Bill S-204 read a second time in Senate of Canada.

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Bill S-204 read a second time in Senate of Canada.

Postby 1eye » Fri Apr 27, 2012 2:42 pm

National Strategy for Chronic Cerebrospinal Venous Insufficiency (CCSVI) Bill

Second Reading

On the Order:

Resuming debate on the motion of the Honourable Senator Cordy, seconded by the Honourable Senator Peterson, for the second reading of Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVI).

Hon. Betty Unger: Honourable senators, I rise today to talk to you about Bill S-204, a strategy for chronic cerebrospinal venous insufficiency, or CCSVI, and the federal role in the investigation of CCSVI.

An estimated 55,000 to 75,000 Canadians live with multiple sclerosis. We are all familiar with this number. It tells us that far too many Canadians and their families are struggling with this frustrating and often debilitating disease. Honourable senators share their frustration. We also share their hope and determination that effective treatments and, ultimately, a cure will be found for this disease.

That is why our government is determined to support the investigation of chronic cerebrospinal venous insufficiency and the Zamboni procedure that has caused so much excitement for MS patients.

I agree with the honourable senator from Sydney, as does the government, that Canadians with MS deserve to know whether the hope and promise of the proposed new procedure rests on solid scientific foundation.

That said, I do not support this bill. The consensus among researchers from around the world is that more research is required.

One key element of Bill S-204 is a requirement that clinical trials on CCSVI be initiated. As honourable senators know, our government committed to supporting a clinical trial last June. About a month ago, the Minister of Health, Minister Aglukkaq, along with Dr. Alain Beaudet, president of the Canadian Institutes of Health Research, CIHR, announced that CIHR was ready to accept proposals for the Phase I/II for clinical trials on CCSVI. Based on the advice of the Scientific Expert Working Group on CCSVI concerning the terms of reference for this research, CIHR formally opened the request for proposals on November 30, 2011.

Honourable senators will be pleased to note that this research is a collaborative initiative between CIHR and the Multiple Sclerosis Society of Canada. The MS Society has told us they support further investigation of CCSVI and are co-funding the study.

Rigorous investigation is the only appropriate response with any new medical procedure. This is difficult for many, particularly with a disease like MS. However, patient safety must not be compromised. Nevertheless, the principles of disciplined scientific investigation cannot be cast aside despite how much we and MS patients might like to see the Zamboni procedure endorsed today. That would not be sound medical practice, nor would it be fair to MS patients. We must be certain that the benefits outweigh the risks. A clinical trial is the first step.

Clinical trials seek evidence on patient outcomes. The main objective of the forthcoming Phase I/II trial will be to determine whether the angioplasty procedure on veins is safe and effective.

It is important to note that venous angioplasty, unlike arterial angioplasty, is not common practice and there is, as yet, no unequivocal scientific evidence that the Zamboni procedure is safe and effective. Phase I will determine whether it is safe. Phase II will determine whether it is effective.

First and foremost, we need to ensure patient safety. In pursuing this trial through CIHR, the government is following the advice provided by the Scientific Expert Working Group.


Bill S-204 also calls for the establishment of an expert advisory panel to advise the minister on the CCSVI treatment, identify criteria for clinical trial research proposals, and advise on the standards for diagnosing and treating CCSVI.

This scientific expert working group reviewed the studies of CCSVI published between 2009 and 2011. These scientific experts recommended the launch of a request for applications — RFA — for a clinical trial and provided terms of reference to guide that research.

Bill S-204 also speaks of the expert advisory group advising the government on CCSVI treatment standards. The scientific expert working group and Imaging Working Group have already been doing some of this work. The Imaging Working Group met last fall to determine the best procedures to standardize imaging of veins in the neck and brain. These standardized ultrasound methods will ensure consistent assessments of the presence of CCSVI in clinical trial participants.

In brief, honourable senators, CIHR's scientific expert working group is already advising the federal government on how best to proceed with regard to CCSVI and MS patients. Why legislate this process when a CIHR scientific expert working group has already been reviewing evidence on CCSVI from around the world for some time now?

I would also point out that these MS initiatives have been supported by a wide range of stakeholders besides the MS Society of Canada. The MS Society has applauded the spirit of collaboration between the federal, provincial and territorial governments and continues to support work in this area.

As we continue to look at this bill, we see that it would require that the government track individuals who have received the Zamboni treatment for CCSVI. Here again, honourable senators, the government has been out front on this issue.

In March of this year, the Honourable Leona Aglukkaq, Minister of Health, announced the creation of a Canadian multiple sclerosis monitoring system. This system will gather and share new knowledge around the use of MS treatments across Canada and on their long-term outcomes. This information will prove to be useful for Canadians living with MS, for the health care professionals who manage their care, and for the researchers who are tirelessly working toward a better understanding of this debilitating disease.

The system, which will measure the benefits and monitor the risks, will be developed by the Canadian Institute for Health Information in collaboration with the Canadian Network of Multiple Sclerosis Clinics and the MS Society of Canada.

The Canadian Institute for Health Information, or CIHI, is an independent organization that analyzes information on the health system and the health of Canadians. This partnership with the Canadian Network of Multiple Sclerosis Clinics will allow for the collection of information from Canadians with MS on a voluntary basis.

It is estimated that the 22 member clinics of the Canadian Network of MS Clinics reach approximately 80 per cent of Canadians living with MS. Imagine the power of this tool to help patients, caregivers and researchers.

With information collected by the monitoring system, CIHI will produce reports on the status of MS and its treatment in Canada. I would like to point out that these initiatives are taking place at the national, pan-Canadian level and in close collaboration with provinces, territories and stakeholders. This speaks volumes about Canadians and how Canada works.

The bill before the chamber also calls for a conference of provincial and territorial ministers to develop a national strategy. Collaboration and dialogue have been at the centre of the government's approach on this issue from the outset. For example, the clinical trial announcement was made by Minister Aglukkaq at the federal, provincial and territorial health ministers meeting in Halifax on November 26, 2011.

Honourable senators, CIHR is committed to working with the provinces and territories as it moves forward with the trial.

The Deputy Minister of Health for Manitoba participates in the scientific expert working group as the provincial-territorial observer. We see similar collaboration within the emerging monitoring system.

CIHI is consulting with provincial and territorial governments, clinicians, technical experts and those with MS from across Canada to ensure the monitoring system's effectiveness and efficiency.

The Minister of Health has shown leadership every step of the way on this file, honourable senators. She has reached out to the MS Society of Canada and consulted with her provincial and territorial counterparts. Like us, and her fellow ministers of health in the provinces and territories, the minister is working to find the best way of moving forward and responding to the needs of those Canadians living with MS.

The government has already acted on the key elements of this bill. We have proceeded with prudence and caution. We have and are relying on the best available scientific evidence. The safety of Canadians is our foremost concern.

As it stands today, the research evidence on CCSVI is mixed. We have put in place the steps to support ethical research, grounded in international standards of excellence. The researchers will need to receive ethics approval from relevant institutional research ethics boards before conducting the trial. The funds will be released and the study will begin if and when ethics approval is granted.

Like all Canadians, we are seeking to better understand the impact this procedure might have on the quality of life of MS patients. We have taken these steps in open dialogue with the provinces and territories. That is why Bill S-204 is unnecessary; it would legislate a scientific and medical issue for which we already have a collaborative system in place.

To quote Dr. Beaudet: "Parliament cannot legislate science."

We in this Senate need to consider the implications of such legislation. Do we want to begin legislating when extensive action is already well under way? We need to use our legislative power prudently or risk diluting its value.

In brief, the government has a plan of action and through federal leadership, funding and collaboration, it is moving that plan forward. Canada is the only country to take on such a trial, demonstrating the government will to do everything it can to give MS patients the answers they need and deserve regarding CCSVI.

Unfortunately, this bill would neither contribute to those answers nor improve the processes already under way to further our understanding of MS and CCSVI.

Therefore, while I understand the goodwill and intentions behind Bill S-204, I cannot support it. Thank you.

The Hon. the Speaker pro tempore: Are there questions or further debate?

Honourable senators, this matter had been standing in the name of Honourable Senator Carignan, who is not here. Is it with your permission, honourable senators, that this matter be adjourned in the name of Honourable Senator Carignan?

Some Hon. Senators: Question.


The Hon. the Speaker pro tempore: Are honourable senators ready for the question?

Hon. Senators: Question!

The Hon. the Speaker pro tempore: It is moved by Honourable Senator Cordy, seconded by Honourable Senator Peterson, that Bill S-204, An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVE), be read a second time.

Is it your pleasure, honourable senators, to adopt the motion?

Hon. Senators: Agreed.

(Motion agreed to and bill read second time.)

Referred to Committee

The Hon. the Speaker pro tempore: Honourable senators, when shall this bill be read the third time?

(On motion of Senator Cordy, bill referred to the Standing Senate Committee on Social Affairs, Science and Technology.)
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