Pfizer Exec Gets Green Light to Sue Over Dirty Trial Data

Pfizer Exec Gets Green Light to Sue Over Dirty Trial Data

March 6th, 2012 // 1:53 pm @

Source: Pharmalot

A former Pfizer oncology director has been given a green light by a federal judge to pursue a whistleblower lawsuit against the drugmaker over claims that allegedly ‘dirty data’ was being hidden from the FDA. And the judge struck down a Pfizer argument that the former employee, who claimed she lost her job over the disclosures, was not protected by a state labor law governing retaliation.

Here is the background: For two years, Delina Ferretti was director of oncology at Pfizer, where she was responsible for handling clinical operations for various compounds and overseeing data reviews. But five months into the job, she noticed a problem with one drug that was in Phase I testing – study participants were using prohibited medications and adverse events were not reported to the FDA.

In effect, the data was dirty. And Ferretti asked two clinical project managers, who concurred, according to her lawsuit. So in November 2008, she told her supervisor that the study needed to be redone and that Phase III testing should not be undertaken. As the lead clinical protocol manager, Ferretti was responsible for overseeing Phase II studies and establishing Phase III studies.

Her entreaties went nowhere, so she later informed Louis Denis, who was director of clinical research for Pfizer Oncology at the time, according to the lawsuit. He allegedly refused to distribute the information to study sites or clinical investigators, and ordered Ferretti to rescind her communications about the data on the drug, which was called PF-0299804 and was part of the PanHER program.

She claims she was subsequently ostracized and later transferred to another program, but ultimately, was given poor performance reviews and was fired in August 2010, but not before reporting the episode to the internal Pfizer compliance hotline. She filed her lawsuit, which you can read here, one month later.

In response, Pfizer argued that California’s labor code, which says that an employer may not retaliate against an employee for refusing to participate in activities that violate state or federal law, did not apply. The drugmaker maintained that Ferretti’s refusal to proceed with the clinical trial work for the drug was not considered protected activity (read here). But US District Court Judge Lucy Koh disagreed.

“Thus, taking all the facts in the light most favorable to plaintiff, as the court must on a motion to dismiss, it is reasonable to infer that plaintiff refused to participate in defendant’s PanHER program because defendant’s PanHER program violated and would continue to violate several federal IND regulations,” Koh wrote in her ruling last week (here is the ruling).

By the way, Ferretti also maintained that Pfizer, at the time her lawsuit was filed, had still not provided a clinical study report to the FDA, allegedly because the drugmaker was concerned about the 200 instances in which study participants had taken other medications and the lack of adverse events reported to the agency or the annual update of an investigator’s brochure.

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