“This is the way the world ends
Not with a bang but a whimper.”
T.S. Eliot
We hoped. We prayed (some of us did, anyway). We researched. We organized. The MS patient population and a few sympathetic practitioners stood up to the medical establishment, goddammit! I wrote forty blog posts about CCSVI (forty-one now). But, given what we know today, there’s something that must be said.
I was wrong.
We were wrong.
For those unfamiliar with this saga, the term CCSVI was coined by Dr. Paolo Zamboni of the University Ferrara, Italy, in 2008. The acronym stands for “chronic cerebrospinal venous insufficiency.” Zamboni theorized that restrictions in the veins that drain the central nervous system — the brain and spinal cord — contributed significantly to MS disease activity. Furthermore, he believed opening such restrictions via balloon angioplasty or the placing of cardiac stents could improve MS outcomes.
The medical establishment would have none of it. With few exceptions, the neurological community, a.k.a. MS doctors, rejected the concept. Many, like my neurologist, supported patients’ efforts to obtain this treatment, knowing that they had nothing better to offer us. But a handful of mainstream neurologists spoke out vigorously against any attempts to pursue CCSVI further.
Nevertheless, a few rogue medical professionals set up research projects and began treating patients for the condition. The medical establishment accused the rogues of acting irresponsibly, risking the health of MS patients, and perhaps worst of all, profiteering from misguided, gullible, vulnerable patients.
To this day, I insist I was only slightly misguided, but I was neither gullible nor vulnerable. I was not a victim. I was simply desperate.
Online patient groups arose organically and became vocal. We wanted to be treated immediately, not years down the road. A group of us patients possessed a scientific slant, and we formed an organization called the CCSVI Alliance, complete with a website called CCSVI.org. We organized the growing body of technical information both for and against the theory.
I must admit, however, that we were not impartial. We advocated for CCSVI. We had a positive bias, and this was reflected in our work. To our credit, the CCSVI Alliance eschewed the anecdotes, the miracle YouTube videos showing individuals rising from their wheelchairs. We sought out the studies and facts, such as they were. But all the scientific papers lacked one thing—the gold standard for potential treatments—placebo-controlled clinical trials.
Reacting to immense pressure from the patient community, mainstream organizations began funding such blinded trials. When the results of these trials didn’t support the theory, we questioned the trial designs and thus the outcomes (sometimes with justification, sometimes not). Finally, Dr. Zamboni himself began a blinded clinical trial, and the results became available a few weeks ago.
Dr. Zamboni’s team concluded that CCSVI treatment doesn’t work. “The procedure cannot be recommended for treatment of patients with MS; no further double-blinded clinical studies are needed.”
For a more detailed discussion of the trial results, I recommend the article written by the MS Research Australia website. I’ll leave it to other bloggers to dive into the weeds. Instead, I’ll address the effect that our pursuit of CCSVI has had on the MS population.
I had CCSVI procedures conducted not once but twice on the veins that drain my central nervous system. I approached these procedures hopeful but not confident. In 2010 I went to Brooklyn, and in 2011 to Albany. I experienced no benefit from either procedure. I experienced no problems either. I experienced nothing. Worldwide, thousands of patients were treated, with the number of procedures peaking in probably 2011 or 2012.
Then, as more and more patients saw no lasting benefit, the phenomenon slowly lost its momentum, and for the past several years very few doctors continued to treat, and very few patients sought them out. One could argue that CCSVI died years ago, but this is the final nail in the coffin, if you will. The founder of the movement has disavowed it. This is the way CCSVI ends, not with a bang but a whimper.
How do we keep something like this from happening again—keep patients from chasing ineffective treatments, keep precious research dollars from being wasted? We cure the damn disease, that’s how. Until such time, patients will take matters into their own hands and demand treatments before they are fully vetted. We will take risks. The odds are, for any given treatment, that the results will be unsatisfactory, but there is nothing so unsatisfactory as being told to sit down and be a good patient.
I’ll acknowledge that a certain segment of the MS population experienced significant and lasting improvement from their CCSVI treatments. I can’t explain that, and I don’t have any interest in doing so. To you folks, congratulations. For the rest of us, it’s time to move on.
With so many technological and organizational tools available to patients, so many lives being overwhelmed by progressive diseases, and a drug approval process that takes much too long, these patient-centered movements won’t stop. You can count on it.
I tried twice as well. Traveling from Michigan to Arizona. Did not work for me, but in my head felt so exciting and full of possibility. Kathy
Kathy, same here. It felt invigorating to be doing something rather than nothing, and the explanation seemed so plausible…
I have a similar feeling about clemastine fumarate, an old antihistamine, that has shown some tendency to encourage the regrowth of myelin. I was all set to go, why not, only to have my pharmacist caution that in combination with other meds I am taking, this new (old) drug would, "significantly lower the seizure threshold." No medication or treatment is without risk, but we have to be smart patients and measure risk against possible benefit. We were all hopeful that CCSVI was a real thing, and I appreciate those pioneers who took it on, carrying the hopes of all of us. Let's keep looking!
Stephen, I'm taking the clemastine fumarate as well. I doubt it'll work, but I don't seem to have any negative side effects or contradictions, so I'll give it 6 months or a year. You definitely don't want to be "lowering the seizure threshold"!
