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.
The pharmacy, using employees in an Ohio call center, encouraged patients — some who had stopped using the drug — to refill their Exjade orders, according to the lawsuit.
The lawsuit seeks tens of millions of dollars in Medicare and Medicaid reimbursements.
purpose: Tesla’s CEO sought to meet senior Chinese officials to discuss the rollout of its ‘full self-driving’ software in China and approval to transfer data they had collected Tesla Inc CEO Elon Musk arrived in Beijing yesterday on an unannounced visit, where he is expected to meet senior officials to discuss the rollout of "full self-driving" (FSD) software and permission to transfer data overseas, according to a person with knowledge of the matter. Chinese state media reported that he met Premier Li Qiang (李強) in Beijing, during which Li told Musk that Tesla's development in China could be regarded as a successful example of US-China economic and trade cooperation. Musk confirmed his meeting with the premier yesterday with a post on social media platform X. "Honored to meet with Premier Li
ARTIFICIAL INTELLIGENCE: The chipmaker last month raised its capital spending by 28 percent for this year to NT$32 billion from a previous estimate of NT$25 billion Contract chipmaker Powerchip Semiconductor Manufacturing Corp (力積電子) yesterday launched a new 12-inch fab, tapping into advanced chip-on-wafer-on-substrate (CoWoS) packaging technology to support rising demand for artificial intelligence (AI) devices. Powerchip is to offer interposers, one of three parts in CoWoS packaging technology, with shipments scheduled for the second half of this year, Powerchip chairman Frank Huang (黃崇仁) told reporters on the sidelines of a fab inauguration ceremony in the Tongluo Science Park (銅鑼科學園區) in Miaoli County yesterday. “We are working with customers to supply CoWoS-related business, utilizing part of this new fab’s capacity,” Huang said, adding that Powerchip intended to bridge
Dutch brewing company Heineken NV on Friday announced an investment of NT$13.5 billion (US$414.62 million) over the next five years in Taiwan. The first multinational brewing company to operate in Taiwan, Heineken made the statement at a ceremony held at its brewery in Pingtung County. It also outlined its efforts to make the brewery “net zero” by 2030. Heineken has been in the Taiwanese market for 20 years, Heineken Taiwan managing director Jeff Wu (吳建甫) said. With strong support from local consumers, the Dutch brewery decided to transition from sales to manufacturing in the country, Wu said. Heineken assumed majority ownership and management rights
Microsoft Corp yesterday said that it would create Thailand’s first data center region to boost cloud and artificial intelligence (AI) infrastructure, promising AI training to more than 100,000 people to develop tech. Bangkok is a key economic player in Southeast Asia, but it has lagged behind Indonesia and Singapore when it comes to the tech industry. Thailand has an “incredible opportunity to build a digital-first, AI-powered future,” Microsoft chairman and chief executive officer Satya Nadella said at an event in Bangkok. Data center regions are physical locations that store computing infrastructure, allowing secure and reliable access to cloud platforms. The global embrace of AI