Here's another overseas arrest of a Big Pharma ex-employee. Japanese police brought in Nobuo Shiraishi, a former Novartis ($NVS) worker linked to discredited studies of the company's blood pressure drug Diovan. Shiraishi is suspected of violating the country's pharma laws by providing false data to researchers, Tokyo prosecutors said in a statement.
As Reuters reports, the allegedly manipulated data was intended for use in advertising Diovan. Japan's false-advertising laws prescribe stiff penalties, including up to two years in prison, a fine of up to 2 million yen ($19,600) or both. The government has already filed a criminal complaint against the company, accusing its Japanese unit of exaggerated Diovan advertising.
It's the latest development in an ongoing probe into Novartis study data. The scandal kicked off with the retraction of Diovan studies, on worries that Novartis employee involvement in the research skewed the results. More recently, scrutiny fell on leukemia drug research; Novartis sales reps allegedly worked directly with researchers and processed data in a study of leukemia drug side effects--including the side effects of Novartis' treatments Gleevec and Tasigna.
Novartis has cracked down hard on its employees as the allegations unfolded. The Swiss drugmaker cut executive pay, dismissed two of its Japanese unit's top employees, and launched its own internal probe. The company also apologized publicly for its role in the data scandals.
Its response to Shiraishi's arrest included another mea culpa: "Regarding the arrest of our former employee, we take this seriously," the company said in a statement (as quoted by Reuters). "We will continue to cooperate completely with the investigating authorities, and we again apologize deeply for the concern and difficulties this has caused."
Meanwhile, Japanese media reports that Novartis' internal investigation unearthed 10,000 cases of leukemia drug side effects that were never disclosed. The 10,000 cases stretch back to 2002 and include some that should have been reported to the Japanese government. The company tells Japan Times that it's now examining the side-effects data in detail. Japanese officials were already looking into allegations involving 3,000 side-effect reports collected last year.