Multiple Sclerosis and Irrational Exuberance

As an addendum, Milvy reports (and I don't know if it's true) that Zamboni attributes MS to iron buildup from venous congestion. If he really believes this, I'm even more skeptical, given the lack of a pathologic correlate. Iron-overload diseases have clear pathologic findings.

the door for quackery is open, and anyone can and will walk in

Because of symptoms and other tests, I underwent an MRI and got a diagnosis of Primary Progressive MS last week. The general public that I talk to, point to "the news" and tell me that "there is already a new treatment" and that I should not be so pessimistic declaring that there is no effective treatment for PP. Does not matter how often I repeat that it was a pilot study as noted by the authors, PP was only 10 patients, and at best, some of the findings warrant further investigation, or I send a copy of the original paper, I get the "you will see soon" that the newspapers got it right.

So that anyone should be changed to everyone, even those with no profit motive. The popular press does it again as a pilot study should not even be reported.

Hang in there, RMM. Assuming from the handle that you're Canadian, I'm sending good thoughts (in a completely non-mystical and materialist way) over the border.

If MS is an immune mediated disease, why has an antigenic target never been found? Why do stroke victims also have oligoclonal banding? Are their t-cells attacking myelin because stroke is an autoimmune disease? In CCSVI the immune system is activated to clean up axonal death caused by hypoxic injury and iron deposition in the brain created by stenosis.

Zamboni is the name of a major street in Bologna-one which leads through Europe's oldest and greatest university. You may know this name as that of an ice machine, and make a joke, but this is because you are uninformed. Rindfleish saw in 1830 that the disease of multiple scars was created by venous congestion. He noted, with only a microscope, that every MS lesion had at its center a vein engorged with blood. MS has always been a disease of venocentric inflammation...Dr. Zamboni's discovery of venous stenosis and reflux explains the mechanism of injury.

I studied the history of MS to help my husband. I brought Dr. Zamboni's research to Stanford, and will continue to inform doctors of his discovery. You can write it off in a paragraph or two, but you obviously do not really care, or you might send your MS patients in to see if jugular or azygos venous stenosis is part of their illness.

I know this is probably futile, but Joan, the antigenic "target" in MS is a chemical called "myelin". We've known this for a couple of decades.

MS immunology is a minefield of complexity. The "antigenic target" probably isn't so simple as a single molecule, but rather is likely to be a suite of associated, and possibly related, components of the myelin sheath. Myelin Basic Protein is the key component. There are a handful of viruses that are loosely associated with MS, in the sense of patients with higher titers of antibodies to those viruses having higher relative risk of MS. Epstein-Barr and human herpes virus type 6 (HHV6) are leading contenders. The abrupt appearance of MS on the Faroe Islands after WWII has long tempted neurologists to look for infectious causes. In summary, it's very certain that MS is an immune-mediated illness, but what regulates it is a mystery.

As for oligoclonal banding in stroke: it's no surprise. Oligoclonal bands are a pretty nonspecific finding indicating inflammatory processes, and the "cleanup" phase after a stroke involves immune activation. The nonspecific nature of oligoclonal banding is a major reason why it's no longer regarded as an accurate diagnostic test for MS.

Zamboni's work is a novel avenue. There are suggestions that iron deposition in brain in MS patients is abnormal, but the findings are subtle. Zamboni has several publications showing detectable obstructions to venous outflow in large fractions of MS patients. So there's a far-fetched hypothesis that almost hangs together.

I think the skepticism on the part of the MS community comes, not from any flaw in Zamboni's theory, but from the fact that so many other perfectly reasonable theories have failed. Even when supported by preliminary data, the failure rate for MS therapies is fantastically high. I wouldn't recommend highly invasive brain surgery (and surgery on the brain's venous outflow system is high-risk indeed) unless there's substantial evidence of benefit. So, for now, I think this kind of treatment should only be carried out in the setting of a tightly controlled clinical trial.

You know what I meant...a specific antigenic target. Or else all diseases that show oligoclonal banding in the CSF are autoimmune attacks on myelin. Like a stroke? Or could it be that the immune system is activated after hypoxic injury due to slowed perfusion, and slowed transit time (both of which we know exist in the MS brain) and a response to axonal death. Why not further study this connection? My husband had two jugular veins which were 95% and 80% occluded on MRV and a reflux of blood into his brain. What is the reticence to consider this? Or is this just futile?

Perhaps I don't know what you meant. Myelin is the target of T-cell mediated immune destruction. T-cells specific for myelin are very strongly implicated. What else could you have meant?

"implication" is not proof. Some researchers believe the oligodendrocytes might be the target. In any event, autoimmunity in MS is still and unknown and unproven theory. We owe it to MS sufferers to find out if venous insufficiency and reflux is part of their disease process. It was for my husband, who is now 8 months past his venous angioplasty procedure, and relapse and progression free.

Your use of "irrational" is misplaced. MS sufferers are excited because they now have a more clever medical model that might explain cause rather than the merely descriptive neurological explanation. Don't trash their hopes. What is irrational is your defense of the MS societies. Most MS sufferers I know have exactly the same opinion of the MS Societies as the Huffington Post.

PAL @3

Thanks for the comment and will. Assumption is correct, as is my initials and city in Ontario, new land of the prescribing naturopath. Have past connections to "the great lakes region" having spent long years at a university not far from you and my father practiced at your institution. Funny you should mention the mystical, as the other day, we all agreed here, that was where we were assigning all the "blame".

Let's hope the Dr Zamboni's discovery doesn't become as mired in the medical/pharma foot dragging shown in Dr Barry Marshall and Dr Warren's h pylori research. It took from the early 80's until they finally received the Nobel prize in 2005. With friends spending $ 2000 a month each for MS drugs it isn't difficult to see who the major opponents will be to such an elegantly simple explanation and solution.

Sharon

The timeline to the acceptance of Marshall and Warren's helicobacter pylori stomach ulcer theory was more like 5-10 years not nearly 30.

The medical pharma foot dragging you falsely allude to was actually the replacement of a largely surgical (repair) and holistic (stress) treatment aetiology theory with one that could be taken care of with antibiotics.

