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Originally Posted by boann
i am sure there are others here who know much more about this, but the two criticisms i have heard of the Gill/Bristol study are:
1) the dosages of levodopa (and other drugs, possibly) were tweaked during the study, and
2) it was open label, and i guess there is another one
3) there were only five participants, i think
but upon thinking about #1 above, i have read plenty of studies that allow levodopa to be added to, say, the dopamine agonist arm of a study that is meant to be comparing the time-to-dyskinesias with the dopamine agonist vs with levodopa - that is standard procedure, as far as i can tell (ridiculous though it seems) - and if that is so, then how can the bristol study be faulted for tweaking levodopa? seems to me they can both be faulted or neither, but one and not the other doesn't seem to make sense to me.
the second two make sense to me - it has always seems like a big waste of money to me to do an open label clinical trial that is meant to evaluate anything but safety... well, i suppose if one observed zero effect, that would tell you something but what are the chances of that, given the power of the placebo effect?
any input would be appreciated, boann
p.s. rosebud, i have the study in pdf, if you would like to read it - i would be happy to send it. let me know.
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There were 5 Bristol and 10 Kentucky patients in Phase I - all improved - 100%. There may have been some dosage tweakage due to dyskinesias, but this is a sign that the med could be working.
The Phase iV study was so quick we blinked and missed it. We called Amgen and the person we spoke to knew nothing about it.
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Quote:
Originally Posted by rosebud
I'm kinda sitting in my tree up here in Canada and trying to follow this story as best I can. But there are a few things I'm not clear on. Did allthe patients in the GDNF trials (with the exception of the Amgen one that's inconclusive) benefit from GDNF? In other words, did it work for everyone who recieved it in the Bristol study, or just a percentage, and if so, does anyone know what the precentage is? I'm asking about the Bristol study because it seems to be the longest, the best run and was not double blind.
I am unclear on which Dr.'s think GDNF has value as a viable treatment and which Dr's are holding the Amgen line. I was under the impression some of the Dr's at Amgen were not happy with the way the corporation stepped in and stopped things. That there are Dr's among the Amgen research team who feel the trial was "Questionable" (picking my words carefully). Is that not correct?
How many Dr's/researchers (people who would be publishing or overseeing these projects) are estimated to be out there...10, 50, 100 whatever?
The courts have to uphold the letter of the law and Amgen clearly has that covered. Isn't the best chance for GDNF research to be kept alive from where it left off is if these Dr.s speak up (regardless of the ramifications to their careers) and support those they took an oath to serve? I don't envy any Dr. in that position if that's the case. Do I have it right?
Lastly, it's sure a sorry statement that it takes a death threat to get one human being to help another human being. Are we surprised?
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First answer is above ...all Bristol improved, all Phase I improved. This is not uncommon when it is not blinded, but these patients continued to receive it during Phase II as well; and some would have us believe that the placebo effect can not only last for more than two years but can continue after the drug is withdrawn.......
The doctors are split in half on this. Four think it didn't work. Four not only laid their reputations on the line, but also didn't remove the equipment. The debate can be followed in medical journals and hard feelings abound unfortunately.
We have never been out to hurt anyone, this is all hurting US. But I must point out, not in the form of an accusation, but just as a simple 1+1=2. Once the equipment was removed from the patients, and this was done as per Amgen's directions, the doctors who removed it followed the Amgen line. ...claiming it didn't work. If the drug would have been granted as compassionate use, which the FDA APPROVED, their patients would have not been able to get it. The doctors could possibly have been sued, unfortunately, even though it wasn't their fault. Amgen seems to be scott free of any personal relationship to the patients in this trial.
All this talk about promising developments can be shattered by a bio tech's ineptness. Ceregene could be sold by phase III because it gets so expensive for smaller companies.....then you have to hope it still has a champion.
Paula