Statement of Dr. Sandy McDonald, May 11, 2010

STATEMENT OF DR. SANDY McDONALD before the SUBCOMMITTEE ON NEUROLOGICAL DISEASE of the STANDING COMMITTEE ON HEALTH


INTRODUCTION

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 other Canadian without a second's thought.

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.


MY PERSPECTIVE

I am a cardiovascular surgeon. (1) I practise in Barrie, Ontario.

(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

I also founded a company called Barrie Vascular Imaging (2), 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.

(2) http://www.barrievascularimaging.com/index.htm.


HOW I GOT INVOLVED

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.


DIAGNOSIS OF CCSVI

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 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 CCSVI.

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.

(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

http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ArtikelNr=279305&Ausgabe=253807&ProduktNr=223840


CCSVI AND MS

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 MS (6), 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.

(6) http://www.cisionwire.com/glasgow-health-solutions-ltd/scottish-doctor-hails-breakthrough-treatment-for-ms

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.


THE PROCEDURE

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 veins (7) is a 2-3 hour out-patient visit done under local anesthesia.

There is in my opinion nothing special about angioplasty (8) 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 1977, patients with MS likely would have their "liberation procedure" performed, probably 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 considerably less investigation prior to its adoption than Dr. Zamboni's balloon venoplasty for the treatment of CCSVI... an important consideration for those who argue against treating blocked 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

A previous witness here, Ms Laurel Radley has told you that the angioplasty in CCSVI
patients with MS has shown a 0/750 risk.


THE CATCH-22 AND THE MISERY

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.


THE DANGERS WE RUN

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 understand (10) 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://www.cbc.ca/canada/story/2010/05/05/ms-rallies.html;
http://winnipeg.ctv.ca/servlet/an/local/CTVNews/20100505/wpg_CCSVI_100505/20100505/?hub=WinnipegHome; )

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)

THE URGENTLY NEEDED INTERIM SOLUTION
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 CCSVI and MS.

The recently requested $10,000,000 for study (13) 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 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.

http://www.leaderpost.com/entertainment/CCSVI+rally+Regina+raise+awareness+Paola+Zamboni+research/2991542/story.html

(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. )

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 patients.


CONCLUSION

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 else.

Doctors are sworn to help their patients. Please let me help mine.

Dr. Sandy McDonald, MD


Parliament Audio Feed. The Dr. McDonald speech starts at about 15-minutes:
http://parlvuvod.parl.gc.ca/StreamLogger/2010/2010-05/00019448.wmv

Speech PDF Download:
http://www.impact-ltd.ca/Dr_M.pdf