Another Japanese university finds data manipulation for Novartis drug

Kyodo

The Jikei University School of Medicine has become the second Japanese university to find that clinical data had been manipulated for a Novartis Pharma drug that lowers blood pressure.

A guest professor, Seibu Mochizuki, who led Jikei’s research on the drug called Diovan, is offering to withdraw his paper on the drug that was published in the Lancet medical journal in 2007, noting grave doubts have emerged about the credibility of the research.

The development came after the Kyoto Prefectural University of Medicine announced in mid-July it had found manipulation of clinical research data on Diovan.

Novartis Pharma, a Japanese unit of Swiss drug company Novartis AG, claimed Monday that a third-party investigation found no evidence a former employee had manipulated or altered the data. The former employee had participated in a group to analyze blood pressure data in the clinical research.

But at a news conference Tuesday, Kazuhiro Hashimoto, chairman of a Jikei investigation committee, indicated that the former employee might have manipulated the data, while noting that this former worker denied such wrongdoing in an interview.

An interim report by the committee said a large part of the blood pressure data on which the Mochizuki paper was based differed from data on medical record.

It also said the Mochizuki paper wrongly described the data analysis group as independent from Novartis Pharma even though the former employee took part in the group.

The data manipulation and incorrect description indicate that the Mochizuki paper is basically defective and lacks credibility, it said.

The report also said Novartis Pharma donated ¥84 million between 2005 and 2007 to a Jikei division to which Mochizuki had belonged. But it also said that the donation had been specified in the Mochizuki paper and there had been no ethical problem.

Jikei launched the clinical research in 2002 to look into whether Diovan could reduce the chances of cerebral stroke and cardiac angina in addition to lowering blood pressures.

The Mochizuki paper in the Lancet concluded that Diovan could reduce the incidence by 39 percent.

Diovan, launched in Japan in 2000, is one of Novartis Pharma’s flagship products. It generated ¥108.3 billion — one-third of the firm’s revenue — in 2012.