The Saddest, Maddest Letter You Will Ever Read in Reply Canada's Health Minister

• Posted by Mary Berukoff on July 30, 2010 at 1:30pm
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The Saddest, Maddest Letter you will ever read in reply to Canada’s Health Minister

Dear Honorable Leona Aglukkag,

My name is Mary Berukoff. I am not a doctor or politician. So why am I commenting on your recent letter in reference to new evidence relating CCSVI (Chronic Cerebrospinal Venous Insufficiency) and Multiple Sclerosis? First, I have twin brothers, 49 years old, with families, who should be in the prime of their working lives but who have been diagnosed both with MS and CCSVI. Second, I am a teacher with a lifelong career in how to process information using critical thinking skills to move from generalities to specifics in non-judgmental ways.

Critical thinking is logical, open-minded reasoning which moves past one’s own subjective views to seek out all possible answers even if it is different than what was originally thought.

So your reply on July 15 makes me very SAD because I wonder if you even read the previously sent material (May 26) because not a single reference to any statement was made. How can any person read 35 pages of material from doctors and politicians and not make some kind of observation? It makes me very MAD because your standardized answer, read before from other politicians, shows a one-sided, non-critical miscomprehension of how the real issue is affecting Canadians. But there is also HOPE with compromise and equality, once the semantics are clarified.

This letter is also addressed to ALL Canadians who may be aware of buzz worthy headlines but not the underlying facts. This information will undoubtedly make them very sad and very mad, too, if they care for basic human rights.

There is a profound discrimination and conspiracy raging in our country and, too many times, the details are omitted. Political agendas are being mixed with health issues best left to qualified doctors to deal with new medical evidence and advancement. Right now, there are some Canadians with diagnosed blockages in their veins who are denied treatment while others can receive it. As MS patients, we demand equal health care, to stop this medical negligence...and so will the rest of Canadians once they better understand a few details why this terrible injustice is happening.

Let me reply to your letter with deductive reasoning to show how important it is to explain what you say. First, your words will be stated (italicized) followed by a few specific details and a conclusion. If, in your opinion, your government’s role in any of these conclusions is inaccurate, please make the necessary corrections. Unbiased dialogue has never been more essential.

YOUR STATEMENT: …the government ..2008 -2009 invested 5.3 million for MS

…through the Canadian Institute of Health Research (CIHR). Since 2000 CIHR has invested 45 million MS research.

DETAILS:

1. Who is the CIHR…council includes neurologist, health management consultant, 2 professors of pharmacology, 2 psychiatrists, 2 molecular biologists, a director of pharmacy, Vice President of Pfizer Canada, 2 cardiologists, a surgeon and a deputy Minister of Health with no medical qualifications.

2. For 2008, MS studies included MS pediatrics, sleeplessness and depression with MS, TH17 lymphocytes and lesions, how to deactivate parts of the immune system, and leg braces to facilitate walking. The cause of MS is still theoretical only.

3. Since 2000, research grants have largely focused on neurotransmitters, molecular biology, neurophysics and even stem cell replacement. Stenosis was not a viable topic. What were the long term research benefits based on this Autoimmune Inflammatory Label… certainly, none for my brothers.

CONCLUSION A: When it is obvious that the balance and focus of CIHR is neurology, immunmodulatory drugs and chemotherapy for MS research, can anyone really expect that somehow they would shift status quo, mid-stream, to verify a physical intervention to improve proper blood flow that just might render previous research irrelevant? What would happen to their jobs, their salaries, their credibility? Of course, their establishment is understandably impervious to change, but professional credence must be given to other specialists and progress of scientific discovery.

YOUR STATEMENT: I have asked Dr. Alain Beaudet, President of CIHR, to provide advice to the government on how to advance research in this important area (treatment and diagnosis of CCSVI)…CIHR in collaboration with the MS Society of Canada will convene an international meeting of top scientists to identify research priorities…

DETAILS:

1. Dr. Alain Beaudet is a neurologist who would need to change his 60 year old theory that MS is an auto immune disease not a vascular problem. How likely will he welcome studies involving biological mechanisms such as physical correction of reflux of venous blood back to the brain that just might alleviate the autoimmune process. He could be typified as an electrician trying to do a plumber’s job.

2. CCSVI is already an identifiable syndrome unanimously recognized by an expert international body (47 countries) in which blood flow from the brain is compromised and is a disease state that by itself must be treated every time it is found with angioplasty. (Exception to the rule...if you live in Canada and have MS, but it is permitted if you don’t have MS.) No MS Canadians can receive this simple treatment locally, either under their provincial health plans or at their own expense...but they can cosmetically lift their brows or breasts.

3. An angioplasty, where a balloon opens constrictions on veins, is not controversial and is often considered more safe and effective than drugs. They have been performed elsewhere in the body as a standard of practice – both with and without stents – for more than a decade. Connection between blocked veins and MS symptoms was identified in the 1930’s and hundreds more research articles and testimonials have corroborated many positive results.

CONCLUSION B. Therein lies the main controversy between neurologists and vascular surgeons. Neurologists call for more research to find a causal link as to why there are such a high number of MS patients with congested veins. Vascular specialists are able to diagnose and dilate narrowed or blocked veins and improve blood flow and, with it, balance and walking, reduce dizziness, fatigue, muscle spasms and incontinence. A scan and angioplasty in a public hospital setting is estimated bout $1500.

YOUR WORDS …in collaboration with the MS Society

DETAILS:

1. Who are these directors of the MS Society and what are their medical qualifications that warrant competent appraisal of research grants? Oddly, for trustees asking for public money, the National MS Society would not disclose their biographies, but here are similar qualifications from directors in the BC /Yukon MS Chapter: sales/training, Brain Injury Society C.E.O, Chartered Accountant, self-proclaimed "passion pusher" fundraiser, director of a scrap-tire recycling program, human resource leader, lawyer,. News Director and morning news announcer, radio and television host and producer, assistant professor of the Faculty of Medicine (Neurology), civil engineer for metro planning, sheriff, and the director of the UBC MS Clinic and Clinical Trials Group.

2. The Medical Information and Education Assistant VP for the MS Society of Canada, Ms. Aprile Royal, has several glowing reports about new exciting (and expensive) medications in the drug pipeline on YouTube. A request for a brief biography was never received, but she is not a Dr. Royal.


CONCLUSION C. This is outrageous that non-medical personnel can debate or override the credentials, training and experience of vascular doctors or that some “talking head” at the MS Society eagerly provides drug information about necessary long term studies. Frankly, only doctors should be able to give this advice.

The MS Society really has had a very close tie to Big Pharma for decades, and as long as nothing changes, the talking heads that address the media and advise Government, will still promote the drugs and fight against a simple angioplasty treatment to correct CCSVI.

YOUR STATEMENT: MS Society of Canada and the National MS Society (USA) announced on June 11, 2010 that they are committing $2.4 million to fund 7 CCSVI research projects...to identify the best methods for screening for blockages.

DETAILS:

1.CCSVI has been described as dangerous and invasive by the neurological

Community and MS Society based on the main opposition that there are no randomized prospective trials. But, they say it’s alright to only take anatomical pictures and study vein irregularities for 2 years.

