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Thursday, May 13, 2010

Complete Statement of Dr. Sandy McDonald- May 11
Thanks to Carolyn for hosting this as a pdf
Thanks to Wayne for sending me the pdf.

...and biggest thanks to Dr. Sandy McDonald---for using his own funds to test and study CCSVI in MS patients, for caring enough about MS patients to investigate and treat CCSVI. For being a true scientist and doctor. We are indebted to you, Dr. McDonald.

Statement of Dr. Sandy McDonald, May 11, 2010
before the
of the
May 11, 2010
(passages in italics not delivered orally; no footnotes delivered orally)

Madam Chair, Madam Vice-Chair, Honourable Members,
We will speak today of CCSVI.
CCSVI is a serious vascular problem. I am a vascular surgeon.
Thank you for this opportunity to address your Subcommittee on this matter of great
importance and, in my opinion, of great urgency.
You have the chance to help to put an end to an enormously troubling situation in which
thousands of innocent victims of Multiple Sclerosis are condemned to a slow or rapid
deterioration of every aspect of their lives, and are deprived of a simple procedure
available to
Every single Canadian found to suffer from a venous abnormality preventing blood from
draining properly from an organ, an abnormality treated perfectly easily by an
angioplasty, an intravenous ballooning procedure which stretches the abnormality away,
can easily get this treatment. Every single Canadian, that is, except those already
diagnosed with MS.
The cruel irony is that this procedure, if used to correct the abnormal cerebrospinal
venous flow, appears quite clearly to help those with MS. At present, however, the
diagnosis of MS precludes patients from this procedure.
I am here to ask you to help remove the obstacles which make it impossible for MS
sufferers to obtain treatment for Chronic Cerebrospinal Venous Insufficiency, and
impossible for doctors to give that treatment even as a matter of compassion.

Statement of Dr. Sandy McDonald, May 11, 2010
I am a cardiovascular surgeon.1 I practise in Barrie, Ontario.
I also founded a company called Barrie Vascular Imaging2, which performs imaging
services on referral from doctors across Canada and, indeed, around the world. I am the
sole shareholder and the President of BVI.

One day, not so long ago, BVI suddenly experienced a flood of calls for imaging to
diagnose venous abnormalities sufficient to cause the brain-drainage problem CCSVI.
We were receiving, and continue to receive, about a thousand calls a week. Many of
these calls, are in themselves heart-rending pleas for help from utterly distraught patients,
parents and spouses.
I researched the matter to see what might have prompted this flood of pleas for help. I
found the news about Dr. Paolo 3 and work on the diagnosis of
CCSVI. At BVI, we started to do some of the imaging requested, and found that an
astonishing percentage of the cases did indeed present verifiable, diagnosable
abnormalities. At first, we found these abnormalities in about 75% of cases.

I realized I was uncertain about finding all the abnormalities. There are five veins
principally responsible for the draining, one of which the azygos running down beside
the heart is impossible to image from the outside and the other four of which, the two
vertebral veins running down the back of the neck and the two jugular veins running
down each side of the throat, have not been the traditional target of ultrasound imaging.
Furthermore, the abnormalities can be of various kinds. Valves inside the vein, meant to
keep the blood flowing the right way, can be faulty or even reversed. Veins can have tiny

(1 I am an FRCS(C) specialist in general surgery and in cardiovascular and thoracic surgery. My certifications are as follows:
ARDMS Certification RPVI 2007
Recertification exam American Board of Surgery 2004
ARDMS certification RVT 1999
Recertification exam American Board of Surgery 1993
B.F.R.C.S. (C) Cardiovascular & Thoracic Surgery 1984
American Board (General Surgery) 1983
F.R.C.S. (C) General Surgery 1982
2 http://www.barrievascularimaging.com/index.htm.
3 http://jnnp.bmj.com/content/80/4/392.full.
Statement of Dr. Sandy McDonald, May 11, 2010
3 internal obstructions or unusual sharp bends or narrowings which obstruct good blood
flow. )

I went to Italy and met with Dr. Paolo Zamboni and he kindly gave me the training
needed to detect the abnormalities and, on the basis of a rigid protocol, to diagnose
BVI is now using Dr. Zamboni's technique and is finding abnormalities sufficient to
diagnose CCSVI in upwards of 90 percent of patients referred to us with MS.4
I am now sharing these diagnostic techniques with others.
I want to make it very clear. We are not finding something which is not there. We are
not using imaging which lies about the obstruction. We are not overdiagnosing these
obstructions. The obstructions are there.
Doing this diagnosis by ultrasound presents no risk to the patient.

It is too early to say whether CCSVI is actually causing the MS or even whether it is
worsening it, or whether the angioplasty in MS patients suffering from CCSVI will
predictably help them with their MS.
However, it is not too early to say that the logic of such connections is very plausible and
makes good scientific sense, and that the anecdotal evidence is already very compelling.
The logic is this. We know that patients with MS have a build-up of iron in deep brain
tissue, an area close to the draining veins.5 It is plausible that the compromised venous
drainage causes red blood cells, laden with iron, to leak from the thin-walled veins into
the brain tissue. As the leaked red blood cells break down, iron is deposited, an immune
response follows and nerve damage develops.
The anecdotal evidence is, as I say, very compelling. More and more doctors are
acknowledging the correlation between CCSVI and MS6, more and more countries are
acknowledging CCSVI as a formally approved diagnosis, and the experience of Dr.
Paolo Zamboni and now the experience of Dr. Marian Simka in Poland, is that virtually
all CCSVI sufferers with MS who undergo the corrective angioplasty experience a
lessening, sometimes dramatic, of their MS symptoms.

(4 In fact, these abnormalities are found very highly disproportionately in MS patients compared to non-MS
patients. We have done 130 imagings so far.
5 http://www.ncbi.nlm.nih.gov/pubmed/20351671;
6 http://ms-info.ca/node/22039.
Statement of Dr. Sandy McDonald, May 11, 2010 )

I have proceeded beyond diagnosis to refer patients for angioplasty in six cases. All six
have seen significant improvement; four of them have seen dramatic improvement.
There have been no adverse effects.
So, as I say, it is scientifically too early to conclude that there is a causal relationship
between CCSVI and MS or a one-to-one relationship between the angioplasty and MS
relief, but the evidence is already very promising.
For your purposes here, I think things can be said this way: if indeed there is a causal
relationship between diagnosable CCSVI and the MS or just the worsening of MS,
refusing the angioplasty and insisting that MS sufferers stick with only the traditional
treatments is insisting on treating the symptoms at huge expense rather than going after
the cause at very low expense. There is no compelling reason to wait before we take the
low-expense route, and there is no reason at all to force MS patients simply to put up with
a diagnosed restriction in normal blood flow.

Angioplasty is a well-known, universally practised procedure. Interventional radiologists
do it virtually every day. It is very low-risk. Angioplasty is commonly used for venous
obstructions (Budd-Chiari syndrome, May-Thurner syndrome, caval interruption).
Dialysis patients commonly require angioplasty to repair a venous stenosis (caused by a
dialysis catheter) and this can be in the jugular veins. There is nothing special about
venous angioplasty. The angioplasty we speak of for jugular and azygus veins7 is a 2-3
hour out-patient visit done under local anesthesia.
There is in my opinion nothing special about angioplasty8 in these veins rather than
somewhere else.9

(7 The vertebral veins are too small for current angioplasty techniques.
8 Angioplasty came into general acceptance without any of the generalized trials now demanded by some
before we can get on with treating CCSVI. As he wrote in his recent, May 6, 2010, The Mednews Express blog, Dr. Lorne Brandes, wrote (http://healthblog.ctv.ca/post/Treating-CCSVI-What-can-we-learn-from- coronary-angioplasty.aspx)
: )
"One would have to be forgiven, then, for suggesting that, had Dr. Zamboni made his discovery in with little or no hesitation, by the eager Gruentzig disciples of that era, and certainly without the stringent time-consuming clinical trials required in the 21st century.
Am I advocating a return to the past? No. But it is certainly sobering to learn that balloon
angioplasty, a highly effective, often life-saving procedure in wide use today, went through
neck veins without years of further study. "
9 Some clinics outside Canada proceed not only by angioplasty but also by the positioning of a stent at the position of abnormality. Dr. Simka is reported to have done this in about 100 cases, without any reported problems. Dr. Zamboni prefers to avoid the stent and to rely on the ballooning angioplasty. So do I. See also http://healthblog.ctv.ca/post/Treating-CCSVI-What-can-we-learn-from-coronary-angioplasty.aspx.)

Statement of Dr. Sandy McDonald, May 11, 2010
A previous witness here, Ms Laurel Radley has told you that the angioplasty in CCSVI
patients with MS has shown a 0/750 risk.

For reasons I do not fully understand, some doctors, some hospitals, some clinics, some
imaging companies have decided that MS patients ought, for no other reason than their
MS, to be deprived of the angioplasty.
For no other reason than their MS they will be deprived of a simple, straightforward
procedure that might actually help them.
As your previous witness Ms. Laurel Radley has explained and as I have seen as well,
some vascular specialists or hospitals with vascular specialists have refused to take
referrals of MS patients from their family doctors and insist on the referral coming from
neurologists (or refuse the MS patients altogether). With the greatest of respect for
neurologists, this puts the patient in a position akin to being refused the help of a
plumber, for a real plumbing problem, unless the electrician permits.
I am a cardiovascular surgeon. I fix blood flow. I am in that sense a plumber.
When I see a plumbing problem, particularly one which deprives the whole house of
good clean water, I want to fix it. When I see the whole house suffering, I want to fix the
pipes. I can do that without harming the wiring in any way and do not see why we
condemn the family to misery while we wait for the electrician.
Just this past week, I had to tell a young patient, whose young life is being expropriated
by MS, that I had found a clear obstruction in the blood flow from her brain. I had to tell
her that this obstruction clearly bears responsibility for her fatigue and likely bears
responsibility for other health problems, too. I could tell her that the technology exists to
correct this anomaly quite easily, quite cheaply and without undue risk. But I had to tell
her that the world as it is makes it impossible for that simple procedure, of a kind
available to everyone else, to be offered to her.

She is not the only one. She is one of thousands. You have only to look at the blogs and
MS websites to know that there are tens of thousands of MS patients in Canada who
simply do not understand10 how it is possible to justify discriminating against them in this
way and depriving them of the chance to find some kind of respite.

(10 http://www.facebook.com/pages/CCSVI-in-Multiple-Sclerosis/110796282297;
http://winnipeg.ctv.ca/servlet/an/local/CTVNews/20100505/wpg_CCSVI_100505/20100505/?hub=WinnipegHome; )

Statement of Dr. Sandy McDonald, May 11, 2010
They are right not to understand. You should not understand, either.
Unless we put an end to this Kafkaesque and perfectly discriminatory situation, we will
very predictably see, besides the misery we all know that MS sufferers and their families
must endure, besides the loss of quality of life and of productivity, besides the great cost
of current treatment, these dangers:
a) MS sufferers will go underground to seek diagnosis of CCSVI. This will increase
the risk of faulty diagnosis.
b) MS sufferers will go underground for the angioplasty, or go abroad,11 to doctors
whom they do not know and who are unpoliceable by Canadian medical orders
and governments.
c) MS sufferers will go to Canadian doctors whom they do not know and will lie
about their history in order to avoid the discrimination they know they will face if
they tell the truth.
d) MS sufferers will launch costly class actions which will needlessly clog our courts
and cost us all as a society.
e) MS sufferers will sue their doctors and hospitals for refusing them treatment on
the basis of spurious and in any event utterly discriminatory reasons.
f) A disproportionately large percentage of MS sufferers will, in their deepening
frustration and desperation, resort to suicide.
In my opinion, we will also see, among the general population, a gnawing worry that
government is there not to help us but to find ways to hurt us.12

Yes, more study is needed. I am happy to contribute to the study. Indeed, through BVI, I
am doing diagnostic imaging which will help to establish what the correlation is between
The recently requested $10,000,000 for study13 by the MS Society is a good start but it
will not help any MS sufferer in the meantime and it is fatally partial if it does not include

11 Facebook discussion (see the site in the previous footnote) makes clear that intelligent, articulate people are already lining up trips not only to Italy and Poland, but to Scotland, Bulgaria, Japan, India and other destinations. See http://www.thebarrieexaminer.com/ArticleDisplay.aspx?e=2559231.
12 http://www.canadafreepress.com/index.php/article/22838.
13 http://www.theglobeandmail.com/news/politics/ottawa-notebook/two-mps-push-liberals-to-go-positive-
for-a-change/article1561031/; http://www.msscoiety.ca/en/releases/nr_20100505.htm. )

Statement of Dr. Sandy McDonald, May 11, 2010
a treatment arm for CCSVI. We will only learn the efficiency of the treatment if we
actually do it. If the study is used as an excuse to do nothing while we wait for the
results, 8 to 10 years, it will actually hurt MS sufferers.
We cannot wait while we study. We cannot tell the MS patients just to wait. We cannot
continue to disqualify MS patients from an angioplasty correction of CCSVI just because
they have MS.
One day, the provincial health authorities will decide that angioplasty to correct CCSVI
in MS patients ought to be paid for as part of our universal health care. One day, they
will realize that doing this will be spending, once, $4-5,000 to eliminate or reduce the
tens of thousands of dollars spent every year on special housing, special care and
enormous medication for every MS patient.
Maybe we have to wait for this to become a public expense. But we cannot wait for the
procedure to be given at all. We cannot tell MS patients just to wait.
We must allow MS patients to obtain, and we must keep the door open for doctors to
deliver, on a compassionate basis if necessary, correction of diagnosed CCSVI in MS

I conclude with my recommendation to this Subcommittee.
If universal health care is not accessible for treating CCSVI in MS patients, then we must
at the very least allow these patients to purchase these services in Canada (just as patients
purchase cosmetic surgery services, bringing revenue to hospitals whose facilities are
rented). These patients have a right to decide.
Please report to the Standing Committee on Health and advise the Minister of Health that
there are unconscionable and unacceptably discriminatory obstacles in the way of
corrective angioplasty for CCSVI sufferers who happen also to be diagnosed with MS.
Please find the way to make clear, at the earliest possible opportunity, that properly
diagnosed CCSVI should lead to angioplasty correction without any discrimination
between MS sufferers and non-MS sufferers.
MS patients have just as much right to proper blood flow from their brains as anyone
Doctors are sworn to help their patients. Please let me help mine.

Dr. Sandy McDonald, MD

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