Drug giant Novartis replaces Japanese trio over side-effects cover-up claim

PUBLISHED : Thursday, 03 April, 2014, 11:00pm
UPDATED : Thursday, 03 April, 2014, 11:00pm


Swiss pharmaceutical giant Novartis said yesterday it was replacing the top executives at its Japanese unit over allegations that the division hid serious potential side effects of leukaemia treatments from regulators.

David Epstein, head of the pharmaceutical division, offered an apology, and said the senior managers "resigned, they are out of the company". Epstein added: "This kind of behaviour is unacceptable and a clear violation of our code of conduct."

A panel of outside lawyers hired by the company said earlier yesterday that sales staff had also hidden their improper involvement in drug studies probing possible side effects of cancer treatments.

The claims come two months after Japanese prosecutors raided Novartis' Tokyo office over claims it exaggerated the benefits of a popular 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 undergoing leukaemia drugs testing.

The probe found sales staff had acted inappropriately by involving themselves in the clinical research at nearly two dozen medical institutions in Japan.

The panel did not find evidence that the data was falsified, but "we noted that there were several irregular practices", said a lawyer speaking on behalf of committee head Kunio Harada.

Failing to report the side effects of a drug "risks violating pharmaceutical law, which could mean an administrative penalty", a health ministry official said.

The company hired the outside lawyers to conduct an in-house probe after allegations surfaced in press reports earlier this year about employees being involved in the testing.

Briton Michael Ferris will replace Hiroko Ishikawa as president of Novartis Holdings Japan, while German Dirk Kosche will 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.