Novartis Replaces Japan Unit Head Ninomiya Amid Drug Test Probe

Novartis AG (NOVN) named Dirk Kosche as the
head of its Japan business today, replacing Yoshiyasu Ninomiya
after investigations showed that the unit involved itself in
drug studies that were supposed to be independent of the

Novartis needs to rebuild a company in Japan that meets
“legal obligations and executes operations ethically” under
new management, the Basel, Switzerland-based drugmaker’s
Japanese unit said in a statement today.

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

Novartis also said today that it appointed Francis Bouchard
to be head of the oncology unit in Japan and Michael Ferris to
be head of a holding company in the country. The company is
having activities since 2011 reviewed by a third party to search
for similar problems and will temporarily suspend supporting
independent studies, it said. The review will be completed by
summer this year and the company will report the results, it

An independent trial which found that Diovan, Novartis’
second-best selling medicine with $3.5 billion in sales in 2013,
cut stroke risks in Japanese people, was retracted by the
European Heart Journal February last year because “critical
problems existed with some of the data reported” in the paper.
The data could have been manipulated, according to a report by
the university which led the study in July.

The Lancet journal retracted another Japan study on Diovan
in September saying “we no longer have confidence in the
published results.”

Failed to Disclose

Novartis Japan said in July it failed to disclose the ties
of its employees in five such Diovan studies conducted between
2001 and 2004 in Japan. The scope of Novartis’s probe into the
research, and whether it was falsified is limited because
Novartis doesn’t have access to raw data of the studies,
Ninomiya said at that time.

Japan’s health ministry filed a complaint with Tokyo
prosecutors against Novartis in January, seeking a criminal
investigation of the company for possibly breaching advertising
rules with Diovan by exaggerating the medicine’s effectiveness
in marketing materials.

Novartis Japan in October said it would set up an outside
committee to advise on governance, tighten the process of
funding trials and hold seminars internally for prevention. In
January, Novartis Japan said its sales staff were involved in a
doctor-led study using leukemia drug Tasigna and that it had
hired a third party for investigation.

Such actions are “unacceptable and against the ethical
standard set by Novartis” and the company will take measures
against those employees, it said.

To contact the reporter on this story:
Kanoko Matsuyama in Tokyo at

To contact the editors responsible for this story:
Anjali Cordeiro at
Phil Serafino

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Novartis Replaces Japan Unit Head Ninomiya Amid Drug Test Probe
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