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Novartis replaces execs in Japan after investigation

Finds irregular practices in clinical trials programme

Novartis building

Three of Novartis' top management figures in Japan have resigned in the wake of an investigation into dubious practices in the company's clinical trials programme.

Yoshiyasu Ninomiya has been replaced as the head of Novartis' Japanese subsidiary by Dirk Kosche, currently the head of emerging markets at the company's oncology division, while Michael Ferris steps into the role of the former Novartis Holding Japan president Hiroko Ishikawa.

Also moved aside is Kazuo Asakawa, head of the Japanese subsidiary's oncology division, which is at the heart of the investigation. He will be replaced by Francis Bouchard, according to Novartis, which has also announced a freeze on funding for physician-led trials in Japan.

A swathe of other company employees has also been dismissed following the external probe, which centres on clinical trials looking at the side effect profiles of various leukaemia therapies, which were designed to support the launch of Novartis' new leukaemia drug Tasigna (nilotinib).

Specifically, the investigators found that Novartis sales staff collected study questionnaires from patients and in one case wrote the side effect ratings on behalf of doctors, although it is understood the rep did not make the diagnosis. The sales staff also included personal information on some of the reports and tried to cover up the inappropriate practices when the allegations first emerged, according to a Wall Street Journal report.

Novartis is also under investigation in Japan over advertising which allegedly included falsified data from trials that inflated the benefits of its blood pressure drug Diovan (valsartan).

There is no suggestion that Novartis' employees falsified data in the leukaemia trials, but the transgressions are serious to potentially warrant an “administrative penalty” from the Japanese authorities, according to the Ministry of Health, Labour and Welfare (MHLW).

Novartis has launched its own investigation into the activities of the Japanese unit – stretching back to 2011 – and said it will publicise the results later this year once completed.

Article by
Phil Taylor

4th April 2014

From: Research, Regulatory

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