Just Say 'No' to Drugs as a First Treatment for Child Problems
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Just Say ‘No’ to Drugs as a First Treatment for Child Problems Barry L. Duncan, Jacqueline A. Sparks, J o h n J . M u r p h y AN D S c o t t D . M i ll e r When children and teens present with behaviour and emotional problems the lure of a quick fix is understandable and drugs present a ready-made solution. Therapists are often hesitant to talk about medication and defer to medical professionals. In this paper DUNCAN, SPARKS, MURPHY and MILLER highlight the explosion in the use of psychotropic medications for children and teens. This trend flies in the face of the American Psychological Association’s recommendation of the use of psychosocial interventions as the first intervention of choice with children and teens. The reliability and validity of psychiatric diagnoses is questioned, in particular against a background of fluctuations in child development and social adaptations, and a compelling critique is provided of the current research findings on the effectiveness of psychotropic medications including antidepressants and ADHD medications. Therapists are urged to shed their timidity and discuss openly the risks and benefits of medication with the knowledge that there is empirical support for psychosocial interventions as a first line approach. Recommendations are offered to engage clients as central partners in developing solutions—medical or non-medical—that fit each child and each situation. A mother has a moment of panic, spying her daughter’s arms crisscrossed with red cuts. medication with the families they see, choosing instead to defer to medical professionals. But to not talk about Aren’t we stepping out of our expertise and professional role to discuss medications with clients? A harried teacher does a double psychiatric drugs in today’s world of While we may be stepping out take when the behaviour of a typically ubiquitous chemical imbalances and of our comfort zones, we are not disruptive middle schooler takes a glossy advertising remedies is to ignore travelling beyond the boundaries of our bizarre turn. Young parents are at a the proverbial elephant in the living expertise to discuss options regarding loss to explain the uncontrollable rages room. Prescriptions of psychotropic treatment approaches for young people of their five-year old. In each case, drugs for children and adolescents have in distress. We need not fear these the spectre of mental illness hovers, skyrocketed. To skip a discussion of conversations or feel timid in the face whispering an urgent command to “get medication is to disregard a growing of medical opinion; the data speak professional help!” Psychotherapists are reality that impacts on children clearly about just how safe and effective often the first stop for help—we, like and their families. The Rx (medical psychiatric drugs are for children. The our clients, feel the pressure to solve the prescription) elephant won’t go away empirical evidence supporting the problem rapidly with the best standard just because we don’t talk about it. benefit of child medication is far from of care. And, more and more, that Our reticence is mirrored in parents substantial, while concerns about safety standard has become synonymous with and children who are reluctant to offer continue to surface. Therapists can use psychiatric medication. an opinion or ask a question about this knowledge to confidently assist With daily pressure on therapists other options or side effects. The end with medication decisions—they can to manage youth behaviour and result is that children, parents, and help children and parents get the facts emotional problems, the lure of a therapists are often shut out of the about risks and benefits, and make quick fix is understandable, and loop—their questions, ideas, and clear the take-home message that there drugs seem a ready-made solution. solutions take a back seat. But how are many paths to preferred ends. But beyond referring families for can therapists broach this topic—after It is not our aim to discredit psychiatric consultations, therapists all, we are not medical experts, or as individual preferences for or are often hesitant to talk about the joke goes, we are not ‘real’ doctors. experiences with medication, or to 32 PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007
