Comments on: Avandia: Lessons Learned By FDA Panel Head http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/ News, Comment and Conversation Sat, 20 Mar 2010 03:22:59 +0000 http://wordpress.org/?v=2.6.2 By: Friday Blog Roundup « The Pump Handle http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16679 Friday Blog Roundup « The Pump Handle Fri, 10 Aug 2007 18:35:11 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16679 [...] Ed Silverman at Pharmalot summarizes the lessons that the chair of the Avandia advisory committee meeting has learned. [...] [...] Ed Silverman at Pharmalot summarizes the lessons that the chair of the Avandia advisory committee meeting has learned. [...]

]]> By: Simon Passanante - FDA panel head shares lessons gleaned from Avandia hearing http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16666 Simon Passanante - FDA panel head shares lessons gleaned from Avandia hearing Fri, 10 Aug 2007 16:33:22 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16666 [...] process. Those lessons, which appear in the New England Journal of Medicine, were summarized by Pharmalot’s Ed Silverman: Lesson One - Make sure you understand the disease, the studies used to evaluate the treatments are [...] [...] process. Those lessons, which appear in the New England Journal of Medicine, were summarized by Pharmalot’s Ed Silverman: Lesson One - Make sure you understand the disease, the studies used to evaluate the treatments are [...]

]]> By: Chris http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16568 Chris Thu, 09 Aug 2007 03:52:43 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16568 Hi Ed, I know - that's why I sent the second message to clarify (I thought) the intent and object of my first comment. I was addressing my comments to Dr Rosen's position which you quoted in your post. I thought the post was worthy of comment. Chris Hi Ed,
I know - that’s why I sent the second message to clarify (I thought) the intent and object of my first comment. I was addressing my comments to Dr Rosen’s position which you quoted in your post. I thought the post was worthy of comment.

Chris

]]> By: Ed Silverman http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16550 Ed Silverman Wed, 08 Aug 2007 22:38:21 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16550 Hi Chris, Professor? Hardly. But yes, I was merely summarizing someone else's editorial. I don't often run editorials written by others, by the way, but I chose this because of the topic, the news value and the author. And I decided not to offer my own comments, simply because I'm curious to see reactions to his thoughts, instead of my own. He chaired the panel; I didn't. All best ed Hi Chris,

Professor? Hardly. But yes, I was merely summarizing someone else’s editorial. I don’t often run editorials written by others, by the way, but I chose this because of the topic, the news value and the author. And I decided not to offer my own comments, simply because I’m curious to see reactions to his thoughts, instead of my own. He chaired the panel; I didn’t.

All best
ed

]]> By: Chris http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16549 Chris Wed, 08 Aug 2007 22:32:29 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16549 The quarterbacking being from Dr Rosen of course, not Professor Pharmalot... The quarterbacking being from Dr Rosen of course, not Professor Pharmalot…

]]> By: Chris http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16547 Chris Wed, 08 Aug 2007 22:30:12 +0000 http://www.pharmalot.com/2007/08/avandia-lessons-learned-by-the-fda-panel-chair/#comment-16547 Ed, I don't have a subscription so can go only by your piece but as I remember when Avandia was approved, I think in 1998 or 99, there wasn't as much knowledge of Type 2 diabetes as now. There was one drug approved- Rezulin - but study designs were still evolving as researchers began to understand the condition better. I suppose now different designs would be used but then it was still an imperfect science. It seems a little harsh that Dr Rosen describes the Avandia story as reported: the FDA could have asked all the questions they wanted and taken as long as they needed, especially with the concerns that arose around Rezulin.My recollection is that SB used the same NDA (application process) used by all other companies and were just as much in the hands of FDA as the rest. It's not always accurate to portray FDA as under-resourced and at the mercy of pharma companies - there are plenty of companies that suffered tremendously because FDA held up their applications during the same period. Interesting piece all the same, with or without Monday morning quarter-backing. Ed,
I don’t have a subscription so can go only by your piece but as I remember when Avandia was approved, I think in 1998 or 99, there wasn’t as much knowledge of Type 2 diabetes as now. There was one drug approved- Rezulin - but study designs were still evolving as researchers began to understand the condition better. I suppose now different designs would be used but then it was still an imperfect science. It seems a little harsh that Dr Rosen describes the Avandia story as reported: the FDA could have asked all the questions they wanted and taken as long as they needed, especially with the concerns that arose around Rezulin.My recollection is that SB used the same NDA (application process) used by all other companies and were just as much in the hands of FDA as the rest. It’s not always accurate to portray FDA as under-resourced and at the mercy of pharma companies - there are plenty of companies that suffered tremendously because FDA held up their applications during the same period. Interesting piece all the same, with or without Monday morning quarter-backing.

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