So actually bigpharma liked that one.

elegantly simple explanation and solution

Sharon, please read the whole paper as linked by PAL above (10.1016/j.jvs.2009.07.096). ScienceDirect will get you there for free; note the sample size, methodological problems, authors caveats, and you will find nothing approaching your description.

I am not a neurologist or vascular biologist, so I will not claim to understand the intricacies of Zamboni's studies. What I do note is:

- Most of the studies Zamboni has published thus far are observational, x correlates with y. Sometimes correlations represent cause/effect. Sometimes they're two independent events happening at the same time. Either way correlation is not mechanism, in any way, shape, or form.

- As has been highlighted by others, basically all the work regarding the association of vascular abnormalities with severity of MS has been done by Zamboni and colleagues. This does not devalue their work, but it does highlight the need for further investigation before sweeping changes to therapeutic recommendations are made.

- From the abstract of Zamboni's J. Vasc. Surg. paper, "The results of this pilot study warrant a subsequent randomized control study." The authors themselves are saying, This is a small study, it provides a lead, but more needs to be done to ensure that this is a legitimate effect being observed.

Any nonprofit society-whether supporting research for MS or cancer or ALS-has a limited amount of money to commit to funding research. It is illogical to throw the lion's share into studying this (or any other) hypothesis based solely on the findings of a single research group in a single, limited study, at the cost of ignoring equally reasonable hypotheses. As PalMD pointed out, there are probably many different forms of MS-or diseases that mimic MS-and they may have very different causes and contributing factors. Autoimmune diseases are strange beasts. Immune-mediated diseases put into the context of the nervous system become immensely more complex.

Sharon, the NIH began promoting the use of antibiotics for the treatment of ulcers in patients with H. pylori more than 10 years before that Nobel was awarded. It did not take a Nobel Prize to change the treatment of ulcers. Certainly the idea was not accepted immediately because it went against the current understanding of the time. But others followed up and expanded on the work. This is part of the scientific process. No one experiment, no one study is without flaws or limitations. If it is a truly revolutionary idea, then it will stand up under further scrutiny.

If I had a nickel for every time I began a study with a small n that looked promising, only to see that the "effect" disappear as soon as the sample size increased I would be a relatively rich man.

Dr. Zamboni is going to have to do a lot more legwork if he wants anyone who knows anything about science and medicine to take his work seriously.

How silly to think the h plori thesis was accepted only after a Nobel - but it took over a decade and a doctor recreating the condition in his own body as further proof to silence the naysayers. The Nobel was the icing.

Zamboni's experiments have been applied here in the USA, albeit with the addition of a stent, and to similar results. The diagnostics are non-invasive; a trip to the cath lab and angioplasty are not major brain surgeries; the research and development has been largely conducted elsewhere and at no expense to America. Zamboni has been up front about the limitations of the data. The theory is simple if those without medical training can grasp the basic explanation.

If your quality of life was slipping away wouldn't you be clamboring for this procedure? Would you stand back and wait for further scrutiny?

Sharon @17

Zamboni's experiments have been applied here in the USA

Citation please, as I am not aware

albeit with the addition of a stent, and to similar results

Citation needed. For internal jugular (IJV) veins, dedicated devices of the correct size for IJVs, are not readily available. They require further development.

angioplasty are not major brain surgeries

True, but are not trivial either, and without the skill of a Dr. Zamboni for this type of procedure; potentially devastating

no expense to America

Go tell the University of Buffalo that, as they are deeply involved.

The theory is simple

Like the other 100 or so that have not been beneficial.

If your quality of life was slipping away wouldn't you be clamboring for this procedure

I have PPMS, and yes my Multiple Sclerosis Functional Composite(MSFC)is not improving, neither my Quality of life (QOL), and no, will not be clamoring, because the worst results are in this group, plus there is just not enough evidence. Although this PILOT study may open some opportunities, there is no rigour. Specifically:
1/failure to maintain open blood vessels in about half of the patients with IJV stenosis
2/a small number of patients
3/lack of an MS control group
4/mixed results
5/open label design, which may inadvertently lead to bias
6/the study was conducted at only one MS Center
7/patients were required to stay on FDA-approved, disease-modifying therapies
8/lack of consistency in MRI protocol

Would you stand back and wait for further scrutiny?

I will go along with Dr. Zamboni, who, in an article from Medscape Medical News (dated December 3, 2009 and written by Susan Jeffrey), Dr. Zamboni emphasizes that "...the current report should be viewed as an interesting finding that urgently requires replication by other groups."
I will also go along with: Jack Burks, MD:
MSAA's Chief Medical Officer
Director of Program Development at the Multiple Sclerosis Comprehensive Care Center Holy Name Hospital, Teaneck, New Jersey "In light of these shortcomings, I would encourage MS patients to wait for scientific results before considering this unproven procedure as part of their own treatment. The current data does not justify the use of this procedure outside of clinical trials. I hear that some people with long standing MS are considering taking a loan to have this procedure done immediately. Some are even thinking of selling their homes to get the needed funds, which have been estimated at more than $80,000. If this hypothesis does not eventually end with a positive treatment effect, these patients will be left with their MS - and no home. Obviously, the investigators and I do not recommend this drastic action at this time."

If MS patients are this eager to try the treatment, then volunteer for trials! My father was part of a chemo trial a couple of years ago now, partly because he hoped it would improve his chances, but also because he realised it was necessary for the general good to have clinical trials. Of course there is some risk associated with trying an unproven treatment, and there won't be enough trial places for everyone to sign up, but the sooner the trials are done, the sooner an effective treatment will become available. (Or you'll find out that it doesn't work after all having subjected only a relatively small number of people to unnecessary brain surgery.)

The quote from the MS society says they'll be fast-tracking grant applications, so hopefully some decent clinical trials will start soon. Look out for recruitment notices.

Pal's beef is with the HuffPo, not with Dr. Zamboni and his method. Zamboni found a new and potentially promising method and wrote it up in a respected journal for further investigation by the medical community. Exactly how you do science. The scientific community is soliciting grant application to take the observation to clinical trail for a more definitive answer. Also exactly as it should be.
It's the hype that distracts science from progress, diverting resources from less hyped but as promising candidates.

stripey_cat@19

True enough, and when there is more positive evidence, trials will start.

