MS Society eNews and CCSVI

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

NMSS IS WRONG WRONG WRONG !!!!!!

Postby ozarkcanoer » Thu Nov 12, 2009 5:15 pm

This is from the NMSS eLetter mailed this week :


"In a collaborative study now getting under way among researchers in Italy and the United States, 16 people with CSSVI are being experimentally treated with balloon dilation, which has been used to treat blocked arteries." :x :x :x

Isn't this study FINISHED !!!!!!!!!!! I mean FINISHED months ago ?????????

I am all for giving the NMSS a lot of leeway, but this is JUST PLAIN WRONG !!!!!!!!!!!!!!!!!!!!!!!!!!
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Postby jay123 » Thu Nov 12, 2009 5:27 pm

It seems like there would be a way to quantify improvements in people, such as lessening of EDSS scores. Perhaps the 'blinded' portion of the research would be the doctors (and though it seems like an easy one, no picking on them I don't mean that literally!). A group of patients could be assessed, then half of them have the procedure without the doctors knowing which one have had it done.
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Postby ozarkcanoer » Thu Nov 12, 2009 5:34 pm

I just may be wrong about my last MAD post. Please somebody help me here !!!!???????????
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Postby radeck » Thu Nov 12, 2009 6:01 pm

As far as I can tell you're not mad and this study was done some time ago. It looked at the effect of dilation on relapse and found that the symptoms tapered off within 4 hours to 4 days. There's a larger study going on that looks at long-term effects on relapse rate, quality of life, and other markers. That paper should appear Tue in two weeks.
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Postby bestadmom » Thu Nov 12, 2009 6:43 pm

One of the things my MS neurologist's research lab has discovered and published is their identification of a biomarker of MS activity. Currently he does spinal fluid analysis for disease activity. If the counts go up, the treatment is not working.

I think that the way to prove if the stents will halt disease activity is by establishing a baseline level of cells pre-surgery and follow-up through lumbar punctures and fluid analysis every X months for Y years and then once a year there after. Cancer treatments have measureable effects, and that is what we need for CCSVI surgery. Anecdotal evidence isn't scientific.

Do the surgeons need to structure a placebo surgery to have acceptance by the medical community? There has got to be a better way.
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Postby Arcee » Thu Nov 12, 2009 6:49 pm

Zamboni's Dec 2008 study was published in the Journal of Neurology, Neurosurgery, and Psychiatry which is indeed peer reviewed. http://jnnp.bmj.com/


Of course, and that is the point, that data from clinical trials on outcome data will be published that way. That full blown scenario just hasn't happened yet but is in the works.

I don't particularly care for the attitude of the MS Societies, and I certainly hope neuros will encourage testing and be open to CCSVI, but until they have outcome data published from clinical trials, they likely will just keep saying is not certain or safe. I'm all for forging ahead, but we all know from many different sources that there are a ton of skeptics out there and many of them are being very clear about what they are waiting to see.
diagnosed RR in spring '04
1 stent placed in left jugular vein 7/15/09
on and off Copaxone
allergric to interferons and Tysabri
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Postby Arcee » Thu Nov 12, 2009 6:54 pm

There's a larger study going on that looks at long-term effects on relapse rate, quality of life, and other markers. That paper should appear Tue in two weeks.


That would be great. Do you know where that is being published?

And Michelle, totally agree there should be a better way than sham surgery. And I certainly hope that there are other things that will be acceptable. I also truly believe that the researchers working on CCSVI will figure that part out.
diagnosed RR in spring '04
1 stent placed in left jugular vein 7/15/09
on and off Copaxone
allergric to interferons and Tysabri
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Postby CNClear » Thu Nov 12, 2009 7:33 pm

Clinical trials will not and have not included any sham surgeries...If you want to know about clinical trials, go to FDA.gov and read the FDA Guidances for Clinical Trials in the Code of Federal Regulations...honestly, no one has to worry that people will get needless surgery to create a control group...isn't even within the realm of possibility. Someone must has misunderstood or someone else must have miscommunicated...


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Postby ozarkcanoer » Thu Nov 12, 2009 7:41 pm

bestadmom... That's great that your neuro has developed this biomarker to test for disease activity !!! But golly my lumbar puncture wasn't so bad, but I had 4 days of that LP headache and then had the blood patch. I don't know if I could make myself go through that again.....
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Postby Jamie » Thu Nov 12, 2009 7:46 pm

Lisa,

Not true.

I heard it from Dake's mouth and he was upset about it.

I even asked him to clarify as I thought I'd misunderstood.

Thought it very unfair and barbaric and he even said 'how could you go in, see a problem and pretend to fix it?'.

There is indeed a push for this.

Hopefully it won't happen and people will come to their senses.

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Postby bestadmom » Thu Nov 12, 2009 7:51 pm

I get a spinal tap every 6 months - and I had 4 intrathecal methotrexate injections, so I've had at least 9 or 10 lp's in the past few years, I had one headache that lasted 6 days but once my doc changed the needle tip, I've been fine. For my last one I took the train home from NYC instead of having my husband drive. I'm used to them.
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Postby CNClear » Thu Nov 12, 2009 8:10 pm

Last Monday, my neuro surprised me by not even taking the material I brought for him, sitting back, crossing his arms, closed his eyes and just kept shaking his head 'no' ! Talk about denial?! :x I haven't given up on him, though. He's only one of many docs at the MS Center of Atlanta and when I get all fixed up...they will all know about it and (eventually) won't be able to deny its efficacy. Besides, there are a whole lot of people with MS sitting around their waiting room, that will want to hear more about it!

I'm counting down the days till I get to Stanford and I've gotta ask Dake about the 'sham surgery clinical trials' if we can't even get our neuros to keep an open mind about this, where on earth would volunteers to undergo surgery for nothing, come from? Who would fund such an unethical trial? What surgeon (who wanted to continue practicing medicine) would actually perform these kind of hack-em-up surgeries? Why would anyone attempt this type of thing when the FDA would never ever sanction it? I mean really! :roll:

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Postby CNClear » Thu Nov 12, 2009 8:24 pm

Clinical Trials are for new drugs and new devices, not for using already approved devices in a new way (which is what Dake is doing by putting stents, commonly used in hearts, in jugs and azygous veins).

Studies will done, that will compare people with MS, who have CCSVI and no stents, to people who have MS, and have had the stents placed in the areas of stenosis, or people with CCSVI & no stents, to people who have CCSVI and stents.

How can you say that doesn't that make sense? (and if I might humbly suggest, go to the FDA website, read the (laborious, but true) documentation regarding clinical trials and then, let's talk again...)

:)

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Postby cah » Thu Nov 12, 2009 8:26 pm

Even if there are sham surgeries - the thought alone makes me puke - sham stents are completely impossible. So, anyone who has had surgery in a placebo-controlled study could easily find out if s/he's really treated with any fairly sensitive metal detector from a well-sorted hardware store. (The first polish patient, Rici, even asked if there would be a problem on the airport.) It is known that knowing whether someone has got real treatment or placebo is a big impact to the effect. (That's why it's blinded.) So I'd say sham surgery is impossible in this case. Hope so!
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Postby jay123 » Thu Nov 12, 2009 8:35 pm

bestadmom wrote: Cancer treatments have measureable effects, and that is what we need for CCSVI surgery. Anecdotal evidence isn't scientific.

Do the surgeons need to structure a placebo surgery to have acceptance by the medical community? There has got to be a better way.


Anecdotal evidence is used to measure the effect of some drugs. I do know for example that the recent fampridine trials had to be done that way. The doctors did not know who got it and who didn't, and had to measure improvent.
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