Panaceia or Hygeia

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Zivadinov proves Zamboni’s “CCSVI” does not exist

Posted by Colin Rose on January 15, 2011

Almost a year ago at a much heralded news conference Dr. Robert Zivadinov, a Buffalo-based early disciple of Paolo Zamboni, claimed to show some difference in the presence of venous flow patterns in the heads of MS patients compared to controls using special Doppler ultrasound techniques that had never been validated. He never published the details of this study and has apparently abandoned ultrasound in favour of MRI venography which gives an overall picture of venous flow patterns in all head and neck veins. Zivadinov has now published a well-blinded study using MRV in MS patients and healthy controls which shows no difference in venous flow patterns in the two groups. There are almost blocked internal jugular veins in some MS patients and some normal people. But such blockages are insignificant because of the extensive collateral veins and the emissary veins connecting intra- and extra-cerebral venous circulations, as I described in my original response the Zamboni hypothesis.

I quote from the Discussion section of the paper: “We did not find significant differences between MS patients and HC subjects or between RR and SP MS patients in regard to collateral circulation. This is indeed an important finding because it does not support collateral circulation as a compensatory mechanism of CCSVI.” Such “abnormal” collateral flow was a crucial part of the Zamboni hypothesis.

As I said in response to Zivadinov’s first “study” of “CCSVI”, real scientific discussion is not conducted by news conference. Those who thought otherwise should now be convinced that only publications in respected journals following the time-honoured format for scientific communication are worthy of consideration.

With this paper and at least three others showing the same result, we now have overwhelming evidence that “CCSVI” is a fantasy, concocted by Paolo Zamboni, a varicose vein surgeon who convinced himself that he could “liberate” his wife from MS by dilating her neck veins. To date, at least $one billion has been wasted on this myth by desperate patients, granting agencies and governments. No further attention or money should be directed at this farce. All MS patients should refrain from paying for “liberation”, a very profitable scam based on the “CCSVI” myth.

12 Responses to “Zivadinov proves Zamboni’s “CCSVI” does not exist”

  1. maldendj said

    “Liberation” story, for me, looks similar to “The Emperor’s New Clothes”:

    “The Emperor’s New Clothes”
    Hans Christian Andersen, 1837.

    An Emperor who cares for nothing but his wardrobe hires two weavers who promise him the finest suit of clothes from a fabric invisible to anyone who is unfit for his position or “just hopelessly stupid”. The Emperor cannot see the cloth himself, but pretends that he can for fear of appearing unfit for his position or stupid; his ministers do the same. When the swindlers report that the suit is finished, they dress him in mime and the Emperor then marches in procession before his subjects. A child in the crowd calls out that the Emperor is wearing nothing at all and the cry is taken up by others. The Emperor cringes, suspecting the assertion is true, but holds himself up proudly and continues the procession…

    • viaferria said

      The ‘Emperors New Clothes’ is such a great story. Swindlers yes, but they weren’t on a fixed university salary as many CCSVI practitioners are.

      But a great story nevertheless. Thanks.

  2. viaferria said

    I think that this study serves to underline the fact that MRV is not so useful when diagnosing CCSVI, something which many other doctors who practice CCSVI treatment will tell you.

    Having now had treatment for CCSVI myself, having entered into it with little expectation and a pessimistic outlook, being rather far gone, yet experiencing real and quantifiable improvement I find this discussion amusing. I know for a fact that time will prove the theory.

    I think that you should re-examine it afresh. There isn’t a criticism that cannot be answered. Honestly, I had no expectation and yet I experienced real benefit. Benefit that drugs previously, though my expectations and optimism were high, could not provide.

    • maldendj said

      Doctors who practice CCSVI treatment need only portable ultrasound machine. They are capable to diagnose CCSVI in less than 2 minutes!
      Dr Marian Simka using doppler scanner to image stenosis in left and right Jugular Veins: 80% right 60% left.
      Bravo!

      • Colin Rose said

        Simka goes through the motions of diagnosing “CCSVI” by placing the ultrasound probe on the neck to impress patients. The Doppler machine makes swishing noises and shows pulsatile tracings. What he does bears no relation to Zamboni’s protocol, such as it is, which requires transcranial Doppler to presumably detect “reflux”. This is one clever, very profitable scam!

      • viaferria said

        I saw the narrowing with my own eyes. I saw stagnant blood with a very slow flow. With my own eyes. I know that you will explain this as a deception somehow. But really, I saw it, I felt benefits despite having no expectations.

