Monday, June 21, 2010

Some Revised Thoughts on the Current State of CCSVI

i0001_0000b-Frame1 Last week, I published a post on my thoughts regarding the current state of CCSVI research and treatment (click here). The post elicited much response, and many well thought out comments were left by readers who both agreed and disagreed with my points of view. As I've stated before, I welcome all readers to post their opinions, as a healthy exchange of ideas is the only way to draw informed conclusions, especially on subjects as new and controversial as CCSVI.

After reading and considering many of the responses arguing that research into whether or not venous blockages correlate with MS, and, if so, whether these abnormalities are cause or effect, were basically a waste of time and that treatment studies should take the forefront, I've changed my original point of view. While I still do think that academic research into the venous abnormalities we've come to call CCSVI is important, I now believe that treatment studies should be given the highest priority possible.

I've come to this conclusion for a variety of reasons. First, treatment studies themselves will show whether or not CCSVI abnormalities are indeed related to MS, and if they play a role in causing or exacerbating the disease. If, under rigorous trial conditions which include pre-and post-procedure neurologic evaluations, patients are found to respond favorably to the liberation procedure, then obviously CCSVI is not only related to MS, but plays an important role in the disease process. If patients fail to respond, then the opposite conclusions can be drawn.

Second, the noninvasive imaging techniques used to detect CCSVI have been shown to be less than reliable, and catheter venography has thus far proven to be the gold standard in finding blockages in the veins associated with the central nervous system. Based on the accounts of both the physicians who have performed the procedures, and patients themselves, Doppler sonography, MRV's, and CT venograms have all been shown to be prone to both false positives and false negatives when compared to the findings of catheter procedures, for a variety of reasons (technological limitations, operator deficiencies, etc.). Thus, any studies based strictly on noninvasive imaging will always have a cloud of doubt hovering over them. Better to cut to the chase, and perform catheter venography on test subjects. If that venography detects abnormalities, these abnormalities should be addressed by balloon angioplasty, which has been shown to be an extremely safe procedure when done by experienced physicians. Again, whether or not patients respond to angioplasty would answer questions of correlation and causation.

Third, if CCSVI does indeed prove to be a major piece of the MS puzzle, we need to refine the techniques and technology of the liberation procedure. Currently, many patients experience improvements soon after undergoing the procedure, only to see those improvements dissipate when their newly opened veins close up again. This phenomenon itself would suggest that CCSVI at least plays a role in the MS disease process, and also indicates that much learning needs to be done about the best practices, procedures, and equipment to be used when undertaking the liberation procedure. Virtually all of the medical equipment currently used in the treatment of CCSVI was developed primarily for use in arteries, which are vastly different in an anatomical sense to veins. Vein specific equipment, especially stents, needs to be developed if the liberation procedure does prove to be a major player in the treatment of Multiple Sclerosis.

Several other concerns have recently come to my attention. It seems to be becoming clearer that CCSVI is likely not just confined to the jugular and azygous veins, as has been thus far thought; the picture appears to be more complex. Dr. Zamboni has recently suggested that abnormalities in the lumbar veins could very well play a major role in progressive illness, and many venograms are finding abnormalities in the vertebral veins as well. The vertebrals are the vessels that return blood to the heart and lungs from the brain when patients are in an upright position. The jugulars take over this function when patients are lying flat. Thus, problems in the vertebrals could theoretically play just as important a role as jugular abnormalities. In my particular case, the catheter venogram done during my unsuccessful liberation procedure turned up blockages not only in my right internal jugular, but also abnormalities in my vertebral veins as well. Unfortunately, there is currently no accepted method for addressing stenosis in either the vertebral or lumbar vessels. Clearly, research into these concerns is necessary.

We must see collaboration between neurologists and vascular specialists if the myriad questions surrounding CCSVI are to be answered in any definitive fashion. I'm aware of several treatment studies that are currently awaiting approval, and of several doctors who are chomping on the bit waiting to get started conducting these trials. They'll have no problem finding patients willing to participate in these studies, but funding may be a dilemma. The MS patient population must get behind the studies, not only in body and spirit, but with their wallets too. When these studies are finally approved and announced, CCSVI advocates the world over, and those who love them, will need to step up to the plate and donate either directly to the institutions conducting the studies, or to nonprofit CCSVI advocacy groups that are currently readying to launch. Patient advocacy has pushed CCSVI out of the shadows and into the spotlight that currently shines on it, and that same advocacy will likely be necessary to take CCSVI from hypothesis to either positive or negative conclusion.

The CCSVI studies recently approved by the MS Societies of the United States and Canada will provide valuable data in assessing many of the questions that CCSVI theory has posed. I'm particularly intrigued by the study that will look at sets of twins in which one has has developed MS but the other has not. In fact, all of the approved studies will add greatly to the CCSVI knowledge base. But for a patient population desperate for answers, suffering with a disease in which time itself is an enemy, answering academic questions simply isn't enough. We must find out, as quickly and definitively as possible, whether or not the liberation procedure is as beneficial to some MS patients as anecdotal reports make it appear to be. Desperate times call for desperate measures, and for many MS patients, myself included, these are indeed desperate times...

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  1. Thank you for this very honest update of your thoughts of CCSVI. Since I've only knowing about this for several months, I am constantly having mixed feelings about the procedure (not having it done, but not wanting to get my hopes up WHEN I do get it done). Like I said in my response to your other post about his, I wonder if waiting to have it done IS a good thing, The more time that goes on, the more the doctors know about it in terms of procedure, effectiveness, etc.

  2. "The MS patient population must get behind the studies, not only in body and spirit, but with their wallets too."

    Well, a lot of MSers are voting with their wallets and going overseas, but I think there's a really easy solution to the money issue.

    Devise a study, funded by insurance, where participants have a 50% chance of staying on their MS drugs post-op. One-half of $30K/year could pay for a lot of treatment and follow-up.

  3. Great post, WK. I agree - there is so much more to learn about CCSVI. We need a strategy, not piece meal studies thrown together seemingly randomly, in order to truly find the answers we are all looking for.

  4. I think you are totally accurate with this post. It wont be just the jugs and the azygos, but instead I believe venograms will reveal entire venous systems that are abnormal due to the compensation of abnormal parts in the system. At this rate though and all this red tape it seems even the next generation will be fighting this turf war. Imagine a world free of MS because professional came together to make it happen! Unfortunately this Country is submerged in GREED! This greed will delay the process without question.

  5. Nice post. I agree more treatment studies need to happen to push the evidence one way or the other.

  6. Spot on; I would only add that for each anecdotal report there is a physician's report which provides a clinical account of the procedure and possibly before and after analysis. This clinical evidence needs to be aggregated in a central study - and this should not be either a complicated or expensive task, but would only require the goodwill of the physician's and their patients.

  7. @nickwerf - this is one of the problems of the people going overseas for treatment - the followup just isn't there, adequately.
    I would still maintain that donating to MS Societies is a good option - they already have a pattern of screening research to ensure it is done properly to provide answers, and it is hard to get study protocols set up without a good framework - and even the treatments should be, as you suggest, part of a study so that information can be compiled and reviewed.
    It's interesting finding all of these stenotic veins all over the body - but I'm still confused. When your body is stressed (either in a good way, through exercise, etc or whatever) the veins adapt to increased blood flow and allow the blood to drain. Perhaps the stenosis occurs through inactivity (forced in your case, Marc)? And I'm still not sure that it is truly an abnormality. I'm looking forward to the studies to prove this yea or nay. Perhaps it is just a normal thing we are now spotting because we are looking at and for it. Maybe if a person is placed in a different position, the supposed abnormality vanishes. It's all a muddle and while I agree that studies should be done which involve the treatment, there may be an ethical block to such things if the strictures haven't been proven to be abnormal. And if they are related to MS, why do we have the difference in sexes and incidence, or why do we have the difference depending on geography (irrespective of genetics)? It's all very puzzling and I am eagerly waiting for research results. Some should be available in October of this year, if not before, from the ECTRIMS conference - and the funded studies (so far - I'm sure there will be more in the regular funding cycle) should have preliminary results in a year or so.
    It's all pretty exciting, but I also want the other research to continue, just in case this isn't the only answer.

