, and they are desperately looking for help. I have researched and spoken with people. I feel passionately that they are being discriminated against in the country of Canada. That is why I am involved.

I had an email last night from a friend of my daughter's whose mother died of MS at a very young age. Lisa emailed me and said, "Thank you very much for what you are doing. If my mother were still alive, she would be proud to have you as an advocate." I guess I do not have to say anything else.

Ms. Duncan: Thank you, senator.

I am on leave from the University of Toronto as a Professor of Health Studies. I do not often talk about myself, so I will keep this to a bare minimum. I won the 1999 American Biological Safety Association Award for contributions to biological safety. I was Canada's lead author on the Intergovernmental Panel on Climate Change for my work on climate change and health. That panel shared the 2007 Nobel Prize. Most recently, I won an international award for my work on brain policy.

I would like to talk about our patients.

Since starting this in 2010, I am in touch with 2,000 Canadian MS patients from across this country. They have my personal email and my phone number. Since May 2010, I sleep with a BlackBerry by my bed for those calls that come at 3:00 in the morning, when people are suicidal.

I have tracked over 450 patients who have had the procedure. I am a scientist. Why did we lose the opportunity to track people at 1, 3, 6, 12, 24 and 36 months? As scientists, we do not "not" collect data. I want you to know that I have had 20 doctors write to me who have had the procedure and begged me to continue fighting for this. They are afraid to come forward — afraid for their careers. They say, "You have to continue fighting, because it works."

Senator Eggleton: Good answers from both of you. Thank you. You have developed a lot of expertise.

Last week, the minister announced the clinical trial Phase I. You both referred to it as beginning on November 1. Does it change anything in Bill S-204?

Senator Cordy: Bill S-204 is more than just asking for clinical trials, so we will obviously have to make amendments to the bill when it carries on.

It is unfortunate that the people in the MS community are feeling distrust of the government; it is unfortunate when people feel that way. When I was in Okotoks last weekend, I said we would be amending the bill and taking out the parts relating to clinical trials because they are starting. Many of them said to me, "Please do not take it out. We are nervous that unless it is in the bill, it will not happen." Having said what they have said to me, we know the bill has to be amended in some ways.

However, the bill calls for a national strategy. It should not be the case that people in Nova Scotia are treated differently than people in Saskatchewan or in British Columbia.

The choices should be there. Not everyone who has MS will choose to have the procedure done, but it should be an option. Not everyone with cancer will choose to have chemotherapy, but it is an option. We have to leave options open. If we are talking about people making choices for their health care, we have to give them the choices, other than simply taking pharmaceuticals. The bill asks for a national strategy.

The bill also asks for follow-up care. We have heard horrid stories. We heard the story of someone who had the procedure done in Poland. That person was back in Canada, went to the hospital and the doctor said to them, "Why do you not go back to Poland for your health care? I am not treating you here." They had to leave the hospital. We have had people who have had the treatment done and they are feeling great and do not want to be on the drugs. They were told by doctors, "If you come off your drugs, I am writing a letter to the provincial department of transportation to have your licence taken away from you."

Senator Eggleton: You have raised that question here before. You talked about the case of Roxane Garland and of people not getting treatment here. That is a serious issue. What do you suggest as an alternative? What do you suggest we do, or can be done, about people being refused treatment because they had this procedure done overseas?

Senator Cordy: The Canada Health Act, and I referred to it in my speech regarding accessibility, says regardless of your illness. This is discrimination against patients who have MS and who have decided to go outside of the country to have the treatment done. New Brunswick is giving people money to go outside the country. Saskatchewan has clinical trials taking place in New York. People are leaving and getting the procedure done and are coming back and not receiving care. That is wrong.

Ms. Duncan: I will pick up on follow-up care and why we need a national strategy.

You should be aware that on December 7, 2010, the President of CIHR assured the Subcommittee on Neurological Disease that, "No physician will refuse to see and treat them for complications of a treatment received abroad." I would therefore suggest that this committee should ask the president to table with this committee the follow-up care practices for each province and territory, and what protocol the federal government accepts. This committee should also ask why the Scientific Expert Working Group reported in one of the ATIPs I have that:

. . . media reports that have stated that Multiple Sclerosis (MS) patients who experience complications after Chronic Cerebrospinal Venous Insufficiency (CCSVI) treatment are not being seen by Canadian doctors are not justified.

What patients or patient advocacy groups were interviewed? What evidence was reviewed? What action was taken? We should all be asking this question: What was the action undertaken by the government to ensure that all patients receive follow-up care, including those with CCSVI and their treatment abroad?

I want you to know that there has not been one week since May 2010 that I have not had a call from a desperate parent, grandparent or spouse asking about follow-up care.

Why do we need a national strategy? We need it because we do have a Minister of Health. We do have a Canada Health Act. Since the government refused to lead and instead only responded, the President of CIHR is on the record as saying they did not see the crisis coming. Provinces took the lead. One province gives money to help patients get treatment overseas. Another province is shipping patients to New York. Ironically, the Saskatchewan people who are undertaking diagnosis of CCSVI for the New York study are trained by Dr. Sandy McDonald, the same doctor who approached this committee and has not been heard from; the man who has undertaken seven procedures of CCSVI on Canadians, who has two peer-reviewed articles on CCSVI; the man who has done duplex imaging on over 1,000 MS patients.

By abdicating national leadership, the government has created medical refugees, or medical hostages, in a turf war, and has turned health care for Canadians with MS into a war zone.

Senator Merchant: Welcome to both of you. I come from Saskatchewan, so I too have heard many stories from people who are phoning me. Saskatchewan has a very high incidence of MS, and it is for that reason that our provincial government undertook to have the trials done in Albany, New York. I believe most of the patients who are going through these trials are people from Saskatchewan, but they did interview over 800 people. I believe the cost to the province is about $2.5 million, though I am not exactly sure how much.

First, regarding the woman who has been mentioned, Roxane Garland, people say to me that we ought to hear from someone who has gone through this experience. I concur with Dr. Duncan that we need to hear from someone who has had patients and has followed this. I hope that we will get to hear from some of these people who are personally involved in this disease and treatment.

Can you tell me if there is an age demographic? You keep talking about suicides. Can you tell me what sort of people get MS?

Senator Cordy: We know that more women than men get MS, and we know that it tends to be younger people. Young adults tend to get it. I did hear last weekend that the age seems to be dropping, and I am not sure why. It is young adults who get it, and more women than men.

Senator Merchant: It is a disease that lingers on for many years. I have had friends who have had MS and eventually died, but they seemed to go on for many years, some of them decades.

Senator Cordy: In some cases, it goes on for many years. In some cases, as in the case of my daughter's friend, her mother was very young when she got it, in her 20s, and it progressed very rapidly. I spoke to a lady on the weekend. If you can imagine this, she and her mother were diagnosed within four months of one another. Her mother died within a few years, very quickly. She said that she was basically laying in bed waiting to die, and then she heard about the procedure and she travelled I think to Egypt — but I am not positive — outside of Canada, to have the procedure done, and her wheelchair is collecting dust in the garage.

