Report on the 7/26 Sclafani CCSVI Symposium

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.
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TFau
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Post by TFau » 8 years ago

mrhodes40 wrote:Nice post Marc! You are smart and on it as usual... I am sorry to hear you were sick. I am so glad you are back and on the mend! I hope it is s uneventfl recovery.

It makes me wonder how much real information can be derived from a 30 person study such as the one at Buffalo. It would seem to make sense to work out the technical aspects of performing the
procedure first before trying to measure it's efficacy
This keeps me awake nights....................... I am serious. :!:
This has been bothering me a lot too, not necessarily the 30 person trial, but the insistence that a large, double blind trial is the only way to scientifically prove anything.

Politicians say that it's not till we do a big trial that we'll know it's safe. That doesn't make sense to me - it's only by studying different cases to learn what should and shouldn't be done that will add to the safety profile. I suppose they mean that such a trial will at least show whether any actual efficacy justifies the risk. But this thinking has been extrapolated to mean that "we won't believe that all of these people have actually had improvements until we see the statistically significant number showing that they actually had improvements." So, if someone has shown 30% improvement, and the trial overall shows 10% improvement over placebo, some would tell those with dramatic improvements that only 10% of what they're feeling is real.

The large scale double blind trial is a regulatory hurdle, and I suppose it's the best that the feds have to justify marketing approval, but I don't think that such a trial should be considered the final scientific answer. I would still seek treatment for my husband based on anecdotal reports even if the trial was a bust - it would only be harder to find someone to do the procedure then.

WK, I hope you're feeling better!

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Post by ozarkcanoer » 8 years ago

Mr Success,

I was the one who was questioning the wisdom of double-blinded studies on a procedure that very gifted IRs have said still has a long way to go to work out the proper protocols. I believe that Dr Dake's upcoming study is going to address just that, and the fine work that Dr Siskin and Dr Sclafani and others are doing and sharing with each other are also helping to address this issue. I believe we are incredibly lucky that these doctors are sharing their experiences with each other and not letting their egos conceal any gains they make as is the case with much academic research.

I am a strong supporter of BNAC. But they are in the unenviable position of trying to straddle the academic world and the CCSVI explosion. They designed this 30 person double-blind study in order to "prove" CCSVI efficacy. Everyone was underwhelmed by the BNSC first 500, so what will happen if the Buffalo first 20 results are at best negative or lukewarm. Could it be because of the inexperience of the IRs doing the procedure ? These are the people the academics will listen to, not Dr Siskin et al.

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Post by MrSuccess » 8 years ago

ozarkcanoer - the Buffalo research is as important as any . I do not agree that 'everyone was underwhelmed' by the results of the first 500 .

In fact .... had the results been ''underwhelming '' ... the chance of getting Buffalo to fund and explore those 30 people for CCSVI and address stenosis problems [ in those they find that have them ] would be absolutley ZERO

Had the first study been proven underwhelming ...... that would have been the end of the road for CCSVI research in Buffalo.

But that is not the case.

In fact ...... the high number of pwMS also displaying CCSVI ..... is what has allowed the Buffalo researchers to further explore the MS-CCSVI relationship.

That's how I see it anyway.





Mr. Success

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Post by drsclafani » 8 years ago

ozarkcanoer wrote:Mr Success,

I was the one who was questioning the wisdom of double-blinded studies on a procedure that very gifted IRs have said still has a long way to go to work out the proper protocols. I believe that Dr Dake's upcoming study is going to address just that, and the fine work that Dr Siskin and Dr Sclafani and others are doing and sharing with each other are also helping to address this issue. I believe we are incredibly lucky that these doctors are sharing their experiences with each other and not letting their egos conceal any gains they make as is the case with much academic research.

I am a strong supporter of BNAC. But they are in the unenviable position of trying to straddle the academic world and the CCSVI explosion. They designed this 30 person double-blind study in order to "prove" CCSVI efficacy. Everyone was underwhelmed by the BNSC first 500, so what will happen if the Buffalo first 20 results are at best negative or lukewarm. Could it be because of the inexperience of the IRs doing the procedure ? These are the people the academics will listen to, not Dr Siskin et al.

ozarkcanoer
It really depends on who the academics are. Dr Siskin is the Chairman of a Medical School department of Radiology.He is well published and has great esteem among his colleagues, myself included. His scientific methods are sound, although I do not think that we should do randomized blinded trials for another year. Just because IRBs and neurologists think this what they want, they must be patient with the science. Let's clarify the techniques before we compare optimum intervention to sham or no treatment.
in the meantime all those observational trials will show what we should expect, when we should retreat, not treat, etc

it took 150 years to clarify the role of veins in MS, a couple of years of thorough learning may be enough to show that a rct is unnecessary.

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Post by Rokkit » 8 years ago

drsclafani wrote:Let's clarify the techniques before we compare optimum intervention to sham or no treatment.
Amen.

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Post by ozarkcanoer » 8 years ago

Dr Sclafani,

There is a lot of egg on my face. It was not my intention to suggest that Dr Siskin is anything other than at the top level of his profession and most highly regarded. I guess what I was trying to suggest is that many neurologists insist that ONLY double-blinded study will convince them of the relation of MS and CCSVI and that the quality of how the procedure is performed may be a major factor. And yes, many people were underwhelmed by the Buffalo first 500. If it had been closer to the 90-10 that Zamboni was reporting then it would have been much more dramatic. By gosh by golly I helped host a party to raise $4,375 for BNAC and went to BNAC for CCSVI imaging and have the greatest respect for Dr Zivadinov. Plus I also have the greatest respect and admiration for Dr Siskin and Dr Sclafani !!!

