Healthy Skepticism Library item: 6181

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Leo J.
The SSRI trials in children: disturbing implications for academic medicine.
Ethical Hum Psychol Psychiatry 2006 Spr; 8:(1):29-41

Abstract:

The recent announcement by the Food and Drug Administration (FDA) requiring pharmaceutical companies to warn patients about the increased likelihood of suicidal thoughts when taking antidepressants was largely due to the recent availability of data that had gone unreported in the original research reports. The current article is a summary of the comparison between the published literature and the recently released data available on the FDA web site, with a focus on Prozac, Paxil, and Zoloft. The discrepancies between the two versions suggest that the scientific community was not given enough information in the published medical literature to make adequately informed decisions about the optimal method for treating emotionally distressed children. There are many voices that want to blame the FDA for its role in the widespread use of these medications. The current article focuses on the role that academic medicine played in the process whereby these medications became so widely accepted.

Keywords:
Child* Clinical Trials* Depressive Disorder/drug therapy* Drug Approval Drug Industry Evidence-Based Medicine Humans Publishing/standards* Serotonin Uptake Inhibitors/adverse effects* Serotonin Uptake Inhibitors/therapeutic use Suicide United States United States Food and Drug Administration