How To Motivate Off-Label Promotion? Gives Reps Trays Of $50 Bills

Three years ago, a former Cephalon manager filed a whisteblower lawsuit over alleged illegal marketing of two drugs – the Treanda treatment for chronic lymphocytic leukemia  and the Fentora painkiller – prompting  the US Attorney in New York to open an investigation into the drugmaker, which is now owned by Teva Pharmaceutical. Now, though, further details are emerging about the extent to which Cephalon executives allegedly conspired to use questionable studies and off-label marketing tactics to boost sales of Treanda, in particular.  The allegations, which were made by a former Cephalon employee listed as 'John Doe,’ cite familiar-sounding shenanigans, but an executive strategy session sheds new light on the effort. Here is the background: Cephalon sought to promote Treanda for an unapproved use - in this case, front-line treatment for indolent, or slowly progressing, non-Hodgkin's lymphoma, according to the lawsuit. The medication was only approved for CLL and second or third-line iNHL. But in 2008, Cephalon executives were nervous that marketing exclusivity tied to orphan drug status would expire in 2015. One off-label effort involved touting a study by a Cephalon consultant, Mathias Rummel, who is the head of hematology at the University Hospital in Giessen, Germany, to physicians and analysts as evidence that Treanda could be widely accepted as a front-line iNHL treatment. However, there were problems with the study - it was not an FDA registration trial, which ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs