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Novartis faces Japan probe

pharmafile | January 10, 2014 | News story | Sales and Marketing Diovan, Japan, Novartis 

Novartis is under pressure in Japan where authorities are looking at the way the Swiss firm promoted its blood pressure drug Diovan.

Last September, the Swiss manufacturer apologised to patients in Japan over the alleged manipulation of data.

While the company’s travails over Diovan do not yet appear on the scale of the problems nagging at GlaxoSmithKline in China – where Novartis is also incidentally under investigation as well as Lilly and Sanofi – the Japan issue has been rumbling since last year and is embarrassing for Novartis.

It has been under the microscope in Japan since allegations emerged that several post-marketing clinical trials of Diovan (valsartan) may have been run by company staff, problems which may have impacted on patients’ trust in Novartis.

Now things seem to have escalated with the news that the health ministry, which had looked into the issue, has filed a complaint with the public prosecutor’s office in Tokyo over adverts which used the dubious figures.

If found guilty of false advertising, Novartis could be hit with a ¥2million fine, or there is the possibility of individuals being faced with a two-year prison sentence.

Sales of Diovan have already been hit following patent expiries in the US and Europe.

The company has apologised, saying that the activities of one ex-employee went “way beyond what we consider appropriate” – although the firm has never named anyone.

However, one cardiologist, Hiroaki Matsubara, a former Kyoto Prefectural University researcher who unexpectedly resigned from his post in February 2013, had a number of his Diovan studies retracted in Japan, the US and Europe.

Another study, the Jikei Heart Trial, came under scrutiny when it was revealed that Novartis employee Nobuo Shirahashi was involved with both – although his only listed affiliation was Osaka City University.

Japanese newspaper The Mainichi has previously reported that Novartis invested ¥100 million in the university’s research.

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.

In addition there have 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 last year found no signs of misconduct.

Adam Hill

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