Japan authorities digging deeper into Novartis' use of flawed Diovan study

Sometimes saying you're sorry just isn't enough. Swiss drugmaker Novartis ($NVS) has repeatedly apologized after learning that a company employee was affiliated with a study in Japan of blockbuster Diovan as a statistician without revealing his ties to the Swiss healthcare giant. But authorities are not satisfied with apologies and intend to go on-site next week for a closer look.

Japanese media is calling it a "raid," saying that experts advising the health ministry came to the conclusion in an interim report that Novartis should be held responsible for studies on the popular blood pressure drug, The Local reports. The panel will also recommend the government tally up an estimate of the cost to Japan's insurers, Japanese media said. Novartis cited the studies when it promoted the drug.

"The panel is examining the possibility of exaggerated advertisement which is a violation of the Pharmaceutical Affairs Act and will urge the government to take strict actions" against Novartis, the Asahi Shimbun reported. It said that when the report is delivered next week, the health ministry will "carry out an on-site investigation" at Novartis headquarters in Japan.

The company reported in July that an independent report it ordered found that while former Novartis employees did work on Diovan trials in Japan without disclosing their relationships with the company, there was no evidence clinical trial data were manipulated. 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 That study was retracted.

Novartis Pharma's president in Japan, Yoshiyasu Ninomiya, apologized a couple of months ago over the scandal saying, "I'm deeply sorry for the trouble we caused for patients, their families, medical professionals, for the improper disclosure and promoting Diovan citing the studies."

But that is not enough. The Local reports that David Epstein, head of pharmaceuticals for Novartis, was summoned Thursday to meet with Health Minister Norihisa Tamura, where he promised to cooperate with the government's investigation.

While Novartis is defending itself against the charges in Japan, it has caught a break on the drug in the U.S. Diovan went off patent a year ago here and the company kept expecting Ranbaxy Laboratories to bring out an approved generic. But the Indian drugmaker was having trouble with the plant slated to manufacture the drug in its own country, and now the FDA has tagged the facility with an import ban. The fact that Diovan rolls on without generic competition has even allowed Novartis to raise its revenue estimates for the year.

- here's the Local story

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