Speech by Senator Jane Cordy

The following is a speech about MS and CCSVI given to the senate on June 5 by Senator Jane Cordy... worth reading:

Multiple Sclerosis and Chronic Cerebrospinal Venous Insufficiency

Resuming debate on the inquiry of the Honourable Senator Cordy, calling the attention of the Senate to those Canadians living with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI), who lack access to the "liberation" procedure.

Hon. Jane Cordy: Honourable senators, I am pleased to speak on my inquiry and to bring to your attention the thousands of Canadians living with multiple sclerosis and chronic cerebrospinal venous insufficiency, or CCSVI. These Canadians and their families continue to plead with this government to move ahead with supporting the CCSVI treatment procedure within the Canadian health care system.

I would like to take a moment to thank Dr. Kirsty Duncan, the Liberal Member of Parliament for Etobicoke North, for the tremendous work she has done for those with MS. In addition to being a Nobel Prize winner, as part of a panel on climate change with Al Gore, she was recently awarded the Pioneer in Healthcare Policy Award by the Society for Brain Mapping and Therapeutics. She was recognized as being one of the best advocates of brain research in Canada.

Honourable senators, 75,000 Canadians live with the progressively debilitating disease multiple sclerosis; another 1,000 are diagnosed with the disease each year. Canada's prevalence rate of MS is among the highest in the world, at 240 per 100,000 people.

The suicide rate for MS patients is a staggering seven times higher than the national average. This is a shocking statistic and indicative of the hopelessness many MS sufferers feel toward finding relief from their symptoms.

Honourable senators, I believe passionately that those Canadians with CCSVI should have access to our medical system. One of the five principles of the Canada Health Act is accessibility. Yet many Canadians with MS have been treated badly by our health care system, and some have even been refused treatment.

Venous angioplasty for those with CCSVI is taking place in over 60 countries around the world. As honourable senators know, Canadians with CCSVI must travel outside Canada to have the procedure done. We are promoting medical tourism here in Canada.

I would like to thank Premier Brad Wall of Saskatchewan who announced on January 12 of this year that his government would support clinical trials for residents of his province. My understanding is that 80 patients have already been selected to go to Albany, New York, which has the largest CCSVI treatment clinical trial of its type. Many Canadians who have travelled to other countries have done so at great financial hardship. One gentleman I met remortgaged his home, others have had community fundraisers, and others have used their savings. This is Canada, where medicare was brought in so that Canadians should not suffer undue hardships as a result of an illness. Unfortunately, some Canadians with CCSVI are suffering financial hardship. Even worse, when they return to Canada, some are refused follow-up care.

Does venous angioplasty work miracles for everyone who has the procedure? From what I have read, one third of patients have tremendous improvement. They would be the so-called "miracles," the ones who go from being bedridden to walking. One third have some improvement, and one third have little to no improvement. If we had our registry in place, which was announced over a year ago, we would have better made-in-Canada data.

Health Canada should support clinical trials in Canada and provide follow-up care to ensure the safety and well-being of those Canadians who choose to have the procedure done, whether here in Canada or abroad. It is shameful how many Canadian MS patients who had the procedure done abroad are denied follow-up care by our health care system. These are Canadians who want and deserve the opportunity to get back some semblance of a regular life, to regain some quality of life.

I am concerned about the CIHR's expert working group set up to study CCSVI. I have spoken in this chamber before regarding this working group. According to the CIHR website, the working group's mandate is:

• The scientific expert working group will make recommendations on further studies including, if appropriate, a pan-Canadian interventional clinical trial that would evaluate the safety and efficacy of venous angioplasty in patients with MS, and will provide advice on the protocols to expedite such a trial (e.g. inclusion/exclusion criteria).

Honourable senators, this is a very important mandate, an important mandate for those members of the expert working group. All Canadians would assume that those on the expert group would be independent and, equally important, would be seen to be independent. We, as politicians, understand the importance of public perception. In fact, honourable senators, Dr. Sandy MacDonald, Dr. Haacke and Dr. Zamboni were not included in the August 26, 2010 joint CIHR-MS Society meeting. The explanation given was that their work would be discussed and including them might bias the discussion. In fact, Dr. Sandy MacDonald, who has performed venous angioplasty on MS patients, and who has a diagnostic imaging clinic in Barrie, Ontario, and whose office trained the imaging diagnostic team in Saskatchewan, was not included as part of the diagnostic imaging meeting held by CIHR last fall. One of the country's leading experts was not invited to be there.

Honourable senators, Dr. Barry Rubin is a member of the CIHR expert working group. He is also the third author of an article called "The 'Liberation Procedure' for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand" in the May 2012 Journal of the American College of Radiology, volume 9, issue 5.

Honourable senators, I am not questioning any doctor's right to their opinion on multiple sclerosis or CCSVI, and I am not questioning their right to publish medical articles on CCSVI. What I am questioning is that a supposedly unbiased, independent member of the expert panel would publish such an article.

One has to question whether this will prejudice the ethical board reviews for CCSVI trials.

This is clearly a conflict of interest and I would hope that Dr. Rubin would step down from the panel of experts. The fear among members of the CCSVI community that have been in contact with me is that the expert panel can no longer be seen as independent, and they fear that perhaps the government's announcement of phase I clinical trials is not meant to proceed but is, in fact, being set up for failure. That would truly be unfortunate. The study should be open, transparent and, above all, should be conducted without bias. This is what Canadians deserve. This is what the CCSVI community in Canada deserves.

Honourable senators, there is a great concern with the CCSVI community that while the government fast-tracked Tysabri and Gilenya for use by MS patients, the government has been reticent about clinical trials for venous angioplasty. Tysabri is known to cause PML, or progressive multifocal leukoencephalitis, which is a rare and usually fatal viral disease. This drug, which was fast-tracked by Health Canada for use by MS patients, has now infected 232 people with PML and killed 49 others worldwide. Gilenya, the other drug fast-tracked by Health Canada for MS patients, has now killed 11 people and is currently under review in Canada.

Unfortunately in Canada, when a drug is under review, we, as Canadians, receive little or no information about the whys or, indeed, about the process of the review. By the way, Gilenya is not supposed to be given to people with a vascular condition, so it should not even be taken by those with CCSVI.

So you see, honourable senators, the drugs Gilenya and Tysabri have been fast-tracked for MS patients, but the venous angioplasty clinical trials for MS patients with CCSVI continues to move at a snail's pace. In fact, we still have not begun to keep records of those who have undergone the procedure. The establishment of a registry was announced in March 2011. The registry is supposed to start in September 2012. We will have lost a year and half of evidence related to venous angioplasty. We could have been tracking and collecting data for those who have had the procedure. We would have had some data on the results one month, three months, nine months and a year after the procedure has been done. Honourable senators, we cannot get this time back.

Honourable senators, on May 10 of this year the FDA issued an alert on the potential dangers of the liberation procedure to treat CCSVI. The FDA regularly issues warnings for pharmaceuticals or medical procedures. These warnings are a positive thing. The more informed a patient is about a drug or procedure, the more informed their decision will be about what course of treatment they wish to follow. These types of warnings provide greater patient safety and transparency. In fact, our Social Affairs Committee has heard over and over again the need for openness and transparency for clinical trials in Canada. The FDA does say, "There is no clear scientific evidence that the treatment of internal jugular or Azygos venous stenosis is safe in MS patients." In fact, this is incorrect as there have been four published studies which conclude otherwise.

As Dr. Bill Code, an anesthesiologist from British Columbia, and a CCSVI patient who has had venous angioplasty, stated:

It's important to take it in perspective. If there has been one direct death, perhaps two, in say 12,000 cases, that's still much less than we're getting from some of the drugs used every day in multiple sclerosis.

Dr. Rob Zivadinov, a neurologist and lead researcher in the largest CCSVI study taking place in Buffalo, New York, concluded that CCSVI does exist, and it is not unique to MS.

Honourable senators, I had the pleasure of hosting a breakfast on CCSVI with Dr. Kirsty Duncan. One of the presenters was Dr. Joseph Hewett, an interventional radiologist and phelbologist. Dr. Hewett was born in Manitoba, but works in the United States. He jokingly said that he works in the United States, but treats a lot of Canadians.

Dr. Hewett currently diagnoses and treats patients with multiple sclerosis and other neurodegenerative disorders using MRI, ultrasound and venous angioplasty, and he has been doing so for over 15 years. The techniques being used to treat blood vessel abnormalities in MS patients are the same techniques that have been used for decades. There is a large and increasing amount of research showing an association between diseases like MS and the blood vessels. As Dr. Hewett said, with a blockage it may take decades for the problems to accumulate, but over the course of years the results of these blockages in the outflow compound themselves. We know that blood vessels play a major role in neurological disease.

Honourable senators, even if you doubt that venous angioplasty for those with CCSVI works, should you not at least get as much information as you can?

As Dr. Hewett said:

• The overwhelming number of patients with MS who have had an improvement in their health as a result of changing the plumbing from their brain should be proof enough that we need to look at this closer — that we need to figure out what is valid and what is not regarding our understanding of the subject. We owe this to the hundreds of thousands of Canadians who are afflicted by neurodegenerative diseases and to the millions of Canadians who care for them.

Honourable senators, I am certain that most of us know someone with MS. Should they have travel to Mexico. Poland or the United States for venous angioplasty? This is a procedure that has been done for decades in Canada. It is performed for Budd-Chiari Syndrome and May-Thurner Syndrome across Canada.

The practice of medicine is continuously changing and evolving. As patients, we must always weigh the benefit-risk ratio of a medical procedure or a medication. Do I take the medication with its risks, or do I not? Do I have the medical procedure with its risks, or do I not?

Honourable senators, I will leave you with these thoughts from Christopher from Nova Scotia:

• As an MS patient I have always been willing to take the risks of increased liver damage, possibility of developing leukemia, increased risk of cardio toxicity . . . and these are with the drugs. I took the "risk" of venous angioplasty. And I won that gamble . . . more than I can say about the risks of the drugs where I came out short-changed.