Rational Use of Medicine in Children-The Conflict of Interests Story. A Review.
Rambam Maimonides Med J
; 10(3)2019 Jul 18.
Article
en En
| MEDLINE
| ID: mdl-31335307
ABSTRACT
BACKGROUND:
United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development.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:
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:
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Rambam Maimonides Med J
Año:
2019
Tipo del documento:
Article
País de afiliación:
Suiza