DrSclafani answers some questions

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

Postby Cece » Mon May 17, 2010 4:13 pm

Back to study design and ethics...it's been said that Dr. Dake is doing a treatment trial with a control group: one group gets the venoplasty with an inflated balloon, the other group gets "venoplasty" without inflating the balloon. I am assuming but not certain that this is on the correct side of the line when it comes to experimenting on vulnerable populations?
"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 L » Mon May 17, 2010 4:19 pm

Thanks so much.
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Postby drsclafani » Mon May 17, 2010 4:20 pm

Johnson wrote:Hi Doc.,

You wrote of patients having a responsibility to participate in trials, and I fully agree. I put my name in for CCSVI trials (at least, tried to) at a number of places (UBC, McMaster, Saskatoon), but I also signed up with Dr. Simka, and will be having my time with his team in three weeks. I cannot wait for trials, and such. My sig. says "RRMS" sine 1993, but I just haven't had the heart to write "& SPMS since 2009".

Besides that blah, blah, do you feel that what Euromedic is doing has any data value over-all in relation to studies? Would it have any value, or might there be any place for a liberated person to participate in a study? Or would that just complicate the design and execution of any study?


if there were a sure trial, irb approved moving forward right now, i might suggest that you participate. but since there really isnt, i fully understand your choice and will root for you fully

I do not want to judge euromedic. they provide a service i cant right now
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Postby drsclafani » Mon May 17, 2010 4:21 pm

Cece wrote:Back to study design and ethics...it's been said that Dr. Dake is doing a treatment trial with a control group: one group gets the venoplasty with an inflated balloon, the other group gets "venoplasty" without inflating the balloon. I am assuming but not certain that this is on the correct side of the line when it comes to experimenting on vulnerable populations?


not particularly blinded if that is what he is doing
i have not heard that he is again treating patients.
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Postby Johnson » Mon May 17, 2010 4:26 pm

drsclafani wrote:
Johnson wrote:Hi Doc.,

You wrote of patients having a responsibility to participate in trials, and I fully agree. I put my name in for CCSVI trials (at least, tried to) at a number of places (UBC, McMaster, Saskatoon), but I also signed up with Dr. Simka, and will be having my time with his team in three weeks. I cannot wait for trials, and such. My sig. says "RRMS" sine 1993, but I just haven't had the heart to write "& SPMS since 2009".

Besides that blah, blah, do you feel that what Euromedic is doing has any data value over-all in relation to studies? Would it have any value, or might there be any place for a liberated person to participate in a study? Or would that just complicate the design and execution of any study?


if there were a sure trial, irb approved moving forward right now, i might suggest that you participate. but since there really isnt, i fully understand your choice and will root for you fully

I do not want to judge euromedic. they provide a service i cant right now

Thanks for rooting for me Doc. It means much.

I would never expect you to judge or comment on Euromedic/Dr. Simka, et al, but was wondering if there was any way to make my own data relevant, or if you might know if they are compiling data? Sorry for my vague question, I am pretty vague in my head these days.
My name is not really Johnson. MSed up since 1993
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Postby Cece » Mon May 17, 2010 4:35 pm

drsclafani wrote:not particularly blinded if that is what he is doing
i have not heard that he is again treating patients.

here it is: not started yet, just proposed...and using general anesthesia instead of limited, now that I reread it.
CureIous, posted in the design a trial thread wrote:
fogdweller wrote:
Billmeik wrote:I guess if the patients were under full sedation during the angio?


You would also have to make an incision. I think the risk, even slight, of placing a patient under anesthesia and making an incision when you know you are not going to treat would be unethical.

However, I am not sure. Could informed consent allow this? If so that could be an anwer!!


That's precisely how Stanford is proposing to structure their study. The patient won't know if the balloon was fully inflated or not. All patients post-study that were in the "non-inflated" category will then have the option of getting the real deal. Simple and eloquent.
Mark

Also I think he may be treating again but keeping it quiet...not sure on that one.
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Postby drsclafani » Mon May 17, 2010 6:54 pm

Johnson wrote:
drsclafani wrote:
Johnson wrote:Hi Doc.,

You wrote of patients having a responsibility to participate in trials, and I fully agree. I put my name in for CCSVI trials (at least, tried to) at a number of places (UBC, McMaster, Saskatoon), but I also signed up with Dr. Simka, and will be having my time with his team in three weeks. I cannot wait for trials, and such. My sig. says "RRMS" sine 1993, but I just haven't had the heart to write "& SPMS since 2009".

Besides that blah, blah, do you feel that what Euromedic is doing has any data value over-all in relation to studies? Would it have any value, or might there be any place for a liberated person to participate in a study? Or would that just complicate the design and execution of any study?


if there were a sure trial, irb approved moving forward right now, i might suggest that you participate. but since there really isnt, i fully understand your choice and will root for you fully

I do not want to judge euromedic. they provide a service i cant right now

Thanks for rooting for me Doc. It means much.

I would never expect you to judge or comment on Euromedic/Dr. Simka, et al, but was wondering if there was any way to make my own data relevant, or if you might know if they are compiling data? Sorry for my vague question, I am pretty vague in my head these days.


How Dr Simka can follow patients from around the worlds is difficult to imagine. Same goes for me doing cases from around north america

i think designing trials is going to have to take this into consideration. How can we remotely follow up without losing patients to followup

videoconferencing?
computer surveys?
collaboration with local neurologists?
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Postby L » Mon May 17, 2010 6:59 pm

drsclafani wrote:
Johnson wrote:
drsclafani wrote:
Johnson wrote:Hi Doc.,

You wrote of patients having a responsibility to participate in trials, and I fully agree. I put my name in for CCSVI trials (at least, tried to) at a number of places (UBC, McMaster, Saskatoon), but I also signed up with Dr. Simka, and will be having my time with his team in three weeks. I cannot wait for trials, and such. My sig. says "RRMS" sine 1993, but I just haven't had the heart to write "& SPMS since 2009".

