Some Very Bad News for CCSVI Advocates… Followed by Some Very Good News…

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But first, a little shameless self-promotion. Next Tuesday, September 7, at 8 PM EST, I will be interviewed live on the Internet as part of a nine week series entitled "MS Voices". I was very flattered to be asked to participate by the host of the series, Karen Gordon (The Self-Healing Coach), as some very impressive names are in the interview lineup, including Scott Johnson (founder of the Myelin Repair Foundation, one of my favorite MS nonprofits), Ashton Embry (founder of Direct-MS, a nonprofit MS advocacy organization), and Stuart Schlossman (founder of MS Views and News, an invaluable resource of MS info with worldwide reach), among a bevy of other very notable people in the MS universe. Truly, I'm delighted to have been included in this group, and I only hope I can hold my own amongst such an all-star lineup. Please register for the live netcast, and tune in next Tuesday night, if only to hear whether or not I make a complete ass of myself (click here to register).

Okay, on with the show…

On Thursday, August 26, the Canadian Institutes of Health Research (CIHR), in collaboration with the MS Society of Canada, convened a meeting of medical experts to determine whether or not the Canadian federal government should fund treatment trials of the CCSVI Liberation Procedure. Thus far, the MS societies of the US and Canada have divided $2.4 million worth of research funding up between seven CCSVI research projects, none of them directly testing the efficacy of The Liberation Procedure, the catheter venogram technique used to open up the blocked veins of patients found to have the venous abnormalities and resultant disruption in blood flow that have come to be called CCSVI.

Treatment trials of the procedure would clearly be the quickest and most effective way of determining the efficacy of the technique, and by doing so, the merits of the entire CCSVI hypothesis. To date, thousands of patients (estimates range from 1000 to 3000) have undergone the Liberation Procedure, many of them spending many thousands of dollars and traveling thousands of miles to foreign clinics for a chance at relieving their debilitating MS symptoms and the insidious progression of the disease, as very few doctors in the US (and none in Canada) are doing the procedure. Anecdotal evidence suggests that, for a sizable proportion of patients, the Liberation Procedure does seem to offer benefit, sometimes to a dramatic degree.

During the procedure, balloons or stents are used to open the blockages in patients' jugular and azygous veins, blood vessels that drain the central nervous system. While there is some acknowledged risk in the use of stents, and some complications have arisen due to their implementation, when balloon venoplasty is used alone it has proven to be a remarkably safe, minimally invasive procedure. Patients usually undergo the procedure with little or no sedation, and many leave the hospital only hours after the procedure is finished. Admittedly, the technique is not without its faults, as many patients see the blockages in their veins return some weeks or months after undergoing "liberation", a problem referred to as restenosis.

Earlier this week, the CIHR announced its verdict regarding treatment trials of the Liberation Procedure: "There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed Liberation Procedure" (click here for announcement). The decision outraged many MS patients and CCSVI activists, this writer included. The CIHR released a 10 page document outlining the evidence presented and the reasoning behind its decision (click here for document).

I find it absoutely unconscionable that the simplest and most direct method of testing the CCSVI hypothesis has been continuously blocked, in large part by individuals and organizations entrenched in and enriched by the standard narrative that MS is an autoimmune disease that is strictly neurologic in nature. The autoimmune theory has held sway for over 20 years now, and has yielded, after countless research man-hours and billions upon billions of dollars spent, a handful of drugs that either modulate or suppress the human immune system. These drugs have been demonstrated to reduce MS relapses and the amount of lesions shown in MRI imaging in some, but by no means all, of the MS patients taking them. Ranging from obscenely to hideously expensive, the available MS drugs do absolutely nothing to address the underlying cause of the disease, and the continued emphasis on autoimmunity has effectively stopped most research seeking to find that cause.

One of the primary reasons cited for not approving immediate trials on the Liberation Procedure were alleged safety concerns for the patients involved. This reasoning is almost laughable. As I alluded to above, when confined to balloon venoplasty, we have thus far seen no major complications, and very few minor ones. These same experts so concerned with patient safety routinely prescribe drugs to those under their care that carry potential side effects the stuff of which nightmares are made.

The CCSVI hypothesis offers a radical departure from standard MS dogma. It is so "outside the box" that many neurologists seem to shun it reflexively, unable to even entertain the idea that MS might actually be of vascular origin, often treating proponents of the idea with derision and barely disguised mockery. A turf war has ensued, pitting neurologists against interventional radiologists (the specialists who perform the Liberation Procedure); tragically, it is the patients that are caught in no man's land, desperately seeking a cure, and finally finding a reasonable explanation of their disease that allows them, at long last, some hope.

On pages 9 and 10 of the document put out by the CIHR (click here) is a list of all of the experts who participated in making the decision to not fund treatment trials. A little googling should easily turn up e-mail addresses and phone numbers for most if not all of these experts. I'm not usually one to advocate open insurrection, but in this particular case I believe that these people should hear from the human beings their decision has impacted, which includes literally every single MS patient in the world, each of whom stand to benefit if CCSVI proves to play a part in the MS puzzle. I urge people to contact these luminaries, and in very polite, rational, but no uncertain terms let them know the misery that comes with waking up each day with MS, and the potentially calamitous effect their decision to delay CCSVI treatment trials has had on them and their loved ones.

Let me be absolutely clear, I am not promoting the harassment of these individuals. Contact with them should under no circumstances be in the form of epithet filled irrational harangues, but rather in personal stories of desperation, disability, and hopelessness. I am calling for advocacy, not agitation. I cannot stress this point enough. Expressing unfocused anger, resentment, and hostility will only make these folks dig their heels in harder, and will set back efforts to bring CCSVI into the mainstream. I am also very specifically pleading against the demonization of the staffers of the MS Societies, who work diligently to assist in the daily battles against the MS scourge that patients must endure. The staffers of these societies have nothing to do with the decisions made by the scientific panels and board members of these organizations. They are conscientious and well meaning, and it's not their fault that those above them seem to have their heads firmly implanted up their own backsides on the issue of CCSVI. So please, direct your frustrations at those responsible, a list of which is thoughtfully provided in the back of the CIHR document, not at those good souls who staff the MS societies.

Okay, enough with the bad news, here's some terrific news. A large-scale treatment trial of the Liberation Procedure has been approved here in the US. Dr. Manish Mehta, working out of Albany, New York, has been given approval to begin a 600 patient trial, scheduled to start in August 2010 and finish in September 2011 (click here for details). The trial will split patients into two groups, one which will get the liberation treatment, and the other a "sham" procedure. Comparing the progress of two groups will reveal whether or not the Liberation Procedure does in fact improve the condition of MS patients, and the degree to which the placebo effect is in play. Following just days on the heels of the discouraging news out of Canada, this approval seems almost heaven sent. The buzz in the CCSVI world is that a second approval is pending, with perhaps even more to come after that.

Of course, these trial approvals do not prove the CCSVI hypothesis, but at long last we will be on the road to discovering, sooner rather than later, using accepted, objective scientific standards, whether or not the Liberation Procedure actually provides relief from MS symptoms. These treatment studies will not answer the vast galaxy of issues swirling around CCSVI, but they will address the single most important question that patients suffering from the son of a bitch we call MS want answered: Does the opening of blockages in the veins that drain the central nervous system improve the physical well-being of Multiple Sclerosis patients?

We wait with bated breath for the answer…