Novartis arm faces criminal case in Japan over exaggerated advertising

Japan`s health ministry today filed a criminal complaint against the local arm of Swiss pharmaceutical giant Novartis AG over alleged exaggerated advertising for its popular blood-pressure drug Diovan, the company said.

The ministry of health, labour and welfare (MHLW) lodged its complaint against Novartis Pharma KK, the Japanese arm of the world's No 2 drug maker, after months of investigations into a university's allegation that Novartis might have skewed clinical study data to promote Diovan (also known as Valsartan).

"Today a criminal complaint was filed by the health, labour and welfare ministry against us over doctor-led clinical research on Diovan for alleged exaggerated advertising banned under the pharmaceutical law," the company said in a statement published on its website.

"We apologise deeply for causing tremendous worries and trouble to patients, their families, medical workers and the public.

"We take this incident extremely gravely and will continue to cooperate fully with the authorities."

The Japanese ministry said in a notice that it suspected Novartis continued to use ads citing the studies after learning data in them had been manipulated. Novartis has denied this and says studies have confirmed the safety and effectiveness of the drug.

The company says it is co-operating with authorities.

Health minister Norihisa Tamura has characterised the incident in which an employee of the drug maker hid his affiliation during a medical study into the effects of the drug, as "extremely regrettable."

Further studies have suggested that the drug had some additional preventative effect on strokes and angina. Novartis used data from these studies to market its drug, playing up its supposed additional benefits.

The ministry did not dispute Novartis' claim that Diovan, which is licensed for use in more than 100 countries is effective in combating blood pressure problems.

Novartis had earlier said that the results of the five Japanese post-registration investigator-initiated Diovan trials that are the subject of the MHLW investigation were not used by Novartis for registration purposes or labelling submissions.

''Therefore, these trials do not have any impact on the information contained in the package insert for Diovan in any country worldwide.''

Under Japanese law, anyone found guilty of exaggerated advertising can be punished with up to two years in prison or a fine of as much as ¥2 million ($19,400).

Novartis Pharmaceuticals chief David Epstein has apologised for the concern the incident caused, but did not say that the company played any role in the alleged violations.