Comments on: FDA Commish On Provenge: What Letters? http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/ News, Comment and Conversation Fri, 10 Feb 2012 19:23:38 +0000 http://wordpress.org/?v=2.6.2 By: Advanced Prostate Cancer » Public Petition About Conflicts of Interest At The FDA http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-152715 Advanced Prostate Cancer » Public Petition About Conflicts of Interest At The FDA Tue, 12 Feb 2008 17:27:29 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-152715 [...] Act had already produced documents that show relevant letters had been addressed to him. http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/ Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member. [...] [...] Act had already produced documents that show relevant letters had been addressed to him. http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/ Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member. [...]

]]> By: Hard Ball http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-131834 Hard Ball Sat, 02 Feb 2008 20:55:01 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-131834 Easy answer. This little band of self-helping mauraders merely pass back sealed envelopes with PRIVATE/PERSONAL "To Andy from Dick" scratched on the face of it. Nor is it not like they can't all have lunch together and plot through the night via cellphones. Nobody upstairs cares how these guys go on in conspiring to enrich themselves. They only ever got that high as payback to start with. The people who put them therein the first place are too deep into their own spider web of con games, only on an even larger scale. This is what our once inspiring democracy has been reduced to. All to the advantage of those who willing take what they can. We are a sad America. Easy answer.

This little band of self-helping mauraders merely pass back sealed envelopes with PRIVATE/PERSONAL “To Andy from Dick” scratched on the face of it.

Nor is it not like they can’t all have lunch together and plot through the night via cellphones.

Nobody upstairs cares how these guys go on in conspiring to enrich themselves.

They only ever got that high as payback to start with.

The people who put them therein the first place are too deep into their own spider web of con games, only on an even larger scale.

This is what our once inspiring democracy has been reduced to. All to the advantage of those who willing take what they can. We are a sad America.

]]> By: Kerry Donahue http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-126528 Kerry Donahue Fri, 01 Feb 2008 01:34:38 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-126528 There are certain documents that are exempted under the Freedom of Information Act (FOIA). The FDA could have responded that the information requested was exempt under one of the many listed categories of exemption. However to do that they would have to claim that exemption and reference it explicitly. That is not what they did so there is no reason to think that they are asserting a privilege that would excuse their performance under FOIA. There are certain documents that are exempted under the Freedom of Information Act (FOIA). The FDA could have responded that the information requested was exempt under one of the many listed categories of exemption. However to do that they would have to claim that exemption and reference it explicitly. That is not what they did so there is no reason to think that they are asserting a privilege that would excuse their performance under FOIA.

]]> By: Bob Freeman http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-126216 Bob Freeman Thu, 31 Jan 2008 22:02:56 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-126216 A political comment, if I may: as long as we continue to elect politicians who distrust, if not hate, government, we are going to continue to have incompetent agency heads. In particular, those who hold the government in low regard are put in charge of running its agencies. If I'm not mistaken the FDA has been "directed" by acting or interim heads during much of this administration. You want public health advocates in charge of HHS divisions, not corporate types or persons beholden to them. In addition to being independent from corporate influences, you also want independence from patient advocacy groups that pursue their own agendas. A political comment, if I may: as long as we continue to elect politicians who distrust, if not hate, government, we are going to continue to have incompetent agency heads. In particular, those who hold the government in low regard are put in charge of running its agencies. If I’m not mistaken the FDA has been “directed” by acting or interim heads during much of this administration.

You want public health advocates in charge of HHS divisions, not corporate types or persons beholden to them.

In addition to being independent from corporate influences, you also want independence from patient advocacy groups that pursue their own agendas.

]]> By: Chris http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125876 Chris Thu, 31 Jan 2008 19:20:43 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125876 If he did not keep the mail or documents received or forwarded them elsewhere, then he would not have any responsive records. That is not necessarily the same as saying that he never saw these documents. If he did not keep the mail or documents received or forwarded them elsewhere, then he would not have any responsive records. That is not necessarily the same as saying that he never saw these documents.

]]> By: Ed Silverman http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125571 Ed Silverman Thu, 31 Jan 2008 17:18:55 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125571 Hi Qetzal, I'm not an attorney, but I believe the phrase refers to conducting a complete search for any and all records described in a request. Those would be the responsive records. If there's a lawyer in the house who can clarify this, please join in. Hope this helps, ed Hi Qetzal,

I’m not an attorney, but I believe the phrase refers to conducting a complete search for any and all records described in a request. Those would be the responsive records. If there’s a lawyer in the house who can clarify this, please join in.

Hope this helps,
ed

]]> By: qetzal http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125482 qetzal Thu, 31 Jan 2008 16:34:31 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125482 Ed, you wrote: <blockquote>FDA commish Andy von Eschenbach’s office has no trace that he received any records concerning the controversial medication, despite a ‘diligent search.’</blockquote> But that's not quite what the letter said. It said: <blockquote>After a diligent search, this office has not located any <i>responsive</i> records.</blockquote> (emphasis added) "Responsive records" sounds like code for "records that we have to give you." Maybe those letters (assuming von Eschenbach's office has them) aren't subject to FOI? Anybody know enough about FOI to comment? Ed, you wrote:

FDA commish Andy von Eschenbach’s office has no trace that he received any records concerning the controversial medication, despite a ‘diligent search.’

But that’s not quite what the letter said. It said:

After a diligent search, this office has not located any responsive records.

(emphasis added)

“Responsive records” sounds like code for “records that we have to give you.” Maybe those letters (assuming von Eschenbach’s office has them) aren’t subject to FOI? Anybody know enough about FOI to comment?

]]> By: Kerry Donahue http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125170 Kerry Donahue Thu, 31 Jan 2008 14:16:26 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-125170 Excellent comments. Soon the world will know what the FDA did to Provenge. CaretoLive will continue to fight for the right of dying cancer patients to have access to Provenge. Congress needs to find a way to make sure life saving treatments for the terminally ill get to them sooner. We hope to avenge the memory of John Fish who fought with CareToLive to undo the injustice at the FDA. CareToLive has still received no response to the FOIA directed at Richard Pazdur. He refuses to respond even though his answer was due in September/October. While 80 men a day die without hope the FDA has asked for more time (beyond the 6 months recently expired)to respond to the CareToLive Citizens Petition to undo this injustice. Many do not have time so PLEASE fix this and get Provenge to the patients now. Hey hey FDA, how about a little overtime for those that have so little time left. Excellent comments.

Soon the world will know what the FDA did to Provenge.

CaretoLive will continue to fight for the right of dying cancer patients to have access to Provenge.

Congress needs to find a way to make sure life saving treatments for the terminally ill get to them sooner.

We hope to avenge the memory of John Fish who fought with CareToLive to undo the injustice at the FDA.

CareToLive has still received no response to the FOIA directed at Richard Pazdur. He refuses to respond even though his answer was due in September/October.

While 80 men a day die without hope the FDA has asked for more time (beyond the 6 months recently expired)to respond to the CareToLive Citizens Petition to undo this injustice. Many do not have time so PLEASE fix this and get Provenge to the patients now.

Hey hey FDA, how about a little overtime for those that have so little time left.

]]> By: Tom Smith http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-123757 Tom Smith Thu, 31 Jan 2008 00:17:37 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-123757 Avon's nose is getting longer and longer(Pinocchio)! How do these people at the FDA sleep at night! Avon’s nose is getting longer and longer(Pinocchio)! How do these people at the FDA sleep at night!

]]> By: Tom Smith http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-123749 Tom Smith Thu, 31 Jan 2008 00:00:28 +0000 http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/#comment-123749 Avon,Scher, Hussain,Pazdur are all responsible for ~20,000 plus men that have died since May 9th 2007. IMHO this was a big conspiracy! Power, MONEY Big Chemo, and Hedge Funds that increased their short positions by over 10 million shares after the AC committee voted 13-4 and 17-0. The only way anyone of right mind would increase their short position by this magnitude would be if they knew a CR letter was going to be issued! That's why the SEC and DOJ need to look into who this short/s were and find out who at the FDA relayed this info to them! As it has been said many times follow the money!!! Lets hope that Dingell and the House Energy and Commerce Committee pursue hearings and get to the bottom of this great injustice to PC patients and family members! Where the hell is the DOJ,SEC??? A sleep at the wheel or turning a blind eye??? Avon,Scher, Hussain,Pazdur are all responsible for ~20,000 plus men that have died since May 9th 2007. IMHO this was a big conspiracy! Power, MONEY Big Chemo, and Hedge Funds that increased their short positions by over 10 million shares after the AC committee voted 13-4 and 17-0. The only way anyone of right mind would increase their short position by this magnitude would be if they knew a CR letter was going to be issued! That’s why the SEC and DOJ need to look into who this short/s were and find out who at the FDA relayed this info to them! As it has been said many times follow the money!!! Lets hope that Dingell and the House Energy and Commerce Committee pursue hearings and get to the bottom of this great injustice to PC patients and family members! Where the hell is the DOJ,SEC??? A sleep at the wheel or turning a blind eye???

]]>