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Post by Rokkit » 8 years ago

ozarkcanoer wrote:And yes, many people were underwhelmed by the Buffalo first 500.
This is true. It left plenty of wiggle room for such commentary as the National Post article "Research casts doubt on new MS theory."

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Post by MS_HOPE » 8 years ago

Mark (or anyone), can you comment on the approximate number of attendees at the symposium? Was the room "crowded"? From the sign-up emails to Holly, do we have any idea how many doctors (in addition to those presenting) were there? Any known members of the media? Thank you!
CCSVI:  Making Sense of MS

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Post by Guider » 8 years ago

Appreciate the post. Very well done. Best wishes for a fast recovery.

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Statistics

Post by Rosegirl » 8 years ago

Hi, Dr. Sclafani

I've read various places that about 1/3 of patients get great results, 1/3 get moderate results and 1/3 don't see any benefit. That leads to several questions.

First, between the doctors at the meeting, do you know how many procedures they have done?

Second, do the ratios above seem to be valid for their patients?

And finally, are those ratios fairly consistent between RR, PS and PP patients?

I know things are changing rapidly as our doctors observe patients over time, but we would all appreciate any insight you can provide.

[ok, I fixed the typo so that it comes to 100%.]
Last edited by Rosegirl 8 years ago, edited 1 time in total.

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Re: Statistics

Post by drbart » 8 years ago

Rosegirl wrote:Hi, Dr. Sclafani

I've read various places that about 1/3 of patients get great results, 1/2 get moderate results and 1/3 don't see any benefit. That leads to several questions.
Including, where did the extra 1/6 of patients come from?

But seriously, I would like to have the surgeons performing these procedures put their heads together and decide what techniques should be practiced by all. I suspect that these numbers vary quite a bit across practitioners (and of course I'm curious to know who gets the best outcomes).

This is by no means scientific, as patients self-select in all sorts of ways. Which is why we need to get as many MSers treated as possible, even if not all practitioners know all the tricks, so we can accumulate enough statistics to discover what works best. (And go back and treat the MSers who might have stuff that's been missed)

The important question is not *who* has CCSVI - everyone except neuros knows the answer to that one - but rather why can't we predict the outcomes of CCSVI treatment?

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Re: Statistics

Post by Cece » 8 years ago

drbart wrote:The important question is not *who* has CCSVI - everyone except neuros knows the answer to that one - but rather why can't we predict the outcomes of CCSVI treatment?
Wouldn't this be because of the varying skill levels of the different IRs at finding and treating stenoses; stenoses themselves vary in terms of staying open or restenosing; and different degrees of actual neurological and spinal damage has been done that the body can or cannot recover from?
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

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Re: Statistics

Post by drsclafani » 8 years ago

Rosegirl wrote:Hi, Dr. Sclafani

I've read various places that about 1/3 of patients get great results, 1/2 get moderate results and 1/3 don't see any benefit. That leads to several questions.

First, between the doctors at the meeting, do you know how many procedures they have done?
about 450 patients
Second, do the ratios above seem to be valid for their patients?
these doctors did not have final data on their outcomes. It was Dr Siskin who mentioned the 1/3 1/3 1/3 outcomes.
And finally, are those ratios fairly consistent between RR, PS and PP patients?
there is only one paper published so far. we have to wait to see things in writing

I know things are changing rapidly as our doctors observe patients over time, but we would all appreciate any insight you can provide.[/quote]

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Re: Statistics

Post by drsclafani » 8 years ago

drbart wrote:
Rosegirl wrote:Hi, Dr. Sclafani

I've read various places that about 1/3 of patients get great results, 1/2 get moderate results and 1/3 don't see any benefit. That leads to several questions.
Including, where did the extra 1/6 of patients come from?

But seriously, I would like to have the surgeons performing these procedures put their heads together and decide what techniques should be practiced by all. I suspect that these numbers vary quite a bit across practitioners (and of course I'm curious to know who gets the best outcomes).

This is by no means scientific, as patients self-select in all sorts of ways. Which is why we need to get as many MSers treated as possible, even if not all practitioners know all the tricks, so we can accumulate enough statistics to discover what works best. (And go back and treat the MSers who might have stuff that's been missed)

The important question is not *who* has CCSVI - everyone except neuros knows the answer to that one - but rather why can't we predict the outcomes of CCSVI treatment?
too early to answer all these questions
we cannot have the answer to which technique works best until we discover the best technique

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Re: Statistics

Post by drbart » 8 years ago

Cece wrote:
drbart wrote:The important question is not *who* has CCSVI - everyone except neuros knows the answer to that one - but rather why can't we predict the outcomes of CCSVI treatment?
Wouldn't this be because of the varying skill levels of the different IRs at finding and treating stenoses; stenoses themselves vary in terms of staying open or restenosing; and different degrees of actual neurological and spinal damage has been done that the body can or cannot recover from?
Well.. good question!

Why do some people, who have had decades of damage, seem to recover completely? What is their damage, exactly? Is it affecting them directly, or does it make them more susceptible to the hypoxia that CCSVI is causing (in addition to the whole inflammation cascade)?

I know a Dake patient who had a history of MRIs all showing active lesions, was a 6.5 on the EDSS scale, yet is asymptomatic today. Does that person still have the damage?

Maybe we should stop using words like "done". As in Dr X did patient A .. who's to say patient A is "done" if A still have symptoms?

Let's "do" as many MSers as we can now, and start learning about what's un-done about the ones who aren't all better.

As I've said before, there should be plenty of money (skim insurance money from CRAB drugs they can not give to 1/2 of the patients) to do this, and assurance that nobody will be considered done unless they no longer have symptoms. Which may never happen, but we need to learn why, and more data will help.

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