Actos Drug Maker Knew of Congestive Heart Failure and Did Not Report It

A former medical reviewer at a U.S. unit of Takeda Pharmaceuticals claims fraud caused tens of thousands of false claims to be made on federal and state health care programs, causing hundreds of millions of dollars in damages.

Helen Ge, former medical reviewer at Takeda states that the company failed to classify “non-hospitalized or non-fatal” congestive heart failure cases as serious from late 2007 to January 2010.

Takeda, like other drug makers, is required to update the U.S. Food and Drug Administration’s Adverse Reporting System. This was not the case for the makers of Actos. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales,” as Ge claimed in the complaint filed in June 2010 and recently unsealed.

Ge claims that on “multiple occasions”, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, she was fired, according to the complaint.

Meanwhile, Takeda is currently facing hundreds of lawsuits from patients alleging that Actos use caused bladder cancer.  Ge claims that Takeda is “riddled with systematic fraud and deceit,” and that the company downplayed data suggesting a link between Actos and bladder cancer.

It seems, once again, that a pharmaceutical company cares about one thing….profits.  Would they ever have voluntarily recalled their drug if this whistleblower did not come forward and report them?

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