DrSclafani answers some questions

[jr5646]

What does the International Rugby Board have to do with CCSVI???


Anyway, let the good Dr. Eat his dinner... IRB stands for Institutional Review Board: US Dept. of Health and Human Services - Guidebook was produced in the early 1980s under contract for the President's Commission by Public Responsibility in Medicine and Research (PRIM&R). PRIM&R is a Boston-based, nonprofit organization that sponsors annual conferences on topics related to the protection of human subjects.

http://www.hhs.gov/ohrp/irb/irb_guidebook.htm


My question (thinking outloud here) at what point is a procedure considered "non" experimental and / or safe? Is it a certain number? Certain number without complications? what? and why would ins. companies pay for experimental procedures/treatments?

The PT database is a GREAT idea... After almost ten years dealing with "deaf" doctors and acadamy award "acting" as if they are listening and or give a crap, a script, bill and dismissing pat on the ass... I would love notiing more than to be heard and taken seriously. I truly believe the success of TiMS is due to the vast wealth of sharing information here.. The "data" is mostly pure and without ulterior motive, which is incredibly more and more difficult to find these days. To harness this resource would be invaluable. I only wish I had the wherewithall to begin something such as this... but I would be more than happy, as others would I'm sure, to contribute experiences.

What Wichita said

[aliyalex]

thanks wichita. that was informative.

[bluesky63]

There's also a sleepiness scale, cognitive measurements, and other assessments that have a degree of objectivity. I think occupational therapists and neuropsychologists would be more familiar with them and could offer up the right tools.

For instance, I just did a sleep study intentionally hoping I could provide a before and after measure for comparison. Quality of sleep is something many people mention, and that's an objective test that we could do.

Beyond that . . . why does this "research" even have to mention MS? What's been discovered is a new way to image and treat venous malformations and measure their effects on various functions. A certain set of symptoms seems to indicate that a venogram makes sense, just the same way that thousands of otherwise healthy adults are given catheter procedures because they have "chest pains" to see if they have an artery blockage -- because the procedure is considered essentially safe.

[Rose2]

Bluesky 63,
You are right on. Why tie it all in with MS? When Dr. Dake treated me it was for venous problems that were identified/diagnosed.
I did not go in thinking it would 'cure' my MS. Of course I was hoping that it might help slow progression, but never in my wildest dreams did I ever think it would result in me doing as well as I am now.

It should go back a few steps to where it was when I started. Looking for venous problems. What happens after treatment is still an unknown and not a promise.
Good post.
Rose ;)

[PCakes]

when you register for the April 14 CCSVI Live Webcast.. http://register.mediasite.com/?nd=login ... setsite=15 ... you are given an opportunity to ask a question.. I submitted "Should CCSVI be treated MS or not?"

[Cece]

In the meantime, I thought it would very helpful to all of us to review the concepts of research and clnical practice and the value and the procedures by which IRBs work.

Okay...so what you were doing was considered clinical but now it will be considered research? And in your day-to-day clinical practice, you're pretty free to do what you do, which is why these angioplasty procedures were okay...and now, with it reclassified as research, you are no longer free to do what you want to do but must first get this IRB board to look over your proposed research and approve it. Even once approved (not guaranteed), there will be oversight, which means paperwork and possibly not being as free to try new things as you go? And also at any time the IRB could decide against the research and shut it down again?

I can see where an IRB would exist to protect the safety and interests of the patients and the reputation and whatnot of the hospital. No hate here...just angst, which is also cooling...I am just really really tired and to have had a date scheduled, I had begun to think of it as a finish line...which it still is, it's just moved.

I suppose the big question is how long of a delay is it until the IRB has a chance to look over and (hopefully) approve all of this? Also, and I don't think you can really post this, but if there is a sense that they are likely to approve it and this is just a formality or if there is some true fighting that you will be doing to keep these procedures going.

[simone]

quote
"So I will follow the boss' directive, grin and bear it and hope to get back in the saddle as soon as possible."


Can not say how much I appreciate your dedication and clarity.

[eric593]

Dr. Sclafani,

Could you please comment on the story of Noreen, who was determined not to have stenoses twice, then this was reversed upon further examination, only to go to India for treatment where no stenosis was found:

<shortened url>

Is this a situation where we really can't be 100% sure until the venogram rules it in/out absolutely?

[jr5646]

Wow... an IRB approval appears extremely complicated, labor / time intensive and potentially costly?

Any best and/or worst case guess how long it may take (assuming you are pressing forward with clinical research)? Any chance of getting an exemption? or even Quality of Life trial? Expedited review?

http://research.downstate.edu/irb/irb.htm

and

http://research.downstate.edu/irb/irb_piguide.pdf

A clinical trial has recently been posted on Clinicaltrials.gov by the Vascular Group (Albany, NY) - Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

http://clinicaltrials.gov/ct2/show/NCT01089686

Maybe this info. can help you in some way????

[costumenastional]

Dear Doctor Sclafani,

i find the following thread of extreme interest. Maybe you could check it out since you are the most capable to interpet. The author claims that our vein problems may not be hereditary but caused by a "stealth" bacteria. I know how it sounds but still...it s a good quick read.

http://www.thisisms.com/ftopicp-102779.html#102779

Your input would be greatly appreciated. If such a hypothesis is true, it could well expain the various vein malformations you have been noticing in other locations appart from the IJVs and the Azygos, not to mention the phenomenon of restenosis AND the relation between CCSVI and MS progression established by Buffalo. Not findings like bones pinching veins though... What do you think???

