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From fraud to false advertising

Luana GeigerAn unusual lawsuit involving a case of scientific misconduct was tried in June 2017 in a Tokyo court. The Japanese unit of pharmaceutical company Novartis and one of its former employees, Nobuo Shirahashi, 66, were found innocent of the charge of using false advertising for Valsartan, a hypertension drug. Shirahashi was found innocent even though there was proof that he had manipulated data in a clinical trial of the drug that was used for scientific articles in journals such as the Journal of Human Hypertension, The Lancet and Hypertension Research. The fabricated results were used in advertising campaigns for the drug in Japan.

Judge Yasuo Tsujikawa found that the fraudulent articles did not fit the concept of false advertising as defined by Japanese laws.“ Posting scientific papers represented the announcement of research results, so it’s difficult to say that this was a measure to stimulate consumers’ desire to purchase the drug,” the judge said according to The Japan Times. The manipulated papers were targeted for retraction after the scandal came to light. Shirahashi was indicted in an action brought by the Health Ministry of Japan and was arrested in 2014. Novartis, which funded the trial, eventually dismissed him.

The former employee had worked as a clinical test data analyst and submitted false information to a University of Kyoto research group about patients to whom the drug was never actually administered. The falsified study suggested that Valsartan, used for years to control blood pressure, had another preventive effect in that its users experienced fewer strokes than patients in a control group. Prosecutors wanted to fine Novartis four million Yen and sentence the former employee to 30 months in prison. The judge’s decision is now being appealed.

The outcome of a lawsuit of this type may have been different in other countries. According to US lawyer Ann Walsh, who worked at the Food and Drug Administration, a similar case might succeed in the US if it was proven that the fraud was cited in any advertising material for the drug that was sent to physicians. “For US courts, any written material distributed with a product is subject to labeling laws,” Walsh told the Retraction Watch website.