University Finds Data Manipulation For Novartis Drug
Tue, 07/30/2013 - 8:15am
TOKYO (Kyodo) -- The Jikei University School of Medicine on Tuesday became the second Japanese university to find that clinical data had been manipulated for Novartis Pharma K.K.'s Diovan blood pressure lowering drug.
The university's guest professor Seibu Mochizuki, who led its research on the drug, offered his plan to withdraw his paper on the drug carried by the British 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 Diovan clinical research data.
Novartis Pharma, a Japanese unit of Swiss drug company Novartis AG, for its part said Monday a third-party investigation found no evidence a former employee manipulated or altered the data. The former employee had participated in a group to analyze blood pressure data in the clinical research.
At a press conference Tuesday, Kazuhiro Hashimoto, chairman of Jikei's investigation committee on the matter, indicated that the former employee might have manipulated the data, while noting the former worker denied such wrongdoing in an interview.
The committee's interim report 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 despite the former employee's 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 yen between 2005 and 2007 to a Jikei division to which Mochizuki had belonged. But it immediately added 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 cerebral stroke and cardiac angina incidence in addition to lowering blood pressures.
The Mochizuki paper on 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, generating 103.3 billion yen or one-third of the firm's revenue in 2012.