Novartis announced changes Thursday to the senior management of its unit in Japan and also placed a hold on all its clinical trials there while it investigates allegations of questionable activities by some staff with regard to clinical trials, including a protocol breach of a Japanese study of its leukaemia drug Tasigna (nilotinib). David Epstein, head of pharmaceuticals at Novartis, remarked that "our company culture and the way we do business in Japan needs to change urgently."
Specifically, the Swiss drugmaker appointed Dirk Kosche, who heads emerging growth markets for Novartis Oncology, to replace Yoshiyasu Ninomiya at the helm of the Japanese subsidiary. Hiroko Ishikawa will be succeeded by company adviser Michael Ferris as president of Novartis Holding Japan, while Francis Bouchard will replace Kazuo Asakawa as director of the unit's oncology division. The drugmaker also dismissed a number of local staff involved in the trials. Novartis stated that it needs to rebuild a Japanese business that meets "legal obligations and executes operations ethically" under new management.
The changes follow the release this week of a report from a third-party investigative panel hired by Novartis, citing numerous examples of "irregular practices" by company staff, including collecting questionnaire responses from study participants, helping doctors write out side-effect ratings of leukaemia treatments, and also covering up evidence of their alleged inappropriate involvement. However, the report did not find evidence that study data had been falsified. Nonetheless, an official with Japan's health ministry commented that a failure to report side effects "risks violating pharmaceutical law, which could mean an administrative penalty," adding that the ministry is communicating with Novartis concerning the issue.
Epstein suggested the management changes and the trial moratorium will likely hurt the company's revenues in Japan over the short-term. Novartis said it initiated a probe in February of the activities of its Japanese unit dating back to 2011 to identify questionable relationships between its employees and doctors selected to conduct independent studies. Epstein noted the company will continue to investigate any inappropriate ties, adding that "we fully expect to find other clinical trials that are problematic." The drugmaker said the review should be completed by this summer, after which it will disclose the findings.
Novartis was already the subject of a criminal complaint filed by Japan's health ministry in January, accusing the drugmaker of violating advertising rules regarding the promotion of its hypertension medicine Diovan (valsartan). The company's Tokyo office was later raided by Japanese prosecutors in conjunction with the probe.
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