DrSclafani answers some questions

[Cece]

After all, we have been quite vocal about the fact that we are not treating MS.

Let's get that one out of the way first. You are so.

Somewhere in the last 77 pages, I remember Dr. Sclafani saying that we couldn't be coy about that we were treating MS because we quite obviously were, and that was why all studies had to have a neurologist partner and keep track of all MS symptoms...although he is allowed to change his mind whenever he wants, although preferably not about appointment dates ever again.

[Someday]

We could always ask the likes of Dr. Freedman and his collegues how they would design such a study.
There would be two outcomes, one that they would realise they have been using us MSers as a cash cow and not doing anything to understand our disease process.Second it would give them something productive to do instead of throwing rocks from a distance, they seem to also be able to extract research dollars for fly by night causes that they could put to good use for us!

NZer1, I wouldn't want trust that man to design any study around CCSVI! As it is, he's probably too busy trying to figure out how to rig his research to prove CCSVI to be a hoax - that's if he gets a research grant...which the MSSC should really deny him. But can we trust even them to do the right thing when they have shown great difficulty in doing so around CCSVI?

How very sad to realize that those who have held our illness in their care and those who have made their living off our illness for all these years - are the ones who have been keeping us from accessing a procedure that can help our illness.

[NormB]

Deleted as I realized it was a hichjack from this topic. sorry

[rettahb]

I've been contacted by the Buffalo study. Do you think it will it be beneficial for me to participate? One thing the contract says is "I understand that the only benefit I will receive from these Tests is the knowledge that I present (or do not present) CCSVI." and then,"Thus, 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." And I don't see any mention of "Venography" the "gold standard." Is it worth the $4500? I am on Dr. Scliafani's wating list and more then anything hope that his study will come through as well. Any input would be appreciated. thx.~r

[Cece]

Is it worth the $4500?

I don't think so...clinically if Simka, Kuwait, and Sclafani are to be believed, every MS patient is presenting with CCSVI...but as has been said here it is your call...

[bestadmom]

I was in the Buffalo study and my mrv images were completely different than my venogram and where stenosis was found. The azygos stenosis can only be inferred from the mrv.

[Trish317]

I've been contacted by the Buffalo study. Do you think it will it be beneficial for me to participate? One thing the contract says is "I understand that the only benefit I will receive from these Tests is the knowledge that I present (or do not present) CCSVI." and then,"Thus, 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." And I don't see any mention of "Venography" the "gold standard." Is it worth the $4500? I am on Dr. Scliafani's wating list and more then anything hope that his study will come through as well. Any input would be appreciated. thx.~r

Are you guaranteed treatment? If it was me, I wouldn't commit to a study where, if they find the stenosis, they may, or may not perform the procedure.

Maybe that's easy for me to say because I don't have MS. I'm here looking for help for my darling man who was diagnosed with primary progessive in 2007. I want him tested and treated NOW. I don't want him to be part of a study. He doesn't have time to wait. His condition is deteriorating rapidly. He's only 58-years-old.

I pray that this is all sorted out quickly. I pray for doctors, like Dr. Sclafani, who believe in the research that's already been done, and who want to proceed, with caution, to help patients who don't have the luxury of time.

I also pray for everyone who gets involved with clinical trials.

[1eye]

For the sake of people like you, I pray that he will win, and be treated soon. I had a friend many years ago with quickly progressing PPMS. He did not fare well. Someone at our protest called it government-sanctioned murder. I think they were right.

At that protest there were people a lot closer to death's door than I am (like real soon now). One man couldn't hear a word of it because CCSVI/'MS' had taken his hearing. Last time I had seen him I was using a walker. By now, we both are wheelchair-bound. I have seen a lot of 'MS' victims who needed neck support. I wonder why?

Damn all those murderers. They did not take an oath of arrogance, or an oath of sadism, or an oath of mouse and human sacrifice.

If I were not an atheist I would believe in some form of cosmic justice. But having been in this situation for 28 years, and having known a sixties-era 'MS' victim, my inclination is to get very scrappy. This is my life, I am fighting for, not some award or sponsorship for scientific achievement. Fight for his.

[1eye]

OMG posting twice in a row. This better be good.