claim that psychiatric drugs are not Explosion in the use of a psychiatrist is made and Jess is ever helpful. We are not wide-eyed psychotropic medication prescribed an antidepressant. anti-drug zealots. Instead, we are for children and teens Jess is not alone. The past decade anti-privileging drugs as a first-line Jess, a 15-year old girl enters school has seen an explosion of psychotropic solution—especially for children and through the front door, proceeds down medication prescriptions for children adolescents. And while we are adamant the hallway and out the back, another and teens (Zito et al., 2003). In about putting clients in charge of the no-show for the day. Jess finds it the United States prescriptions for decision to medicate and have been difficult to attend to classroom work, antidepressants have increased at a writing passionately about the lack preferring to hang out with the pony rate of 11 per cent each year from 1994 of demonstrated efficacy of drugging she helps care for as a part-time job. At to 2000, and five per cent each year children for nearly ten years, we are the school meeting, Jess’s mother states since, a total of over eleven million actually in the mainstream of current that she found marks on her daughter’s prescriptions written annually. The scientific thinking, The American arms, apparently self-inflicted with number taking antipsychotic medicines Psychological Association Working Group her father’s pen knife. A referral to soared 73 per cent in the four years on Psychotropic Medications for Children and Adolescents, 2006 states: ‘It is the opinion of this working group that…the decision about which treatment With daily pressure on therapists to manage to use first…should be guided by the balance between anticipated benefits youth behaviour and emotional problems, and possible harms of treatment choices… the lure of a quick fix is understandable, For most of the disorders reviewed herein, there are psychosocial treatments that are and drugs seem a ready-made solution. 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’. (p. 175, emphasis added) The report further points out: ‘Ultimately, it is the families’ decision about which treatments to use and in which order. A clinician’s role is to provide the family with the most up-to- date evidence, as it becomes available, regarding short- and long-term risks and benefits of the treatments.’ (p. 175) The APA is hardly an organization known for going out on a limb or taking risky liberties with the data! This knowledge means that when children experience difficulties, discussions about solutions can be open, creative, and evolving, and encompass a range of views about change based on each person’s concerns, circumstances, and preferences. While medication may be useful for some children, it does not have to dominate intervention strategies or monopolize talk about change. Therapists can expand the range of options, and their clinical roles, even in circumstances that typically trigger prescriptions. Illustration: Shannon Rose PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007 33
ending in 2005, far outpacing the to neuro-imaging research as proof Yeah…I told my mom about Nick (Jess’s increase in adults—over 2.5 million positive of the biology of behavioural boyfriend). She knows we broke up. youth in the US per year are prescribed and emotional problems. A highly Therapist: Is that what’s bothering you antipsychotics (dosReis, Zito, Safer, publicized study claimed to show the most now? Gardner, Puccia & Owens, 2005). that the brains of ADHD-diagnosed Jess: Yeah. That, and school sucks. Spending on drugs like Ritalin for children were smaller than their non- Jess, her mom and the therapist behavioural problems exceeds any other ADHD counterparts (Castellanos et talk about how Jess cuts herself to help category for the first time, including al., 2002). However, anatomy Professor with the emotional hurt. They also antibiotics. The number of kids taking Jonathan Leo and researcher David talk about Jess’s boredom with her one or more prescription medicines to Cohen report that the control group classes and her desire to work more treat mental health-related conditions was two years older, heavier, and taller to earn money and not ‘waste time’ at has hit nearly nine per cent. If Jess than the ADHD diagnosed children, school. They listen to Jess and value that she feels comfortable enough to let them into her world. All agree that We are not wide-eyed anti-drug zealots. the first order of business is for Jess to be safe. Since Jess is adamant about Instead, we are anti-privileging drugs not wanting medication, they agree to set up a safety plan. The practitioner as a first-line solution—especially ensures that Jess is the primary architect of the plan, prompting her to for children and adolescents. identify strategies that she believes will work. Instead of cutting at night when she felt down, Jess planned to listen to lived in a foster home, she would be 16 undermining any conclusion about music, get in her mom’s bed or call her times more likely to be medicated; if brain size and ADHD (Leo & Cohen, friends. Jess writes the strategies down the diagnosis ended up bipolar disorder 2003). Despite fifty years of efforts to and signs an agreement to tell her mom or ADHD, her chances of being on find one, no reliable biological marker or call the therapist if she feels like it is more than one medication at the same has ever emerged as the cause of any not working. time would be as much as 87 per cent psychiatric ‘disease’. There are many ways to reach desired (Duffy et al., 2005). Knowing there is