Last week a new article analyzing ALL the data from ALL the short term clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine was published in PLOS Medicine, [Public Library of Science, a peer reviewed open-access journal.]
Click Here to Read: “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration” Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria, Thomas J. Moore, Blair T. Johnson, February 26, 2008.
The Editors’ Summary includes the following:
“WHAT DO THESE FINDINGS MEAN?
These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients. The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most the severely depressed patients unless alternative treatments have been ineffective. In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.”
So was the marketing of these drugs not justified based on the submitted data, or are the authors biased as some advocates of SSRIs as first line treatment for depression claim?
Some interesting comments on the article are at:http://tinyurl.com/3dpx6o
Paul Mosher