FDA Lax On Clinical Trials Safety
This is so not a surprise: the agency has few inspectors, inspects few test sites and often after trials are complete. And so on.
A report is due from HHS's Inspector General later tdoay. The New York Times has this advance piece, in which no less than Art Caplan offers:
"'In many ways, rats and mice get greater protection as research subjects in the United States than do humans,' said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania."
I wonder why the feds have such a hard time understanding that regular old citizens--you know the ones who pay the freight around here--expect the agency to have a tense relationship with the companies it's supposed to regulate. But then this an agency that is set to approve Zyprexa for use in teens even though the drug has killed over 1,000 Americans.
More on this later.
Posted by Philip Dawdy at September 28, 2007 12:03 AM
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Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been.
Now there is a big problem, and we wonder why the words corrupt, and scumbag come into discussion, when you read further into that article, and take a look at CL Psych's post, then all of us should go out and drink whiskey straight up.
What the hell.