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Challenges in Mass Mental Screening: Validity and Risks

mental screening, false positives, diagnostic uncertainty, mental illness, evidence-based

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Challenges in Mass Mental Screening: Validity and Risks

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  1. National Academies of ScienceSci-Tech Policy Fellows Seminar“Screening for Mental Illness in Youth: Good Preventive Medicine?” Vera Hassner Sharav President Alliance for Human Research Protection February 22, 2006

  2. Mental Screening: A Race to False Certainties • “Screening has the potential to do more harm than good.” D. Mant & G. Fowler Mass Screening: Theory & Ethics, British Medical Journal, 1990, 300:916-918.

  3. “Criteria that should be satisfied before any mass screening is undertaken” • The disease should be common & serious; • Its natural history should be understood; • There should be a good screening test; • Acceptable treatment should be available; • Screening should favorably influence outcome. • How many positive tests will prove…false? • How will the quality of the test, intervention & follow-up be audited? D. Mant & G. Fowler Mass Screening: Theory & Ethics, British Medical Journal, 1990, 300:916-918.

  4. Mass Mental Screening: Minimum Criteria • What is the purpose of screening? • What evidence intervention is effective? • What risks of harm may follow? • How many “positive” results proved false? • What is the benefit /risk of treatment compared to no treatment? • Is there scientificevidence demonstrating that screening & drugs have “saved lives?”

  5. When is it Science, when Myth? • Mass mental screening in America’s schools is conducted on the hearsay of those who invoke the mantle of science without adhering to its fundamental principles or methods of validation. • What is the evidence that screening “suicidal” on a 10-minute questionnaire is a valid indicator of risk? • How reliable & valid is mass screening if 84% of those who tested “positive” for depression/ suicidality, were false?

  6. TeenScreen Predictive value: 16%; False-Positive rate, 84% • “sensitivity of 0.75, specificity 0.83, and positive predictive value 16%.” • “The [ ] positive predictive value of 16% would result in 84 non-suicidal teens being referred for further evaluation for every 16 youths correctly identified.” David Shaffer, MD. Columbia Suicide Screen: Validity and Reliability JAACAP, 2004, 43: 71-79 What medical/ scientific value does a screening instrument have with a false-positive rate of 84%

  7. Evidence or Disease Mongering? • “More than half of Americans will develop a mental illness at some point in their lives, often beginning in childhood or adolescence.”NIMH-Harvard B. Carey Most Will Be Mentally Ill at Some Point, Study Says, NYT, June 7, 2005 • “research indicates that alterations in neurotransmitters such as serotonin are associated with the risk for suicide.” NIMH, In Harm’s Way, 2003 • “Fifty percent of Americans…are you kidding me?” Dr. Paul McHugh, former chairman of psychiatry, Johns Hopkins, in NYT, 6-7-2005

  8. What evidence supports psych theories / diagnoses/ Rx ? • How is mental illness defined? • Are the diagnostictools reliable & valid? • What evidence supports a biological cause for depression / mental disorder? • What evidence of a neurochemical basis for depression? • What evidence supports claims that psychotropic drugs have a favorable benefit / risk ratio?

  9. How is Mental Illness Diagnosed? • “all of psychiatry’s diagnoses are merely syndromes [or disorders], clusters of symptoms presumed to be related, not diseases.” Joseph Glenmullen, M.D. psychiatrist, Harvard Medical Prozac Backlash, 2000, p. 195. • “The problem is that the diagnostic manual we are using in psychiatry is like a field guide and it just keeps expanding and expanding…” Dr. Paul McHugh, former chairman of psychiatry at Johns Hopkins. B. Carey Most Will Be Mentally Ill at Some Point, Study Says, NYT, June 7, 2005

  10. Psychiatry’s diagnostic manual • "The DSM-IV criteria remain a consensus without clear empirical data...the behavioral characteristics specified in DSM-IV, despite efforts to standardize them, remainsubjective...” American Psychiatric Association DSM-IV p. 1163

  11. How reliable or valid is a diagnosis of mental illness in children? • “what it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures.” U.S. Surgeon General Report, 1999, p.5 • “it is difficult to draw clear boundariesbetweenphenomena that are part of normaldevelopment and others that areabnormal.” World Health Organization. Chapter 2: Burden of Mental and Behavioural Disorders, 2001

  12. “Diagnostic Uncertainty” • “The normally developing child hardly stays the same long enough to make stable measurements... • the signs and symptoms of mental disorders are often also the characteristics of normal development.” Surgeon General Report, 1999 • “diagnostic uncertainty surround most manifestations of psychopathology in early childhood” Benedito Vitiello, MD, Chief, Child & Adolescent, NIMH Psychopharmacology for Young Children, Pediatrics, 2001, 108:983-989

