SHOT DOWN BY MY NEURO

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby Needled » Thu Jun 11, 2009 9:19 am

You guys are great – love your thoughts, comments and suggestions! He didn’t discourage me at all in terms of CCSVI, but he did show that he’s not someone I can count on to listen and be on my side. Contacting him wouldn’t have been my first choice. But my PCP, who is great, asked me to get his opinion on it since he was the MS expert. They have been colleagues for a long time, and I felt like I didn’t have much of an option, especially since my PCP is more important in terms of CCSVI. Plus, if he thought like my PCP, it would have been very helpful to have him on board. My PCP told me to keep him updated and to let him know if I ran into roadblocks. That’s a conversation I’m not looking forward to. “Um, doc, your friend’s a narrow-minded, arrogant idiot. Now can you find me an intelligent vascular doctor/interventional radiologist who may be open to new thoughts and ideas?” Guess I’ll have to work on my wording. :roll:
Just one more thing, and I’ll stop. One of his more condescending comments came while he was talking about the stents. While he was listing all the reasons why they weren't appropriate – they weren’t proven, it wasn’t a commonly accepted practice, they don’t have a history, it was an invasive procedure -- he threw in "...and then what happens if you develop progressive multifocal leukoencephalopathy?" to which I responded, "I’m not talking about Tysabri." I think that's when it officially went downhill. Imagine a doctor trying to maintain his importance by throwing around “big words” like I was a 5-year old who didn’t understand anything. That’s not someone I want to deal with.
OK, that's it, I promise. Thanks for listening!
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Postby patientx » Thu Jun 11, 2009 10:31 am

I think PML is becoming part of the MS company line, like "take an injectable DMD as the first-line treatment." A few days ago, I was talking to an MS nurse at the Cleveland Clinic, specifically about Campath. She said, yes, it looks effective, but has significant risks, like PML. I mentioned that no cases of PML have been reported with Campath, and, in fact, the CAMMS223 report specifically says no PML cases. She replied, yes, but with all of the new, harder-edged treatments, especially the mab's, they are including PML as a warning, just to cover their rears.

I guess my long-winded point is that it sounds like PML is now a standard warning. Though, it's odd that your neuro associated stents with it.
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Postby zap » Thu Jun 11, 2009 10:50 am

akaheather wrote:
is that they'd have to do a trial on a 1000 patients, then a double-blind trial on another 1000 patients


A double-blind trial???? How would that work? What, some would get MRV's and some would just sit in a tube while some monkeys banged on pots and pans?


lmao
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Postby cheerleader » Thu Jun 11, 2009 10:50 am

The PML reference is HI-Larious!!!
Like, having a major vein opened to allow adequate drainage from the brain and spine (with an FDA approved treatment, thank you) will somehow allow a killer virus to attack. Ummm....no, that killer virus would be linked to the immune-modulating therapies you neuros have been hawking.
Actually, upon further retrospection, it's not funny, it's kinda sad. He was just trying to scare you with big, multi-syllabic words....and you knew what they meant.

How dare you be an educated patient and read research on the "internets"???

Marie's right...we're almost at the "Magic 1000" number of patients-

363MSers and 472 controls=835 people. All MSers showing evidence of CCSVI, and in the case of the third and fourth (studies), stenoses too. The concordance is so astounding one can accept lower numbers too.
That is pretty darn close to the fantastical 1000 people he demands be studied.

Plus 5 at Stanford and 9 in Poland = 849 and it's rising everyday!

Cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby mrhodes40 » Thu Jun 11, 2009 1:05 pm

I bet someone could tell us how many people were being studied in the phase 3 toxacin was it anything close to 1,000? How many of our current therapies have 1,000 in the stage 3? Seems like when I get my MSQR the studies recruiting have much MUCH lower numbers than that. AM I wrong on that?

And as for the PML comment, you called it exactly.
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Postby daverestonvirginia » Thu Jun 11, 2009 1:22 pm

I would like to say I am surprised at his attitude, but I am not. You did nothing wrong and he should not have treated you in that way. If I was you I would look for a new doctor.
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Postby akaheather » Thu Jun 11, 2009 8:33 pm

How many of our current therapies have 1,000 in the stage 3? Seems like when I get my MSQR the studies recruiting have much MUCH lower numbers than that. AM I wrong on that?


Phase II
Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients.

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment.

I know our phase II tovaxin trials only had 150, but I'm not sure about phase III.
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Postby akaheather » Thu Jun 11, 2009 9:15 pm

And it looks like the winner is ...1200.

Check out this article talking about two new oral drugs being tested for MS.

In the Phase III study of 1,200 patients with the RRMS, approximately 80 percent of MS patients who took the drug cladribine remained relapse-free for two years compared to only 61 percent of those participants given a placebo.

