The U.S. District Judge F. Dennis Saylor issued an order to unseal a whistleblower case by a former Takeda Pharmaceuticals medical reviewer involving the failure to report bladder cancer and Congestive Heart Failure (CHF) adverse events for the diabetes drug Actos.
The whistleblower is Dr. Helen Ge, a medical doctor and former safety consultant to Takeda’s pharmacovigilance division. Dr. Ge worked to review adverse events and to identify and evaluate potential safety signals for the diabetes drug Actos, the only drug in the same class and competing with GlaxoSmithKline’s Avandia.
Dr. Ge had direct knowledge of the Actos bladder cancer risk and, according to the complaint, encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Takeda’s adverse event database for Actos held more than 100 bladder cancers reported to the company, but only 72 reported to the FDA, which Dr. Ge referred to as “a serious discrepancy.” Takeda, like other drug companies, is required to update the U.S. Food and Drug Administration’s Adverse Event Reporting System.
Takeda Pharmaceutical Co. failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, Dr. Ge claimed in a lawsuit. Additionally, the company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, and supervisors directed the whistleblower to change her “related” assessment to unrelated.
According to her complain, Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and that, as a result of this, the Congestive Heart Failure events were being under-reported to the FDA. As a result of her complaint, her contract with Takeda was terminated.
“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,” Ge said. Takeda wanted to push that Actos was safer than GlaxoSmithKline Plc (GSK)’s Avandia diabetes drug, and that the company downplayed data suggesting a link between Actos and bladder cancer, according to the complaint.
In 2007, the FDA ordered Takeda and Glaxo to place its strongest warning on the labeling of their drugs about the risk of congestive heart failure, a condition that occurs when the heart doesn’t adequately pump blood. 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. The Justice Department decided not to intervene in the suit, after reviewing the claim, but the plaintiff hopes that additional evidence will be enough to persuade federal regulators to take a second look.
Nina, owner of NinaRotz.com, is a freelance writer and blogger. Nina’s work has been published and linked on Associated Content, Yahoo! Shine, Yahoo! Voices, eHow, Live Strong, CNN, USA Today, The Wall Street Journal, as well as various online magazines and blogs.