MS Society eNews and CCSVI

CureIous · Post by **CureIous** » Thu Nov 12, 2009 7:39 pm

Dumb question deleted by author

bestadmom · Post by **bestadmom** » Thu Nov 12, 2009 7:41 pm

Jay123,

That is great that the famridine trials used anecdotal evidence. I guess therre's no other way. Thank you for letting us know. That leaves more options for reporting improvements with stent surgery.

prof8 · Post by **prof8** » Thu Nov 12, 2009 10:32 pm

Bestadmom-- why do you get spinal taps every 6 months? Is it because you are on tysabri?

MrSuccess · Post by **MrSuccess** » Thu Nov 12, 2009 11:02 pm

CN Clear ...what a jerk your Neuro is ...I do hope you find another one , with a sense of respect for patients. Eyes closed ? I'd have booted the chair out from under that SOB.

Fear not. By now you will have read here at TIMS ,about the amazing , bold , and couragous Doctors advancing CCSVI. It will go forward.

Atlanta is a big city ....is it possible to get a new Neuro ? I'd like to think so.

Mr. Success

bestadmom · Post by **bestadmom** » Fri Nov 13, 2009 3:18 am

Prof8,

Yes, I'm on Ty and my neuro does 2 tests every 6 months for the jc virus one blood test and one spinal fluid test. To me it is well worth it.

zap · Post by **zap** » Fri Nov 13, 2009 7:35 am

Ugh. My new GP did the same thing pretty much. Didn't want to take the printouts I'd brought in at all, and warned me about how "vulnerable to pseudoscience" people who find out they have MS are. Said he couldn't see how such a problem could conceivably lead to MS ... although he hadn't read any of it, hadn't thought about it, hadn't asked any questions .... and in fact hadn't even understood that the blockages were in the VEINS and not the arteries (he offered to set me up with a doppler scan of my blood flow, but when I pushed for details it became clear this was not available for the veins, just the arteries) ... blegh!

You would think that the almost insignificant results seen with the CRABs drugs would be a flag to doctors that maybe the paradigm they are based upon is missing something, but sheesh ...

radeck · Post by **radeck** » Fri Nov 13, 2009 7:54 am

Arcee wrote:
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?

We've talked about this work and publication A LOT in various threads, but the abstract is hard to find. It's here:

http://docente.unife.it/paolo.zamboni/p ... 3691#33691

The abstract (included below) doesn't mention the crucial thing we've heard from Joan that all patients who had relapses also had re-stenosis (i.e. there's a possibility that stents would lead to even lower relapse rate), but hopefully that'll be in the paper itself. I've read somewhere here that it will come out on Nov 24th, but don't know where and how certain that date is...

Abstract:
Objective: Chronic cerebrospinal venous insufficiency (CCSVI) is a vascular picture characterized by combined stenosies of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJVs), and the azygous vein (AZY), with development of collateral circles and insufficient drainage proved by increased mean transit time in cerebral MRI perfusional study. CCSVI is strongly associated with multiple sclerosis (MS), a neurodegenerative disease considered autoimmune in nature. Aim of this study is to evaluate the safety of CCSVI endovascular treatment and the influence on the clinical outcome of the associated MS. Methods: Sixty-five (65) consecutive patients affected by CCSVI subdivided by clinical course of MS into 35 with relapsing remitting (RR), 20 with secondary progressive (SP), and 10 with primary progressive (PP), underwent percutaneous transluminal angioplasty (PTA). Mean follow-up lasted 18 months. Vascular outcome measures: postoperative complications, venous pressure, patency rate. Neurological outcome measures: cognitive and motor function assessment (MSFC), rate of MS relapse, rate of MRI active positive enhanced gadolinium MS lesions (Gad+), QoL MS questionnaire. Results: Endovascular treatment of CCSVI was feasible in Day Surgery with a minor and negligible complication rate. Postoperative venous pressure was significantly lower in the IJVs, and in the AZY as well (p<0.001). The risk of restenosis in the IJVs was higher as compared to the AZY (IJVs patency rate 53%, AZY patency rate 96%, respectively: OR 16, 95% CI 3.5-72.5 p<0.0001). Clinical outcome measures of MS were significantly improved by CCSVI endovascular treatment, especially in the RR group: rates of relapse- free patients passed from 27% to 50% postoperatively (p<0.001), and that of MRI Gad+ lesions from 50% to 12% (p<0.0001); MSFC at one year improved significantly in RR (p<0.008), but not in PP or SP; finally, physical QoL improved significantly in RR (p<0.01) and in PP patients (p<0.03), with a positive trend in SP (p<0.08). Mental QoL showed significant improvement in RR (p<0.003) and in PP (p<0.01), but in SP did not. Conclusions: PTA of venous strictures in CCSVI patients is safe, and especially in patients with RR clinical course demonstrated to positively influence clinical and QoL parameters of the associated MS respect to preoperative assessment. Restenosis rates are elevated in the IJVs but very promising in the AZY, suggesting the need to improve endovascular techniques in the former. The result of this pilot study warrants a subsequent randomized control study.

patientx · Post by **patientx** » Fri Nov 13, 2009 8:10 am

CNClear wrote: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...

Lisa

It may not be considered surgery, but at least one trial in the past did use a sham procedure - the original trial for plasma exchange.

Also, a quick search turned up this:

http://www.hss.cmu.edu/philosophy/londo ... urgery.pdf

radeck · Post by **radeck** » Fri Nov 13, 2009 8:22 am

This has been discussed in other threads, it seems to me a sham procedure is out of the question ethically. There's absolutely no need for having the CCSVI-MS trials be placebo controlled for them to be scientifically rigorous.

And as a side, I'd say the Interferon and Copaxone trials weren't placebo controlled in the true sense either. Patients were given either a drug with characteristic side effects, making them aware that they were on the real drug, or an injection with no side effects. In a way, the patients on the real drug were on the placebo, hence it is not surprise that they did about 30% better on various measures, similarly to somebody on placebo would do better (you can read up on how powerful the effect is really). So trying to live up to the standards set by these trials would really not be that great.

patientx · Post by **patientx** » Fri Nov 13, 2009 9:25 am

radeck wrote:This is not a procedure to tweak some mysterious knobs with some unpredictable outcome (like with any of the MS drugs), it is treatment of a known problem with a known resolution.

Given the many posts and statements that the long-term effects of this stent surgery are unknown, I don't think this statement is accurate.

It is not MS treatment!

Then why is it being discussed here?

Arcee · Post by **Arcee** » Fri Nov 13, 2009 9:36 am

This has been discussed in other threads, a sham procedure is completely out of the question ethically. This is not a procedure to tweak some mysterious knobs with some unpredictable outcome (like with any of the MS drugs), it is treatment of a known problem with a known resolution. It is not MS treatment! Whether it works in MS or not, time will tell (actually, to some extent time has already told...), and there's absolutely no need for having the CCSVI-MS trials be placebo controlled for them to be scientifically rigorous. This is BS myth, as simple as that.

Well, I have to respectfully disagree about some of this. I've had lengthy conversations about sham procedures with people who conduct clinical trials and they say that with proper design, and even in the CCSVI context, they are ethical. Am not saying it has to happen or will happen, but there are knowledgeable people out there who think it is a possibility.

As for the other ways to define and constrain a large-scale MS-CCSVI clinical trial to make it scientifically rigorous - - I think the debates will rage as they seem to do for all kinds of trials. I hope they rage early and often and outcome data becomes available as soon as possible. Moreover, I hope that options exist for people who don't want to wait and/or don't really care about such trials.

Whenever and wherever additional solid outcome data is published it will be exciting to share it, especially with those who have remained unmoved by what so many of us believe, and experience, to be something revolutionary.

radeck · Post by **radeck** » Fri Nov 13, 2009 9:40 am

patientx, I agree that safety is an important issue, especially with stents as opposed to the safer angioplasty. One can only hope that those using either are carefully weighing the risks and benefits.

ozarkcanoer · Post by **ozarkcanoer** » Fri Nov 13, 2009 9:43 am

How could you sham the stenting procedure ??? People who post here who have had the stenting can feel the stents in their necks !!!! I guess shamming would be putting a stent in a place that is NOT stenosed, LOL.

bestadmom · Post by **bestadmom** » Fri Nov 13, 2009 9:50 am

Radeck,

I agree with you and want the treatment. I've spoken to several interventional radiologists who are intrigued. One in particular is willing to do the surgeries on the east coast. He, like DR .Dake, is not versed in MS. He's driven to help people and find casues and cures. He's accomplished, published and runs a dept at a highly regarded university hospital.

Because he personally needs some proof of causation of MS he is hesitant. I asked why not treat CCSVI for what it is and separate it from MS. Nope, not happening yet. There is supposedly "nothing broken" so no reason to take the risk of surgery.

Until there is a cause and effect proven, whether it be MS or headaches or who knows what, only those doctors who have the freedom and the inclination to help us, will. Our job is to find those doctors.

radeck · Post by **radeck** » Fri Nov 13, 2009 9:55 am

Bestadmom, I completely agree with you, which is why trials (without sham surgeries) are and will be very important.