Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVI)


Senator Jane Cordy September 28th, 2011

National Strategy for Chronic Cerebrospinal Venous Insufficiency (CCSVI) Bill

Second Reading—Debate Adjourned

Hon. Jane Cordy moved second reading of Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVI).

She said: Honourable senators, it is my pleasure to speak today on Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency treatments for multiple sclerosis patients in Canada. The bill received first reading on June 26 this year.

I would like first to thank Dr. Kirsty Duncan, the member of Parliament for Etobicoke North for the work she has done in fighting for clinical trials for those who have MS. With her scientific background, Dr. Duncan has closely followed the research being conducted around the world, while showing compassion to literally thousands of Canadians affected by this devastating disease. Working closely with those directly affected by multiple sclerosis, their families, friends, along with those in the medical field, she has advocated for clinical trials here in Canada since 2010. Dr. Duncan has work tirelessly to bring this debate before parliamentarians, and I must credit her for being instrumental in formulating Bill S-204, the bill before us today.

This past winter, Dr. Duncan hosted two meetings on Parliament Hill to provide information to MPs and senators about multiple sclerosis and the treatment of CCSVI in Canada. At both non-partisan meetings, there were MPs representing all the political parties as well as both Liberal and Conservative senators.

At the first meeting we heard from medical experts Dr. Sandy McDonald, who is the only Canadian doctor to have performed the diagnosis and treatment of CCSVI and who was trained by Dr. Paolo Zamboni; Dr. Mark Haacke, who is a world leader in diagnostic imaging with extensive experience in establishing and describing venous anatomy and flow characteristics in MS data; and Dr. David Hubbard, a board certified neurologist and medical director of the Applied MRI Institute in San Diego.

At the second meeting we heard from those who have MS and have received venous angioplasty from Dr. Bill Code, from Steve Garvie and from Vito Maltese, whose son, Matthew Maltese, was diagnosed with relapsing remitting MS in June of 2000, at the age of 16. Over the next 10 years, Matthew lost all the feeling in his left side until he had venous angioplasty, when he regained almost full sensation to his left side. He has not had another MS attack.

After hearing from the medical doctors and then from those who have MS and have had venous angioplasty, I remember thinking, "This is Canada — we have to do something to help those with MS and their families." Then I remember thinking that "we" included me, which is why, in March of this year I began a Senate inquiry on multiple sclerosis, chronic cerebrospinal venous insufficiency and the venous angioplasty procedure to correct abnormalities in veins to the brain. Those who heard my speech last March know that I do not believe that Canadians with MS should have to travel outside of Canada for venous angioplasty treatment. Angioplasty is a common procedure in Canadian hospitals. I also believe that Canadians who have MS should not be refused imaging tests to diagnose CCSVI.

After speaking on my inquiry, I received hundreds of emails from Canadians who have MS and from their family members. I was also fortunate to meet with many of them.

I want to personally thank each and every one of these Canadians who were so willing to share their stories. These are incredible people who are fighting not only their disease but are also, unfortunately, fighting the system.

It is because of them and because of Dr. Kirsty Duncan that I have introduced this bill in the Senate. As I stated in this chamber last spring, nearly 75,000 people in Canada live with multiple sclerosis. Another 1,000 Canadians are diagnosed with the disease each year and, honourable senators, nearly 400 Canadians are dying from the disease each year.

Multiple sclerosis is a devastating disease. It is the most common neurological disease affecting young adults and is two to three times more prevalent in females than in males. The symptoms of MS can be anywhere from mild to debilitating. MS sufferers may experience vision problems, loss of balance, loss of coordination, extreme fatigue, speech or memory failure, muscle stiffness and paralysis.

The causes of multiple sclerosis are still unknown and there is no cure at this time. It is found that in MS patients there are high levels of iron deposits in the brain, and evidence shows that a possible link exists between these high levels and the deterioration of the patient.

Studies of MS patients by Dr. Zamboni have shown a high percentage of MS patients have a condition known as chronic cerebrospinal venous insufficiency, or CCSVI. CCSVI is a vascular abnormality which restricts the flow of blood from the brain and is potentially the cause of the high levels of iron found in the brain of MS patients.

In order to treat CCSVI, Dr. Zamboni began treating MS patients with an angioplasty procedure to correct the abnormality in veins to and from the brain. Many doctors around the world have begun administering the same procedure to treat CCSVI on MS patients. What has been found in many of those patients who have undergone this procedure is that they often experience improvements to their MS symptoms. Some of these improvements are dramatic, some less so, but it is becoming increasingly evident that venous angioplasty can alleviate some symptoms and improve the quality of life of those living with MS who have CCSVI.

Dr. Sandy McDonald from Barrie, Ontario, was trained by Dr. Zamboni in the CCSVI diagnostic technique and has been sharing the technique with others. He has found almost 90 per cent of the MS patients he has seen have CCSVI.

Over the last several years the procedure has been offered and administered to MS patients in countries such Italy, Poland Scotland, Japan, India, Mexico and the United States. However, as of today Canadian MS patients are prohibited from getting the treatment here in Canada.

Honourable senators, I applaud the government for the two recent announcements regarding MS: the announcement of an MS registry on March 23, 2011; and the announcement of clinical trials for CCSVI on June 29 of this year.

As much as these announcements provided MS patients and supporters in Canada with much needed hope and promise, there still remains much uncertainty. Unfortunately, there has been a real lack of information following these announcements.

With respect to the registry, we do not know what information will be collected. When will the collection of this information begin? Will this registry be designed to enable the long-term tracking of all MS patients, including those who have chosen to undergo treatment outside of Canada, or will it just simply track a sample of patients? What is the budget for the registry? Is there a budget for the registry?

This announcement was made over six months ago, and we still do not have any details or any timeline for its implementation.

With respect to clinical trials, the announcement was made three months ago and just as many questions are still left unanswered. What funding will be provided for the trials? How is the budget determined? Is there in fact a budget? When will the funding be available? What is the timeline? How many patients will be part of the clinical trials? Will there be multiple locations across Canada for the trials?

MS patients would like information. Families of those with MS would like information.

Honourable senators, clinical trials of this nature require outsourcing, which means contracting a qualified research organization. The process starts with the government tendering process. Two to three months are required for the request for proposals to be prepared, followed by a two-to-three-month response time with an additional month to review the bids and to select a successful bidder. A minimum of three months will be needed to write the protocol, followed by one to two months to receive sign-off by all participants and three months to submit and gain approval by the regulator.

Following the tendering process, the actual work will begin with ethics approvals, practitioner training and, eventually, patient enrolment. Depending on the sample size required, full patient accrual could take six months, with patients then being followed for a year or two. After that, six months will be needed to analyze the data, write the report and make a submission to the regulator.

If the process started today, a Phase III trial would not begin before the fall of 2014. This is the reality of clinical trials.

Honourable senators, time is important when dealing with MS. For MS patients, three months can mean the difference between mobility and lack of mobility, working and being unable to work.

The Canadian Institutes of Health Research is recommending a Phase I or Phase II clinical trial, but Dr. Duncan argues — and I agree — that there is no need for a Phase I trial, which is usually undertaken to assess safety, because angioplasty is an accepted standard of care practice. Angioplasty has been performed since 1977. Surely an Adaptive Phase II/III trial can be adopted.

To those MS patients who are excited about the announcement and the promise it brings to the improvement of their quality of life, let us not wait for another year to pass before clinical trials commence. Let us begin the process now.

The membership of any expert advisory panel that is set up during the clinical trials should be comprised of actual experts in the field of diagnosis and treatment of CCSVI, something that seems to have been missing from previous government expert panels considering this issue. We need the most qualified and the most experienced persons leading this research.

