Novartis Workers Failed to Disclose Ties in Japan Studies

Novartis AG employees failed to disclose their involvement in Japanese research on the blood-pressure medicine Diovan, including a study that has since been retracted by a medical journal.

Former Novartis Japan unit employees worked on five Diovan trials initiated by doctors and didn’t list their affiliations to the Swiss drugmaker in the studies. The omission was improper and could have eroded trust in scientific processes, the head of the company’s Japanese unit said. A report commissioned by Novartis found no evidence that the ex-workers manipulated scientific data, the Basel, Switzerland-based drugmaker said in a briefing held in Tokyo today.

“I’m deeply sorry for the trouble we caused for patients, their families, medical professionals, for the improper disclosure and promoting Diovan citing the studies,” said Yoshiyasu Ninomiya, head of the Japan unit.

The trials found Diovan, the company’s second-best selling medicine with $4.4 billion in sales last year, cut stroke risks in Japanese people. In February, one of the studies was retracted by the European Heart Journal, which said “critical problems existed with some of the data reported” in the paper.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 on July 11 on its website.

The five studies were conducted between 2001 and 2004 in Japan at the Jikei University in Tokyo; Chiba University, east of Tokyo; Kyoto Prefectural University of Medicine, western Japan; and Nagoya University, central 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. The company will work with universities to determine what happened, he said.

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