DrSclafani answers some questions

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

Postby fogdweller » Tue Jun 22, 2010 12:25 pm

drsclafani wrote:
belsadie wrote:Did I miss it? Did the good doctor get IRB approval??? Does anyone know??



NO!!!!1
THE GOOD DOCTOR DID NOT GET APPROVED. THE GOOD DOCTOR GOT SHOT DOWN. I HAVE NOT RECEIVED THE OFFICIAL REJECTION BUT AMONG THE ISSUES THAT WERE RAISED AGSINST MY PROPOSAL WERE

1. AN OBSCURE GERMAN ABSTRACT REPORTING TEN PATIENTS THAT SHOWED NO ASSOCIATION BETWEEN CCSVI AND MS
2. A NEWLETTER OF SOME FORM STATING THAT ONLY RANDOMIZED TRIALS SHOULD BE PERFORMED.
3. THAT RANDOMIZED CONTROLLED STUDIES WERE ALREADY UNDERWAY IN BUFFALO. ANYONE KNOW ABOUT THAT?
4. THAT THE NATIONAL MS SOCIETY RECOMMENDED AGAINST TREATMENTS
5. THAT PATIENTS WERE BEING CHARGED FOR PROCEDURES. AND I HAD NO FUNDING
6. AND OF COURSE, THE WALL STREET JOUIRNAL TALKING ABOUT DAKES COMPLICATION AND DEATH



ANYBODY KNOW OF ANYONE INTERESTED IN INVESTING IN A PROCEDURE SITE?


SORRY TO ALL OF YOU. I AM SO UPSET :cry: :cry: :cry: :cry: :cry: :cry: :cry: :cry:



One thing the regular readers of this thread understand is how difficult accurate diagnosis of CCSVI is and how important training and proper protocol is. A small study by an inexperienced group in Germany should not be a basis for denial of your efforts, especially since your training and experience is far superior to theirs. We need much work done to determine accurate and proper diagnostic efforts, and a blanket refusal based on the fact that some people have been able to get results different than others is a reason for more studies and treatment, not less. Treatment, frankly, seems more straight forward than diagnosis and should follow a CCSVI finding with no problem since it is NOT a procedure that has ever had any adverse events, unlike stenting, and you proposed only angioplasty if I recall correctly.

Did they even give you an opportunity to revise and try again, or was it a flat rejection with no opportunity to keep trying??

ps. check your pms.
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Postby Cece » Tue Jun 22, 2010 12:29 pm

drsclafani wrote:1. AN OBSCURE GERMAN ABSTRACT REPORTING TEN PATIENTS THAT SHOWED NO ASSOCIATION BETWEEN CCSVI AND MS
2. A NEWLETTER OF SOME FORM STATING THAT ONLY RANDOMIZED TRIALS SHOULD BE PERFORMED.
3. THAT RANDOMIZED CONTROLLED STUDIES WERE ALREADY UNDERWAY IN BUFFALO. ANYONE KNOW ABOUT THAT?
4. THAT THE NATIONAL MS SOCIETY RECOMMENDED AGAINST TREATMENTS
5. THAT PATIENTS WERE BEING CHARGED FOR PROCEDURES. AND I HAD NO FUNDING
6. AND OF COURSE, THE WALL STREET JOUIRNAL TALKING ABOUT DAKES COMPLICATION AND DEATH


Just to try and figure out the IRBs viewpoint: Dr. Sclafani had said that he considered the association between CCSVI and MS to have been proven robustly enough. (IRB disagrees, point 1.) He proposed the next step to be a large scale patient safety study. (IRB disagrees & seems to think it should go straight to randomized trials, point 2 & 3...although IRB also has safety concerns (point 6)).

The stance of the MS Society is being used against us...this is happening in Canada too, I don't know what to do about it, it is sickening. And the catch-22 funding issue: insurance will fund this as individual treatments, so there wouldn't seem to be a need for funding. :(
Last edited by Cece on Tue Jun 22, 2010 1:54 pm, edited 1 time in total.
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Postby ozarkcanoer » Tue Jun 22, 2010 12:29 pm

HappyPoet,

I paid to get the imaging done at BNAC. And I got my results. I have CCSVI and I was glad to pay for the results. The people at BNAC are fantastic !!! Their 30 person trial of the procedure is NOT FOR PAY !!!! This is important to understand. The data from my testing will be part of their MS/CCSVI database. BNAC is a "good guy" in the CCSVI story.

And Dr Sclafani is a GOOD GUY too.

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Postby tzootsi » Tue Jun 22, 2010 12:33 pm

Kings Hospital had the opportunity to be on the cutting edge of an exciting breakthrough in medicine. It was to be spearheaded by one of the world's most knowledgeable doctors in treating CCSVI. They blew it.
Hopefully, there are other avenues you can explore.
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Postby prairiegirl » Tue Jun 22, 2010 12:40 pm

Dr. S,
Your open communication and advocacy is so appreciated here. You have a big international community of supporters rooting for you and hoping for a solution to the IRB stonewall. There will be a solution... best in your quest :idea: !
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Postby kc » Tue Jun 22, 2010 12:47 pm

OMG I think I am going to be sick! WTF is wrong with people? WE ARE SUFFERING PEOPLE!!! I am a strong believer in karma and those who made this assisine decision better watch out.

Hell I am even perturbed when I see the words "Experimental new procedure". In my mind the experiment is over and let's get down to business fixing people so we can once again function/work in society.

Please Dr. Scalafani keep with it for us!
We are with you.

kc :evil:
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Postby CharW » Tue Jun 22, 2010 12:48 pm

First they ignore you, then they laugh at you, then they fight you...then you win! Ghandi
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Postby girlgeek33 » Tue Jun 22, 2010 12:50 pm

You have an army, ready at your disposal. All troops ready for orders, leaders ready to lead... This MonSter affects all walks of life. We can accomplish so much with our collective experience!!!

(haha, 'This Is War' by 30 Seconds to Mars just came on radio...)
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Postby costumenastional » Tue Jun 22, 2010 1:21 pm

mshusband wrote:we need to watch what we say ... who we say it to.


sorry...i dont see any reason for this.

i can only think of an experienced proffessional that is not allowed to take a promising step forward at this time, without any obvious reason.
while i could say a lot about this, i wont, only due to respect for Sclafani and surely not because i care about people who dont take seriously serious matters.
and of course because i believe he will bounce back cause he doesn't seem like a quiter to me.
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Partner/Satelite Clinic

Postby bmk1234 » Tue Jun 22, 2010 1:24 pm

This is just another battle, we all know how to fight.

I'm no Dr. but in my simple mind, the best (and quickest) way to get up and running would be to partner with another DR. S we know and open a satelite clinic in Brooklyn, NY. Then another location, and another, etc.

I believe this could be very successful.

If a business plan was prepared, I believe there would be investors interested.
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Postby arielmt » Tue Jun 22, 2010 1:36 pm

girlgeek33 wrote:
Cece wrote:
drsclafani wrote:3. THAT RANDOMIZED CONTROLLED STUDIES WERE ALREADY UNDERWAY IN BUFFALO. ANYONE KNOW ABOUT THAT?


It's a small study of 30 patients. First ten are getting the treatment as a safety/pilot twenty. Of the next twenty, half will get the treatment and half will get placebo. I don't know how 'underway' it currently is.

:cry: :cry: :cry: :cry:

I cannot believe this. But it'll be ok. You cannot keep a good doctor down.


People are starting to get contacted and scheduled for this. But they MUST be on DMDs or they are disqualified from the study!!!!


This is true. I am in Buffalo and was contacted yesterday to be in the first cohort of 10 people to receive testing (to be conducted today and tomorrow) and, if positive for CCSVI, receive treatment next Wednesday.

I was disqualified because I do not take any disease modifying drugs (DMDs). It was mentioned that 5 others preceding me were disqualified for the same reason.

I was told that the first cohort of 10 were to prove the safety of the procedure. The second cohort of 20 would have a 50% chance of actually receiving angioplasty. The other half would receive a sham procedure.

I would not have had to pay for any of this were I able to participate.

At this time, this is the only treatment study the BNAC is doing. All of their other studies are for imaging. The results from the first study of 500 were released this spring. The primary current study will ultimately have 1,700 people and I participated in this in April. That's a blind study, the results are not given to participants and I did not pay for it.

Another study is the self-funded study. For this, they are charging $4,300 for a set of tests (more than just MRv and Doppler ultrasound) and a clinical visit, in which the results are given. However, they require you to sign a legal disclaimer that states "any information you gain from these Tests is purely informational and educational and will not be able to be used by you or any other person to diagnose, cure, treat, mitigate, or prevent your MS." I'd have to say that's just a CYA because they know darned well what people will do with their positive results.

I am so very sorry to hear that Dr. Sclafani did not get IRB approval. It makes no sense. I will offer to help in any way I can with finding a facility that will support Dr. Sclafani and assist with fundraising.

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Postby magoo » Tue Jun 22, 2010 1:43 pm

bestadmom wrote:...just like the days of coat hanger abortions. Things will change.


My thoughts exactly.
Rhonda~
Treated by Dake 10/19/09, McGuckin 4/25/11 and 3/9/12- blockages in both IJVs, azy, L-iliac, L-renal veins. CCSVI changed my life and disease.
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Re: Partner/Satelite Clinic

Postby Cece » Tue Jun 22, 2010 1:59 pm

bmk1234 wrote:I'm no Dr. but in my simple mind, the best (and quickest) way to get up and running would be to partner with another DR. S we know and open a satelite clinic in Brooklyn, NY.

Would treatments done in this fashion be something he could publish on?

It's not just about him getting to treat, it's also the need for him to research and publish. :(
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NY Times Article on Dr. Sclafani's procedure

Postby jfhcrgvr » Tue Jun 22, 2010 2:06 pm

The link to the article on the procedure that helped to save a police officer's like did not work for me this morning. Can anyone tell me why? I would like to forward it to someone who may be able to help with funding.
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Postby BrendaReqier » Tue Jun 22, 2010 2:15 pm

I am sickened that the IRB has acted in this way. It seems they are grasping at the most illogical straws with good science and evidence staring them right in the face.
Please don't give up, We will win this battle.
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