A whistle-blower claims that Takeda Pharmacueticals failed to provide accurate reports about hundreds of congestive heart failures associated with the its diabetes medication Actos. The allegations were made public as part of a lawsuit filed by former Takeda medical reviewer Helen Ge. See the Bloomberg write up here.
Ge claims that the company failed to classify “non-hospitalized or non-fatal” congestive heart failure cases as serious from late 2007 to January of 2010. She alleges that the motivation for concealing these adverse events from regulators was driven by economic decision to improve the safety profile of Actos to increase sales.
Takeda, like all other drug manufacturers, is required to provide an accurate representation of adverse events to regulators, and if these allegations are true, Takeda has attempted to circumvent this requirement in an effort increase profits.
Ge claims that Takeda’s culture is “riddled with systematic fraud and deceit.” She claims that in addition to the hiding congestive heart failure risks, the company also downplayed their own data suggesting a link between Actos and bladder cancer.
The U.S. Justice Department and 24 states have declined to join Ge’s lawsuit, but her attorneys are confident that documents attained during discovery will induce the government to join the case.
The suit was filed under the False Claims Act and seeks to recover damages on behalf of governments that have paid for tens of thousands of false claims through health care programs.