  8. Nice post again, Marc.

    I don't think that there's any doubt that organized patient advocacy is going to have to be the main driving force behind research and testing of CCSVI if it's going to get done in time to do enough people enough good.

    The MS Society is the single biggest obstacle to exploring the exciting new knowledge of the MS disease process.

    Then there are the neurologists, MS 'experts', who, in fits of professional chest-beating, won't even take the time to look at factual CCSVI documention.

    I'm afraid that walking softly and carrying a big stick isn't the answer. Stomp around and get loud, very loud or the CCSVI opponents will bury CCSVI in a flurry of improperly conducted studies and stone-faced ego for years and years.

  9. Amen Marc, Great, envy inducting writing as usual. It just makes so much sense. Here I am with jugulars, that by two doctors' evaluation, look like drinking straws, yet I has SO platued in my improvements. I read about others who are SP that still seem to be improving and just know there's more to the puzzle. I've always felt that way, but never paid any attention to all the ancillary circuilatory stuff "talk". So this especially piqued my interest when you were talking about all the vetrebal veins and the like. Looks like I need to take a trip to Dr. Sal!!

  10. It's been 3 weeks for me now Marc.... My improvements have been many. Some subtle to the naked eye, some not. I am so grateful that I got the chance to be helped. The illness is gone, I can feel myself healing and getting stronger. I hope you get your chance. Have you thought of going overseas where they have more experience in difficult cases like yours?

  11. Note to Dabble and the Mad Sow: if you assume that venous stenosis isn't abnormal (wouldn't that mean that they'd have to stop treating stenoses in organs other than the brain now, too?), neither is a large nose or a flat chest and I don't see a whole bunch of neurologists and not-for-profit spokespeople running around stopping surgery, *major* surgery, for that.

    MS is just special, I guess.

    I'm rather picky about what I'm being asked to believe. A person has to draw a line or the next thing you know, you're leaving pans of milk out for the fairies.

  12. Still wondering about the chicken/egg phenomenon in this...and I hope that neurologists and vascular surgeons can come together on this and work as a team to figure out this conundrum...
    but if it is indeed a vascular issue, then pray tell how do the dmd's work to lessen lesion load?

  13. The chicken/egg thing is not a phenomenon or a conundrum, it's a theory that got thrown into the mix by panicking neurologists to muddy the CCSVI waters. Red herring, jackalope, snipe.

    The idea that some combination of environment, genetics and/or magic pixie dust creates spagetti out of veins stretches the bounds of common sense.

    However, it may be possible, that perhaps, just maybe, Vitamin D may have have some bearing on venous development, although I would be very surprised if that involvement wasn't limited to the gestation period. Over a longer term and much longer research, that matters but I don't see why it ought to delay treating the physical condition.

    I'm not an expert but my understanding is the the DMDs don't work for most people, and don't work really well in the rest and they come with a load of potential side effects that have Big Scary Teeth. I'm not sure that they lessen the lesion load but they may slow progression down just a tic, or not, depending on what study you believe. If MS is auto-immune, the DMDs should work a lot better. I mean, they can make drugs that very reliably keep whole transplanted organs from being rejected.

    The way I do the math, the neurologists need to pick up their auto-immune game before they have the right to pick the CCSVI theory apart.

    I wonder what Judge Judy would say?

  14. Carla-there is indeed much that is still to be learned about CCSVI, and much about the theory is still unclear. As a matter of fact, it could turn out that CCSVI is a red herring, and actually bears no relation to MS at all. I don't believe this to be the case, but contrary to what some of CCSVI's most fervent supporters assert, CCSVI is still theory, not fact. The more we learn about CCSVI, the more questions arise, and as I say in the above post, it now appears that more blood vessels than originally thought appear to be involved in CCSVI. Interventional techniques need to be perfected, and new equipment needs to be devised, all while scientists attempt to prove or disprove the theory. Different patients will have different tolerances for the uncertainties surrounding CCSVI, and for many it might be a good idea to wait for the smoke to clear.

