Behold the wit and insight of Slate Star Codex:
lots of studies have shown Seroquel is effective for depression, lots of guidelines suggest Seroquel as a backup depression treatment, and doctors have been (correctly) prescribing it for such for a long time. Doctors also very commonly prescribe it for sleep and dementia; I think is less evidence-based, but it’d be a lie to say it wasn’t common as dirt or that it didn’t work for these things (safety is the problem).
So what was happening was that AstraZeneca was promoting Seroquel for the things it was actually being used for, as opposed to the thing the FDA said it was supposed to be used for. Doctors are allowed to use drugs for whatever they want based on their own analysis and their best judgment, but pharmaceutical companies are only allowed to promote it for the FDA-approved indication, which at that point was psychosis and bipolar depression.
The reason the FDA hadn’t approved Seroquel for depression wasn’t because it was a bad idea. It was because in order to get the FDA to approve anything for anything, you must perform the appropriate ritual of putting a zillion dollars into a big pile, then burning it as a sacrifice to the Bureaucracy Gods. AstraZeneca had performed the ritual for bipolar and psychosis, but was still in the process of performing it a third time for depression. Once they finished, the FDA approved it as an adjunctive medication for depression, but also fined them hundreds of millions of dollars because they had advertised it for depression – merely based on evidence and clinical practice – before the FDA had told them they were allowed to.
“Doctors are allowed to use drugs for whatever they want based on their own analysis and their best judgment, but pharmaceutical companies are only allowed to promote it for the FDA- approved indication…”
“To get the FDA to approve anything for anything, you must perform the appropriate ritual of putting a zillion dollars into a big pile, then burning it as a sacrifice to the Bureaucracy Gods”
A ritual which, I might add, takes over a decade to perform.
