DrSclafani answers some questions

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

Postby NZer1 » Sat Jun 26, 2010 12:20 pm

Italy's announcement should be of help eh Dr.! :D
See it some times takes a little adjustment from the 'universe' to get things aligned. :P
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Postby drsclafani » Sat Jun 26, 2010 2:18 pm

girlgeek33 wrote:
Cece wrote:to anyone who saw
pm me what I missed!! :wink:


Me too, feel like I missed a joke or something...


the joke is on me
i put a pm on the site by mistake.
i am glad that neither anyone read it or they are quiet.
i didnt want to embarrass anyone by divulging personal information

nuff said
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Postby L » Sat Jun 26, 2010 2:24 pm

drsclafani wrote:
girlgeek33 wrote:
Cece wrote:to anyone who saw
pm me what I missed!! :wink:


Me too, feel like I missed a joke or something...


the joke is on me
i put a pm on the site by mistake.
i am glad that neither anyone read it or they are quiet.
i didnt want to embarrass anyone by divulging personal information

nuff said


you were pretty quick on your feet!
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Postby pklittle » Sat Jun 26, 2010 2:24 pm

drsclafani wrote:
girlgeek33 wrote:
Cece wrote:to anyone who saw
pm me what I missed!! :wink:


Me too, feel like I missed a joke or something...


the joke is on me
i put a pm on the site by mistake.
i am glad that neither anyone read it or they are quiet.
i didnt want to embarrass anyone by divulging personal information

nuff said


Dr!! Do we not have enough excitement going on? Big LOL !! :lol:
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Postby fogdweller » Sat Jun 26, 2010 2:26 pm

zinamaria wrote:sbr487,

But I do not think a lawsuit is going to 'show' anyone anything. Have you considered that this could jeopardize the good doctor's position at the hospital, in many ways, one of which is in terms of his efforts to help us, which includes IRB approval which does not seem like a done deal, because I think the doctor plans to re-apply. Zina


They could also demand that he stop contributing to this blog on risk of being suspended, since they could legitimately argue that his participation and contributions result in their being sued.
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Re: CCSVI in Italy

Postby drsclafani » Sat Jun 26, 2010 2:29 pm

QueenMum wrote:From Cheerleader on Facebook:

Today-In Rome--CCSVI becomes a recognized vascular conditionShare
Today at 8:22pm

Today in Rome, the Italian CCSVI Society met with the Ministry of Health, and it was decided that CCSVI can be diagnosed as a stand alone disease, without being correlated to MS. It was also decided that Dr. Zamboni can go forward with his blinded clinical trials of CCSVI in MS. Although there was no time-line given for testing and treating CCSVI, the ministry has promised to move quickly--

here's a google translate of a press release:

The cerebrospinal chronic venous insufficiency, "is recognized as a disease"

The Association CCSVI in multiple sclerosis - Onlus "asks guidelines for diagnosis and therapy. Tobacco: "The State shall take responsibility to implement what the scientific community in the world has crossed"

ROME - The cerebrospinal chronic venous insufficiency (CCSVI) is recognized in Italy as a disease in itself that can be quickly drawn up guidelines to be able to diagnose and treat beyond its correlation with multiple sclerosis. This is called the association "CCSVI in multiple sclerosis - Onlus" the Ministry of Health in a just concluded meeting between representatives of the association and Albert Zangrilli, president of the second section to the Board of Health in the same ministry. "While science makes its way to validate the correlation between MS and CCSVI - Tobacco said - as, we ask that, since the Ccsvi has already been validated by the scientific world as it has been validated his therapy, the state will face load to implement what the scientific community worldwide has already validated and to draw up guidelines with respect to this disease occur until the science correlation.

Found in several trials around the world in people with multiple sclerosis, CCSVI is a disease that affects the cervical and thoracic veins that because dell'inspessimento anomalous venous walls, remove inefficient blood from the central nervous system. The correlation between the two diseases in Italy is a study whose results, explain the association, are expected at the end of next year. "Today's meeting went very well - added Tobacco - The Ministry has taken note of our request." The timing, however, there are still some news. "On this we had no indications, but the ministry made us know that it will mobilize more quickly." (Ga)


i would suspect that this would have no bearing on the United States.
I could try and get rejected again or i could try to accomodate their concerns.
its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

plan A...ccsvi stands on its own. what are the symptoms?
headache? fatigue? spasticity? how does one differentiate that from MS? anyone other than MSers get ccsvi? Can't differentiate it? need a trial for ms patients. because it is a vulnerable patient population. anyone know of a treatment option for ccsvi that is proven? no? need a treatment protocol and trial.
standard of care: what is the standard of care ? where? not in the US? Italy? where is that? when did they set the standard of care in the US? need a trial, treat vs no treat.

see the problems
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Postby drsclafani » Sat Jun 26, 2010 2:32 pm

L wrote:
drsclafani wrote:
girlgeek33 wrote:
Cece wrote:to anyone who saw
pm me what I missed!! :wink:


Me too, feel like I missed a joke or something...