Senator Merchant: I have also been told by people who have undergone this trial and have paid for it out of their own pockets that sometimes it is necessary to go out of the country more than once. Is that typical? What have you found? They make a big investment on their own because they need some resolution.

Ms. Duncan: They all have made big investments. I want you to know that I tackled this problem as I would any other scientific problem. I have paid out of my own money to travel to seven of nine international conferences on CCSVI. I have spoken as a scientist at them at well. I went to all the experts. I asked for their unpublished data. I have reviewed MRIs. I have watched the procedures. The government has not done that.

We have learned a lot in the last two and a half years. The question that the government asked was whether this is linked to MS. The question should have been, does this improve quality of life? People do not get better from MS. There are different kinds of MS. In the worst case, secondary progressive MS, there are no drugs. No drugs have ever made anyone better. I saw someone who had secondary progressive MS leave a wheelchair and walk. He has now left assisted living. He is now back working full-time.

I never want to hope-monger. I am a scientist. I am very clear. The results seem to show that one third significantly improve, one third moderately improve, and maybe a third not, but no drug has ever done that.

Senator Cordy: We know, as you said earlier, that people have had great expense. I have heard of people who have remortgaged their homes to travel outside the country. I have been part of community fundraisers where people are trying to raise money so they can travel outside the country. People have used up all their savings and have gotten money from friends and relatives to travel outside the country for the treatment.

You are right that the government does not have the data to say, "Does this have to be done more than once?" This is why the registry or the collection of data is so important. To be waiting for 18 months for the collection of this data is just very sad indeed.

Senator Peterson: Given the higher incidence of MS in Saskatchewan, I assume the provincial government has decided to move forward on clinical tests. Are they doing this unilaterally, in isolation? Is there any advice from the Government of Canada?

Senator Cordy: They are basically doing it on their own. When they came out with the clinical trials, it was before the Government of Canada was going to come out with any national clinical trials. I give full credit to Saskatchewan for doing that.

Ms. Duncan: Can I pick up on that? I really want to be clear.

By the time of that August 2010 meeting, eight provinces were pushing for action on CCSVI. The President of the MS Society had asked the government for $10 million for clinical trials for CCSVI in May of 2010. That money has not been provided. The President of CIHR was open to those trials. The provinces wanted it, and yet there is a unanimous decision not to go forward.

Again, we applaud Saskatchewan for actually doing the science. All we have ever asked is, do the science. We need that information.

As Senator Cordy pointed out earlier, we have had a safety study done in the United States. It was done by Dr. Mandato, et. al., with 240 patients. One hundred of those were Canadians. The safety study has already been done. The complication rate was about 1.6 per cent.

Senator Peterson: When Saskatchewan residents return after having this treatment, are they afforded health care or are they denied it?

Senator Cordy: They should be afforded health care because it is part of the Canada Health Act.

Senator Peterson: I understand that, but that was not the question. Have they not been afforded?

Senator Cordy: I am not sure what province the people I spoke with were from, but Roxane was from Saskatchewan, was she not?

Ms. Duncan: Yes.

Senator Cordy: She was not given health care when she returned.

Senator Peterson: Some are and some are not. We are suggesting we have a two-tiered health system in Canada.

Senator Cordy: I am telling you that MS patients have been discriminated against in the Canadian health care system.

Senator Seth: The topic we are discussing is very confusing and difficult. It is emotional. We see too many patients with MS.

I am reading that the Government of Canada has already announced that the safety and efficacy of this method of endovascular treatment for a person who has MS should be reviewed and a clinical trial is to be co-funded by CIHR and the Multiple Sclerosis Society of Canada. Once it has been approved through the research ethics, I think they are ready to promote the clinical trial. The most important part is that after going through this endovascular surgery for chronic cerebrospinal venous insufficiency, which we think is related to multiple sclerosis, we are not yet getting the results so well. The complications are really very high, from what I understand.

The Government of Canada is doing something and is in the process of trying to do more. Should we not just wait and see until we have gone through the trial phase, instead of sending our patients abroad and doing the follow-up? It really does not give us complete research as far as Canada is concerned.

Ms. Duncan: As you know, because you are a physician, time is of the essence when it comes to MS. Today is one year and ninety-seven days since the government announced clinical trials for CCSVI, and they have yet to begin. Since the announcement, there will have been three new MS diagnoses daily, for a total of almost 1,400 new MS patients in Canada. The 55,000 to 75,000 Canadians with MS will have worsened on average by one disability score, and some 530 Canadians will have died. One month can mean the difference between working and not working, walking and not walking, or living in care or not.

The government has said they will do clinical trials. We understand they will start on November 1. I want to point out again that in New York there has been a safety study involving 240 patients, over half of which were Canadian. The findings were that endovascular treatment is a safe procedure. There is a 1.6 percent risk of major complications. Why is Canada repeating a safety study with another 100 patients?

I want to be clear that there is real concern among doctors and patients about the potential negative bias that may be exerted on the trial. If the study is to be double blinded, all project investigators must be blinded. There should also be an arm's-length data safety monitoring board to review real-time, in an unblinded fashion, all adverse events and serious adverse events. It is critically important that the project investigators and radiologists and our surgeons receive appropriate training from individuals experienced in CCSVI diagnosis and treatment methodologies. This is really important. Many doctors say that it can take 60, 100, 200 or more procedures to become comfortable with it. There will be only 100 procedures, so we want them to be practised and competent. We want to make sure that the study also measures potential changes in quality of life.

Senator Cordy: Your question was this: Should we not wait? About 400 MS patients are dying a year. The suicide rate is seven times higher than the national average. Those are alarming statistics. A 1.6 risk of complications has been shown in the safety studies that have been done. I would say to you that when you look at the risk benefit analysis, you will find that the benefit is pretty high, probably much higher than many of the drugs that MS patients are taking. We are saying, and I said it earlier, that not every MS patient with CCSVI will say that they want the treatment — the same as not every person who has cancer will say they want chemotherapy. We want choices for MS patients who are living in Canada — that they have a choice other than taking drugs.

The Chair: I remind colleagues to be as brief as possible. We will attempt to get through the speaker's list, but I believe our guests agreed they would follow up with written answers to questions we get on the record.

Ms. Duncan: Absolutely.

Senator Martin: I thank both of you for your presentation today and the passion with which you speak. It is clear how invested you have been on a personal and professional level.

I have a few questions regarding clinical trials in other jurisdictions. Senator Cordy talked about the one that took place in Albany, New York. Have other jurisdictions also done the Phase I clinical trials? You have gone to conferences, but would you speak of other clinical trials that have been undertaken?

Senator Cordy: Ms. Duncan will probably answer that better than I. Health Canada and CIHR speaking frequently about how we are so far ahead; but we are not so far ahead. We are far behind many countries. Over 50 countries in the world are performing venous angioplasty, and clinical trials are taking place in many jurisdictions. I will ask Ms. Duncan to answer that question.

Ms. Duncan: This procedure is being undertaken in 60 countries around the world. By February 2012, 30,000 procedures had been undertaken. There is a growing body of literature, and published clinical studies show improvements in quality of life, improvements in fatigue, in the so-called "brain fog," and in bladder function. I would be happy to table that literature with this committee.

