Seroquel Study 15
The Washington Post has an article providing more detail on Study 15, the Seroquel study that saw the same fate as many pharmaceutical company drug trials do that the companies don't like: they stick them in their glove compartment - even deeper than I would stick my parking tickets in college. The chickens came home to roost on my parking tickets about 9 months later. AstraZeneca has had this study stuffed away for 12 years.
For the folks that made a ton of money off Seroquel and have since left AstraZeneca, it all worked out just fine, didn't it? Is it that same warm fuzzy feeling I got when I learned that many of the guys that caused the AIG debacle got huge bonuses? No, the feeling is different for two reasons.
First, the guys at AIG did not act because they were indifferent to the potential harm to others. The AIG problem was that the decisions made were foolishly but without intent to deceive anyone. Second, we lost money in the AIG debacle. But it was just money. AstraZeneca's failure to disclose what they knew about Seroquel is a public health issue so there is a lot more at stake than just dollars and cents. As the Post article says, AstraZeneca officials "explicitly discussed misleading physicians. So if I'm picking out bad guys, the people who made the call to hide Seroquel Study 15 from doctors and patients rank well ahead of the AIG bonus guys, our current villains of the month.
Where was the FDA? They knew about this Seroquel study and told no one. This is Reason #6,345,392 why giving the FDA the only keys to the store of insuring drug safety would have been insane. The Supreme Court got Wyeth v. Levine right but now Congress need to go back and fix Medtronic v. Riegel so medical device manufacturers cannot hide behind the FDA's tattered skirt.
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