Novartis Japan unit charged over research manipulation

Japanese prosecutors Tuesday laid charges against the local unit of Swiss pharmaceutical giant Novartis in a widening scandal over claims that falsified data were used to exaggerate the benefits of a popular blood-pressure drug.

Prosecutors also indicted former employee Nobuo Shirahashi, 63, alleging he manipulated the data in clinical studies that were later used in marketing the drug Valsartan.

The dual charges laid by the Tokyo District Public Prosecutor's Office—which allege that Novartis bore responsibility for Shirahashi's actions—came several weeks after he was first arrested and authorities raided the offices of Novartis Pharma KK in the Japanese capital.

The drug studies suggested Valsartan—sold under the brand name Diovan in Japan, and licensed for use in more than 100 countries—could help prevent strokes and angina, in addition to its acknowledged benefits in combating .

The firm used data from those studies to market its , playing up its supposed additional benefits.

"We take the arrest of our former employee and the indictment of our company very seriously," the unit said in a statement on its website.

"We deeply apologise to patients, their families and medical workers as well as Japanese people for causing these concerns and trouble," it added.

The 's Japan unit has also been embroiled in another scandal over allegations it did not properly disclose the possible side effects of leukaemia treatments.

In April, Novartis replaced the top executives at its Japanese arm over those allegations.

Under the country's pharmaceutical law, anyone found guilty of exaggerating advertising can face up to two years in prison or a fine of as much as two million yen ($19,000).

add to favorites email to friend print save as pdf

Related Stories

Japan prosecutors arrest ex-Novartis employee over data

Jun 11, 2014

Prosecutors on Wednesday arrested a former employee of the Japanese unit of Swiss pharmaceutical giant Novartis for allegedly manipulating research data to exaggerate the benefits of a popular blood-pressure drug.

Japan prosecutors raid Novartis over drug ad scandal

Feb 19, 2014

Japanese prosecutors on Wednesday raided the offices of the local arm of Swiss pharmaceutical giant Novartis over alleged exaggerated advertising for a popular blood-pressure drug, local media said.

Japan files criminal complaint against Novartis arm

Jan 09, 2014

Japan's health ministry on Thursday filed a criminal complaint against the local arm of Swiss pharmaceutical giant Novartis over alleged exaggerated advertising for a popular blood-pressure drug, the company said.

Japan to seek criminal prosecution of Novartis

Dec 18, 2013

Japan's health ministry intends to file a criminal complaint against the local arm of Swiss pharmaceutical giant Novartis over alleged fabrication of drugs data, a report said Wednesday.

Recommended for you

Using computers to design drugs

Aug 22, 2014

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

Aug 22, 2014

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

Aug 21, 2014

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments