Thursday, March 04, 2010

Lisa Bero - Bias in drug trials



Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

2 comments:

Anonymous said...

That was 2001 - 2002 and only discusses the behavior of the companies.

While at the FDA on mulitple occassions with different drugs I saw FDA officials pressure reviewers to change their conclusions, reviewers call negative studies positive, and sponsor's lie or provide intentionally misleading conclusions in advisory committee meetings with the FDA simply beinq quiet or saying we agree when we knew it wasn't true.

Things are much worse now.

ex-FDA reviewer

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