My employer asked me to falsify data!
an153878 at anon.penet.fi
an153878 at anon.penet.fi
Wed Dec 27 00:03:08 EST 1995
I have been employed by two separate, very small biotech
companies in the San Francisco Bay Area in which at various
times I have been asked to falsify data that was being collected
in order to submit an IND (Innovative New Drug Application)
to the FDA (Food and Drug Administration). I must post
anonymously because in no way do I want these experiences
associated with my career.
I hold a Bachelor's Degree in Molecular Biology and have
been employed as a Research Associate on both occasions
which these incidents occurred. The first time I was shocked.
It was quite an eye-opening experience to find out that
my PhD scientist superiors weren't really scientists after
all, but science fiction novelists, selling their claims to
the FDA in order to milk the investors that made all of our jobs
and paychecks possible. They wanted me to fabricate materials,
methods, results and conclusions in my lab notebook for
experiments they could not afford to have performed!
It was difficult for me hang around there much longer, so I
decided to move on. My next employer was about the same size
company, say 50 employees average. Going into my sixth
month there, I was informed that I would be transferred to
a project where my job would depend upon me reproducing the
data of another associate whose work had never been shown to
be reproducible, yet their data supported the efficacy of
the experimental drug being tested. I was very suspicious.
Aren't standards borne from reproducibility? I pointed out
that the person's work was not of a reproducible nature and
suggested my results would come from the experiments I performed
rather from the results of an associate. Within a week, this company
fired me, without giving me a reason. They actually asked me
to resign, which I refused; I needed my unemployment benefits.
I am wondering how common it is in the biotech industry to
encounter data falsification. Has anyone else out there
encountered it? Does anyone think the FDA would lift their
eyebrows if they were to read this post? Would the FDA even
be interested in knowing the names of my employers? What are
the legal implications of being employed by a company that
submits falsified data to the FDA? What are the legal implications
of being named a co-author on a publication which contains
fabricated data? How difficult is it to prove allegations like
Thanks for any helpful discussion or suggestion.
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