09 April 2007
The Brave New World
There's finally lots of talk about changes in the US drug safety system. The notion of active surveillance is rearing its head. Don't be surprised if it supplants the existing passive system all the medical officers at FDA are used to. The passive system produces data no one can interpret. The active system doesn't leave a lot of room for interpretation--the rates are elevated or they're not. That's not to say there isn't room for differences of opinion. There's lots of that kind of room, and as usual, it's the opinion of the FDA which will govern what makes it onto the label and what doesn't. However, the possibility exists for some rational labels, ones based on data the essense of which everyone can agree. Sounds like too much sanity for the pharmaceutical world? Perhaps. But it beats having to license technology from the likes of Lincoln Technology just because everyone else (read: FDA) has it already. Drug Safety: 1 Data Mining: 0. That's a score which looks pretty from where I sit.