Novartis Responds to Whistleblower Allegations

The company issued a response to Ed Silverman at Pharmalot yesterday.  See Pharmalot and Question Authority for more (and "Comments" on Pharmalot for a somewhat heated exchange with John Mack yesterday). "On May 22, 2007, Novartis was served with a complaint filed in Morristown Superior Court by a former employee whose employment was terminated earlier this year. The complaint alleges improprieties with presentation and statistical analysis of clinical data related to Tasigna. We do not comment on matters of pending litigation, however, we want to emphasize that we are confident in the integrity of our data. Novartis has proactively shared all information with the FDA, the European Agency for the Evaluation of Medicinal Products and other health care authorities where Tasigna data is currently under review. The integrity of the safety and efficacy data for our medicines is paramount and Novartis has rigorous processes in place to ensure the accuracy of data generated in all of our clinical trials. We believe that Tasigna is an important and potentially life-saving new medicine for patients with chronic myeloid leukemia. Regarding questions as to whether the recent delay has anything to do with the lawsuit, our response is: No. The FDA extended the goal date by three months to provide time for a full review of amendments to the NDA proactively made by Novartis. These amendments provide new analyses of the longer-term follow-up data of CML patients with nearly a year of Tasigna treatment."