Very comprehensive feature article in the August issue of Nature Biotechnology of the issue of off-label prescribing and off-label promotion. Jerry Avorn and Steve Nissen perform according to their usual scripts -- but once you get beyond the preening and posturing there's a lot of good information, facts and figures and perspectives from both the US and the EU.
Two issues that are touched on but not really pursued (not surprisingly considering the readership of the journal) are that of (1) the fundamental freedom of free speech and (2) the fact that if drug companies overplay their hands when it comes to off-label promotion there is no shortage of liability lawyers ready to go after them. (Although this article does contain a list of selected healthcare-related fraud cases involving off-label use.)
The complete Nature Biotechnology article can be found here.
Important and timely reading for all of you drugwonks out there as well as for folks like Mr. Waxman.
Two issues that are touched on but not really pursued (not surprisingly considering the readership of the journal) are that of (1) the fundamental freedom of free speech and (2) the fact that if drug companies overplay their hands when it comes to off-label promotion there is no shortage of liability lawyers ready to go after them. (Although this article does contain a list of selected healthcare-related fraud cases involving off-label use.)
The complete Nature Biotechnology article can be found here.
Important and timely reading for all of you drugwonks out there as well as for folks like Mr. Waxman.