Ms. Kirsty Duncan (Etobicoke North, Lib.): Monday, October 25, 2010
Mr. Speaker, last week, the Parliamentary Secretary to the Minister of Health said:
We are currently awaiting the results of seven clinical diagnostic trials....
If the medical experts agree that there is sufficient evidence to warrant
clinical trials, then our government will fund them.
I would like to address the seven correlational studies being undertaken,
question the need to replicate these studies and argue that there is in
fact sufficient evidence to warrant clinical trials in Canada now and
that our government should fund them.
In countries around the world. evidence now exists that 80% to 97% of MS patients show one or
more venous abnormalities. This is higher than ultrasound or MRI because
angioplasty, the gold standard, was used. These studies were undertaken
in separate centres in space and time by separate operators and yet
show similar results. Why will the government wait another two years for
repeat studies?
Time is brain in MS and patients cannot afford a two year delay. Thirty percent to 50% of MS patients who are
untreated worsen by one EDSS score in one year. Fifty percent with
relapsing remitting MS later develop a progressive form of the disease
for which there are no drugs, and up to two-thirds of patients
experience cognitive impairment, which can affect daily functioning,
employment and social life.
There is a well-known rationale for supporting an association between MS and venous obstruction, namely,
MS plaques are venocentric, as identified by Rindfleisch as early as
the 1800s and Putnam in 1935 who said it was “...almost inevitable that
venular obstruction is the essential immediate antecedent to the
formation of typical sclerotic plaques”.
Increased iron content in plaques and vessel wall may be a biomarker of tissue damage
and may be caused by changes in vascular flow and increases in
intracranial pressure.
There may be as many as 48 categories describing the types of vascular abnormalities in the chest, neck and
spine that have now been identified by Dr. Haacke, a world leader in
diagnostic imaging. These abnormalities include: stenosis in one or more
major veins draining the brain; truncular venous malformations; lack of
flow in one or more of the major veins; malfunctioning or stuck valves;
reflux in the deep cerebral veins or the jugular veins meaning that
blood flood actually reverses and travels toward the brain instead of
draining to the heart; and other abnormalities.
Astonishingly, one patient was actually born without jugulars, the deep cervical veins
substituted. In other patients the deep cervical veins and vertebral
vessels are almost non-existent.
Over 3,000 procedures have been undertaken worldwide in over 50 countries. More important,
neurologists are seeing their patients get better, with reduced brain
fog, fatigue and improved circulation and motor skills, as demonstrated
through improved EDSS scores.
As Dr. Zamboni, the pioneer of the technique, told the neurological subcommittee last June, the
diagnosis and treatment of CCSVI are safe, had resulted in significant
improvements in the quality of life of many MS patients and that
clinical trials were needed.
Why is the government refusing to undertake clinical studies? Why not follow Canadian patients who felt
forced to seek treatment overseas? Why lose this important data? Why not
lead instead of follow 50 other countries and yet refuse to ask for
their data and expertise? Most important, why ensure that Canadians be
subjected to devastating MS for at least another two years?
Ms. Kirsty Duncan (Etobicoke North, Lib.): Tuesday, October 19, 2010
Madam Speaker, MS patients are deteriorating and their frustration is
growing, further hurting their disease. There is only one thing worse
than having devastating MS, and that is knowing the liberation procedure
might improve quality of life and being denied access to trials.
The parliamentary Subcommittee on Neurological Disease had four meetings
with the world CCSVI experts, including Dr. Zamboni, who said the
diagnosis and treatment of CCSVI were safe, had resulted in significant
improvements in the qualify of life of many MS patients and that
clinical trials were needed.
While I personally met, spoke with and reviewed data with leading CCSVI researchers internationally,
including Dr. McDonald, the only Canadian who has been trained by Dr.
Zamboni and has performed the procedure in Canada, and Dr. Haacke, a
world leader in diagnostic imaging, the government actually refused to
listen to the subcommittee experts. Our committee heard from the best
and brightest.
Is this a new trend, as people at the August 26 meeting also refused to listen to experts, supposedly for fear of
biasing the sample? Yet two witnesses had previously spoken vehemently
against the procedure.
There was important pertinent information that the August 26 reviewers missed, possibly 25 different
venous abnormalities in the neck and chest, including missing jugular
veins, truncated jugular veins at the clavicle, in the middle of the
neck, spider veins, stenosed veins, string-like veins, imaging of iron
deposits in the brain, video of reflux in the deep cerebral veins, the
internal jugular veins and flow or lack thereof in the internal jugular
veins. MS patients with primary and secondary progressive disease can
also experience an improvement in brain fog, circulation, fatigue and
motor skills.
Patients do not want to wait possibly two more years for the results of seven correlation studies. MS patients have
done their homework and know that researchers from Bulgaria, Canada,
Italy, Kuwait, Poland and the United States are all presenting similar
results, namely, that 87% to 97% of MS patients show venous abnormality.
