Day3SamiTimimi

www.heartandsoulofchange.com June 19, 2010 Children, therapy, and psychiatric drugs: What does the evidence say? Sami Timimi What’s up doc? • Qualified mid-1960s • Paediatrician in UK and Gaza strip. • 1978 and 1992, he directed the National Perinatal Epidemiology Unit in Oxford. • appointed in 1992 to direct the UK Cochrane Centre. • At present, Sir Iain Chalmers is the editor of James Lind Library. • Evidence base that addresses patient’s concerns. 1

www.heartandsoulofchange.com June 19, 2010 The Medical Model Equation Diagnosis + Prescriptive Treatment = Cure or Symptom Amelioration Gold standard • Randomised Controlled Trail (RCT). • Double blind. • Placebo v active ingredient. 2

www.heartandsoulofchange.com June 19, 2010 Psychiatry and the evidence • Hotel manager decided to test how good his new beds were. • Half his guests were given the new beds, the other half were given no beds. Whose evidence is it? • That’s not a fair comparison cries a competitor. • A big multinational firm offers to help with a study to compare their super luxury “it’ll cost ya” bed with a similar one. On top of that they’ll do the interviews, publicity, and pay you for the privilege of doing the study in your hotel. 3

www.heartandsoulofchange.com June 19, 2010 Stimulant prescriptions England per year 1994: 6,000 2007: Over 550,000 Long term prescription starts before evidence for any long term effectiveness or safety is available Companies have the power to change cultures and to do so in an astonishingly short time David Healy, 2006 4

www.heartandsoulofchange.com June 19, 2010 antidepressants and children • Childhood, child rearing and child development are cultural constructs • Variety of ‘discourses’ enable ‘childhood depression’ to emerge • MacDonaldisation of children’s mental health and economic dynamics • Use of anti-depressants start before evidence • “psychosocial and pharmacological treatments [for children] are vital” (Birmaher et al., 1996) The early studies • Failure of TCAs well- documented. • Emslie et al, 1997 and 2002. Lilly employees or consultants. Prospective defined primary outcome measure no significant difference. • 1 clinician rated scales found difference, 2 client rated did not. • No mention about any children attempting suicide (in 2003 disclosed 2 in 48) • In 2003 Prozac spared – not because of risk, but perceived benefit 5

www.heartandsoulofchange.com June 19, 2010 Panorama and new guidance • Panorama on BBC in 2002: 70,000 calls and 1,500 e-mails from viewers reporting similar reactions (agitation, aggression, suicidal thoughts). • Government launches enquiry through CSM. • December 2003 CSM issues guidance that all SSRIs (bar fluoxetine) should not be prescribed to under 18s. Similar guidance follows in other countries. Attempt to save antidepressants • Aug 04 “Depressed Adolescents Respond Best to Combination Treatment” TADS. Compared Prozac, Placebo, CBT, CBT+Prozac. • Lack of advantage of placebo, 6v2 suicide attempts. • Follow up 6 months – group differences disappear. • June 07 – ADAPT: SSRI+routine care, SSRI+routine care+CBT. 6

www.heartandsoulofchange.com June 19, 2010 Early 07- alleged increase suicidality 07- • US graphs show little decrease in antidepressant prescribing for 2004, but a 17% increase in suicides amongst the young that year (compared to 2003). • The figure for decreasing rates of antidepressant prescription is based on the 2005 prescription levels. • Complaint by Netherlands psychiatrists on small numbers and interpretation of data. Rise in stimulants • Proven efficacy in short-term, no proven effectiveness in the long- term. • Long term outcome literature (systematic reviews)- No evidence for beneficial outcome with stimulants. • No drug company in its literature mentions the fact that 40 years of research says there is no long-term benefit of medications. That is something parents need to know W. Pelham, 2004. • two thirds significant side effects. • Rare but serious side effects include psychosis, stroke and sudden death. • Animal research. • Illicit use, sensitization to future drug use. 7

www.heartandsoulofchange.com June 19, 2010 The MTA study • MTA study- 4 groups – Meds, beh, meds+beh, com. 36 months no advantage to stimulant over behaviour therapy. those on medication an average of an 3in shorter and 4kg lighter. “The medication management group functioned better at 14-24 months, but was associated with worse functioning and greater need of additional school services at 36, 48, 72, and 96 months” (Swanson, 2009). • Analysis using ‘hierarchy of ‘hierarchy outcomes’ outcomes’ approach. No differential effect on academic achievement, parent- parent-child relationships, peer relationships. Worse on delinquency and substance misuse. Panorama November 2007 8

