Dr. Helen Ge, in a qui tam lawsuit recently unsealed, claims that Takeda hired her under contract in September 2008, charging her with the task of reviewing various drugs in the Takeda portfolio—including Actos and bladder cancer—for various adverse reactions.
In her whistleblower complaint, which was filed under seal on June 18, 2010, Dr. Ge asserts that at a time when in excess of 100 cases of Actos bladder cancer had been reported to the company, the US Food and Drug Administration (FDA) only received 72 of those reports.
Actos became the golden child, almost overnight, in Takeda's drug portfolio after GlaxoSmithKline's Avandia was linked to a greater risk for heart attack and other cardiac events. Doctors switched their Type 2 Diabetes patients to Actos in droves, thinking that Actos carried less risk for Actos heart failure and other adverse reactions, to their patients.
To that point, Ge also asserts in her Actos lawsuit that Takeda failed to report all cases of Actos heart failure to the FDA. "Takeda instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as 'serious adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA," Ge says in her lawsuit, which was recently summarized in Lawyers Weekly USA (3/19/12).
When Ge approached Takeda with the accusation that the pharmaceutical company was underreporting cases of Actos heart failure and congestive heart failure events to the FDA, her contract with the firm was abruptly terminated.
Lawyers Weekly USA reports that last year, the FDA issued a safety bulletin surrounding the concern that taking Actos for more than 12 months is associated with an increased risk for bladder cancer. Type 2 diabetes is one of the maladies affecting some of the largest pockets of the US population. Treatment to manage diabetes is an ongoing process. Mitigating the risk for Actos bladder cancer, therefore, would require coming off Actos after a year and switching to other medications.
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"Takeda has caused thousands, if not millions, of false claims to be made on federal and state health care programs," the Actos lawsuit asserts. The case asserts causes of action under false claims statutes of no fewer than 24 states.
The qui tam whistleblower lawsuit for Actos bladder cancer and other Actos side effects was unsealed by US District Court Judge F. Dennis Saylor, in late February.