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Novartis Never Filed 10K Side Effect Reports on 10 Drugs

Novartis Never Filed 10K Side Effect Reports on 10 Drugs

June 13, 2014 — Novartis has confirmed that at least 10,000 reports of side effects from ten different drugs were destroyed or never filed by employees in the company’s Japanese unit, according to a report by the Wall Street Journal.

Some drugs involved in the investigation include:

  • Gleevec: Leukemia treatment
  • Tasigna: Leukemia treatment
  • Xolair: Asthma treatment
  • Exelon: Alzheimer’s disease patch
  • Neoral: Immunosuppressive drug for organ transplants

Yesterday, prosecutors in Japan arrested Nobuo Shirahashi, 63, for allegedly altering data in a study involving Diovan, a best-selling blood pressure drug, to make it seem superior to its competitors. He is accused of falsifying data in studies conducted for Novartis in 2010 and 2011. According to the WSJ:

“The research on Diovan was conducted by several Japanese universities, some of which later found that the results had been falsified. Novartis has acknowledged a conflict of interest in the studies since it knew that Mr. Shirahashi took part without acknowledging his affiliation in published papers.”

In addition to the problems with Diovan, the WSJ reported that an internal investigation by Novartis found that some staff participated in a cover-up by shredding documents and deleting online files.

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