2. Not one of the projects is focused on problems with venous blood flow return or improving intervention techniques. Not a single vascular doctor, or other experts, were accepted. Angioplasty is NOT innovative, experimental, or dangerous and has been appropriately evaluated for decades! Proper blood flow matters!

3. The small sample size (200 clients) itself creates a problem because of the danger of sample bias. Double-blind control groups only make sense when testing drugs with one active ingredient to monitor. But MS is a multifaceted disease and it would be near impossible to find subjects who have similar backgrounds, vein malformations, blood flow and MS symptoms, Two years of comparing vein pictures will be inconclusive and reason enough to discontinue this research, as has been suggested.

CONCLUSION D…to be open-minded, research and treatment cannot be exclusive. CCSVI diagnosis and treatment as a non MS-specific therapy has enough current evidence and observation to proceed in fair and equal funding and clinical trials.

YOUR STATEMENT: Our government will continue to work with the MS Society of Canada and CIHR to encourage researchers to apply for funding to further the knowledge of CCSVI and MS.

DETAILS:

1. Guess how much of your donations to the Multiple Sclerosis Society go to administration fees..58%... ranked # 2 for charity work drawn from your donations.(I knew it was bad but this is disgusting.)

2. T-3010 forms filed by the Multiple Sclerosis Society of Canada show that the 10 highest paid administrators at the MS Society of Canada make the following salaries plus full benefits:

5 people make from 80,000 to 119,999

2 people make from 120,000 to 159,999

3 people make from 160,000 to 199,999

3. Rather than “working together” on government policies, you must start examining this “advice” from the MS Society, their research foundations and educational consortiums which receive heavy funding from pharmaceuticals. In fact, many such charitable organizations are sometimes referred to as trade associations or opinion makers for drug companies. M.S. Society has not taken one single step or made any effort to interview patients who have already had the procedure, to better understand or investigate the results.

CONCLUSION E: It is clear that “working” with the MS Society will only endorse well entrenched medical models where new data is being ignored (or camouflaged as images without context) and primary spokespersons are well funded and strongly resistant to change. They would face massive layoffs because of the lack of ability to no longer siphon a large portion of donations and use it for Administrative fees. Pharmaceutical companies would have large financial losses because their very expensive meds wouldn’t be the only source of proven “treatment” anymore.

Put these conclusions A, B, C, D, and E, together… and you have a conspiracy and the basis of great unwarranted discrimination with no regard for patients’ rights outside of old theories with very limited positive testimonials.

• CIHR has no track record for MS as a vascular condition.

The point is neurologists in their Neurology Annuals can defend their rights to practice old autoimmune drug-based paradigms…but they MUST NOT drag along MS patients who want a second opinion to try something else.

• MS Society Directors are rich in advocating for their status quo with no personal disclosures and no medical qualifications.

The point is they MUST NOT override qualified surgeons and their research on congested veins where MS is not the issue.

Dear Honourable Minister, you can see why your letter without these critical components has made us very SAD…and probably many others who endure this devastating disease. What about tax payers who pay this heavy burden of health care? Once informed with facts, why would anybody choose to pay $30,000 of more annually for drugs per patient with limited effects when a simple angioplasty has resulted in so many positive results.

But I AM MAD...VERY MAD because I can see, every day, the toll price my brothers and their families are paying for lack of critical honest information. Your government policies have put so many MS citizens into untenable positions.

Time to think deductively again.

Here are our rational choices. What option would you choose if you truly understood the devastation of this disease, personally and economically?

PREMISE: wait five to seven years for research ratification via MS Society who support a drug pushing' monopoly on treatment options

DETAILS:

1. Continue to accept a doctor telling you that there is no evidence that possible blockage in your Internal Jugular Veins 'doesn't matter really'

.

2. Continue to take your recommended drugs with the belief that it is much better for you than good blood flow. Ignore recent studies that suggest that the so-called CRAB drugs have no statistically significant long-term effects ( Copaxone, Rebif, Avonex, and Betaseron,) These standard drugs are administered by injection and cost up to $30,000 per year covered by Pharmacare and taxpayers.

3. Continue a crippled day-by- day existence because neurologists say unproven and vascular doctors are shut down.

PREMISE: become patient activists and seek physicians with catheter skills and begin these treatments

DETAILS:

1. If we have a vascular problem...let us be treated for the vascular problem first.

2. The fact that clinical improvements occur cannot be disputed. Although

the placebo effect cannot be ignored, some of the anecdotal positive results have been impressive. Patients are experiencing undeniable benefits, clearly unmatched by any know MS medication. Even before leaving the procedure room, patients describe improved cognition and a return of sensation and reduction in neuralgia within minutes.

3. 47 other countries approve this treatment and Canadians are forced to spend as much as $10,000 abroad without the benefit of protocols or follow-up care. It also seems that more and more American Interventional Radiology and Endovascular Therapy Clinics and doctors are opening their hands to help. Approximately 1,000 successful liberation treatments done to date around the world should be enough to encourage the Canadian health-care system to allow the treatment as an option to patients – even if on a pay-per-service basis

Call to Hopes and Actions as the Honourable Health Minister of Canada.

1. Note the immediate red flags that come up with a little bit of research…expecting CIHR doctors or MS Society directors to find critical and logical answers and displace decades old theory…highly unlikely. They have milked the potential cash cows for the MS drugs industry and MS charity industry for decades.

2. The M.S. Societies are not acting in our best interests and many patients now are loudly informing media, government and public donors that they are not buying their statement that “ the MS Society endeavors to change government policies, private industry practices and public attitudes in ways that will benefit people affected by MS.” They show rude discourtesy in not answering questions and lack credibility in delivering any medical competence…out of 15 Government relations committee and staff only one person is a MD.

3. Embrace the good news that you already have considerable enthusiastic support of both the Liberal and NDP health critics at the federal level. With your federal financial support, changes at the provincial level may be faster coming. Take a direct role with Provincial Health Ministries and their advisory panels. Demand that they watch the videos and talk directly to individuals who have already been diagnosed and treated. We do not need them to conduct more studies, just investigate the evidence that already exists. Tough economic times require you to be more fiscally responsible in your health budgets. Imagine how quickly the upfront cost would be recovered as use of MS drugs became less common.

4. Initiate real research into blood flow anomalies that will include neurologists, vascular specialists and interventional radiologists working together! Debates about widespread applications should not displace patients’ rights who FIRST need proper clinical trials with diagnosis, treatment and follow-up research. Angioplasties must be allowed whether you have MS or not. Invite specialists like Dr. Sandy McDonald or Dr. Maggisano to initiate a full -scale research trial. The government should fund CIHR to immediately facilitate a registry that will capture the patients accessing CCSVI around the world to determine any change in neurological and vascular symptoms…true CCSVI research.

5. Stop the greatest health travesty of all by anticipating non-medical personnel at the MS Society to define parameters of advocacy or research. Our health decisions and futures will not be handled by fundraisers, accountants and scrap metal dealers, amongst others! In fact, it is time to review and start new legal standards where professional fundraisers with no medical background should have no right to request millions of Canadian tax payers money to fund their special interest research projects or when the Board of Directors refuse to publicly state their expertise. (Example, the current CEO of MS Society of Canada who recently requested $10 million dollars of government money for their interpretation of CCSVI.)

