Quote:
Originally Posted by paula_w
Imark, does budipine have a market name like nortriptyline is Pamelor, etc.
do you know if it is approved in the US?
Laura,
"Thou shalt not sell a treatment in the USA previously approved in Europe without conducting double blinded trials with a placebo !"
Does that include sham surgery?
"it does"
The FDA has spoken. Reasoning is not required. Best example i can think of is duodopa . I"m sure there are enough recipients in Euope 10 [well we keep saying 10 but it's probably been 15 now] years into the use of this treatment in Europe . Perry Cohen consulted for them at one point and helped to arrange some of the communications.
The fierce urgency of now quote that Bryn used is also the first thing you read in our book. That quote is from Martin Luther King and it fits like a glove. Let's start stressing that we want patients at any pd policy planning, clinical trial planning , or process reviews tables as well as on IRBS. We want it now! Our goal should be to cancel the world pd cogress in Montreal in 3 years due to lack of Parkinson;s disease.
and imark thanks for the tip about budipine. is it available in Canada?
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Paula,
I've been watching this over a year now as it is the most viable alternative to DBS once oral meds have run their due course. I asked my doctor about the hold up and why it was necessary to run essentially two trials...hmmm...last I checked Euros do not have a different set up for their gut than we do here. Then I hear there are problems with the pump here; my question is why does the pump have to vary from the Euro design? The real answer: someone wants to tweak an "American version" by changing the tubing or something in order to corner a patent or otherwise profit. My doctor pointed out numerous other treatments including many off-label available around the globe but not here without FDA interference. Don't these redundant tests waste millions in tax dollars and cause unneeded delay in getting treatment to us border on the unethical? I understand needing controls and standards, but when a therapy is now undergoing longitudinal studies in other countries, isn't that showing how ludicrously pointless the trials here are?
Is it any wonder why MS patients have formed their own clinical trials? I wish we could get more info on how they started doing this. If we could get funding and the right people involved it, we could actually make a difference in some lives.
I have watched a few videos on using the pump and it really just seems to take a few minutes. It beats waking up with a severely dystonic foot and having to hobble around for 30 minutes for meds to kick in. The pump is designed to give you a bit of a dopamine surge first thing so you kick on that much quicker. I also read that some patients actually require less of the medicine than they do with oral thanks to the steady plasma levels provided by the the pump. Just the relief of not having to time your life around meds wearing off is worth it to me. We could always start a line of fashionable pump bags...
Anyway, here is a good video from the
EPDA web site (scroll all the way down).
As for the knowing that you are placebo, it is masked somehow. I thought I read that you still take your oral meds. So people with treatment benefit would lower their oral meds and people with placebo wouldn't know any better. They would still have a pump but it would be filled with something inert. That is the way I understand it but could be wrong.
Why don't you copy/paste your questions and start a new thread under clinical trials? Just a thought...
Laura