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• W2974261467 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." @default.
• W2974261467 created "2019-09-26" @default.
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• W2974261467 date "2019-10-29" @default.
• W2974261467 modified "2023-09-25" @default.
• W2974261467 title "Too Many Avoidable Suicides Occur Worldwide in Young Patients" @default.
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• W2974261467 doi "https://doi.org/10.5041/rmmj.10374" @default.
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