moved that Bill C-280, An Act to establish a National Strategy for Chronic Cerebrospinal Venous Insufficiency (CCSVI), be read the second time and referred to a committee.
Mr. Speaker, multiple sclerosis was, in her words, “quickly stealing her life”. In 2008 she began life in a wheelchair. In 2010 she had treatment for chronic cerebrospinal venous insufficiency, or CCSVI, to restore proper blood flow. Last week, she walked. She walked all day with her walker. In her words, “Damn, this is beautiful”.
In May 2010 my colleague, the member of Parliament for St. Paul's, and I wrote an open letter to the health minister, asking for clinical trials for CCSVI and a registry in Canada. We were ignored. There was no response.
I then had a four hour take note debate on CCSVI granted in June 2010. The neurological subcommittee I founded had four meetings on CCSVI. We heard from the leading international researchers, Dr. Zamboni, Dr. Simka, Dr. Haacke and Dr. McDonald. All said that clinical trials were need. This time the world's experts were ignored. The government did not budge.
In the summer, when I questioned a top-ranking CIHR official as to why we could not have a registry, he explained, “Because we don't know what is being done overseas”, and it was outside the mandate of the Canadian Institutes for Health Research, or CIHR. Why did he not know that in Poland, each MS patient is seen by a neurologist, has a doppler, an MRV, an eye test, pictures before and after the procedure and video of the actual procedure? Yet again, I was ignored.
Eventually the government put in place a political process to decide whether to go ahead with clinical trials.
In August 2010 the CIHR, in collaboration with the Multiple Sclerosis Society of Canada, convened a meeting of “top researchers”, with a special emphasis on neurovascular issues, including the recently proposed condition called CCSVI.
Why were international experts in CCSVI not invited to the August 26 meeting, given that all significant CCSVI research had been conducted internationally?
Why was Dr. Haacke not included, given that he is a world leader in imaging? Why was Dr. Simka, who by that point had performed more than 300 CCSVI procedures, not included? Why was no one with expertise and experience in treating CCSVI invited? Why were those who had publicly criticized the validity of CCSVI allowed to participate, given that they were biased?
It was an expert group with no experts in the imaging and treatment of CCSVI. Moreover, no data were presented from international scientific conferences, no site visits were made to labs and operating theatres, just blind acceptance of a handful of studies, including two which had been accepted for publication in an astounding six weeks.
One must ask why students were assigned to work on such an important literature review and what criteria the CIHR used to reduce the identified 19 PubMed studies to a list of just nine studies.
It was a cursory review, at best, by “top researchers”, particularly when two major conferences had taken place by August 2010 and over 1,500 procedures had been performed worldwide, with encouraging results in patients with relapsing-remitting MS and primary and secondary MS.
Astoundingly a large body of research examining the role of abnormal vasculature in MS was completely ignored, despite the fact that the CIHR was actually made aware of the long history of abnormal vasculature in MS in June 2010.
The first observations related to abnormal vasculature in MS in the literature appeared in Cruveilhier in 1839. Today there is extensive literature examining such areas as venous stenosis, cerebral hydrodynamics and venous hypertension, hypoxia, inflammation and cerebral plaques, vascular damage to nerves, as well as reduced perfusion and even loss of small vein visibility in MS.
Why was the information presented at the August 26 meeting regarding abnormal veins in MS and iron accumulation in MS brains omitted from the summary report?
By the time of the August meeting, eight provinces and territories were pushing for action on CCSVI. The president of CIHR was open to clinical trials and the president of the MS Society of Canada had asked for $10 million for clinical trials. How then could there have been unanimous agreement not to undertake clinical trials at the August 26 meeting when both presidents were in attendance at the behind closed doors meeting? Was it perhaps because on August 24 it was discovered that the president of CIHR did not have the money, that it was over committed by $10 million and that the Minister of Health would need authority from cabinet for new money?
On September 13 and 14, the federal-provincial-territorial ministers of health met in St. John's, Newfoundland. Who was present, what presentations and arguments were made regarding CCSVI, were all sides of the issue presented. Most important, why in some cases did provinces change their positions? Despite my freedom of information request, the list of expected participants at the St. John's meeting is blocked out, The list of experts is blocked out. The decision is blocked out. The considerations are blocked out.
Over the past 18 months, I have been personally in touch with over 1,500 MS patients across Canada. Of those, over 400 have now been treated and my data mirrors the international data, namely, one-third significantly improve, one-third moderately improve and one-third experience minimal to no improvement. Regardless, there are no drugs for the progressive forms of the disease and no drug has ever reversed the symptoms of devastating MS.
I receive three and four personal notes each week and innumerable phone calls detailing their progress. Many are primary and secondary progressive MS patients. Their changes include improved circulation, changes in the colour and temperature in their faces, hands and feet, a reduction in both searing nerve pain and constrictive pain, a reduction in brain fuzziness and improvements in motor function, vision and hearing. One Canadian said:
“I’m busting at the seams to let everyone know, I have... I had the...procedure...the benefits are phenomenal, my numbness on left side disappeared immediately, vision has improved tenfold...drop foot gone, fatigue gone. I walked the furthest I have walked in over two years 2 days after the procedure...benefits are PRICELESS.