Well I ran that delayed-treatment study design idea past my sister. She is somewhat of a stats fiend, and a Prof. of Psychology. She is also *on* an IRB. She said it was fine, the control group was no-treatment, and had no problem with subjects taking other MS drugs, or being swapped out into the treatment cohort from the non-treatment after a while, as long as all these changes are taken into account in the analysis. Of course less of this kind of number-crunching is necessary, the more careful you are about matching the subjects, so that the mix stays the same.

She seemed to agree that placebo is a red herring, especially if you already have a no-treatment group, and it is obvious to them, so there can be no bias.

It strikes me you could swap new people into both control and non-control and take a sort of running average on your results, with periodic reports at arbitrary intervals, but *that* idea I have not run past her. She's out right now.

[Cece]

She seemed to agree that placebo is a red herring, especially if you already have a no-treatment group, and it is obvious to them, so there can be no bias.

Yeah, I read up on sham surgeries some today (someone else posted this awhile back: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1888585/). It talks about a Parkinsonian's research trial where they drilled burr holes into the skull in the placebo group (to mimic the real treatment). Also states 35% as the estimated placebo effect for surgeries.

I personally would hate to be shammed or to be the shammer. I am still worried though that a randomized treatment trial, multicenter, with a placebo group, is the fastest way to widespread acceptance and therefore CCSVI treatment for all. And I am all for fast. Which is why I am reluctant to see sham surgery completely off the table.

[fogdweller]

In my unexpert opinon, there are two ways you could go. First, you need some objective and measurable thing to test ... e.g. fatigue level if you can figure out how to measure it, or walking ability, or the 6 pin hand coordination method.) I really don't want to test Relapse Rate. That is what all the drug trials did, and none of the drugs slowed progression, and since I have PPMS and have never had a Relapse in my life, this is not attractive to me.)

Then you take a bunch of test subjects and divide them randomly into test or control arms, treat the test arm and do not treat the control arm, and follow them long enough to comare the effect on whatever the measurable thing is.

Or you can treat everyone, and compare wilth historical data.

However, you are going to have some placebo effect on the treatment group, so they can be expected to do better than the untreated/historical group regardless, and I do not know what the placebo effect is. We might have a good number from all the drug tests, I don't know if that would translate over to a surgical procedure.

I don't think sham treatment would be ethical. Any risk, no matter how slight, would probably be considered too much if there was guaranteed no possible benefit (since they were not getting any treatment) and no fake procedure I can think of could fool me into thinking I had an angioplasty. At a minimum I would need to get an incision and be on anti-clotting drugs.

I can think of quite a few rather objective measures. MRI leasion load. When I first went on disability, the insurance company wanted to challange the fact that I had some cognative deficit, so they ran me through a full day of testing. The examiner said it measured many things and could not be faked, so there must be some good cognative standards we could use.

[mrhodes40]

cece wrote

I would propose a venogram for the control group and endovascular treatment for the treatment group.

Forgive me for butting in here but would this not result in some "treatment" in the control group?

IF a control had a membranous obstruction could it not "accidentally" be corrected by venogram alone and would this be enough to confound the results?

Are you seeing any of these membranous issues?
marie

[drsclafani]

unfortunately, there is no alternative to angioplasty and or angioplasty with stenting for CCSVI. Thus the control in this circumstance is NO TREATMENT. One cannot compare Liberation to drug therapy. Afterall, we have been quite vocal about the fact that we are not treating MS.


Can't you compare venoplasty PLUS drug treatment to just drug treatment? We could have both groups be on an accepted treatment, right? So the treated group would also be on one of the accepted therapies as well as undergo venoplasty.

we could study this. but First safety. no one has corroberated zamboni yet. We hear lots of anecdotes about recurrents after encouraging early outcomes. We need to clarify this before we can compare drug therapies.

why argue with it. by proving safety we clarify techniques safety and complications and patients get treated.

we are not ready for randomization.

lets get several 200-300 patient studies completed and we will have learned a lot. that will allow many patients to be treated while proving safety and efficacy.

then we can move toward stent versus no stent, venoplasty plus ms therapy vs venoplasty without drug therapy, etc. you get my idea. in the mean time we can treat a couple of thousand patients while we assure to the medical community that no one has been treated dangerously

[Cece]

1eye, with the delayed treatment idea, how do you control for the effect of season on MS relapses? For example, more relapses in summer? If you're taking control data in one season (summer, for example and comparing it to treated-group data in the next season as more and more people get treated and leave the control group, then doesn't the effect of the change of seasons mess with the data?

[1eye]

i don't know. make it a 2 year trial?