  3. beveikrimtas said

    @Colin

    Not that simple.

    Zivadinov didn’t disprove CCSVI; he disproved the “regular” MRV for its recognition. Next article will be on MRV using Haacke’s ‘protocol‘ as “the most suitable and highly sensitive method”. Someone could call Dr. Haacke as a ‘patent troll’ ‘cause he will receive a kickback from every single “MRV- by Haacke protocol” use in States (that’s why he got it patented in US) but it will be free in Europe (at least for now), the latest Siemens machines provide SWI protocol for free.

    Zamboni’s ties with States are more prominent than he shows. Zivadinov is a mutual friend of Zamboni on the ‘Quest for Toxic Iron Deposits as a Cause of MS’. This is happening for the last several years. I believe they are in contact somewhere from 2003-2005, they both published articles on “Iron and MS” in 2006, and that was not a coincidence. In 2008 Zamboni was paid (take a guess by whom, but don’t believe that the university got it covered) for his ‘visiting professorship’ in Buffalo. Please notice that this happened before his major ‘pilot’ paper on CCSVI became published in 2009. BTW, Dr. Weinstock-Guttmann is a direct coordinator from Buffalo (read Biogen) to Zamboni’s team, and you can see her name all over in his papers. Also, Zamboni got some ‘pocket money’ from Harvard (Bakshi, former Buffalo/Biogen man, why we are not surprised?) next year for the same reason. God bless the Iron in MS! LOL

    Why the Iron in MS is so important? First of all, it will save the current pipeline of MS drugs in whole and will secure their continuous use; second, it will promote new drugs lines addressing to this newly ‘discovered’ MS agent. Big Pharma is less interested in interventional treatment, but they already started (from 2006!) new drug lines for venous stenting complications. This addition will be heavy, I estimate the annual cost of these ‘new drugs’ somewhere in 10.000 USD range per CCSVI treated MSer, of course it could be higher.

    Maybe be it is more clear for you why Zamboni so vigorously protects DMD use after CCSVI treatment?

    IR’s are of different breed, they don’t care about MS at all, well, partly ‘cause they don’t understand it. You said one billion earned last year, who cares. I wrote somewhere one year ago that there will be a market for 12 billion annually on CCSVI treatment alone.
    And this market will be made, greed is good, isn’t? There is more, you not only perform the “liberation” once (by the meaning of the word ‘liberation’ it should be performed once and forever) but you will do it several times, then you’ll treat the complications of that “liberation”, then you’ll go after other veins …, maybe you got the point. They will be busy for decades ahead.

    Big Pharma wins from this “interventional activity” also; would you like to know how? Imagine that you’ll get hundreds of thousand of additional patients (not aged as usual, which means they will be “in play” for a long time) with early dementia as a result of messing up with jugulars, how about that? BTW, the majority of CCSVI-treated-MSers after transitory ‘boost’ will decline faster, therefore the increased consumption of DMD’s is virtually guaranteed.

    Of course, Zamboni is a scammer, but he is a ‘Clever Scammer’. He managed to get an ultimate support from everybody:

    1) from Big Pharma for Iron Deposits in MS (DMD protection and supply of early dementia cases in the future),
    2) from IR’s for new opportunity to earn huge profit (sort of ‘easy money’),
    3) from MRI and Doppler tests performing MD’s and techs for the same reason as number 2,
    4) from MSers as Messiah who will eventually “liberate” them (and who cares about long-term consequences, “I want it now” attitude dominates).

    Loud applause + Standing ovations! Well done!

    Here are a couple of links, real stories:

    http://crucialsuz.blogspot.com/2011/01/third-times-not-charm.html

    http://www.thisisms.com/ftopict-15030.html

  4. […] Zivadinov proves Zamboni’s “CCSVI” does not exist […]

  5. maldendj said

    New research by neurologist Robert Zivadinov has found that chronic cerebral venous insufficiency may be the result of multiple sclerosis, not a cause. Zivadinov has found that chronic cerebral venous insufficiency may be the result of multiple sclerosis, not a cause:

    University at Buffalo, news release:

    Higher CCSVI Prevalence Confirmed in MS, but Meaning of Findings Remains Unclear

    Release Date: April 13, 2011

    BUFFALO, N.Y. — A just released study on the relationship between multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI), a narrowing of the extracranial veins that restricts the normal outflow of blood from the brain, found that CCSVI may be a result of MS, not a cause.

