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

Rose, Klaus.
2023
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Title
Abuse of Minors in Clinical Studies : A Worldwide Ethical Challenge for the 21st Century.
Author
Rose, Klaus.
Edition
1st ed.
ISBN
9781804411360
9781804411353
Published
Bradford : Ethics International Press Limited, 2023.
Copyright
©2023.
Language
English
Description
1 online resource (305 pages).
Summary
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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Abuse of Minors in Clinical Studies
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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 &
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.

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