This Is MS Multiple Sclerosis Community: Knowledge & Support

Excellent point Dr. Cumming and as we all know participants will talk or communicate via the internet sharing their thoughts. They will be instructed not to discuss the study with anyone, but it happens.

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It's a paradigm shift

Yup. The researchers have to punch the patients in the neck too while they're under. This is getting more ethical by the minute.

(Please no one misinterpret this as actual advocating for neck punching. I find the difficulties of designing these placebo arms nearly insurmountable. The question too that if they're testing against placebo, how long is placebo usually seen in MS patients, I don't know if we can answer that.)

I am concerned that some accidental clearing of webs/membranes will result in some benefit to the placebo group that will then be written off as placebo, but far more concerned that the ballooning will be ineffective and the patients will restenose and have a higher complication rate of clotting because of the anticoagulation choice at Albany (with Dake's study, not as worried about this).

I am concerned with Dake's study because he said this first study was to get preliminary results and then he will be able to obtain funding for a larger study. (This was in the ccsvi.org video.) He did not say what that funding would be coming from, I am happy if it's NIH or MS society money (although with how they treated Dr. Haacke, how likely is this?) but not if it's stent manufacturer money. Stents may do more harm than good, particularly in these low flow veins in patients who are often young when MS strikes with a lifetime ahead. If he's testing stents in CCSVI, I want it to be against best-practices angioplasty and we're not there yet. He's an excellent researcher and I have been impressed by him in the videos and in the line-up of presentations he's doing at ISET and in the durable results we are hearing from some of the Stanford '09 patients, although that is anecdotal. So he might end up proving stents are best even if they are not.

There are so many issues with these trials.

Cece, do you have a links to the actual protocol details (not the information on clinical trials.gov)?

Here's something on the BNAC trial from June, they were a little tight with the details but from the claim that patients wouldn't know, it would seem that sedation is the only way to achieve that.

Last I heard BNAC phase 2 was stalled for lack of funding, anyone know differently?

I know, there's a catch 22 if I rant against stent manufacturer money and then rant against lack of funding....

I'll check around for what we know of the other trials. HappyPoet, if you're around, any word on how Mehta's trial is doing? He'd submitted that Medicare letter that they denied, is he stalled for lack of funding or are things going forward there?

But if you read Holly Barr's post in the other forum, Dr. Sclafani and his group are clearly accepting medicare ...

So ... there can't be a both ways.

I'm not sure what Dr. Mehta's group is playing at. My guess is that it's a billing code issue, or else that medicare shouldn't pay for clinical trials or something ...

That's a strange paradox going on there - because medicare is being used elsewhere.

The letter was very clear, Medicare refused to pay for venoplasty for MS because there was not enough research to support it. It explicitly stated that this included the procedure both in the trial and on its own. There was something along the lines of that, it's clearly not researched, that's why you're doing a trial.

But with some time to think about it, angioplasty for venous malformations is being covered and is well established as a treatment. What's being studied is the association of this with MS, which does need research. So the idea that the researchers are not treating MS, they are treating venous malformations, is accurate.

I couldn't find them if they're out there.

If my memory is correct, I know that Dr. Dake's imminent trial has a sham arm but he kept the length of the trial to 3 months. There are no stents being tested in this initial trial, only ballooning vs placebo.

Dr. Siskin's trial is limited to patients who live locally so that they're able to keep up with the follow-up. I have assumed but have no real way of knowing that he'll use the same anticoagulation in the trial that he uses with his other patients (Plavix, IMO not the best choice, but I could be wrong about that).

I know the least about Dr. Mehta's trial. It has an ambitious large-scale (400 patients being treated, 200 in the sham arm). With his regular patients, he treats them in two separate procedures as he'll only treat a single jugular at a time due to concerns about risk, but someone said that in his trial he will do it in a single procedure.

Here's what bestadmom had to say about the small Georgetown trial that was abruptly stopped due to lack of results:

It was said that Dr. Neville of Georgetown was going to be publishing a paper on this, I can't imagine that'll be positive.

Also from bestadmom in that link, Dr. Lynn in FL also has something that's IRB approved. I haven't heard much about that, perhaps it's a registry or pilot study.

just an observation .... many of these fine medical professionals have been most generous with providing their research results ...... although .... it would be expected that most of what they have discovered will remain private ..... until a later date.

releasing dribs and drabs of information ...... can easily lead to a misconception. And that cannot help advance CCSVI treatment.

Until such information is fully disclosed ...... we will have to subside on all of the feedback provided by those that have had the procedure.

And THAT ..... sure looks good .



Mr. Success