This Is MS Multiple Sclerosis Knowledge & Support Community

adamt wrote:

L wrote:
Perhaps she is only looking for stenosis and not also for problems with valves?

the doctor said she will test Every vein in my body for stenosis with the dye.

she expressed she will be checking the sacral venous plexus and other 'plexus' veins, as she said some MS patients dont have these veins

is looking/checking the plexus veins the same as checking the valves?

thanks

see you next week! studying every vein in the body could take that long

not sure why they are checking those veins unless as zamboni, they are in a trial. no one has suggested that yet

lets not get vein imaging crazy!

Lyon wrote:

drsclafani wrote:they (the IRB) have several options

1. accept protocol as written. Liberations can begin. Yeah!!!
2. Accept provisionally with specific wording changes. Liberations resume Yeah!!!
3. Request detailed changes. This would require revision of the application. The revision would be reviewed at the next meeting of the Group reviewing my application. Each group meets once monthly
4. outright rejection (i do not think this is a possiblity.

drsclafani wrote: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

Dear Dr Sclafani,
Hopefully this doesn't seem too early and rude to ask.

I know that gut feeling is the best you can do but did you get the idea that there was room for negotiation if you were able to meet certain criteria (funding source, randomization, etc..) or did it seem an obvious no-go regardless of any hoops you might have been willing to jump through?

it was written quite clearly. that if i wanted to resubmit, i could but that it would not be a continuation of this proposal but another new application

Cece wrote:

drsclafani wrote:2. The reason to look for a May thurner syndrome is not because anyone thinks there is an association. Zamboni only found about 3 patients in more than 100 patients.

MT is estimated to have a prevalence of 2-3% in the normal population, so thanks for giving us Zamboni's numbers, it sounds like they're the same.

I think empathy may make doing a randomized trial more difficult, if that is the direction your irb wants you to go?

As I said before (and Cece, i am surprised you didnt quote this

i am a kohutian and believe in empathic immersion. thus if my patient feels pain or fear, i must get into that experience. I must also hold on to my Self at the same time and function

so i would say a sham operation that leaves a patient hopefull, would allow me to experience that hopefullness. similarly, if they were angry, i would have to experience that anger

i guess i am saying that it might make it more difficult but not overwhelming

This requires courage and patience, but if CCSVI goes underground and does not fully disclose everyting to the scientific community, it will be written off as another kook theory peddled to a vulnerable population and this will give it a stain that will set it back years.

Agreed, although it is painful to hear of the stopages, if this all goes underground we will not hear of or be able to validate the successes either.

hope410 wrote:I wonder if the new understanding that M-T syndrome may be occurring and significant lower veins may also be blocked might also shed some light on why some people seem to worsen following vascular treatment.

If only upper veins are unblocked, the increased flow throughout the entire closed circuit venous system created by the better blood flow is going to encounter these blockages lower down.

I wonder if it would cause even greater reflux in these persisting lower blockages (or whatever mechanism is discovered to create the eventual demyelination) and thus cause a worsening for some people in their health neurologically. I visualize a dam in a river that is unblocked, and the pent up water is unleashed and goes crashing downstream. But if it then encounters another blockage, it's going to be hitting up against it at full force, greater than even before, since the earlier blockages had resulted in only a trickling stream of water getting the whole way through when there were multiple blockages. Now, the water flows at much greater rate and force, hitting on the lower dam. That's going to create some problems, I would imagine.

Just a simple thought that might be completely off base....

your idea is not quite right. the problem with MT is that blood from the leg is being routed through the vertebral plexus and other veins. But this may only contribute to the disease not cause it

.

1eye wrote:I need an email address to send my money to. I suggest we get John Robinson sorted before anything else. So is it you, Dr.S, or somebody you trust?

I have seen Holly referred to but I too am sure she doesn't want her email bombarded.

This is why need an email to send money to. CCSVI Alliance seems right and it is to be hoped trustworthy. All we need from them is what we have from Cece and an address for the fund to use instead of Holly's (unless she volunteers.) I propose someone (not me) go through and add up pledges and keep the Alliance honest. There will soon be real $ so it'll need a bank account.

i believe that if your desire is to support my research, then sending money to the alliance willl not get it there.
Of course you should consider whether supporting the alliance is also in your interest too

but no money to me please now....a nice vintage 1997 port would be ok

Dr Sclafani wrote

if i wanted to resubmit, i could but that it would not be a continuation of this proposal but another new application

So, let's all put our heads together, (with a little help from Italy, Albany, etc?), and come up with a proposal they WILL accept...

flipflopper wrote:You are right Cece. I would not be interested in answering questions either at the moment if I was in his shoes.

ditto

but i am trying to get back quickly to take my mind off my disappointments

Cece wrote:

BCSailor wrote:could someone please point me to

Dr. Sclafani, it is a kindness to us to allow us to 'be here for you'...if you're depressed, you can come on back, we're depressed too.

