JAMA on fda warning

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

JAMA on fda warning

Postby Cece » Tue Jun 26, 2012 10:06 pm

a JAMA write-up on the FDA warning. nothing new here.
http://jama.jamanetwork.com/article.asp ... G.facebook
“Our view and the view of some of our colleagues is that there shouldn't be a clinical trial, because CCSVI isn't a proven clinical entity,” Stüve said. “Patients shouldn't be exposed to the risks.”

No exposure to the risks, no exposure to the benefits.
Since when is central venous stenosis not a proven entity? Tell it to superior vena cava syndrome. Tell it to the dialysis patients.
I am tired of the controversy. Let's get some solid research in favor of CCSVI.
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Re: JAMA on fda warning

Postby Robnl » Wed Jun 27, 2012 3:02 am

Since when is central venous stenosis not a proven entity?


Since some people don't want to understand ccsvi..... :wink:
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Re: JAMA on fda warning

Postby CureOrBust » Wed Jun 27, 2012 6:07 am

Since when is central venous stenosis not a proven entity?

A recent review of the evidence on CCSVI and MS concluded that the CCSVI theory isn't consistent with the evidence and that surgical procedures intended to fix this problem shouldn't be undertaken outside a clinical trial (Awad AM et al. Ther Adv Neurol Disord. 2011;4[4]:231-235). The review noted that various biological assays have not consistently detected CCSVI in patients and that there is no histopathological evidence of venous abnormalities in patients with MS.
Its the link with MS that they are saying is unproven. They even provide the reference for the statement / position.
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Re: JAMA on fda warning

Postby Billmeik » Wed Jun 27, 2012 7:50 am

here is no histopathological evidence of venous abnormalities in patients with MS.



Histopathology ( refers to the microscopic examination of tissue in order to study the manifestations of disease. Specifically, in clinical medicine, histopathology refers to the examination of a biopsy or surgical specimen by a pathologist, after the specimen has been processed and histological sections have been placed onto glass slides. In contrast, cytopathology examines free cells or tissue fragments.



Im thinking the autopsy study by Dr. Fox is kenda sorta this.
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Re: JAMA on fda warning

Postby Cece » Wed Jun 27, 2012 10:20 am

Are any researchers following up on the Dr. Fox study to confirm his findings? I agree with 1eye, that was histological evidence of venous abnormalities found in autopsied MS patients and not in autopsied controls.

It's sloppy writing if they said that CCSVI is not a proven entity (in and of itself) but meant that CCSVI is not proven to have an association with MS. These are two important separate questions we need answered.
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Re: JAMA on fda warning

Postby 1eye » Wed Jun 27, 2012 3:01 pm

I agree with 1eye, that was histological evidence
I didn't say that. But it was a very good point. Besides the usual tripe we get outright falsehoods. From the AMA, of all places. What is this world coming to? I just watched all of the latest video Dania posted. It's good it's out there, and she goes out of her way to say it's not a recommendation, but she seems to be saying we should avoid angioplasty and go directly to a bypass. We don't know of anybody's patency even a year after this kind of bypass. Even if restenosis with angioplasty is inevitable, isn't it worthwhile for a lot of people for a long time?

I am getting concerned, that because of the war in the foreground, the poor patient in the background is getting shrapnel injuries. Will we no longer be able to discern a good way forward? Can people who have had good results from angioplasty please come forward? I had them. I am still happy about it. If I died tomorrow I would not say it was wrong, because it wasn't. Instead of the irresponsible warnings why can't the AMA even tell the truth about the condition?
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Re: JAMA on fda warning

Postby Cece » Wed Jun 27, 2012 3:38 pm

1eye wrote:It's good it's out there, and she goes out of her way to say it's not a recommendation, but she seems to be saying we should avoid angioplasty and go directly to a bypass. We don't know of anybody's patency even a year after this kind of bypass. Even if restenosis with angioplasty is inevitable, isn't it worthwhile for a lot of people for a long time?

I think it's a misunderstanding of the nature of restenosis. Restenosis happens. It's why stents were invented. If stents are too major of an intervention for our veins, then bypass is far too major of an intervention. Restenosis is treatable by repeat venoplasty. Vein injury may not be treatable by repeat venoplasty but that is why the IRs should be doing everything in their power to minimize vein injury. Jugular bypass is the ultimate in vein injury: the vein is deliberately cut in half.
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Re: JAMA on fda warning

Postby munchkin » Wed Jun 27, 2012 6:21 pm

I don't think by-pass should be considered as a first or second choice if you have options.

Some of us (me) had our jugulars damaged so much we don't have any options. Remember the start of CCSVI, no options from the neuros. CCSVI was high risk, no history, no published data beyond Dr. Zamboni's paper and a few posters. Well, I can't have a stent put in one of my jugulars because it is gone, the only option is a by-pass. The other jugular is about 85% scared and ballooning won't keep it open. The IR's I talked to are hesitant or completly against a stent in the other jugular and if that were to clot I have no option.

As I get more disabled; faster than at any other time during my illness; I want a choice.
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