Novartis has also undergone scrutiny for its sales representatives allegedly working directly with researchers and study data for its leukemia drugs, Gleevec (imatinib) and Tasigna (nilotinib). Hospital officials at the University of Tokyo Hospital revealed that doctors let Novartis employees collect patient data and allowed Novartis access to records for all of the 255 trial participants. According to the hospital director, Takashi Kadowaki, "Novartis employees were 'virtually managing the study'." The hospital is investigating four other leukemia research programs after receiving information of Novartis employee involvement.
A panel of third party investigators, all of whom were attorneys, found for than 20 instances of improper behavior among Novartis' local sales representatives. Novartis also breached clinical trial protocol when its employees had inappropriate involvement in clinical trial data collection processes. Upon revealing these misconduct allegations, Novartis employees attempted to cover-up their actions by shredding documents and deleting files. A member of the panel of investigators stated that:
"We can't rule our that these activities have been carried out at an organizational
level [...] these things have become an everyday occurrence for them, without any
notion that this was inappropriate."
Most recently, Japanese police arrested ex-Novartis employee, Nobuo Shiraishi, for allegedly discrediting studies by manipulating data, which was intended for use in advertising Novartis' blood pressure medication, Diovan (valsartan). The Japanese government has filed a criminal complaint against Novartis regarding accusations that its Japanese manufacturer exaggerated its advertising of Diovan.
Prosecutors alleged that Shiraishi violated Japan's pharmaceutical laws, which prohibit providing researchers with false data. Under Japanese law, false-advertising can result in penalties including imprisonment for up to two years, a fine of 2 million yen (US$19,600), or both.
Japanese reports state that an internal investigation at Novartis revealed 10,000 cases of side effects, which were never disclosed, from one of its leukemia drugs. These 10,000 cases of hidden side effects data back to 2002, and include data that should have been reported to the Japanese government. The investigation into these 10,000 cases of hidden side effects is now taking place in addition to allegations from 2013 on 3,000 side-effect reports collected by Novartis last year.
Japanese authorities arrest ex-Novartis employee in data-manipulation scandal
Japanese officials: Novartis failed to report side effects of leukemia drug
Novartis ousts top Japanese execs amid fresh misconduct allegations
Novartis Japan staffers shredded and deleted to cover trial misconduct, panel finds
Japan files a criminal complaint against Novartis for 'exaggerated' Diovan ads