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This are the slides used by Barry in his presentation at the Vatican. The presentation asked if the clinical trial evidence supports the global rising of prescriptions to youth. The answer is an …

This are the slides used by Barry in his presentation at the Vatican. The presentation asked if the clinical trial evidence supports the global rising of prescriptions to youth. The answer is an unequivoval "NO." Guidelines are offered for prescriptive practice to youth.

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  • 1. The Question of the Use of Psychiatric Pharmaceuticals in Paediactrics
    Pope Benedict XVI: “Scientific predictability also raises the question of the scientists’ ethical responsibilities...Certainly this means avoiding needlessly alarming predictions when these are not supported by sufficient data…But it also means avoiding the opposite, namely a silence born of fear, in the face of genuine problems.”
  • 2.
  • 3. Children and Prescription Rates Increasing Globally
    In the US, spending for meds for child behavior problems eclipsed any other drug category, including antibiotics
    While the US leads the world in psychiatric prescriptions to youth, global use of ADHD drugs has increased by 274% and antipsychotics have doubled across Europe
  • 4. Children and Prescription Rates Increasing Globally
    The number of youth taking 1 or more psychiatric medicines has hit nearly 9% in the US, 6% in the UK, and 3% in Australia—although not one clinical trial has examined polypharmaceutical intervention with children
  • 5. Study of poor children found that 26% on antipsychotics; Poor children 4 times more likely to be on antipsychotics
    57% of foster children are taking 3 or more psychiatric drugs, 6 times national average
    • Children in state custody greatest predictor of psychotropic drug use
    • 6. Children in foster care 16 times more likely to be medicated…Gabriel
  • Gabriel Was a Foster Child
    Gabriel was on Vyvance for ADHD, Lexapro, an antidepressant, Zyprexa, an antipsychotic, Symbyax, also an antidepressant, and Adderal for ADHD.
    7 year old Gabriel hung himself on April 19
  • 7. The QuestionsChildren and Psychiatric Drugs
    Are the skyrocketing rates of prescription justified by clinical trial evidence?
    Are physicians who prescribe psychotropic medications following the scientific mandates of evidence based medicine?
  • 8. The QuestionsChildren and Psychiatric Drugs
    Are children, by virtue of their powerless & dependent position, victims of an industry motivated by greed rather than science & ethics?
    Are the differential rates of prescription of psychiatric drugs to poor children a violation of equitable & human health care?
  • 9. AntidepressantsThe Evidence
    Of 15 published and unpublished clinical trials, only 3 show superiority to placebo on primary measures; none on patient or parent measures.
    Antidepressants carry at least double the chance for suicidal ideation and behavior…Black box warning…Nicole
  • 10. Emslie Trials: Two of the 15 Finding No Difference on Primary Measures
    8 and 9 week RCTs
    Compared fluoxetine (Prozac) and placebo
    Concluded that Prozac was superior to placebo and FDA approval followed
  • 11. The Emslie Studies
    Both studies proclaim Prozac “well tolerated” and safe.
    Failed to discuss the 6% dropout due to manic (akathisia) reactions (3 x placebo) or double suicidal rate.
  • 12. The Multimodal Treatment Study of Children with ADHD (MTA)
    Large 14 mo comparison of managed med v. BT v. combined v. TAU (medicated)
    19 outcome measures
    All 4 groups improved
    Concluded that MM superior to BT & Combined brought no advantages
  • 13. Stimulants MTA: The Evidence
    • Found advantage to med group on 3 of 19 measures
    • 14. At 36 months, tx groups did not differ.
  • StimulantsThe MTA Adverse Events
    64% of the children experienced ADRs; 11% were rated as moderate, and 3% as severe.
    Follow-up reveals sig. growth reduction with no rebound
  • 15. Treatment of Early Onset Schizophrenia Spectrum Disorders
    TEOSS compared two SGAs (Risperdal & Zyprexa) to a FGA (Moban).
    At the end of eight weeks, the “response” rate was 50% for those treated with Moban, 46% for Risperdal, and 34% for Zyprexa; 41% didn’t complete 8 weeks.
  • 16. TEOSSSuicide
    1 suicide & 8 (8%) were hospitalized for suicidality or worsening psychosis—at risk excluded.
    Weight gain resulted in suspension of Zyprexa arm.
    Adverse events “frequent.” “May place many youth at risk for diabetes and cardiovascular problems.”
  • 17. Sparks, Duncan, Cohen, & Antonuccio, Fatal Flaws to Watch For
    Given the infiltration of industry influence, discerning good science from good marketing requires a willingness to engage primary sources
    Flaws cast doubt on claims that medication should be a first line solution for any problem.
  • 18. Fatal Flaws of Drug Studies Patient versus Clinician Ratings
    You are feeling better!
    Patients & clinicians differ on impressions of improvement
    Outcome measures are most often clinician-rated
    When patient ratings are used, no difference results
    If patients don’t know they’re better, how much better are they?