Senator Martin: I asked that question because we are doing a study on clinical trials. It seems very fitting to be looking at this specifically. You spoke of New York and both of you mentioned it several times.

Yesterday in committee we found out that we do not have a mutual recognition agreement with the U.S. We have been talking about how important it is to keep clinical trials in Canada. I am pleased to know we will be starting our own clinical trials. It will be important for Canadians to have them in Canada with the standards that we hold and the fact that we do not have one with an MRA. However, I hope that with your expertise you will be able to recommend some of the expert experience from what has happened in other jurisdictions so that Canadian clinical trials can be done with that much more efficiency and effectiveness. I think we are all waiting for such results. I am happy to know that we are doing our own because we have been talking about how important it is to have our own trials.

Ms. Duncan: May I address that, Senator Martin? The Member of Parliament for St. Paul's and I asked for this in May 2010. We believe in the science. We want to make sure this is a safe procedure. We want to make sure it is efficacious. We want to make sure the effect lasts a long time. Much has happened in two and a half years: 60 countries with 30,000 procedures. Why is our government ignoring those results? Why is the government wilfully ignoring the results of the studies? That should be a concern to everyone here. A clinical trial is being done in Saskatchewan through New York. That is one study. A second study involves 100 Canadian patients. Why are we repeating this? Do we not want Canada to be at the forefront of international research?

Senator Cordy: I am excited that Canada is starting clinical trials. It has been very slow, but we have been asking for it. This is part of the bill. I am excited about it, so do not get me wrong. Dr. Sandy McDonald from Barry, Ontario, was trained by Dr. Paolo Zamboni. He has performed the venous angioplasty procedure. He actually did it in Canada before he was stopped from doing the procedure. He is working with Saskatchewan where he is training others who are diagnosing to determine whether the MS patient actually has CCSVI. A very high percentage of them have the blockage in their veins, but not all of them. Dr. Zamboni is training people in Saskatchewan on how to diagnose it, and Dr. McDonald was not even invited to be part of the expert working group. That blows my mind. He is probably our leading expert in Canada, yet he was not invited. The expert working group is a whole other subject.

Senator Seidman: Thank you very much for your testimony. I dare say that no one around this table and no one listening to this committee would ever dispute the seriousness and the heartbreaking aspects of a disease like multiple sclerosis. There is no question that it is complicated and difficult to diagnose and treat. As with most neurological diseases these days, we lack the science to clearly move us forward in a satisfactory way. Initially, I had planned to go through the bill to know what you are proposing to see if we had made a significant amount of progress in achieving what you have put forward, given how things have evolved over the last 12 months and the announcement last Friday. However, instead I would like to address the science you referred to because it is particularly significant.

It appears that over the last couple of years an ever-increasing number of studies have shown less certainty about the relationship between MS and CCSVI. Also, there have been distinct alarm bells recently about the procedure, so much so that in May 2012, the FDA issued a news release that said: "FDA issues alert on potential dangers of unproven treatment for multiple sclerosis." In this news release, the FDA made it clear that injuries and death were associated with liberation therapy and the procedure, and that even though they are exploring a link between MS and CCSVI, the studies are inconclusive.

If I simply look at the studies that have been done in 2012, not even a full year, I see that five studies have been published. All five of those studies have shown that there is insufficient evidence to say that CCSVI is more prevalent in patients with multiple sclerosis. This year, four studies have been published on the surgical intervention. Of those studies, two of them have found very interesting things, both of them exactly the same. They are homogeneous, which is, as you know, in science, extremely important. What have those studies found? They have found that, in essence, the self-reported gains that occur after surgical intervention tail off after three months. The question then arises, is there a real gain or is it merely a placebo effect?

All this to put forward for your commentary, because you have presented what, to you, is a very definitive picture of enormous certainty. I am asking you to examine the evidence that is out there, because that is what science is all about. That is what medical science is all about. That is what people in Canada expect of us. They expect us to follow rigorous scientific procedure, so that we can indeed ensure Canadians' safety in medical treatment.

If the medical science world is saying to us, ever increasingly over the last two years, we are less and less certain about this procedure and, in fact, about the relationship between CCSVI and MS, how can we ask Canadians to accept this? Why would we not wait for medical science to come to some more definitive results? When peer review suggests that this procedure is appropriate and safe, then we would say, "Great."

The Chair: I am sure you are going to have a significant answer here and we are getting near the end. I will break into your response at some point to get the questions on the record from Senator Day and Senator Verner — and Senator Eggleton, I believe, has an additional question or two — so that, as you have agreed, you can follow up with the answers.

I am sure you want to get to this question. Would you, please?

Ms. Duncan: I want to be very clear. I have examined the evidence. I am a scientist. My whole career is science and I will not risk my scientific reputation.

While you address five studies, I tabled a very comprehensive list of the studies to CIHR. I sent them a letter of all the studies, by methodology, by diagnosis, by invasive treatment or not. I can provide a much greater list than the list you have provided. Science is about the balance of evidence, so we want to be as comprehensive as we can.

You brought up the FDA alert. It is very important to pay attention to. We all have to pay attention. I want to point out that that alert came from a non-peer-reviewed paper written in the U.S., and one of our expert members, Dr. Ruben, was the fourth author on that paper. He is an expert on our expert working group. I would like you to know he is on the record as saying that prior to serving on that group he had never seen an MS patient.

I want to finish by saying there is a real dichotomy between the way drugs are examined versus CCSVI procedure. Tysabri was fast-tracked by Health Canada, despite the fact it was known to cause a fatal brain infection called PML. As of September 5, 2012, there have been 285 confirmed cases of PML worldwide; 62 have died. I would like to know why the government fast-tracked a drug that was known to cause a fatal brain infection. You should look at the adverse effects of this drug as well, but in a procedure, 30,000 done worldwide, we believe there have been four deaths. Can someone explain the dichotomy there to me, please?

The Chair: I will get the other questions, and if you have an additional question I will get it on the record, too.

Senator Day, could you outline your question? We want to get an answer to it and they will respond subsequently.

Senator Day: Being an engineer, as opposed to a scientist, I tend to be more applied and practical on these approaches. I heard what my colleague had asked you. I am looking back at your bill and the second "whereas" clause where you talk about the fact that it has been discovered that 90 per cent of MS patients have CCSVI. I am assuming that CCSVI, which is the restricted flow of blood to the brain, is a condition that was known before the relationship with multiple sclerosis was highlighted by the Italian doctor a few years ago.

First, are you standing by what is in the second clause, that 90 per cent of multiple sclerosis patients have some level of CCSVI? Second, your clinical trials all relate to CCSVI, which is a condition broader than multiple sclerosis. It does not say trials of people with multiple sclerosis. That is really why all this has arisen, because of the Italian doctor's thesis that they are related and some results are being seen.

Do we know that the clinical trials are going to work on that relationship and help us understand whether that is or is not a good thesis? All you are asking for here are clinical trials with people with CCSVI, whether or not they have multiple sclerosis.

The Chair: Senator Day, the clerk will ensure that the transcription of that question goes to our witnesses and you will have it in writing exactly as related, because it they are very important questions.

[Translation]

Senator Verner: I am going to speak in French. My question follows on the question Senator Seidman asked.

You referred a few times to a study that was done in the United States with 240 patients that you felt was conclusive. My question will be quick. If this type of study exists in the United States, why did the United States issue dire warnings? I was trying to understand why the two did not go together.

[English]

Senator Seidman: Essentially my question was part two of what I wanted to ask you about. Given the announcement on Friday, given the specifics under your national strategy in the request in the bill, we could go through A, B, C, as you have requested, and see how that aligns with what was announced on Friday. For example, where you say the monitoring aspect, that all MS patients who have the treatment should be monitored, there is already in the announcement on Friday a monitoring system set up. That is just one example.

If we could have some response from you, as you go through your national strategy request, about what is missing and what is there, that would be helpful. Thank you.

The Chair: Thank you.

Thank you, witnesses, very much. I think Senator Seidman expressed it well. Everyone here is well aware of the significance of this disease symptom and we very much appreciate your appearance with regard to the bill that you are sponsoring and supporting. I also want to thank my colleagues for being efficient and reasonable with regard to their preambles to help us. We did get all the questions on the record and we look forward to your follow-up to those.

I wish to welcome our next panel of witnesses. We have Dr. Alain Beaudet from the Canadian Institutes of Health Research. From the Canadian Institute for Health Information, we have John Wright, President and CEO; Jean-Marie Berthelot, Vice-President of Programs; and Ann Chapman, Manager of the Canadian MS Monitoring System. From the Public Health Agency of Canada, we have Rodney Ghali, Acting Senior Director of Partnerships and Strategies Division.

We will not likely have time for you to respond during this session to all the questions that my colleagues would like to ask. I would ask you to agree to follow up this meeting with answers to those questions to get them on the record and the clerk will correspond with you to send the actual transcript questions to you. Would you be prepared to agree to that? Thank you. I see the answer is unanimous among our witnesses.

Without further ado, I will proceed to Dr. Beaudet.

Dr. Alain Beaudet, President, Canadian Institutes of Health Research: Thank you, Mr. Chair, for inviting me to speak about CIHR's activities related to multiple sclerosis and the condition referred to by the Italian physician Dr. Paolo Zamboni as chronic cerebrospinal venous insufficiency, or CCSVI.

As you know, CIHR has been heavily involved in this file over the last three years. When I first appeared before parliamentarians on this matter two years ago, proponents of CCSVI argued, based on the original study by Dr. Zamboni, that this condition was a cause of MS. This hypothesis has since been largely discredited. In fact, there is now even doubt as to whether there is prevalence of the CCSVI condition in patients with MS. Indeed, whereas some of the studies published since the original Zamboni report have suggested that MS patients showed a higher incidence of CCSVI than controls, others have been unable to replicate these results.

Still, a meta-analysis of all scientific evidence published to date, commissioned by the CIHR, led to the conclusion that there was a small but statistically significant increase in the incidence of venous abnormalities in patients with MS as compared to controls. Based on these conclusions, our Scientific Expert Working Group recommended that CIHR support a small-scale, Phase I/II clinical trial to evaluate the safety and efficacy of the venous angioplasty procedure proposed by Dr. Zamboni. A call for research proposals was therefore developed and launched last winter.

CIHR was criticized at the time for what was deemed by some as an overly cautious approach to evaluating the Zamboni intervention, and we were asked to move directly to a larger Phase III clinical trial. We argued that it would be neither scientifically nor ethically justifiable to proceed differently with this trial than for any other clinical trial; that is, without first investigating the safety of the procedure. Our call to caution was to be later validated by reports of major complications associated with venous angioplasty, some of them leading to death. In fact, earlier this year, an international scientific committee concluded that a clinical trial involving a large number of patients would be premature and, as such, was rejected when Dr. Zamboni proposed to conduct a Phase III trial on the 679 parents.

Not surprisingly, a few months ago, the U.S. Food and Drug Administration, the FDA, issued an alert about the potential dangers of venous angioplasty in patients with CCSVI. The FDA has also requested that a private clinic in California suspend the enrolment of patients, as they did not receive device exemption to conduct their trial involving over 1,000 patients.

Several research teams submitted proposals to CIHR in response to its call. These proposals were rigorously evaluated by a panel of international experts, who recommended that we fund the application submitted by Dr. Anthony Traboulsee from the University of British Columbia, which ranked first in the competition.

MS patients participating in the trial are to be recruited over four sites. As announced by the Minister of Health at the Health Ministers' Meeting in Halifax last week, two sites, one in Vancouver and one in Montreal, have now received approval to proceed from their ethics review boards and will be starting to recruit patients in the next few weeks. Two additional sites, one in Winnipeg and one in Quebec City, are currently seeking approval from their respective institutional ethics review boards, a process, may I add, that is totally independent from CIHR.

In a first phase, MS patients exhibiting CCSVI will be randomly selected to receive either the angioplasty treatment to enlarge neck veins or a sham treatment consisting of a catheter insertion without vein enlargement.

In a second phase carried out a year later, the groups will switch, so that in the end all patients will eventually be submitted to treatments, a pattern which is called a crossover trial.

Patients will be monitored over a two-year period, which is key to determining the outcomes of venous angioplasty over the long term.

[Translation]

Please allow me to make some clarification about the rigor of this randomized therapeutic trial, which is the result of close collaboration between the Canadian Institutes of Health Research, the provinces and territories and the Multiple Sclerosis Society of Canada.

In fact, it is important to know that Canada is one of the rare countries to undertake this type of double-blind controlled study. Another similar study has just begun in the United States, under the direction of Dr. Siskin, in Albany, New York. A third study, the protocol of which closely resembles the one in the Canadian study, has been under way for a few weeks in Australia. Lastly, a fourth clinical trial, very small in scale, is planned for later this fall in the United Kingdom.

[English]

It is only through rigorous, double-blinded studies of that kind — of the kind that is being carried out in Canada — that we will finally get the answers we all seek on whether venous angioplasty has a lasting impact on MS symptoms in patients exhibiting CCSVI.

In conclusion, I would like to inform you that, next month, the Scientific Expert Working Group will hold a final meeting to discuss the results of the seven studies funded by the Canadian and U.S. MS societies to determine whether there is a link between CCSVI and MS. We are hopeful that these careful, parallel studies will help shed definite light on this issue.

A synthesis review funded by CIHR on this matter will be updated in the coming months to take into consideration the results of these seven studies. I will gladly provide the committee with a copy of this meta-analysis as soon as it becomes available.

Thank you for your attention. I would certainly be pleased to take your questions.

The Chair: Thank you. I should note that the witnesses agreed to their speaking order. I will invite Mr. Ghali to speak next.

Rodney Ghali, A/Senior Director, Partnerships and Strategies Division, Public Health Agency of Canada: Thank you, Mr. Chair and honourable members of the committee. I am pleased to be here today to speak on the issue of MS and to provide an update.

