Victoria became pregnant at a young age. During her pregnancy, she was unable to consistently make responsible choices for herself and her developing child, often indulging in alcohol and drugs. As a result, her son Brian was born prematurely at 7 months. By the time Brian entered preschool, he became increasingly difficult for Victoria and his teachers to control, his interactions with other children at times violent and aggressive. Desperately trying to manage Brian’s outbursts, Victoria confides in a child psychiatrist who puts Brian on Ritalin. Within a couple of months, Brian’s outbursts subside, and much to everyone’s relief (Brian’s included), he is now able to sit through his preschool classes with limited distraction. He begins to enjoy relating with other kids and no longer receives negative attention at school. Several years later, Brian, now a very diminutive 9 year-old, writes a paper for a class assignment in which he suggests that everyone should have treatment like him to “make them behave,” and that “all kids with broken brains should have them fixed, too.” When Victoria learns of this, she speaks with Brian, who says he is confused why some kids can “be good without pills,” and wonders if people would “still love him if he stopped taking his.”1
To some, this story tells of the triumph of administering drugs like Ritalin to children with certain behavioral profiles, such as attention-deficit/hyperactivity disorder (ADHD). Before being treated, Brian is uncooperative, anti-social, and unresponsive to linguistic persuasion. His behavioral disposition persisted and continued to worsen before treatment, and his prenatal exposure to toxins suggests that Brian may have suffered neurodevelopmental abnormalities that contributed to his social dysfunction. By comparison, Brian’s treatment is a successful attempt to bring him “up to speed” with his peers: he now exhibits self-control, can develop meaningful relationships, and attends to his schoolwork.
However, to others, this story highlights concerns about identity formation, self-worth, and growth retardation in drug-treated children. The issue is that Brian has begun to realize how he acts, what he thinks, and how he feels are all in some way a result of the treatment, and that this sets him apart from his “good” peers. Brian’s perception of himself in relation to the world around him has been changed in a fundamental way that will shape his identity as he matures. The hope is that Brian’s caretakers will support his healthy exploration of these concepts and reassure him that his worthiness does not depend on drugs. Also of concern is Brian’s stunted growth, which may be a result of long-term Ritalin treatment.
As a whole, Brian’s story illustrates both the successes and perils of psychopharmacological treatment in very young children. With respect to social functioning, there may be clear, long-lasting improvements for some with ADHD; others may fail to respond, or worse, experience adverse side effects. This brings up the issue of safety, which has been studied to a very limited extent in young children and begs the following question: “Despite their psychosocial benefits, how safe are these drugs for the vulnerable brains and growing bodies of preschoolers?” In order to address this question, I’ll provide an overview of the current body of research into the safety and efficacy of these drugs, along with current trends in ADHD diagnosis and treatment.
Methylphenidate, often referred to by its trademark name Ritalin, and amphetamine (trademark Adderall) are by far the most commonly prescribed drugs used to treat ADHD in preschoolers 4-5 years of age. Both drugs are psychostimulants, meaning they can enhance alertness, and have been shown to reduce classical ADHD symptoms of hyperactivity and inattention. While the exact data on how many prescriptions have been issued to preschoolers alone are unclear, the CDC estimates that just over 4% of all children aged 4-10 took psychostimulants as of 20072. Trends have been increasing since the early 1990’s and can be expected to continue. Aligned with this expectation is the American Academy of Pediatrics’ (AAP) October 2011 release of new clinical practice guidelines supporting the use of psychostimulants in 4 and 5 year-olds3, which the CDC also endorses4. The AAP claims, “there is now emerging evidence to [prescribe to] preschool-aged children.” What is this emerging evidence, exactly?
Of the two psychostimulant drugs most commonly prescribed to preschoolers (and there are a handful of others), only Adderall has received Food and Drug Administration (FDA) approval for use in children this young (also keep in mind that a clinician may prescribe an FDA-approved medication to treat basically any condition in any person, a practice known as “off-label” usage; so, prescribing almost any drug on the market to preschoolers is fair game). One might expect that FDA approval would be based on studies illustrating that Adderall is safe for preschoolers; however it is worth noting that no double-blind, placebo-controlled clinical trial of Adderall in preschoolers has ever been conducted. This basically means that tens if not hundreds of thousands of children are currently taking a drug without most stringent science to back it up, which even the AAP notes has “little evidence to support its safety and efficacy.” On the other hand, Adderall has been studied and deemed safe for older children (6+ years); however, studies have shown decreased drug metabolism and clearance in preschoolers, making the FDA’s extrapolation problematic5.
Ritalin’s effects in preschoolers are better characterized, though the FDA has not officially approved its use in children this young. While a dozen or so studies have examined the effects of Ritalin in preschoolers, only one double-blind, placebo-controlled trial has been carried out. This study, known as the Preschool ADHD Treatment Study (PATS) was completed in 2006 and forms the basis for the AAP’s statement that “methylphenidate is safe and efficacious for children in this age group.” The findings of PATS are encouraging and corroborate the AAP’s claims of efficacy: nearly 2/3 of the 140 children who received 10 months of continual treatment had improvements in ADHD symptomatology6. However, some safety concerns were raised. A small number of subjects dropped out of the study due to adverse side effects, but more concerning was that the Ritalin-treated group experienced 20% less than expected height gain, and 55% less than expected weight gain compared to their unmedicated peers. A similar study in older children suggested that growth-suppressed children never catch up to their unmedicated peers7, and this effect could be even more pronounced when medication is begun earlier in development.
It is clear that additional research studies are necessary. The aforementioned trials only begin to address issues of safety and efficacy, and given the (increasing) prevalence of ADHD diagnoses, the AAP’s recommendation to its 60,000 clinicians to provide drug treatment seems premature. It is important to mention that the AAP recommends Ritalin as a secondary treatment option; behavioral therapy is first, and ideally combines parent, teacher, and peer-based programs. However, the CDC indicates that over 2/3 of children with ADHD currently receive drug treatment8, and a recent study found a 4.9-fold increase in the rate of doctor’s office visits resulting in both an ADHD diagnosis and psychostimulant prescription over the past 18 years9. So, either the behavioral therapy isn’t working, or is being bypassed altogether in favor of pills. Keep in mind that behavioral therapy requires a large time commitment by parents and teachers, and the benefits are often not seen for months. In contrast, pharmacotherapy requires relatively little time and energy, and the effects on a child’s behavior may be seen within days. Obviously, the latter option is far more accessible and alluring.
For Brian, we can only hope that his caretakers will continue to closely monitor his behavior and make the best possible decisions with respect to his course of treatment, whether or not that necessitates the use of Ritalin. But not all kids are so fortunate. The reality is that many children are not surrounded by engaged parents and educators willing to put forth the time, effort, and patience required for behavioral therapy. These children, such as those in foster care or from underserved communities, may be particularly vulnerable to being unnecessarily medicated, over-medicated, or both. Evidence for this comes as early as 1999, where data from the Michigan Medicaid system showed that 57% of children aged 3 and younger with ADHD were treated with as many as 22 different medications in 30 combinations and monitored less than every 3 months10. Although most prescriptions written for preschoolers are psychostimulants, off-label use of antidepressants and antipsychotics is prevalent, and these drugs often have never been tested in young children.
We all want our children and adolescents to thrive and develop into well-balanced, happy adults. This motivation has driven more than two decades of research into ADHD diagnosis and treatment. But it is exceedingly important that we proceed with caution and not be clouded by delusions that a drug, whether now or in the future, will act as panacea. The neurobiological underpinnings of ADHD are complex and vary greatly across individuals. As we have seen, considerable variation also exists in terms of drug sensitivity and metabolism. So while some children have and will continue to benefit greatly from psychostimulants, others will not. Consequently, it is imperative that as ADHD research progresses, scientists and clinicians devote time and resources to developing multimodal treatment strategies that blend behavioral therapy with pharmacotherapy and can be tailored to the individual needs of the child. Multimodal strategies are recognized as the most effective form of treatment for ADHD in children11. On the social level, we must have adequate safeguards in place to advocate on behalf of children most vulnerable to overmedication. We should also be prepared to confidently address the inevitable questions of identity and self-worth that our children will quarrel with, as well as to retrospectively defend our decision to medicate them.
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Want to cite this post?Kohn, J. (2012). Psychostimulants in preschoolers: Panacea or Pandora's Box? The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2012/04/psychostimulants-in-preschoolers.html
1. This story was adapted from Stein Z, Chiesa BD, Hinton C, Fischer KW. “Ethical issues in educational neuroscience: Raising children in a brave new world.” The Oxford Handbook of Neuroethics. Ed. Illes J and Sahakian BJ. New York: Oxford University Press, 2011. 803-819.
2. Visser SN, Bitsko RH, Danielson ML, Perou R, and Blumberg SJ. (2010) Increasing prevalence of parent-reported attention-deficit/hyperactivity disorder among children – United States, 2003 and 2007. Morbidity and Mortality Weekly Report. 59(44): 1439-1443.
3. Wolraich M, Brown L, Brown RT, DuPaul G, Earls M, Feldman HM, Ganiats TG, Kaplanek B, Meyer B, Perrin J, Pierce K, Reiff M, Stein MT, Visser S. (2011) Subcommittee on Attention-Deficit/Hyperactivity Disorder; Steering Committee on Quality Improvement and Management. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 128(5): 1007-1022.
4.Recommendations from the American Academy of Pediatrics (AAP). http://www.cdc.gov/ncbddd/adhd/guidelines.html. Accessed 28 Mar 2012.
5. Wigal SB, Gupta S, Greenhill L, Posner K, Lerner M, Steinhoff K, Wigal T, Kapelinski A, Martinez J, Modi NB, Stehli A, Swanson J. (2007). Pharmacokinetics of methylphenidate in preschoolers with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 17 (2): 153-164.
6. Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. (2006) Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers with ADHD. J Am. Acad. Child Adolesc. Psychiatry. 45(11):1284-1293.
7. Swanson JM, Elliott GR, Greenhill LL, Wigal T, Arnold LE, Vitiello B, Hechtman L, Epstein JN, Pelham WE, Abikoff HB, Newcorn JH, Molina BS, Hinshaw SP, Wells KC, Hoza B, Jensen PS, Gibbons RD, Hur K, Stehli A, Davies M, March JS, Conners CK, Caron M, Volkow ND. (2007) Effects of stimulant medication on growth rates across 3 years in the MTA follow-up. J Am Acad Child Adolesc Psychiatry. 46(8):1015-27.
8. Attention Deficit/Hyperactivity Disorder: Data & Statistics in the United States. http://www.cdc.gov/ncbddd/adhd/data.html. Accessed 1 April 2012.
9. Sclar DA, Robison LM, Bowen KA, Schmidt JM, Castillo LV, Oganov AM. (2012). Clinical Pediatrics. E-pub ahead of print. Accessed 1 April 2012.
10. Rappley MD, Mullan PB, Alvarez FJ, Eneli IU, Wang J, Gardiner JC. (1999). Diagnosis of attention-deficit/hyperactivity disorder and use of psychotropic medication in very young children. Arch Pediatr Adolesc Med. 153(10): 1039-1045.
11. National Resource Center on ADHD: Diagnosis & Treatment. http://www.help4adhd.org/en/treatment/treatmentoverview. Accessed 1 April 2012.