Welcome! This blog contains research & information on lifestyle, nutrition and health for those with MS, as well as continuing information on the understanding of CCSVI and cerebral hypoperfusion. This blog is informative only--all medical decisions should be discussed with your own physicians.

The posts are searchable---simply type in your topic of interest in the search box at the top left.

Almost all of MS research is initiated and funded by pharmaceutical companies. This maintains the EAE mouse model and the immune paradigm of MS, and continues the 20 billion dollar a year MS treatment industry. But as we learn more about slowed blood flow, gray matter atrophy, and environmental links to MS progression and disability--all things the current drugs do not address--we're discovering more about how to help those with MS.

To learn how this journey began, read my first post from August, 2009. Be well! Joan

Thursday, March 2, 2017

UBC CCSVI Clinical Trial

I want to say upfront, I am not hopeful regarding the results of the University of British Columbia (UBC) CCSVI trial.  The preliminary results may be most dramatically revealed at the Society of Interventional Radiologist conference on March 8th in the Marquis Ballroom of the Marriot in Washington DC.  I have a pretty strong hunch they will be negative and will not show any benefit in venoplasty for CCSVI.  

I wish I could be more upbeat and say that this trial will give CCSVI venoplasty intervention a fair shot, but I've been concerned about bias and an ill-conceived trial since the beginning.  Anne Kingston wrote the best article on this topic back in 2012--
"Finally, CCSVI Clinical Trials.  So Why is Everyone So Pissed Off?"  link

Here is what I thought about Traboulsee's 2014 CCSVI imaging study- Scientific Misconduct?

Fast forward to 2017.  Even though the UBC CCSVI study is still on-going, preliminary results have been fast-tracked for a release at a vascular conference in the US.  This research was submitted to the SIR conference after the deadline for submissions in September. This is from the SIR website, where the investigators are allowed to explain why their presentation deserves consideration.  

Please provide a justification below for this abstract's eligibility to be considered for late-breaking submission.

This will be the first presentation of a randomized, double blind clinical trial of jugular and azygos venoplasty in MS, including patient reported, clinical, and MRI outcomes. The presentation will include all data from the first 48 weeks in all patients after their first procedure only, comparing sham to venoplasty.

This is a multicenter trial with an independent trial coordinator. The database was locked December 23, 2016 and the authors were (and still are) blinded to the outcome. It is a trial of sufficient magnitude and scientific rigor that it deserves presentation at a major society meeting
.
link  (search "Traboulsee" to see the submission)

Get that? The trial coordinators and authors claim to still be blinded to results. Seems odd, right? Why submit to SIR, a "major society meeting" without knowing the results? And why now? Why not wait until all the data has been collected and collated?

I believe the reason the UBC study was submitted to SIR, before completion and after the SIR deadline, is because Dr. Zamboni announced, at the Veith Conference in November 2016, that his Brave Dreams Trial had been completed and results would be published in mid-2017.
link  

The UBC team submitted their abstract after Dr. Zamboni's announcement, as I believe they wanted to get out in front of the Brave Dreams published study results and put the final "nail in the coffin," ring the last "death knell", be the "last word" (or fill in any of the other hyperbolic titles for anti-CCSVI publications over the last five years.) I honestly think they want to kill this research and be done with it.

I have a hunch we will be reading a lot of negative CCSVI stories in the media in the next few days. Here's a first example from Vox:  
This is why you shouldn't believe that exciting new medical study

Joan, wait... (you say to me) this UBC study is gold-standard research! You sound like a conspiracy theorist. Science is science. Blinding and placebo controlled trials are what you have been asking for! This is exactly what the vascular connection to MS needs---independent study. That doesn't mean you get the results you want! Also, didn't you say you're done with all of this???


Yes, you're absolutely right.  And I am done, but felt it was important to go on record.  Here's my problem. This study does not look at blood flow before and after treatment.  They did not measure venous pressure--so how could they possibly know if stenosis had been treated?

The results of this study are not all objective.  Dr. Zamboni has stated that the Brave Dreams trial results are objective.  Objective results are numbers and stats and things that can be measured and tallied using unbiased machines.  Venous pressure is an objective measure.  Not questionaires from subjective humans compiled by even more subjective humans. 
There was no retreatment for restenosis in the UBC trial (a problem for 50% of patients) or suggested aftercare and lifestyle intervention.  Jeff had to be retreated at Stanford, as he developed intimal hyperplasia.  He also had aftercare treatment and drastically changed his lifestyle, diet and exercise program.  
Angioplasty for carotid artery stenosis has had placebo control trials, and you know what metric they used to measure success?  Size of stenosis and blood flow.  That's it.  Not a questionaire asking "how are you feeling?"  The researchers measured blood flow before and after and at monthly intervals up to a year.  They used ultrasound to see how carotid stenosis looked, if there was restenosis it was re-treated.   And most importantly, after treatment,  they put the study participants on an aftercare program, making sure they had blood thinning treatment and that they exercised and ate better.  Trial participants quit smoking or lost weight, if warranted.  Because without aftercare and lifestyle changes, restenosis can be immediate, and all gains from angioplasty are lost.  IRs know this.   link