The agency's work is part of a broader Government of Canada approach to addressing MS and other neurological conditions. Research is a key component of this approach, and Dr. Beaudet has already spoken about the recently launched initiative.

The agency is supporting the development of an MS monitoring system, a pan-Canadian data system designed to measure and monitor the health status of MS patients. The Canadian Institute for Health Information is developing the system. We will provide an update.

An important component of the government's approach is to address gaps in information about neurological conditions, broadly speaking, so we build an accurate picture of these conditions and their effects on Canadians. MS shares much in common with other neurological diseases, which is why the government has made an investment of $15 million over four years in the National Population Study on Neurological Conditions, an initiative designed to learn more about these conditions and their impact on Canadians. The agency is working in partnership with the Neurological Health Charities Canada, or NHCC, a coalition of organizations including the Alzheimer Society of Canada, the Parkinson Society of Canada, and the MS Society of Canada that represent people with chronic, often progressive neurological diseases.

The NHCC provides leadership on brain health, evaluating and advancing new opportunities for collaboration specific to advocacy, education and research projects.

Federal collaboration with the NHCC is ensuring that we bring the best expertise on neurological conditions to the table; that stakeholders are engaged and involved in the process; that we are studying the most important issues related to neurological conditions; and that key findings from this collaborative work are disseminated back into the community for the benefit of individuals and their caregivers.

It is the NHCC that proposed the National Population Health Study on Neurological Conditions because of the significant information gaps that exist. They wanted to create a new collaboration based on the fact that these conditions share many common features, most notably the impact on the daily lives of those living with neurological conditions, their families and their friends.

This study is filling important knowledge gaps. It will provide a clearer picture of the state of neurological diseases in Canada and give Canadians living with these diseases and their caregivers a chance to tell their stories. It will also aid governments and stakeholders in the planning of programs and providing services.

The study will provide us with key information to improve our knowledge about prevalence, risk factors, use of health services, economic costs and the impact of these conditions.

For example, it will allow us to project the future burden of key neurological conditions over the next 5 to 20 years. Being able to forecast the impact of neurological diseases over the next few decades is particularly crucial in the context of an aging population.

The study will allow us to better understand the impact on individuals in their homes, communities and their families and caregivers, which can improve the quality of care and their overall quality of life. It will also identify health and community-based needs and gaps for those affected by these conditions.

The projects under the study are well under way. In 2014, a comprehensive report will be published and a dialogue will be held so that policy-makers, researchers and stakeholders can discuss the findings and what they mean for approaches to neurological diseases going forward.

This initiative combined with CIHR's research and CIHI's work on the MS monitoring system represent a comprehensive suite of actions that will move our knowledge base forward and provide us the evidence to support policy and program development and improvement. Our collaboration with stakeholders is bringing the perspectives of those living with neurological conditions to every aspect of the work we do. This is critical to the relevance of the work because it grounds us in the real challenges facing Canadians with neurological conditions and their daily lives.

Through continued collaboration with the provinces, territories, health charities, stakeholders, researchers and input from patients, we are addressing the knowledge gaps related to MS and other neurological conditions, providing Canadians with the best possible information for treatment and management of their condition.

John Wright, President and CEO, Canadian Institute for Health Information: Good morning. On behalf of the Canadian Institute for Health Information, I would like to thank you for the opportunity to appear before the Standing Senate Committee on Social Affairs, Science and Technology.

Since 1994, CIHI has played a unique role in Canada's health sector. As an independent not-for-profit corporation that provides essential information on Canada's health system and the health of Canadians, our vision is simple: better data, better decisions, healthier Canadians.

In March 2011, Canada's Minister of Health announced the creation of the Canadian Multiple Sclerosis Monitoring System and indicated that the federal government would provide CIHI with funding to develop this system. At CIHI we recognize the importance of the MS monitoring system for the thousands of Canadians living with this disease, their families and Canadian society as a whole. For this reason, we started working immediately with our partners on this important project.

At each stage of development we worked in close collaboration with people living with MS and their caregivers. We also worked with the Canadian Network of MS Clinics, the MS Society of Canada, clinicians, researchers, international experts and various levels of government.

I am pleased to report that as of September 2012 this system is in place and ready to receive data. Currently, clinics across Canada can submit data using a file extracted from their local MS registry. To make this happen, we are working one on one with volunteer clinic sites and their respective ministries of health to determine clinic-specific needs to participate. This critical work will serve as a model for successfully bringing MS clinics across Canada on board over the next several months.

In addition, work is well under way to develop a second option for submitting data, a secure online web tool. This tool will be available as of April 2013 to MS clinics, community neurologists and family physicians that care for Canadians living with MS.

The new Canadian MS Monitoring System will significantly increase the amount of information available to people living with MS, clinicians, researchers and the public to help improve care and quality of life for the estimated 55,000 to 75,000 Canadians living with MS. More specifically, this information will help measure disease patterns across Canada, identify variation in the use of treatments and monitor long-term patient outcomes associated with different treatment options.

The information collected on treatments received by patients living with MS will include procedures associated with CCSVI. However, it is important to note that the Canadian MS Monitoring System is not a CCSVI registry; rather, it is a pan-Canadian resource that will be relevant and useful, and will provide great information to all Canadians living with MS.

As we move forward, we will continue to work closely with people living with MS, our advisory committees, the jurisdictions, various levels of government and stakeholders, to continue to ensure standardized, longitudinal, pan-Canadian data on MS. It is data that, in the words of one of our advisory committee members who lives with MS, can "offer hope and help us move from what might work to what will work to find solutions."

Thank you for your time. We will be happy to answer questions.

The Chair: Thank you very much. As the sponsor of the bill, I will give Senator Cordy the first opportunity to ask questions.

Senator Cordy: Thank you. I love the saying "better data, better decisions, healthier Canadians." I hope you do not mind if I use it.

Dr. Beaudet, with respect to agreement 1148 to support the Scientific Expert Working Group between the CIHR and the MS Society of Canada, who made the grant application for the president's fund, when, how much was the grant, and could you table the letter from the MS Society requesting the grant to the committee?

Dr. Beaudet: I want to make sure that I answer your question properly. You are talking about the proposal for the clinical trial?

Senator Cordy: The president's fund. The MS Society was given money from the president's fund.

Dr. Beaudet: That was to organize the working group?

Senator Cordy: Yes.

Dr. Beaudet: Now I know what you are talking about.

Senator Cordy: Who made the grant application for the president's fund?

Dr. Beaudet: The MS Society.

Senator Cordy: Would you mind tabling the letter from the MS Society requesting?

Dr. Beaudet: Absolutely.

Senator Cordy: Thank you very much.

I would like to talk about follow-up care. I know that in 2010, when you were before the House of Commons Subcommittee on Neurological diseases, you said that no physician will refuse to see and treat them for complications of a treatment received abroad. I know you and Dr. Duncan have certainly had a lot of conversations about follow-up care since the summer of 2010. Dr. Duncan has brought concerns forward to you about appointments being cancelled, driver's licences being threatened. I know people who have been refused care or they are being threatened that their driver's licence would be taken from them. This past summer, we know that Roxane Garland, from Saskatchewan, died of a urinary tract infection and certainly her family would say that she was refused follow-up care.