[newfie-girl]

Hi Dr. Sclafani !

If I may also suggest
This site is so full of valuable information and I really feel that we have the potential here to really make a difference for ourselves who suffer from MS and have been liberated, but also, for those of us, who have not yet been so fortunate to be liberated.

As I see it, we would all agree that CCSVI is something we all, as MSers, have in common, so now lets look for another common denominater, ( i don't mean for you, personaly to take this on, as you have enough on your plate to deal with) but in regards to your interest in CCSVI and the possability of setting up some sort of data base. I would like to see us, (we the people of TIms) take this a step further and include some sort of category, or a separate identity from CCSVI to include men and women, in a separate group, as women are affected in higher percentages by MS then men. We could all document our personal medical experiences and symptons BEFORE diagnosis, and compare, esp, in women, cause our bodies are so more sophisticated then men

I hope you can all see where I am trying to go with this.......It all seems so complicated to write down, but with the power of the internet, and the amazing people on this site, we could try and put something together to make this work. Knowledge is powerful and after all, who better to figure out the complexity of this disease, than those who are afflicted by it. So much more to say about this idea but I'll leave it at that and wait and see your responses. I know you all will have an opinion.

Thank you Dr. Sclafani for all your hard work and dedication to our cause. You are our HERO

[Rokkit]

http://for-greet.squarespace.com/journa ... india.html

That's a great article eric593. I particularly like all the info Simka provided:

Dr. Simka has been informed about Noreen’s experience in India and has responded as follows:

"We have already operated on 212 patients and in 10 of them (5%) no venous blockage was found intra-operatively, despite obvious sonographic and MR evidence for CCSVI. We cannot interpret these findings unequivocally. One explanation is that in some patients we are over-interpreting sonographic and MR findings. But also - standard venography is not 100% sensitive, since (an) intravenously situated catheter changes slightly (the) behavior of the vein. Interestingly, one of our "negative" patients was readmitted and during (a) second intervention (2 months after the first one) obvious pathology was found and after balloon angioplasty the patient experienced (a) big clinical improvement. So, perhaps these venous lesions are more "active" than can be suspected and are not always seen. The other argument for this option is that in several our patients who were found pathology only on one side, (a) follow-up after one month following procedure has revealed a stenosis on the other side that has been initially found normal. Please find the above-stated as conjectures rather and not as clinical evidence. Nevertheless, the things are very complicated."

[patientx]

Almost all of these narrowings occur near the confluens of the jugular vein with the subcclavian where valves are seen normally in about 85 per cent of patients. Problem is these valves are highly dysfunctionally developed in patients with MS. I think the IVUS really shows this really well.The venogram shows narrowing but the IVUS shows that the narrowing is valvular.

These narrowings are not inflammatory strictures and they are not "buildup of tissue on the wall of the vein (sort of like plaqeu).

How do you determine that the narrowings are not caused inflammation?

I have fantasized about creating research measurement tools to learn about the subjective experiences after liberation. Imagine capturing the data and partnering on such a project.

Have you approached any neurologists about partnering on such a study, i.e. where you would perform the procedure, and they would do the follow-up evaluation using standard MS clinical tests, like EDSS, MSFC, QOL surveys, etc?

Thank you again for staying around to continue answering questions here.

[SammyJo]

drsclafani:

I have been thinking about how to harness the energy and experience of patients on this site. I have fantasized about creating research measurement tools to learn about the subjective experiences after liberation. Imagine capturing the data and partnering on such a project.
what do you think?

We have the same fantasy to track patients after liberation, we are making the attemp on this sticky thread, CCSVI Tracking http://www.thisisms.com/ftopict-8346.html

First post is a template suggestion, patients asked to track symptoms, EDSS, Fatigue, and the MSIS scale which I programmed to make it easier to get a score. None of these are perfect, but we need numbers to show change over time.

For now this is just a stab at voluntary tracking, not rigid data collection like a form based system, but it could be coded up, just like one I've been filling out for years, NARCOMS (Global Patient Registry to facilitate multi-center research in the field of MS). Nice if you could ask them to add a check-box for CCSVI, then we there would also be comparison back in time for patients like me already in there.

I saw a study the other day, said high Internet use among MS patients, 93%. Online would be a great way to follow CCSVI progress.

[drsclafani]

Quote:


I really like this idea. The neurologists assess MS patients using the EDSS and FSS scores, but they are complicated and over-emphasize the ability to walk.

To gather subjective information from patients, a much simpler list of symptoms in a questionnaire with a numeric rating would be more effective I think. Something easy to fill out, for example using a scale from 1 to 5.

Once we have a tool like that, we could start gathering control data by having members of this forum rate themselves every month. We could plot the collective control data against the patients ratings who receive the liberation treatment. By keeping the symptoms separate, we would be able to see which are improved (or degraded) by the treatment. And, we could see how they change over time for both groups.

The idea came to me shortly after Larmo sent me an email speaking about the power of the group and mobilizing efforts to help.

If they want data, let's give it to them and get it in a peer reviewed journal or two. It won't be class I evidence but it will have the power of numbers.

I would be honored to lead this patient based research project if the group wants. Of course, I would have to run it through the Downstate IRB.

Wouldn't that be a kick in the ass. to have you guys involved in an IRB sanctioned project!