Former Takeda safety consultant Dr. Helen Ge filed a whistleblower lawsuit against Takeda alleging the company failed to report bladder cancer and Congestive Heart Failure (CHF) events to the FDA for Actos, a type 2 diabetes drug. U.S. District Judge F. Dennis Saylor has ordered the whistleblower case unsealed.
According to the lawsuit, Ge was met with resistance when she attempted to report bladder cancer as related to Actos, and was terminated from Takeda when she complained about the under-reporting of CHF events in relation to Actos.
Ge says that the adverse event database for Actos at Takeda contained more than 100 bladder cancer events listed, while Takeda only reported 72 to the FDA. Ge also said that she was ordered to change Actos related congestive heart failure cases to unrelated, and that the company failed to classify non-fatal or non-hospitalized cases of CHF as serious in regulator reports.
In the whistleblower lawsuit, Ge said, “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.”