The Scientific Expert Working Group said many times that media reports which stated that MS patients who experience complications after CCSVI treatment are not being seen by Canadian doctors are not justified. Where did you and the expert group get your information in terms of no one being turned away for treatment after they have gone abroad?

Dr. Beaudet: First, I would like to confirm that indeed I said that. I said I found it unacceptable that patients would not get proper follow-up care, and I will reiterate that statement.

However, you have to understand also that the CIHR is not in a position to ensure that the physicians provide adequate care. I did get assurances, however, from the various colleges of physicians, as well as professional societies, such as the Society of Family Physicians and the Royal College, that everything in their power would be implemented to ensure that patients receive the proper care, which is, as you know, in the end, the responsibility of professional colleges.

We also wanted to be proactive to ensure that the colleges themselves and, through the colleges, the physicians, would be fully informed of the progression of this file. We have been regularly providing them with updates on CCSVI — the literature, the results of publications and our own actions — to ensure that they could, in turn, inform the patients. We have been recommending strongly to the colleges that they should take all the necessary steps to ensure that patients would receive the proper care. I am sure that, in most cases, this is actually what happened.

Senator Cordy: That most patients are receiving the care?

Dr. Beaudet: Yes.

Senator Cordy: Did you speak to anyone from the national CCSVI society or people who have returned from having the treatment done abroad to see whether or not they feel they have been getting proper care when they return to Canada?

Dr. Beaudet: I have not.

Senator Cordy: Certainly I would think that most members of the medical community would say indeed the patients are, but I have spoken to hundreds of patients and many of them have been refused care when they return or have been refused MRIs before they head out of the country.

Dr. Beaudet: We have to be careful. These are two very different things. First, there is being refused care, but then some patients want specifically to have, for instance, Doppler analysis of their neck veins, which is not a diagnostic procedure that is currently recognized for MS. It is possible that it might have been refused. We are talking about, on the one hand, ensuring that people in distress are properly cared for, and on the other, not necessarily accepting to provide any type of test that the patient may request. If it is not considered as being an appropriate test for the condition, in the end, it is for the physicians to determine what to do.

Senator Cordy: In this case, the doctor did recommend it, but when the clinic found out she had MS, it was refused.

Dr. Peter Liu, Director of CIHR, when asked about his opinion of CCSVI, said, and I will quote from his report, "My own interpretation of the data is that CCSVI is likely a contributing factor in a restricted subset of MS patients." He went on to say, "We need a much larger, multi-centred trial."

When the announcement came out on Friday, I was delighted that the announcement came out that the government is moving ahead with clinical trials. I think all Canadians are happy this is starting. However, the press release said that they were pan-Canadian trials. When I think pan-Canadian, I think of it being across the country. I am from Nova Scotia, and MS patients from Atlantic Canada are excluded. Patients from Ontario are excluded from this study. I am curious why it said pan-Canadian when it will only be B.C. and perhaps in Manitoba.

Dr. Beaudet: That is a good point. Now we are talking about the interpretation of the word "pan-Canadian." When we launched the call, we were clear that we wanted this call to be multi-site and that the sites would involve several provinces. Of course, we received a number of proposals. It so happens that the selected proposal that we received was proposing sites in three provinces.

Was that a sufficient number of provinces? I think you have to balance two things. I recognize the willingness of patients across Canada to participate in the trial. You have to recognize also that you want more than one site. You do not want all the sites in the same province. On the other hand, you do not want too many sites either. I will tell you why. In particular, there is such variability in the diagnosis of this condition that the more sites, you increase the chance of variability. We feel, and certainly the committee who ran that proposal felt, that there was a good compromise between having sites in certain places in Canada and not too many sites that you would have such variability in diagnostic and therapeutic procedures that you would increase the variance between the results at each site.

Senator Cordy: I can see that you do not want 13 sites across the country.

Dr. Beaudet: You need to also have the expertise at each site, neurological, radiological and vascular. You need all three.

Senator Cordy: If people from Nova Scotia are willing to travel to Poland or Italy or Mexico, I think they would be willing to go to Montreal. However, the press release clearly said that people have to live within driving distance of the clinical trial.

Dr. Beaudet: That is correct.

Senator Cordy: All of Atlantic Canadians are excluded from this trial.

Dr. Beaudet: It is also for the manageability of the trial, senator. As I am sure you understand, these patients will be followed extremely closely for over two years. They will undergo two surgical procedures, and they will be going to the clinic very often for a battery of tests. It is just a question of cost control and convenience that we are restraining the patients to near the sites.

A trial on 100 patients is not cheap; it is a $6 million trial. If we are to talk about pan-Canadian, there is something that is very pan-Canadian and absolutely fantastic in this trial. This is not a trial started by the Government of Canada. It is a true partnership between the provinces and the federal government, and each and every province in which there is a site has agreed to collaborate and participate financially in the funding of the trial. This is a very positive example of strong collaboration on a very specific health problem between the provinces and Canada, and it should be mentioned.

The Chair: I have given Senator Cordy a little extra leeway, so I will try to get the rest of the senators to focus.

Senator Eggleton: Dr. Beaudet, you mentioned in the early part of your presentation that it has been disproved that CCSVI causes MS. I did not think that was the issue, though. I thought the issue now was whether the CCSVI procedure improves a person's quality of life.

I noted that Dr. Traboulsee, who will now head up this study, is of the same view. He has traditionally followed, as I understand it, a different path that does not involve recommending or carrying out this procedure. Is he sufficiently neutral in this regard to be able to examine this? He seems to have a particular direction in this historically.

Dr. Beaudet: The way a double-blind trial is built, Dr. Traboulsee will not know what patient receives what treatment, whether the patient receives the sham procedure, or whether the patient actually receives the angioplasty procedure. Neither will the patient, by the way. That is what "double blind" means. There is no way he could influence the outcome of the trial.

Senator Eggleton: The question of whether this procedure, venous angioplasty, is a routine procedure or not is also something that I want to explore. I think the health minister said it is not, but we heard evidence earlier that a lot of this is happening around the world. Could you comment on that?

Dr. Beaudet: Absolutely. It is a routine procedure in arteries. Arteries have a tough wall with lots of elastic fibres and lots of resistance. You can put a balloon in there and open them up, and they will come back. You do not risk modifying, hurting or degenerating the endothelium. You do not risk breaking open an artery with a little balloon.

Things are very different with veins, and that is where it becomes a little more unusual. Has it been used in veins before? Yes, it has, in some cases, such as in patients that have been dialyzed for a long period of time and who tend to develop a stenosis of their kidney veins. Angioplasty is used in those cases to open the vein. What has been noticed in those cases is that there is a tendency, because the veins have such a small wall and so few elastic fibres, for the vein to re-collapse after a short while. There are very, very few data, in fact, on the long-term consequences of angioplasty in neck veins because it was just not being done routinely.

The danger is the dissection of the vein. Also, the endothelium of the vein is very fragile. Putting a catheter and opening a balloon in the vein could have some deleterious effect on the endothelium that could lead to stenosis later on. That is a real concern. There have been some unfortunate incidents of that kind following this procedure, so I do not think we should take it lightly.

