Comments on: Dendreon, Provenge And Conflicts Of Interest http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/ News, Comment and Conversation Fri, 10 Feb 2012 22:09:56 +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/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-152722 Advanced Prostate Cancer » Public Petition About Conflicts of Interest At The FDA Tue, 12 Feb 2008 17:31:57 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-152722 [...] Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member. http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/ There’s a lot more information for anybody who wants to pursue this further. If you can see [...] [...] Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member. http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/ There’s a lot more information for anybody who wants to pursue this further. If you can see [...]

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]]> By: Lili http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-46288 Lili Tue, 18 Dec 2007 21:29:18 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-46288 Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. I know how important it is to cure cancer---but do you know how many advisory groups are paid off??????? My husband died becuase of the lies about all pharmaceutical medications. Americans should abide by truth, honest and ethical values. Americans do not know how to live with honest morals. Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. I know how important it is to cure cancer—but do you know how many advisory groups are paid off???????
My husband died becuase of the lies about all pharmaceutical medications. Americans should abide by truth, honest and ethical values. Americans do not know how to live with honest morals.

]]> By: Anonymous http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15751 Anonymous Tue, 24 Jul 2007 12:42:51 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15751 The facts of this and similar cases will be exactly what a democratic administration (coming soon to the white house) will use to justify massive reforms in prescription drug development and promotion. The facts of this and similar cases will be exactly what a democratic administration (coming soon to the white house) will use to justify massive reforms in prescription drug development and promotion.

]]> By: Paul Haider http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15703 Paul Haider Tue, 24 Jul 2007 01:59:45 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15703 Dr. Scher has been granted a level of public trust and the stewardship of such position demands the highest levels of ethical and moral conduct. Voting on and participating in an FDA advisory meeting in order to determine which drugs receive FDA marketing approval in which you play a decisive role in and in which he has a financial interest in (or counter interest in), is contrary to unbiased public concern and counter to the fiduciary duty he accepted as a special government employee and FDA panel advisor. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests. There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government. Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. Those voting in the minority, very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from Provenge may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report). A request for a Conflict of Interest Waiver was requested by Dr. William Freas, Director of Scientific Advisors and Consultants for CBER, on February 5, 2007. The request was concurred by Vince Tolino, Director of Ethics and Integrity, on February 26, 2007. On March 8, 2007, Dr. Howard Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon's FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. I don't understand how the need for Dr. Howard Scher's individual services could outweigh the above demonstrated conflict of interest created by the financial interest attributable to Dr. Scher. I can't imagine an individual participant with more financial conflicts of interests sitting on the FDA advisory panel for Provenge. It is my fear that Dr. Scher's financial interests have come before the best interests of terminal AIPC patients. Dr. Scher has been granted a level of public trust and the stewardship of such position demands the highest levels of ethical and moral conduct. Voting on and participating in an FDA advisory meeting in order to determine which drugs receive FDA marketing approval in which you play a decisive role in and in which he has a financial interest in (or counter interest in), is contrary to unbiased public concern and counter to the fiduciary duty he accepted as a special government employee and FDA panel advisor. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests.

There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.

Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. Those voting in the minority, very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from Provenge may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report).

A request for a Conflict of Interest Waiver was requested by Dr. William Freas, Director of Scientific Advisors and Consultants for CBER, on February 5, 2007. The request was concurred by Vince Tolino, Director of Ethics and Integrity, on February 26, 2007. On March 8, 2007, Dr. Howard Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon’s FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. I don’t understand how the need for Dr. Howard Scher’s individual services could outweigh the above demonstrated conflict of interest created by the financial interest attributable to Dr. Scher. I can’t imagine an individual participant with more financial conflicts of interests sitting on the FDA advisory panel for Provenge. It is my fear that Dr. Scher’s financial interests have come before the best interests of terminal AIPC patients.

