Pharma Whistleblower

A former manager at Genentech claims the company bypassed ethical and clinical guidelines in order to rush a promising drug through clinical trials.

Aug 16, 2012
Cristina Luiggi

A former Genentech senior clinical program manager filed a lawsuit against the company claiming she was unfairly dismissed after voicing her concerns that a clinical trial of a promising new drug violated safety regulations and jeopardized the health of its human participants.

While she was at Genentech, Juliet Kniley was in charge of the Pi3 Kinase program, which was ushering the cancer drug into clinical trials.

“This was the first time this drug was being tested in humans so they didn’t know what to expect,” Emily St. John Cohen, one of Kniley’s attorneys, told The San Mateo Daily Journal. However, according to the lawsuit, in the summer of 2009 Kniley’s higher ups instructed her to proceed with the clinical trials even though they had yet to clear the approval process. When Kniley refused, she was removed from the program. Afterward, she says she was verbally harassed, received negative reviews for her work, and eventually let go—a move that she claims was done in “pure retaliation.”

Genentech has denied Kniley’s allegations. “All of our clinical studies are conducted in compliance with international guidelines according to Good Clinical Practice and must be approved by regulatory authorities and Ethics Committees or local Institutional Review Boards,” a company spokeswoman stated in an email to Pharmalot.