Citation

Rose K, Neubauer D, Grant-Kels JM. Rambam Maimonides Med. J. 2019; ePub(ePub): ePub.

Affiliation

Department of Dermatology, UConn Health, Farmington, CT, USA.

Copyright

(Copyright © 2019, Rambam Heath Care Campus)

DOI

10.5041/RMMJ.10374

PMID

31545703

Abstract

United States (US) and European Union (EU) laws attempt to counterbalance the presumed discrimination of children in drug treatment and drug development. The US Food and Drug Administration (FDA)-rewarded pediatric studies with antidepressants triggered in 2004 an FDA black-box warning of suicidality in young patients. Fewer antidepressants were prescribed, and the number of completed suicides of young persons increased. The dilemma between this warning and the need to adequately treat young depressed patients remains unsolved. We analyzed the history of drug development, the evolving view of diseases in young patients, US/EU pediatric laws, and pediatric studies triggered by FDA/European Medicines Agency (EMA) in depression and other diseases on the background of developmental pharmacology; financial, institutional, and other interests; and the literature. The FDA/EMA define children administratively, not physiologically, as <17 (FDA)/<18 years old (EMA). But young persons mature physiologically well before their 17th/18th birthday. Depression occurs in young persons, has special characteristics, but is not fundamentally different from adult depression. Young persons are not another species. Regulatory requirements for "pediatric" studies focus on "pediatric" labels. Many "pediatric" studies, including those in depression, lacked and lack medical sense and harm patients by placebo treatment although effective drugs exist. The FDA has partially abandoned separate "pediatric" efficacy studies, but not in psychiatry. Clinicians, parents, institutional review boards, and ethics committees should become aware of questionable "pediatric" studies, should re-evaluate ongoing ones, consider to suspend them, and to reject new ones. The concept of separate "pediatric" drug approval needs to be abandoned.

Language: en