Japan readies false-advertising charges against Novartis in Diovan data probe

Japanese officials say they are preparing to prosecute Novartis ($NVS) for false advertising after two universities found falsified data in a disputed Diovan study, The Japan Times reports. According to AFP, the Health Ministry plans to seek punishment not only for Novartis Pharma KK, the company's Japan unit, but also for individuals involved in the data-manipulation scandal.

The Swiss drugmaker's domestic unit has been under investigation in Japan for several months since a former employee was linked to research indicating that the blood pressure drug could help prevent strokes and angina. The former employee had participated in the research without disclosing his ties to Novartis.

According to the Times, Kyoto Prefectural University of Medicine and Tokyo-based Jikei University School of Medicine each had found that clinical study reports, which concluded that Diovan could help prevent stroke and angina, included falsified data. The Jikei medical school retracted related research published in The Lancet in 2007.

Yesterday, Jiji Press reported that Nagoya University, one of the other schools that conducted Diovan research, found no evidence of data manipulation. Chiba University also said Tuesday that it did not uncover any false data in the Diovan studies.

The Times says Novartis has cited the questionable data, supporting Diovan as a preventive tool, about 700 times in ads since 2006. Japan's Health Ministry plans to file a criminal complaint about this advertising, under a pharmaceutical law that prohibits "exaggerated" drug promotions. The penalty is up to two years in prison or a fine of up to 2 million yen ($19,400).

If any employees are personally fined, it won't be the first time local workers have suffered financially from the scandal. In October, Novartis Pharma chief David Epstein actually cut Japanese executives' pay until the data probe is resolved. Sales of Diovan have declined since the scandal broke, Epstein said during the Oct. 3 press conference, but Novartis is more worried about the fallout's effects on its global reputation.

"I would once again like to apologize for Novartis' involvement in this issue," Epstein said then. "Controls have been put in place to ensure this cannot happen again."

- check out the AFP story
- get the Japan Times news
- see the Jiji Press story
- read the Daily Press piece

Special Reports: Top 10 Pharma Companies by 2012 Revenues - Novartis | 10 Largest U.S. Patent Losses - Diovan