Novartis under investigation for manipulating data in Japanese clinical trials

Swiss drug major Novartis (NOVN: VX) has said it regrets the inconvenience caused by its investigator-initiated trails in Japan after it was accused of submitting research papers with manipulated data for the blood pressure drug valsartan.

Newspaper The Mainichi reported that Japan’s Ministry of Health, Labor and Welfare is examining the effects that the manipulated data has caused on the public finances for medical insurance. It added that the Ministry’s health panel has also concluded that Novartis Pharma KK, the Japanese subsidiary of Novartis AG that distributes valsartan in Japan, should be held responsible regardless of whether it was involved in the tampering of data, and should be made to pay compensation.

A statement from Novartis said that David Epstein, division head of Novartis Pharmaceuticals, met with Norihisa Tamura, the Minister of Health, Labor and Welfare of Japan, on Tuesday following an invitation by the Minister in Tokyo.