DrSclafani answers some questions

[pelopidas]

I am ready now. All i need is about $5M.

That's $1000 from 5000 families (or 1 year of fingolimod for 104 MS patients). Seems like it's time for e-fundraising.

..Seems that if you need money, ask someone in Greece! Brilliant!

[Cece]

CCSVI Alliance has a page for direct research funding. You can see what BNAC, Dr. Haacke, and Dr. Dake have set up to receive donations.
http://ccsvi.org/index.php/helping-the- ... ch-funding

[1eye]

On a related (by gifting) topic, pwCCSVI need to start signing brain-donation cards, and also need guidance if they are to direct them to CCSVI research. What would be a good place to go for this kind of direction? Is there such a thing as vein donation? I still say I want my tombstone to read "On placebo."

[Cece]

What formal steps should be made in order for the scientific community to acknowledge beyond doubt that CCSVI is real and has non-trivial consequences? After all the hard and pioneering work done by you and other physicians, i find it incomprehensible that objections on CCSVI are still "existential".

Take 1-2 hundred patients, half with MS and half healthy controls with no symptoms and compare their venography and IVUS blindly. if there is a difference we establish by gold standards once and for all that patients with MS have abnormal venous drainage. If there is no difference, then we go home.

take 1-2 hundred patients with MS, catalog all signs and symptoms, divide them into two groups: one group receives venoplasty, or valvuloplasty using venography and IVUS to confirm successful treatment, the other group receives a sham operation. Both groups blinded to whether they have had treatment or sham. Compare improvements in symptoms for a year.Determine whether there is a benefit in the treated patients. DO NOT focus on whether there MS improves or not. That is a study for later.

That is my opinion.

Would an IRB allow invasive venography+ivus of healthy controls?
How long will it take to raise $5 million?
It is fantastic to hear you talking trials. It was back in 2010 that you were saying that it was too soon for randomized controlled trials. Two years later, it is no longer too soon.

[mo_en]

Dr S, the following pictures are from
No Evidence of Chronic Cerebrospinal Venous Insufficiency at Multiple Sclerosis Onset by
Claudio Baracchini, Paola Perini, Massimiliano Calabrese, Francesco Causin, Francesca Rinaldi, Paolo Gallo

[A] This is Figure 3 shows, verbatim, "a representative case of pMS having a CCSVI pattern but normal VGF.". The full caption is:
"FIGURE 3: (A) ECDS in pMS patient in the supine position: IJV stenosis with septum. (B) Venography in the same patient,
supine position: no lumen irregularities. (C) Venography, 45-degree tilt: normal drainage. ECDS 5 extracranial echo-color
Doppler sonography; IJV 5 internal jugular vein; pMS 5 possible MS."


It seems obvious, but i would like to hear your opinion on the RIJV venography images.

This is Figure 1. The caption beneath says:
"FIGURE 1: ECDS in a ‘‘jugular drainer.’’ (A) IJV (in blue) and CCA (in red). (B) VV (in blue) and VA (in red). (C, D) CSA of IJV in
supine and in sitting position, respectively. (a–c) Serial B-mode image of a jugular valve: a, open valve; b,c, closing valve. CCA
5 common carotid artery; ECDS 5 extracranial echo-color Doppler sonography; IJV 5 internal jugular vein; VA 5 vertebral
artery; VV 5 vertebral vein."


Would you say that pictures a,b and c are sonographic evidence of an immobile upper valve leaflet? It hardly changes position in relation to the vein wall.

[Cece]

Would you say that pictures a,b and c are sonographic evidence of an immobile upper valve leaflet? It hardly changes position in relation to the vein wall.

It looks like the upper leaflet is immobilized in the a,b,c images, while the lower leaflet has moved to different positions.
Really interesting images.

[David1949]

I can see why it takes a special talent to read ultrasounds. To me they all look like ink blot tests.

[jillMEnz]

Dr. Sclafani,
Are you aware of the FDA letter sent to Dr. Mehta? If so, does this have any bearing on you treating CCSVI? Do you see any additional challenges because of this, such as insurance or liability?
I ask because I'm concerned that treating physicians may back off. I'd love to know your opinion.
Thanks as always.
Rhonda

I thought that the letter was one sided and rather negative. as to the concept of CCSVI. However, the FDA was following the letter of the law in critiquing dr Mehta's study for lack of an IDE. It is well known that an IDE is expected when devices are investigated for new indications.

How difficult will the FDA be in approving IDEs? Will the FDA delay worthwhile studies? or inhhibit investigation? Will it object to investigatory studies because of divergence in results of ultrasound studies? Will the FDA efforts worsen the political atmosphere for scientific investigation? Or will it embrace the concept, and guide and aid development of good studies? because some studies using ultrasound did not confirm the Zamboni results? Will anyone ever study CCSVI as a separate entity that seems to happen with prevalence in MS rather than debate endlessly whether CCSVI causes MS or whether treatment of CCSVI has an effect on MS.

As I said from the beginning, i thought it was premature for trials last year. Given the experiences i have had in treating patients previously treated by others with underdiagnosis, under- and overtreatment, excessive usage of stents, etc, i am quite confident that i made a correct decision.

I am ready now. All i need is about $5M.

As far as treating patients, i could not in good conscience stop treating now after seeing first hand the positive effects in so many patients. I have thought about liability but there are good safety studies in print and there are good outcomes data that i cannot ignore. I will continue to treat patients. I will also definitely notify them of the FDA opinion on this. It is all part of good practice: an informed patient, making intelligent decisions.

Dr Sal,
Maybe you could apply to the JK Rowling Foundation. Her mother died of the very rapid form of MS. It's a huge foundation - will be on the web. The other one that comes to mind is the Bill Clinton foundation

[Robnl]

I can see why it takes a special talent to read ultrasounds. To me they all look like ink blot tests.

Are you a neurologist??

[NHE]

[A] This is Figure 3 shows, verbatim, "a representative case of pMS having a CCSVI pattern but normal VGF.". The full caption is:
"FIGURE 3: (A) ECDS in pMS patient in the supine position: IJV stenosis with septum. (B) Venography in the same patient, supine position: no lumen irregularities.

I may be mistaken, but I'm having a hard time agreeing with that statement on image B.


NHE

[jillMEnz]

this is a link to a lot of famous celebs and their charities

http://www.looktothestars.org/celebrity/171-jk-rowling

surely one of these could help? Esp Rowling

[Cece]

Any new and interesting images or cases to share?
What a week, with the FDA warning. I am frightened about the prospect of not having access to ongoing care.

[milesap]

Read on the CCSVI locator site that the letter from the FDA was not signed and may have not been vetted, if that is the case who actually sent it?

[Cece]

That was from Dr. Mike Arata:

The recent FDA advisory regarding CCSVI deviates from previous advisories from the FDA in that it was not signed. This suggests it may not have been fully vetted. Perhaps coming from a regional branch rather than headquarters in Maryland.

Apparently it is unusual for an FDA advisory to not be signed.

[ThisIsMA]

this is a link to a lot of famous celebs and their charities

http://www.looktothestars.org/celebrity/171-jk-rowling

surely one of these could help? Esp Rowling

As a grant writer, it seems to me that JK Rowling would be the right person (with deep pockets and a compassionate heart) to fund Dr. Sclafani's study. But I went to the link above, found that the charity she runs that funds MS Research is here:

http://www.volanttrust.com/

And then found that she is not considering MS related applications "for the foreseeable future." If we could just get her excited about the concept of CCSVI, perhaps that might change.

Here's the quote from the "Volant Charitable Trust" website:

J K Rowling is supporting major research into neuroregeneration and Multiple Sclerosis at the University of Edinburgh. The Anne Rowling Regenerative Neurology Clinic is being set up in Edinburgh with the substantial donation J K Rowling made in 2010. The Trust is therefore not considering MS related applications for the foreseeable future.

Of course there are other foundations out there that might be willing to help fund the study. And direct fundraising of individual donations is another option to pursue.

Dr. Sclafani, I hope you will consider setting up a nonprofit entity to accept donations for your future CCSVI study. That would open up more avenues of support. Or perhaps the CCSVI Alliance could create a dedicated fund for accepting donations for your study. Since they are a 501(c)(3) nonprofit, this would accomplish the same thing.

Mary Ann