    Bart-I appreciate the inventiveness of your funding idea, but I don't think any medical research has been funded by any insurance company at any time in medical history. Insurance companies simply aren't in the business of funding research. Not to say that your idea doesn't make some sense, especially since the CCSVI, if proven correct, would save the insurance companies huge sums of money by negating the use of expensive MS drugs, but somehow insurance companies just don't think that way. I'm not sure I would trust results from insurance funded research any more than I trust the results of pharmaceutical funded research. Too much skin in the game...

    anonymous-we do indeed need a unified strategy, as thousands of patients are being treated without being properly tracked, and all this treatment, while possibly helping the patients, is not helping to prove or disprove the theory to scientific eyes.

    Anonymous-greed is indeed a problem, as we've managed to turn chronic diseases into billion-dollar a year industries in this country. Hard to stop the momentum of the money machine...

    blah-thanks for your comments, we do need to pick up the pace of research...

    Nick-compiling the already available data is a good idea in theory, but I'm afraid that the wide discrepancies in the assessment of patients before liberation, and the follow-up of patients after liberation make this prospect almost impossible. Most of these procedures have been done in the total absence of the input and assessment of neurologists, who, despite being depicted as the bad guys, are still needed to properly assess patients both before and after treatment.

    Dabble-thanks for your insightful post. There are indeed many things that are known about MS that do seem to not fit with the CCSVI picture. I suspect that like all things MS, CCSVI will tell the story for some patients, but not all. This is a very heterogeneous disease, and probably is not in fact one disease but a collection of them that share common characteristics. Certainly, the association between MS and EBV looks extremely strong, and CCSVI doesn't explain the common comorbidities with other autoimmune diseases. Still, as I said, CCSVI will likely prove to be THE answer for some patients, but for others will play a limited role in their disease, if it plays any role at all.

  15. Natalie-I admire your evangelical fervor, but casting the MS Societies and neurologists as "the enemy" is counterproductive. We'll need neurologists to confirm the benefits of liberation to the CNS. The people I know who work for the US MS Society are truly dedicated to finding a cure for the disease, and if you search a few posts back, I posted a video portrait of an MS patient who has been devastated by the disease, made by her devoted daughter who works at the NMSS's headquarters in Denver. That daughter (Beth Clark) would do anything to find a cure for her long-suffering mom. The MS Societies also serve many other vital functions, including patient support and political advocacy. Likewise, most neurologists are devoted to finding a cure to MS. I agree that many may be blinded by preconceptions and resistance to ideas outside their specialty. Hard to say, though, that they refuse to look at scientifically valid data regarding CCSVI, because there is actually very little peer-reviewed published data out there, and that's the only kind of data that scientists are trained to take account of.

    I must disagree with you about stomping around and getting loud, because that risks getting CCSVI advocates painted as the lunatic fringe of the MS community, which again would be counterproductive. Chimpanzees and Panthers both command attention, and I prefer the way of the Panther, using guile and cunning to achieve my goals. Martin Luther King Jr. and Gandhi both achieved great things through quiet determination. This is not to say we need to be meek, but targeted aggression is far more effective than scattershot noise.

    Lew-thanks for your kind words about my scribbling abilities, but I've read some of your writing, and you've nothing to be envious about. I think you're entirely correct about the complexities that have yet to be discovered regarding CCSVI. We've only just peeked underneath the rock, there's lots more to uncover.

    Anonymous-a heartfelt congratulations on your continued improvement. I would consider traveling overseas if I thought there was a significant chance that my condition could be properly treated, but my case has been reviewed by Zamboni, and even he isn't quite sure what to make of it. I'm hoping to undergo more testing sometime soon to help clarify the picture. Thanks for the suggestion, though.

    Natalie-the CNS venous system has been so little studied that most vascular specialists that I've spoken to (and I've spoken to quite a few) say that it's difficult to say what "normal" is in regard to that system. Unlike arterial anatomy, venous anatomy differs widely from patient to patient, and has lots of redundancy built in. True, blockages in other parts of the body do cause known conditions, but not all venous blockages are of detriment to those that have them. This is one of the unknowns of CCSVI, and the Buffalo study showed that about 25% of healthy subjects exhibited the abnormalities we call CCSVI. Certainly, there is at least the possibility that CCSVI plays no role in MS. I personally don't believe that to be the case, but I acknowledge that my belief has not yet been proven. Rigorously controlled treatment studies would go a long way towards clearing up many of the questions that still need to be answered regarding CCSVI, and in a timely manner.