Besides that blah, blah, do you feel that what Euromedic is doing has any data value over-all in relation to studies? Would it have any value, or might there be any place for a liberated person to participate in a study? Or would that just complicate the design and execution of any study?


if there were a sure trial, irb approved moving forward right now, i might suggest that you participate. but since there really isnt, i fully understand your choice and will root for you fully

I do not want to judge euromedic. they provide a service i cant right now

Thanks for rooting for me Doc. It means much.

I would never expect you to judge or comment on Euromedic/Dr. Simka, et al, but was wondering if there was any way to make my own data relevant, or if you might know if they are compiling data? Sorry for my vague question, I am pretty vague in my head these days.


How Dr Simka can follow patients from around the worlds is difficult to imagine. Same goes for me doing cases from around north america

i think designing trials is going to have to take this into consideration. How can we remotely follow up without losing patients to followup

videoconferencing?
computer surveys?
collaboration with local neurologists?


I have friends in New York, one used to live in Park Slope actually. I could tie in the odd visit with a follow up : )
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Postby Cece » Mon May 17, 2010 7:07 pm

I'm scared enough of restenosis that I like the idea of follow-up visits.

With collaborating with local neurologists, maybe that would work if the measurements were consistent across users (so that neurologist a and neurologist b would each give the same patient the same score).
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Postby drsclafani » Mon May 17, 2010 7:19 pm

Cece wrote:I'm scared enough of restenosis that I like the idea of follow-up visits.

With collaborating with local neurologists, maybe that would work if the measurements were consistent across users (so that neurologist a and neurologist b would each give the same patient the same score).


it would have to be very controlled. bias would also be a part of it
plus lots of data to enter might not make me popular with busy neurologists



lets see what squeakycat designs for remote followup surveys of patients
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Postby Donnchadh » Mon May 17, 2010 7:50 pm

I am starting to have ethical and financial concerns about some of the parameters of the proposed controlled studies.

First of all, as someone who actually underwent the balloon procedure, it would be very difficult to partially inflate a balloon just enough for a MSer to perceive it and at the same time not be enough to relieve the stenosis.
All this just to fool the patient they have been treated? So the study can be "blind"? This isn't a pharma pill being tested.

With over 400,000 MS sufferers in the USA alone, the idea that the considerable cost and effort (hospital, Doctor, staff, supplies) of a venogram would be absorbed just to prove a point is inhumane. It a waste of limited resources, and cheats a sufferer out of a chance to really be cured.

Right now, there is a lopsided ratio of Doctors actually being able to perform the liberation procedure and truly desperate MSer's who need this only opportunity to be saved from MS. We don't have 20 years to "prove" CCSVI.

A different standard of proof is needed; recording the objective observations (pre- and post- operation) of physical disabilities and patient narratives. Inductive reasoning is needed here. Each successive liberation procedure supplies the data needed to determine what's doing on.

Donnchadh
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Postby newlywed4ever » Mon May 17, 2010 7:50 pm

"i can see that. But lets not exclude PPMS because of the results in ten patients.

this is a tough thing. perhaps part way into the safety trial we can break out the ppms patients and treat on compassionate grounds"


I LIKE this idea ALOT!!

(I don't have a clue how to do the quote thing - sorry)
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Postby Donnchadh » Mon May 17, 2010 7:55 pm

newlywed4ever wrote:"i can see that. But lets not exclude PPMS because of the results in ten patients.

this is a tough thing. perhaps part way into the safety trial we can break out the ppms patients and treat on compassionate grounds"


I LIKE this idea ALOT!!

(I don't have a clue how to do the quote thing - sorry)


When you see some post you would like to quote, just click on the QUOTE icon located on the upper right hand side. Your cursor arrow will be transformed into a hand when you hover over the QUOTE icon.

It will automatically open up a new window where you can reply.

Hope this helps.

Donnchadh
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Postby Donnchadh » Mon May 17, 2010 8:02 pm

Donnchadh wrote:
newlywed4ever wrote:"i can see that. But lets not exclude PPMS because of the results in ten patients.

this is a tough thing. perhaps part way into the safety trial we can break out the ppms patients and treat on compassionate grounds"


I LIKE this idea ALOT!!

(I don't have a clue how to do the quote thing - sorry)


When you see some post you would like to quote, just click on the QUOTE icon located on the upper right hand side. Your cursor arrow will be transformed into a hand when you hover over the QUOTE icon. Click once on the left hand side of your mouse.

It will automatically open up a new window where you can reply.

Hope this helps.

Donnchadh
Kitty says, "Take that, you stenosis!"

Got MS?.....Get Liberated!
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Postby newlywed4ever » Mon May 17, 2010 8:06 pm

Donnchadh wrote:
newlywed4ever wrote:"i can see that. But lets not exclude PPMS because of the results in ten patients.

this is a tough thing. perhaps part way into the safety trial we can break out the ppms patients and treat on compassionate grounds"


I LIKE this idea ALOT!!

(I don't have a clue how to do the quote thing - sorry)


When you see some post you would like to quote, just click on the QUOTE icon located on the upper right hand side. Your cursor arrow will be transformed into a hand when you hover over the QUOTE icon.

It will automatically open up a new window where you can reply.

Hope this helps.

Donnchadh


Thanks, Donnchadh! Not sure I did this right, but I can keep practicing.

MORE Importantly! I agree with you about a study using fake venoplasty by not inflating; I cringed when I read that post.
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