Abuse of Minors in Clinical Studies: A Worldwide Ethical Challenge for the 21st Century
Title: Abuse of Minors in Clinical Studies
Subtitle: A Worldwide Ethical Challenge for the 21st Century
Subject Classification: Medicine and Medical Ethics, Childhood Studies, Science, Research
BIC Classification: MMG, JFSP1, MB
BISAC Classification: MED071000, BUS070130, MED069000
Binding: Hardback, pp.306
Publication date: 17th May 2023
ISBN (printed book): 978-1-80441-135-3
ISBN (web pdf): 978-1-80441-136-0
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With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide.
This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Author: Klaus Rose was successively Global Head Pediatrics in two large international pharmaceutical companies and is now Chief Executive Officer of klausrose Consulting, Pediatric Drug Development & More, Riehen (BS), Switzerland
This title is currently being reviewed. Please check back for further updates in due course.