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Ethics issues in the diagnosis and treatment of ADHD © Copyright 2010 Outline • • • • • • • What is ADHD? Prevalence of ADHD Why treat ADHD? The MTA study Patterns in drug treatment Behavioral vs pharmaceutical treatment Ethical questions What is ADHD? Diagnosis is complicated At least six signs of either inattentiveness or hyperactivity and impulsiveness – At least six months duration – Significant impairment in family or social relations, or schoolwork American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders IV Text Revision Many overlapping comorbidities ADHD often associated with other psychiatric disorders: – Anxiety disorders – Tic disorders – Oppositional-defiant disorder – Conduct disorder Only about one in three diagnoses of ADHD are not complicated by another mentalhealth disorder. How prevalent is ADHD? • Most common mental-health disorder among U.S. children • 3% to 8% of preschool and school-age children • ADHD diagnoses increased by 3 percent annually between 1997 and 2006 National Institutes of Mental Health Centers for Disease Control and Prevention Consequences of ADHD Uncontrolled ADHD is associated with: - Poor educational and work prognosis - Divorce - Motor vehicle accidents - Future problems with crime Educational and work outcomes 149 ADHD and 76 controls followed 13+ years. At time of assessment, subjects were 19-25 yrs old. H=hyperactives; CC=community controls H(%) Retained a grade 42 Suspended from HS 60 Special Ed in HS 44 Graduated HS 68 Years of education 12 Attending college only 5 Working and attending school 18 Working only 54 Not working or in school 22 Ever fired 55 CC(%) 13 18 10 100 13.4 26 47 20 7 23 Barkley et al. J Am Acad Child Adolesc Psychiatry. 2006. Domestic cost: divorce Divorce and attention-disordered children seem to go together. By the time those children are 8 years of age, 22.7% of them have seen their parents divorce. In control households, the rate was 12.6%. Among households with attention-disordered children older than 8, the comparable rates were 15.3% for children with ADHD, 10.7% for controls. Wymbs, Pelham et al. J Cons Clin Psychol. 2008. Wymbs, Pelham et al. J Cons Clin Psychol. 2008. Dangerous behind the wheel Young drivers with ADHD are more likely than controls to be cited for speeding, to have their licenses suspended, and to be rated by themselves or others as unsafe drivers. Been in an injury accident: ADHD-60% Controls: 17% Been in 2+ accidents by early adulthood: ADHD-40% Controls-6% Barkley et al. J Int Neuropsychol Soc. 2002. Barkley et al. Pediatrics. 1996. Young adults with ADHD commit more crimes 147 hyperactive, 73 control youth Followed up 13+ years after initial contact. Subjects 20-21 years of age. Hyperactives Controls Stolen property 85% 64 Broken into home 20 8 Assaulted with weapon 22 7 Drug possession 52 42 Ever arrested 54 37 Barkley et al. J Clin Psychol Psychiatry. 2004. It’s a costly illness Annual societal cost per child: Health, mental health: $2,636 Education: $4,900 Crime, delinquency: $7,040 Yearly total cost per child: $14,576 Pelham et al. Ambul Peds. 2007. Total annual societal cost of ADHD relative to other chronic conditions Major depressive illness: Substance abuse: Stroke: ADHD: $44 billion $180 billion $53.6 billion $36-52 billion The ADHD estimate is based on a modest prevalence rate of 5%. Pelham et al. Ambul Peds. 2007. Treatment of ADHD Stimulant medication Behavioral therapy Combination of meds and behavioral therapy AAP Committee on Quality Improvement. Pediatrics. 2005. In the mid-1990s, the NIMH funded the firstever controlled study aimed at comparing behavioral and medication treatments for ADHD. The results of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA) were first published in 1999. The MTA - Six sites - 597 children, aged 7-9.9 years - Randomly assigned to 1 of 4 treatments • Medication management (MedMgt) • Behavior modification (Beh) • MedMgt and Beh combined (Comb) • Routine community care (CC) MTA Cooperative Group (MTACG). Pediatrics. 