INITIAL SEVERITY AND ANTIDEPRESSANT BENEFITS: A META-ANALYSIS OF DATA SUBMITTED TO THE FDA This is a landmark study for several reasons: 1. The authors analyzed every SSRI study for four of the new-generation antidepressants submitted to the FDA for approval. Drugs included fluoxetine (Prozac), venlafaxine (Effexor), paroxetine (Paxil), and nefazodone (Serzone). 2. The number of patients was over 5000, and included a total of 35 trials. Usual drug trial only number in the hundreds of patients so a bigger study size is preferable as it provides a bigger population to see a drug's performance. My summary of it: A recent meta-analysis (def: evaluation and analyis of all drug studies available) by Kirsch, et. al. of all clinical trails submitted to the FDA for the licensing of four new-generation antidepressants showed only a modest benefit over placebo and when unpublished trial data was included the benefit fell below accepted criteria for clinical significance. The authors concluded that antidepressants showed clinically significant improvement only for the most very severely depressed patients and no difference for moderate levels of initial depression. Drug-placebo differences are relatively small, even for relatively depressed patients and the efficacy (effectiveness and usefullness) was attributed to a decreased responsiveness to placebo rather than increased responsiveness to the drug.
Lauren DeWitt, R.Ph.
*******NOTE FROM AMY: Drug companies test their pills against placebos (sugar pills) in trials to attempt to prove effectiveness. This breaks the blind by making it obvious to the researchers who is on drugs versus placebo, and the patient often doesn't think the drug is doing anything if they don't feel weird side effects. Drug companies also commonly code suicides and worsened depression as "no effect" and then if something bad happens or a study is very damaging for the marketing, they call it proprietary information and keep it hidden. Hopefully recent laws will stop this practice but I personally do not trust that the drug companies are going to comply willingly with so much money at stake. I attended a lecture a couple of years ago given by Dr. Graham Emslie... a prominent drug trial researcher. He admitted that they have not ever proven antidepressants effective and that the drugs have caused suicide. However he thinks they should keep trying to prove effectiveness in trials. Le's put a stop to these trials and say "NO MORE deaths so researchers and drug companies can profit and hook more patients!!!" You might be interested in the webcast of an NPR story called "Drug Test Cowboys" - people actually make a living enrolling in trials, and if you listen all the way to the end you will learn that if people report side effects, they are often kicked out of the trials and paid a pro-rated fee. Here is the url: http://www.npr.org/templates/story/story.php?storyId=9961631
|