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Actos Whistleblower Claims She was Preventing from Reporting Bladder Cancer to FDA

Filed March 28th, 2012 Laurie

A whistleblower case involving a former Takeda Pharmaceuticals medical reviewer has been opened by U.S. District Judge F. Dennis Saylor. Dr. Helen Ge was a safety consultant to the company’s pharmacovigilance division. Part of Ge’s job was to reverse the adverse events of drugs in order to identify and evaluate safety signals for the diabetes drug Actos.

According to the lawsuit, Ge had direct knowledge of an increased risk of bladder cancer associated with the medication. When she attempted to report the risk, she was met with resistance from her superiors. Over 100 cases of bladder cancers related to Actos were reported to the company, but only 72 were reported to the FDA. Ge said the discrepancy was a serious one.

Takeda also failed to accurately report to regulators hundreds of cases of heart failure associated with Actos. The lawsuit claims the company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, and supervisors directed the whistleblower to change her “related” assessment to unrelated.

“Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales,” Ge said. Taketa was allegedly intent on marketing Actos as being safer than GlaxoSmithKline’s diabetes drug, Avandia and wanted to downplay data pointing to a link between Actos and bladder cancer.

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