Take my husband's reversal of gray matter atrophy on MRI.  No one can call that placebo!  He doesn't just feel better or have less brain fog.  His brain shows objective healing on MRI.   He has had no new lesions, and his old ones have shrunk. Another objective measurement from Jeff's venoplasty treatment was blood flow.  His jugular vein blood volume doubled after being stented.  Other research has shown that CSF flow increased after treatment for CCSVI.  link  These are all benefits which can be measured using medical equipment, and are not part of the UBC data.

I fear the UBC researchers are going to say any subjective benefit after treatment is placebo. That there are no objective benefits in those treated, because they have not measured blood flow, CSF flow and gray matter atrophy. They certainly didn't retreat restenosis. And Charcot will be laughing, once again, at how easily he is able to control the mind of the hysteric, labile, desperate MS patient. link

To recap my concerns:
1. Not objective results.  Too easy to claim "placebo"  No measurement of blood flow before/after
2. No treatment for restenosis (as in angioplasty trials)
3. No aftercare or lifestyle changes required (as in angioplasty trials)
4. Timing of release is suspicious
5. A history of bias and nay saying against CCSVI from trial lead investigator
Don't be discouraged. No matter what the UBC researchers claim, or how loudly they say it, it isn't over. Italy and Australia still have their trials. And we have other reseachers looking at the vascular connection. This research is not going away. Not with the ISNVD, not with The Gladstone Lab, The Kipnis Lab, the Nedergaard Lab and others--all committed to getting to the bottom of the vascular connection to diseases of neurodegeneration.

And I may be wrong!! Let's hope for that! Please let me be wrong!!!!
In the meantime, live your best, vascularly healthy life.
(Because I'm right about that part :-) )

Joan







16 comments:

  1. I have said this a few days ago ... This should be a very exciting time ... FINALLY the #CCSVI results are in.
    Unfortunately ... not many are excited.
    Why? These so called researchers have no experience, have already decided that this was set to fail. Too many conflicts of interests and called this cutting edge treatment a hoax. I will be surprised if anything good will result. But, I have to try to keep the faith.

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    1. I would love to be wrong, Shirley. But as you've mentiones, the timing, and the history of the researchers, and the lack of objective measurements and restenosis treatment all point to a negative result. Yes, keeping the faith and taking care of your own health are most important. xoxox

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  2. I looked up what was said on the SIR 2017 abstract. Not sure what it means. "Justification for late-breaking abstract submission eligibility. Please provide a justification below for this abstract's eligibility to be considered for late-breaking submission. This is a multicenter trial with an independent trial coordinator. The database was locked December 23, 2016 and the authors were (and still are) blinded to the outcome. It is a trial of sufficient magnitude and scientific rigor that it deserves presentation at a major society meeting". https://www.sirmeeting.org/index.cfm?do=cnt.search I wonder if they will talk mostly about what a "great study they have done" to give themselves credibility. I share your view that and am not optimistic. Traboulsee has not been supportive of CCSVI -

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    1. The UBC team submitted their abstract late, after the September deadline, Florence. In order to have the abstract be accepted, they had to give a "justification" for inclusion at the SIR conference. It's posisble they will not talk about results, and will simply discuss the study and how they are doing it. That would actually be a relief!

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    2. They only have 10 minutes ... this should be interesting.

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  3. Joan, you write about facts where UBC will likely talk about alternative facts. We are wise to their shinanigans!!! We are connected to Dr Zamboni and Dr Schelling and Dr Kipnis and the Australian team. We cannot be fooled. Thank you dear heart for being our guiding light and always lighting our way. Regardless of the up coming spin from Traboulsee and team, keep looking up everyone!!! I have HOPE.

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    1. I am trying to be positive but don't have any hope regarding the UBC CCSVI Clinical Trials. It does look like "The presentation will include all data from the first 48 weeks in all patients after their first procedure only, comparing sham to venoplasty". If the results were positive towards CCSVI I think they would be waiting, thus I think they have negative results to present. My guess is that this presentation will be well covered by the media and a lot of importance will be placed on it even before the study is completed or published.
      https://www.sirmeeting.org/index.cfm?do=abs.viewAbs&abs=4225

      However we will keep fighting and will win in the end. I am certain of that.

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  4. Considering billions has been donated to MS why has no one ever opened up hospitals to help MS patients with the money donated ?

