Police raid Novartis Tokyo office
pharmafile | February 20, 2014 | News story | Medical Communications, Sales and Marketing | Diovan, Japan, Novartis, tokyo
Authorities in Japan have raided the premises of Novartis’ Tokyo operation as part of an ongoing investigation into the promotion of Diovan, according to media reports.
The Swiss firm is under pressure in the country where, last September, it apologised to patients over the alleged manipulation of data.
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.
The health ministry 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 ¥2 million fine, or there is the possibility of individuals being faced with a two-year prison sentence.
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.
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 is embarrassing for Novartis.
Sales of Diovan have already been hit following patent expiries in the US and Europe.
Last month Novartis announced it was shutting down a plant in New York State that made Diovan and malaria treatment Coartem, affecting 525 jobs, as it looks to help offset revenue decline.
Novartis may transfer some employees to other locations, he added, meaning not all the jobs could be under threat.
This announcement came in the same week that Novartis said it would also cut 500 ‘support jobs’ in its native Switzerland to “free up resources to hire employees to market new products this year”.
Adam Hill
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