6. Welcome MS citizens as informed and intelligent, who understand the risks if any, and who do not need a paternalistic establishment to protect them behind a science façade of “controversial treatment.” We are NOT desperate, vulnerable, or overwhelmed by unproven unsafe therapies. We know that “hope” doesn’t equate to empirical data…but there is nothing else with so much potential…6 weeks after receiving a one hour angioplasty in Egypt, a MS sufferer for 33 years is now learning to play golf again “because the ground isn’t rocking any more!” We read evidence everyday of other improvements in quality of life that no drug treatment with vast public monies has even come close to emulating. Please respect and honor the right of individuals to seek second opinions and make decisions as it relates to our personal health.

6. Canada Health Act and Medicare System will continue to be renowned for high moral and ethical standards and can be on the leading edge of CCSVI testing and treatment. Imagine the benefits that would accrue not only to MS patients but to society as a whole without the need to pay for their MS drugs and accommodate their incapacities.

Finally, let us particularly listen to doctors who have lived the MS experience and treatment successfully…

I believe that when a new treatment has practically only minor possible complications (as reported by Dr. Zamboni with venogram and angioplasty) and a good potential for benefits, as opposed to pharmacological treatment rich in side-effects, the need for rigorous scientific double-blind trials is unethical nonsense. We need a few more vascular surgeons and radiologists to start treating vascular anomalies (strictures of the jugular veins) on their own merit, not mentioning MS. (Dr. Campalani, 35 year career cardiac surgeon with MS, also treated for CCSVI with much improved quality of life.)

Honourable Minister, there are thousands of MS patients in our great and humane country who have been told that their symptoms have nothing to do with abnormal blood flow around the brain. For those who believe differently that there is enough research and evidence, give them their liberty in making their own decisions. Liberate the hands of skilled Canadian surgeons so we don’t have to travel at high expense and worry.

For many of us there are no other choices versus a young life being stolen from our families …rapidly losing the ability to walk, to look after their children, homes, gardens, even personal self-care.

Help us leave a better legacy for the Canadian Health Care System.

Sincerely,

Mary Berukoff, on behalf of Matt and Dan and families.

PS. Read the enclosed article How to Stop MS Bullying and Start MS Compromise…it’s all about compromise at this stage.

PPS. CONGRATULATIONS to Saskatchewan’s Premier Brad Wall to help fund clinical trials of this promising therapy for multiple sclerosis patients...his vision will be shared by the remaining premiers if they are critical and compassionate thinkers as well.

