Newspaper article The Daily Yomiuri (Toyko, Japan)

Novartis Case Reflects Corporate Culture in Japan

Newspaper article The Daily Yomiuri (Toyko, Japan)

Novartis Case Reflects Corporate Culture in Japan

Article excerpt

Even after Swiss drug giant Novartis AG has replaced executives at its Japanese unit Novartis Pharma K.K. in response to the firm's inappropriate involvement in clinical research on a therapeutic drug for leukemia, it will be a long, uphill struggle for the firm to recover trust.

On Thursday, Novartis announced it had replaced three Japanese executives of Novartis Pharma with foreign staff to take responsibility for the problem, apologizing and explaining that the Japanese unit's corporate culture was to blame.

At a press conference Thursday, Novartis President David Epstein emphasized that Japan-based employees tended to put relationships with doctors before those with patients, a tendency not seen Western countries. He also said the Japanese unit needs innovative changes.

The research in question was aimed at identifying differences in side effects between conventional leukemia drugs and a new drug. The research was conducted mainly by the University of Tokyo Hospital and other 21 hospitals. It subsequently came to light that employees of Novartis Pharma were deeply involved in the clinical research beginning in the research planning phase. In addition, data on all 255 participating patients was leaked to the company.

An outside investigative committee on Wednesday harshly criticized the clinical research as "deeply micromanaged research by a pharmaceutical company."

The committee said that the research was apparently conducted in hopes of using the findings to help boost sales of the new drug, which had suffered a slowdown. In addition to systematic cover-up attempts by the firm, the committee said the firm may have become aware of two cases involving severe side effects while obtaining data on the patients involved, but failed to report the cases to the government as required by the Pharmaceutical Affairs Law. "The sheer scale of the issues is rather frightening," Kunio Harada, a lawyer who chairs the committee, said.

The company was also involved in a case of data falsification in clinical research for the Diovan hypertension drug last year, in which a former Novartis Pharma employee was found to have been inappropriately involved in the research, which was conducted by Kyoto Prefectural University of Medicine, Jikei University and others.

Novartis also entrusted another third-party committee to investigate whether there was any inappropriate employee involvement in other clinical research activities led by doctors since 2011.

Epstein said at a press conference that he had not been aware of research misconduct at all until the problem involving the Diovan drug came to light. …

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