  • 19. Patient versus Clinician RatingsEmslie, MTA ,TEOSS
    Emslie: No difference on patient rated measures
    MTA: No difference on only blinded measure (blinded classroom raters); and on the child’s rating & peer’s rating
    TEOSS: Used no patient rated measure; minimal improvement counted as response on PANSS
  • 20. Fatal Flaws of Drug Studies Time of Measurement
    Medications are never prescribed for short periods of time
    8-12 week trials inadequately determine effect; differences start to dissolve by 16 weeks
    Drug trial time frames: logistics or strategy?
  • 21. Time of MeasurementEmslie, MTA, TEOSS
    Emslie studies 8 & 9 weeks
    MTAendpoint at 14 months; but BT was discontinued up to 6 mos before endpoint measurement! Comparison was med v. withdrawn BT, making the finding that only 3 measures superior even more amazing
    TEOSS: Long term follow up revealed only 12% responded to treatment
  • 22. Time of MeasurementTEOSS
    The 54 who “responded” during the initial 8 weeks entered into the 44-week maintenance study
    40 of 54 dropped out because of “adverse effects” or “inadequate response.” Only 14 of 116 youth responded and stayed on it for as long as one year—only 12%.
  • 23. Fatal Flaws of Drug Studies Conflicts of Interest
    Because of industry influence, most journals now attempt transparency regarding funding sources & author affiliations.
    With these as caveats, readers
    can approach the study with a warranted skepticism & a more careful analysis of trial methods & conclusions.
  • 24. Conflicts of InterestEmslie, MTA, & TEOSS
    Emslie: Emslie & Wagner paid consultants for Eli Lilly, the funders. Other 6 listed as employees and “may own stock in that company.”
    MTA: Lead investigator, Peter Jensen, and five other authors have ties to pharmaceuticals; Jensen is a consultant to Novartis, the makers of Ritalin, the drug in the MTA. 
    TEOSS: Lead investigators paid consultants of the makers of the antipsychotic meds used in TEOSS
  • 25. Fatal Flaws of Drug Studies Minimization of Risks
    Lack of standardized measures for adverse events; mostly from spontaneous report
    Rhetoric obscures data; Conclusions for tolerability and safety do not reflect findings
    This won’t hurt a bit
  • 26. Psychiatric Drugs TheRisks That Don’t Make the Ads
    Antidepressant Risks:Mania—5 times the rate of placebo; ‘Warning’ for suicidal behavior—twice the rate of placebo; stunted growth
    Stimulant Risks:‘Warnings’ for suicide and cardiac risk; loss of 1 cm and 2.7 kg per yr; Mania, psychosis, cardiac sudden death; 64% report adverse reactions
    Antipsychotic Risks:Diabetes, obesity; EPS, tardivedyskinesia, neuroleptic malignant syndrome, suicide, akathisia
    A risk/benefit analysis does not support drugs as a 1st line treatment.
  • 27. In a Study of RisperidoneReyes et al. (2006) Assert:
    “Risperidone has consistently demonstrated efficacy and safety in both controlled short-term and open-label long-term studies” (p. 402). Five studies are cited to back this claim—two short-term and three, longer-term
  • 28. Besides Somnolence, Elevated Serum Prolactin, Weight Gain, EPS, and TD
    Overall, 76 of the 77 participants in Turgay et al. reported adverse events, close to 92% in Croonenberghs et al., and nearly 91% in Findling et al.
    Yet, all report: “generally safe” and “well tolerated” in every abstract and conclusion
  • 29. Conclusions Practices Antithetical to EBM
    When clinical trials are critically examined…the evidence does not support drug treatments as a first line intervention.
    Knowing that there is no compelling evidence to medicate, we are free to discuss the risks/benefits & other alternatives: Church, community, counseling to help families choose in concert w/ values, culture, & preferences.
    Bottom Line: Look at the evidence yourself and draw your own conclusions
  • 30. Where Children Are ConcernedThe Stakes Are Higher
    Do not have a voice to say no & depend on adults to safeguard wellbeing; poor children have fewer adults watching over them & are vulnerable to dangerous drugs used for control rather than therapy, and therefore require more to ensure equitable care.
  • 31. The Evidence and Ethics DemandA Higher Standard of Equitable Care
    1) Psychosocial intervention first—especially to the poor
    2) No off label prescribing;
    3) No polypharmacy
    4) Separate pharmaceutical company influence from science and practice
    5) Monitor treatment response with patient rated measures
  • 32. The ChurchIn Addition to Spiritual Leadership
    Has a rich history of benefiting humanity, comforting the frail and disenfranchised, protecting the sanctity of human life, and strengthening families. The Church may be the only power on earth that can counter the forces of corporate greed that have no moral or ethical conscience.
  • 33. For There To Be Social JusticeFor There To Be Equitable Care
    Accurate data & solutions that value family, Church,& community
    Education of health/ pastoral professionals to enable risk/benefit discussions
    Prevention of spread of practices that are greed motivated not evidence based—a call to action to participants…Nicole
  • 34. Although a clinical trial will never address it
    The use of psychiatric drugs in paediatrics begs yet another question: Do these drugs interfere with spiritual development, the voice of the soul, and one's ability to commune with the Divine?