Transcript A Dubious Diagnosis - Children's Mercy Hospital

Ethics issues in the diagnosis
and treatment of ADHD
© Copyright 2010
Outline
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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 mental-health
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:
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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
Stolen property
Broken into home
Assaulted with weapon
Drug possession
Ever arrested
85%
20
22
52
54
Controls
64
8
7
42
37
Barkley et al. J Clin Psychol Psychiatry. 2004.
It’s a costly illness
• Annual societal cost per child:
– Health, mental health:
– Education:
– Crime, delinquency:
• Yearly total cost per child:
$2,636
$4,900
$7,040
$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 first-ever
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
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Medication management (MedMgt)
Behavior modification (Beh)
MedMgt and Beh combined (Comb)
Routine community care (CC)
Outcome measures
• 5 distinct domains
– parent-teacher-rated ADHD symptoms
– parent-teacher-rated oppositional-defiant disorder (ODD)
symptoms
– Wechsler Individual Achievement Test reading score
– A “negative/ineffective discipline” factor
– 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”
• Days/year of medication
• Daily dose
– methylphenidate (MPH)
– methamphetamine:
• Lifetime dose (mg) of MPH:
184
365
15-20mg
10 mg
36mg
20mg
10,800
175,000
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
• 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.
Wymbs, Pelham et al. J Cons Clin Psychol. 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
• 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):
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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
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.
Resources
(cont’d)
Hawthorne S. ADHD drugs: Values that drive the debates and decisions. Med
Health Care Philos. 2007 June;10(2):129-40.
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).
Last updated 10/19/10