The 2011 whistleblower lawsuit filed by former Takeda medical reviewer Helen Ge against the pharmaceutical company, which alleges that Takeda downplayed the number negative events associated with the type 2 diabetes drug Actos, including bladder cancer and heart failure, that it reported to the FDA.
The whistleblower lawsuit, which was unsealed earlier this year, further alleges a financial connection between Takeda and Cleveland Clinic’s Dr. Steven Nissen, who authored a meta-analysis that showed Avandia, also a type 2 diabetes drug, was more dangerous than Actos. The lawsuit also alleges that Nissen was the principal investigator for the Actos phase 2 PERISCOPE trial, and that the trial used technologies invented by Nissen as part of the trial. For this, the suit claims, “payment Nissen received from Takeda through Cleveland Clinic Foundation was estimated to be $8 million to $10 million” for this participation in PERISCOPE, while Cleveland Clinic garnered over $13 million in revenue from Takeda for the Nissen invented imaging technologies.
Nissen has previously stated that he received no personal income from the drug maker, and that the funds Ge estimates that Cleveland Clinic received were off base.