Takeda’s Adverse Event Database for Actos
The same whistleblower who has accused Takeda Pharmaceuticals of obscuring the seriousness of heart failure reports linked to Actos has also alleged that the company handled Actos bladder cancer reports the same way. Dr. Helen Ge, a former medical reviewer for the company, made the allegations in an Actos whistleblower lawsuit unsealed last month in Massachusetts federal court.
According to Ge’s complaint, Takeda’s adverse event database for Actos held more than 100 bladder cancers reported to the company, but only 72 were reported to the Food & Drug Administration, which Dr. Ge referred to as “a serious discrepancy.” Ge also alleges that at least 40 people enrolled in a study at Yale University were diagnosed with bladder cancer while taking Actos. Though Yale reported all of the cases as “related to” Actos, Ge claims that when she attempted to report them to the FDA database, she was directed to change her assessment by her superiors and Takeda-Japan.
Ge also that the company did not properly classify cases of congestive heart failure associated with the type 2 diabetes drug when they were reported to the FDA Adverse Event Reporting System. Ge claims Takeda was trying to make Actos appear safer than Avandia.
Pharmaceutical companies are required to report drug side effects to the FDA. But according to Ge, Takeda directed its medical reviewers to “change their professional opinion regarding the classification of Actos adverse events” on multiple occasions between 2007 and 2010. Ge also claims that when she protested, her contract with Takeda was terminated.