Novartis’ Japanese subsidiary was raided yesterday as part of an investigation into allegations of mis-promotion of its hypertension drug Diovan.
The Japanese authorities are looking into a complaint – filed by the Ministry of Health, Labor and Welfare (MHLW) in January – which alleges that Novartis advertising carried falsified data from trials that inflated the benefits of Diovan (valsartan).
If the allegations turn out to be true, the perpetrators face fines of up to 2 million yen (around $20,000) and up to two years in prison, according to local press reports. While the material impact to the company would therefore be light, it could damage Novartis’ reputation in the world’s second-largest pharma market.
News of the claimed data falsification first emerged last month and at the time Novartis strenuously denied the allegations, suggesting it was not involved in the research that is said to be flawed and unaware of any data manipulation.
It has remained tight-lipped on the latest development, limiting itself to saying it will cooperate with the Japanese authorities’ investigation. Novartis has also been drawn into the ongoing probe into corruption by the pharmaceutical industry in China.
Diovan was the driver for Novartis’ top-line growth in recent years, although it has since succumbed to patent expiration in most world markets, including Japan. Sales reached a peak of around $6bn in 2011 but fell to $3.5bn last year and are expected to decline further with the start of generic competition in the US this year.
Alzheimer’s probe
Meanwhile, the raid comes in the wake of another Japanese health ministry probe into data falsification. The MHLW is also investigating an anomaly in a $31m neuroimaging study involving Alzheimer’s disease patients that was backed by 11 pharma companies, including Pfizer, Bristol-Myers Squibb, Takeda Pharmaceutical and Astellas Pharma.
A Tokyo University professor is acting as a whistleblower in that case, claiming that researchers have manipulated data in the ongoing J-ADNI study and included patients not eligible for enrolment, according to Business Monitor.