2004. Outcome measures • 5 distinct domains 1) parent-teacher-rated ADHD symptoms 2) parent-teacher-rated oppositional-defiant disorder (ODD) symptoms 3) Wechsler Individual Achievement Test reading score 4) A “negative/ineffective discipline” factor 5) parent-teacher rated total social skills MTACG. Pediatrics. 2004. Outcomes at 24 months • All four groups improved • Comb and MedMgt improved more than Beh or CC Change in ADHD symptoms Treatment group Comb Med Mgmt Beh CC baseline 2.01 (.56) 2.06 (.53) 2.05 (.56) 2.02 (.58) 24 months 1.17 (.66) 1.21(.68) 1.38 (.69) 1.40 (.68) (lower number in “24 months” column indicates improvement) MTACG. Pediatrics. 2004. In 2007 the American Academy of Child and Adolescent Psychiatry endorsed medication as the first-line treatment for ADHD. It advocated the use of behavioral approaches only in cases of very mild attention problems, or as an adjunct to medication. American Academy of Child and Adolescent Psychiatry Higher doses, no more drug “holidays” Before MTA 184 Days/year of medication Daily dose methylphenidate (MPH) methamphetamine: Lifetime dose (mg) of MPH: 15-20mg 10 mg 10,800 After MTA 365 36mg 20mg 175,000 Swanson & MTACG. APA. 2008. How to choose a treatment “…the decision about which treatment to use first (should) be guided by the balance between anticipated benefits and possible harms of treatment choices…which should be the most favorable to the child.” “By this we mean, the safest treatments with demonstrated efficacy should be considered first before considering other treatments with less favorable profiles.” APA Task Force on Medication and Psychosocial Treatments in Children and Adolescents APA Task Force (cont’d) “For most of the disorders reviewed herein, 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.” “Thus, it is our recommendation that in most cases, psychosocial interventions be considered first.” APA Task Force on Medication and Psychosocial Treatments in Children and Adolescents Pelham et al conducted an experiment in which they treated subjects using different treatment sequences…i.e. behavioral followed by drugs, or drugs followed by behavioral strategies. Enhancing the Individualized Education Programs of children with ADHD using a Daily Report Card Procedure Fabiano GA, Pelham WE, Waschbusch DA, Massetti GM, Summerlee M, Naylor J, Vujnovic R, Robins ML, Carnefix TB, Volker M, Lopata C, Rennemann J, Yu J. (2008, June). Poster presented at the Institute of Educational Sciences’ Third Annual Research Conference, Washington, DC. Conclusions By the end of the school year, 92% of children required more than the initial low dose of either medication or behavioral therapy. Medication doses were similar to those in community practice and much lower than the MTA medicated sample. Pelham et al. 2008. Conclusions (cont’d) Almost all parents attended parent training when offered first, but more than two thirds failed to attend parent training when medication was given first. Twice as many (25%) of those offered behavioral treatment first refused medication, compared to when medication was offered first. Behavioral treatment followed by medication resulted in better uptake of multimodal treatment. Pelham et al. 2008. Components of Effective Comprehensive Treatment for ADHD Behavioral Parent Training -- use always Behavioral School Intervention -- use always Intensive Behavioral Child Intervention -- use when needed Medication -- use when needed Pelham W. Life in ADHD Intervention after the MTA: Treatment Modality Combinations, Components, Sequences and Doses Ethical questions: what is best for each patient? Limitations of behavioral treatment • Doesn’t work for all children • Some parents can’t master techniques • Must be broad to help entire family • Initially more costly than medication Pelham W. Life in ADHD Intervention after the MTA: Treatment Modality Combinations, Components, Sequences and Doses Limitations of drug therapy • Doesn’t work for all children • Effect stops when medication does • Doesn’t affect several important variables (e.g. academic achievement, family problems, peer relationships) • Poor compliance over long term Pelham W. Life in ADHD Intervention after the MTA: Treatment Modality Combinations, Components, Sequences and Doses Drug limitations (cont’d) • No evidence of long-term effects • Reduction in height and weight • Lack of information about long-term safety -Swanson & Volkow. 