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Was the FDA Review for Xanax XR Biased?

"[Xanax] may be less effective than clinicians and scientists have been led to believe, based on publications in medical journals," according to a recent article in Neuroscience News.

The article was based on research originally published in Psychological Medicine titled, "Unpublished trials of alprazolam XR and their influence on its apparent efficacy for panic disorder." The study tested for publication bias with alprazolam (Xanax) by comparing efficacy for panic disorder using results from published literature and the U.S. Food and Drug Administration (FDA).

Publication bias might have overstated the drug's effectiveness by over 40% — Erik Robinson, Neuroscience News

The researchers reviewed publicly available FDA data from phase 2 and phase 3 clinical trials conducted for extended-release alprazolam (Xanax XR) for the treatment of panic disorder. Of the five trials that were conducted for the FDA review, only one showed a positive outcome. According to Robinson, "Of the four not-positive trials, two were published conveying a positive outcome; the other two were not published."

Our study throws some cold water on the efficacy of this drug. It shows it may be less effective than people have assumed. — Erick Turner, MD, senior author of the study

This article and study reveal the all too common practice of cherry-picking studies and massaging their conclusions to gain FDA approval for a new drug. A practice that has left millions dealing with the life-altering after effects of poorly tested medications. And a practice that continues to this day.



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