Last Updated Nov 14, 2010 12:41 PM EST
The "Accutane problem" illustrates how badly managers respond to crises if they unfold slowly over time (like GlaxoSmithKline's wacky Paxil factory) rather than rearing their heads suddenly (like the data corruption scandal at Sequenom). The Paxil scandal ended in a $750 million settlement with the feds 10 years later; Sequenom swept out its C-suite last year and the company is basically back on course.
Unfortunately for people who suffer from severe, chronic acne, Accutane is a slow-moving crisis, which is why the FDA and the companies that still make it (Roche gave up) aren't under any particular pressure to consider whether the drug should be banned. The bad news about Accutane (or generic isotretinoin, as it is now marketed) has come out in dribs and drabs, over years. Each event is serious but not in the grand scheme of things particularly shocking. It's only when you clump them all together that you think, "Wait, aren't suicide and bowel disease rather serious risks for a drug that isn't treating a life-threatening condition? Shouldn't someone look into this?"
The latest drop of news is the BMJ's study of 5,756 patients which shows a heightened risk of suicide among those on the drug. Exactly 128 of them attempted suicide. Six months or more after treatment the risk of a first attempt at suicide is almost double (standardised incidence ratio of 1.93) that of the background rate. The caveat: Chronic acne sufferers already had a higher risk of suicide going in to the study.
Whether that's enough to prompt the FDA to look again at a drug that's poisonous enough to kill a fetus, we don't know. It may just be another easily ignored drop in the bucket.
- Bad Data: How Quants Convinced Roche to Compromise Patient Safety
- Can Roche Handle the Truth? "A Few Good Men" Case Could Expose Acne Drug Dangers
- Acne Drug Accutane's Side Effect Is Death. So Why Is It Still on the Market?
- Roche's Accutane: Suit Over Death of Congressman's Son Nixed