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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…
just a note: there's no link on dr mehta trials in albany. my usual source is (not sure you were referring to that)
including criteria (there are others) is to have rr-ms or sp-ms. (i have pp or pr, no one knows). also, you need to have a 50% stenosis of the extracranial veins.
anyway, very interesting post ... a lot of info.
i wish you the best in the 'ms voices' series.
serge-thanks, fixed it...ReplyDelete
Just wanted to say that I loved your text! You probably know this already but you spoke every word in every patients and relatives of patients minds! My mother has MS and no drug is helping her get better. She tried Betaferon and Tysabri and we all know the scary possible side effects that Tysabri can cause. Since 2009, the first time we heard about CCSVI and Dr. Zamboni, we have been devouring every pice of literature we can find about this. I sincerely wish painfull and disabeling MS symptoms to everyone that stands in the way of at least studying this theory! It is incredibly unfair and negligent of that board not to approve the trials! I hate them so much right now... It's sad that this society gives so much importance to money and so little importance to helping each other :(
Well... sorry for the long text full of hatred and despair but unfortunately this is how that CIHR people made me feel :(
Good luck with the new move. Great line up there. Just do what you do and you'll fit right in there.ReplyDelete
Scotland MS Society used up one million unpaid hours (2008) by there calculations (population 5 million).
I just see MS Society as a telesales operation. The staff are just people with feelings but they are encouraging a group only out to satisfy business concerns, their time and goodwill is being mis-mananaged & that's detrimental to PWMS.
If you make an ass of yourself, it'll be a first, veryone does it, so don't worry, even hardened celebrities get stage fright every so often. Tuesday, September 7, at 8 PM EST? The best thing to do is not to think about it. lol. Seriously, you'll be an old pro soon enough, I look forward to your contributions.
Great post. I have done the email thing, I've done the phone call thing. All with unemotional facts. As a person that is diagnosed PPMS and still working, I can't believe the short sightedness of the MS Society and the Neurological community. They are behaving like a pubically traded company and can't look beyond the next dip in their stock price. They need to look at long term results and benefits. I feel that the MS Society has dealt itself its own death blow if CCSVI has merit(I believe it does, procedure date 9/13).
CCSVI will either be the piece of the missing MS puzzle or not. The waffling of the people supporting the MS community might even be acceptable if it was just that. It is to obvious that they are not waffling, they just don't want it to work.
I agree with you that many if not all of the individuals working at local MS chspters are good people. They have no control of how the organization proceeds. I just find it extremely frustrating everytime I see or hear the MS Society motto "A world free of MS". I have said this before, but the MS Society needs to change their mission statement to "helping people with MS cope with the desease". That is what the local chapters do so well. I am afraid this mis-step by the national organization will cost them dearly. The local chapters will feal the pain the most when funding begins to slow, and that is a shame.
Fantastic column! You are so right that calm, rational (albiet angry)discussion is the best route.
Let's all get to work!
Just signed up for next Tuesday night's call, Marc. I'll catch it on the west coast at 5 pm before I leave my office for choir practice.ReplyDelete
Just want to make mention of two other items of good news: the CCSVI registry IRB approval granted this week to Dr. David Hubbard in San Diego; and the formation of the International Society for Neurovascular Disease by Dr. Sclafani and others in the group of presenters at the July 26th CCSVI symposium at SUNY Downstate in Brooklyn.
Thanks for your continued fine efforts on this blog.
Great news Marc, I like the idea of a man in the trenches adding a unique personal view point on the CCSVI conondrum. Shameless self promotion with a sprinkle of bashfulness was a nice touch. I've read many of your past blogs and I would personally promote Mr Kamikaze as a heavy weight in the all-star line-up. Your knowledge, personal and overall awareness of this subject is second to non(obsequious bow). And, in true NY fashion you'll do it your way!ReplyDelete
Great post but surely we all know by now that the CIHR along with the MS Society doctors are a sham organisation populated with paid drug industry lobbyists and spoksemen! This accusation was recently researched and posted on Facebook by CCSVI in Multiple Sclerosis:ReplyDelete
Dr. Alain Beaudet and the Pharmaceutical Industy---what you need to know.
by CCSVI in Multiple Sclerosis on Wednesday, September 1, 2010 at 10:46pm
Canada-What you need to know part 2. Dr. V. Wee Yong
by CCSVI in Multiple Sclerosis on Wednesday, September 1, 2010 at 11:22pm
Canada-What you need to know part 2. Dr. V. Wee Yong
by CCSVI in Multiple Sclerosis on Wednesday, September 1, 2010 at 11:22pm
CIHR's response, though disheartening, was none-the-less to be expected. They will never change their stance but it is up to all of us to expose them! By doing so we may be able to change the politician's minds, who ultimately will make the decisions. We need an investigative reporter from the national media either/or in the U.S. and Canada. I have sent letters to politicians in Ontario and Ottawa with details of the very dedicated Society of Interventional Radiologist's position paper on CCSVI which will be published this month in their medical journal:
I've had a positive response from one of my local members of provincial parlement the Hon. Dwight Duncan, Ontario Minister of Finance:
Thank you for your letter of September 1, 2010 expressing your support for CCSVI. Mr. Duncan appreciates you taking the time to bring this matter to his attention.
Please be assured Mr. Duncan has read your letter and brought it to the attention of the Honourable Deb Matthews Minister of Health and Long-Term Care.
Minister Matthews will respond directly to your concerns.
Thank you once again for bringing this matter to Mr. Duncan's attention.