    The study, conducted by University at Buffalo researchers, appears in the current issue of Neurology, the journal of the American Academy of Neurology.

    Robert Zivadinov, MD, PhD, associate professor of neurology in the UB School of Medicine and Biomedical Sciences and president of the International Society for Neurovascular Disease, is first author on the paper.

    Zivadinov says of the findings: “Given the intense interest in the hypothesis that CCSVI is a possible cause of MS, independent evaluation of CCSVI was identified as an urgent need.

    “Our results indicate that only 56.1 percent of MS patients and 38.1 percent of patients with a condition known as clinically isolated syndrome (CIS), an individual’s first neurological episode, had CCSVI.

    “While this may suggest an association between the MS and CCSVI, association does not imply causality. In fact, 42.3 percent of participants classified as having other neurological diseases (OND), as well as 22.7 percent of healthy controls involved in the study, also presented with CCSVI.

    “These findings indicate that CCSVI does not have a primary role in causing MS,” says Zivadinov. “Our findings are consistent with increased prevalence of CCSVI in MS, but substantially lower than the sensitivity and specificity rates in MS reported originally by the Italian investigators.”

    CCSVI is a complex vascular condition discovered and described by Paolo Zamboni, MD, from Italy’s University of Ferrara. It is characterized by narrowing of vessels draining blood from the cranium. Zamboni hypothesized that this narrowing restricts the normal outflow of blood from the brain, resulting in alterations in the blood flow patterns within the brain that eventually cause injury to brain tissue and degeneration of neurons, leading to MS.

    Zamboni’s original investigation in a group of 65 patients and 235 controls showed that CCSVI appeared to be strongly associated with MS, increasing the risk of having MS by 43 fold.

    The results of the UB study are based on 499 participants in the Combined Transcranial and Extracranial Venous Doppler Evaluation (CTEVD) study, which began at the university in April 2009.

    The study group consisted of 289 persons with MS, 163 healthy controls, 26 with OND and 21 with CIS.

    MS patients also were defined by disease type: relapsing-remitting (RR), secondary progressive (SP), primary-progressive (PP), progressive-relapsing (PR) and MS with neuromyelitis optical (NMO) — a type of MS that affects the optic nerves and spinal cord exclusively.

    All patients underwent transcranial and extracranial echo-Doppler scans of the head and neck. Persons were considered “CCSVI-positive” if they met two or more of five venous hemodynamic (VH) criteria.

    Prevalence rates were calculated in three groupings: only subjects with positive and negative CCSVI diagnoses; only borderline cases included in the negative group; and subjects who fulfilled any of the five criteria.

    When only positive and negative CCSVI cases were considered, results showed a CCSVI prevalence of 62.5 percent in MS patients, 45.8 percent in those with OND, 42.1 percent in CIS, and 25.5 percent in healthy controls.

    When borderline cases were included as negative for CCSVI, prevalence figures were 56.1 percent in MS patients, 42.3 percent in those with OND, 38.1 percent with CIS and 22.7 percent in healthy controls.

    When all cases that met at least one of the five VH criteria were included in the analysis, CCSVI prevalence was 81.3 percent in MS cases, 76.2 percent in CIS patients, 65.4 percent in OND cases and 55.2 percent in healthy controls.

    The highest prevalence was seen in relapsing primary-progressive MS (89.4 percent), followed by non-relapsing secondary-progressive MS (67.2 percent), NMO (66.6 percent), primary-progressive MS (54.5 percent) and relapsing-remitting MS (49.2 percent). CCSVI prevalence was substantially higher in progressive MS than in non-progressive MS patients. In addition, patients with a progressive MS disease subtype had higher CCSVI prevalence than those with non-progressive MS.

    “The higher prevalence of CCSVI in progressive MS patients suggests that CCSVI may be a consequence, rather than a cause, of MS,” says Bianca Weinstock-Guttman, MD, co-principal investigator of the study and UB professor of neurology. Therefore, the possibility that CCSVI may be a consequence of MS progression cannot be excluded and should be further investigated.

    “Several studies have reported that patients with progressive MS show decreased blood flow through the brain’s neuronal tissue, indicating that CCSVI may be secondary to reduced perfusion,” says Weinstock-Guttman. “In addition, we recently showed an association between the severity of CCSVI and reduced cerebral blood flow in brain parenchyma of MS patients in an published pilot study.”