I too was treated in CA after a year of reading and watching. I did getting my mental edge back for a good year but that was it
I knew it could have been the placebo effect and now I am fairly certain of that. No regrets. It was a carefully considered risk and I had an excellent, ethical Interventional Radiologist.
Well put. No regrets here either.
I so appreciate your retrospection here MItch. I feel as if you and others can't be blamed for your enthusiasm. Makes perfect sense on why you would lobby so hard behind it.
Thanks Kate!
Desperation leads to victimization. If the physician treating you harbored suspicion that CCVI provided only placebo at best, but went ahead and did it (interventions are highly lucrative), then you were victimized. You just didn't know it.
Victimization is only one of many possible outcomes for desperate patients who pursue cutting edge treatments. I didn’t rely on the interventional radiologists (the practitioners of CCSVI treatment) to help me assess the potential efficacy of the procedure. I already knew that it was a long shot before I spoke to the doctors. They didn’t recruit me. I recruited them. In fact, both of these interventionists went to great lengths to make sure that I understood that they could give no assurances about whether the procedure would help me or not. They didn’t pressure me at all. If anything, they discouraged me. We discussed the risks, and I made an informed decision, a calculated risk. I was wrong, but not because I was deceived. I was wrong because I was impatient. I didn’t feel I could wait 3 to 5 years for the studies to be completed before undergoing the procedure.
Hey Mitch, just playing devils advocate here, as my days of CCSVI advocacy ended years ago. Like you, I never took on CCSVI as religion, and always stressed that patients shouldn't let hope eclipse reason.
That said, while this study does refute the use of the "Liberation Procedure" as a viable MS treatment, it doesn't really disprove the hypothesis that blood flow issues to have some sort of impact on MS. I'm confident that these blood flow issues don't have a causal effect, but it's still possible that aberrant blood flow may impact some MS symptoms and perhaps the ultimate severity of the disease. Not totally convinced of this, but just saying…
Certainly, the role of blood flow on MS and other neurologic diseases still deserves legitimate scientific research. One hopes the baby won't be thrown out with the bathwater…
Agreed. Another way to look at the silver lining is that we studied the relationship between the vascular system and MS (which is very similar to what you said). Theoretically, the medical field can learn as much from failed trials as they can from successful ones, but will they? With so much research being funded by pharmaceuticals, as you pointed out in your blog on numerous occasions, we will probably just see more $60,000 per year treatments rather than following up on leads that may have been generated by CCSVI research.
Hi guys,
I have read each of your columns for years and have to say that you each have a disease that is different to each other and mine, also the Reality is that MS hasn't been defined.
In other words when a multi-factorial disease is laid like a blanket over many sufferers many won't fit.
All the factors haven't been assessed in either of you guys and also again in Reality do you have the same disease or the same problems. Consider the details that have been assessed about each one of your diets and the testing of things like gut biome by a Functional Medical Professional who is well versed in the effect of diet, Lifestyle and Environmental impacts as cascade triggers.
Just because you have a label, MS, it doesn't mean that eg CCSVI is not going to have a part to play in every PwMS' disease management or that the issue has been assessed completely.
Put another way many PwMS have gained benefits from PTA that have lasted which means the comments in the column(s) by Mitch and the comments you each made above are bs.
How does that feel to hear that your opinion on CCSVI as an treatment option is not valid, and that opinion could negatively impact the people who could benefit investigation and quality treatment if they believe or take your opinions as being sound or researched logic!
I must add now that I have spat my first download at you guys,
Marc and Mitch,
Do you each have a 'flawless' vascular system?
Has Jeff Beal and Mrs Paulo Zamboni benefited from treatment?
Seems like the number of people who are better off from having CCSVI treatment are known!
There's a lot here to digest. I'll just say that I respect your opinion that CCSVI theory is not dead. Regarding your question, "how does it feel to hear that your opinion…?", it doesn't feel good or bad. I certainly didn't post a piece like this without expecting arguments from people who disagree with me. Thanks for commenting.
George used to say he would crawl up a fat man's ass if it would cure him.
Desperation is reason enough to try any port in the storm when your life is deteriorating rapidly before your very eyes.
MS makes everyone a victim. And, many approved medical procedures are performed with just a crap shoot chance of success. Easy to judge when one is healthy and a know it all. Choice is personal.
Well written Mitch and Marc.
Hilda, thanks for your supportive words. You never had to wonder how George felt about something, did you?
He told it like it is, no "lets pretend".
I miss him so much.
And, I appreciate that you, as well, tell it like it is.
I had FIVE. I sought out a doctor, gave him literature, got him on board. My neurologist called the IR a “cowboy”. I have a stent in my azygous vein. No better, no worse. Another battle lost against MS.
I have never had CCSVI liberation treatment. I did experience notable improvements with MS after joining a study with Dr. Raymond Damadian, original inventor of the MRI, and Dr. Scott Rosa. They feel MS it is related to blocked CSF flow, usually from head and/or neck trauma. I am SPMS, Placebo? I got my eyesight back and could drive again. Over 5 years, no regression.
Linda, thank you so much for writing. I was also treated by Dr. Rosa — very nice man. Alas, I didn't notice any improvement. Congratulations on your success with him.
Does liberation treatment help anyone…more than a placebo? If so, then more research needs to be done. Blood flow is involved; it can be seen by MRI. When the CSF flow is opened up, the blood flow is returned. I have seen this myself of myself with MRI performed by Dr. Damadian and Dr. Rosa.