2008. - Pelham W. Life in ADHD Intervention after the MTA: Treatment Modality Combinations, Components, Sequences and Doses Risks of stimulants Most common side effects (>5% incidence): • • • • • Appetite suppression and weight loss Headache Stomach ache Tics Sleep disorders Questions about stimulants and cardiac arrhythmias US Food and Drug Administration Cardiac toxicity and black box warnings Feb 2006: US FDA’s Drug Safety and Risk Management Committee voted 8-7 for a “black box warning” for all stimulant medications. March 2006: FDA’s pediatric advisory committee voted only NOT to require a black box warning. Feb 2007: FDA ordered stimulants to carry a patient guide warning of cardiovascular and psychiatric complications. US Food and Drug Administration Patient guide for Adderall Heart-related problems: – sudden death in patients who have heart problems or heart defects – stroke and heart attack in adults – increased blood pressure and heart rate Mental (psychiatric) problems: – All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility – Children and Teenagers new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ADDERALL XR®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. US Food and Drug Administration Quantifying cardiac risks A study sponsored by the FDA and the AHRQ is tackling the question about cardiovascular risks in children and adults who take stimulants. Results of the Multicenter Observational Cohort Study to Assess Cardiovascular Risks of Medications Prescribed for ADHD are expected in 2010. US Food and Drug Administration Summary • ADHD can be debilitating • Debate continues about optimum treatment • Uncertainties remain about consequences of long-term use of stimulant medication • Decisions must be individualized for each patient and family Free downloadable materials (http://ccf.buffalo.edu/resources_downloads.php) Fact sheets, including: • • • What Parents and Teachers Should Know About ADHD ADHD Psychosocial Treatment Information Sheet ADHD Medication Information Sheet Treatment materials, including: • • Creating a Daily Report Card for the Home Conducting an Outpatient Medication Assessment and Ratings Assessment Instruments, including: • • • Impairment Rating Scales Parent/Teacher Disruptive Behavior Disorder Rating Scale Clinical Intake Interview http://ccf.buffalo.edu/resources_downloads.php Resources – Centers for Disease Control and Prevention – A point-counterpoint on the merits of ADHD diagnosis and treatment: ADHD: Serious Psychiatric Problem or All-American Cop-out? A Debate Between Richard J. DeGrandpre, PhD and Stephen P. Hinshaw, PhD. – Brown RT, Amler RW, Freeman WS et al. Treatment of Attention deficit/hyperactivity disorder: An Overview of the Evidence. Pediatrics. 2005 June;115(6):749-757. – Diller L. Running on Ritalin: A Physician Reflects on Children, Society and Performance in a Pill. – Graham LJ. Countering the ADHD Epidemic: A Question of Ethics? Contemp Issues in Early Childhood. 2007;8(2):166-169. – Hawthorne S. ADHD drugs: Values that drive the debates and decisions. Med Health Care Philos. 2007 June;10(2):129-40. Resources (cont’d) – Parens E, Johnston J. Facts, Values, and Attention-Deficit Hyperactivity Disorder (ADHD): an update on the controversies. Child Adolesc Psychiatry Ment Health. 2009;3(1). – Singh I. Clinical Implications of Ethical Concepts: Moral Self-understandings in Children Taking Methylphenidate for ADHD. Clinical Child Psychology and Psychiatry. 2007;12(2):167-182. – Singh I. The Voices study: Voices on identity, childhood, ethics and stimulants: children join the debate. – Sparks A, Duncan B. The Ethics and Science of Medicating Children. Eth Human Psychol Psychiatry. 2004 Spring 6(1).