Editor's Corner

Just when you think the FDA is getting the message about drug safety, it stumbles its way through another PR disaster. This time the drug in question is Ketek, and the disaster was last week's revelations that an FDA official had issued a searing memo questioning why children's lives were being put at risk so that Sanofi-Aventis could determine if the controversial antibiotic could work as a therapy for ear aches and tonsillitis.

In recent months we've been treated to a series of reports raising questions about the agency's approach to approving the drug, which has been linked to multiple cases of liver failure. A late-stage trial was riddled with reported fraud. And the real-world results the agency relied on from Europe seem a far-from-exact approach to establishing safety. The agency needs to have the ability to respond swiftly and effectively when these cases come up. Anything less will simply underscore a growing sense in the public that the bureaucracy at the FDA is not effective when it comes to protecting them from dangerous side effects. - John Carroll