Novartis May Face Criminal Charges In Japan Over Diovan Research

The Japanese Health Ministry may file a criminal complaint against Novartis over the Diovan research scandal, according to reports. Last fall, you may recall, the ministry convened a panel that found the drugmaker should be held responsible for the imbroglio.  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and submit records to the government would include fines, having clinical trials halted and drug approvals may be rescinded (back story).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. Last May, Novartis admitted that two employees had varying levels of involvement in ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs