DrSclafani answers some questions

[sbr487]

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?

I have read that one attempt to correct defective gene resulted in the patient system going haywire (I believe he died) ...

[Cece]

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!

[FlashHack]

As I understand it, the FDA presides over drugs and DEVICES. The devices would have to be stents, which have never been approved by the FDA for use in VEINS, only in Arteries. Use of a device or drug that has been approved by the FDA for another purpose is very common and is known as "off label" use.

[BooBear]

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.

[Cece]

Ah, that makes sense! So a doctor planning to do angioplasty with stents could run into FDA approval issues?

[FlashHack]

Informative link on IRB: http://en.wikipedia.org/wiki/Institutional_review_board
Institutions that conduct human research and receive funding from Health and Human Services (HHS) must have an IRB that operates according to federal guidelines (i.e., no IRB = no government funding). The IRB process entitles the institution to certain protections from legal action related to research. The FDA and HHS are the two government stakeholders in the IRB process, but an IRB is set up by the private institution that is conducting the research.

[fogdweller]

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.

[Cece]

patience, patience, patience...
I'll have a Phd in patience by the time this is through...
anyone think we will still hear today? It is into the evening in Italy now...our rock star has more than earned a good night's rest tonight.

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.

I find that so strange...that line between "can't do this, it's unproven" and "must do this, it's proven" is mighty slim.

[bestadmom]

Cece,

Patience until Monday. We'll be lucky if it's sooner.

[mshusband]

Yes ... enjoy the weekend ... infromation will come in time. We've waited months ... what's another beautiful weekend?

I've heard the same thing as Bestadmom.

[Cece]

thanks bestadmom & mshusband...Monday will be fine...so long as he does not lose his way and end up in China with a case of TGA...

Dr. Scaflani, may I repeat my question which was probably lost between IBT Posts. Thank you.

BBE wrote:
I have a question:
Dr. Scaflani, is it true that some people have and some don`t have valves in jugular veins? It is said that you don`t need valves above your heart. I wonder what prevents people without valves to get reflux.

It is true that not all people have valves in the jugular veins. According to some autopsy results, about 15% of patients do not have valves in both jugular veins.

it is not true that all patients somehow do not get reflux, it is likely that there is reflux. reflux up the jugular vein transiently may not be a signficant problem most of the time, however there are reports of transient global amnesia (TGA) in patients with high pressure reflux.

OK, i cannot resist the opportunity to describe what TGA is NOT: it is NOT losing your way home while traveling around the world. It is a short term and intermittent episode of complete amnesia.

I ran across that one while digging for info on actin (which has something to do with smooth muscles of the veins, in one post DrS mentioned it is abnormal in CCSVI patients, but what is actin and what does it do?).

Yes, we've waited months...and, really, a lifetime...so one more weekend is not much...even in this age of instant information.

[zinamaria]

zinamaria wrote:
Hello all,

Just thought to mention that there is no way Sclafani, while with
Zamboni, does not have internet access...they all have computers with
internet. He's most likely way to immersed to post right now.
zina


U got that rigjt sister


Hey, I'll be in the Sclafani gene pool any time! Don't forget to try the gelato, especially 'nocciola' ...half and half with chocolate e molto buono!!
zina

[SofiaK]

Dr Sclafani:

Do all MS patients have vein narrowing? An MRV should show any narrowing, no?

I’m confused because I’m hearing different things.

Many thanks,
Sofia

[L]

Dr Sclafani:

Do all MS patients have vein narrowing? An MRV should show any narrowing, no?

I’m confused because I’m hearing different things.

Many thanks,
Sofia

Now these figures are rough, from the top of my head, but I believe that Zamboni found a 100% correlation, Simka 92%, Zivanidov 55% but a figure around 85% with progressive MS and Kuwait 100%. Then Bochum found 22% but, we guess, that they weren't quite trained to the degree necessary. How else to square the circle but to conclude that?

[scorpion]

L maybe Simka and Zamboni's results were skewed. That is another conclusion one can draw. Dr. Sclafani please share your response as to why some of the people on this board are relapsing after the liberation procedure. Does that make you question the relevance of the CCSVI?