MEDICAL PAPERS

Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

Irving Kirsch1*, Brett J. Deacon2, Tania B. Huedo-Medina3, Alan Scoboria4, Thomas J. Moore5, Blair T. Johnson3

1 Department of Psychology, University of Hull, Hull, United Kingdom, 2 University of Wyoming, Laramie, Wyoming, United States of America, 3 Center for Health, Intervention, and Prevention, University of Connecticut, Storrs, Connecticut, United States of America, 4 Department of Psychology, University of Windsor, Windsor, Ontario, Canada, 5 Institute for Safe Medication Practices, Huntingdon Valley, Pennsylvania, United States of America

February 2008

Conclusions

Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.

http://paxilharmschildren.com/doc/10.1371_journal.pmed.0050045-S.pdf

Olfson M, et al.; Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults: A Case-Control Study

Arch Gen Psychiatry.2006;63:865-872

Conclusions: In these high-risk, antidepressant drug treatment does not seem to be related to suicide attempts and death in adults but might be related in children and adolescents.  These findings support careful clinical monitoring during antidepressant drug treatment of severely depressed young people.

  http://paxilharmschildren.com/doc/Literature1Olfson.pdf

Ethical Human Psychology and Psychiatry, Volume 8, Number I, Spring 2006

The SSRI Trials in Children:  Disturbing Implications for Academic Medicine

Jonathan Leo, PhD

Parrish, FL

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.

 http://paxilharmschildren.com/doc/Literature2-SSRIChildrenLeo2006.pdf

BMC Medicine

Research article Open Access

Suicide attempts in clinical trials with paroxetine randomized against placebo

Ivar Aursnes*1, Ingunn Fride Tvete2, Jorund Gaasemyr2 and Bent Natvig2

Conclusion: Our findings support the results of recent meta-analyses. Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may also be present in adults. 

Aursnes Ivar, et al., Suicide attempts in clinical trials with paroxetine randomised against placebo; BMC Medicine 2005, 3:14 i:10.1186/1741-7015-3-14

 http://paxilharmschildren.com/doc/Literature3-BMC-Suicideattemptsinclinicaltrialswithparoxetine-2005.pdf

Serious Adverse Drug Events Reported

to the Food and Drug Administration, 1998-2005

Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD

The interesting thing with this study is that paroxetine (Paxil) came in at #15 for death and #5 for serious injury and disability - Table 4. Most Frequent Suspect Drugs in Death and Serious Nonfatal Outcomes, 1998-2005.

This quite significant considering the thousands of different prescription drugs and over counter remedies sold and marketed in the US over this period.

Citation:

Thomas J. Moore, AB; Michael R. Cohen et al, ARCH INTERN MED/VOL 167 (NO. 16), SEP 10, 2007

Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

 http://paxilharmschildren.com/doc/Literature4ArchInMED.pdf