Dr. Robert Zivadinov of the neuroimaging analysis centre in Buffalo, N.Y.and also a professor of neurology at the University of Buffalo, worked on an early study with Dr. Zamboni in search of evidence that blocked veins restrict blood flow and lead to iron deposits in the brain. Now Zivadinov is part of a team at the University at Buffalo that is trying to confirm the link between blocked veins and MS. The team is enrolling hundreds of MS patients from the U.S. and Canada to have specialized neck scans to look for narrowed veins.

The study aims to show whether the condition is present in all MS patients, most or just some, and whether it occurs in people with other neurological conditions. Although is not a clinical trial, looks like a logical first step to identify candidates, and they had over 8,000 applicants a couple of weeks ago, so guessing it is now in the five figures. How many of those understand what they are trying to sign up for, for imaging only, no treatment, I have no idea.

"MS sufferers are excited because they now have a more clever medical model that might explain cause rather than the merely descriptive neurological explanation. Don't trash their hopes."

What MS sufferers now have is nothing more than a hypothesis that might either pan out or fizzle. Why get so emotionally invested in a preliminary hypothesis that is statistically likely to end in a let down? How clever is the model if it turns out to be wrong?

It may be an interesting hypothesis worthy of further investigation, but at this time, it doesn't really present anything beyond the possibility of potential hope down the road. Today, MS sufferers have no reason to change anything based on this news.

I never understand why advocating reason and rational thought is considered trashing someone's hope. Where will the accusations of trashing hope be if this turns out to be a dead end?

I am reminded of the current XKCD strip:

XKCD 678: Researcher Translation

That said, Dr Zamboni doesn't appear to be the one hyping this research up. It's the media doing that, and PalMD is right to call them out on it.

The comparison to H. pylori is silly. For one thing, the H. pylori connection was widely accepted long before the Nobel was awarded. That's not unusual. Although the science-related Nobel Prizes were originally intended to relate to discoveries made in the preceding year, some early embarrassments caused the committee to shift to recognizing only discoveries which had been "tested by time". One random example: Chandrasekhar (he of "Chandrasekhar limit" fame, and after whom the Chandra X-ray Observatory is named) won his half of a Nobel Prize for physics 53 years after he published his work on stellar evolution.

So, Sharon, if you think Marshall and Warren had it tough with H. pylori, think of poor Chandrasekhar.

Thanks for posting this. I heard about the new MS research while having dinner with my partner's family, and someone was ready to jump all over the medical community, because of their "resistance to try new treatments", and how they've "wasted" all this time purusuing auto-immune treatments instead of this avenue. We changed the subject soon thereafter (I was a guest and didn't want to wade into a "Gee, how bad is science, anyway?" discussion), but I'm glad to see some balanced reporting so that if the topic comes up again, I'm able to view it with some perspective.

Slightly OT @ PalMD and Joan: the framing of MS as a neurological problem is a major hurdle to MS research.

The National Multiple Sclerosis Society itself considers MS a neurological disease with a theoretical autoimmune etiology. (See http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/in….)

Meanwhile, the rheumatology literature is crystal clear that MS is an autoimmune disease. (Taking my pick of sources and looking at: "Multiple sclerosis: an autoimmune disease of multifactorial etiology," Bernard CC, Kerlero de Rosbo N, Curr Opin Immunol., Vol. 4, No. 6 (Dec. 1992), p. 760-5.)

Autoimmune diseases in the aggregate are more common than cancer, while MS is something of an orphan disease. The isolation of the National MS Society from other autoimmune disease advocacy organizations has major consequences for NIH research dollars among other things. There is great strength in numbers -- and in community.

Dr. Zamboni responds, "I Invite Scientists to develop MS models"-
http://www.ottawacitizen.com/health/invite+scientists+develop+models/23…
....the autoimmune concept in MS is built on feet of clay -- the animal model EAE (experimental autoimmune encephalomyelitis) where the antigen is brain tissue from another animal. In contrast, the recent description of CCSVI in MS demonstrates how inadequate EAE is. EAE assumes that brain circulatory function is normal and thus does not reflect what really happens in humans.

In turn, I invite scientists to develop a new model of MS, which takes into account the presence of extracranial venous blockages. I disagree that the development of a new animal model has to precede further studies on patients. This would be a parallel track.

It is irresponsible to delay further studies on the value of the endovascular treatment of CCSVI in MS, the so-called liberation procedure. Patients need to have clear answers and it is mandatory to face the problem. Either to organize educational programs for Doppler screening of CCSVI in MS, or to find support for a randomized controlled trial on liberation procedure are more than urgent and reasonable projects.

Don't get emotionally involved with your hypothesis. It doesn't love you.

joan Beal @26

And your point is? Relevant to?? Responding to whom???

I have read this entire article and all the comments that follow. I personally find this article to be informative as all I have heard since being diagnosed with MS (kind unknown, debating on RRMS or PPMS, so far looks like PPMS) on November 30th of this year is "Hey look into CCSVI." I have worked in the medical field for over 20 years and I happen to know a lot of physicians. I am saddened that so many individuals would so willingly want to get this surgery as it can cause complications. I feel that everyone needs to take the wait and see approach and allow the medical community to do their clinical trials that are blinded, key word being blinded! This is not something to take lightly. And yes I have spoken to 8 physicians over the last 2 weeks one including my father-in-law who is a well respected research scientist at a very prominent hospital here in the US. He is world renowned in cancer research and has made a major breakthrough in cancer treatment, etc. Of the 8 physicians one was a vascular surgeon and one was a neurologist. All of them agreed a blinded study needed to be performed and they are not convinced CCSVI is a cure for MS and that the immune system is clearly involved. One thing I do not see mentioned much at all is this: "If MS is not an autoimmune disease than why do DMD's work to slow down progression?" It just doesn't add up and this chick will not be getting any type of procedure until thousands have shown it is an effective treatment for MS and then I cannot even say I will go for it due to other health issues such as a blood clotting disorder.

Sign me,

Frustrated and confused by people that have MS. All anyone has done since I have been diagnosed is stress me out even more and confuse the you know what out of me all because of CCSVI hitting the news from day one of my diagnosis. I'm simply fed up!

Dr. Zamboni might not have developed his hypothesis at all if it weren't for love - his wife's MS is what prompted him to do the research. How could he not be emotionally involved?

I am one of the "MS sufferers" that most here seem to be patronizing and told not to get too excited or hopeful. I'm not a scientist. I do think I have a good deal of common sense, which I realize doesn't count in your circles.

In Dr. Zamboni's research group, over 90% of the clinically definite MS group had something wrong with blood flow from the brain - bad veins. The control group, some of whom had different neurological disorders, did not. My position is this, and I know I speak for many (but not all) - whether or not CCSVI causes, or is caused by, or is just strongly correlated with MS, if there's a possible 90% chance that I have a problem with blood refluxing into my brain, I should damn well be able to get a doppler scan and an MRV to find out so I can act accordingly. For me this might include dietary and exercise changes (though I know that sounds stupid to you because there haven't been any clinical trials done on that). It's my body and I have the right to know. And what's the harm in looking? Hey either the theory pans out or not. The sooner we know, the better. As I understand it, current drug therapies only work for around 30%. Not even half a chance. I think those odds suck.

I would not "rush out" to get an invasive procedure, but I sure would consult a vascular specialist. I think that would be warranted if I had a blocked and refluxing jugular vein or two, no? Don't you think that if this is a widespread issue that simply occurs somehow beside MS, that maybe the vascular surgeons and device makers would want to get on that?

Why is it OK for my neurologist to put me on long term antibiotic therapy because a very small study was done in Calgary that showed a slight improvement in the time before a first relapse, but getting a scan to check for CCSVI is somehow ridiculous because not enough large studies have been done yet? Oh btw I had to stop the antibiotic because it was horribly staining my teeth, inhibiting the absorption of several essential minerals including iron, I was bruising easily, and it had destroyed all my healthy gut flora so I felt worse than before I started it.

I've seen notes from the recent CCSVI conference in Bologna. Lots of specialists were there who are very interested in this. UBC has a study ready to go, they just need funding - $500,000. Buffalo. Hamilton, ON. Stanford, etc. If there was nothing there, I doubt all these researchers and specialists would be remotely interested.

Don't be so quick to judge people with MS (not all of us are suffering all the time, you know) for being excited about CCSVI theory. Until you know what this disease is like to live with, you have absolutely no idea how desperate one could become for just some relief, let alone a cure. And when you've always been told "it's an autoimmune disease but gosh darnit, we just don't know why yet" and someone comes along with what very well could be a mechanism - bad plumbing - that could be fixed? Well that sounds a whole lot more exciting to me than a daily injection with horrible side effects and a whopping 30% chance of keeping me from becoming debilitated.

i've grown so tired of the whole rant of how medical science proceeds too cautiously, and real treatments are being denied for decades because we want to know something works before we go doing it to everyone.

it's about risk vs benefit. if we don't know the benefit and we don't know the risk, we don't know anything. and then there's no making an informed or rational decision.

pushing premature or poorly-investigated interventions on people with false promises far beyond the current data is IMO the highest level of unethical conduct, far more than delaying a potential intervention while we gather data about whether it is a worthwhile idea or risk with little benefit.

i have a close family member with RRMS, and would love to see a more effective way to help this person. i am also not interesting in seeing them put their health at greater risk and raise their hopes falsely for something that may or may not even be helpful.

leigh, why do you hate people with MS?

To Any Pessimist of the CCSVI theory: Do you honestly think the medical field or any of the upcoming 'real research' would be happenning if it wasn't for patient demand. NOT... I whole heartedly agree with the words above of K.Ross.
Perhaps in the article's closing statement the word 'Pessimism' should be substitued for the word 'enthusiasm'.
"Diseases that inspire fear, as MS legitimately does, attract a great deal of emotional attention. This type of attention, when applied to real research, can drive progress in science. When this enthusiasm is decoupled from science, the door for quackery is open, and anyone can and will walk in."
Or perhaps the word 'profit' is more appropriate than the word 'fear'?

@ Michelle (33)

You have a very poor view of science, it seems. Research is rarely about profit, it is about learning the truth and helping people. We urge caution for the reasons outlined by PalMD and many other commenters above.

If the pilot study results pan out, great! If not, well, a negative result is still a contribution to understanding what MS isn't.

My personal opinion is that the media is being totally unethical in reporting on this pilot study. Drumming up a public clamor for one hypothesis can end up underfunding other promising hypotheses and delay real progress. Scientists in the field are far better suited to evaluate hypotheses than some random member of the public.

JP,

Well said.

I couldn't have said it better myself JP and if it weren't for research scientists such as my father-in-law breakthroughs in cancer would not be found. I also agree with your perception of the media as they should not report on something that is so small and again, I will say not a blinded study. Taking 65 or 100 individuals with MS and performing a procedure on them is just pure self serving in my humble opinion. Am I educated, yes, do I work in the medical field, yes, and I would never in my life have a procedure performed on me with such a small amout of subjects.

As for the people that have had this procedure done and I have read many testimonials the common factor I have heard is less fatigue. Well let's see, when I take a heparin injection to travel, I have less fatigue, why, because my blood is flowing more, the blood is thinner, that's a no brainer. As for no relapses after the procedure isn't it to soon to tell? They believe my first relapse was over 2 years ago and then I did not have another one until nearly 2 years later, we are all different. And no I was not on any DMD's. I also noted many of the individuals did not have relapses prior to the procedure being performed, so how can you say for sure this is all related to the MS?

I really believe unless you are a physician or a scientist and a blinded study is done to show proof you are spreading the word of CCSVI with false pretense or hope.

One might ask what I do in the medical field and no I am not a neurologist and yes I have read so much on CCSVI my brain is about to explode. Am I in research, am I a vascular surgeon, NO, but I am in a related field none the less. Do I have MS, YES, so I see the desire to find a cure, however like all studies, again it must be unbiased and a blinded study with no emotion whatsoever involved. Grasp and hold onto what you wish, I'm merely stating how important it is to be careful on how much you spread the word on something that is not proven as of yet and Dr. Zamboni being on the research end should know better. If it proves to be part of the MS process, hooray, progess has been made, to call it a possible cure, come on people it is clearly known the immune system is involved just as it is with cancer, lupus, and the list goes on. So go spend your money on a theory not yet confirmed. Personally I would rather spend my money on a nice trip to a place I have never been.

Okay I'm finished now, beat me up all you want, but believe me I'm much stronger than MS will ever be and if that's the case imagine how strong I can be to argue my point.

Merry Christmas All!!!!!!

NewToMS, respectfully, you make it sound like Dr. Zamboni and his team were ballooning open the veins of people with MS for the hell of it. No. He did it because they had blocked veins which he thinks may be connected to them having MS. Is there ever a case where blockages in draining blood from anywhere is a GOOD thing that should not be treated? I would say no, and since that was the Dr.'s area of study before this, he knows full well what refluxing blood does to tissue. I'm pretty sure the subjects were willing to have this done, too. I have to say, any CCSVI researchers will have no shortage of MS patients who are willing to be involved in studies. Just because you don't want to be involved with a new procedure doesn't mean nobody else is or should be. You're new to MS - a lot of people are suffering with it more than you can imagine at this point. They will be the guinea pigs/pioneers, and hopefully some day soon you and I will be able to thank them for it.

My god it's not like angioplasty or shunting to open blocked vessels is some bizarre new procedure! Doing it on veins is a bit different but yeesh, you'd think he was performing brain transplants or something.

Of course the immune system is involved with MS, but WHY? is the question. The refluxing blood and the iron left in the brain might be the trigger. It sure seems to make more sense than a virus or bacterial infection nobody has yet, in alllll the years of MS research been able to identify. NOBODY has answers for MS. I think it's important to listen when someone presents something as compelling as CCSVI.

You know, anyone with enough money can go into a clinic and have their breasts sliced open and bags of goo installed, or have their face carved off and sewn back tighter for no reason other than they think it'll make them prettier. Dr. Zamboni, a vascular specialist and university medical professor fixed some broken veins and thinks he may be on to a treatment for a pretty much untreatable and very much horrible disease, and he's getting called a quack and a charlatan by a blogger who claims he's all about communicating the joy. What a f'ing joke.

@K.Ross, First off I never said Dr. Zamboni is a quack or a charlaten, so don't address something to me that I never said. Second, I probably have more damage to my CNS than most people who have had MS for years. Many I talk to do not have L'Hermittes Syndrome, permanent eye damage from optice neuritis and I cannot feel my left leg at all along with numb hands. For all you know I could be a person of great interest to you, to help find that almighty cure. Furthermore I never suggested they were angioplasting veins for no reason at all, so get your facts straight before speaking. I merely said and I'm using layman's terms for all, that a blinded study (do you know what that means) with a placebo effect (do you know what that means) needs to be done. Scientific medicine is not new and many new developments have been put in place due to the great scientists of our world and many have been found to be faulty and go no where. So allow the scientists to do their job and if somoene wants to volunteer so be it, all the more power to them.

Why is it that one Doc comes forth and we are to believe him/her right away and jump on the bandwagon, now that is give me an f'ing joke. Oh pardon me as a few others believe this needs further investigation and surely it does, but at the request of so much pressure from so many MS patients. I have seen it a lot lately, put the pressure on and they will do it, so they have no choice or get bad publicity and no future funding. One wonders if the God awful media weren't involved would this even be going anywhere, we all know how media frenzy gets things rolling. Are the studies being done because the research scientists think it warrants further investigation or was the push and pressure to much to bare for fear of losing future funding. Who knows, only time will tell...

My god it's not like angioplasty or shunting to open blocked vessels is some bizarre new procedure!

You are correct that angioplasty is not a new procedure, and fortunately this allows us to know some of the risks associated with it. Radiation exposure is one, as it is generally done under fluoroscopy. Related to that is the risk of allergic reaction to the contrast medium used, and the risk of kidney damage as the body clears the stuff, so if a patient has kidney problems, they should think twice before getting this procedure done. (And it's important to try to look for a realistic benefit rather than the benefit you hope it will have. Obviously, if it completely cures MS, that would justify the risk for most patients, but does it?) There is also the ever-present risk with any procedure of this sort that the doctor might make a mistake, or the vein may not be as strong as believed. And when you're working in the brain, the consequences get very serious for that sort of thing, because the result would be a stroke, especially if the patient already has clotting problems. Perhaps if the patient is on blood thinners, you'd have them fitted with a filter instead, and then wean them off the thinners, but that approach has risks too.

So the risks from this procedure are fairly well established. They're not insignificant, so to decide whether or not to do it, you need to know what the benefits will be. This pilot study shows promise, but I'd personally like to see more extensive data before letting anybody muck around in my brain.

I do not feel Dr Zamboni is being at all irresponsible. On the contrast, he's doing an excellent job pursuing a promising line of research while communicating accurately the state of his work. The problem is the media blowing it out of proportion. I think it's great that the media wants to report on this kind of preliminary research, but they need to do it more accurately. This kind of sloppy journalism is, in my opinion, what's *really* killing the newspapers. They like to blame the ready availability of the Internet, but their crappy investigative skills are definitely a part of the problem.

Thank you Calli for stating the risks so eloquently. I for one will not be a candidate for this sort of surgery because of having had a deep vein thrombosis. Messing with veins is a tricky business in and alone of itself, but when you factor in a combination such as a blood clotting disorder that I myself have you are flirting with many potential problems, such as: strokes, heart attacks, another deep vein thrombosis with the potential for it to travel to the heart, brain or lungs, which may result in the statement before of having a stroke or heart attack, but going to the lungs and potentially causing a pulmonary embolism, no thank you. I would much rather have crappy MS and see my 4 year old daughter grow up, graduate high school, and get married than take the risk of dying while having a procedure formed that we are not sure that the long term benefits are even worth it.

And I totally agree on the media spotlight being well overstated that this might be a cure.

NewToMS, I didn't mean to imply that you had said Dr. Z is a quack, but the blogger who wrote this original post. Sorry, should have been more clear. I wasn't speaking of you at all there. I think we are somewhat on the same page, I have stated more than once that I would not rush out to get a risky invasive procedure until it's proven to be of benefit. Some would, and if they want to volunteer for the studies I say more power to them. But I still stand firm that if there is a great chance that I have vein blockage of any kind, it's my right to know regardless of whether it has anything to do with my MS or not. I might adjust my diet in a few ways, and also the way that I get exercise if that were the case.

