Abuse of Minors in Clinical Studies : A Worldwide Ethical Challenge for the 21st Century.

Intro -- Foreword -- Chapter 1 -- Introduction -- References -- Chapter 2 -- Care of Children in History -- Midwifery, classical academic medicine, and medicine's ancient roots -- Hygiene and prevention of infectious diseases -- Baby &amp -- infant nutrition -- Child advocacy -- The American Academy of Pediatrics (AAP) and conflicts of interest -- Children's rights and their alleged right to have properly tested medicines -- Conclusions -- References -- Chapter 3 -- What is a Child? -- Conclusion -- References -- Chapter 4 -- Emergence of Pediatric Medicine in the 20th Century -- Surgery -- Cancer and other malignancies -- Vaccines and vaccination -- Rheumatology -- Depression -- Conclusion -- References -- Chapter 5 -- The Thalidomide Disaster Triggers Modern Drug Development -- References -- Chapter 6 -- Children as "Therapeutic Orphans" and Developmental Pharmacology -- No major disasters in pediatric medicine -- Developmental physiology and pharmacology -- Children: a neglected population? -- On-label/ off-label use of drugs in children -- Extrapolation from adults to "children" -- Pediatric exclusivity -- Reality is slowly kicking in, but this is not yet officially recognized -- References -- Chapter 7 -- Questionable Pediatric Studies -- Cancer and malignancies before the 18th birthday -- Malignant melanoma -- Autoimmune arthritis in minors/ juvenile idiopathic arthritis (JIA) -- Epilepsy -- Regulatory territorial demands -- Bizarre conclusions from pointless studies -- Misogynist studies -- Multiple sclerosis -- Further questionable studies -- Conclusions -- References -- Chapter 8 -- The Declaration of Helsinki and Research in Minors -- References -- Chapter 9 -- The International Committee of Medical Journal Editors (ICMJE) -- References -- Chapter 10 -- The Council for International Organizations of Medical Sciences (CIOMS).

References -- Chapter 11 -- Institutional Review Boards (IRBs) and Ethics Committees (ECs) -- References -- Chapter 12 -- Gillick Competence -- References -- Chapter 13 -- New Conflicts of Interest in Medical Research -- References -- Chapter 14 -- Neonatology -- References -- Chapter 15 -- Conclusions and Outlook -- References.

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.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.