Biotech giant Genentech put participants in its human trials for a cancer drug at risk by not following clinical rules and fired a high-level employee who questioned why the company was racing toward the approval deadline, according to a lawsuit filed by the worker who said she was targeted for whistle-blowing.
The suit filed in San Mateo County Superior Court by Juliet Kniley, a former senior clinical program manager at Genentech, alleges she was harassed, demoted and eventually let go after questioning the company’s failure to follow federal guidelines governing clinical trials.
The alleged violations put participants in the clinical trials "at unnecessary risk of death and injury,” according to the suit.
A message from a Genentech representative said she had no immediate knowledge of the suit.
Kniley worked with the Pi3 Kinase program team which was committing "illegal and unethical conduct” by deviating from scientific and ethical standards for human trials, according to her suit.
"This was the first time this drug was being tested in humans so they didn’t know what to expect. What was happening is management was speeding ahead without first waiting for the results of the earlier studies,” said Emily St. John Cohen, one of Kniley’s attorneys.
Kniley had received nothing but excellent reviews and promotions but, after complaining to higher ups about the team’s alleged violations of several laws and safety regulations in the fall of 2008, the suit claims that one doctor in particular verbally harassed and belittled her. Kniley also claims she was excluded from meetings which left her unable to fully function in her job and was twice told that Roche — Genentech’s parent company — would "take this molecule away from us” if it saw the more realistic timelines she presented.
In July and August of 2009, Kniley said she was instructed to let the clinical trial go ahead without the necessary approvals but, after refusing, was demoted and removed from the program.
The downgrade and removal was "pure retaliation” and damaged Kniley’s reputation at the company and in the community, the suit alleges.
Kniley’s performance review for that year was negative, which the suit claims was inaccurate, and she claimed the retaliation — and as a result other poor performance reviews and denial for a new position — continued until her termination Aug. 30, 2011, according to the lawsuit.
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