SSRIs, Efficacy, Safety & Children: Ethical and Scientific Concerns. FDA Advisory Meeting. Julie Magno Zito, PhD Associate Professor of Pharmacy and Psychiatry University of Maryland, Baltimore February 2, 2004. Ethical issues in pediatric pharmacology-1 .
FDA Advisory Meeting
Julie Magno Zito, PhD
Associate Professor of Pharmacy and Psychiatry
University of Maryland, Baltimore
February 2, 2004
IRB approved consent is an explicit contract between families and the study investigator to produce knowledge to advance science. When negative findings are suppressed, the contract is breached.
Assure participants that they will receive knowledge of the findings of the study.
Derivan, et al., J Child Adolescent Psychopharmacology, 2003, in press
Absence of knowledge on the extent of unpublished trial data creates uncertainty among the public and health professionals.
Registration of IRB approved trials should be required to improve awareness of the completeness of studies and subsequent publication.
Dickersin and Rennie, JAMA, 2003
Maintaining proprietary restrictions on the publication of selected clinical trial data has led to publication bias and it distorts meta-analysis.
Lexchin, et al. BMJ, 2003
Distorted information in medical journals leads to biased interpretation.
For example, the abstract of the recent JAMA study on sertraline for depression in children and adolescents implies that favorable response occurred in both younger (6-11) and older (12-17) youths.
Wagner, et al., JAMA, 2003
Ages 6-11 -24.05 sertraline p= n.s.
Ages 12-17 -21.55 sertraline
-18.20 placebo p=.01