Novartis Admits Employees Participated In Independent Diovan Trials

  For the first time since opening an internal probe into clinical trials run in Japan for its Diovan blood pressure drug, Novartis has acknowledged signs of wrongdoing. In a statement on its web site, the drugmaker has admitted that two employees had varying levels of involvement in clinical trials that were initiated by investigators but were supposed to have been independent. “Our current understanding is that one of our former employees had varying levels of involvement in five investigator-initiated (Diovan) trials in Japan. In addition, a second former employee, who reported to the first former employee, had involvement which was limited to one of these trials,” the drugmaker writes. The admission comes after several papers were retracted and a prominent researcher, who was the principal investigator in most cases, resigned a position from a major university. The cascading chain of events has prompted increasingly unflattering coverage in the media in recent months, which ultimately prompted Novartis to investigate. We will repeat some background from an earlier story: The controversy erupted after several papers co-authored by Hiroaki Matsurbara, formerly of Kyoto Prefectural University, were retracted. These included the main publication of 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 used in its promotions. The study helped Diovan become a huge...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs