Comments on: Provenge Activists Take To YouTube http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/ News, Comment and Conversation Mon, 22 Mar 2010 01:04:32 +0000 http://wordpress.org/?v=2.6.2 By: MyPharmalotID http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20165 MyPharmalotID Fri, 21 Sep 2007 22:26:39 +0000 http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20165 Just incredible...CDER (Dr. Pazdur), which fought to control the Advisory Committee on Provenge (and lost that battle), and CBER, which won the responsibility for overseeing the meeting, fought an internal political battle over which division would control approvals of drugs such as this. Yet, by a series of actions that included the use of two panel members (Drs. Scher and Hussain) with significant, unreported conflicts of interest; invited letters to the FDA that were intended to disparage Provenge (we still do not know who within the FDA asked Drs. Scher, Hussain, and Fleming to write their letters to the agency; nor do we know who assisted Dr. Scher, for one, with the preparation of his letter (and what these letter writers' COIs were)); the leaks of all three of these letters to the non-peer-reviewed The Cancer Letter (the FDA has yet to identify the mole within its organization...by the way, has that person also leaked information to hedge funds and others on Wall Street?); and the possible threat of some type of demonstration around May 8 that would have embarrassed the FDA while Congress was debating this year's PDUFA legislation, CDER succeeded in derailing Provenge approval. So, while the agency is forcing Dendreon to provide additional data on a drug that its own AC voted 17-0 as being safe and 13-4 as having demonstrated substantial evidence of efficacy, as many as 60,000 or more men will die of prostate cancer...many of whom could have benefitted from Provenge. And the FDA is supposed to be the agency that protects the nation's health? Give me a break! Just incredible…CDER (Dr. Pazdur), which fought to control the Advisory Committee on Provenge (and lost that battle), and CBER, which won the responsibility for overseeing the meeting, fought an internal political battle over which division would control approvals of drugs such as this. Yet, by a series of actions that included the use of two panel members (Drs. Scher and Hussain) with significant, unreported conflicts of interest; invited letters to the FDA that were intended to disparage Provenge (we still do not know who within the FDA asked Drs. Scher, Hussain, and Fleming to write their letters to the agency; nor do we know who assisted Dr. Scher, for one, with the preparation of his letter (and what these letter writers’ COIs were)); the leaks of all three of these letters to the non-peer-reviewed The Cancer Letter (the FDA has yet to identify the mole within its organization…by the way, has that person also leaked information to hedge funds and others on Wall Street?); and the possible threat of some type of demonstration around May 8 that would have embarrassed the FDA while Congress was debating this year’s PDUFA legislation, CDER succeeded in derailing Provenge approval.

So, while the agency is forcing Dendreon to provide additional data on a drug that its own AC voted 17-0 as being safe and 13-4 as having demonstrated substantial evidence of efficacy, as many as 60,000 or more men will die of prostate cancer…many of whom could have benefitted from Provenge.

And the FDA is supposed to be the agency that protects the nation’s health? Give me a break!

]]> By: Ray http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20152 Ray Fri, 21 Sep 2007 20:38:59 +0000 http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20152 As always Ed, thanks for keeping the Provenge Saga out there! As always Ed, thanks for keeping the Provenge Saga out there!

]]> By: phil_vardena (Pharm. D.) http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20151 phil_vardena (Pharm. D.) Fri, 21 Sep 2007 20:17:09 +0000 http://www.pharmalot.com/2007/09/provenge-activists-take-to-youtube/#comment-20151 I just wished to thank you....Your effort in shedding light over the FDA shortcomings is amazing. Please keep it up and runnning! Regards, phil I just wished to thank you….Your effort in shedding light over the FDA shortcomings is amazing.
Please keep it up and runnning!
Regards,
phil

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