Download A Dubious Diagnosis - Children's Mercy Kansas City

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 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):
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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:
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What Parents and Teachers Should Know About ADHD
ADHD Psychosocial Treatment Information Sheet
ADHD Medication Information Sheet
Treatment materials, including:
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Creating a Daily Report Card for the Home
Conducting an Outpatient Medication Assessment and Ratings
Assessment Instruments, including:
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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).