Japanese panel says Novartis' Diovan ads may have broken the law

Novartis' ($NVS) troubles in Japan just keep growing. Now, a government panel is zeroing in on its Diovan advertising. Officials say the promos may have broken Japanese law--and that could lead to fines and jail terms, Bloomberg reports.

It's yet another aftershock in the ongoing Diovan data scandal. Earlier this year, medical journals retracted studies that had found Diovan helped cut patients' risk of stroke. Former Novartis employees had been involved in the research, without disclosing their ties to the company. Novartis says it investigated and found no evidence that the former workers manipulated data.

The latest problem is this: Novartis touted the blood pressure drug as a way to reduce stroke risks. Officials say there wasn't enough evidence for that claim because the data cited came from those studies whose validity is now in question. The government panel also says that money Novartis gave to two universities for classes was also intended to support the Diovan trials--and that makes Novartis a sponsor of the research. Presumably, that's something Novartis should have disclosed.

The Jikei University School of Medicine, however, said its own investigation had not ruled out misconduct on the part of the former Novartis worker on a study done there. The employee himself has denied any wrongdoing. That study was retracted.

The panel report, released Monday, expressed some sympathy for Novartis' position on Diovan. But the group's compassion only went so far. "The competition for hypertension drugs must have been fierce, ... and any drugmaker would have thought additional evidence to differentiate its products could help increase sales," the panel's report states (as quoted by Bloomberg). "The government should conduct an on-site inspection and take stern action."

According to Bloomberg, violations of the law prohibiting overpromotion of drugs can be severe. Individuals face a jail term of as long as two years. Companies can be fined as much as 2 million yen ($20,000) and, more importantly, have their operations suspended.

- read the Bloomberg piece

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