Chronic Cerebrospinal
Venous Insufficiency
A new paradigm and therapy for multiple sclerosis.
BY SALVATORE J.A. SCLAFANI, MD
COVER STORY
Figure 1. Preprocedural MR venogram shows a venous
plethora of collateral veins throughout the neck. Arrows
point to perceived stenoses of the distal lower cervical
portion of the IJV.
neurological disorder of young adults. It is quite possible
that some of the protean manifestations of MS,
including fatigue and lethargy, headaches, and cognitive
dysfunction, may actually represent symptoms of CCSVI
itself.8
CCSVI is more insidious in its onset than acute
venous insufficiency. In fact, the association of CCSVI
with MS has been largely ignored despite Charcot’s original
description of the relationship of the cerebral veins
and inflammatory lesions that are the hallmark of MS.9
Zamboni proposes that CCSVI has a role in the
pathogenesis of MS. He suggests that resistance to cerebrospinal
venous outflow causes vicarious redistribution
through small collateral veins that cannot handle
high flow.10 He also suggests that tight endothelial junctions
widen to allow diapedesis of red blood cells,
T cells, and other immune cells into the brain, resulting
in inflammation and hemosiderosis that is reminiscent
of what is seen with venous insufficiency of the lower
extremities. This is supported by iron deposition as seen
on susceptibility-weighted magnetic resonance imaging
(SW-MRI), which reveals that the inflammatory MS
plaques always surround a central venous structure.
MRI shows that the central vein and surrounding
plaque have abnormal quantities of iron. Pathologically,
the basement membranes of these deep veins are thickened,
and hemosiderin deposits are present in the wall
of and adjacent to the deep cortical veins. T cells and
macrophages violating the blood-brain barrier provide a
working explanation for the autoimmune cascade that
result in demyelination and the neurological manifestations
associated with MS.
DIAGNOSIS
Ultrasound
One could argue that the diagnosis of MS is sufficient
to justify catheter venography to identify venous abnormalities
worthy of angioplasty. However, Zamboni used
ultrasound imaging to noninvasively screen patients who
might have CCSVI, and this algorithm persists as the route
of detection. His protocol includes transcranial and
extracranial Doppler to detect deranged hemodynamics
and B-mode ultrasound to detect stenoses and changes in
cross-sectional diameters in the supine and the upright
positions. He states that two of five characteristics lead to
a diagnosis of CCSVI. The five characteristics are (1) reflux
within the IJVs or vertebral veins, (2) reflux within any of
the deep cerebral veins, (3) no flow in the IJV on activation
of the thoracic pump upon inspiration, (4) failure of
the IJV to increase in diameter in the supine position
compared to the erect position, and (5) any B-mode
abnormality such as septum, stenosis, abnormal valve, etc.
MR Venography and Computed Tomographic
Venography
Others have used cross-sectional venography to
evaluate venous stenosis (Figure 1). The majority of
sites use MR venography, but occasionally, computed
tomographic venography is also used. To evaluate the
dural sinuses and the veins of the neck, two-dimensional
and two-dimensional contrast-enhanced imaging
is used. These cross-sectional studies show a variety
of findings that include venous narrowing and collateral
vessels throughout the neck. Occasionally, narrowing
or occlusions of the dural sinuses are noted,
but for the majority of times, findings are restricted to
the neck. However, there is poor correlation between
the anatomical findings on MR venography and subsequent
catheter venography. Many areas of narrowing
on MR venography are not constant and are not
reproduced during catheter-based studies.
Hemodynamics of Cerebral Venous Drainage Explain
False-Positive Findings on MR Venography
To explain this enigma, one must understand the
hemodynamics of cerebral venous outflow. The brain
has two methods of venous drainage: blood drains
42 I ENDOVASCULAR TODAY I JULY 2010
COVER STORY
Figure 2. Bilateral IJV venography shows opacification of the
vertebral plexus and drainage through the vertebral veins
(arrows).Both IJVs had focal stenoses at the confluens of the
IJV with the subclavian vein.Angioplasty improved but did
not eliminate the stenoses.
JULY 2010 I ENDOVASCULAR TODAY I 43
COVER STORY
In this article, Dr. Salvatore Sclafani presents an introduction
to chronic cerebrospinal venous insufficiency (CCSVI)
and the current understanding of its association with multiple
sclerosis (MS). Much of the initial evidence supporting
this possible relationship has been reported by Dr. Paolo
Zamboni and colleagues. Using duplex ultrasonography and
transcranial Doppler studies, they have documented the frequent
association of abnormal venous hemodynamics with
MS. In one study of 109 MS patients and 177 age- and gender-
matched controls, subjects underwent a blinded transcranial
and extracranial color Doppler sonographic assessment
(TCCS-ECD) of five parameters related to venous outflow
hemodynamics. These five criteria are detailed by Dr.
Sclafani in his review. In controls, only 2.7% of the measurements
were abnormal, whereas in MS patients, 47% of measurements
were anomalous.1
In a study comparing duplex ultrasound with contrast
venography, 40% to 70% of MS patients had evidence of
flow disturbances and/or venous stenosis by TCCS-ECD. Of
these patients, 86% and 91% had obstructive disease of the
azygos or internal jugular veins, respectively, as assessed by
traditional catheter venography.2
Some of the symptoms of MS mimic those observed in
patients with superior vena cava syndrome. Relief of superior
vena cava obstruction with venous angioplasty and stent
placement, if required, provides swift and dramatic resolution
of the symptoms of impaired cognition and fatigue.3 Thus, it
is not surprising that patients with CCSVI associated with MS
also report rapid relief of these nonlocalizing symptoms.
It is well-recognized, however, that many symptoms of MS
fluctuate and are largely subjective. It is possible that in the
initial nonrandomized patient series reported to date, the
improvement in symptoms could reflect a strong placebo
effect. Nonetheless, the biological plausibility linking cerebral
venous congestion to inflammation that is the hallmark of
MS requires serious consideration. Whether the relief of the
venous obstruction will have an impact on the course of the
neurological disease remains to be seen.
Although the initial observations relating CCSVI and MS
are interesting and potentially paradigm-shifting, they now
need rigorous testing. As Dr. Sclafani correctly points out,
there are life-threatening adverse effects that may complicate
endovascular management of CCSVI. A randomized clinical
trial is needed to assess the risks and benefits of endovascular
treatment of this condition. There are many physicians and
others who have endovascular skills who are promoting and
developing centers for treating these patients without regard
for the lack of scientific data to support therapy. Patients
with this disease have frequently suffered for long periods of
time, often without great relief of symptoms and are often
desperate for any alternative that may offer hope.
We remain very concerned about the possibility of misleading
these individuals or exposing them to additional risk, outside
of scientific efforts to get a better understanding of this potentially
exciting therapy. Given the concerns of the neurology
community, it would be unfortunate if the attempts to advance
this field suffer the consequences of premature promotion of a
procedure that could mislead patients, payors, and regulators.
Accordingly, we propose a global initiative to meticulously
document the prevalence of venous anomalies in MS, by
comparison to age- and gender-matched healthy individuals,
as well as those with neurological disease not due to MS. In
part, recent grants from the National MS Society awarded to
seven investigative groups to study CCSVI will help initiate
this effort in the United States and Canada. These observations
may provide a basis for a clinical trial in MS to assess
the long-term safety and efficacy of endovascular procedures
in restoring normal venous hemodynamics, in relieving the
nonlocalizing symptoms secondary to venous obstruction,
and in slowing or halting the inflammatory and demyelinating
processes. In parallel, the development of animal models
will advance our understanding of how CCSVI may influence
or even initiate the pathophysiology of MS.
Michael D. Dake, MD, is Professor, Department of
Cardiothoracic Surgery, Stanford University School of Medicine
in Stanford, California. He has disclosed that he receives
grant/research funding from Cook Medical. Dr. Dake may be
reached at mddake@stanford.edu.
Barry T. Katzen, MD, is Founder and Medical Director of Baptist
Cardiac and Vascular Institute and Clinical Professor of Radiology
at the University of South Florida College of Medicine in Florida.
He has disclosed that he is a member of the scientific advisory
board for W. L. Gore & Associates. Dr. Katzen may be reached at
barryk@baptisthealth.net.
1. Zamboni P, Menegatti E, Galeotti R, et al. The value of cerebral Doppler venous hemodynamics
in the assessment of multiple sclerosis. J Neurol Sci. 2009;282:21-27.
2. Zamboni P, Galeotti R, Menegatti E, et al. Chronic cerebrospinal venous insufficiency
in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009;80:392-399.
3. Kee ST, Kinoshita L, Razavi MK, et al. Superior vena cava syndrome treatment with catheterdirected
thrombolysis and endovascular stent placement. Radiology. 1998;206:187-193.
COMMENTARY
The Relationship Between CCSVI and MS
BY MICHAEL D. DAKE, MD, AND BARRY T. KATZEN, MD
44 I ENDOVASCULAR TODAY I JULY 2010
COVER STORY
anteriorly through the internal jugular
system in the supine position and posteriorly
through the vertebral system when
erect. In the normal, upright patient, the
jugular vein collapses (narrows) because
there is not enough blood flow through
it to maintain distension. In the supine
position, the normal IJVs distend
because the supine position favors jugular
flow. The same issues apply when
there is increased resistance to jugular
flow. The alternate vertebral venous outflow
system shunts blood away from the
jugular veins. Because pressure is normally
low and only marginally rises with
obstruction, distension of the obstructed
system does not occur.
As a result, many of the narrowings seen in CCSVI
are caused by compression of a collapsed system by
external forces rather than due to stenoses. This may
lead to unnecessary angioplasty. The common areas of
questionably physiological stenosis seen on MR venography
are located at the skull base, adjacent to the
carotid bulb, or where strap muscles exert compression.
VENOGRAPHY AND VENOGRAPHIC
OBSERVATIONS
Venography remains the gold standard for evaluating
the anatomy of the veins draining cerebrospinal blood
flow. It should be emphasized that a reliable assessment
of the azygos system can only be done by using catheter
venography.
Technique
The venographic evaluation is begun by placing a
headhunter catheter in the left femoral vein with the
purpose of excluding May-Thurner syndrome. The
catheter is subsequently placed in the left ascending
lumbar vein to assess the lumbar veins for hypoplasia
and other abnormalities. The left renal vein is then
catheterized to look for abnormalities of the renal vein
tributaries. The purpose of these three studies is to look
for causes of increased blood flow into lumbar veins
that might be compromised by azygos stenosis.
The catheter is then placed in succession into the
AZV and both IJVs. The catheter is positioned in the
AZV at the junction with the hemiazygos vein. Contrast
venography is done twice: first at 3 mL/s for a total volume
of 10 mL to look for reflux, followed by a second,
fuller injection at 8 to 10 mL/s for a total volume of 20
to 30 mL to delineate all the anatomy. The AZV and its
tributaries are imaged to include the chest and
abdomen. Some physicians measure pressures, but I
have not found this to be helpful. Any stenosis is treated,
as will be described later.
The catheter is then withdrawn from the AZV and
advanced sequentially into each IJV. Catheterization of
the IJV may be challenging because funneled narrowing
of stenotic valve leaflets occurs near the origin of the
vessel. Occasionally, an incomplete duplication is present
posterior to the main ostium. This may make
catheterization confusing and difficult. Two contrast
injections are performed: one with a slow injection of
3 mL/s for a total volume of 10 mL and one with a fuller
injection of 8 to 10 mL/s for a total volume of 20 mL.
Film rates of 3 to 6 frames per second are necessary to
get sufficient detail of the valves and to detect ostial
narrowing that may become obscured as contrast
enters the brachiocephalic veins and overlaps the confluens
where stenosis is often located. Any stenoses or
other outflow obstructions are treated at this time.
Diluted contrast abnormalities (50:50 mixture of saline)
is helpful in the IJV evaluation because valve abnormalities
and some webs may be obscured by very dense
contrast media.
Venographic Findings
First, there are numerous collateral veins when outflow
obstructions are present (Figure 2). These veins may be
wildly abnormal and include hypoplasias and early divisions
that reconnect to a larger conduit. The vertebral
veins may be enlarged and can be confusing in their
appearance. The pathology of this disease is a truncal
malformation of the veins that is probably genetically
determined; it is not an inflammatory or postphlebitic
stenosis. Much of the resistance to blood flow is related
to abnormal valve development. Fused, reversed, thick-
Figure 3. IVUS in resting state at the level of the stenosis of the central cervical
IJV (A) shows narrowing of the IJV, which is collapsed around the catheter.
The thoracic pump was activated, and flow into the IJV improved (B). IVUS
shows distension; therefore, angioplasty was not performed.
A B
ened, and other abnormally located and developed
valves cause resistance to flow. Atresias, hypoplasias,
duplications, webs, septums, and kinks also occur. Most
of these abnormalities are located centrally near the confluens.
Challenges occur when more peripheral narrowings
are present, which may be physiological.
INTRAVASCULAR ULTRASOUND
Diagnosis by venography can also be subtle. I have
found that intravascular ultrasound (IVUS) is very helpful
in identifying some of these abnormalities, as well as
in differentiating the narrowed veins caused by inadequate
volume from the narrowed veins resulting from
stenosis (Figure 3). IVUS enables a real-time assessment
of the distensibility of collapsed veins. Simple maneuvers,
such as slow sustained inspiration by activating the thoracic
pump, allow improved distension of the vein and
confirms that the narrowing is not fixed. Further, IVUS
allows detection of improper or incomplete valve movement.
Finally, incomplete duplications of the jugular vein
may not be detected without IVUS.
TREATMENT OPTIONS
Treatment of these abnormalities is still in development,
and the ideal methodologies for treatment have
not yet been established. Essentially, only one team has
published an outcomes study.1 Results were encouraging
but showed limitations. Angioplasty with high-pressure
balloons of diameters 4 mm greater than nominal diameters
in 2- to 4-cm lengths is performed with venographic
control. Inflations to maximum pressures for 30 to 60
seconds were used several times. Some of these obstructions
are very resistant, and Cutting balloons (Boston
Scientific Corporation, Natick, MA) are used with
increasing frequency. Dr. Sinan Tariq, the leader of the
Kuwaiti national trial, has been using valvulotomy
devices with some success (personal communication,
April 2010). Stenting is performed by some investigators
for resistant narrowings. However, no reports have been
published about their outcomes. I have not used stents
in any cases yet.
AFTERCARE AND FOLLOW-UP
The procedure is performed under local anesthesia
in an ambulatory setting. Most patients are kept in
the hospital for 1 or 2 hours and then discharged.
Most physicians treat patients with clopidogrel or
short-term anticoagulation with heparins, enoxaparin,
or fondaparinux. Clinical and imaging follow-up varies
among investigators. Assessment tools are predominantly
clinical and include an expanded disability status
score (EDSS), which is a neurological assessment of
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46 I ENDOVASCULAR TODAY I JULY 2010
COVER STORY
eight areas of the central nervous system, along with
certain measures of disability and restriction in daily
life. These scores are added up to give a rating on the
EDSS, which ranges from 0 (normal) to 10 (death due to
MS). From step 4 onward, the ability to walk becomes
the key factor in determining the EDSS score.
OUTCOMES
It must be emphasized that only one team has published
any clinical results, and although promising,
they were not overwhelming. Zamboni’s group
described an open-label experience of patients with
MS who were allowed to stay on disease-modifying
drugs for their MS. The results were encouraging, with
statistically significant improvements in cognition and
motor function and reduced exacerbation rates, and
MRI confirmed diminished new brain lesion development.
The patients who have shown the most positive
results are those in the relapsing-remitting phase of
the disease. Patients with primary progressive MS, for
whom there is no proven treatment, had the least positive
effects.
However, the dilatations are not always durable,
with approximately half of the patients developing
restenosis between 8 to 14 months. It is interesting
that all patients who suffered from an exacerbation of
symptoms had a restenosis and that no patients who
had durable angioplasty experienced restenosis.
Overall, the procedure is well-tolerated, and patients
do not require sedation. The complications reported
in Zamboni’s trial were minimal. I have had one early
thrombosis that did not respond to thrombolytics and
one case of atrial fibrillation that I thought might have
been a response to treatment that modified autonomic
neural transmission, but resolved within 12 hours.
Those interventionists who have used stents have not
yet reported outcomes in the literature.
Dr. Zamboni cautions against stents because they
are not designed for placement at the confluens of the
jugular vein with the subclavian vein where the jugular
vein widens. Improved flow is shown to significantly
increase the diameter of these veins. He worried about
migration in his article, and indeed, one of the early
patients treated with stenting by another interventionist
is reported in the lay press to have required open
heart surgery for stent retrieval.
CAVEATS
CCSVI has not been well-accepted by the neurological
community. Many leaders strongly oppose this
treatment on the grounds that no randomized
prospective trials have taken place, and they describe

