ISEPPPositionPaperADHD

International Society for Ethical Psychology and Psychiatry Position Paper: Are the American Academy of Pediatrics New ADHD Guidelines Justified by the Evidence? The American Academy of Pediatrics (AAP) recently updated their guidelines for thediagnosis and treatment of attention-deficit/hyperactivity disorder (ADHD) to include preschoolchildren and adolescents (www.pediatrics.org/cgi/doi/10.1542/peds.2011-2654). PreviouslyAAP published clinical guidelines addressed the diagnosis and treatment of ADHD for school-age children ages 6-12. The AAP states that emerging evidence now supports expansion of theage range to preschool children. The lowered age limit for treatment in the new AAP guidelines inevitably will increasethe use of stimulant medications for this vulnerable age group. In the first three years of thelast decade, spending for ADHD drugs increased 183% for children overall (Medco HealthSolutions, Inc., 2004), and the prescribed use of these drugs and diagnoses of ADHD continue torise (http://psychiatryonline.org/cgi/content/abstract/appi.ajp.2011.1103038). In 2007, 9.5% ofchildren between the ages of 4 and 17 were diagnosed with ADHD, with 60% taking prescribedstimulants. These numbers are sure to swell as pediatricians are given the green light toprescribe psychostimulants for very young patients. Is the AAP’s expansion of its ADHDguidelines warranted, particularly given the likely consequence that many more children underthe age of 6 will take these drugs for at least a portion of their earliest years? Prescriber and parents/caregiver decisions to treat very young children with ADHDdrugs must be based on a rigorous risk/benefit analysis. Treatment related evidence for theAAP clinical ADHD practice guidelines relied on a recent review prepared by the Agency forHealthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services 1

(Charach, 2011). This review examined 15 reports representing 11 investigations of the use ofpsychostimulants by preschoolers and claimed that studies found the drugs to be safe andefficacious. However, the review acknowledges that “the evidence comes primarily from short-term trials lasting days to weeks with small samples” (p. Es-8). When comparingmethylphenidate with parent behavior training (PBT), the review concludes: The SOE [strength of evidence] for use of PBT was judged high due to number of studies and consistency of results. The SOE for methylphenidate [MPH] was judged low because there is only one good-quality study [The Preschool ADHD Treatment Study (PATS)] . . . Both interventions are effective, with no adverse events reported for PBT, while there are adverse effects with MPH. This favors the use of PBT for preschoolers at risk for ADHD due to disruptive behavior.” (p. ES-8) The assessment of efficacy for PATS in this review is optimistic. While PATS foundmodest significant differences on endpoint measures between the drug and placebo, only 21%of best-dose MPH achieved defined criterion for remission set for school-age childrendiagnosed with ADHD. Moreover, 30% of parents spontaneously reported moderate to severeadverse events in all phases of the study, and 11% discontinued due to intolerability (Wigal etal., 2006). Adverse events included irritability, repetitive behaviors, tics, and emotionaloutbursts. For those children who remained on medication, annual growth rates were 20.3%less than expected for height and 55.2% for weight (Swanson et al., 2006). NIMH director Inselissued an unenthusiastic endorsement based on PATS: “preschoolers may benefit from lowdoses of medication when it is closely monitored, but the positive effects are less evident and 2

side-effects are somewhat greater than previous reports in older children"(http://www.nimh.nih.gov/press/preschooladhd.cfm). Other noteworthy studies challenge the wisdom of giving our youngest children thesedrugs. The American Psychological Association (APA) Report of the Working Group onPsychoactive Medications for Children and Adolescents (APA Working Group, 2006), analyzingforty years of trials, found overall effect sizes for ADHD drugs in the moderate range, with lowto moderate ranges for academic productivity and in the zero range for academic achievement(Conners, 2002). The Working Group noted the lack of data supporting long term efficacy orsafety and highlighted that stimulants, while reducing symptoms, show minimal efficacy ingeneral life domains of the child, including social and academic success. The MultimodalTreatment Study of Children with ADHD (MTA) (MTA Cooperative Group, 1999), the largest,most complexly designed trial of interventions for ADHD, found equivalent outcomes formedicated and non-medicated groups at 36 months (Jensen et al., 2007), with non-reboundeddecreases in growth for children on Ritalin (Swanson et al., 2007). In March of 2006, the Drug Safety and Risk Management Advisory Committee of theFDA urged stronger warnings on ADHD drugs, citing reports of serious cardiac risks, psychosis ormania, and suicidality for children taking them. The drugs reviewed by the committee wereprimarily amphetamines (Adderall and other brands) and methylphenidate (Ritalin, Concerta,and others). Adverse effects included increases in heart rate and blood pressure which areassociated with a number of events such as stroke or heart failure. According to a report in theWall Street Journal (Dooren, March 15, 2006), a memo from the FDA review team stated thatthey were particularly struck by the fact that signs of psychosis and mania occurred in children 3

who had never been at risk for these before and at standard ADHD medication doses. Thereview found 1,000 reports of psychosis or mania possibly linked to the drugs from January 1,2000 through June 30, 2005. While it was not definite what caused the hallucinations, theevents resolved when the children stopped their ADHD medications. Additionally, many of thechildren hallucinating were under the age of 10, an age group where such experiences areextremely rare. Despite the advisory committee’s black box recommendation, the FDA decidedto forgo a black box for all ADHD drugs (Aderall has a black box for cardiac risk and Strattera forsuicidality) and, instead, to highlight risks on the label and include an information guide forparents with each prescription.i Stimulant medications have been associated with increased emergency room visits. Arecent study found that thousands of children go to the ER with chest pain, stroke, high bloodpressure, fast heart rate, and overdose on these drugs. While many of these young people mayhave had legitimate prescriptions, others likely take the drugs for recreational or performancereasons. Prescription drug abuse has become the new drug habit for youth, with nearly one infive teens reporting abuse of prescription medications to get high (Partnership for a Drug FreeAmerican, 2006). Is this a path we want to set for our youngest? A review of past studies on the effect of ADHD drugs on children’s growth found thatthe drugs suppress both height and weight for the duration of the trials that were studied(Drappatz et al., 2006). The effect persisted after adjustment for age, study quality, treatmentduration, and stimulant type. Height and weight effects were noted by the AHRQ review. In thePATS, for those who remained on MPH, the annual growth rate was 22 percent (1.4cm/yr.) lessthan expected for height and 55 percent (1.3kg/yr) less than expected for weight. 4

No long-term trials examining the use of ADHD drugs begun in preschool years arediscussed in the AHRQ review. The authors state: “Evidence that psychostimulant use inchildhood improves long-term outcomes was inconclusive” (p. vii). The review refers to thenatural course of maturation of young children as confounding results from longer termstudies—essentially, children often mature out of their troubling behavior patterns. Moreover,the AHRQ review notes that the majority of studies examining the long-term safety and efficacyof ADHD drugs are industry-funded and may result in “enhanced representations of efficacyand safety” (p. ES-9). The authors issue the following summary of their risk/benefit analysis:“The increasing use of off-label prescriptions for very young children is concerning, especially asPBT is effective for the disruptive behavior which is often the primary impairment when ADHDoccurs in preschoolers” (p. 171). In closing, they conclude: “There is one primary implicationfrom the review of interventions for preschoolers at risk of ADHD: the first line intervention foryoung children is evidence-based PBT. Other interventions may also be effective, but furtherresearch is required before definitive recommendations can be made” (p. 171). It is clear that the very review relied upon by the AAP to support its expansion of ADHDguidelines was non-committal, at best, regarding the use of ADHD drugs for preschoolerbehavior problems. Based on their own investigation, opening the floodgates for ADHDmedications for children under the age of 6 is not justified. When it comes to the very youngestin our society, we must ere on the side of extreme caution and utilize known interventions thatdo not entail the significant risks of powerful psychostimulant drugs. In light of current evidence, the International Society for Ethical Psychology andPsychiatry (ISEPP) strongly opposes the new AAP Guidelines and urges the AAP to reconsider 5