In another successful phase III study of over 1,200 patients with RRMS, 80 to 84 percent of MS patients who were given daily dosages of the drug fingolimod remained relapse-free after one year in comparison to only 67 percent of study participants who received Avonex, a typical injectable drug used to treat MS.


Of course, this is for medication, not a precedure...
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Postby mrhodes40 » Fri Jun 12, 2009 7:08 am

thanks Heather! Boy I still say the 835 peopel studied so far makes a pretty good showing for itself---as long as we acknowldge that that means ONLY that it is well shown that these stenoses are present in MS patients and not that it means that treatment will "cure" MS , we do not know that at this point.

But then again it gets back to physical facts and as you say "we are talking about a procedure". Stent placement for stenoses is not new or revolutionary though it does have consequences...as well as a known benefit of restoring blood flow to a normal rate.

If a person has a stenosis and we can see impaired drainage in that individual, does it matter that we are not sure how that will impact MS?
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http://www.thisisms.com/ftopic-7318-0.html This is my regimen thread
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Postby Sharon » Fri Jun 12, 2009 10:31 am

If a person has a stenosis and we can see impaired drainage in that individual, does it matter that we are not sure how that will impact MS?

Exactly -- how many other things were being affected by the impaired drainage let alone the MS?
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Postby CureOrBust » Sat Jun 13, 2009 6:44 am

I have not followed the numbers closely, but the 850 number, does that include the 100 or so that are in the actual "liberation" trial by Zamboni? I would assume he would only be treating MS patients who were diagnosed with a CCSVI.

And I am sure I read somewhere on here, that Dr Dake had around 50 patients being scanned for his paper.
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Postby Sharon » Sat Jun 13, 2009 6:59 am

Cure -

I do not believe that Dake has 50 patients scheduled. My understanding was he was wanting about 20-25.
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Postby mrhodes40 » Sat Jun 13, 2009 8:48 am

Yes I included the liberation 100 because they all have stenoses of course, and the numbers of people so far are evidence only of that

but OTOH the liberation 100 are also the first 100 of the evidence as to whether or not it helps to treat stenoses.

I wonder how many trials were done before they started using balloon angioplasty on vessels other than those they first tried it on?

For example I know that before anyone had ever used balloons on ANYTHING there were trials to show it was an effective technique. These were paid for by the balloon manufacturers.

Once it is established as an FDA approved effective technique, I BELIEVE that the surgeon is permitted to use his judegement and apply it in any situation he feels it will effectively open up the vessel in question. I beleive it is not necessary to trial it for every application. I believe that techniques once approved are free to be used in any applicable situation.

Considering Holly was given pre approval by Medicare for her stent procedure it seems that this is probably true.

This does not mean that MC is endorsing the use of stents for MS; it means they endorse the use of them in situations where the bloodflow is demonstrated to be reduced below certain parameters. (I read on a site somewhere that it must be in excess of 50%--but don't quote me I can't reference it).

does anyone know anything to dispute this or add to it at all? Know of any studies on later uses for stents or balloons that indicates 1000 people were needed to show it helped or before it was allowed for the new application once it had been established as a technique? just thinking out loud here
I'm not offering medical advice, I am just a patient too! Talk to your doctor about what is best for you...
http://www.thisisms.com/ftopic-7318-0.html This is my regimen thread
http://www.ccsvibook.com Read my book published by McFarland Health topics
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Postby Arcee » Sun Jun 14, 2009 1:57 pm

Cure, Sharon -

I think at one point I had written that Dr. Dake had seen or was 'seeing' 35 - 50 people with MS. I do not know what 'seeing' constitutes, but that was the rough range that he mentioned to me and also to a doctor who spoke with him. I would imagine that he sees more than he treats, so to speak.

- Randi
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Postby Crabby » Sun Jun 14, 2009 2:54 pm

mrhodes40 wrote:Once it is established as an FDA approved effective technique, I BELIEVE that the surgeon is permitted to use his judegement and apply it in any situation he feels it will effectively open up the vessel in question. I beleive it is not necessary to trial it for every application. I believe that techniques once approved are free to be used in any applicable situation. [snip] does anyone know anything to dispute this or add to it at all?


My understanding is that stents are just like drugs -- they're approved for particular uses by the FDA, but once approved, can be used off-label by doctors for uses not specifically approved by the FDA.

Here's a link to a discussion of a couple of studies that found that approximately half of all drug-eluting stent procedures are off-label. I can't recall if someone already posted whether Dr. Dake uses bare metal or drug-eluting stents, but I imagine that bare metal stents are also often used off-label.

Link: http://www.aats.org/multimedia/files/Th ... y-2007.pdf

Not surprisingly, there seem to be questions regarding the efficacy of off-label uses of drug-eluting stents.
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