www.heartandsoulofchange.com June 19, 2010 NICE guidelines Oct 2008 • Like other systematic reviews of ADHD medication treatment, NICE notes the inadequate reporting of study methodology, possible publication bias, limited reliability of results, inadequate data regarding adverse events, and lack of RCT evidence of any long term benefit from taking stimulants, correctly concluding that the evidence does not support using medication as a first line treatment for mild or moderate ADHD. • Yet, on the basis of one reference (flawed as refers to 14month MTA outcome), and citing expert opinion, NICE concludes that medication should be used as a first line treatment in ‘severe’ ADHD. • In its report of the “consensus conference” the guideline states that “Even the most ardent supporters of non-pharmacological interventions in ADHD recognised the importance of pharmacological treatment in the most severe cases” (p121). Anti-psychotics TEOSS – olanzapine, risperidone, or molindone for psychosis. After 8 weeks half have discontinued, less than 45% response, many side effects, olanzepine arm stopped. By 1 year only 10% remained in study. Marketed now to treat aggression and irritability, (autism/mentally retarded). Widely used for aggression and newly created ‘childhood bipolar disorder. Risk of high blood sugar, obesity, diabetes, raised prolactin, and other metabolic adverse prolactin, reactions . Also tardive dyskinesia, neuroleptic dyskinesia, malignant syndrome, akathisia. akathisia. FDA data from 2000-2004: at least 45 child deaths; 1,328 reports of serious reactions. 9

www.heartandsoulofchange.com June 19, 2010 Morgan and Taylor (BMJ, 2007) • “Antipsychotic drugs in children with autism” recommended ‘off-label’ use of anti-psychotics in children with autism and behavioural disorder/irritability. • Quoted 2 studies as the evidence base. • Both 8 weeks. Around two thirds rated ‘improved’. • Over two thirds experience ‘somnolence’. • 2.7 v 0.8 kg and 2.7 v 1.0 kg weight increase. Cultural incorporation 10

www.heartandsoulofchange.com June 19, 2010 The decline of the medical model? • NICE September 2008 concludes “the disorder remains one that is defined at a behavioural level, and its presence does not imply a neurological disease” and “The diagnosis of ADHD does not imply a medical or neurological cause” Yet refers to ADHD as a ‘neurodevelopmental’ disorder. • Psychosocial treatments should be first line for mild/moderate ADHD. Lancet editorial October 2008 • “We know little about the long-term effects of psychiatric drugs in children. Side-effects of anti psychotics include shaking, damaged bones, reduced fertility, obesity, and increased risk of heart attack, diabetes, and stroke. Stimulants can damage the heart and stunt growth. Antidepressants can increase the risk of suicide in children. Do these drugs work? Evidence is often scant—and, where it exists, is largely discouraging.” • “Many patients have argued for years that psychiatric drugs are often more harmful, and less effective, than doctors believe. Increasingly, these patients are seen to be right. If psychiatry is to retain its claim to rationality, it must allow patients, including children, to be heard, and not merely drugged.” 11

www.heartandsoulofchange.com June 19, 2010 The APA Task Force The decision…should be guided by the balance between anticipated benefits and possible harms...there are psychosocial treatments that are solidly grounded in empirical support as stand-alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Flaws in Evidence Base • Compromised blind. • Selection bias and design for favourable drug response. • Reliance on clinician ratings. • Time of measurement. • Conflict of interest. • Minimization of risks. • Unfair comparisons. • Statistical significance is not clinical significance. • Reliance on abstracts (e.g. in reviews). 12

www.heartandsoulofchange.com June 19, 2010 Therapy for children and families • Better outcome found when parents/carers included, particularly for behavioural problems. • Therapeutic alliance with parents AND children additive. • Group therapy for young people with behaviour problems can make it worse. • Poverty, parental mental health problems/criminality, single parent status, callous/unemotional child all predict poor response to parenting programmes. Consensus based not evidence based • Disease paradigm. • Psychiatric diagnoses do not link with biology, aetiology, treatment or outcome. • Use of medication as disease specific treatment. • Matching models of psychotherapy with diagnoses. • NICE mental health guidelines. 13

www.heartandsoulofchange.com June 19, 2010 Quick reminder on common factors “Good News” About Therapy • The average treated client better off than about 70% of the untreated sample. • In the treatment of anxiety and depression, therapy: – Is more effective; – Is less expensive; – And more problem free than medication. 14

