Novartis Braces for Yet Another Japanese Malpractice Investigation


According to The Japan Times, Novartis AG (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.

Novartis, for its part, notes that it has provided funding for leukemia research to the University of Tokyo Hospital for the past three years, to the tune of 8 million yen, or approximately $1.3 million. An editorial by The Japan Times argues that the government is responsible for ensuring that companies don’t have such easy access to clinical trials conducted at public institutions like the Tokyo Hospital. “The government needs to expand its support for researchers so that they don’t have to rely on money from the pharmaceutical industry,” the editorial reads, per FiercePharma.

This is not Novartis’ first offense in Japan, either. Last summer, Novartis employees were involved in a clinical trial of the drugmaker’s blood pressure medication Diovan, and earlier this year Japanese officials filed a complaint saying that Novartis had been advertising the drug using falsified data.

Novartis has since sacked its Japanese executives and has replaced them with representatives from its operations in Germany, Britain, and Canada.

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