DrSclafani answers some questions

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

Re: IRB Proposal

Postby drsclafani » Sun Jun 13, 2010 3:12 pm

Trooper wrote:
drsclafani wrote:
Donnchadh wrote:Dr. Sclafani:

WHEN the IRB approves my proposal, I will post it on my website and will move transparently and let the chips fall where they may.

my proposal calls for reangioplasty for the first episode of restenosis and consider a stent for a subsequent restenosis. AT that time the patient falls out of protocol.

Thus i should start writing my next protocol now for submission to the IRB
eh?


Does Dr. S mean this website or another ?


Thx

T :)


once i have IRB approval I will post images of each case with a history of the patients problem.
i will share failures and success, complications and triumphs

this i will do from my own website dedicating a page to each hero along the way
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Postby drsclafani » Sun Jun 13, 2010 3:15 pm

JCB wrote:What a guy, I don't know who has more devoted fans than Dr. S. Does anyone have any ideas on what we could do for him to show our appreciation for his efforts? If you do PM me, I will try to get something going.


no one is cured yet. mostly we have a lot of answers

save your ideas and remember that money will be needed for a randomized trial to prove this and make the TREATMENT undeniable to insurers and neurologists

we have just started the journey my friends
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Postby drsclafani » Sun Jun 13, 2010 3:16 pm

1eye wrote:How about a cake all decorated with veins, Or glass of the champagne?


oneye
you are one sick puppy.
only a vampire could think that one up


:wink:
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Postby drsclafani » Sun Jun 13, 2010 3:19 pm

simone wrote:
drsclafani wrote:

Can't wait to hear stories. discoveries. Hope you have some time to enjoy Italy and a little rest.
Sending you virtual hugges.....


i am anxious to tell you about my experience with the ferrara/bologna team, but first let me catch up with questions
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Postby drsclafani » Sun Jun 13, 2010 3:22 pm

Donnchadh wrote:Dr. Scalfani:

Posted 14 of the 40 venograms taken during my liberation procedure.

Donnchadh


http://www.thisisms.com/ftopict-12139.html


none of those images showed the area most likely to be causing problems. There did appear to be a web on some of those images but the usualy culprit is located near the subclavian vein

i hope they imaged the entire vein
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Postby drsclafani » Sun Jun 13, 2010 3:23 pm

L wrote:
drsclafani wrote:Your almost 150000 views of DrSclafani answers some questionsm.


Should this be in the Guiness Book of Records?

i doubt this is even close to the record. anyone know?
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Re: FDA?

Postby drsclafani » Sun Jun 13, 2010 3:31 pm

girlgeek33 wrote:Okay, I've heard of IRB and I get the process. But someone has just posted something that a hospital shut down a Doc in FL because the procedure is not FDA approved. This is the first I'm hearing that FDA is in the mix at all. Does FDA approve procedures such as this? I thought they were drugs & food. So I guess I want to understand. What happens after IRB and studies are done. Does the data collected go to the FDA? Do they decide if this is an acceptable treatment? What is the next step after a successful study?


1. the FDA is responsible for assessment and followup of all medications and devices. They do not approve procedures.
2. Devices used in la liberation include stents (hopefully infrequently) and balloons and catheters and drugs (contrast media).
3. devices are studied and receive approval for specific indications. Stents were originally approved for treatment of bile duct obstructions for cancers.
4. once a device is approved, a doctor may use it for other indications. for example biliary stents were used to treat atherosclerotic stenoses of blood vessels and angioplasty balloons (originally approved for arteries) were used in veins.
5. generally FDA does not get involved in such translation unless there are reported undo risks or complications or someone makes objection
6. hospitals can determine whether they want "off label" use of medications and devices.
7.payors may choose to withhold payment for off label use if it is not used as part of an IRB study
8. use by a doctor off label usually requires documentation of the need.
9. after a while and with sufficient paper publications, an off label use can become "standard of care'. Standard of care does not require IRB but of course any research, even on standard of care treatment requires irb supervision.
10. failure of a device requires reporting to FDA
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Postby drsclafani » Sun Jun 13, 2010 3:35 pm

mshusband wrote:Could be a mis-understanding ... FDA, IRB, legal counsel ... might just be rumors and whatnot right now ...

Don't worry, this is picking up more steam by the day ... once one IRB gets through, the rest will follow because they will know what to write.


in a perfect world that is true, but each IRB may require different standards.

Currently there are two types of IRB protocols being spread around
1. open label studies of a cohort of patients to look at safety, identify problems, understand the patient and their reactions to the procedures, detecting pitfalls, etc. That is what i plan to do.
2. randomized prospective trials. these will pit one treatment against another

I do not think that randomized trials are appropriate at this time and would advise caution against joining one. We will probably speak more about this now as trials go on line. I will explain my rationale after answering all these outstanding questions.
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Postby drsclafani » Sun Jun 13, 2010 3:38 pm

girlgeek33 wrote:
mshusband wrote:Could be a mis-understanding ... FDA, IRB, legal counsel ... might just be rumors and whatnot right now ...

Don't worry, this is picking up more steam by the day ... once one IRB gets through, the rest will follow because they will know what to write.


I've been trying to find out what happens after IRB approval and study finishes. Does it just get written up in Medical Journals and become available or does one of the Health & Human Services Departments review and make a determination? I'm on the web site and can't find anything after the study is concluded, what happens next...


the study gets published and doctors decide based upon the results how to treat, not treat, study some more, advise patients, prove value to insurers, refute assertions of danger :wink: boo
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Postby drsclafani » Sun Jun 13, 2010 3:42 pm

sbr487 wrote:A bit off topic - but how does FDA (or any other) body give a go ahead for new medicines since the safety cannot be quantified. Do they use any specific parameters? Or since someone has to go first, they just approve everyone?.


safety is quantified in complications and percentage who get it. doctors, hospitals and patients decide what is acceptable risk (and sometimes lawyers and state agencies provide some punishment when things go wrong)
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Postby drsclafani » Sun Jun 13, 2010 3:44 pm

Cece wrote:I think that's why there's the whole process: first stage I safety trials, with some large dosages to see how much a person can handle; then stage II, IIb, III. As it proves itself, it can move on. Takes a long time!


it does. our system is actually very cautious compared to other states like europe community. so we see advances after europe. i always go to european meetings to see what will be coming down the pike in the US.

we are risk averse because of our legal system, history with thalidomide, etc
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Postby Cece » Sun Jun 13, 2010 3:45 pm

drsclafani wrote:
L wrote:
drsclafani wrote:Your almost 150000 views of DrSclafani answers some questionsm.


Should this be in the Guiness Book of Records?

i doubt this is even close to the record. anyone know?


I googled, this is all I found:
The Most Popular Forum Post Ever In China

Whereas blogging is popular in the United States, the Chinese have traditionally preferred the bulletin board systems and forums instead. Blogging is an individual activity with some comments from visitors. Forums are special subject community areas in which various people posts on a defined subject (such as media, society, family, etc.) and people can comment. A blog is made or unmade by one individual, whereas forums depend on the collective participation of many people.

The following story appeared in Nanfang Weekend. It follows the story of one particular forum post at the Tianya Club. The post first appeared in February 22, 2005. Since then, it was been viewed more than 223,000 times, and almost 4,000 people have commented on it. It is estimated that it will take a person 7 hours to read through the whole thread. With the national exposure from Nanfang Weekend, there will probably be another huge traffic surge.

This is from five years ago so it is likely outdated. :)
http://www.zonaeuropa.com/20050911_1.htm
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition
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Postby drsclafani » Sun Jun 13, 2010 3:46 pm

BooBear wrote:To that point, Flash, the FDA has no say on the use of angioplasty, right, as that is neither a device nor medicene- but a procedure. :)


stenting is a procedure that requires stents. and actually angioplasty is a procedure that requires devices.. they are called angioplasty balloons and they are all tested and manufacturing is overseen by the FDA
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Postby pegmegrund » Sun Jun 13, 2010 3:57 pm

drsclafani wrote:
L wrote:
drsclafani wrote:Your almost 150000 views of DrSclafani answers some questionsm.


Should this be in the Guiness Book of Records?

i doubt this is even close to the record. anyone know?

I don't know if it's a record, but there's a thread on the lostpedia forums (for fans of the TV show Lost) that has over 44,000 replies and 1,600,000 views.

We've got a ways to go, but we're with ya for the long term! :wink: Nice use of the emoticons in your request for us to not post new questions. Notice how Cece and I were behaving ourselves and just answering yours!
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Postby drsclafani » Sun Jun 13, 2010 4:17 pm

fogdweller wrote:
Cece wrote:My understanding is that medical devices are under the FDA umbrella, so if there were a new venous stent it would need to go through the FDA process, but that angioplasty itself is an already allowed procedure and further regulatory approval is not necessary for it.

So the course of action is: perform research (under IRB approval for patient protection); publish; other people perform complementary research and publish; IRs and neurologists everywhere read the published research and change their approach based on the findings.


I was on Sr. Staff in a small start-up company working for FDA approval of a new device, and my experience is that this is exactly correct.

As some of the following posts point out, off label use of drugs and devices is common, and is not controlled (forbidden) by the FDA. However, a medical institution such as a hospital or clinic might forbid practicioners to use ists facilities to do that procedure. That is where the IRB comes in. A hospital (e.g. Stanford) might forbid surgeons (e.g. Dake) in its facility from implanting stents in MS patents because of lack of adequate facilities, or percieved dangers, or other reasons. With IRB approval, however, they may be permitted to do so in a study.

This is why some Dr.'s, (e.g. Sclafini) were able to do the procedure until they were ordered to stop. There are still a lot of Dr.'s apparently doing the surgery under the radar, and that is why a lot of us are frustrated that there aren't more courageous doctors and facilities doing the procedure.

One addendum: After publication and approval by some important scientific group, the procedure might become "standard of care" so that every competent surgeon is supposed to try to apply this procedure. And that is not always based on huge studies. For example, inducing hypothermia in cardiac arrest patents became the standard of care after a study of only 56 patients.

in the past that was the case, but as our society has become "evidence based" things do not often become standard of care without proof.

you might call these doctors flying under the radar courageous, but i am becoming disenamoured with many of them who are just doing the procedure without intention of going to any form of trial. we owe it to society to document procedures and publish the results
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