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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.

By | August 16, 2012

image: Pharma Whistleblower Flickr, Brian Turner

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.

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Avatar of: LouiseM

LouiseM

Posts: 6

August 16, 2012

Genentech says: “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,â€쳌

All that may be true, and Kniley's accusations could still be correct. Genentech must answer her charges, which is that they began human trials before they received their clearance to do so. Their argument actually boils down to, "Well, we got it, so what's the big difference?"

The difference is Genentech's *certainty* that they would get the approval. After all, look at the lawsuits they would have been targets for of the drug hadn't gotten approval - testing an unproven drug *without* approval. Genenetch *knew* they would get approval.

How did they know that? Who, in the approval process, is in Genentech's pocket? And, if they will take Genentech's money, who else can buy - or has -bought theme?

God help us all. The only way for a federal regulator to be able to vote on the baisi of favoritism is because they have a self-justification, something like, "Well, human life like the ones being lost don't really matter. After all, they were sick and probably going to die soon anyway."

Sometimes ir seems that we have a whole government with a majority of people that think that way about other human beings, and more who are fighting to join them. How much would they take to ruin *your* life, though illness, debt, financial ruin, or death?

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