Tuesday, February 15, 2005

Changes in the Drug Safety Landscape

The New York Times today has two articles about changes at the FDA.  One mentions that the Agency has a new commissioner.  The second informs us that the FDA is creating anew board to monitor drug safety.  Also the New England Journal of Medicine published today was a set of early-release articles about the safety concerns that have arisen regarding Cox-2 inhibitors (Vioxx, Bextra, Celebrex).  The articles are on the NEJM website now, and will be printed in the 3/17/2005 issue. 

The Cox-2 story has attracted a lot of attention, and I am not sure I have anything to add to the volumes written already.  However, the Corpus Callosum is all about connections, and the two topics -- the changes at the FDA, and the Cox-2 story -- are indeed connected.  The top job at the FDA has been vacant for a long time, possibly because not a lot of people actually want the job right now.  And the creation of a new drug safety board is a direct response to the public concern about the Cox-2 inhibitors, among other recent and brewing matters.  However, the Bush Administration does not have good record when it comes to addressing matters of public safety.  Do the current efforts exceed our expectations, or do they fall short?

I know, that's not exactly a cliffhanger, for those familiar with my general opinions.  Even so, if interested, read the supporting evidence and the conclusion at The Rest of the Story.