The SSRI Trials in Children: Disturbing Implications for Academic Medicine

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.

Is the Efficacy of “Antidepressant” Medications Overrated?

“…The efficacy of antidepressants in children is particularly tenuous (Leo, 2006). A recent meta-analysis (Spielmans & Gerwig, 2014) found no significant differences between newer-generation antidepressants and placebo on self-reported depressive symptoms (p = 0.36) or measures of quality of life, global mental health, self-esteem, and autonomy (p = 0.13).…”

“…Imipramine produced significantly greater improvement in HRSD scores than fluoxetine. The second trial (N = 219) employed an unusual design feature: a drug run-in phase (Leo, 2006). When all trials are combined, mean weighted improvement on the HRSD was 8.3 points for fluoxetine and 7.3 points for placebo.…”

The ethics of paediatric anti-depressant use: erring on the side of caution

“…The link between antidepressant use and suicidality has been noted for a number of years, first in adults and then in children 16. However clinical trials investigating this risk have been hugely controversial with problems such as conflicts of interest,17 and selective publication 18. On balance, the evidence suggests that antidepressant medication leads to an increased risk of suicidality in 2–3% of children and adolescents and in 2004 the FDA put a “black box warning” on all antidepressants in the US to that effect 19.…”

“…During this time period prescriptions have continued to rise unabated and reports from the US and Canada22 show that the fastest rising age group for antidepressant prescriptions is in the pre-school range. Worryingly, one of the reasons for this misalignment of evidence and practice may be due to the ignoring of scientific evidence when it goes against traditional, accepted medical convention 33 34…”

Ethical Issues in Treatment and Intervention Research With Children and Adolescents With Behavioral and Mental Disorders

“…Over the last several decades, research has resulted in substantial progress in the development of effective behavioral and pharmacological treatments for a wide range of childhood disorders (Hibbs & Jensen, 1996;Kazdin & Weisz, 2003;Phelps, Brown, & Power, 2002). Despite such progress, limitations in scientific knowledge and continuing controversies concerning treatment of child and adolescent mental disorders (Leo, 2006) create an imperative to conduct research to establish the efficacy of treatment (Kazdin & Weisz, 2003;Phelps et al, 2002). However, the design and implementation of research concerning psychological and psychopharmacological treatments for children and adolescents with mental disorders raise inherent ethical challenges that need to be addressed (Derivan, Leventhal, March, Wolraich, & Magnozito, 2004;Hoagwood, Jensen, & Fisher, 1996).…”