Tokyo court clears ex-Novartis employee of charges he exaggerated Diovan drug results in ad

Kyodo, JIJI

A former employee of Swiss pharmaceutical giant Novartis AG’s Japanese unit has been found not guilty of exaggerating advertising claims for the blood pressure-lowering drug Diovan.

Besides clearing 66-year-old Nobuo Shirahashi on Thursday of violating a pharmaceutical affairs law that bans fraudulent and exaggerated advertising, the Tokyo District Court also found the Tokyo-based sales arm Novartis Pharma K.K. not guilty.

While acknowledging that clinical trial data for the drug were manipulated, presiding Judge Yasuo Tsujikawa said the drugmaker’s published research paper based on the data was not an advertisement that falls under the pharmaceutical law’s purview.

The court concluded that the act of making doctors post articles written based on provided data in an academic journal does not amount to extravagant advertising.

“Posting the articles on the journal 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.

The research papers on the Diovan study were retracted after the data falsification came to light.

Prosecutors were seeking a 30-month prison term for Shirahashi and a fine of ¥4 million for the company.

According to the court, Shirahashi took part in a research project at the Kyoto Prefectural University of Medicine as a clinical test data analyst. He supplied the research team with manipulated data concerning patients who were not given the drug.

In 2011, the team eventually published in a medical journal a research paper showing those who were administered the drug suffered strokes at a lower rate than those who were not given the drug.

The court said the publication of the paper in an academic journal “cannot be regarded as a means to motivate clients to buy” the drug.

“While we are dissatisfied with the facts acknowledged by the court, its conclusion was a level-headed one,” a defense lawyer for Shirahashi said.

A senior prosecutor said the ruling will be appealed.

Shirahashi, who was indicted in July 2014 after the health ministry filed a criminal complaint against Novartis Pharma, pleaded not guilty in the trial, as did the company.

“We will continue making efforts to ensure that clinical studies on drugs and activities by pharmaceutical companies are conducted appropriately,” the Health, Labor and Welfare Ministry said in a statement issued after the ruling.