Japan’s health ministry filed a complaint with Tokyo prosecutors against Novartis AG, seeking a criminal investigation of the company for possibly breaching advertising rules with its Diovan hypertension drug.
The complaint accuses Novartis of exaggerating Diovan’s effectiveness in marketing materials, according to a statement on the agency’s website. Novartis will fully cooperate with Japanese authorities, the Basel, Switzerland-based company said in a statement today.
A ministry panel in September said that Novartis promoted Diovan as a treatment for cutting stroke risks without sufficient evidence, a breach that could lead to fines and jail terms, a government panel said in an interim report in September. Diovan is among Novartis’s best sellers with $4.4 billion globally in 2012 sales.
“We deeply apologize for the great worry and inconvenience we have caused to patients, their families, those in the medical field and the Japanese people,” the company said in its statement.
The drug maker got about $5.4 billion, or 9.5 percent, of its global revenue from Japan in 2012, data compiled by Bloomberg show.
Two studies finding that the high blood-pressure treatment also cut the risk of stroke were later disputed. Kyoto Prefectural University of Medicine and Jikei University said data used in two Diovan studies it conducted, initiated by doctors, could have been manipulated.
Medical journals including The Lancet and European Heart Journal this year retracted the Kyoto and Jikei studies on Diovan. The Japanese health ministry panel has also said it found a conflict of interest regarding funds given by Novartis to the two universities.
Novartis, which donated 570 million yen ($5.4 million) to Kyoto Prefectural and Jikei universities for running classes, also expected part of the funds to be used to pay for the drug trials, the panel said. The Basel, Switzerland-based drugmaker was therefore a sponsor of the studies, it said.
In July, Novartis said some former employees of its Japanese unit who worked on the Diovan trials failed to declare in the studies their affiliations to the drugmaker. A report commissioned by Novartis found no evidence that the former workers manipulated scientific data, it said at the time.