  13. Children’s Mental Health Crisis? • Rx trends seem to support claim. • Despite diagnostic uncertainty, more spent on psych drugs for kids than antibiotics. M. Freudenheim Behavior Drugs Lead in Sales for Children, NYT, May 17, 2004 • 1 of 10 teenage boys who visits a doctor leaves with Rx for a mental condition. • 25% of teens Rx psych drugs "did not have an associated mental health diagnosis.“ C.P. Thomas, et al, Trends in use of psych meds among adolescents, 1994-2001, Psych Services, 2006, 57:63-69. • “No other society prescribes psychoactive medications to children the way we do.” Lawrence Diller, MD, pediatrician Kids on drugs, Salon.com, March 9, 2000

  14. Surreal Rx for Disaster • “Even before their first birthday, babies can suffer from clinical depression, traumatic stress disorder, and a variety of other mental health problems.” Florida Strategic Plan for Infant Mental Health, 2001 • “Psychopharmacology is on the horizon as preventive therapy for children with genetic susceptibility to mental health problems.” David Willis, M.D., Medical Director, NW Institute Pediatric News, January, 2004 • What evidence supports these claims?

  15. Cult of “Serotonin Deficiency” How is normal brain chemistry defined or measured?

  16. “Chemical Imbalance” • “Patients [have] been diagnosed with ‘chemical imbalances’ despite the fact that • no test exists to support such a claim... • there is no real conception of what a correct ‘chemical balance’ would look like.” Psychiatrist David Kaiser, MD Against Biologic Psychiatry, Psychiatric Times, December 1996, Vol. XIII (12)

  17. Entrenched Mythology • “Depression is most likely due to an inherited predisposition to a chemical imbalance in the brain.” NYU Child Study Center http://www.aboutourkids.org/aboutour/disorders/depressive.html • “underlying serotonin dysfunctionmay play a major role in defining the suicidal threshold….  • Effective treatment of depression may reduce mortality or improve the outcome after acute myocardial infarction or stroke and lower the risk of suicide.” Dr. Kevin Malone & Dr. John Mann Columbia University Serotonin and the Suicidal, 2004. http://www.suicidereferencelibrary.com/test4~id~443.php • Where is the evidence?

  18. American Foundation for Suicide Prevention Research Award, 1995 • to Dr. John Mann, chairman Psychiatry, Columbia University: • "for his breakthrough research on serotonin levels as a predictor of suicide risk. Dr. Mann's research has helped to uncover the chemical imbalances that occur in depressed patients, and his work on hormonal abnormalities in suicidal patients has fostered the development of tests that predict suicide risk.” • Pure fantasy unsupported by science

  19. PLoS Medicine Review Delivers Decisive Blow, 2005 • “Contemporary neuroscience research has failed to confirm any serotonergic lesion in any mental disorder...” • “there is no scientifically established ideal “chemical balance” of serotonin, let alone an identifiable pathological imbalance.” • “Not a single peer-reviewed article ... supports claims of serotonin deficiency in any mental disorder.” Jeffrey Lacasse & Jonathan Leo PLoS Medicine, 2005

  20. Flawed Science, Faulty Logic • Psychiatry’s rationale for Rx drugs rests on the failed “chemical imbalance" theory. • Drugs are said to correct brain chemistry. • Lacking evidence, psychiatry presumes that a deficiency exists, citing as “evidence:” “SSRI’s increase serotonin levels.” • By that logic, low levels of aspirin in the brain cause headaches.

  21. Psychiatry’s causal theories remain speculative: “intelligent design?” • Without a coherent scientific theoretical foundation, psychiatry cannot claim to be practicing evidence-based medicine.

  22. SSRI Efficacy-Unsupported by Science • "SSRIs are the most commonly used treatment for adolescent depression, because of the proven efficacy [ ] in placebo-controlled trials…" D. Brent and B. Birmaher (2002) Adolescent Depression, NEJM, 2002, 347:667-671. • Scientific evidence from controlled clinical trials contradict such claims of SSRI efficacy.

  23. Evidence Overturns Myth of Efficacy • 12 of 15 controlled pediatric SSRI trials failed to demonstrate an effect >placebo. • “Many of the trials that failed to show evidence of efficacy did so because the placebo response rate was so high…[82%]” • “It is unclear in these cases whether the trial results were negative because the medication was not effective…” Cheung, Emslie, Mayes, Use of antidepressants to treat depression in children & adolescents, CMAJ, 2006 , 174:193-200

  24. Evidence Contradicts Adult Efficacy • Analysis of FDA data: 47 randomized placebo-controlled adult efficacy trials: • “the mean difference between response to antidepressant drugs and response to inert placebo is very small.” • Placebo duplicated 80% of SSRI effect. • “[This] has been a “dirty little secret”, known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data and reached conclusions similar to ours.” Kirsch, Moore, Scoboria, & Nichols, The Emperor's New Drugs, Prevention & Treatment, 2002 , 5 art. 23/

  25. Evidence: SSRIs IncreaseSuicide Risk FDA Black Box Warning, 2004 • Suicidality in Children and Adolescents “The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%.” FDA Advisory July, 2005: • “suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients.”

