Japan’s Health Ministry said on Wednesday they are filing a criminal complaint against the local arm of Swiss pharmaceutical company Novartis due to what they consider the “exaggerated marketing” of a high blood pressure drug they were trying to push on the market. Allegations of influencing the medical studies of Valsartan have hounded Novartis Pharma KK last year due to an employee participating in the study under false pretenses.
Health Minister Norihisa Tamura called the incident “extremely regrettable,” referring to the discovery that one of Novartis’ employees hid his affiliation with the pharma giant when participating in a study that was looking into the effects of Valsartan, marketed as Diovan in Japan, to lower blood pressure. An investigation by a panel of experts has concluded that Novartis should be held responsible for the manipulation of the data in the studies.
However, the company has denied knowledge of any plan to skew the data while the ex-employee and other researchers in the study also denied that they did any sort of manipulation. The studies showed that the drug has a prophylactic effect on strokes and angina and so Novartis used this data to market the drug, emphasizing its additional benefits aside from lowering the blood pressure. Novartis Pharmaceuticals chief David Epstein apologized for the trouble caused by the allegations, but did not acknowledge they were responsible for it.
This is the first time in Japan that a criminal complaint will be filed against exaggerated pharmaceutical advertising. Under the pharmaceutical law, this could be punishable up to two years in prison and a fine of two million yen. Tokyo’s Jikei University School of Medicine and the Kyoto Prefectural University of Medicine have retracted the conclusion of the research done over the drug, while Chiba University said they could not see any data manipulation. However, later on, it was discovered they failed to disclose the scholarship donation amounting to 91 million yen made by Novartis from 2007-2009.
[ via AFP ]