Comments on: Bayer And Trasylol: ‘It Was A Set-Up’ http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/ News, Comment and Conversation Mon, 08 Sep 2008 03:25:43 +0000 http://wordpress.org/?v=2.5.1 By: Simon Passanante - Researcher gets heat after reporting truth on Trasylol http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16544 Simon Passanante - Researcher gets heat after reporting truth on Trasylol Wed, 08 Aug 2007 21:35:42 +0000 http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16544 [...] Pharmalot reports that not long after the advisory was posted, Alexandar Walker of Harvard’s School of Public Health came forward and claimed that Bayer hired him six months before to review a database they compiled of 67,000 bypass patients who received Trasylol.  He found the same results that Dr. Mangano found in his study.  Bayer neglected to mention their study to the FDA. [...] [...] Pharmalot reports that not long after the advisory was posted, Alexandar Walker of Harvard’s School of Public Health came forward and claimed that Bayer hired him six months before to review a database they compiled of 67,000 bypass patients who received Trasylol.  He found the same results that Dr. Mangano found in his study.  Bayer neglected to mention their study to the FDA. [...]

]]> By: X http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16365 X Sun, 05 Aug 2007 19:12:20 +0000 http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16365 http://www.sptimes.com/2007/08/05/news_pf/Worldandnation/Drug_warnings_fall_fl.shtml http://www.sptimes.com/2007/08/05/news_pf/Worldandnation/Drug_warnings_fall_fl.shtml

]]> By: Hank http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16363 Hank Sun, 05 Aug 2007 18:39:35 +0000 http://www.pharmalot.com/2007/08/bayer-and-trasylol-it-was-a-set-up/#comment-16363 Knowingly hiding data from the FDA is a criminal felony and should be prosecuted as such. Unfortunately (in my view), the record shows that it virtually never is, even in the most blatant cases. The recent Oxycontin story is yet another example of what we can expect from some (most?) Justice Departments vis a vis industry. FDA also has an "integrity policy" that sometimes bans individuals or CROs from submitting data for a period of time. And I _believe_ Warner-Lambert was once put on a kind of extended probation after several cover-ups of manufacturing defects (best known involving Dilantin). That's about as severe as it gets. Knowingly hiding data from the FDA is a criminal felony and should be prosecuted as such. Unfortunately (in my view), the record shows that it virtually never is, even in the most blatant cases. The recent Oxycontin story is yet another example of what we can expect from some (most?) Justice Departments vis a vis industry.

FDA also has an “integrity policy” that sometimes bans individuals or CROs from submitting data for a period of time. And I _believe_ Warner-Lambert was once put on a kind of extended probation after several cover-ups of manufacturing defects (best known involving Dilantin). That’s about as severe as it gets.

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