Novartis Braces for Yet Another Japanese Malpractice Investigation

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According to The Japan Times, Novartis AGĀ (NYSE:NVS) failed to inform the Japanese government of several serious side effects associated with its leukemia drug, Tasigna. Novartis knew of more than 10 cases in which patients experienced serious side effects while being treated with Tasigna, but did not report these instances to Japanese officials. As a result, the Health, Labor, and Welfare Ministry has opened an investigation into whether or not Novartis broke the country’s pharmaceutical affairs law.

Two instances of serious side effects occurred during a highly scrutinized clinical trial conducted at the University of Tokyo Hospital, according to FiercePharma. During the trial, Novartis compared the effectiveness of various leukemia treatment, including the experimental drug, Tasigna, a follow-up to the company’s previous blockbuster leukemia treatment Gleevec, which is due to expire this year.

Previously, Japanese officials found that Novartis employees were more involved in the trial than is legally allowed. At least nine Novartis sales representatives were responsible for collecting patient questionnaires and then faxing them to the hospital, according to FiercePharma. Doctors are supposed to personally return the questionnaires; patient information shouldn’t have been handled by Novartis representatives at all. The trial, which took place between April 2013 and January 2014, involved collecting data from more than 3,000 patients being treated with Tasigna, according to The Japan Times.

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