How about the following? “I jumped, I jumped with my child”. “I wore a pair of shoes for the first time in three years. It may not seem like a big deal to you, but it's a big deal to me”. One man who has suffered for 20 years and walked with two canes has thrown them away and went horseback riding with his daughter.
I have asked hundreds of written questions of the government, I have hosted breakfasts for MPs and senators with Drs. McDonald, Hubbard and Haacke and with patients. I have attended six international conferences on CCSVI and no government official has ever attended one.
For over a year, the process failed Canadians with MS. It put in place a scientific expert working group with no CCSVI expertise or experience, 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 then published an article showing a relationship between CCSVI and MS 14 months after the August 2010 meeting. One must ask why an expert working group would have to contract out a literature review. It also analyzed interim and final results from seven Canadian and U.S. MS societies-funded studies, for which we already had answers.
While the government failed to put in place an expert working group, it did, however, manage to fast track in 2006 Tysabri, a drug which was known to cause a fatal brain infection. In a few short years, 181 people have acquired the infection and 38 have died as of November 1. Yet there was a hesitation to undertake clinical trials for angioplasty, a procedure undertaken daily in hospitals across the country.
Canadians with MS deserved science and they deserved evidence-based medical practices. Sadly, MS patients could not have evidence-based practices if their government refused to collect any evidence either through clinical trails or a registry.
Finally, in March 2010, 10 months after our initial request, the government reversed its position and announced a registry for MS, although no details or timeline were given for its implementation.
Tragically, tracking the patients will not begin until July, 2012, 31 months after Canadians began travelling overseas for treatment.
Since when do scientists fail to collect data? As one Canadian neurologist, who had the CCSVI procedure, said to me, “If we had collected the evidence in a registry for the last many months, would we still be calling these anecdotal stories?” This sentiment has been echoed by numerous physicians with MS who have had the procedure, who have written to me, although afraid for their careers, and have begged me to continue fighting because “the procedure works”.
On June 20, we welcomed the New Hope for MS Tour to Parliament Hill and we announced that we would table bills in both the House of Commons and the Senate, calling for a national CCSVI strategy and clinical trials. We were all enormously grateful to the caring, compassionate, tireless advocate, Senator Jane Cordy.
On June 28, CIHR's expert working group met and, on June 29, the Minister of Health reversed her position and announced clinical trials.
Up until two weeks ago, all we had were announcements for clinical trials and a registry. Canadians with MS across the country understand the cynical politics of two weeks ago. They understand that Motion No. 274 was moved up to be debated before this bill. They understand that the motion keeps the status quo.
Specifically, the following groups were against Motion No. 274: CCSVI Alberta/Edmonton, with 2,000 members; CCSVI in MS Toronto, with 3,200 members; CCSVI MS Nova Scotia, with 1,333 members; and CCSVI Ontario, with 422 members, totalling more than 7,500 Canadians with MS and their families.
MS patients also understand and are deeply offended by the announcements for phase I/II trials on November 25, which was to pre-empt this bill. They understand that it will take roughly three years to proceed with the phase III trial, or a randomized, controlled multi-centre trial with large patient groups. MS patients say that November 25 was a sad day for all Canadians living with MS. They are calling it “Black Friday”.
My bill calls on the Minister of Health to convene a conference with the provincial and territorial ministers responsible for health for the purpose of establishing a national strategy for CCSVI in order to: ensure that proper health care is not refused to a person on the grounds that that person is seeking or is obtaining the treatment for CCSVI outside of Canada; identify the most appropriate level of clinical trials for the treatment of CCSVI in Canada in order to place Canada at the forefront of international research; estimate the funding necessary to undertake those clinical trials in Canada; establish an advisory panel to be composed of experts who have been or are actively engaged in imaging or treating individuals with CCSVI; and ensure that clinical trials begin in Canada by March 1.
Leading CCSVI physicians and researchers in North America recommend an “Adaptive Phase II/III trial”. I have a copy of that letter here. They recommend that clinical trials for the CCSVI procedure occur in multiple centres across Canada with a large patient group.
Finally, I beseech, I implore the government to do the morally right thing and heed the science and undertake adaptive phase II/III trials. Eighteen months have passed since our initial request for clinical trials. On average, 400 Canadians die of MS each year. By the end of this year, 800 will have died from MS related complications or suicide, while the government ignored the science. Thirty-one months will have passed by the time the government implements a registry.
There is no excuse not to image. Imaging is safe. There is no excuse not to treat. Angioplasty is an established, low-risk standard of care. There is no excuse not to undertake clinical trials that would put Canada at the forefront of medical research.
Canadians with MS are waiting, getting sicker and, in some cases, dying. I am profoundly sorry that the government abandoned Canadians with MS in their hour of need. I am sorry that they had to beg for the health care they paid into all their lives. The government must fight for families, develop a national strategy and undertake adaptive phase II/III trials.