]]> By: Tom Smith http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15685 Tom Smith Mon, 23 Jul 2007 23:22:05 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15685 Hey SEC WAKE UP!!!!! Hey DOJ WAKE UP!!!! Men are dying from AIPC earlier than need be! Why are you not looking into this travesty??? SCHER/Novacia-Schering Plough deal! Scher and Proquest which holds large position in Novacia and -0- shares of DNDN!!! Over ~30K dead from PC since Black Wed. 5/9/07 Hey SEC WAKE UP!!!!! Hey DOJ WAKE UP!!!! Men are dying from AIPC earlier than need be! Why are you not looking into this travesty??? SCHER/Novacia-Schering Plough deal! Scher and Proquest which holds large position in Novacia and -0- shares of DNDN!!! Over ~30K dead from PC since Black Wed. 5/9/07

]]> By: Michael Higgins http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15675 Michael Higgins Mon, 23 Jul 2007 18:45:37 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15675 If COI's can influence the outcome on a drug like Provenge, then how many more drugs meet their demise due to competing mercenary interests. The president's appointments in his two terms of office continue to disapoint. At the FDA, first Lester Crawford was corrupt ... and now we have an ineffectual Von Eschenbach (that is the best we can say about him at this point). FEMA and the disaster in New Orleans has shock value and hence greater publicity. However, the cost in lives due to the FDA is much much greater. If COI’s can influence the outcome on a drug like Provenge, then how many more drugs meet their demise due to competing mercenary interests. The president’s appointments in his two terms of office continue to disapoint. At the FDA, first Lester Crawford was corrupt … and now we have an ineffectual Von Eschenbach (that is the best we can say about him at this point). FEMA and the disaster in New Orleans has shock value and hence greater publicity. However, the cost in lives due to the FDA is much much greater.

]]> By: Craig Payne http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15668 Craig Payne Mon, 23 Jul 2007 14:08:04 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15668 Mr. Silverman... Excellent coverage. Please consider a follow-up article further delving into the particulars of the Provenge "story" and the morally unjustified FDA decision to deny a clearly Safe and Superior treatment from those terminal patients with no acceptable alternative. Some recipients of Provenge are alive and well over 6 years later. For a certain percentage of those with end-stage prostate cancer, the FDA's decision will not only result in needlessly premature death, but needless death period! Something is terribly wrong at the highest echelons of the FDA. Thankyou, from every prostate cancer patient in America...but especially from those who have end-stage disease. Mr. Silverman…

Excellent coverage. Please consider a follow-up article further delving into the particulars of the Provenge “story” and the morally unjustified FDA decision to deny a clearly Safe and Superior treatment from those terminal patients with no acceptable alternative.

Some recipients of Provenge are alive and well over 6 years later. For a certain percentage of those with end-stage prostate cancer, the FDA’s decision will not only result in needlessly premature death, but needless death period!

Something is terribly wrong at the highest echelons of the FDA.

Thankyou, from every prostate cancer patient in America…but especially from those who have end-stage disease.

]]> By: John Greenwood http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15667 John Greenwood Mon, 23 Jul 2007 14:05:42 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15667 Thank you for taking time to investigate this most important issue. The story was well done. Thank you for taking time to investigate this most important issue. The story was well done.

]]> By: The Dude Abides http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15665 The Dude Abides Mon, 23 Jul 2007 10:09:34 +0000 http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/#comment-15665 Jason, you got lucky with your trade because you shorted Dendreon for the wrong reasons. Provenge would not compete with hormone therapy, as the treatment indication that Dendreon is going for is hormone-refractory prostate cancer. In other words, the stage of prostate cancer where it becomes terminal because hormone therapy no longer works. There are probably at least 100,000 people in the US currently who are at this stage of PCa, with another 50,000 whose PCa becomes hormone refractory each year. At $40K per treatment, that's a pretty big market. Jason, you got lucky with your trade because you shorted Dendreon for the wrong reasons. Provenge would not compete with hormone therapy, as the treatment indication that Dendreon is going for is hormone-refractory prostate cancer. In other words, the stage of prostate cancer where it becomes terminal because hormone therapy no longer works. There are probably at least 100,000 people in the US currently who are at this stage of PCa, with another 50,000 whose PCa becomes hormone refractory each year. At $40K per treatment, that’s a pretty big market.

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