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.

http://tinyurl.com/otrpe

from
Vivismo!
http://www.clustermed.info/
www.clusty.com

this is a very organised search engine.

I do apologize for not answering these posts and will do so today or tomorrow. Seems it was my turn to have a metabolic /who knows what else meltdown and ended up in the hospital for a few days. I know what it wasn't anyway. But have some following up to do. Today i want to post about the experience there with meds, which is always a challenge but will get back to this one ASAP.

I think there were 15 patients in Bristol, all showing improvement. mOre to come.

thanks for the interest!
paula

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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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