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Novartis faces data fraud charges in Japan

Published on 03/07/14 at 09:21am
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Novartis is facing criminal charges in Japan over the alleged falsifying of data for its once big-selling heart drug Diovan.

The Swiss firm is to be charged by Japanese authorities for failing to oversee the work of its ex-employee Nobuo Shirahashi, Tokyo prosecutors announced this week.

The former Novartis employee is accused of providing false data to researchers whose findings were used to promote Diovan (valsartan).

Shirahashi participated in research by Kyoto University in the early 2000s while working for Novartis. The resulting research paper, which was published in the influential European Heart Journal in 2009, was retracted last year after heart doctors raised concerns about the quality of the data.

None of the scientists have been charged with data manipulation, although the head researcher has now resigned.

While the firm has not named the employees or the trials by name, it has long been believed that Shirahashi was at the centre of the scandal.

Novartis originally said Shirahashi had ‘an adjunct position’ at the University and, “being famous in the statistician community, merely gave advice on what type of statistical analysis to use”.

But in March this year the Japanese newspaper The Mainichi reported that Novartis invested ¥100 million in the University’s research.

The firm later admitted in its statement “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator initiated valsartan trials in Japan”.

Shirahashi will now be charged separately with manipulating data that was used to promote Diovan. He was also re-arrested for further questioning earlier this week, having first been detained several weeks ago.

The offence carries a maximum prison term of two years, a fine of up to ¥2m (£11,500), or both. Under Japanese law, companies can face criminal convictions for failing to prevent employees from carrying out wrongdoing.

The charge against Novartis carries a maximum fine of ¥2m. Around 1,500 charges of this kind were laid against firms in Japan last year.

Spate of retractions

This has been a long running affair that stretches back to 2012 – with the cardiologist Hiroaki Matsubara (who is a former Kyoto Prefectural University researcher), also having a number of his Diovan studies retracted in Japan, the US and Europe.

In December 2012, the Japanese Circulation Society retracted two of Matsubara’s papers, citing ‘serious errors in data analysis’ in both.

A 2012 paper claimed that Diovan helped diabetics to avoid heart disease; the other, published in 2011, claimed benefits for high-risk hypertensive patients.

There have also been five retractions of Matsubara’s Diovan studies by the American Heart Association, and the major Kyoto Heart Study was also retracted from the European Heart Journal.

Matsubara has stood by his conclusions saying that the errors were accidental, and a Kyoto Prefectural University committee in January found no signs of misconduct.

But the once prominent cardiologist unexpectedly resigned from his post at the University in February, fuelling speculation that he was working in some capacity for Novartis. The University is now investigating these claims for a second time now that he has left his academic post.

Matsubara has not been named by Tokyo officials this week.

Changing culture

In September last year the head of Novartis’ pharma division David Epstein apologised for the debacle, saying: “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the [Japanese] ministry.”

This week Epstein went further, saying the company was ‘committed to changing the culture’ at its Japanese unit. Novartis has already replaced the senior management of the subsidiary.

Sales of Diovan hit ¥119.2 billion (US$1.3 billion) in 2011, making it the top-selling drug for Novartis’s Japanese subsidiary and the third-best-selling drug in Japan.

Globally the drug brought in $5.7 billion in 2011 before losing its patents in major markets, including the US, last year.

Ben Adams

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