the implications for lowering the age for which ADHD drugs may be recommended. The ISEPPfurther urges the AAP to retract their new guidelines until such evidence surfaces that ADHDdrugs provide an acceptable risk relative to their benefit for children under the age of 6. ReferencesAPA Working Group on Psychoactive Medications for Children and Adolescents. (2006). Report of the Working Group on Psychoactive Medications for Children and Adolescents. Psychopharmacological, psychosocial, and combined interventions for childhood disorders: Evidence base, contextual factors, and future directions. Washington, DC: American Psychological Association.Charach, A., Dashti, B., Carson, P., Booker, L., Lim, C. G., Lillie E., Yeung, E., Ma, J., Raina, P., Schachar, R. (October, 2011). Attention Deficit Hyperactivity Disorder: Effectiveness of Treatment in At-Risk Preschoolers; Long-Term Effectiveness in All Ages; and Variability in Prevalence, Diagnosis, and Treatment. Comparative Effectiveness Review No. 44. (Prepared by the McMaster University Evidence-based Practice Center under Contract No. MME2202 290-02- 0020.) AHRQ Publication No. 12-EHC003-EF. Rockville, MD: Agency for Healthcare Research and Quality. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.Conners, C. K. (2002). Forty years of methylphenidate treatment in attention- deficit/hyperactivity disorder. Journal of Attention Disorders, 6(Suppl. 1), S17-S30.Dooren, J. C. (2006, March 15). FDA urges stronger warnings on ADHD drugs. Wall Street Journal, p. D6. 6

Drappatz, J., Khwaja, O. S., Neovius, M., & Sarco, D. P. (2006). Growth in children with ADHD treated with stimulant medications: A meta-analysis. Poster Session presented May 1, 2006 at the Pediatric Academic Societies annual meeting, San Francisco, available at http://www.abstracts2view.com/pas/search.php?search=do&intMaxHits=10&where[]= &andornot[]=&query=KhwajaJensen, P. S., Arnold, L. E., Swanson, J. M., Vitiello, B., Abikoff, H. B., et al. (2007). 3-year follow- up of the NIMH MTA study. Journal of the American Academy of Child & Adolescent Psychiatry, 46(8), 989-1002.Medco Health Solutions, Inc. (May 18, 2004). Medco study reveals pediatric spending spike on drugs to treat behavioral problems. Retrieved May 24, 2004, from http://www.drugtrend.com/medco/consumer/drugtrend/trends.MTA Cooperative Group (1999). A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56 (12), 1073-1086.Partnership for a Drug Free America (2006). Generation Rx: National study confirms abuse of prescription and over-the-counter drugs. Retrieved July 11, 2006 from http://www.drugfree.org/Portal/DrugIssue/Research/Teens_2005/Generation_Rx_Stud y_Confirms_Abuse_of_Prescription#Swanson, J. M., Elliott, G. R., Greenhill, L. L., Wigal, T., Arnold, L. E., et al. (2007). Effects of stimulant medication on growth rates across 3 years in the MTA follow-up. Journal of the American Academy of Child and Adolescent Psychiatry, 46(8), 1015-1027. 7

Swanson, J., Greenhill, L., Wigal, T., Kollins, S., Stehli, A., Davies, M. et al. (2006). Stimulant- related reductions of growth rates in the PATS. Journal of the American Academy of Child & Adolescent Psychiatry, 45(11), 1304-1313.Wigal, T., Greenhill, L., Chuang, S., et al. (2006). Safety and tolerability of methylphenidate in preschool children with ADHD. Journal of the American Academy of Child & Adolescent Psychiatry, 45(11), 1294-303.i The current prescribing label instructions emphasize that children should receive a physicalexamination and a review of personal and family history for relevant cardiac events prior to startingstimulant treatment. Pretreatment ECG screening is recommended when abnormalities are suspectedand some advocate across-the-board ECG screening. It is unknown the extent to which these guidelinesare followed in practice. 8

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ISEPPPositionPaperADHD

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