Swiss pharmaceutical giant Novartis yesterday said it was replacing the top executives at its Japanese unit over allegations the division hid serious potential side effects of leukemia treatments from regulators.
David Epstein, the head of the firm’s pharmaceutical division, said the senior managers “resigned, they are out of the company,” adding that “this kind of behavior is unacceptable and a clear violation of our code of conduct.”
“I’d like to once again apologize for Novartis’ involvement in this issue,” Epstein told a press briefing in Tokyo.
Photo: AFP
The move comes after a panel of outside lawyers hired by the company said earlier yesterday that sales staff also hid their improper involvement in drug studies probing possible side effects of cancer treatments.
The claims marked another blow for the drugmaker, less than two months after Japanese prosecutors raided its Tokyo office over claims Novartis exaggerated the benefits of a blood-pressure drug.
In the latest case, the panel found that staff had removed evidence from the Novartis office of their links to the research, which pointed to at least two cases of severe reactions in patients participating in the testing of a leukemia drug.
The probe found that sales staff acted inappropriately by involving themselves in the clinical research at nearly two dozen medical institutions in Japan.
The panel did not find evidence that data were falsified, but “we noted that there were several irregular practices,” a lawyer speaking on behalf of committee head Kunio Harada said.
Failing to report the side effects of a drug “risks violating pharmaceutical law, which could mean an administrative penalty,” a Japanese health ministry official said.
“We are communicating with Novartis officials over the issue,” he added.
Yesterday, Novartis said Briton Michael Ferris would replace Hiroko Ishikawa as president of Novartis Holdings Japan, while German Dirk Kosche would replace Yoshiyasu Ninomiya as head of Novartis Pharma, also part of the global firm’s Japanese business.
Canadian Francis Bouchard is to succeed Kazuo Asakawa as director of the Pharma division’s oncology business.
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