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Former Novartis Japan Employee Held for Data Manipulation

A former employee of Novartis AG’s Japanese unit was arrested in Tokyo on charges of manipulating data on a drug study, the latest setback for the pharmaceutical company in the country.

Nobuo Shirahashi, who was a director of the unit’s scientific affairs department, violated pharmaceutical law by understating side effects in a study that evaluated hypertension drug Diovan’s efficacy in cutting stroke risk and getting researchers to publish it, the Tokyo prosecutors office said in a faxed statement today.

Shirahashi couldn’t be reached and Novartis Japan declined to make contact information for him or his lawyer available.

Japan’s health ministry in January filed a complaint to Tokyo prosecutors against Novartis, seeking a criminal probe of the subsidiary for possible breach of rules by exaggerating Diovan’s efficacy in marketing materials. Novartis Japan in a statement today apologized for “the concerns and inconvenience” it has caused and said it would continue to cooperate with the investigation.

“We take the arrest of our former employee with utmost seriousness,” the company said.

Basel, Switzerland-based Novartis has faced a string of difficulties in Japan, including improper involvement in independent studies on Diovan and cancer treatment Tasigna. An investigation by a third-party commission appointed by the company disclosed earlier this year that Novartis employees destroyed evidence and may have obtained patients’ personal information during a doctor-led leukemia study.

Novartis in April named Dirk Kosche as head of its Japan business, replacing Yoshiyasu Ninomiya amid the investigations.

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