The Diovan data scandal in Japan has spawned a criminal action against Novartis ($NVS). The country's Health Ministry lodged a complaint against Novartis today, accusing its domestic unit of exaggerated advertising.
It's the first-ever action of its kind against a drugmaker, the Japan Times reports. Under the country's pharmaceutical law, anyone found guilty of exaggerated advertising can face up to two years in prison or a fine of up to 2 million yen (about $19,400).
The criminal complaint isn't unexpected; Japanese authorities warned as early as September that Novartis could face criminal penalties for its Diovan promotions. The advertising in question was based on studies suggesting that Diovan (valsartan), a drug for high blood pressure, could prevent strokes and angina.
The problem is that a former Novartis employee had been involved in reporting the stroke-prevention data--and did not disclose his affiliation with the drugmaker. 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.
Novartis has said that it wasn't aware that the studies included fabricated data. But the company cracked down on its Japanese operation in the wake of the scandal. In October, Novartis pharma chief David Epstein cut local executives' pay by 30% and apologized publicly. "I would once again like to apologize for Novartis' involvement in this issue," Epstein said at the time. "Controls have been put in place to ensure this cannot happen again."
Authorities say Novartis has cited the questionable data, supporting Diovan as a preventive tool, about 700 times in ads since 2006.
- read the Japan Times story
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