Tuesday, March 20, 2007
Julie Hilden has posted a Writ column on the Zyprexa document leak. She comes out essentially where I do on the propriety of the conduct of the parties involved -- suggesting that they should have tried the legal methods first. I think without making that effort, any attempt to argue that the leakers were engaging in civil disobedience is silly.
She raises reasonable questions about the value of the protective order in mass torts in the first place, which, as I've noted before (and will address in an in-progress law review article) really depends on how much you consider the litigation system to be a mechanism for public information distribution as opposed to the resolution of private disputes. I think people can reasonably come down on either side on that issue; I would prefer that the information-forcing take place through regulatory means rather than litigation, which is an extremely imprecise tool for such things, but then again, there's plenty of reasons to doubt the FDA's ability to do information forcing well, at least today's FDA.
And she also assumes something that I still haven't seen to be clearly true -- that the documents in fact provide reliable information that was not available before. (I still have not reviewed the actual documents.) Most of the coverage suggests that the documents have all sorts of unpleasant behavior by employees (including most likely improper off-label marketing), but I haven't seen the sort of thing that actual physicians would want to rely upon in making prescribing decisions. Nor have I seen anything that indicates that the leaked documents contained, for instance, data that should have been given to the FDA but was not. I'm open to being wrong on both counts -- and will be reviewing the documents for the article -- but it's not self-evident at this point.
Regardless, it's worth a read.
(Apologies for incoherence - it's my daughter's spring break and her friend's here, so there's more noise than usual...)