  16. Debbie D/Natalie-the fact that DMDs are effective in some patients does not disprove the CCSVI theory. In fact, CCSVI provides an elegant model as to why the immune system becomes activated in the CNS, and none of the doctors treating CCSVI deny immune system involvement in the disease process. Dr. Simka has recently stated with relative certainty that CCSVI alone doesn't explain MS. According to the CCSVI model, a long-term disruption of hemodynamics creates inflammation in the CNS, and that inflammation in turn activates immune system involvement. Therefore, drugs that modulate or suppress the immune system would be expected to have a beneficial effect in the CCSVI disease model.

    MS is a complicated condition, very heterogeneous, and its presentation differs greatly from patient to patient. Likewise, the cause is probably just as complex. I'm sure that, in many patients, CCSVI plays a role. I'm equally sure that CCSVI alone isn't the whole enchilada. Certainly, genetics play a role (the children of type I diabetics are twice as likely to develop MS as the general population), and environmental agents (pathogens and toxins) also play a part. I've said for quite a while that autoimmunity is bullshit, and even in a CCSVI worse case scenario, in which the theory is proven to be totally false, at least the research going into it has forced physicians to take a broader view of the mechanisms that cause MS. It's definitely time to autoimmunity to bed

  17. Thanks for the response, Marc.

    My problem is that I do not believe, having educated myself on CCSVI 'in theory' [:)], that the MS Society and the neurological community are acting in the best interests of MS patients.

    You know yourself that the CCSVI theory is powerfully and practically compelling and I'm pretty sure that if you had the means, you'd be scanning patients (with/without MS) like a madman, bursting your heart to get that answer because, realistically, it's more than possible to get a fast, accurate answer. The MS Society wants the answer, too, on a shoe-string budget, at least 2 years down the road. Baby steps.

    I think that MS patients are entitled to be angry, very angry indeed, about the reception that CCSVI has received from both the MS societies as well as the MS experts in the neurological community.

    Meanwhile, I'll go with you on targeted, um, targets rather than the scattershot noise. I dislike aggression but staying silent is not an option.

  18. Marc
    As always, I find your posts to be sane and thoughtful. And calm.

    My thinking is that CCSVI is going to open up a new branch of medicine exploring how venous abnormalities impact neurological health. How exciting this is! The ramifications are potentially wondrous.

    I am hoping the scientists and doctors can work together to set up a data collection system so we can all contribute, even if we are not in a study.

    Myself, I am weighing the risks of going ahead with treatment now versus the risk of waiting a year or two.

    Anne in Toronto

  19. I had the protocol established by Mark Haacke to test for CCSVI and my venous structure was normal, as in NO abnormalities. I most definitely have MS. While I think it's a piece of the puzzle, it's not "the answer." I truly believe the stem cell therapies being established offer a tremendous amount of promise for a treatment for some. Unblocking the veins may be a treatment for others. But the question remains....what causes this beast to surface??

  20. My understanding is that non-invasive scanning, when done by a properly trained technician using the correct protocol, can determine venous structure in the jugular veins but not in the azygous venous structure, which is deep within the middle of the chest. In his study, Dr. Zamboni found MS patients with stenosis in the azygous but only during an invasive (endovascular) venography. It's considered a very safe procedure by the experts.

    So you don't know if your venous structure is normal unless you go for the gold standard of a venography.

    With respect to the idea of CCSVI being merely a piece of the puzzle, I like the old saying about if you hear hoofbeats, think horses, not zebras and with that in mind, CCSVI is a darned good answer. Marc brought up some other venous issues somewhere in the comments as well, which I think have merit (and I should re-read).

    I'd have a lot more faith in stem cell research save for three things. One, there hasn't been a whole bunch of successes so far. Two, most health systems simply couldn't shoulder that kind of burden for treatment and thirdly, it's an unthinkably dangerous roll of the dice for something so theoretical and totally unproven.

    As for what triggers MS, I believe that studies have shown that the brain damage starts long before symptoms occur. I imagine that there's a sort of tipping point where the brain/body simply can't keep up with the mess anymore.

    I'm am so going to get thrown out of here!