A Japanese University Denies Diovan Research Was Manipulated

For the first time since the scandal erupted in Japan over Diovan research, one of the universities that ran clinical trials to gauge the virtues of the Novartis heart drug is denying any data was manipulated. Late last week, Nagoya University released an interim report refuting the charge, according to The Yomiuri Shimbun. The drugmaker and several Japanese universities have been rocked by a series of retracted papers concerning the medication, a huge seller in Japan that reached $5.6 billion in worldwide sales in 2011 before generics became available. That was also when questions were first raised about Diovan research conducted there, as well as ties between researchers and Novartis. The scandal unraveled earlier this year after Hiroaki Matsubara, a prominent researcher and principal investigator in several trials, resigned from Kyoto Prefectrual and the school later acknowledged underlying data was manipulated. The Jikei University School of Medicine came to the same conclusion (see this) and Shiga University of Medical Science acknowledged questionable data. The episode prompted Japan to consider new legislation to regulate clinical studies. And penalties for failing to preserve and submit records to the government would include fines, having clinical trials halted and drug approvals may be rescinded (back story). Novartis could also face suspended operations, which would be a blow since Japan accounted for nearly 10 percent of its overall revenue. As for Nagoya, the uni...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs