Science Friction

Last week's conclave of FDA advisory panels to discuss Ketek telithromycin is likely to be remembered as an inflection point in the debate over drug safety, exposing conflicts about how risk should be assessed and communicated, and providing a harbinger of the decision-making complexity that is certain to flow from regulatory reforms Congress is likely to enact next year.

The two days of discussion on Ketek provided a forum to air independent expert views about scientific, medical and ethical controversies that have been the subject of intense debate within and among FDA, the medical community, Congress, and the drug industry. ...