Comments on: Provenge: Setback In Congress, Progress In The Lab http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/ News, Comment and Conversation Sat, 30 Aug 2008 11:15:00 +0000 http://wordpress.org/?v=2.5.1 By: Kyoto27 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157611 Kyoto27 Thu, 14 Feb 2008 20:41:21 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157611 Re the setback in Congress, as noted by a wise observor, "it is ironic this word would come down on a day when Congress could find an entire half day to berate a baseball player for taking performance-enhancing drugs. If Roger Clemens is harmed from taking these drugs (assuming for a moment he did), he (a) made his own choices and now has to live with them, and (b) he has more than enough money to buy himself some pretty nice healthcare. Contrast that with prostate cancer patients. They don’t get a choice. The FDA took it away from them. It isn’t just one man, it’s thousands—perhaps reaching tens of thousands by the time Provenge is finally on the market. Apparently the Senate decides where it will focus based upon not whether the issues are worthy of Congressional attention, but the likelihood of whether they can get their mugs on cable news for a few hours. They ought to be ashamed. And we mean really ashamed.” Ed, I hope you will also ask our Congressional friends if they feel any shame --even a little? The Provenge Story has exposed a Heart of Darkness in this country that few other stories have exposed ---and the Fourth Estate has maintained --ex-the Ed Silvermans of this world, a significant silence that is as odd, as it is disturbing. Re the setback in Congress, as noted by a wise observor, “it is ironic this word would come down on a day when Congress could find an entire half day to berate a baseball player for taking performance-enhancing drugs. If Roger Clemens is harmed from taking these drugs (assuming for a moment he did), he (a) made his own choices and now has to live with them, and (b) he has more than enough money to buy himself some pretty nice healthcare.

Contrast that with prostate cancer patients. They don’t get a choice. The FDA took it away from them. It isn’t just one man, it’s thousands—perhaps reaching tens of thousands by the time Provenge is finally on the market.

Apparently the Senate decides where it will focus based upon not whether the issues are worthy of Congressional attention, but the likelihood of whether they can get their mugs on cable news for a few hours.

They ought to be ashamed. And we mean really ashamed.”

Ed, I hope you will also ask our Congressional friends if they feel any shame –even a little? The Provenge Story has exposed a Heart of Darkness in this country that few other stories have exposed —and the Fourth Estate has maintained –ex-the Ed Silvermans of this world, a significant silence that is as odd, as it is disturbing.

]]> By: Tony F http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157414 Tony F Thu, 14 Feb 2008 18:12:57 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157414 As of today, 23,240 men had DIED in the 9 MONTHS since the May 9, 2007 delay in approving or granting a conditional approval of Provenge... "Hello, FDA!" ... is anyone awake at the switch? Grant "Conditional Approval" pending the completion of the current confirmatory study... remember, you can yank your Conditional Approval at any time if any untoward event(s) come up not previously experienced. Save our men with TERMINAL prostate cancer!!! As of today, 23,240 men had DIED in the 9 MONTHS since the May 9, 2007 delay in approving or granting a conditional approval of Provenge…

“Hello, FDA!”

… is anyone awake at the switch?

Grant “Conditional Approval” pending the completion of the current confirmatory study… remember, you can yank your Conditional Approval at any time if any untoward event(s) come up not previously experienced.

Save our men with TERMINAL prostate cancer!!!

]]> By: Bob DeVivo http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157248 Bob DeVivo Thu, 14 Feb 2008 16:04:01 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157248 Any further delay in the approval of Provenge is absurd! We now have proof that this safe treatment extends life. To continue to brutalize PC patients with chemo makes no sense. Any further delay in the approval of Provenge is absurd! We now have proof that this safe treatment extends life. To continue to brutalize PC patients with chemo makes no sense.

]]> By: Dennis http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157221 Dennis Thu, 14 Feb 2008 15:45:22 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157221 FDA is making the biggest mistake in terms of Provenge. No side effects and prolongs patient lives. What more can you ask. Approve Provenge!!! FDA is making the biggest mistake in terms of Provenge. No side effects and prolongs patient lives. What more can you ask. Approve Provenge!!!

]]> By: Paul http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157187 Paul Thu, 14 Feb 2008 15:18:27 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157187 This study goes right to the heart of Dr. Scher's criticism and worries that the Provenge survival results were merely by "chance." This study goes right to the heart of Dr. Scher’s criticism and worries that the Provenge survival results were merely by “chance.”

]]> By: Phil Vardena (Pharm. D.) http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157114 Phil Vardena (Pharm. D.) Thu, 14 Feb 2008 14:45:34 +0000 http://www.pharmalot.com/2008/02/provenge-setback-in-congress-progress-in-the-lab/#comment-157114 IF DNDN is able to demonstrate the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T) with overall survival, this is a "lateral" proof: Provenge works! If Provenge were NOT to work, DNDN would NOT be able to demonstrate any correlation! Have a nice day everyone! Regards, IF DNDN is able to demonstrate the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T) with overall survival, this is a “lateral” proof: Provenge works!

If Provenge were NOT to work, DNDN would NOT be able to demonstrate any correlation!

Have a nice day everyone!

Regards,

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