Rational Use of Medicine in Children-The Conflict of Interests Story. A Review.
Journal
Rambam Maimonides medical journal
ISSN: 2076-9172
Titre abrégé: Rambam Maimonides Med J
Pays: Israel
ID NLM: 101538065
Informations de publication
Date de publication:
18 Jul 2019
18 Jul 2019
Historique:
entrez:
24
7
2019
pubmed:
25
7
2019
medline:
25
7
2019
Statut:
epublish
Résumé
United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development. We analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature. The US and EU definitions of a child are defined administratively (rather than physiologically) as being aged <17 years and <18 years, respectively. However, children mature physiologically well before their seventeenth or eighteenth birthdays. The semantic blur for these differing definitions may indicate certain conflicts of interest. Pediatric healthcare today is better than ever. Regulatory-related requirements for "pediatric" studies focus on labeling. Most of these studies lack medical usefulness and may even harm "pediatric" patients through administration of placebo and/or substandard treatment, despite the resultant publications, networking, patent extensions, and strengthened regulatory standing. Clinicians, parents, and ethics committees should be aware of these issues. New rules are needed to determine new pharmaceutical dose estimates in prepubescent patients, and when/how to clinically confirm them. Internet-based structures to divulge this information should be established between drug developers, clinicians, and regulatory authorities. A prerequisite for the rational use of pharmaceuticals in children would be to correct the flawed concept that children are discriminated against in drug treatment and development, and to abandon separate "pediatric" drug approval processes.
Sections du résumé
BACKGROUND
BACKGROUND
United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development.
METHODS
METHODS
We analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature.
RESULTS
RESULTS
The US and EU definitions of a child are defined administratively (rather than physiologically) as being aged <17 years and <18 years, respectively. However, children mature physiologically well before their seventeenth or eighteenth birthdays. The semantic blur for these differing definitions may indicate certain conflicts of interest.
CONCLUSIONS
CONCLUSIONS
Pediatric healthcare today is better than ever. Regulatory-related requirements for "pediatric" studies focus on labeling. Most of these studies lack medical usefulness and may even harm "pediatric" patients through administration of placebo and/or substandard treatment, despite the resultant publications, networking, patent extensions, and strengthened regulatory standing. Clinicians, parents, and ethics committees should be aware of these issues. New rules are needed to determine new pharmaceutical dose estimates in prepubescent patients, and when/how to clinically confirm them. Internet-based structures to divulge this information should be established between drug developers, clinicians, and regulatory authorities. A prerequisite for the rational use of pharmaceuticals in children would be to correct the flawed concept that children are discriminated against in drug treatment and development, and to abandon separate "pediatric" drug approval processes.
Identifiants
pubmed: 31335307
pii: RMMJ.10371
doi: 10.5041/RMMJ.10371
pmc: PMC6649781
doi:
Types de publication
Journal Article
Review
Langues
eng
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