You did say this:

Taking 65 or 100 individuals with MS and performing a procedure on them is just pure self serving in my humble opinion. Am I educated, yes, do I work in the medical field, yes, and I would never in my life have a procedure performed on me with such a small amout of subjects.

..and that is where it seemed to me that you implied that Dr. Zamboni was somehow reckless in his study.

My whole beef with blog posts like this and that of Colin Rose is that they make it sound like Dr. Zamboni's team is a bunch of hacks who are advocating a procedure just to stroke their egos, or that they are somehow irresponsible. It's just not the case.

Some so-called journalists can be irresponsible, yes. I don't consider Huffington Post to be journalism - it's a blog like this one is, accountable to nobody. I do find it vexing that some would keep this story out of the media altogether because they don't want to us poor, misguided MS patients to see anything that's not "proven by science". But somehow pumping us full of drugs that have a very small chance of helping is A-OK. I mentioned that I was put on a drug that only a very small study was done on. A drug that taken long term (and I was told it would be indefinitely) is incredibly damaging to the body.

Let's face it. Doctors don't know everything even though most of them certainly think they do. If they did, MS would have been cured or at least efficiently managed by now. LOL - they can't even cure a cold. Let's hope for some research to be done on CCSVI quickly. That way it can be proven or dis-proven and we can use it to help us, or move on.

Happy Holidays. Sorry for the misunderstanding.

K Ross, I completely understand what you are saying and being on the research side of things I just know that 65 to even a couple of hundred subjects is not a feasible study and when emotion is involved the study is even more scrutinized and viewed differently. This is why research medicine uses hudreds to thousands of subjects such as Buffalo is doing to validate their findings and with physicians that do not know much about MS or at least the full research side of it, therefore making it a blinded study. The placebo effect is to guarantee that the procedure has benefits therefore creating a valid procedure.

You are very fortunate in the fact that if the study turns out to be valid that you will be able to get the procedure done. I'm in total envy of all of you that can potentially benefit from this, as I cannot. No vascular surgeon would touch me with a 10 foot pole to do this procedure at all because I have a looming friend called a blood clotting disorder thereby making it risky to perform any type of procedure on my veins. Unfortunately it looks as though I have to hold my breath in hopes that I'm one of the lucky 30% by being on copaxone, although they are leaning towards diagnosing me with PPMS, so what good does anything do, right?

I believe we all have our rights and as far as the sources of blogs etc. I am not familar with either of the ones you mentioned. I am a US citizen and maybe they are Canadian sources but irregardless I do see many Facebook posts that people are desperate to have this procedure formed with not having all their ducks in a row so to speak.

I wish everyone the best and Happy Holidays!

While the hypothesis is interesting, referring a patient for this type of procedure at this point would be as ethical as referring someone for a Lakota Sun Dance. There is no reason to think at this point that there is a favorable risk-benefit profile.

NewToMS, I sincerely hope you respond well to the copaxone. I know of a couple of people who are indeed doing beautifully well on meds. Please take good care of yourself. You (and obviously some others here) might find this "unscientific" because there are no clinical trials done, but I would strongly urge you to see if you have any food sensitivities (enterolab.com is the most accurate available, or you can try an elimination diet). I think it can benefit us greatly by keeping our immune systems calm; main offenders tend to be gluten, legumes and soy, bovine dairy, and/or eggs (usually chicken). Highly recommended reading would be "Primal Body - Primal Mind" by Nora Gedgaudas. There's actual science in that book, in fact I think every doctor should read it to augment their generally laughable nutritional knowledge. Keep your hopes up, maybe this CCSVI theory is a beginning step in a completely different paradigm for MS. I have hope now, whereas before I didn't have any, other than my own strength of will and a very strict diet.

PalMD, have you actually heard of anyone referring for this procedure, or any surgeons willing to perform it who aren't lined up to perform a clinical trial? Willing to name names? If not, then what's your beef? Or are you just a militant skeptic wanting to spread misery to sick people at the holidays?

We all agree that more research needs to be done. That's why so many of us have been agitating for the MS Society to use some of its $105 million or so yearly budget to get some of it done NOW. Not 2 years from now, but now. Researchers are ready, patients are more than ready. The only thing holding up progress at this point is cash.

K Ross, research is indeed going on. Don't you read the reports? Always some in the NMSS's magazine even if they dare spend some money on things like lobbying and helping local people directly instead of on research (though I don't like how they use much of their $). My neuro is involved in research (though not of this at the time) and I've been involved in a study though I'm ineligible for most of them.

I'm one with MS who is very uncertain about this iron hypothesis. I've had a pretty bad time of it with MS but my iron levels have been just fine. The only thing majorly off with my blood work was uric acid serum levels. (Apparently people with MS tend to have lower uric acid serum levels than most people and people with MS having an exacerbation tend to be even lower still. I wonder what that has to do with MS.) Parts my white cell count was a little high, too, but not by very much. I can't see that the iron idea makes any sense and can't see that, if it did, no one noticed it before.

NewToMS, I kind of hate some people with MS, too. I hate the superstitious sort that firmly hold that if you only do this, that, or the other, you'll be perfectly fine. (If this was true, why would MS be feared?) The kind that harp on various ideas about epidemiology while explaining away why whatever "reason" they come up with as to why I in particular have MS must be wrong, they had another waiting in the wings to take its place. And I hate those who'd tell me I'd be just fine as well as those who would tell me horrific stories.

It's true as you say, PalMD, that Multiple sclerosis (MS) is fascinating illness that can range from mild annoyance to debilitating nightmare, though perhaps as one with the condition, I wouldn't exactly call it "fascinating" so much as "unpredictable". MS is quite unpredictable, though, as I understand, it's getting to be less so. (By this I mean that, on the basis of initial signs and symptoms at diagnosis, disease form, and time between first relapses if it's a relapsing kind, some neurological societies are becoming more comfortable with the idea of giving a general prognosis like saying that certain factors are associated with a better or worse progression.) I, for one, think that being realistic is much better than clinging to false hope -- and I'm very sorry there are many people with MS who seem to think otherwise, who think that hope is the most important thing even if it might be false. That can be dangerous for them and frustrating for me and bad, I think, for the MS community as a whole.

K Ross, believe it or not I am a vegetarian. I do not eat eggs or many gluten products. In fact I mostly eat organic fruits and veggies. I really don't think my diet makes any difference. I have no food allergies at all. I work in a high stress environment and love it, but my MS loves it too apparently.