Honourable senators, it is time to move away from government announcements and promises and move toward government action on the issue. The aim of this bill is to do just that — to legislate government action with a definitive timetable. MS patients in Canada deserve as much.

Bill S-204 is an act to establish a national strategy for chronic cerebrospinal venous insufficiency. It calls on the Minister of Health to convene a conference with provincial and territorial counterparts for the purpose of establishing a national strategy. This national strategy must ensure that clinical trials are started for the treatment of CCSVI and estimate and identify the appropriate source of funding required to undertake these trials. There must also be tracking of individual Canadians who have been treated for CCSVI outside of Canada.

It is imperative that the federal government take a leadership role in developing a national strategy for MS. Often when a treatment shows promise it is fast tracked. No one can deny that the CCSVI treatment on MS patients shows promise, yet many MS patients are still waiting for our health care system to act while 50 other countries are doing clinical trials. Canadians deserve better.

The lack of follow-up care is a missed opportunity for made-in-Canada care by our health care system to better serve Canadian MS patients and to better understand CCSVI and the possible relationship with MS. We in Canada are still not collecting data, despite the minister's announcement six months ago in March of this year. Six months have passed since the minister's announcement of a registry. The promised registry of those Canadians who have undergone venous angioplasty would better track and collect data on the MS patients' progress. This data is extremely important, and the register should be started immediately so that we have Canadian data.

However, what is really needed in order to better study and understand the possible relationship between CCSVI and MS are clinical trials here in Canada. There is no better way for Canadian scientists and doctors to study the issue than by conducting our own clinical trials instead of relying on second-hand data. We need made-in-Canada scientific evidence to make the best decisions related to the treatment of patients with MS.

The minister obviously believes this since she made the announcement in June, three months ago. Now is the time to act.

We as Canadians need made-in-Canada scientific medical evidence. We deserve it. An end of this discrimination against MS patients must be our goal here.

It is a sad truth that the suicide rate for MS patients is seven times higher than the national average, a shocking statistic indicative of the hopelessness many MS sufferers feel toward finding relief from their symptoms.

This treatment is showing too much promise around the world to be ignored here in Canada. This is evident from the government's policy reversal and announcement that it is now supporting clinical trials — a stance the government was opposed to prior to the June 2011 announcement. I am very pleased that the government has listened and will now support clinical trials.

We owe it to Canadians diagnosed with MS and to their families to provide them with the best possible care. Canada is far behind on this issue, and it is inexcusable that we do not yet have clinical trials. As evident from the aggressive timetable set out in this bill, this is an issue of utmost importance for MS patients in Canada. My hope with this bill is that the Minister of Health will set a timetable as soon as possible to bring provincial and territorial counterparts together for the purpose of developing a national strategy on the treatment and follow-up care for Canadians living with MS.

Honourable senators, this is not a partisan issue. I am sure that most senators here today know courageous Canadians who are living with multiple sclerosis. I was extremely pleased to hear the health minister's announcement on June 29. The lack of public information since then has not been encouraging.

It is time to get started with clinical trials here in Canada. It is time to have a national strategy for MS patients. It is time to have an advisory panel of experts who are engaged in imaging and treating those with CCSVI. It is time to include those patients who have MS into Canada's health care system according to the Canada Health Act principles of universality and accessibility.

Honourable senators, I would ask that you talk to Canadians who have MS and to their family members. They have stories full of courage and some disappointments, but mainly they have stories of hope. Listen to the stories of people like Steve Garvie, Jenny Powell, Christopher Alkenbrack, Edna Lee, Dr. Bill Code, Matthew Maltese or Tim Donovan. They will inspire you with their determination.

Canadians have been left waiting too long for government action on this issue. With the passage of this bill, we have the opportunity to end the agonizing wait by Canadians with MS and their families. Honourable senators, I ask you to support this bill so that we can move forward with hope starting today.