After Novartis Scandal, Japan Considers Penalties For False Data

In the wake of the scandal over research for the Diovan blood pressure drug, the Japanese government is considering 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and submit records to the government would include fines, having clinical trials halted and drug approvals may be rescinded, The Yomiruri Shimbun reports.
The Health, Labor and Welfare Ministry plans to establish a committee to investigate details of cases in which data was falsified and debate on the proposed Pharmaceutical Affairs Law is expected to begin later this week. Although there are ethical guidelines, Japan does not currently have a law regulating clinical studies, so researchers are not subject to punishment, the paper notes.
The impetus for the proposal was the controversy over Diovan research, which greatly embarrassed Novartis and a leading Japanese university. Hiroaki Matsubara, a prominent researcher who was the principal investigator in several trials, resigned his position from Kyoto Prefectrual University of Medicine several months ago and school officials more recently acknowledged that underlying data was manipulated.
Matsubara co-authored papers between 2008 and 2012, including 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. Novartis (NVS) used this in its promotions (more here), helping Diovan become a huge seller in Japan and sales reached $5.6 billion wor...

Source: Pharmalot - August 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs