Posted by JLM on November 5, 2002, at 19:25:04
In reply to Re: Lexapro 'failed' trial, posted by Anyuser on November 5, 2002, at 18:35:55
Well, the point is, we don't know how many studies they submitted for the NDA approval process. There could very well be 10 studies that show no positive effect from the drug. We don't
know because there is no requirement to publish the negative studies, and certainly Forrest wouldn't want anyone to see them. The fact that you have to submit a FOIA request to get them says a lot.Generally, it doesn't matter how many negative studies are sent to FDA for the NDA process. Prozac was approved on the basis of two positive studies. The other studies showed marginal benefits or NO benefits over placebo or impipramine. And yet the drug was still approved. As astounding as it sounds, all it takes generally is TWO POSITIVE studies to get approval, regardless of the number of negative studies submitted. Politics at FDA has a lot to do with it.
poster:JLM
thread:109458
URL: http://www.dr-bob.org/babble/20021101/msgs/126582.html