- Jul 1, 2014
Investigators looking into allegations of data manipulation by a former Novartis employee over papers on hypertension drug Diovan have found evidence that some data were manually inserted, NHK reported Tuesday.
The manual addition of some numerical data to the research papers indicate the 63-year-old ex-employee, Nobuo Shirahashi, arrested last month for alleged data tampering in the Diovan papers authored by a doctor at Kyoto Prefectural University of Medicine, might have falsified the data to make the drug appear more attractive than what real clinical data suggested.
In the research data seized at Shirahashi’s home, investigators found traces of somebody putting some data manually, when the norm is to put them automatically using statistics software, according to NHK.
Investigators are expected to indict Shirahashi Tuesday on alleged violations of the Pharmaceutical Affairs Law.
Shirahashi’s lawyers have denied wrongdoing by the employee, saying that, while he did add data to the papers, he did not falsify them, NHK said.
- Ex-Novartis Pharma K.K. Employee Arrested Over Drug Data (biospace.com)
- Former Novartis employee arrested over tampered drug data (ajw.asahi.com)
- Third Japanese University Shakes Finger at Novartis AG’s Diovan Studies (biospace.com)
- Japan prosecutors arrest ex-Novartis employee over data (channelnewsasia.com)