Christopher's awesome letter to Ms. Aprile Royal of the Canadian MS Society:

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Today at 2:28pm

July 19 2010

Mrs. Aprile Royal
Assistant Vice President
Medical Information & Education
Multiple Sclerosis Society of Canada
Toronto, Ontario


Mrs. Royal,

I am writing this letter to address some concerns in the position that you are putting forth to represent a Society that exists because I am sick. I was diagnosed with Multiple Sclerosis in 1992.

You recently were quoted by the Barrie Examiner in an interview that you did with them on the topic of Chronic Cerebrospinal Venous Insufficiency, or CCSVI for short. Some of the statements that you made only proved to me as an MS patient that the MS Society of Canada no longer represents me or the many ten of thousands of Canadians who have been diagnosed with Multiple Sclerosis.

To your benefit, I can honestly say that some of the statements that you made are true. You are quoted as saying, “It`s not so simple with one single cause.” It is true that there may be more than one single cause and that MS is a complicated, multi-facetted condition that has stumped the medical community and researchers since it was defined in the medical literature by Charcot, in 1868. It is also true that CCSVI has not yet been established as the ultimate cause for Multiple Sclerosis, and more research is needed to make the links and solidify the cause and effect relationship between venous flow problems and Multiple Sclerosis, if indeed these links exist – which I strongly suspect that they do.

You are well aware that the Multiple Sclerosis Society of Canada does not make decisions at the level of government as to which procedures are offered to the Canadian public, and which procedures are not. However, our government, policy makers and health officials, look to your organisation for the lead on these issues – therefore your power to influence either for or against CCSVI research and venoplasty treatment for MS patients is real and concrete. No decisions will be made until the MS Society of Canada gives the go ahead to leaders, politicians and medical experts or until your organisation has lost so much credibility that it will no longer take the lead in the research.

However, Dr. Zamboni himself, made a plea to the Canadian government to offer this treatment on a compassion basis, especially to those for whom the immunomodulatory therapies do not work, or who have progressive forms of the disease and therefore are not eligible to take these therapies. Many researchers and medical experts in Canada have also tried to influence the decision-making process and encourage further research at the same time as offering the actual treatment for CCSVI in the form of angioplasty, an effective, safe way to treat venous flow problems.

Let me cite the case of Barb Farrell, a woman in the Royal Victoria Hospital in Barrie, Ontario. As you are well aware of Barb`s case, it is appalling to me that this treatment was not offered to this woman, who would have obviously died in a very short time if she had not had the angioplasty to unblock the restricted blood flow in her internal jugular veins. A private benefactor paid not only for Barb`s procedure to be performed but for an entire medical team to accompany her on a private flight to and from the American clinic where the procedure was performed. If the MS Society`s position on CCSVI were not so utterly cautious, then Barb would have been able to have this procedure performed in a Canadian hospital. I do not even want to think of the outrage of the MS Community if Barb`s case had been ignored.

What more proof do you need to see the links ? Any member of the Canadian population, tax payers, and thousands of people that once donated to your society, can see the problems with the foot-dragging by the MS Society. You, your Society, and all that you represent, would have let this poor woman die, for the sake of not allowing a perfectly safe procedure that has been proven time and time again to improve the quality of life of patients with MS.

We have cases of medical doctors who have gone overseas for treatment. Dr. Gianfranco Campalani, a heart-surgeon in Ireland, had the treatment twice. I personally met a Canadian doctor who had primary progressive MS in Poland when I was there in May to have an angioplasty myself. A very close personal friend of mine knows a neurologist whose daughter has MS, and sought the procedure. Yet this person must remain under a cloak of silence for fear of a backlash from colleagues. Hundreds, if not thousands of Canadians, are seeking treatment outside the confines of double-blinded clinical trials. Many primary care physicians are eye-witnesses to the improved quality of life that can be offered to those who seek treatment overseas.

I have personally met more than a dozen people who have had the angioplasty, and have spoken on the phone with a total of at least 25-30 people who have travelled to Poland, Bulgaria, India, Germany and France to seek the treatment…..and they are all experiencing improvements. Many of these people, myself included, have progressive forms of the disease, and improvement was not something that was part of our vocabulary – until our problems with venous flow issues were dealt with.

Further on in the interview, you proceed to give some historical background on MS, and liken it to the electrical wiring in a house that is malfunctioning. I find it interesting that the list of symptoms given, namely “a loss of balance, impaired speech, vision problems, extreme fatigue, a cognition fog and physical weakness” are symptoms that are either diminishing or disappearing completely for hundreds of people who have had angioplasty. I`m not a medical expert, but it makes sense to me that if I have a venous flow problem or an inverted valve causing reflux of blood up into my brain, that I would see some improvements if the problem were fixed. Basically, as an MS Community, we fail to see why you fail to see the links that are so obvious. Anyone in the general population can see it, why can`t you ? Your resistance to the research and accusations of “placebo effect” are paving the highway to the downfall of your great organisation.

Furthermore, and one point that I have failed to see for quite some time : What makes you think you (or any other employee of the MS society, neurologist, etc.) are a vascular specialist, as CCSVI is a venous flow problem ? Why would I trust neurologists to take the lead in the research into a vascular issue any more than I would trust an endocrinologist to perform orthopaedic surgery ? In the four Canadian studies funded by the recent requests for CCSVI grants – Dr. Brenda Banwell, Dr. Fiona Evanne, Dr. Anthony Traboulsee and Dr. Katherine Know are all neurologists by training. Dr. Carlos Torres is a neuroradiologist. Why would we leave the research into a vascular condition in the hands of neurologists ? I know of no other area of research where we would allow this. Canada is already falling way behind in the research, as they try to protect organisations that I will not name here.

You try to put on an air of helping people, and funding research, yet you naysay anything that remotely proves Dr. Zamboni`s hypothesis of CCSVI. Your organisation has been at the forefront of gross misinformation provided to the public about CCSVI as well as the leaders in modern-day witch hunts. Let me give you a few examples:

1. The Buffalo Study – I have heard some of your top neurologists and members of your medical advisory board quote on many occasions the results of phase 1 of the Buffalo Study. Many in the medical field have quoted this study as “disproving” the theory of CCSVI, saying that 26% of the general population has narrowed veins as well. This is ludicrous, as Dr. Zadinov himself, in a presentation to the American neurological society, talked about these statistics, and the problems with this study. So on one hand, neurologists are all over the map when Zamboni himself says that more study needs to be done – which he never denied himself – but on the other hand, when it comes time to discredit Zamboni, your Society does so, only to put into question the true competency of their specialists. Dr. Zadinov himself admitted that this 26% of the population actually had familial links to the MS population being tested. Why would your “specialists” confidently quote statistics from a faulty study ?

2. The one case where a stent migrated. I have heard this argument ad nauseam about how dangerous this procedure is. It is true that a patient of Dr. Dake in Southern California died due to a reaction to a pharmaceutical product given post angioplasty. Even this woman`s family has written and stated that her death was not caused by the procedure, but by a pharmaceutical product. In the case of the migrating stent, it is true that the person in question needed further surgical intervention, and this is truly unfortunate. Yet how many surgeries every day in Canada go awry for other conditions, yet this is considered by the medical community the normal course of things ? In light of frequent new deaths from many of the pharmaceuticals used on MS patients, how can you even mention one incident in the hundreds of procedures performed ? If you truly want to continue touting yourselves as the providers of credible and reliable information, as you do on your national website in several places, then may I suggest that you keep abreast of the latest developments.

3. The BC witch trials. A few months back I remember hearing about a case of a doctor who performed angioplasty on a couple of patients in British Columbia. Unfortunately, these patients had MS, because if they had had any other venous condition and did not yet have a diagnosis of MS, they would have been provided medical treatment in a Canadian hospital. As you well know, both of the patients that had the treatment, are doing significantly better. Yet, a top neurologist, might I say one affiliated with the MS Society, decided to go on a modern-day witch hunt to burn this doctor at the stake. So, here we have a case of someone actually doing better, and yet the doctor that made him better had sanctions imposed on him. This is not the only case of doctors and clinics being shut down, as there are many other examples of this just south of the border, but I think the point has been made clearly enough.

All of these cases, and more, make me feel like I`m in the middle of the most amazing John Grisham novel that I`ve ever read. I can`t wait to live the ending.

Further in the course of your interview, you go on to state something to the effect that one of the concerns is that Zamboni didn`t use the EDSS scale in his trial. And this is a problem because ???? These misplaced arguments are scattered throughout the useless drabble and the confusing discourse that we are hearing time and time again from members of the MS Society when they don`t know what else to say. Please, sit down and come up with some stronger arguments than that. Most family doctors who deal with MS patients on a daily basis don`t even know where their patients are rated on the EDSS scale. That you would even mention that goes to show how little you have to say about the true issues at hand.

Another point that you raise is that of stenting. As a member of the medical profession, with the title of RN and an MEd, I can not fathom why you have not read the literature about vascular stenting, and the number of conditions in which it is readily and effectively used. Interventional radiologists and vascular surgeons stent all kinds of veins when there is a chance of restenosis. This information is readily available, and is accessible in any good medical textbook on the subject. It is in no way controversial for other conditions that affect venous flow.