    E. Ann Yeh, MD, UB assistant professor of neurology and a major collaborator on the study, noted that of the 10 pediatric MS patients who participated in the study, five presented with CCSVI (50 percent), yielding prevalence similar to that in adult MS patients.

    “Although the sample size was too small to draw any firm conclusions, these results suggest that CCSVI is also present in children and is not the result of aging,” she says.

    Concludes Zivadinov: “The differences between our study, the original Italian CCSVI study and other recently published studies also emphasize the need for a multimodal approach for the assessment of CCSVI. In addition to Doppler sonography, use of selective venography, magnetic resonance venography and intraluminal Doppler methods can provide more evidence for the true prevalence of CCSVI in MS.”

    Additional UB researchers involved in this research are: Karen Marr, Murali Ramananthan, PhD, Ralph H. B. Benedict, PhD, Cheryl Kennedy, MPH, Makki Elfadil, MD, Justine Reuther, Christina Brooks, Kristin Hunt, Michelle Andrews, Ellen Carl, Michael G. Dwyer and David Hojnacki, MD. Gary Cutter, PhD, from the Department of Biostatistics, University at Alabama, Birmingham, also played a critical role in the research.

    The study was supported by the Buffalo Neuroimaging Analysis Center, Baird MS Center and the Jacobs Neurological Institute, all from UB, as well as the Direct MS Foundation, the Jacquemin Family Foundation and more than 500 individual donors.

    The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB’s more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.

  6. maldendj said

    And here is the article, published online before print
    , April 13, 2011 (doi: 10.1212/WNL.0b013e318212a901 – Neurology WNL.0b013e318212a901):

    Article

    Prevalence, sensitivity, and specificity of chronic cerebrospinal venous insufficiency in MS

    R. Zivadinov, MD, PhD, K. Marr, RVT, RDMS, G. Cutter, PhD, M. Ramanathan, PhD, R.H.B. Benedict, PhD, C. Kennedy, LMSW, MPH, M. Elfadil, MD, A.E. Yeh, MD, J. Reuther, BA, C. Brooks, BA, K. Hunt, BA, M. Andrews, BA, E. Carl, BA, MS, M.G. Dwyer, BS, MS, D. Hojnacki, MD and B. Weinstock-Guttman, MD

    – Author Affiliations:
    From the Buffalo Neuroimaging Analysis Center (R.Z., K.M., C.K., M.E., J.R., C.B., K.H., M.A., E.C., M.G.D.), The Jacobs Neurological Institute, Department of Neurology, University at Buffalo (R.Z., M.R., R.H.B.B., A.E.Y., D.H., B.W.-G.), and Department of Pharmaceutical Sciences (M.R.), State University of New York, Buffalo; and Department of Biostatistics (G.C.), University of Alabama, Birmingham.

    Address correspondence and reprint requests to Dr. Robert Zivadinov, Department of Neurology, School of Medicine and Biomedical Sciences Buffalo Neuroimaging Analysis Center, 100 High St., Buffalo, NY 14203 rzivadinov@bnac.net

    Abstract

    Background: Chronic cerebrospinal venous insufficiency (CCSVI) was recently described in patients with multiple sclerosis (MS). A subject is considered CCSVI positive if ≥2 venous hemodynamic (VH) criteria are fulfilled.

    Objective: To determine prevalence of CCSVI in a large cohort of patients with MS, clinically isolated syndrome (CIS), other neurologic diseases (OND), and healthy controls (HC), using specific proposed echo-color Doppler (ECD) criteria.

    Methods: Transcranial and extracranial ECD were carried out in 499 enrolled subjects (289 MS, 163 HC, 26 OND, 21 CIS). Prevalence rates for CCSVI were calculated in 3 ways: first, using only the subjects for whom diagnosis was certain (i.e., borderline subjects were excluded); secondly, including the borderline subjects in the “no CCSVI” group; and finally, taking into account subjects who presented any of the VH criteria.

    Results: CCSVI prevalence with borderline cases included in the “no CCSVI” group was 56.1% in MS, 42.3% in OND, 38.1% in CIS, and 22.7% in HC (p < 0.001). The CCSVI prevalence figures were 62.5% for MS, 45.8% for OND, 42.1% for CIS, and 25.5% for HC when borderline cases were excluded (p < 0.001). The prevalence of one or more positive VH criteria was the highest in MS (81.3%), followed by CIS (76.2%), OND (65.4%), and HC (55.2%) (p < 0.001). CCSVI prevalence was higher in patients with progressive than in nonprogressive MS (p = 0.004).

