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Ministry targets Novartis claims for legal action

Kyodo

The health ministry is making final arrangements to file a criminal complaint with prosecutors against Novartis Pharma K.K. over alleged exaggerated advertising for a blood pressure-lowering drug in violation of the pharmaceutical affairs law, ministry officials said Wednesday.

The Health, Labor and Welfare Ministry initially planned to file the complaint with the Tokyo District Public Prosecutor’s Office on Wednesday, but delayed the move to make further preliminary arrangements with the prosecutors, the officials said.

Clinical studies by two Japanese universities that concluded the blood pressure drug Diovan reduced the risk of cerebral stroke and angina were found to contain false data.

The Japanese sales arm of Swiss pharmaceutical giant Novartis has claimed that it was not aware of the false data in the reports.

In an interim report last September, however, a health ministry panel said the company’s use of these reports for promoting Diovan sales could amount to exaggerated advertising.

Kyoto Prefectural University of Medicine and Tokyo-based Jikei University School of Medicine are among five Japanese universities that conducted a clinical study in or after 2002 on the drug launched in Japan in 2000.

The two universities published their respective reports in or after 2007 on the study, in which a Novartis Pharma employee participated. Last July, they announced clinical data in their reports had been manipulated.

Novartis Pharma cited these reports about 700 times in advertisements in medical journals and leaflets for medical doctors.

Annual Diovan sales in Japan have exceeded ¥100 billion since 2005. The drug is sold in some 100 countries.