Prosecutors arrested a former Novartis Pharma K.K. employee on suspicion of violating the Pharmaceutical Affairs Law on Wednesday, alleging he falsified clinical research data to be used for advertising the company's hypertension drug Diovan.
The Tokyo District Public Prosecutors Office's special investigation squad found grounds to suspect that Nobuo Shirahashi, 63, from Kobe, manipulated clinical research data at Kyoto Prefectural University of Medicine and had articles carry false information that Diovan is more effective than other drugs in preventing stroke.
According to the announcement by the special investigation squad, Shirahashi, who was the head of Novartis Pharma's section in charge of research at universities, was involved in data analysis of clinical research at the university between November 2010 and September 2011 and created false charts stating that Diovan reduced the incidence of stroke. He is alleged to have provided the falsified clinical research data to researchers at the university.
Shirahashi also allegedly had the researchers write an article based on the manipulated clinical research data and had them publish it at an overseas journal between January and October 2011, thereby spreading false information regarding Diovan's effectiveness.
During investigations by the Health, Labor and Welfare Ministry and Minato Ward, Tokyo-based Novartis Pharma, Shirahashi denied his involvement in the falsification of the clinical research data, saying, "I only analysed the data at the request of the researchers and never falsified it." He is believed to have denied the allegations made during questioning by the special investigation squad.
Shirahashi was also involved in clinical research at Jikei University, Shiga University of Medical Science, Chiba University and Nagoya University.