"Pediatric" Drug Studies Might Be the Largest Abuse in Medical Research in History. It Is Time for Lawyers to Step In.
| Autor: | Rose K; klausrose Consulting, Riehen, Switzerland., Grant-Kels JM; UConn Health, Farmington, Connecticut, United States., Striano P; Pediatric Neurology and Muscular Diseases Unit, Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, 'G. Gaslini' Institute, Genova, Italy., Oishi T; Howard University College of Pharmacy, Washington DC, United States., Neubauer D; Department of Child, Adolescent & Developmental Neurology, University Childrens' Hospital, Ljubljana, Slovenia., Ettienne EB; Howard University College of Pharmacy, Washington DC. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of law and medicine [J Law Med] 2023 May; Vol. 30 (1), pp. 131-154. |
| Abstrakt: | 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 Patients are not treated at all (placebo group) or below standard-of-care (comparison to outdated treatment).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. Competing Interests: The authors declare no conflicts of interest with respect to the research, authorship, and/or publication of this manuscript. |
| Databáze: | MEDLINE |
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