www.heartandsoulofchange.com June 19, 2010 Evaluations of Treatment Models • With few exceptions, partisan studies originally designed to prove the unique effects of a given model have found no differences -nor has recent meta-analyses. meta- • “Dodo Verdict” Youth & Family Therapy • Meta-analysis found meager differences (.2 ES) (Varhely, Miller, & Wampold, 2008) • Behavioral approaches in direct comparison to other bona-fide child treatments offer no advantage. (Spielmans, 2005) • There is little differential efficacy between approaches to marriage and family therapy. (Shadish & Baldwin, 2002) 15

www.heartandsoulofchange.com June 19, 2010 Limitations of the ‘Dodo’ • Pentony (1981) 3 models: 1. Placebo: Therapist and ability to raise hope and expectation. 2. Re-socialisation: usual habits and beliefs analysed, challenged, new ones learnt. 3. Contextual: opportunistic, uses range of analysing, challenging and suggesting new at same time. • Contextual: least researched. • ? Evidence just reflects ‘ethics of care’ • Cross-cultural validity? Based Children’s court primarily on dyadic relationships and ‘individualistic’ psychology. Does Diagnosis help? • Case definition developed in response to Rosenhan’s critique not scientific evidence (cause, course, or treatment). • Epidemiology started producing high rates of mental disorder. If 20-30% disordered, why not more visible? What is disorder what is ‘self- inflicted’ e.g. alcohol? • Diagnosis based public health measures (education and screening) does not improve outcomes (e.g. defeat depression campaign). • Few diagnosis-specific ‘treatments’. • psychosis, melancholic depression, mania, phobias, learning difficulties addictions, and characterlogical present since DSM 1. Little consensus on finer divisions. 16

www.heartandsoulofchange.com June 19, 2010 Drug treatment and common factors • TDRCP: clients of the most effective psychiatrists (top one-third) who received a placebo had better outcomes than those of the least effective psychiatrists (bottom one-third) receiving medication. top psychiatrists in the placebo condition also had the best outcomes in the drug condition. • study of 6000 therapists (Wampold & Brown, 2005) found that when clients of more effective clinicians were medicated, the medication was more successful than for clients of less effective therapists. • 90% of depressed participants who reported high expectancies for improvement responded to drug treatment, compared with 33% of those who expected the medications to be “somewhat effective” (Krell et al,2004). Importance of placebo Efficacy of antidepressants • Psychiatrist in placebo 80 arm in TDRCP was 70 best performing 60 therapist. 50 percent • Placebo effects 40 improved significant improvement 30 20 in 50-60%. 10 • 80-90% of improvement 0 v antidepressant is antidepressants v placebo placebo. 17

www.heartandsoulofchange.com June 19, 2010 No such thing as ‘antidepressants’ • Disease-centred model: drugs correct abnormal brain state, therapeutic effects on presumed pathophysiology, effects differ between those who are ill and volunteers, paradigms such as insulin for diabetes. • Drug-centred model: drugs create abnormal brain state, therapeutic effects derive from impact of drug-induced state on emotions/behaviour, paradigms such as alcohol and social anxiety. Length in treatment • Kopta et al (1994): 1. Acute distress 5 sessions. 2. Chronic symptoms 14 sessions. 3. Characterological 104 sessions. (for 50% response rate). 18

www.heartandsoulofchange.com June 19, 2010 Relevant to psychosis too • Scottish Schizophrenia Outcomes Study-Enabling patients with schizophrenia to report on their own needs promotes engagement with clinicians and aids in recovery. • PLAO Study Group- positive therapeutic relationship was found to predict fewer hospitalizations in new patients but not in established ones. • Recovery movement. User movement. Peer support significantly associated with improved outcomes. Medical model of psychosis • 20-40% full or partial recovery from schizophrenia in West. • Even higher in low and middle income countries – family support, de-stigmatising and more empowering meanings. • Better outcomes for social inclusion e.g. work. • ‘Internal stigma’ poorer outcome, more likely amongst those who ‘accept’ they are mentally ill. • ‘Disease like any other disease’ most associated with stigmatising attitudes (e.g. dangerousness, unable to cope). 19

www.heartandsoulofchange.com June 19, 2010 Evidence based • Relational paradigm. • Building on client resources (including family and community) and deal with context. • Focus on client-therapist relationship. • Importance of meanings. • Focus on outcomes and be prepared to ‘fail successfully’. • Have paradigms for long- term working available. • Use of medication in short- term, pragmatic manner. 20

Day3SamiTimimi

by Barry Duncan on Jun 05, 2010

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