Let`s do a little bit of cross curricular work, and touch on the area of mathematics. You mention that in Zamboni`s second study, there is a very high rate of re-stenosis, thus requiring another angioplasty after an average of nine months. Well, we know from Dr. Sandy MacDonald`s presentation to the Parliamentary Sub-Committee on Neurological Disease that the cost of an angioplasty in Canada is about $ 1,500. If I have an angioplasty every nine months, as this would be the worst case scenario, it would cost the medical system about $ 6,000 over a 3 year period. The cost of MS medications for the same period would easily surpass $ 60,000. The cost effectiveness of treatment for CCSVI is a much greater savings to the Canadian public and to private medical plans nation-wide.

I can hear your objection, “But we are not yet sure that the links are there between CCSVI and MS, therefore we need to continue taking the medications.” To that I will answer with a quote from Dr. Gianfranco Campalani, the Irish Heart Surgeon who has had two angioplasties: “I always refused to take any medication whatsoever because I don’t believe you should take drugs to treat something the doctors don’t know the origin of.” So even if there is no causal link between CCSVI and MS, we still have no further insight into the actual origin of the disease. Even all of the drug companies state something to the effect that “the origin of MS is unknown”. If the origin is unknown, how then can we treat it ? Yet you so confidently promote the use of pharmaceuticals from various companies as if you actually knew something about the nature of MS. All of the pharmaceutical companies have a disclaimer to the effect that the precise way that they act on MS is unknown. It is strange that you are so sure that MS is not a venous flow problem, and it is “an immune mediated demylenating disease of the central nervous system”. (Direct quote from your training session on April 2, 2008 in Toronto). Your beliefs on the origins of MS have no more credibility than do the initial beliefs that CCSVI is possibily at the origin of the disease. Yet you know from the historical writings of Dr. Jock T. Murray that MS was always thought to have a venous link – which is precisely why in the 1930s all MS patients were given blood thinners.

Anyawy, I do believe that I have addressed the most important issues raised during your recent interview with the Barrie Examiner.

I would love to discuss these issues with you over the phone, and would be more than willing to do so. I’ll send you my private e-mail, and phone number, and trust that you will get back to me at a time that is convenient for both of us.

Warmest regards,


Christopher

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in his own words

A treatment for multiple sclerosis that upsets Big Pharma

By Philip Lillies

| July 16, 2010

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In a breakthrough in the treatment of multiple sclerosis, last summer Dr. Paolo Zamboni, a vascular surgeon from the University of Ferrara in Italy, made public the results of findings from his study of 65 MS patients.

Dr. Zamboni and colleagues investigated CCSVI -- Chronic Cerebrospinal Venous Insufficiency -- a condition characterized by blockages in the veins causing problems in the blood flow drainage from the brain and/or spinal cord of sufferers. This condition has been shown to contribute in a significant way to the many symptoms of multiple sclerosis. It can be relieved by angioplasty, which is a simple surgical treatment that removes the blockages.

Despite the results of Zamboni's and other significant studies, my research into the media's coverage of angioplasty as a treatment for multiple sclerosis reveals that the mainstream media, with some notable exceptions (examples of which are here, here and here) , is generally presenting arguments that are favourable to maintaining the pharmaceuticals' monopoly on treatment options (examples here, here and here). Overall, the media has failed to do its journalistic duty to research all sides of the issue. They have failed to take the numerous testimonials and positive research results seriously and are failing to take into account the costs and benefits of angioplasty versus those of MS drugs that in the end offer little to no long-term benefits.

Pharmaceuticals provide millions of dollars every year to MS Societies in the U.S. and Canada, and the MS Societies in turn advertise the drugs developed by the pharmaceuticals and encourage their members to have full confidence in these drugs, even when alternative treatments, such as diet and angioplasty, might be more effective in alleviating the symptoms of the disease.

In fact, the MS Society of Canada claims to receive less than two per cent of its funding in pharmaceutical grants -- see Myth #2 in the link above. Additional direct assistance to the MS Societies of Canada and the US would be in the form of free education materials, speakers, and expertise, as well as paid advertising in MS Society newsletters; however, total assistance would certainly be a relatively small percentage of total budget, hundreds of thousands in Canada and millions in the U.S., but direct assistance is perhaps not the main source of influence on MS Society decision making.

Eminent neurologists and MS research foundations also receive extensive funding from pharmaceuticals, as revealed in a full disclosure article critical of CCSVI treatment that appeared in the Annals of Neurology (Khan et al, January 2010, Annals of Neurology ).

In addition to funding their research, the pharmaceutical industry also influences through leaders -- see below -- through an educational organization known as the "Consortium of Multiple Sclerosis Centers." Page two of the report explicitly states that the CMSC is a partner with the pharmaceutical industry, other non-profit advocacy and services organizations (which would include MS Societies), and MS professional organizations.

Seven of the 11 authors of the report (including the first four, senior authors) disclosed receiving significant financial support from pharmaceuticals that produce drugs for MS. In addition, the pharmaceuticals are key players in an organization known as the "Consortium of Multiple Sclerosis Centers" whose main function is to influence MS thought leaders such as neurologists, researchers, and directors of MS Societies.

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The medical establishment, in general, is hesitant to embrace a finding that would shift some of the burden of treatment for MS from neurologists to interventional radiologists, vascular surgeons, and experts in blood flow and imaging. One can only speculate about why this shift is so difficult for them.

One factor might be professional pride, but a more important factor might be the re-training that is necessary, both for doctors and technicians. As it stands now technicians lack the training to detect the blockages, even when they have the latest Doppler ultrasound equipment; and surgeons are flabbergasted at the thought of performing interventions on veins, which unlike arteries, are pliable and difficult to manipulate.

The upfront investment required to support the required changes, which would affect personnel and equipment, is also an impediment to recognition of CCSVI treatment by provincial health plans. So despite the enthusiastic support of both the Liberal and NDP health critics at the federal level, without federal financial support, changes at the provincial level may be slow in coming. In fact, the upfront cost would quickly be recovered as use of MS drugs became less common.

It is not surprising, then, that the mainstream media, when it follows the lead of the medical establishment and the MS Society, presents a biased picture that does not contribute to our understanding of the costs and benefits of CCSVI treatment. MS patients demanding the right to angioplasty for CCSVI are often depicted as a mere advocacy group attempting to badger the scientific community because of their hope for a miracle cure. The hundreds of positive reports and internet videos depicting MS patients who have benefited substantially from the treatment are dismissed as mere testimonials with no scientific merit.

Then there are the weasel words that are used to depict MS patients as emotional, subject to the whims of an unpredictable disease characterized by attacks and remissions, which renders them susceptible to quackery, psychological boosterism, and the much touted "placebo effect." Angioplasty itself is often referred to as "the liberation treatment," which suggests the wild and radical aims of those advocating for it. Research directors working on projects funded by pharmaceuticals and spokespersons from the MS Society are frequently quoted speaking out against the treatment without regard for the inherent bias such spokespersons would be expected to have.

