High Court Backs Not-Guilty Ruling over Novartis Falsified Data

November 20, 2018

Tokyo--Tokyo High Court on Monday backed a not-guilty ruling by a lower court for a former Novartis Pharma K.K. employee over a research paper based on falsified data on clinical research into hypertension drug Diovan.

In the lawsuit against the 67-year-old former employee, Nobuo Shirahashi, and the Japanese unit of Swiss drug giant Novartis AG, Presiding Judge Masaharu Ashizawa did not recognize the paper as exaggerated advertising banned by the pharmaceutical affairs law.

The focus was on whether the research paper claiming the superiority of Diovan over other drugs on the basis of falsified data breaches the law. The research paper was published mainly on the website of a medical journal.

Ashizawa said that the research papers of academic journals are published for experts and not aimed at attracting customers.

"Even if data produced by Shirahashi were false and he had a researcher write a paper using the falsified data, this was not regarded as advertising," the latest ruling said.

Prosecutors claimed that with the dissemination of information becoming easier through the Internet, false and exaggerated data must be widely regulated.

But the high court rejected the claim, saying that worries would arise about possible harm to the development of research if academic papers become subject to regulations.

The court concluded that new legislation is needed to respond to such problems.

In March 2017, Tokyo District Court recognized that Shirahashi intentionally falsified data but judged that the release of the research paper could not be regarded as a means of stimulating consumer demand.

The court thus handed down a not-guilty ruling, saying that the paper was not considered to be exaggerated advertising. Prosecutors appealed the decision.

In the clinical research of Diovan conducted by Kyoto Prefectural University of Medicine, Shirahashi took statistics and analyzed data. He was indicted for allegedly providing data falsified to be advantageous for Novartis to a doctor for the release of the research paper in 2011-2012.

An official of Novartis Pharma said that the company was found not guilty again but feels socially and morally responsible. Jiji Press