<From their philosophical point of view and from their future interests on future organization and approvals, they do risk diminishing their clout. But apparently they view the damage of losing on this one as so large, they're willing to accept that risk.>
or they see CBER taking control of Provenge approval, most notably by interrupting the panel voting in mid-stream (when it was going the wrong way) to clarify the efficacy question, as already having diminished their clout, so that publicly challenging CBER and appealing to the FDA after the fact isn't much of a risk in their eyes either. in fact, they will look like heroes in the unlikely event that Provenge/9902B fail - they will then gain back all that lost clout & then some and it will be CBER that has the credibility issue...
that said, i think Pazdur knows that Provenge is safe and has a very good chance of significantly extending lives of AIPC patients, particularly in combo with taxotere, but it seems clear that he was the driving force behind Scher & Hussain's letter writing campaign and very likely the leaker of the letters to TCL, which tells me he values his position and the CDER/ODAC approval process he largely controls more than patients.
I further suspect Pazdur already has plans to make it up to Scher & Hussain for the credibility hit they took on his behalf if & when Provenge is approved and commercially successful, so the risk they may have perceived for going out on a limb & covering for their boss is miniminal also.
what needs to happen here is a thorough investigation of who leaked the contents of not one but two supposedly confidential letters to the FDA that potentially if not in reality influenced the public trading of a stock. Those found to have violated FDA &/or perhaps SEC policy and rules should be severely & publicly sanctioned (i.e. dismissal).
AI