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  5. Joan, the MS/CCSVI community thanks you for writing in such a coherent logical manner. Mistrust is high with MS Societies these days, and the predicted results of these trials were foreseen long ago. Research is a "dog eat dog" world, and the fierce competition to be the one on top is, in this particular situation, unconscionable. MS patients are still held hostage by the yolk of the almighty dollar and by unproven autoimmune theories.

    We will prevail....one day. As one amazing lady that I know says, "Onward and upward". :)

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    1. Yes thanks Joan. Onward and upward. Science will win in the end. This is not science ... they are manipulating the media!

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    2. Thanks, Christopher and Flo! Keep living well, and getting the info out there. You two are a couple of my heroes. Yes, science will win. xoxo

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  6. Exactly Shirley. It seems society in general as well as the powers that be have lost all sense of critical thinking or respect for science. The study was designed to fail from the beginning starting with more than obvious bias and obvious conflicts of interests. Just the reason the woman from the NMSS, who have had their fangs out and sharpened, since the beginning hurt my head. Thank you for your excellent synopsis Joan

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  7. As expected, Traboulsee did a bogus trial. Salvatore Sclafani was at the conference where the bad results were revealed. He was appalled because they used the WRONG venoplasty balloons! Some were low pressure balloons. When they did use high pressure balloons, they used small ones and even then they may not have inflated them properly! The exact same trick that the Buffalo trials used! Those poor people 104 people all got a sham venoplasty.

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  8. OK Joan.. I don't know who you are but this I do know. You my dear can not speak definitely on a treatment for a disease you do not have. I HAVE MS, diagnosed in 2006 after YEARS of misdiagnosis, confirmed by MRI. I FEEL the effects of this disease both from a neurological deficit and physical deficit standpoint, they are not the same. I am NOT able to make any objective comments regarding your husbands MS effects as I am NOT him. Every single MS patient has similar let me say..clear cut deficiencies but none of us are the same. I get very ANGRY when people who do not have this disease make comments, opinions,evaluations or conclusions of their own on something they personally don't FEEL. I HAVE a vascular blockage..I feel it's effects..I am not STUPID enough to believe for one minute Dr. Zamboni is anything other than a hack wannabe who scammed a few desperate MS patients into the false sense of belief that this ridiculous procedure would even remotely work. You and these cronies here commenting, some may or may not have MS, on the efficacy of this treatment infuriates me. Perhaps this procedure did help your husband, perhaps it is psychosomatic on his part, not accusing just speculating. However after 15 years and 11 after diagnosis I can say without a doubt..the risks associated with this procedure and the alleged benefits of it do not balance in my case, specifically my case..and I have had this disease far longer than your husband. We feel great pressure from our families to undergo these experimental treatments more for their benefit, than our own..that is a fact..I say this from personal experience. Watching our loved ones feel helpless makes us feel obligated to try something new. But only true acceptance of fate brings peace and the ability to endure what we must suffer alone. No person without this disease will ever fully understand or comprehend that. And likewise people who do not have this disease should NOT be commenting on how "wonderful" it works. Did it ever occur to you for a minute your husband is just telling you what you want to hear? Because guess what..lying to our closest family is the first thing they teach us in MS 101. Obviously, you have a right to your opinion as you wrote clearly supports this treatment, but ask yourself if you have the right to have this opinion when you yourself do not have this disease? Are you grasping at straws and ignoring the science or are you personally qualified because you suffer from this disease to make such an assertion? I am qualified, and I wouldn't have this surgery if it were FREE or prolonged the inevitable fate I was set out to have. Genetics can't be cured by bs treatment, period. And yes I take it personally when people try and convince me that some new treatment will work when Zamboni's own data showed otherwise. I likely, but do not know definitely, if I inherited this disease as I refuse genetic mapping options. I have likely, but again do not know for certain, passed on this genetic flaw to one or both of my daughters. Science has eluded us on this mystery and will continue to do so until such time we all fit into this nice little cookie cut scenario non patients like to place us in. Until that day comes, we should all be mindful of our opinions if they don't personally pertain to us. And let me finally say, I am happy for your husband, truly I am. I support his decision if that is what HE felt was best for him. But we are not all the same, nor do we have the same symptomatic progressions or deficiencies, hence the true point of this UBC study was to show that side also..and you missed the obvious. Bravo.

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    1. You're right, Jacquie. You don't know me, or my incredible husband of 33 years, composer Jeff Beal. (maybe google some of his interviews on MS and how he's doing) You also don't know the vascular professionals at Stanford University who treated him, based on his MRV showing no jugular flow. You don't know the hundreds of medical professionals who belong to the International Society for Neurovascular Diseases, who are working on figuring out the vascular connection to MS, nor the thousands of people with MS around the globe who are part of this research and discovery. And you're right, I don't know you. But your note to me speaks volumes. I wish you health, peace of mind and better days. Truly. Joan

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