Senator Eggleton: The information we had earlier was that the success rate for this is rather high. I believe we heard the rate of 1.6 per cent failure in terms of the operations that have been carried out. However, many of the drugs that have been used have much higher death rates, such as Tysabri. Can you comment on that?

Dr. Beaudet: I think you put your finger on the heart of the issue. Losing even one patient to a procedure that is not efficient is not acceptable. The whole purpose of this trial is to determine whether we can state that the procedure is relatively safe and that there is an efficiency that justifies taking the risks associated with it, as with any other procedure. It is always a case of balancing the risks and the benefits. We do not know how, in an objective way, we can evaluate these benefits. That is what we are trying to do.

Senator Eggleton: Yet some drugs out there seem to be a bigger risk or carry a greater danger. What are we doing about that?

Dr. Beaudet: It is the risk-to-benefit ratio.

Senator Seidman: You use interesting words. You said, "an objective way to evaluate" what is a very significant and risky surgical intervention, potentially. As I did with Dr. Duncan earlier, I will address the science with you because you alluded to that at the beginning of your presentation, Dr. Beaudet. There have been 20 or so studies published in the peer-reviewed scientific journals since 2009, as I said to Dr. Duncan. All five studies published in 2012 appear to demonstrate much less certainty that there is a relationship between CCSVI and MS. Could you explain to us why that is important? I would appreciate it.

Dr. Beaudet: With great pleasure. There are two things. In the original study, Dr. Zamboni claimed that 100 per cent of the patients with MS had CCSVI. No one has been able to reproduce that data — no one. Dr. Zamboni claimed that CCSVI was actually the cause of MS. No one has been able to replicate this, and, in fact, this theory has been largely abandoned.

There is the possibility that a co-morbidity develops, i.e., as MS develops perhaps other neurological diseases develop. As well, vascular abnormalities develop. Now we are talking about something very different: an association between the two. You are absolutely right: Certain studies showed zero association, some studies showed a strong association, and other studies showed slightly superior than normal.

That is why we commissioned a metanalysis that took together all the studies that could be put together. In some cases we do not have enough methodological details to include the study. We had two of those done. The results of the metanalyses were reported to the expert working group and, in both cases, the metanalysis came up with huge variants but statistical significance. There seems to be something there.

As you know, this was against a backdrop of patients going abroad and coming back with many anecdotal claims that they were improving, and of huge pressure on the medical profession asking CIHR what we should tell them. Can we prevent them from going abroad? Can we tell them it is all poppycock and they should not go? Can we tell them that it is a waste of their time and money? It is dangerous. Until you have a clinical trial rigorously carried out double-blind to tell you whether it has a real effect or a placebo effect, you cannot answer those questions.

We are asked why we did not do the trial before. Until we had the data suggesting that there was at least a strictly significant association, it would not have been ethical to carry out the trial. That is the way science works. There is not a single scientific community at CIHR that would have accepted a proposal under those conditions. Since it was approved, it was found that now there is enough scientific evidence, although weak, to justify ethically subjecting patients to this procedure.

It is difficult, and it shows you the difficulty that we face when we are going ahead with a trial or not going ahead with a trial. You need to have a modicum of scientific basis. It could end up that we will realize a few years down the road that, yes, the angioplasty procedure has an effect, but it has nothing to do with the association. When we are putting a catheter in the vein, we are releasing a peptide, and that peptide improves the "brain fog" in patients and their quality of life. We do not know.

Senator Seidman: That is a good response in terms of understanding the issues.

[Translation]

Senator Verner: Dr. Beaudet, you have already answered my question about the choice of two provinces, as Senator Cordy mentioned previously.

Instead, I wanted to refer to the bill. The fourth whereas states that clinical trials have demonstrated "the safety of using balloon angioplasty in treating CCSVI". That is the exact wording.

I would like to focus on the safe nature of the procedure. Do you know whether these treatments that have been declared safe have been approved by government authorities? Or have other types of clinical trials been done? Where are these statements coming from?

Dr. Beaudet: I am asking myself the same question because I do not think it is safe, and I do not think that there is evidence in the literature that shows it is safe. If it were, we would not be continuing a study that is supposed to demonstrate its efficacy and its safety. Phase one concerns the safety aspect, and phase two concerns the efficacy.

In fact, it is so unsafe that the FDA in the United States interrupted a study because it felt that there was not sufficient data to demonstrate the safety, and as long as there is no double-blind randomized study available, we could not make that kind of conclusion.

Senator Mockler: This is certainly a subject that affects all Canadians. When I was a member of the New Brunswick cabinet, from 1999 to 2006, our government did a lot of work for multiple sclerosis. I know that you already had a good reputation at that point. I would like that to be on the record in the Debates of the Senate.

I have a few questions that came to mind. I cannot let certain comments made by the previous witnesses go unaddressed.

When they say, and I quote:

[English]

New Brunswick provides funds to patients who travel outside the country for treatment. We seem to be promoting medical tourism here in Canada.

[Translation]

My second observation is this:

[English]

One of the pillars of Canada's Health Act is "accessible," which means reasonable and uniform access to insured health services, and that no one may be discriminated against on the basis of income, age, and health status.

[Translation]

Are Canadians being discriminated against based on their income, age and health status?

Dr. Beaudet: No. Emphatically, no. I would like to come back to the explanation of that clinical trial that will be done in three provinces at four sites. It is important to understand that access to a treatment is not going to be given to one group of citizens over another. That is not what this is about. Rather, what this involves is determining whether we can allow this treatment to be used on patients with multiple sclerosis who have vascular abnormalities. And in that respect, we cannot have a study on 100 patients—which is not a large number—who are completely scattered across the 10 provinces. What we have in mind, first and foremost, is a study that is as solid as possible, scientifically speaking.

As I explained earlier, we obviously do not want to have the study focused in one province but, at the same time, we do not want to have so many sites that we end up with a variance that does not allow us to draw any conclusions.

The goal is not to give patients access to treatment, but to determine if the treatment is effective and safe. Once we have the results that show us this, and we have compared the results with those of other studies, we will be able to make recommendations to colleges of physicians in the various provinces that will make decisions about access to therapy. The CIHR is already proactive in communicating with the researchers of very similar studies, where we know that the same scientific rigor has been applied in the study to ensure that the results can be analyzed together, as a result multiplying the possible generalization of the results.

Senator Mockler: Does Canada currently have a two-tier health care system?

Dr. Beaudet: No.

[English]

Senator Seth: Based on listening to everything, Dr. Beaudet, there is a little correlation between multiple sclerosis and this CCSVI intervention, yet we are proceeding with further research and procedures to continue to see the outcome first.

Of our Canadian patients suffering with MS, they are really getting confused, because the U.S. is going very fast and doing the surgery and going into trials. Will that be the effect we feel here? How come we are not going so fast?

Dr. Beaudet: We are going at the same speed, senator. There is one trial at the same rigour that is being carried out in the United States, and it is just starting, like our trial. In fact, Canadians will be participating in that trial because Saskatchewan and the Yukon will be sending patients as part of that trial.

