Citation

Rose K, Grant-Kels JM, Striano P, Oishi T, Neubauer D, Ettienne EB. J. Law Med. 2023; 30(1): 131-154.

Copyright

(Copyright © 2023, Thompson - LBC Information Services)

DOI

unavailable

PMID

37271955

Abstract

A new type of research has emerged with United States and European Union pediatric laws that request/demand separate clinical studies for vaccines and drugs in minors less than 18 years of age. Physiologically, minors mature before their 18th birthday. Medicine treats the body, not the administrative status. Many "pediatric" studies are performed in minors that bodily are no longer children, which makes them pointless. Traditional malpractice litigation in clinical research involves patients that were harmed in clinical studies. In the new type of "pediatric" studies, drugs known to work in humans are retested, pretending that "children" are uniquely different, which is incorrect. Minors are not another species. Patients are not treated at all (placebo group) or below standard-of-care (comparison to outdated treatment). Pediatric laws are the law, but not a free pass for harming patients. Where "pediatric" studies violate accepted norms of medical practice, lawyers should be aware of this challenge at the interface of medicine and law.

Language: en

Keywords

Child; European Union; Humans; United States; *Child Abuse; *Biomedical Research; *Malpractice; better medicines for children; Lawyers; malpractice litigation; pediatric clinical trials; pediatric drug development; pediatric laws