The Japanese Ministry of Health, Labor and Welfare yesterday filed a criminal complaint against the local arm of Swiss pharmaceutical giant Novartis AG over alleged exaggerated advertising of a popular blood-pressure drug, the company said.
The ministry lodged its complaint against Novartis Pharma KK following months of scandal after a university said the data in clinical studies might have been skewed to promote blood-pressure drug Diovan, which is 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,” a statement on the company’s Web site said. “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.”
Japanese Minister of Health, Labor and Welfare Norihisa Tamura has characterized as “extremely regrettable” the incident in which an employee of the world’s No. 2 drug maker hid his affiliation during a medical study into the effects of the drug.
The resulting studies suggested the drug, which is licensed for use in more than 100 countries, had some additional preventative effect on strokes and angina.
The firm used data from the studies to market its drug, playing up its supposed additional benefits.
There is no suggestion that Diovan is ineffective in combating blood-pressure problems.
Under Japan’s pharmaceutical 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 (US$19,400).
Novartis chief executive David Epstein has apologized for the concern the incident caused, but did not say that the company played any role in the allegations.
Meanwhile, prosecutors in New York said a Novartis unit paid kickbacks to a specialty pharmacy in exchange for recommending refills of a blood-transfusion drug it produces, according to an amended complaint filed on Wednesday in a civil case brought by state and federal prosecutors in New York.
East Hanover, New Jersey-based Novartis Pharmaceuticals Corp boosted its sales of the iron-reduction drug Exjade by giving referrals and rebates to pharmacy BioScrip, which recommended refills to its patients, but often ignored to warn them about the drug’s potentially fatal side effects, which include kidney failure and gastrointestinal hemorrhaging, according to the complaint filed in the federal court in Manhattan.
BioScrip, based in Elmsford, New York, agreed to pay US$15 million to settle charges that it caused pharmacies to submit tens of thousands of false claims to Medicare and Medicaid, New York Attorney General Eric Scheniderman said.
“This arrangement between Novartis and BioScrip was dangerous for patients and is against the law,” Scheniderman said in a statement. “Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients.”
In a statement, Novartis Pharmaceuticals disputed the allegations and said it would defend itself against the litigation.
As part of its settlement with the government, BioScrip said that, beginning in 2007, Novartis told the pharmacy its refills for Exjade patients were too low and that it would lose referrals if it did not raise its numbers, according to court documents.