The Canadian Medical Association Journal recently featured an editorial in which it argued that the medical establishment was on the side of the plain folk, guarding them against being overwhelmed by unproven therapies that had not been evaluated for safety and effectiveness, while preventing public monies from being diverted for use in untested procedures.

The truth is that despite concerted efforts to depict it otherwise, the issue here is not one of science but one of ethics. There is already ample evidence that the treatment has a high probability of being beneficial to a large number of MS patients. Detractors, however, raise the question of whether the costs outweigh the benefits. There is, in fact, ample evidence for those willing to take the time to look for it that this question has been amply answered in the positive (see here and here). Angioplasty, which is a medical procedure of long standing, can easily be adapted to treatment of CCSVI, and the treatment works. Why it works is still undetermined, but no one is arguing that it works by some mysterious energy or élan vital. There are several promising leads (such as build up of iron within the brain) that can be the subject of future scientific investigation. Patients themselves are amassing the evidence of success on the electronic bulletin boards of websites like "This Is MS." The videos are very moving, and it is hard to dismiss them as anything but overwhelming evidence for the effectiveness of the treatment.

Detractors like to point out that the benefits of the treatment cannot be considered long-term because veins are subject to collapse after stretching. However, even if the veins collapsed again and needed to be re-stretched annually, this would still be more cost effective than most MS drugs, which cost up to $30,000 per year and marginally slow the course of the disease at best.

In fact, recent studies have suggested that the so-called CRAB drugs have no statistically significant long-term effects. CRAB drugs are Copaxone, Rebif, Avonex, and Betaseron, the standard drugs used to treat MS. They are administered by injection and cost up to $30,000 per year. Because we don't have a pharmacare program in Canada, the cost of these drugs can be a considerable burden to those lucky enough to be able to afford them at all.

In addition, using vein stents (no this is not a new technology either) could eliminate the need for additional treatments.

CCSVI itself is characterized in the mainstream media as unproven and controversial. Maybe, after all, it is a fairly normal condition. However, CCSVI is not controversial. It has been unanimously recognized by an expert international body as an undesirable congenital malformation. In 2009, at a conference on venous malformations (UIP09), experts from 47 countries voted unanimously in favour of officially including the stenosing lesions found in CCSVI in the phlebology consensus document and guidelines.

How dangerous is the treatment? As of today, the treatment has been applied over 1,000 times with reports of only one death following improper placement of a stent. Many MS patients, whose lives are in ruins, are willing to take the risk. And the risk can be compared with the risk of taking MS drugs, which are very unpleasant and hardly risk free. For example, a common drug for MS causes liver damage. Another recent study suggests that there are two types of MS -- similar symptoms but different diseases -- and if you treat one of the types of MS with one of the commonly prescribed CRAB drugs you may actually make the disease worse.

The medical establishment is demanding double-blind testing on the Zamboni method, which works well on drugs but is almost impossible to do with a surgical intervention. There is, of course, the questionable ethics of not correcting obvious problems once the surgical intervention has begun. In addition, given that the patients are not under general anaesthesia during the procedure, and in light of the fact that most doctors are probably lousy actors, the blind is going to be hard to maintain.

The University of Buffalo has received funding to try a double-blind test on a small sample, but any results are almost certain to be contested. The small sample size itself creates a problem because of the danger of sample bias, which is all the more likely as MS, unlike say breast cancer, is such a multi-faceted disease. Ideally you would want patients that were similar in background, venal malformations, and symptoms, except some would be given the treatment and some not. Unfortunately, this similitude is going to be impossible to achieve.

Double-blind testing does make sense for drugs, where the blind is relatively easy to maintain and ethics may be less of an issue when the benefits of the drug really are uncertain. It would seem that more usual for surgical interventions is to try it if it seems to work, and evaluate based on tracking of results over multiple treatments.

Perhaps this is what Dr. Zamboni means when he says that every Canadian should be given the treatment but also that the treatment should be given in a context of scientific study. This try-and-track approach was used with the original angioplasty procedures that were performed on arteries in the 70s, for example. It has also been used with radical mastectomy for breast cancer and caesarean sections, both of which have lately been given a serious re-evaluation. One notable procedure that the try-and-track approach was used on was scoping of knees. Now, after over a million trials, it would seem that scoping is being rejected as a valuable treatment.

Blind testing of drugs seems to suffer from a problem that is the contrary of the try-and-track approach. Once a drug is approved it may readily be prescribed for conditions that don't meet the test specifications. Notably, it may also continue to be prescribed even when tracking suggests that it may be dangerous under certain conditions. This appears to be the case with one of the commonly prescribed CRAB drugs, which as mentioned before under certain conditions may actually make the disease worse.

There is also a danger that the medical establishment will dismiss the benefits by setting the bar too high. Keeping in mind that the only long-term benefit of the CRAB drugs appears to be modulation of the attacks (so that the disease progresses just as quickly but with less serious attacks and remissions), we should not expect immediate and obvious benefits from every treatment. Benefits may, after all, be both restorative and preventive. Those in the early stages of the disease might not perceive any benefits even though unblocking their veins might prevent future deterioration. Those in the middle stages of the disease are most likely to notice perceptible benefits. Those in the final stages of the disease, after their muscles have atrophied making recovery impossible, might not notice any benefits, but at least they would benefit from prevention of further deterioration.

Some patients have complained that perceived benefits are fleeting, lasting merely months. Indeed, if their veins collapse again they may need to travel once again to Europe to have the treatment redone. Unfortunately, travelling abroad can easily cost $15,000, so can't be repeated too frequently. The solution is, of course, to make the treatment locally available, then it would cost only a few thousand dollars at most. Even if this procedure needed to be repeated annually, it would be much cheaper than treatment with MS drugs, which costs tens of thousands of dollars annually.

The MS Societies of Canada and the US have tried to accommodate pressure from the medical establishment while appeasing patients by providing $2.4 million of support to seven small basic research projects over the next few years. However, the paltry amount of funding and the focus on basic research has simply further raised the ire of the MS community. Not one of the projects is focused on improving intervention techniques, and some of them, such as testing for similar conditions in the brains of Alzheimer's patients, would appear to be aimed primarily at fortifying the arguments of detractors. In addition, some of the projects appear to have been chosen because the researchers have not in the past worked with Dr. Zamboni, which might seem logical, except that part of Dr. Zamboni's contribution was precisely in the area of techniques for the detection of venal blockages.

At this point, based on the evidence of thousands of case histories and several scientific studies, the science points to a cost/benefit trade off that is wildly on the positive for providing the treatment. The benefits would accrue not only to MS patients but to society as a whole which needs otherwise to pay for their MS drugs and accommodate their incapacities. The research at this point needs to focus on refining the technique. And despite how the mainstream media tries to depict it, pressure from advocacy groups is being correctly aimed, not at short-circuiting the scientific method, but at overcoming the intransigence of the medical establishment.

Philip Lillies is a community and labour activist, secretary to the Moncton chapter of the Council of Canadians, secretary to the Moncton District Labour Council, and vice-president for the Public Service Alliance of Canada to the New Brunswick Federation of Labour. He lives in Moncton, New Brunswick, with his wife, Anne, who is afflicted with multiple sclerosis and is on a waiting list for angioplasty at a treatment centre in New York State.