    Conclusions: Our findings are consistent with an increased prevalence of CCSVI in MS but with modest sensitivity/specificity. Our findings point against CCSVI having a primary causative role in the development of MS.

  7. maldendj said

    Article from The Wall Street Journal:

    MS Study Debunks Blocked-Vein Theory

    U.S. NEWS, APRIL 13, 2011, 4:20 P.M. ET.

    MS Study Debunks Blocked-Vein Theory
    By THOMAS M. BURTON

    A new multiple-sclerosis study debunks a theory about a potential cause for the autoimmune disease that had been embraced by patients around the world, who had turned to risky surgeries to unblock neck veins when drug treatments didn’t work for them.

    The first large look at whether vein blockages in necks cause MS concludes that such blockages don’t have a “primary causative role” and might instead be a result of the disease. The peer-reviewed study by researchers at the State University of New York at Buffalo is to be presented in Hawaii on Friday.

    The theory that blockages in the jugular or other veins that drain the brain might contribute to MS has spread globally over the Internet among patients badly debilitated by MS who weren’t necessarily helped by drugs. Many of these patients have undergone expensive and risky surgeries to have veins unclogged.

    The vein-blockage theory originated with Italian vascular surgeon Paolo Zamboni. In 2009, he reported finding “conclusive” evidence of vein blockages in 100% of 109 MS patients and zero in 177 healthy patients. He dubbed the blockages “chronic cerebrospinal venous insufficiency,” or CCSVI. Dr. Zamboni couldn’t be reached for comment.

    The new study found a relationship between MS and blocked veins, but concluded that the results “suggest that CCSVI may be a consequence rather than a cause of MS.”

    MS expert Lawrence Steinman, a neurologist at Stanford University, said, “Certainly the [vein blockage] hypothesis carries less and less evidence the more that it’s studied. He cautioned that “people running around the world to get this procedure done ought to look at the evidence and save themselves the money.”

    Dr. Steinman, an inventor of the MS drug Tysabri, said he has no financial connections to the vein-unclogging procedures or to Tysabri. He was among those critical of a Stanford colleague who in 2009 implanted stents and performed other procedures on patients to unclog veins before the university shut down the program.

    Timothy Coetzee, chief research officer for the National Multiple Sclerosis Society, called the Buffalo study “an important addition to our understanding of MS.” while noting that other research is under way, including some funded by the society.

    The 500-person Buffalo study included 289 MS patients, 21 patients who had experienced only one MS attack, 26 patients with other neurological diseases and more than 160 healthy “control” patients.

    The study found that about 44% of the MS patients tested had no blocked veins, while slightly more than a quarter of the healthy subjects did have blocked veins. Some 42.3% of patients with other neurological conditions had blockages, as did 38.1% of patients who had experienced one MS attack.The researchers noted that the blockages were more prevalent in longer-term forms of MS.

    The research is to be presented at the American Academy of Neurology meeting in Honolulu.

    Robert Zivadinov, the Buffalo neurologist who led the study, theorized that vein blockage might result because people with relatively advanced MS are able to move less and have less blood flow to their brains.

    • perwest said

      And then what to do about it? If the chicken comes before the egg? Or the egg comes before the chicken? Doesn’t matter…
      Here is a education of the concept of any Ecosystem, showing what is of importance. For the patient. Especially the sector of mass balance should be of interest.

      http://www.globalchange.umich.edu/globalchange1/current/lectures/kling/ecosystem/ecosystem.html

      And especially the formula: NET CHANGE = INPUT + OUTPUT + INTERNAL CHANGE

      The NET CHANGE is out of balance and the ecosystem, represented by human brain. What part of the formulae can be changed, lowering the NET CHANGE without causing harm to the patient? I suggest the OUTPUT. Many patients seems to benefit from this modern and proven, safe CCSVI-PTA way of trepanation, allowing the patient’s brain to breath, allowing the patient to do positive progression.

      Why not just start treating jugulars/azygos, and follow as Mr. Ebstein and Mr. Barr might be shown to the doorway, instead of neurologselvish insisting, that the bugs have to be hanging around, calling for more medication, because this is what ones carrier is based upon.

      Panacia or Hygeia. Which one to choose, if one is a real doctor?

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