Comments on: FDA To Hold February Meeting On Lilly’s Prasugrel http://www.pharmalot.com/2008/10/fda-to-hold-february-meeting-on-lillys-prasugrel/ News, Comment and Conversation Fri, 10 Feb 2012 21:33:08 +0000 http://wordpress.org/?v=2.6.2 By: Doc http://www.pharmalot.com/2008/10/fda-to-hold-february-meeting-on-lillys-prasugrel/#comment-378422 Doc Sat, 18 Oct 2008 02:08:45 +0000 http://www.pharmalot.com/?p=16647#comment-378422 CV MD, Good points. Another thing the FDA must really think through on this agent is the following. No matter how restrictive they may make the label, even including a black box - if necessary, they know many physicians will use the product out of label in patient groups in which it should be restricted. This expanded use will undoubtedly lead to unecessary serious bleeding and possible death. Does the FDA really need or want that outcome? CV MD,
Good points. Another thing the FDA must really think through on this agent is the following.

No matter how restrictive they may make the label, even including a black box - if necessary, they know many physicians will use the product out of label in patient groups in which it should be restricted.

This expanded use will undoubtedly lead to unecessary serious bleeding and possible death. Does the FDA really need or want that outcome?

]]> By: CV MD http://www.pharmalot.com/2008/10/fda-to-hold-february-meeting-on-lillys-prasugrel/#comment-378371 CV MD Fri, 17 Oct 2008 16:33:46 +0000 http://www.pharmalot.com/?p=16647#comment-378371 Given what we currently know about this new agent, it is understandable if there is a lot of debate going on within the FDA. While there were some clinical benefits shown in the pivotal trial, there were clearly some serious questions as to the ultimate effect of the drug. It appears that the Lilly and Daiichi-Sankyo researchers are now faced with some significant holes in their database. They need to answer the question as to why certain subsets of the population had more bleeding than others. If these patients need less drug, there is no data on the lower dose. If the lower dose is used, will there still be clinical event benefits? We all know that Big Pharma companies have a strong tendency to over-market drugs once they get them approved. Lilly has some major egg on its face regarding Zyprexa and still faces huge fines. In addition, it seems that their new CEO was one of the people responsible for Zyprexa marketing. With their track history, can they be trusted to limit themselves to restricted marketing? There is doubt as Big Pharma continues to go for profits over patients. The public will likely be the ones that suffer and the companies and their executives negotiate the payment of huge fines without admitting wrongdoing and laugh all the way to the bank! Given what we currently know about this new agent, it is understandable if there is a lot of debate going on within the FDA. While there were some clinical benefits shown in the pivotal trial, there were clearly some serious questions as to the ultimate effect of the drug. It appears that the Lilly and Daiichi-Sankyo researchers are now faced with some significant holes in their database. They need to answer the question as to why certain subsets of the population had more bleeding than others. If these patients need less drug, there is no data on the lower dose. If the lower dose is used, will there still be clinical event benefits? We all know that Big Pharma companies have a strong tendency to over-market drugs once they get them approved. Lilly has some major egg on its face regarding Zyprexa and still faces huge fines. In addition, it seems that their new CEO was one of the people responsible for Zyprexa marketing. With their track history, can they be trusted to limit themselves to restricted marketing? There is doubt as Big Pharma continues to go for profits over patients. The public will likely be the ones that suffer and the companies and their executives negotiate the payment of huge fines without admitting wrongdoing and laugh all the way to the bank!

]]> By: Doug Bremner MD http://www.pharmalot.com/2008/10/fda-to-hold-february-meeting-on-lillys-prasugrel/#comment-378327 Doug Bremner MD Fri, 17 Oct 2008 04:02:00 +0000 http://www.pharmalot.com/?p=16647#comment-378327 Yeah! Are they gonna give it to the welfare cheats as well? Yeah! Are they gonna give it to the welfare cheats as well?

]]> By: Doc http://www.pharmalot.com/2008/10/fda-to-hold-february-meeting-on-lillys-prasugrel/#comment-378305 Doc Fri, 17 Oct 2008 00:44:01 +0000 http://www.pharmalot.com/?p=16647#comment-378305 About itme the FDA called an advisory meeting on this one. About itme the FDA called an advisory meeting on this one.

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