Could the solution be to work within the hospital and put a different proposal forward to the irb once again? Still hard to believe it went from the admin saying this did not even need irb oversight to irb rejection. Is the solution to put an irb proposal in at SUNY instead of King's County? I tried to breakdown what the irb rejection points were, to see what they would approve...would they approve if you were doing a randomized trial? But ethically you don't want to? And you'd need funding?

You'd said awhile back that you had an offer to join such a creature but an objection was that some of the doctors lacked experience...this was also your criticism of the BNAC study...and that after forty years of experience and twenty patients, that was when you could even begin to feel confident in treating ccsvi. What should a randomized trial require of its doctors' experience before they begin the trial?

if i were writing a multicenter trial, i would have a course, probably lasting five days, followed by a requirement of 30 procedures reviewed by the primary investigator before allowing a doctor to begin enrolling cases into a a randomized trial

[quote="1eye"]Sounds to me as if Dr. Zivadinov should have a cohort of people with CCSVI/'MS' who are NOT on the DMDs if he wants to prove anything about DMDs. If he doesn't, he certainly cannot be trying to show that they are irrelevant to CCSVI/CVI. It sounds like he is trying at least to make sure they stay relevant to 'MS'.

If he does not test CCSVI treatment against a cohort who are not on DMDs, then his results are irretrievably linked to DMDs. It doesn't prove CCSVI treatment is efficacious, it proves only that the combination of CCSVI treatment and DMDs is. That is a win for DMDs, isn't it? It makes no scientific sense. Just good business sense.
quote]


one of the criticisms of dr zamboni's paper was that patients were on DMDs and thus there was no way to know whether any positive effects were due to dmd or liberation

it seems like even a randomized study of lib/no lib while on DMDs will leave that question dangling and diminish any for forcefullness of any improvements for liberationl

drsclafani wrote:

Cece wrote:[quote="BCSailor"

What should a randomized trial require of its doctors' experience before they begin the trial?

if i were writing a multicenter trial, i would have a course, probably lasting five days, followed by a requirement of 30 procedures reviewed by the primary investigator before allowing a doctor to begin enrolling cases into a a randomized trial

i would think publishing results especially that are used as reference should require no less.

so good to have you back

drsclafani wrote: if i were writing a multicenter trial, i would have a course, probably lasting five days, followed by a requirement of 30 procedures reviewed by the primary investigator before allowing a doctor to begin enrolling cases into a a randomized trial

From what I have read about how much you learned in Italy and through your experience, it sounds as though this would be necessry to a useful and repeatable result. Kinda of shows what the small study in Germany (belgum?) was worth. One more reason why your IRB should not have relied on those results to deny your right to further study this issue!

That being said, such a study would be HUGELY expensive. How could we do something a little less extravagent that still had meaning?

Hi Dr., the thing that gets me most about the result from the IRB application is the way they don't make reference to the positive outcomes that have occurred world wide with the treatments done so far. The procedures that you alone have done doesn't seem to register on their radar.
I call that incompetence on their part. There are so many outcomes that scream out to do more trails, its incredible that the IRB have put up such a weak and generally speaking unrelated reasoning for turning down your application. It is unjust that they have the gall to turn down the application in the face of so much evidence that is contrary to their excuses, and your purpose in the application is to advance QOL benefits, not cure MS.
I look forward to hearing their formal reply so it can be challenged!!!!!!
Stay positive Dr. there will be a reason in this, we have yet to see it and move to magnificent outcomes.
Just had a broken tooth pulled and having TN as well I'm ready for a fight, and I also feel your pain, thanks Dr. once again.
Nigel

Ok
the IRB had many valid arguments and some arguments that revealed the inadequacy of my appliication. I did not make some points forcefully enough and thus they argued against my application because they thought the trial was for other purposes. For example i called my study a "safety and efficacy study". perhaps if i had stated it as a safety and observational study, they would have addressed it differently.

They made an excellent point about the patients being charged for the procedures, something most of you would have had no objection to. But if only those who can afford to pay were in the study, it would have meant that poor people would have been excluded and exclusion because of poverty would have gone against the priniciples of the Belmont Commission.

there are other points that i take exception to, but all in all, i do not think that they were intentionally biased as much as they were biased by the current publications which, other than zamboni, are lacking. It makes me quite unhappy that khan's opinion paper was accepted because of the weight of the journal it was published in.

Paolo has argued hard for publications and in a hurry. unfortunately without IRB approval, there isnt much to write

i am recovering