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Whistleblower Lawsuit Claims Actos Health Risks Hidden

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A whistleblower lawsuit is pointing to more potential Actos safety problems, alleging that the drug’s maker hid the seriousness of congestive heart failure cases associated witht he drug. Actos (pioglitazone) is prescribed for the treatment of Type 2 diabetes and is manufactured by a U.S. unit of Takeda Pharmaceutical Co.

According to whistleblower, Helen Ge, a former Takeda medical reviewer, Takeda Pharmaceutical allegedly neglected to provide accurate reports to regulators concerning hundreds of congestive heart failure cases linked to Actos, said Bloomberg News. The unfiled reports spanned from late 2007 to January 2010, said Ge, in the complaint filed in federal court in Boston. Drug makers are mandated to update the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (AERS).

“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the complaint, filed June 2010 and just recently unsealed, wrote Bloomberg News. “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 added.

The case, filed by Ge on behalf of the government and against Takeda Pharmaceuticals North America Inc., became public after the U.S. Justice Department declined to join the case late last month; 24 U.S. states also declined to join according to Ge’s attorneys, said Bloomberg News. The attorneys say they are unconcerned with the Justice Department’s decision as its decision is typical and companies tend to settle cases when the government intervenes, said Bloomberg News. Plaintiff attorneys also feel that discovery documents will likely induce the government to become involved but that, regardless, Takeda violated the False Claims Act.

According to the complaint, Ge alleged that Takeda routinely “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” Ge said that when she refused, “her contract was summarily terminated,” wrote Bloomberg News. The complaint noted that Takeda wanted Actos to appear safer than GlaxoSmithKline Plc’s Avandia diabetes drug.

Ge sued under the federal False Claims Act and similar state statutes and seeks to recover damages on behalf of those governments and, as is typical in whistleblower cases, would be entitled to 15-30% of any recovery, Bloomberg News explained. “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, the complaint stated. Takeda’s culture is “riddled with systematic fraud and deceit,” and minimized data pointing to an Actos bladder cancer link, the complaint noted.

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