Office of the Hon. Dwight Duncan MPP Windsor-Tecumseh
Telephone: (519) 251-5199 Fax: (519) 251-5299
Our politicians must be encouraged to learn the truth and resist the so-called findings of the drug companies sympathisers and their paid stooges. This type of unethical behaviour is unfortunately all too common these days. It's like the war that the cigarrette companies waged against those who opposed and exposed them. More recently, we've been exposed to the lies and spin by BP about the Gulf of Mexivo oil spill. However, if we are persistent enough the TRUTH will prevail! It's just too bad that regarding MS, we who are suffering and most vulnerable must endure this type of stress. It's not doing our health any good at all.
Marc, Dr. MacDonald was told by Dr. Alain Beaudet himself that anyone who had expressed public support of CCSVI was EXCLUDED from the CIHR meeting deciding on the matter. Dr. MacDonald called that process "fatally flawed."ReplyDelete
Thanks again for another informative post.
I'm with you 100% on this position. thank you for expressing it so well.
I believe thoughtful letters from those who have benefited from the liberation procedure should be written too. I know my letter will not speak of desperation or hopelessness, rather I will speak of joy and hope because I have had relief of so much of my suffering. my result has made me evangelical.
It is shocking that the same editor who is leading the neurologists charge to kill research into CCSVI and MS, was appointed in April to Obama's bioethics advisory panel, at the US academies of science in D.C. I hope they look at this problem and I hope he has the wisdom to recuse himself when they do. May I suggest polite, thoughtful letters to them as well.
You write very well.ReplyDelete
I'm responsible for lobbying for a newly formed CCSVI Advocacy Group in Alberta Canada. I'll be using your post at our next meeting and encouraging our members to contact the CIHR, MS Society and government officials involved in the patronizing decision.
We all have the right to disagree but no one has the right to be disagreeable.
I was as shocked and appalled, and then overjoyed and encouraged at the announcements.
You wrote "not at those good souls who staff the MS societies" ... I think that blame has to be placed squarely on the MSSC and the president of the CIHR in this instance. The former was heavily involved in choosing the list of so called experts in CCSVI research and the latter has former ties with Biogen Idec affiliates.
The local MSSC chapter president here in Newfoundland resigned over this, and coupled with the self dealing board elections they engaged in back in June - it is safe to say that the MSSC has lost its way. IMHO
=newly diagnosed, despite fifteen years of symptomsReplyDelete
= new to your blog and so proud of you.
Well said, awesome post
NIce post. Looking forward to hearing you on Tuesday. Did you listen to Geroge Jelenik last night? Did you have any thoughts on it to share with the class? And are we going to be able to ask you questions on Tuesday? That will be awesome.ReplyDelete
Signed up for MS Voices - now to just get the brain to remember hahaReplyDelete
Marc, I think that CCSVI has thrown a wrench in among the neurologist's cogs and they don't really know how to fix it.ReplyDelete
We have today a complete mass of anecdotal stories and those will be anecdotal until proven one way or the other. Nobody will prove anything just sitting there or just being sceptic.
The sceptics of CCSVI grab the placebo effects and the sceptics of cannabis did the same. Those buggers forgot their medical oath and didn't have the word emphaty in their vocabulary. I will never understand and will never accept that if something makes me feel better, then no SOB is going to stop me using whatever. There is no death registered to neither cannabis or CCSVI. So what is the problem?
Here in Sweden some inferior neurologists presented a paper where they found zilch result for CCSVI and they stated that there were two deaths correlating to the liberation treatment. That was of course nonsense and their paper consequently likewise.
Is it then surprising, that now a lot of ms-sufferers start to accuse the pharma industry for conspirations?
Now when we consider CCSVI is thinking out of the box wouldn't the continuation be that we have to re-think about the whole thing about the origin of ms?
I don't accept that our neurologists just sit there and have opinions. They should become active and get new socks on their feet.
You Marc, have a very nice way of expressing yourself, but I am 71 years old and am cheesed off.
When I read the CIHR statement, it looked like propaganda to me. They deliberately cited the only three studies that found no correlation between CCSVI and MS (all of which have been challenged because of poor methodology), downplayed the rigorous study at BNAC, and ignored the 25+ other studies published that support the theory. A good list is available atReplyDelete
One bit of slightly good news - I wrote a letter to the Minister of Health pointing out that the CIHR's recommendations were unprofessional and unethical. I copied the CIHR, MS Society, my MP, and Dr. Kirsty Duncan, MP, who I believe is the Liberal health critic. She responded with a phone call and pointed out that she has traveled to conferences - paying her own way - to learn more about CCSVI, and supports the funding of immediate trials of the Liberation treatment. So if there is an election soon, and the Liberals win, there is a chance that our new Minister of Health will be ready to reverse this decision.
My wife and I have resigned from the MS Society of Canada. We simply cannot understand how they can believe that a two-year delay in trials of the Liberation treatment can be in the best interest of people living with MS. Our friends and family are also resigning en masse, via e-mail and letters to Yves Savoie.
More good news! I just spoke with The Great Annette Funicello's husband, Glen Holt. They have a neuro science foundation and are building a new website, they want to support CCSVI research in a big way! watch for it!ReplyDelete
I have listened to you on the radio talk show. I want to tell you that you have inspired me and I want to thank you for that. I signed the petition "The Liberation Treatment for MS Patients". I'm asking you to sign this petition to help us reach our goal of 10,000 signatures. I care deeply about this cause, and I hope you will support our efforts and pass it along.Thank you
1869 Juno Ave
Ottawa, ON K1H 6S6