A former medical reviewer for Takeda Pharmaceuticals has accused the company of downplaying Actos bladder cancer cases, as well as congestive heart failure, when reporting adverse events to the U.S. Food & Drug Administration (FDA). The allegations were made in an Actos whistleblower lawsuit unsealed last month in U.S. District Court, District of Massachusetts.
According to Bloomberg News, the complaint was first filed in 2011 by Helen Ge, who claims her contract with Takeda was ended after she complained about the way Takeda had instructed medical reviewers to report Actos adverse events to the FDA. All drug makers are required to update the FDA’s Adverse Event Reporting System when they receive side effect reports.
According to Ge’s whistleblower lawsuit, she personally reviewed at least 10 bladder cancer cases reported by Yale University involving patients treated with Actos who were enrolled in a postmarket study investigating Actos and bladder cancer. Ge further claims that Yale reported that at least 40 other subjects in that study 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. She further alleges that Takeda’s adverse event database for Actos held more than 100 bladder cancers reported to the company, but only 72 were reported to the FDA, which Dr. Ge referred to as “a serious discrepancy.”
This past June, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The June safety communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda officially recalled Actos from the French market in July.
In her whistleblower lawsuit, Ge also alleges that Takeda failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010 when they were reported to the FDA. The Actos label has included a Black Box Warning – the FDA’s most serious safety alert – regarding its association with congestive heart failure since 2007.
According to her complaint, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments” on multiple occasions. She claims Takeda wanted it to appear that Actos was safer than Avandia, a rival diabetes drug made by GlaxoSmithKline. As we’ve reported previously, Avandia sales have been restricted by the FDA because of its association with heart attacks.
“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’s lawsuit alleges.
“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, she claims.
Ge’s Actos whistleblower lawsuit was filed under the federal False Claims Act, which allows whistleblowers to bring suit on behalf of the federal government, and entitles whistleblowers to as much as 30 percent of any recovery. While the U.S. Justice Department has so far declined to intervene in Ge’s lawsuit, she is pursuing it herself.