National MS Society's posting about FDA safety communication on CCSVI

[agate]

The National MS Society has posted a news item about a recent FDA "safety communication" concerning the CCSVI procedure.

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Many very well-informed and capable people, some from this board, have had this procedure done and have felt that it was beneficial. I'm not sure how serious an alert this FDA "safety communication" is. Maybe someone who knows more will come along and shed some light on the situation.

[Virginia]

Agate, thanks for calling this to our attention. It is interesting. I am not sure how much or how long the people who have felt it was beneficial continue to feel
that way. I have not read anything on it in quite some time now, and have not been anyplace else to read about it.

[SalpalSally]

I remember "Lady" having the treatment. I haven't heard from our dear friend for a long time. She had reported some positive changes at the time and shortly after the CCSIV procedure, but nothing in the last several months.

I sure wish she would report in.

Ladyyyyyyyyyyyyy...........?

[agate]

Yes, she is one. I haven't heard from her in a long, long time either.

[boston/maine]

I had the procedure
and have not had any change at all. :(

[agate]

Jan, you had the CCSVI procedure nearly a year ago, I think--?

It's too bad you've seen no improvement.

I've noticed some people are considering having the procedure done a second time even though the first one didn't help--or maybe because the first one didn't help....

[Cherie]

I am in communication with 8 people who have had the procedure done. All reported improvement initially and all went back to pre-procedure levels of functioning after 2-10 weeks. Three have had the procedure repeated with improvement lasting 2-6 weeks. One is having the jugular vein replaced with a graft from his leg next week.

The problem seems to be that the stents are moving or are causing clot formation in the vein (they are using arterial stents as there are none yet developed for use in veins which do not have the muscular walls that arteries have to hold them in place). I do not know the figures but a number of people have died post-procedure from stents that have moved and caused pulmonary embolism or heart attack.

Since the majority of these procedures have been done outside of clinical trials specifically for PWMS who have narrowing or occlusion of the neck or chest veins, the NMSS is advocating that trials be set up to study this phenomenon and to do the repairs in a controlled environment with strict post-op monitoring over a set period of time.

[Herodotus]

hello all,

i think one of dr. dake's (stanford) early patients had a stent that migrated down to the heart, requiring open heart surgery. one lady died from a subdural hematoma after the procedure, but was already @ risk for this. @ least to my recollection. i read the book "CCSVI as the cause of multiple sclerosis" by marie a. rhodes, a nurse who had the procedue done w/not much benefit. she states there are much better, biodegradable stents in the pipeline. that's the only time to get one imho. an interesting book. i've contacted an IR @ having this done, but am delaying it due to an injury. did note this paper out of buffalo (dr. zivadinov) - says CCSVI dosn't really affect disability, but more severe CCSVI is associated w/primary & secondary progressive MS. don't know what to make of that. here's the paper:
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afa the FDA's warning, this procedure is surgery like lighting a bottle rocket's a space launch (think that's from dr. sclafani on this is ms) i firmly believe there's something to this CCSVI - it's just not clear yet if it's a consequence of MS, or a cause, or a contributory factor. this topic has been addressed since early on in the study of the disease. for instance, here's one by dr. franz schelling, in the 60's i believe,MS, the image & its message.
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it's really long, but he lays it all out. the hubbard foundation has a nationwide study (IRB) 4 CCSVI. he's interesting - is a research neurologist whose son was diagnosed w/MS, had the procedure, & now he's researching this.

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in fact, the foundation had a symposium in san diego may 12-13, where dr. terry wahls spoke, among others.

enjoy the info, and best regards,

gabby, er - herodotus

[Lyon]

Many of the ccsvi proponents are upset that most of the medical community doesn't take the theory of ccsvi seriously and also most ccsvi proponents are seemingly convinced that the lack of interest by the medical community is due to a conspiracy by "BIG PHARMA" and/or that the medical community is afraid to read the "science" behind the theory or aren't capable of understanding the "science".

In truth, one quick glance at the "science" behind the theory of ccsvi shows that the most recent initiator of the vascular theory, Paolo Zamboni, had originally claimed to have found 100% specificity between people with MS and his self described diagnosing criteria for ccsvi. Of course, that got the intention of the world's media because, had it been true, that's exactly what anyone involved with MS has been looking and hoping for.

Sadly though understandably, even though the news quickly gained the interest and hopes of a worldwide slew of laymen and professionals who saw a nice profit margin in it, the 100% specificity quickly proved untrue. Even though a lot of ccsvi proponents consider Dr Zamboni a great and honest man, sort of a savior, how should someone trained in medicine who has made such a profound and obvious mistake be viewed historically? The man was college educated in the field of science so there is no doubt he is aware that it's literally impossible to ever attain 100% specificity and if he really did believe the results he claimed, he should have gone over his results with a fine tooth comb before announcing them.

I'd like to make it sound nicer but Dr Zamboni's claims of 100% specificity which started all the ccsvi hysteria only allow two options of consideration, incompetence or dishonesty.

It shouldn't be a surprise that the medical community and science in general are hesitant to seriously consider or stand behind someone who is obviously incompetent or dishonest. In truth Dr Zamboni lost the interest of anyone who's support he required with his original claim of 100% specificity because which was a dead give away of the caliber of his version of "science".

The point is that there justifiably are times, MANY times that the "science" behind a theory is so naive and poor that it only requires a quick glance to expose that it doesn't warrant expensive studies and trials when funding is already in short supply for other things which actually do show valid reasons for interest.

A tell-tale sign that only foundation for ccsvi is patient hope and interventional radiologists interest in the profit margin is the very fact that the world's interest in ccsvi was originally "justified" by Dr Zamboni's claims that ccsvi was 100% specific to people with MS. When that claim was quickly proven inaccurate the story (and interest in the profit margin) quickly changed to the current thinking in which ccsvi is now reportedly "specific" to a host of diseases which might be helped by angioplasty......which recently was reported to be the most often performed medical procedure, despite having been performed for over 50 years without having shown clear cut benefit over other options.

[agate]

There have been quite a large number of articles in medical journals lately questioning the value of the CCSVI procedure.

One, for instance, is called "The 'Liberation Procedure' for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand" and is by Michael N. Brant-Zawadzki, MD, Daniel S. Bandari, MD, Jose J. Puangco, MD, and Barry B. Rubin, MD, PhD (Journal of the American College of Radiology, May 5, 2012, pp. 305-307).

Some excerpts:

Subsequent anecdotal reports and dramatic success of venoplasty in patients with MS were widely documented by patients on social media networks and by the press, so news of the procedure spread quickly. A number of interventionalists promote and provide the procedure,in the absence of a proven pathophysiologic construct of causation or any rigorous trials, and charge patients directly for this procedure,with little or no follow-up care. Serious questions have been raised about the specificity of venous anomalies detected by ultrasound as representing a surrogate marker for the disease [7-9], and conflict of interest on the part of Zamboni has been raised [10]. Despite claims of safety [11], seriouscomplications are being reported.

Two prior patients have died after the liberation procedure,one from an intracranial bleed [17] and one from complications of attempted thrombolysis of a clotted stent in the internal jugular vein[18]. Emergency open-heart surgery to retrieve a stent that embolized from the internal jugular vein to the heart [19], embolization of a stent placed in the azygous vein to a renal vein, thrombosis of a stent in the internal jugular vein with clot extension into intracranial veins,compression of cranial nerves by stents in the internal jugular veins[20], and thrombosis of the subclavian vein and pulmonary embolism after internal jugular venoplasty by a brachial vein approach have all been documented. Importantly, because the number of liberation procedures carried out worldwide is unknown, and because not all patients who have undergone this procedure have received careful follow-up, the prevalence of both the minor and serious complications of this therapy is currently unknown.

Despite limited data to support the scientific validity of the theory of chronic cerebral spinal venous insufficiency as a cause of MS, and observational trials of this therapy that have major methodologic flaws [21,22], interventionalists have begun offering the procedure to patients, and some private clinics are enthusiastically promoting this therapy. Onthe basis of an analysis of the most recent evidence on this topic, some of which has not yet been published, national MS associations, including Canada’s and that of theUnited States, have recently supported the conduct of phase 1(safety) trials of this therapy. Given the 2 patients reported herein and other reported complications, we conclude that the liberation procedure is not without significant risks. Greater transparency regarding the experience of complications may make it inadvisable to treat patients on demand using this procedure, especially outside of the confines of a peer-reviewed efficacy trial.

Although some would agree that a randomized, blinded clinical trial is necessary to settle the issues raised in the controversy surrounding this procedure, others would agree that not all controversial procedures require such an expensive approach. Funding trials of a procedure that has minimal basis in rational, empirical knowledge seems questionable. At this point, the procedure rests in the same category of “medical” management as chelation therapy for atherosclerosis (which failed just such a trial), treatment of breast cancer with laser photodynamics, Laetrile for cancer, and other unproven therapeutics found in the retail sphere. When consumerism and patient advocacy groups pressure the scientific and political establishment, reasonable accommodation is warranted. The question is, What is reasonable? It may be that the operators believe in the therapy as much as the understandably desperate patients. The subsidiaryquestion is, When is healing “faith healing”?

---

Except for Dr. Rubin, the authors are at
Hoag Memorial Hospital Presbyterian, Neurosciences Institute, Newport Beach, California. Dr. Rubin is from the Division of Vascular Surgery, Toronto General Hospital, Toronto, Ontario, Canada.

I can't post a link to this article as it's a .pdf file obtained through Interlibrary Loan. Anyone wanting to read the entire article can probably get it through the local public library's Interlibrary Loan service.

[Gabriella7]

Montel Williams had this procedure done at the Hubbard Foundation and he did discuss it with Dr. Oz last year. He only said that it helped with his balance and with heat intolerance. It is going to help those patients who like him have stenosis in the veins but it does not appear to be a long lasting treatment. He has gone on to promote other foods, supplements and his blender on the Oz show. IMO at this time it is not worth the risk involved until it is perfected with the proper stents for the veins and then only if it proves to be of benefit in clinical trials done here in the US.

I believe it is not safe to go to one of the overseas clinics that have sprung up because of the need of MS patients for a treatment and the greed of the medical people who are operating in these clinics. JMHO. Patients who have the procedure need follow-up care which they cannot get if they have traveled to another country such as Costa Rica, Mexico, etc.

Gabriella

[agate]

Now the Journal of the American Medical Association or JAMA has an article about the risks of CCSVI--"FDA Warns about the Risks of Unproven Surgical Therapy for Multiple Sclerosis" (June 27):

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