Comments on: Sanofi-Aventis Gave Fake Ketek Data To The FDA http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/ News, Comment and Conversation Fri, 10 Feb 2012 18:13:33 +0000 http://wordpress.org/?v=2.6.2 By: Simon Passanante - Investigations into fake Ketek data continue http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-159526 Simon Passanante - Investigations into fake Ketek data continue Fri, 15 Feb 2008 17:09:54 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-159526 [...] Pharmalot notes, the FDA subsequently reviewed the 2002 safety study and discovered that several doctors had [...] [...] Pharmalot notes, the FDA subsequently reviewed the 2002 safety study and discovered that several doctors had [...]

]]> By: Donna http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-157492 Donna Thu, 14 Feb 2008 19:15:50 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-157492 Lisa, Welcome Back.........:) Lisa,

Welcome Back………:)

]]> By: Lisa Van S http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-157322 Lisa Van S Thu, 14 Feb 2008 16:44:05 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-157322 Ol Cranky A female PPD testified before O and I last year. Ol Cranky

A female PPD testified before O and I last year.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-154792 Justice in Michigan Wed, 13 Feb 2008 15:52:44 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-154792 As usual, agree with OC. Just want to highlight the FDA side of the story, which is critical. It appears at least two officers in FDA's Office of Criminal Investigations - created in '92 exactly for such circustances - were blocked by unnamed "senior FDA officials" from probing what Aventis knew about the marked-up study. I very much hope we learn the those names. Just for their own accountability. But, yes, they would also make good posterfolk for FDA preemption. As usual, agree with OC. Just want to highlight the FDA side of the story, which is critical. It appears at least two officers in FDA’s Office of Criminal Investigations - created in ‘92 exactly for such circustances - were blocked by unnamed “senior FDA officials” from probing what Aventis knew about the marked-up study.

I very much hope we learn the those names. Just for their own accountability. But, yes, they would also make good posterfolk for FDA preemption.

]]> By: ol cranky http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-154713 ol cranky Wed, 13 Feb 2008 14:59:37 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-154713 Submitted in good faith my arse! If there's any information in the monitoring reports that something was amiss (my guess there is if they have a former PPD CRA as a key witness) or other reports provided to Aventis by the CRO, there should be documentation of how the sponsor handled the issue. I've been underwhelmed by PPDs performance for many years and their study management work has been absolute crap even when a monitor indicated problems on a report but <b>it is the responsibility of the study sponsor to ensure the study is compliant with GCP/CFR/ICH</b>. Way too many people on the sponsor side think that the transfer of obligations to a CRO is a transfer of responsibility. If the CRO is preventing critical information from bubbling up to the sponsor (and, sometimes, they do), and the sponsor can prove they showed due diligence in the review of all information relayed by the CRO (including monitoring reports) then the sponsor can claim they made a good faith effort. Otherwise, people down to the study management level at a sponsor need to step up. The problem is that too many people in study management at the sponsor either just want to make things nicer, are inexperienced, or are absolutely afraid of the consequences they will face by relaying or acting on concerns they have. The reason for the latter is they've seen what happens to people who do relay or act those concerns and/or don't drop the issue when it has not been addressed adequately. Submitted in good faith my arse! If there’s any information in the monitoring reports that something was amiss (my guess there is if they have a former PPD CRA as a key witness) or other reports provided to Aventis by the CRO, there should be documentation of how the sponsor handled the issue.

I’ve been underwhelmed by PPDs performance for many years and their study management work has been absolute crap even when a monitor indicated problems on a report but it is the responsibility of the study sponsor to ensure the study is compliant with GCP/CFR/ICH. Way too many people on the sponsor side think that the transfer of obligations to a
CRO is a transfer of responsibility. If the CRO is preventing critical information from bubbling up to the sponsor (and, sometimes, they do), and the sponsor can prove they showed due diligence in the review of all information relayed by the CRO (including monitoring reports) then the sponsor can claim they made a good faith effort. Otherwise, people down to the study management level at a sponsor need to step up.

The problem is that too many people in study management at the sponsor either just want to make things nicer, are inexperienced, or are absolutely afraid of the consequences they will face by relaying or acting on concerns they have. The reason for the latter is they’ve seen what happens to people who do relay or act those concerns and/or don’t drop the issue when it has not been addressed adequately.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-153806 Justice in Michigan Wed, 13 Feb 2008 05:45:40 +0000 http://www.pharmalot.com/2008/02/sanofi-aventis-gave-fda-fake-ketek-data/#comment-153806 Every time you think it can't get scuzzier, it gets scuzzier. Every time you think it can’t get scuzzier, it gets scuzzier.

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