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In Remembrance
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Join Date: Aug 2006
Location: Florida
Posts: 3,904
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In Remembrance
Join Date: Aug 2006
Location: Florida
Posts: 3,904
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cere 120 phase III?
Received this through Pipeline email and copying here with Perry Cohen's permission. The placebo effect is a troublesome factor to deal with and appears to be interfering with treatments that can work.
They haven't given up on cere 120. Phase III still on the table.
Perry's email exchanges:
I talked with Ray Bartus today who indicated that Ceregene thinks they now know how to design a successful clinical trial for PD and they want to get back to the FDA with a new design to start another trial in mid 2009. He mentioned they were doing something with the dosing and were going to educate patients to have no expectations and use strict rules to minimize the placebo effects, and he wanted our help with this. I told him that he may be undermining some of the benefits of the treatment by reducing positive interaction effects between the placebo benefits and the treatment (the logic of this interction effect is that by restoring some of the function of dopamine neurons the body can more consistently sustain the 'placebo' benefits from hope and positive expectations which would allow greater activity and further reinforce benefits). He pointed out that FDA requires placbo controls which I know is true in practice, even though the FDA Law does not require a placebo. He wants me to reassure people in the community that Ceregene is not giving up. I indicated that we would do whatever we could do to make the study a success. I also said that he can request that FDA patient consultant participate in the meeting.
I also talked with Dave Banks about the FDA requirement for placebo, which he confirmed is ranked well above the 10 commandments and the Koran in absolute authority at FDA. He said he would work with us to present a case for alternative designs. He is also now aware of the Ceregene meeting and will work on getting patient consultants assigned.
end of email.
So we have a trial being designed that must follow certain regs and in doing so the numbers won't show success? Throwing lower expectations into the mix.....will that work? I'm sure glad they are still trying!
What to do with this natural response of self healing? The link between emotion and dopamine production is truly complex.
paula
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paula
"Time is not neutral for those who have pd or for those who will get it."
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