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SSRIs, Efficacy, Safety & Children: Ethical and Scientific Concerns Julie Magno Zito, PhD Associate Professor of Pharmacy ...
Ethical issues in pediatric pharmacology-1  <ul><li>IRB approved consent is an explicit contract between families and the ...
Ethical issues in pediatric pharmacology-2 <ul><li>Absence of knowledge on the extent of unpublished trial data creates un...
Ethical issues in pediatric pharmacology-3 <ul><li>Maintaining proprietary restrictions on the publication of selected cli...
Scientific concern-1: Distortion <ul><li>Distorted information in medical journals leads to biased interpretation.  </li><...
Scientific concern-2: Distortion <ul><li>For example, the abstract of the recent JAMA study on sertraline for depression i...
Scientific Concern-3: Sertraline Response by Age Group <ul><li>Ages  6-11 -24.05 sertraline  p= n.s. </li></ul><ul><ul><li...
Scientific concerns-4:  Phase III and IV Safety Issues <ul><li>Activation, agitation, hyperactivity, and restlessness occu...
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4006OPH1_04_Zito

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Transcript of "4006OPH1_04_Zito"

  1. 1. SSRIs, Efficacy, Safety & Children: Ethical and Scientific Concerns Julie Magno Zito, PhD Associate Professor of Pharmacy and Psychiatry University of Maryland, Baltimore February 2, 2004 FDA Advisory Meeting
  2. 2. Ethical issues in pediatric pharmacology-1 <ul><li>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. </li></ul><ul><li>Assure participants that they will receive knowledge of the findings of the study . </li></ul><ul><li> </li></ul><ul><li> Derivan, et al., J Child Adolescent Psychopharmacology, 2003, in press </li></ul>
  3. 3. Ethical issues in pediatric pharmacology-2 <ul><li>Absence of knowledge on the extent of unpublished trial data creates uncertainty among the public and health professionals. </li></ul><ul><li>Registration of IRB approved trials should be required to improve awareness of the completeness of studies and subsequent publication. </li></ul><ul><li>Dickersin and Rennie, JAMA, 2003 </li></ul>
  4. 4. Ethical issues in pediatric pharmacology-3 <ul><li>Maintaining proprietary restrictions on the publication of selected clinical trial data has led to publication bias and it distorts meta-analysis. </li></ul><ul><li> Lexchin, et al. BMJ, 2003 </li></ul>
  5. 5. Scientific concern-1: Distortion <ul><li>Distorted information in medical journals leads to biased interpretation. </li></ul>
  6. 6. Scientific concern-2: Distortion <ul><li>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. </li></ul><ul><li>Wagner, et al., JAMA, 2003 </li></ul>
  7. 7. Scientific Concern-3: Sertraline Response by Age Group <ul><li>Ages 6-11 -24.05 sertraline p= n.s. </li></ul><ul><ul><li>-22.20 placebo </li></ul></ul><ul><ul><li>Ages 12-17 -21.55 sertraline </li></ul></ul><ul><ul><li> -18.20 placebo p=.01 </li></ul></ul>
  8. 8. Scientific concerns-4: Phase III and IV Safety Issues <ul><li>Activation, agitation, hyperactivity, and restlessness occur frequently (0%-55%) in SSRI trials in youths suggesting a lack of standardized measurements. </li></ul><ul><li>Behavioral toxicity research can separate symptoms associated with drug from underlying psychiatric symptoms. </li></ul><ul><li>Suicide is a rare event requiring surveillance research in large populations. </li></ul>
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