no irresistible ends. Not every child is Jess and not The push to medicate young people scientific justification to medicate, the every parent will react the same way. is fueled partially by the belief that therapist is free to put other options on What will work can only be known one problems are biological and require the table and draw in the voices of Jess child and one family at a time after an medical intervention. Web pages, and her mother. open consideration of options. doctor’s office brochures, magazine Mother: Jess, you can’t keep doing this. Validity and reliability of articles and TV advertisements I don’t want you to hurt yourself. psychiatric diagnosis describe depression, ADHD, What’s wrong? What do you want? mood swings, and the like as brain Jess: (Shrugs shoulders and Michael, age 13, is home from dysfunctions. Even when we know they looks down.) residential treatment and recently are promotions from drug companies, Therapist: Jess, we just want to make reunited with his mother who is pictures of neurotransmitters or talking sure you’re safe? What do you think now attending regular Narcotics serotonin cartoons are powerful, lasting will help? Anonymous meetings. When images. This biological perspective is Jess: I don’t know. confronted about his ‘clowning’ also backed up by impressive sounding (Everyone just sits for a while. in math class, Michael makes a clinical studies. Social explanations There is genuine puzzlement and beeline for the door and is found and solutions are not accorded the same concern from everyone in the room— hanging halfway up the flagpole weight in the media as medical ones there does not seem to be a way out o like a frightened monkey. In short and are a distant second when it comes f the dilemma.) order, Michael’s diagnosis is changed to research funding and marketing. As Mother: Jess, do you want to take the from ADHD to early onset bipolar a result, claims are rarely questioned medicine that Dr. Stevens gave you? He disorder. His medication is changed and the assumption that child and said you were clinically depressed and from stimulants to anticonvulsant and adolescent problems have a biological that it would help. antipsychotic medications. basis has become accepted fact. Jess: No! I don’t want to take any pills. ‘Early onset bipolar disorder’ has an Cartoons notwithstanding, I’ve got to do this myself. ominous ring to it. At first glance biochemical imbalances and other Mother: Okay. medication seems the most logical so-called mind diseases remain the Therapist: Jess, do you want to talk with intervention for preventing a slide only territory in medicine where me and your mom, or maybe just one of us into more distress and coping with diagnoses are permitted without a alone, about some of that stuff we talked the disorder. Diagnosis, as the sole single confirmatory test (Duncan, about last week? gateway to medications, provides Miller & Sparks, 2004). Many point Jess: (after a lengthy pause, thinking) the official rationale for medical 34 PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007
intervention. The belief that diagnosis like the old ones, but these are even worse. as making sense within the context of can provide accurate identification of Mom says I should take them, but they the child’s life. And if medication is a discreet disorders is a key assumption make me feel weird! part of treatment, children can monitor that underlies medication prescription. Therapist: I saw what the doctor said in whether medication is useful and, with Therapists may feel that they have the report he sent me. It says that it seems the help of adults, can be in the driver’s little choice but to assume that a like your moods kind of go up and down. seat in medication decisions. diagnosis explains what is wrong Does that seem right to you? Are research findings on the and provides a solution. Michael: Yeah. Kind of. I never know if effectiveness of psychotropic In spite of its widespread mom is going to, you know, go off again. medication reliable? acceptance, the validity and reliability It’s hard to sit there in class when I keep of psychiatric diagnosis is suspect thinking about that, so I just start joking Six-year old Kyle, according to his (Duncan et al, 2004; Sparks, Duncan around. Then Mr. Riley gets on my case, parents, ‘flies into a rage at the drop of a & Miller, 2006). In particular, and I haven’t even done anything so I say hat.’ They note that Kyle’s rages occur diagnostic validity is questionable ‘I’m outta here!’ when playing with his three-year when it comes to children. According Therapist: Wow. That makes a lot of old sister and they fear that he may to the World Health Report, ‘Childhood sense. No wonder you wanted to do hurt her. Kyle’s mother shares with a and adolescence being developmental something to get that thought out of your therapist her concern that Kyle might phases, it is difficult to draw clear mind for a while. have a mental illness and wonders boundaries between phenomena that are Michael: So, you mean I’m not crazy? whether medication could help. When part of normal development and others It was important for Michael to parents hear that even young children that are abnormal’ (World Health make sense of his own experience can be mentally ill and that problems Organization, 2001). The notion of and actions, and to understand these result from undiagnosed disorders, it stable, fixed psychiatric syndromes as reactions to stressful events. The makes sense that they may adopt this does not fit the fluctuations of child therapist refused to allow the diagnosis point of view when other explanations development and adaptation to social or his situation at home to get him and options are not readily available. environments—children change off the hook. They brainstormed The decision to pursue psychotropic continually with age and context. ways that Michael could deal with drugs is based largely on the belief that Reliability has to do with whether or his stress without getting in trouble. they work. People assume that Prozac not clinicians looking at the same array The therapist returned to the pills and similar drugs are the intervention of symptoms will come up with the because Michael expressed discomfort of choice for child and adolescent same diagnosis. If there is independent with them. Referring to the outcome depression, and that stimulant agreement on a diagnosis amongst measure the therapist was using, the medications are consistently effective professionals, it is considered reliable. practitioner suggested that Michael for children labeled with ADHD. Robert Spitzer, the primary architect monitor his response to the medication Pediatricians and family doctors also of the DSM, commented on the ability to determine whether it was working or endorse such assumptions based on of the DSM to provide consistent making him feel worse. published evidence from clinical trials. agreement in clinical diagnosis: ‘To say Instead of certain diagnoses The clinical trials most often cited that we’ve solved the reliability problem resulting in knee-jerk prescriptions, for medication effectiveness include: is just not true…It’s been improved. But troubling behaviour can be validated the two clinical trials that gained if you’re in a situation with a general clinician it’s certainly not very good. There’s still a real problem, and it’s not clear how to solve the problem’ (Spiegel, 2005, p. 63). In other words, Michael might well be diagnosed with depression if he were seen by a different clinician, or may not have received a diagnosis at all. A bipolar diagnosis can last a lifetime; out-of-the ordinary child behaviours tend to be time-limited. Recognizing the potential negative effects, the American Counseling Association’s Ethical Code supports counsellors who refrain from making a diagnosis. Returning to Michael, consider the therapist’s response to his diagnosis: Therapist: Hey, Michael, how’s it going? Michael: Not so good. The doctor says I have some kind of…I forget. Anyway, he gave me these new pills to take. I didn’t PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007 35
Prozac FDA approval for childhood inactive pill takers easily, effectively between medication and placebo depression conducted by psychiatrist un-blinding the study and skewing groups tend to dissolve by 16 weeks. researcher Graham Emslie of the results. In support of this theory, a Without longer term follow-ups, University of Texas Southwestern meta-analysis conducted by psychiatrist researchers cannot make accurate Medical Center and colleagues researcher Joanna Moncrieff of the conclusions about effectiveness in (1997, 2002) (hereafter called the University College of London found everyday life. The Emslie studies were Emslie studies); and the Multimodal that when studies used active placebos, of eight weeks duration, calling into Treatment of ADHD (MTA) little or no differences were found question their usefulness in real-world examining the efficacy of Ritalin versus between the dummy pill and the drug decision making. behavioural and combined intervention (Moncrieff, Wessely & Hardy, 2004). A key component of evaluating (MTA Cooperative Group, 1999, The Emslie studies used inactive, sugar any drug trial is learning who 2004ab). pill placebos drawing into question paid for it and what the authors’ The gold standard for research is the integrity of the study’s double potential conflicts of interest are. The the randomized, double blind, placebo blind. Evidence of the compromised pharmaceutical industry’s influence controlled trial. In this design, two double blind were apparent in the drug over scientific inquiry has, in some groups are formed, presumably similar manufacturer’s own records where ways, become almost a cliché. In since they are selected randomly from ‘it was not uncommon to see notations May of 2000, the editor of the New the initial pool of applicants. One defining the patient’s blinded treatment, England Journal of Medicine, Marcia group gets the