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Novartis calls in third-party trial reviewer after Japan SAE scandal

By Gareth MacDonald+

17-Jun-2014

Novartis calls in third-party trial reviewer after Japan SAE scandal

Novartis has called in a third party organization to review how it conducts clinical trials in light of the adverse event reporting scandal that broke in Japan last week.

Last Saturday, the Japan Times reported that an internal investigation by Novartis revealing that, since 2002, as many as 10,000 serious adverse events caused by the firm’s drugs have not been reported to authorities in the country.

Novartis told in-Pharmatechnologist.com that: “These developments relate to ongoing issues in Japan that first came to light in January 2014. Novartis has taken strong action in Japan to address what are clearly unacceptable practices. 

This includes replacement of the local senior management team, third party review of investigator initiated trial programs and remedial training to ensure compliance with the company’s Code of Conduct. 

The firm added that it is “Cooperating fully with the authorities in Japan.  Novartis recognizes the culture at our business in Japan must change and is doing everything possible to achieve this.”

Further details of the third party reviewer were not provided.

Researcher arrested

The news follows just days after Japanese authorities arrested a former employee of the Swiss firm linked to data manipulation.

According to a report in the New York Times Noburo Shiraishi arrested on suspicion of violating Japan’s pharmaceutical laws by providing false data to researchers, whose work was intended for use in advertising the blood pressure pill, Diovan.

In a press statement Novartis said:  “We will continue to cooperate completely with the investigating authorities, and we again apologize deeply for the concern and difficulties this has caused.”

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