February 3, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Zurich, Switzerland-based Novartis AG reported today that Japan’s Ministry of Health, Labor and Welfare (MHLW) sent the company pre-notification that it would suspend the company’s Japanese business unit, Novartis Pharma K.K., temporarily.
“While we would need to evaluate the details of any proposed business suspension Order from the MHLW,” the company said in a statement, “we believe that the financial impact will be manageable.”
The business suspension is reported to be for about 15 days. The suspension is apparently related to the company’s failure to report the side effects of two of its leukemia medications, Tasigna and Gleevec.
This follows problems Novartis has had with the Japanese unit over the last year. In May the health Ministry began investigating the Tasigna study, which found that, of 3,000 Japanese patients taking the drug, 30 had side effects, some which weren’t reported to the government appropriately.
It also follows the arrest of a former Novartis AG employee, Nobuo Shirahashi, for suspicion of falsifying research data. Shirahashi was accused of altering data involving blood pressure medication Diovan. Other staffers were alleged to have shredded documents and deleted online files. The company made changes to top management in Japan as a result, and re-evaluated and modified its governance practices.
On Jan. 9, 2014, Japanese prosecutors pressed criminal charges against Novartis. The findings indicates the company broke the law by using misleading advertising about Diovan. The penalties for the charges could include a fine of up to $19,000 and a prison term of up to two years.
“It’s no easy matter for the company to regain trust,” said Iwao Kuwajima, chair of the Japanese Organization of Clinical Research Evaluation and Review in a statement. “This is a huge issue.”
The Diovan data was created by researchers at several Japanese universities. Later analysis found some of the data had been faked. Novartis executives have denied company involvement.
The company’s sales were also hit by the scandal. According to company records, Japan accounts for about 25 percent of Diovan sales. “Since last year, we’ve been saying in our news conferences that we need to regain any trust we’ve lost from the issue,” said Yumi Ishii, Novartis spokeswoman in a statement. “That position does not change.”
“The filing of criminal complaints is a symbolic move,” said Shinichiro Ueda, professor of clinical pharmacology at the Graduate School of Medicine at University of the Ryukyus in Okinawa in a statement. “It not only hurts Novartis’s reputation, but also indicates how the Japanese medical community needs to raise the quality of its clinical research.”
At this time, there are no further details about the 15-day suspension.
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