  26. Harvard Medical Record Review • Within 3 months of treatment: • 22% of children suffered drug-induced psychiatric adverse effects (PAE) • "Overall, 74% of children and adolescents experienced an adverse event to an SSRI over the course of their treatment." • Evidence supports PAEs were drug-induced: "Re-exposure to an SSRI resulted in another PAE in 44% of the group." Willens, Biederman, et al. "Systematic Chart Review of the Nature of Psychiatric Adverse Events in Children & Adolescents Treated with SSRIs," J Child & Adolescent Psychopharmacology, 2003, 13:143-152

  27. Science or Science Fiction? • “Research has established that evidence-based screening programs are one of the most effective means of youth suicide prevention. Research has also shown that one of the best times to catch youth at risk of suicide is in high school.” TeenScreen Director, Laurie Flynn, Testimony, U.S. Senate Hearing on “Suicide Prevention and Youth: Saving Lives”2004 • “noevidencethat screening for suicide reduces either suicide attempts or mortality. There is little evidence on the accuracy of screening tools.” US Preventive Services Task Force Report, Screening for Suicide Risk, 2004 ttp://www.ahrq.gov/clinic/3rduspstf/suicide/suiciderr.htm

  28. TeenScreen Violates Federal Pupil Protection Rights Act • Mandatory written parental consent to any survey or non-emergency examination re: • “mental and psychological problems of the student or family” PPRA, 1998 • “Parental passive consent …. was obtained.” David Shaffer MD, JAACAP, 2004 School official (Indiana): “We would probably see the level of participation drop way off (if active consent were required).” D. Rumbach, Student's parents object to TeenScreen South Bend Tribune, January, 19, 2005

  29. Dark Side of Mental Screening • A psychiatric label impacts the course of a child’s life; accompanies him forever and exposes both child & family to: • stigma *discrimination *emotionaldistress *loss of autonomy & decision-makingauthority * gov’t. coercion *Rx drug abuse • TreatmentRisk: severe adverse drug effects ---One survey found that 91% (9 out of 10) children referred to child psychiatrist get Rx for psychoactive drug Stubb & Thomas, Survey of Early-Career Child & Adolescent Psychiatrists, JAACAP, 2002, 41:123-130

  30. Aliah Gleason, 13, Victim of Screening & Rx Psych Drugs • falsely labeled “suicidal” • forcibly removed from parental custody • committed to psych hospital • physically restrained 26 X • forcibly drugged with 12 psychotropic drugs • forced to take toxic “drug cocktails” never tested for safety or efficacy • cut off from contact with her parents for 5 months • Returned under Court order & weaned off drugs “Medicating Aliah,” by Rob Waters Mother Jones, May, 2005

  31. “Evidence-based” Medicine or child abuse? • Most psych drugs not approved for children • SSRI Antidepressants--Zoloft, Celexa, Lexapro, Desyrel • Anti-anxiety drug--Ativan • Two atypical antipsychotics-- Geodon and Abilify • An older antipsychotic--Haldol • Two anticonvulsants—Trileptal, Depakote • Anti-Parkinson's drug--Cogentin • At her discharge from a State mental hospital • Aliah was on5different psych drugs • Risperdal was then added to her “cocktail” • Most of these drugs carry FDA-mandated Black Box warnings of potentially lethal side-effects

  32. “First, do no harm…” • Overarching ethical consideration: • --Absent reliable scientific diagnostic tools; • --Absent evidence of clinically significant treatment benefits; • Given scientific evidence of substantial harm—including death—from treatment; • What is the ethical justification for exposing children to serious risks of harm from screening leading to psychoactive drug treatment?

  33. New Freedom Commission policy recommendations for mass mental screening are notsupported by any scientific evidence. • The programs recommended by the NFC: • TeenScreen: a dubious, 10 minute questionnaire predictability rate only 16%. • TMAP: Texas Medication Algorithm Guidelines NFC Report http://www.mentalhealthcommission.gov/reports/reports.htm • TeenScreen & TMAP are both designed to increase psychotropic drug consumption.

  34. A Perfect Market Expansion Tool • TeenScreen is scientifically invalid • Benefits—Unproven No evidence TeenScreen reduces suicide • Risks of harm from Treatment—proven Antidepressants increase risk of suicide • TeenScreen value: political & economic Government endorsed dragnet converts healthy children into drug consumers. • 350 Colorado students were screened twice using Columbia’s TeenScreen & Dr. Shaffer’s DISC: • 50% were declared “suicidal” Mental Health Association, Colorado http://mhacolorado.org/aboutUs.html#Americashealth

  35. Rationalizing 84% False-Positive • “in practice a specificity of 0.83… could reduce the acceptability of a school-based prevention program.” • “However, it is important not to lose sight of the fact that many of these so-called false-positive cases may be experiencing painful depressive symptoms with social and academic impairment and are likely to benefit from treatment.” David Shaffer, MD, JAACAP 2004

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