Ssris efficacy safety children ethical and scientific concerns
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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 .

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SSRIs, Efficacy, Safety & Children: Ethical and Scientific Concerns

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Ssris efficacy safety children ethical and scientific concerns

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

Ethical issues in pediatric pharmacology-1

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


Ethical issues in pediatric pharmacology 2

Ethical issues in pediatric pharmacology-2

Absence of knowledge on the extent of unpublished trial data creates uncertainty among the public and health professionals.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


Ethical issues in pediatric pharmacology 3

Ethical issues in pediatric pharmacology-3

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


Scientific concern 1 distortion

Scientific concern-1: Distortion

Distorted information in medical journals leads to biased interpretation.


Scientific concern 2 distortion

Scientific concern-2: Distortion

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


Scientific concern 3 sertraline response by age group

Scientific Concern-3:Sertraline Response by Age Group

Ages 6-11 -24.05 sertraline p= n.s.

-22.20 placebo

Ages 12-17 -21.55 sertraline

-18.20 placebo p=.01


Scientific concerns 4 phase iii and iv safety issues

Scientific concerns-4: Phase III and IV Safety Issues

  • Activation, agitation, hyperactivity, and restlessness occur frequently (0%-55%) in SSRI trials in youths suggesting a lack of standardized measurements.

  • Behavioral toxicity research can separate symptoms associated with drug from underlying psychiatric symptoms.

  • Suicide is a rare event requiring surveillance research in large populations.


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