Comments on: FDA To Mine Big Databases For Safety Problems http://www.pharmalot.com/2008/05/fda-to-mine-big-databases-for-safety-problems/ News, Comment and Conversation Fri, 10 Feb 2012 22:41:58 +0000 http://wordpress.org/?v=2.6.2 By: CMC guy http://www.pharmalot.com/2008/05/fda-to-mine-big-databases-for-safety-problems/#comment-357263 CMC guy Fri, 23 May 2008 22:48:23 +0000 http://www.pharmalot.com/?p=13775#comment-357263 "Another problem is that sometimes patients suffer problems after receiving drugs because they are sick, not because the drug is to blame, the Times writes." This statement may be news to some of the posters here who blame pharma for development of "bad" drugs. Even with well designed and conducted clinical studies it is hard to sort out causal relationships with complex or individual variations. At the same time does not mean companies should weaken vigilance or be dismissive in determining correlations. “Another problem is that sometimes patients suffer problems after receiving drugs because they are sick, not because the drug is to blame, the Times writes.”

This statement may be news to some of the posters here who blame pharma for development of “bad” drugs. Even with well designed and conducted clinical studies it is hard to sort out causal relationships with complex or individual variations. At the same time does not mean companies should weaken vigilance or be dismissive in determining correlations.

]]> By: Laurie http://www.pharmalot.com/2008/05/fda-to-mine-big-databases-for-safety-problems/#comment-357255 Laurie Fri, 23 May 2008 16:32:04 +0000 http://www.pharmalot.com/?p=13775#comment-357255 Using Medicare data, which is better than nothing, would only track those on Medicare....so what about the "younger" population? Using Medicare data, which is better than nothing, would only track those on Medicare….so what about the “younger” population?

]]> By: david http://www.pharmalot.com/2008/05/fda-to-mine-big-databases-for-safety-problems/#comment-357254 david Fri, 23 May 2008 16:26:33 +0000 http://www.pharmalot.com/?p=13775#comment-357254 FDA insists the spontaneous system accounts for 1% of all episodes of serious adverse events. That estimate is from a study more than two decades old. The problems with the spontaneous system (GIGO) are so well known to pharmacoepidemiologists and other drug safety specialists that few are willing to invest the energy needed to examine methods to use the system. There has been a a collaboration between industry and FDA to bring data mining to the spontaneous system, but it is hardly an unqualified success, and not everyone agrees with its use. Hence this new approach (which has been used by pharmacoepidemiologists for more than two decades). Hopefully, we'll finally start to get good data upon which to make policy. FDA insists the spontaneous system accounts for 1% of all episodes of serious adverse events. That estimate is from a study more than two decades old. The problems with the spontaneous system (GIGO) are so well known to pharmacoepidemiologists and other drug safety specialists that few are willing to invest the energy needed to examine methods to use the system. There has been a a collaboration between industry and FDA to bring data mining to the spontaneous system, but it is hardly an unqualified success, and not everyone agrees with its use. Hence this new approach (which has been used by pharmacoepidemiologists for more than two decades). Hopefully, we’ll finally start to get good data upon which to make policy.

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