Otherwise, there were indeed some trials in the United States carried out without the proper authorizations or under the right conditions, and the FDA shut them down. We are not behind. We are moving at the same speed as Australia, the U.K. and the U.S., and usually these are good comparators for us.

Senator Seth: In fact we should be telling patients that we are not behind and that we are doing the best. We conservatively want to ensure we are safe and the results are very good. That impression is a lot better than saying, "Okay, we are not doing anything."

Dr. Beaudet: You said it better than I could.

The Chair: That is not a question, so we will leave that.

Dr. Beaudet, and perhaps Mr. Wright, I had some questions I want to raise relative to other questions, but I will go to Senator Merchant, who has just come on the list. I always try to let my colleagues go first.

Senator Merchant: Thank you very much. I appreciate it.

I come from Saskatchewan. Our premier and our government announced about a year and a half ago that they were going to proceed. I could be wrong but I believe they got frustrated with the speed at which, nationally, we were moving toward these trials. They are going to do the study in Albany, New York. Are you satisfied they have met all the criteria that you feel are necessary to proceed?

Dr. Beaudet: Yes, I do think that the New York trial is actually very similar to ours. It is a serious trial and I would not have any worry about Canadian patients being part of that.

I did hear that we were moving slowly, but you heard what the process is like: Designing a proper call for proposals; giving the researchers the time to design a solid trial; getting together with partners and researchers across the land; submitting a trial to us; having this trial; and having the proposals evaluated. It was validated by an international panel of experts, and all the experts who reviewed the proposals submitted to us, with the exception of the chair, were from outside Canada. We did not want to bias the process in any way. I was not even aware of who was part of the committee that reviewed the applications.

Then, once an application was selected, we had to wait for each site to come up with a positive recommendation from the local ethics review board. For all the reasons I have mentioned, it is a complex protocol to study for the review boards.

Let us be glad that we are ready to go. I must say it has been a pleasure to interact with the provinces throughout this process. We have worked together in partnership. I have kept them informed and we have been in constant communication. As I said, there is now the financial participation of the provinces that have sites, and I think this is great. It is a good example as to how things should be working.

Senator Eggleton: I would like to follow up on that. If the New York study is a valid study and involves Canadians as funded by the Province of Saskatchewan, why do we need to do this other study here? These studies take some time. Meanwhile, we could be going on to Phase II instead of doing a Phase I study. There are people dying all the time. Why would we not hook into this one where we already have a hook anyway and go to Phase II?

Dr. Beaudet: Senator, it is a Phase I/II trial. It is a Phase II trial with a safety component, so it is I/II.

We did discuss the possibility of merging the two trials with the U.S., and we weighed the pros and cons. It is complicated to send Canadian patients abroad in the same way it is complicated to send them between provinces. Looking at the complexity of the protocol and the number of visits and exams involved, we felt that it would be better scientifically to have the two trials in parallel but to take steps that would allow us to merge the results eventually so that we can increase the end.

In all fairness, it is something that certainly did cross our minds. We feel that we are adding scientific strength by having these two parallel trials and then, at the end, doing a meta-analysis of the results. This is what the experts recommended to me, Senator Eggleton.

Senator Eggleton: Did you get Dr. Sandy McDonald involved?

Dr. Beaudet: I got researchers involved, researchers funded by CIHR or the NIH. I did not get people who cannot get grants.

The Chair: We will not get into an argument over individuals here. Points have been made with regard to individuals, and they are on the record.

The issue here is one of a very complicated process. This is a trial, and I want to use this term advisedly, not simply of popping a pill but rather a surgical intervention with substantial ancillary issues that arise in such an intervention. You have made observations helping to inform us with regard to the nature of that and the importance when one goes into a study such as this so that, to the best degree possible, the procedures used in the clinical trial settings are similar enough that the results can lead to a conclusion on the specific question asked. Is that a reasonable comment?

Dr. Beaudet: Totally.

The Chair: The nature of this procedure has now had the benefit, as Senator Seidman mentioned, of a number of people in different countries apparently having done some studies in this area. On the basis of her question and on the basis of your answer, it seems like there may be a trend developing with regard to the conclusions being drawn as time goes by, that is, as we better understand everything from the detection of veins to what is happening in the patient following what is the specific treatment they receive.

You do not need to answer this today if you are not able to, and I would welcome a follow-up.

Perhaps, Mr. Wright, since you folks monitor MS issues, could you give us an indication as to whether there has been any significant change in the evidence that has been coming forward in the scientific literature with regard to time?

The second thing that I would like to ask you, if you can, and I do not know if this information is available to either of you, but I have read reports that certain requests for trials have been turned down in other countries. In fact, if memory serves me, and it may not and you will correct me immediately, it was my understanding that Dr. Zamboni had requested a trial in Italy and that it had not been approved. It is my understanding further that some of those who appeared with Dr. Zamboni in the initial reporting have subsequently developed different opinions with regard to what they were actually involved with at that time and where they are now with regard to this issue.

I do not want a quick and dirty answer on this. I would rather have something that the committee can see in writing with regard to these issues. If you specifically, Dr. Beaudet, could respond, and Mr. Wright, if that is an area that your organization follows to the degree that you would feel confident in responding to the question, I would welcome it with you as well.

Dr. Beaudet: We will be pleased to send you a detailed response to that question. Just as an overview, yes, this is science, it is evolving, it is changing and we are learning new things. I would say that, by and large, what we are seeing is less and less studies showing a strong association between CCSVI and MS and more and more studies showing negative results or showing equally high incidence of CCSVI in patients with other types of neurological disorders.

Another very surprising finding, the stenosis of the veins, the usual cardinal criterion for CCSVI, if there is any abnormality at all, from the post-mortem studies that have appeared since or more sophisticated imaging techniques, the real culprit could be perhaps valvular problems in the neck veins and not at all a stenotic problem. Thing are evolving. We are learning. We can give you the papers and how things are evolving very specifically.

The Chair: Would you give your own analysis? We may not want to read the whole medical documents. Your reference to them will be fine, but I am asking you for an answer, not to put it over on to them.

Dr. Beaudet: As for the turned-down trial, yes, Zamboni's trial was indeed turned down because it was too large, and he was told to be a Phase I/II trial, as we are doing in Canada, and not start with Phase III. That is not how science proceeds.

The Chair: I want to get Senator Cordy's last question on the record.

Senator Cordy: This committee always seems to give homework.

We have some excellent panel members going to appear on other days, but we have no panellists who have actually had the procedure done. When we had our study on poverty, we met with people living in poverty. I know we did in Halifax and in Toronto. When we did our study on mental health and mental illness —

The Chair: Are you leading to a question for the witness?

Senator Cordy: I am asking if we can have people appear as panellists.

The Chair: We will discuss that as a committee.

Thank you, witnesses for being here today. I thank my colleagues for attempting, in most cases, to minimize their preamble and get to the importance of the question and the witnesses for being willing to answer those questions, and particularly to be willing to follow up and answer the questions that have been put to you specifically.

(The committee adjourned.)