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Article #2636

When mistakes are made

#2636
From: John Bates
Date: Tue, 23 Apr 1996 00:00
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Why mistakes are made

Pharmaceutical development is littered with examples of compounds which have made
it to market ... and have been prescribed to man ... only to reveal serious toxicity.
Thalidomide is of course one of the earliest well documented example, but latterly we
have seen serious toxicity with certain non-steroidal anti-inflammatories,
benzodiazepines and countless others. 

The problem has always been the same. The toxicology studies have been performed ..
but since the toxicologists didn't know how to assess the toxicity of the compounds in
question (since they were "unknowns" from the toxicity stand-point) the assessments
were inappropriate and therefore the true toxicity's were missed. 

Can anyone tell me about similar oversights for one or two compounds which have
been cleared for release into the environment but subsequently found to be dangerous.
I know of course there are many examples, but having experience in the
pharmaceutical industry I'm not too sure which are the best examples. I need examples
which are well documented. Specifically  I need information on what  toxicity tests
were actually performed prior to release (i.e. why the tox studies failed).

Any advice would be greatly appreciated.

John Bates Ph.D, Cambridge, UK (ae55@cityscape.co.uk).
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From: ae55@cityscape.co.uk (John Bates)
Subject: When mistakes are made
Date: 1996/04/23
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