American Hold ‘Em
August 13th, 2009 | Posted by Kerry DonahueHold the deck.
On the other hand:
That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.
There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.
If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).
That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.
The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……
I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.
The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.
What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?
The deck was stacked. The dice were loaded. Everybody knows!
With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others?
I get the point that if the data was from a larger trial or the endpoints were hit (as they are now), yadda, yadda, than there would have been no room for the political maneuvering and other skullduggery. But that also makes the point, that without the negative changes to the process itself and without a process free from corruption, the evaluation of Provenge, can not itself be evaluated.
It is maintained the proper position is that if proper due process had been provided to Provenge it would have been approved. Once the failed process become known to the commissioner (as it did) it was up to the commissioner to correct it, but the commissioner did not get those vibes from the Prostate Cancer foundation (PCF). If the PCF was supporting Provenge at that time Provenge would have gotten at least a reshuffled deck, but we know now how that game was being dealt from the bottom of the deck.
While you can argue the reasonableness of the decision you can’t with the hindsight of IMPACT argue that the right decision was made, only that the wrong decision could have been made for the right reasons.
The CareToLive Citizen Petition asked for reconsideration with proper due process being afforded. FDA said “no” and they said “no” after they already had the interim data in hand and after they had reason to believe Dendreon hit the endpoints at final. This was the ultimate smack in the face for the Patients. This was also an extremely stupid move for the image of the FDA.
For those that think the FDA decision to deny in May 2007 was reasonable do you also think that their October 20008 denial was reasonable too??
How about their May 2009 denial (Citizen Petition denied)?
All CareToLive has ever sought was a fair and proper due process be afforded to the Provenge BLA and despite their efforts the FDA has yet to give fair and proper due process to Dendreon free of the corruptive influence of others with contrary interests.
There was too much money bet against Dendreon for it to be approved as it should have been in May 2007. Take Scher, Hussain, Pazdur and von Eschenbach out of the equation and Provenge would have been approved in May 2007.
That it wasn’t approved 2 ½ years ago is a human tragedy.
Remember Richard Pazdur in his May 2008 interview said that the reason it was not approved was because there was an ongoing trial (IMPACT) and if on completion it showed that Provenge did not work, the FDA would be made to look silly. Who thinks the risk of the FDA looking stupid is a good reason to deny Provenge to late stage cancer patients. If you think that is a good enough reason than you are right to believe it was a reasonable decision.
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Tags: Alison Martin, Andrew Von Eschenbach, BLA, Care To Live, CareToLive, CBER, CDER, Deep Capture, DeepCapture.com, Dendreon, FDA, Howard Scher, Kerry Donahue, maha hussain, Mark Mitchell, Michael Milken, PCF, Prostate Cancer, Prostate Cancer Foundation, provenge, Richard Pazdur