A former medical reviewer for Takeda Pharmaceuticals has filed a whistleblower lawsuit alleging the company hid heart risks associated with its Actos type 2 diabetes drugs. According to a report from Bloomberg News, whistleblower Helen Ge claimed Takeda failed to properly report hundreds of congestive heart failure cases associated with Actos to the U.S. Food & Drug Administration (FDA).
Ge’s whistleblower lawsuit was filed in June 2010 in U.S. District Court, District of Massachusetts. It was unsealed recently, when the U.S. Justice Department declined to join the lawsuit, Bloomberg reported. Despite the federal government’s refusal to join her suit, Ge is going ahead with her claim. The lawsuit was filed under the federal False Claims Act, which entitles GE to as much as 30 percent of what the government recovers.
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, Takeda allegedly failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010.
“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 allegedly 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.
Ge’s lawsuit alleges Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments” on multiple occasions. She further alleges that when she complained, Takeda ended her contract.
“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, Ge alleges.
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.
As we’ve reported previously, Actos is the best selling type 2 diabetes drug in the world, and according to the Associated Press, Takeda says the drug accounted for $3.4 billion in sales in 2011. However, U.S. sales of Actos fell by roughly 3 percent last year.
The past year has not been a good one for Actos. In 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.
The Actos bladder cancer controversy has sparked a wave of litigation against Takeda in the U.S. Actos bladder cancer lawsuits were recently consolidated in a multidistrict litigation in U.S. District Court, Western District of Louisiana.
In a study released August 24, 2010, Actos was found to have the same dangerous heart side effects as Avandia. The study conducted by HealthCore Inc., analyzed the medical records of 28,938 people from 2001 to 2005 who took either Avandia or Actos. The data showed that about 4 percent of each group died from heart failure or a heart attack.
