Judge in Japan lets Novartis off the hook in advertising scandal

A judge has found Novartis and a former employee not guilty on charges of false advertising tied to the use of manipulated data in a research paper on Novartis' Diovan.

Novartis has escaped a false advertising charge in Japan tied to questionable data on its heart drug Diovan. It was one of a series of missteps for the Swiss company that culminated in a 15-day suspension of its business in the country.

On Thursday, a judge found the company and a former employee not guilty on charges of false advertising tied to a research paper that used manipulated clinical data to show that patients taking Diovan were less likely to suffer strokes, Japan’s Mainichi newspaper reports.

Presiding Judge Yasuo Tsujikawa found that while the research paper circulated in Japan was based on manipulated data, the paper couldn’t be classified as pharmaceutical advertising. A prosecutor told the newspaper that the decision will be appealed.

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The scandal had erupted in 2014 when it was learned that research analyst Nobuo Shirahashi, who worked for Novartis, had not disclosed his affiliation while working on postmarketing studies. Tokyo's Jikei University School of Medicine retracted its Diovan research, published in The Lancet, after determining that some of the data was fabricated. Kyoto Prefectural University of Medicine also said its Diovan data was incomplete.

The trial’s outcome was particularly good for Shirahashi. Prosecutors had recommended 30 months in jail for the 66-year-old man. For Novartis, they had recommended a fine of ¥4 million (about $35,000).  

Shirahashi’s lawyer said that while they were dissatisfied with the facts established by the court, the decision “was a level-headed one," the newspaper reported.

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At about the same time that the research scandal was surfacing, authorities also found that Novartis had not properly reported side effects of Tasigna and Gleevec when used to treat leukemia. That led the government to suspend the drugmaker’s business in Japan for 15 days. It was the first time Japan has cracked down on side-effects reporting this way. It also led the company to offer a public apology to patients, physicians and the public.