Patients want clinical trials. MS patients know 3,000 procedures have been done
worldwide and understand the hypocrisy that after just 27 procedures
with a stroke sucking vacuum, the vacuum was deemed safe enough to
implement in 10 Canadian hospitals.
The government should know that its August 26 ruling, based on the narrowest possible review of
science, is already forcing desperate MS patients overseas. What
assurances do Canadians have that they are going to a reputable clinic
with adequately-trained people who have undertaken a sufficient number
of procedures and what follow up is available to Canadians, as many must
often return overseas?
The government should also be aware that some doctors are refusing to treat their patients upon their
return. I am hearing from patients across the country that their
appointments are being cancelled and not re-booked, liver tests for MS
drugs are being cancelled and several have been threatened with, “No
doctor will treat you should you develop a blood clot”. This is illegal
and unethical.
I implore the government to do its job, which is undertake what it failed to do this summer. Science can only progress
through reviewing all of the available evidence, from meeting and
speaking with those engaged in the science and treatment, to asking if
they are willing to share their expertise and results, to reviewing the
published material, to doing site visits to labs and operating theatres
and to come to a conclusion based on evidence, all of the evidence. The
longer the delay, more will sicken and die.
==
Ms. Kirsty Duncan (Etobicoke North, Lib.): Wednesday, September 22, 2010
Madam Speaker, Canadians living with multiple sclerosis are fighting their
disease and fighting for clinical trials for the new liberation
procedure for chronic cerebrospinal venous insufficiency, or CCSVI.
We had a parliamentary subcommittee on neurological disease that heard
four hours of testimony from the leading researchers in the world on
CCSVI, including Dr. Zamboni, who pioneered the liberation procedure,
and Dr. Simka, who has undertaken the most procedures globally. These
researchers indicated that, according to their initial studies, both the
diagnosis and treatment of CCSVI were deemed to be safe and have
resulted in significant improvements in the quality of life of many MS
patients.
Instead of listening to the leading researchers internationally, the government chose to accept the recommendations of a
panel, held behind closed doors with no minutes. Why were only nine
papers reviewed? Why were no leading experts called for their expertise?
Where was the scientific rigour in making sure panellists were not
biased?
At the end of July, I travelled to New York to learn the latest science at an international symposium for CCSVI. Researchers
from Bulgaria, Italy, Kuwait and the United States were all presenting
similar results, namely that 87% to 90% of MS patients show venous
abnormality. Of the 400 cases reviewed by Canada's Dr. McDonald, 90%
show a venous problem.
We need evidence-based medicine in Canada. The question I have is why have we not been collecting it? There
are two ways to collect evidence and we have been calling for both:
clinical trials and a registry. When I spoke to a high-ranking official
in July, I was told a registry was not possible because “we have no idea
what is being done overseas”. I explained that it was not exactly true.
For example, in Poland, each patient is seen by a neurologist and has
an MRV, a Doppler scan, and an eye test. Before-and-after liberation
photos are taken, and during the actual procedure there is video.
Finally, a long, complicated form is filled out, including EDSS scores.
It seems to me as a scientist that there is data to be collected.
I would like to identify some incongruities. Over the last four decades,
only 7% to 20% of surgeries performed in hospitals have ever been
double-blind tested, yet detractors of the liberation theory are
insisting on sham surgeries in some of society's most vulnerable.
Often in medicine, when a treatment shows promise, it is fast-tracked. A
recent example is a new device that can suck out stroke-causing blood
clots. Very quickly, 27 patients across 10 hospitals were rescued from
strokes by the device.
Over 1,500 liberation procedures have been performed worldwide, yet we are told there is not enough evidence
for clinical trials in Canada.
As an example from MS, a few years ago a drug that was known to cause a fatal brain infection was
fast-tracked, and 68 people have acquired the infection and 14 have
died. Yet there is the hesitation to undertake clinical trials for
angioplasty, a procedure undertaken daily in hospitals across this
country.
I am in touch with over 1,000 MS patients across this country. I have a list of over 150 people who have been liberated. One
toddler said, “My mommy's not broken anymore”. One woman who was a
quadriplegic is now writing.
I am also in contact with physicians who themselves have been liberated. As one explained, “My
province allowed me to practise for decades, but after liberation, I
cannot even get a hearing”. He questions, “If we had collected the
evidence in a registry for the last many months, would we still be
calling this anecdotal stories?”
==
Detail Links of comments:
On our first day back in Parliament, I read the following statement (1 minute):
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&Parl=40&Ses=3&DocId=4656017
On our third day back, I presented the following (5 minute-late show; if you go to the link, scroll down to 6:30)
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&Parl=40&Ses=3&DocId=4658923#OOB-3280397
I have since presented two more late shows regarding CCSVI.
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&Parl=40&Ses=3&DocId=4699810#OOB-3383977 (scroll down to ~6:45 pm)
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&Parl=40&Ses=3&DocId=4716906#OOB-3409859 (scroll down to ~6:45 pm)
http://www.facebook.com/note.php?note_id=145189825527219&id=100001004163324