11/20/2012 9:23:50 AM
Helen Ge is now 0-for-2. Earlier this month, a federal judge tossed two different whistleblower lawsuits that the former drug safety consultant had filed against Takeda Pharmaceuticals. She alleged the drugmaker misrepresented or altered descripions of adverse events for the Uloric gout treatment and failed to report instances of bladder cancer and congestive heart failure concerning the Actos diabetes pill to the FDA. A former associate medical director at Harvard Clinical Research Institute, Ge was hired as a medical reviewer in the Takeda pharmacovigilance division. As we reported previously, she repeatedly lodged complaints about alleged discrepancies and shortcomings in reporting assorted and sordid adverse events, but was shown the door for her trouble. The separate whisteblower lawsuits were subsequently filed earlier this year. In the lawsuit concerning Uloric, Ge charged that Takeda avoided reporting adverse events, such as bone marrow failure, or that occurred after patients took the pill and one of several other medications. Interactions caused some patients to experience fatal reactions, severe bleeding or renal failure. She also claims Takeda failed to properly amend the labeling to reflect the alleged harm that could be caused by interactions.
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