Beth, Yes it's definitely interesting the responses you get from so many people that have MS. I actually thought I could lean on others with MS and I'm finding out that is quite the contrary. All I ever get is mixed views on eat this or that, don't do this or that, etc. Really it gets old fast. My whole issue is that what might work for one does not work for another, as we all know MS treats all of us differently from one day to the next. No 2 patients are alike. So, I have pretty much distanced myself from the MS community and will do what I feel works best for me. Mixed views and signals just isn't my fashion so to speak.

As for this whole CCSVI thing, hope and having something to hold onto isn't necessarily the right way to go about things and I feel too many people have too much hope. I too have a high white blood count and I have for many years, but the Docs said nothing more as they could never find anything wrong. We all know that scene don't we? Having a high white blood count is indicative of an immune system problem, too high, hmmm go figure overactive immune system maybe? It is also indicative of an underlying problem, WOW I have MS, LOL. I too have a high uric acid level and my iron is way A okay. One of the many things I have been tested for recently and over the years is for Anemia, hence iron levels. It's quite interesting as you are the very first person to mention this. When my neuro saw my levels from my spinal tap he gasped as he couldn't believe how high they were, especially my white blood count. He said they were the highest he has ever seen and he has been practicing for over 25 years. Veins may play a part in the MS process but it is not a cure, the levels in ones body indicate that alone will not uphold. We already know the outcome of stents in veins which are not usually done, they are mostly used for arteries. Let's see, one open heart surgery patient and 1 so far with blood clots while being on a blood thinner from stents being used. Small number maybe, but what if thousands had this procedure would it be a higher number of patients with migrating stents to the heart or end up with blood clots, both very deadly by the way. Get a blood clot and you are treated like a queen for fear you will die under a hospital's watch, been there and done that. As for the angioplasty, read the stats on those procedures, WOW, veins closing up again with a 50% rate and a vein can only take so much. Scientists, physicians and healthcare workers can only do so much and I think for now I prefer to have my MS and beat the odds verses flirt with disaster. I think it's very sad when I see a comment such as this: "Why can't they find a cure, what is wrong with these doctors?" Well, why can't you, the person making the statement, find a cure? They are people like you and I and it's not fair to play the blame game. And oh, don't even get me started on the whole, my neuro doesn't know a thing kick, it's just not fair to them, not fair at all. They are physicians doing their jobs to the best of their ability, they are not GOD!

Happy New Year!

This comment is for the electronic record, posterity so to speak, to emphasize the absolute balderdash going on out there. CTV news this morning awarded this story (CCSVI) as one of five of their top medical breakthroughs for 2009. On the screen it is described as "Liberation treatment for Multiple Sclerosis". Subsequently there were two phone calls to me, (guess they missed the original)then a short explanation where I said it is too early to tell. Both reactions were that on the TV they said it is a treatment. Both said I was rejecting out of hand. Using a more common expression: WTF or for polite company; arrogance of ignorance.

NewToMS: Good luck, choose your fights to conserve energy. For the really ignorant tell them MS is as individual as fingerprints and yours are all down at the hospital with the educated, working with the best resources currently available. Works for me, but my mistake has been giving too much credit at the outset for some of these "well intentioned" people, that is, not assuming ignorant stupid mind bending woo from them at the start. If you really want to get a blank stare, tell them that they just bent your grey matter into the holes in your white matter. Only those with MS can really say that.

I feel as though I'm wearing out my welcome here, LOL. Thanks RMM Barrie, much appreciated, but I love a good battle none the less. How dare CTV news, I take it that is Canadian TV, correct, annouce such a finding that is not proven yet. Geeessshhh people, 65 individuals and some others to equal what 100 or so. I cannot believe how irresponsible and gullible people are. I think I might try and ask all of them on Facebook, that are fans of CCSVI, to please give me $5.00, each of them. Wouldn't that be a nice chunk of change, that's how desperate people are. Hey give me $5.00 and I will help you get tested, HA, HA, sorry couldn't resist.

Believe it or not. I read a post today that said this: "Could I have gotten narrowed veins from having a whiplash or neck injury in a car accident?" Oh it was on FB and the answer was, yes it is possible. I almost peed myself laughing at that one. Okay, so now we are onto the theory that if you had a neck injury in a car accident, your veins might be narrowed therefore resulting in MS, OMG, is that stupid or what? I mean come on, does that mean only people further from the equator have car accidents that result in a neck injury and people who live closer to the equator don't have car accidents as much, or what? I think I'm going to pee my pants again. Oh wait, just wait, I almost forgot, Canada has a high MS rate, you lousy drivers you, how dare you run into each other so much, LMFAO. Oh one more thing, if that were the case than half of freakin America would have MS. Okay now I did pee my pants.

NewToMS @ 48

Click on the CTV link and you can watch it in living colour (Canadian spelling of course) plus the written material. The background in the clips of the doctor is our Parliament building.

CTV is a national commercial network, while CBC is a national network government funded. Both have English and French outlets. We of course get all of the "American" networks, and watch them when there is nothing else on our stations, which is frequent.

I emailed CTV and told them that the coverage using the word treatment was unethical. Should have asked them if the background image of a political institution was a subliminal message for the usual hot air.

Rather than car accidents, the undiscovered secret of why Canada has a higher MS rate than the southern U.S. is from riding snowmobiles on rough terrain. It is further exacerbated by drinking "screech" at the same time.

@PalMD : Joan Bealâs story of her husband's disease is interesting. Joan has been the major online patient advocate for âCCSVI.â Her husbandâs MS sounds very atypical. MS never causes âabnormal blood numbers, high liver enzymes, [and] high SED rateâ. It can cause fatigue. But all of these can be caused by hepatitis. One could hypothesize that during her husbandâs trip to a high altitude he was infected with a hepatitis virus, the resolution of which was coincident with the âliberationâ procedure for his MS. His fatigue improved but it had nothing to do with âliberationâ. If high altitude caused MS many living above a certain altitude would have it. So here we have an opera singer determined to find the cure of her husbandâs medical problems, acquiring a little internet medical knowledge, getting into diagnosis and treatment of what could be two diseases or maybe just hepatitis, attracted by facile, unproven, superficially attractive concepts and then promoting it over the social interaction sites on the Web. Thousands of MS patients are now bombarding neurologists and MS societies with demands for âliberationâ and much money is being wasted by the gullible.

----------------------------------

Hi everyone-
Itâs just one person. Joan Beal, wife of MS patient Jeff Beal. We were the American family featured in the CTV documentary in part 2. Thereâs been alot of comments and some anger expressed as to âwho set us this page???â. I just want folks to know that I started this page over the summer. Because I wanted to get the word out. Iâve been writing about CCSVI research on ThisIsMS.com since last December. Thatâs where Ashton Embry found me as âCheerleader.â Lots of folks have been discussing this treatment over the last year at ThisIsMSâ¦we have an amazing online community. And thatâs how Avis Favaro found me. Come visit us and learn more.

Iâve been searching for the vascular connection to my husbandâs MS since his diagnosis. And I have worked many months, reading medical journals online and learning all I could about the history of MS. When a friend on ThisIsMS.com posted Dr. Zamboniâs CCSVI research, it made sense with everything I had noticed in my husbandâs MS- his first flare occurred after an hypoxic event (lack of oxygen to the brain) at high altitude, and he had many abnormal blood numbers, high liver enzymes, high SED rate, and overwhelming fatigue. These appeared to me to be signs of hypoxic injury to his brain. And in Dr. Zamboniâs research he found iron deposition, slowed perfusion and hypoxic injury to gray matter were the real insult to MS brains. And this was caused by closed veins. The blood heading back to the heart couldnât get there in a timely matter, and it injured brain tissue. The demyelination happened AFTER the gray matter injury. By allowing oxygen to flow and stopping iron deposition with the Liberation procedure, Dr. Zamboni found a way to halt the demyelinating lesions and slow MS progression. And to relieve many of the worst symptoms of MS, including fatigue, depression, spasms, sleep issues and more.

I am not a doctor. I was trained as an opera singer. But I can write like a doctor now, because I wanted to learn all I could. There is no ulterior motive to this page. I just wanted to help other MS patients. Once I saw my husbandâs twisted jugular veins on MRV technology, and his improvement after having them corrected- I knew this was real.

I promise I will never write and sell and e-book. Really. The supplement/diet/lifestyle program I made up for Jeff is on here for free. Look for Endothelial Health program in the notes section.

We all need to be our OWN ADVOCATES. No one will do the heavy lifting for us. If you want someone to learn about CCSVI, print out the research, print out the press and mail or bring the packet of information to the doctors you hope to reach. Thatâs all I did. Really. I tell you how to do it. Read the notes for âdubious doctors.â Read all the notes I wrote upâ¦I tried to explain all of this in plain english.

So, go start your own Facebook or web page!! Please!!! Lots of folks are organizing around the globe. Thereâs no trademark on CCSVI, and Dr. Zamboni would be thrilled to have his research tested by other doctors. Heâs wanted to get the word of CCSVI outâ¦.and thanks to Avis Favaro and Elizabeth St. Philip, now it is!
Iâm just one gal who loves someone with MS. Really.
My best to everyone fighting to cure this horrific disease,
Joan

See my blog for details of the junk science underlying the Zamboni myth:

http://medicalmyths.wordpress.com/2009/11/24/the-zamboni-myth/

Colin Rose go fuck yourself. See MY blog.

I have just officially recieved my diagnosis as RRMS and I take offense to this notion that "we have developed some pretty-effective treatments". I don't consider 30-40% delay in progression to be "pretty effective".
I read about an australian study that suggested the immune system attacked the cells after they had died. Really they have been going down this immune system path for a long time now and haven't made that much progress, yes my immune system must be playing a role but it's not the whole picture. CCSVI at least explains a whole lot more and gives me more hope than my visit to the MS clinic (what a joke).
Right now I am assessing my options and scrapping up the funds to go abroad to at least get tested sounds like my best option. Although it would be nice to be looked after in my own country by my own doctors especially considering the follow up care.
I am 27 years old I don't want to be in a wheelchair in 10 years or less. My nerologist says the fact is that 2/3rds of RRMS patients become PPMS patients. I envy those of you that don't have MS but have such strong opinions on the matter.

Oh by the way internist..."mildly annoying" is stubbing your toe, it hurts, you know why and then it goes away and never bothers you again, in fact you can forget it ever happened. There is nothing mildy annoying about MS, except people like you and Mr. Rose.

The thing about the ABC drugs (the ones that you're describing as "30-40% delay in progression") is that no, they aren't great, but I'll take an extra (average) 18 months without any particular exacerbation, if that's the best medicine can offer yet.

There's also been progress in treating symptoms. The gabapentin isn't a cure: but it helps with the spasticity and the nerve pain. The welbutrin isn't a cure either--but it's useful, for a disease in which depression is such a common symptom. Beyond that, what my doctor mostly has to offer is caffeine for fatigue (provigil did nothing for me after the third day) and steroids once in a while. Steroids don't cure optic neuritis, but they make it go away faster. Steroids during optic neuritis also (probably, statistically) delay other symptoms. No, it's not great; but it's better than I'd have had a generation earlier.

I know someone who has a very mild case of RRMS. When she was diagnosed, there was absolutely nothing medicine could do for her. So she went home, stopped giving blood, and told nobody at all that she had MS. Including her husband. They were married 25 years after that, and he never knew. That's one edge of the bell curve: one exacerbation 15 years after the diagnosis, which went into remission on its own. Forty years after diagnosis, she's in better shape, physically, than most people manage at 79. But that's not medicine, it's luck or good genes. If there'd been any treatment on offer, maybe she would have told at least a few people about her diagnosis. Hard to tell.

Agreed, MS is more than mildly annoying. I've had to cut back activities, because I don't have the energy. And I have to say no to things when I'm feeling okay, or I will pay for it later. But that doesn't make this proposed treatment more likely to work. Worthy of research, yes, but that's different from jumping on a plane to try anything and everything.

Oh, a number that might be a bit more reassuring: 1/3 of us have no exacerbations after diagnosis. But that 1/3 tend to disappear from follow-up: why go to the doctor if nothing is changing and you don't need treatment? Or if you're just getting one prescription that your GP can write just as well as a neurologist.