I liked what Biogen CEO Jim Mullen had to say when I saw him a couple months back.
He wants us to regain perspective on risk. The “safe and effective” mantra doesn’t make sense. Actually drugs are inherently unsafe, even OTC products. Instead we should look at the risk of unforeseen outcomes (i.e., adverse events) versus the risk of forgoing therapy.
On Sunday, he was interviewed in the Boston Globe’s On the Hot Seat column. I enjoyed this exchange, which was consistent with what I heard him say before:
December 11, 2006
Q Do you support the creation of a new group at the FDA to specifically look at post-marketing studies and analyze the incidence of adverse events?
A We don’t need a new group. They definitely need some more systems, and we need some harmonization with the Japanese and European regulators. It’s a very poor idea to propose a safety agency. It loses context. Safety can only be reviewed in the context of the medical condition you’re treating.