an153878 at anon.penet.fi wrote:
: 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
: this?
Very difficult.
FDA appears mostly to focus on safety data for the initiation of
clinicals, and efficacy thereafter. While this is an appropriate focus (I
am a big supporter of FDA), there has been a tendency to let some products
through without sufficiently checking the scientific justification for
study. An example is Centoxin from Centocor. With the exception of the
inventors, every scientist that I know of who worked with this so-called
human IgM anti-endotoxin knew that it was irrelevant for sepsis. The
clinical trials were halted when it was noted that patients who received
placebo were surviving at a higher frequency than those receiving "drug".
You're caught up in a multi-billion dollar machine, and maybe you've
worked at a couple of companies with over-zealous management. Check to
see if there are two sides to the story before trying to whistle-blow.
Rick
--
--
-- cytact at netcom.com
