Trial Data For Novartis Drug Was Manipulated: Japanese University

Several months after various scientific papers for the best-selling Diovan heart drug sold by Novartis were retracted and a prominent researcher, who was the principal investigator in most cases, resigned his position from Kyoto Prefectrual University of Medicine, school officials now acknowledge that the underlying data was manipulated. This amounts to an about face - in January, the university conducted a probe and maintained there were no "irregularities." The research was begun in 2004 by Hiroaki Matsubara, a former professor at Kyoto who co-authored papers between 2008 and 2012. These included the Kyoto Heart study, which was published in the European Medical Journal in 2009 and claimed Diovan reduced the risk of heart attacks and strokes, which Novartis (NVS) used in its promotions (more here). The study helped Diovan become a huge seller in Japan and sales reached $5.6 billion worldwide in 2011 before generics became available. In a press conference, Kyoto vp Shinji Fushiki said the investigation showed that “it is highly likely that this conclusion was erroneous,” although the university is not questioning the effectiveness of the drug to lower blood pressure. "Those involved in the research give accounts that do not match up with each other, so we don’t know who did manipulation where.” Nonetheless, his lawyer tells The Japan Times that he was not involved in the manipulation. In a statement sent to us, the drugmaker says that "we are unfamiliar with how the ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs