Did Takeda Pharmaceutical downplay reports of heart failure in Actos patients? That's the accusation from a whistleblower who's sued the company. According to the suit, Takeda's U.S. unit didn't red-flag heart failure cases that weren't fatal and didn't require hospitalization when reporting them to the FDA.
As Bloomberg reports, a former Takeda medical reviewer, Helen Ge, alleges that those case reports weren't classified as serious adverse events as they should have been. In fact, the suit says, company officials told medical reviewers to "change their professional opinion" when assessing adverse events for FDA reporting. Ge says she was fired when she raised questions about the practice.
Actos and its rival drug, Avandia, in 2007 got FDA warnings that their use could exacerbate heart failure. Takeda wanted to make Actos appear safer than Avandia, Ge's suit claims. "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," the suit claims (as quoted by the news service). Avandia has since has been severely restricted in the U.S.
Ge sued under the False Claims Act in 2010, and the suit was recently unsealed, Bloomberg says. The Justice Department decided not to intervene in the suit, after checking out the claims. But Ge's lawyer says he believes that additional evidence will persuade prosecutors to join up.
- read the Bloomberg story