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Old 01-09-2009, 03:01 PM
LindaH LindaH is offline
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Join Date: Aug 2006
Posts: 230
15 yr Member
LindaH LindaH is offline
Member
 
Join Date: Aug 2006
Posts: 230
15 yr Member
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Paula raises many important issues. One of them is that it's time to demand more facts about the role of the placebo effect in clinical trials for PD. We've been told for years it is especially strong in PWP because the expectation of treatment can increase dopamine production -- even in our dopamine starved brains and can last for a long time. Many of the phase I trials that showed promising results and then "failed" in phase II have been explained away by the placebo effect. We need more precise definition of what the placebo effects is and how long can it last. Can expecting to get better reasonably bring about the magnitude of improvements that Peggy wrote about and actually last for 2 years? 4 years? 6 years?

Or did she get better because Spheramine worked for her? just as gDNF worked for many of those trial participants in both phase I and II. Both of these treatments have been shelved. It would be difficult to find funding to reinstate the trials after being labeled as "failures." The Parkinson's community cannot afford to let that happen to CERE120 too. Ceregene should do further analysis of the data and also seek, listen to and analyze the experiences of the trial participants like Carolyn to try to determine what really failed -- the treatment or the trial design.
Dr. Michael Hutchinson, one of the trial doctors who supported reinstatement of treatment for the GDNF trial participants, often said -- if you want to know if a treatment is working -- look at the patients. It's a shame he wasn't listened to then.

For listing of recent "Failed" and terminated PD trials see:
http://pdpipeline.org/terminated_thearpy_thru2004.htm
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