the joke is on me
i put a pm on the site by mistake.
i am glad that neither anyone read it or they are quiet.
i didnt want to embarrass anyone by divulging personal information

nuff said


you were pretty quick on your feet!



its a guy thing and I do not have MS
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Postby drsclafani » Sat Jun 26, 2010 2:35 pm

Cece wrote:to anyone who saw
pm me what I missed!! :wink:


if cece didnt see it, i suspect no one saw it

lucky me
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Re: Symptoms of CCSVI

Postby drsclafani » Sat Jun 26, 2010 2:39 pm

LauraV wrote:Laura

nope, sorry
collecting data on a group of patients and writing and publishing it all is doing research on patients and it requires IRB.
But the idea of writing it down, finding out whether adding it all up is the goal of the academic life[/quote]

Please forgive me if I'm being dense here. I just want to clarify a few things in my mind.....I know that you want to perform CCSVI procedures for MS patients and that is your goal. That being said, is there any way around this? Does this mean that we cannot have you treat our CCSVI as a separate condition without any mention of MS? Does that mean that there isn't any way the IRB would let you do venous angioplasty for CCSVI at all?[/quote]

laura

firstly, let me restate what i said above. the idea of writing down data, analyzing it and publishing it for the betterment of mankind, that is the goal of the academic life

secondly, my protocol was for the treatment of CCSVI, not the treatment of MS. The problem is that if you leave out patients with MS, there is not patient population and thus in north america one cannot seem to separate ccsvi from ms
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Postby drsclafani » Sat Jun 26, 2010 2:41 pm

Algis wrote:Dear Doctor;

Beside the 'left entry' of the iliac stuff; there is also that CTOS story that could play some ball in the game.

What are your thoughts about the whole picture?

Thank you for your time :)


algis, to be honest, i cannot get my hands around that yet.
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Postby Cece » Sat Jun 26, 2010 2:41 pm

drsclafani wrote:
Cece wrote:to anyone who saw
pm me what I missed!! :wink:


if cece didnt see it, i suspect no one saw it

lucky me

8)
drsclafani wrote:its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

Would it still have to be a full two years if you did a randomized trial? Would there be set points along the way where, if CCSVI treatment is working well and proven itself, the trial would be considered successful and it would be ended earlier than a full two years? Could you limit the subject population to people who would maybe have the least amount of damage from such a wait (I'm thinking people like me, although NOT ME, who have RR with lesser disability), also since these are the people who seem to be showing the greatest response to CCSVI treatment? And: did you catch some sun today? Summer is short....
Last edited by Cece on Sat Jun 26, 2010 3:47 pm, edited 2 times in total.
"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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Re: Symptoms of CCSVI

Postby fogdweller » Sat Jun 26, 2010 2:51 pm

drsclafani wrote:secondly, my protocol was for the treatment of CCSVI, not the treatment of MS. The problem is that if you leave out patients with MS, there is not patient population and thus in north america one cannot seem to separate ccsvi from ms


I am a bit confused. I think you are saying that you need IRB approval to conduct a study, and that makes sense. But do you also need IRB approval to do any procedures at all? For example if you find CCSVI because you are examining a patient for symptoms such as headaches, fuzzy thinking that you think might be connected to poor circulation, etc., would you be able to treat that patient (not an experimental subject, and not being treated for MS) without IRB approval?

I think that is the question that Laura was asking, and the same one I asked a few months back. If you have CCSVI, and angioplasty is a well accepted treatment for improving vascularization due to narrowed vessels, you ought to be able to treat it. Where is the experimentation?
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Postby Cece » Sat Jun 26, 2010 2:54 pm

here is what he's said in the past on the matter of why he can't just treat an individual:
drsclafani wrote:
Algis wrote:
a doctor can treat someone with a standard technique for a new indication. HE CANNOT TREAT A GROUP without IRB.


Why not to treat 50 (500) 'individuals' then :? Not trying to be a smart ass but isn't a group merely a suite of individuals? That's just picky'ing around (just invented that one to suite my needs; without approval :P).


doctors dont treat groups. maybe shrinks do....ie group therapy, but most of us treat a patient and each patient is assessed and treated individually. Once you get into group dynamics, the stadards of the world is you are doing an experiment and doing experiements on vulnerable groups is fraught with danger

and more of that conversation:
drsclafani wrote:
hope410 wrote:I'm very surprised at this distinction between one versus many too. If you had one patient who benefited from an off-label use of something or new use for established procedure, wouldn't you have an obligation to treat others/everyone the same way?


no, because it is unproven and not the standard of care. Using it on everyone would imply that it is the standard of care

And did casting a broken left leg to set it while it healed require a different IRB process than a broken right leg?

Or is my analogy not the same as this situation, i.e., a broken left leg is the same as a broken right leg, but a blocked liver vein is not the same as a blocked azygous vein? So ballooning different veins is very unique and therefore ballooning different veins needs separate IRB protocols and investigations? Is each different vein going to require its own IRB oversight, or at some point, is a vein just a vein just a vein?



I'm really confused by what the problem is when veins ARE ballooned already and have been, as you said, for decades.


no one needs an IRB to treat a vein problem. What causes the controversy is that you have a new treatment in a group of patients (MS) for which there is no standard of care
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Postby drsclafani » Sat Jun 26, 2010 3:04 pm

Wonderfulworld wrote:Dr. Sclafani
thank you for this thread. I have read the different user experiences on TIMS with valve issues (Erika, LR1234, Rici) and I realise searching for answers on how to treat valve issues is less 'looking for a needle in a haystack' and more 'do I need a needle, and will it be what I'm looking for if I do find it' :lol: .

I had a Doppler scan done, it showed a diminished flow in the left Internal Jugular Vein (IJV), with an immobile valve at the IJV-innominate junction. Increased right IJV flow. I have not yet had any CCSVI treatment.


again....this would be a negative doppler ultrasound as you only mentioned one of the five findings of ccsvi and a diagnosis requires two for zamboni
they mention increased ijv flow on the other side. THIS IS NOT A SIGN OF CCSVI. i guess i really do need to do the study of the imaging tests (specifically ultrasound) you have had taken to see if they follow the protocol. Tonite i shall start a request for an irb exemption. However if anyone can anonymize their cd, i can look at it now.

I have 2 questions.
I feel much better when I use Niacin occasionally to achieve a 'flush'. I have read that this lowers blood pressure. I seem to have lower blood pressure normally but I am wondering could this be a possible positive adaptation by my body to reduce blood flow through the faulty IJV valve, therby reducing in turn the volume of refluxed blood into the brain? Also, presuming I ever developed high blood pressure, the potential for problems would surely increase if I have an immobile IJV-valve?

its really not a pressure phenomenon. its a flow phenomenon.

I was pregnant in 2007/2008 and I experienced problems with losing consciousness within 30 minutes of staying sitting down - I would get to the point of fainting. It would only be resolved by standing and walking around. My obstetriican could not find any reason for it but did say 1/1000 pregnant women seemed to get this. I found it an interesting epidemiological statistic given MS's 1/1000 prevalence (although this obviously includes the boys!). Could this passing out while seated, during pregnancy, have been related to an immobile IJV-valve? I ask in order to see if this can strengthen the case for seeing a vein-specialist.

perhaps this is compression of the inferior vena cava and a reduction of the blood returning to the heart. perhaps it was some problem with your heart rhythm. I am really guessing.

Many thanks in advance for your thoughts.

I am also very interested to hear from any others considering or having undergone CCSVI who have a valve problem in their IJV - I know of Erika, LR1234 & Rici, but maybe there are others out there............[/quote]

there are many many people with problems with the valves. this is one of the most common causes of ccsvi
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Re: other options...

Postby drsclafani » Sat Jun 26, 2010 3:19 pm

ThisIsMA wrote:Hi Dr Sclafani,

Are there small private clinics that do angioplasty? If so do they have IRB's? If not, might it be possible to partner with such a clinic?

Also, what would it cost to open such a clinic? I'm sure it would be in the millions, but how much? We are an army after all... and some of us are grant writers!

I read that a Dr. Hubbard at the Hubbard Foundation in in San Diego has received IRB approval for CCSVI testing and angioplasty. He owns an fMRI machine that is used to:

<<investigate the neurophysiological foundations of consciousness and meditation and their influence on brain functioning, health and peace. >>

Dr Hubbard's son was diagnosed with MS and CCSVI and had the angioplasty with clear benefit. So he is a believer (and probably an interesting person as well)!

I wonder if you could fly out there for one week a month or every other month or twice a year or some such thing and do CCSVI procedures under the approval of Dr Hubbard's IRB? You'd be learning and gathering more publishable information and helping people.

Also, if a small German study of 10 people that found no CCSVI in people with MS can be published and believed, surely your testing and treatment of 20 people with 100% found to have CCSVI and 50% showing clear improvement with angioplasty would be publishable! Don't you think? ( I hope I got those rough numbers right).

Also, is it too late to sign up with the group who wanted to include you in their CCSVI trial? If they are not experienced enough, could you take on a mentoring role and help them do better work?

I know most of my brainstorms don't pan out, but throwing ideas out there might spark another idea that might work!

There is a way to move forward out there somewhere...

Mary Ann


mary ann most ideas dont pan out, even for the most brilliant so thank you for thinking of ideas. they are pretty good. we think alike too

in order to publish results, and you desperately need scientific results in order for you to really decide your best options, one must have the work overseen by an IRB. Dr. Hubbard has an IRB. Freestanding privately owned programs can write an protocol but it must be overseen by an IRB to safeguard patients.

a treatment clinic could be built for a six figure sum using good used equipment and could actually be profitable as long as insurers choose to pay for procedures. and i will bet we find that sleeping giant waking up soon.

several contributors here have recommended joining into another IRB sanctioned trial. however each institution must itself apply to its own irb for approval in the institution. there is no guarantee that what one irb approves, another will not.
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