drug being tested; the or in some cases to find fluoxetine (Prozac) Angell called attention to the problem other, a placebo. In this design, neither plasma concentration results’ (FDA, of ‘ubiquitous and manifold…financial study participants, researchers, nor 2001, June 25, p. 19). associations’ of authors to the companies assisting clinicians, should know who The instruments chosen as primary whose drugs were being studied is in which group—that is, who is measures in drug trials are clinician- (Angell, 2000, p. 1516). Why is it taking the real drug and who is getting rated. Frequently, client ratings of important to know who sponsors a the dummy pill. This helps eliminate improvement differ from clinician’s, study? One recent review (Heres, the bias that comes when participants often in ways that run counter to Davis, Maino, Jetzinger, Kissling & and researchers know who is in each findings of drug effectiveness. In Leucht, 2006) looked at published group, and weeds out factors like hope both clinical trials that resulted in head-to-head comparisons of five and expectancy that could interfere FDA approval of Prozac, no client- popular antipsychotic medications. In with determining what is actually rated measures indicated superiority nine out of ten studies, the drug made responsible for any differences found of the drug over placebo. However, by the company that sponsored the between groups. The validity of the both studies concluded that Prozac study came out on top. trial depends upon the ‘blindness’ of outperformed placebo. How valid Without an appreciation of the participants who rate the outcomes. can an assessment of improvement role industry influence plays in how However, most studies do not use be if the client does not agree with the study is designed, carried out, active placebos—pills that mimic the it? In the first Emslie study, two and disseminated, it would be easy effects of real drugs. Rather, they use out of four clinician-rated measures to accept bottom line conclusions as inert sugar pills as the placebo which indicated a difference between the fact. However, recent regulations now makes it possible for most participants placebo and SSRI groups. Two client- require authors to fully disclose their and clinicians to tell who is getting rated measures found no difference. affiliations, allowing a more critical the medication. Inert sugar pills, or Similarly, the primary measure of appraisal of any study’s conclusions. inactive placebos, do not produce the the second study failed to show a The first Emslie study, published prior standard side effect profile of actual significant difference—all client- to disclosure requirements, did not drugs—dry mouth, weight loss or gain, rated and two clinician-rated scales identify author affiliations. However, dizziness, headache, nausea, insomnia showed no difference. Out of seven, FDA data indicate that Eli Lilly and so on. Study participants are likely three clinician-rated measures showed sponsored the study. The second and to be on the alert for these types of significant differences between the approval-clinching trial of Prozac for events and, since most have been on experimental drug and placebo. If child and adolescent depression lists medications before, many are familiar children and their parents do not author affiliations on the first page. with these effects. As a consequence, detect improvement over placebo, how Here, readers learn that Emslie is these subjects are likely to identify effective are the drugs? a paid consultant for Eli Lilly, who correctly which group they are in Standard time frames for clinical funded the research and whose product (Fisher & Greenberg, 1997; Sparks & drug trials are 8 to 12 weeks. In was being investigated. The remaining Duncan, in press). contrast, most prescriptions for youth authors are listed as employees of Researchers interview participants psychiatric medication assume that the Eli Lilly and ‘may own stock in that throughout the study to collect drug will be taken for much longer. company’ (p. 1205). Combining this information about change and side Assessing how well a drug does in an information with the ‘unblinding’ effects. On-going interviews that listen 8 to 12-week period cannot portray that results from inactive placebos for or are active in asking about side an accurate picture of the drug’s seriously calls into question whether effects can reveal the active versus performance in real life. Differences the researchers, either employees or 36 PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007
consultants of the company whose drug (the 7–9 year old children) rated MTA authors have significant ties to was under investigation could, with so themselves as no more improved when drug companies. Specifically, Jensen much at stake, remain objective. using medication than when using is listed as a consultant to Novartis, Recent pooled analyses of both behavioural or community alternatives. the makers of Ritalin, the drug under published and unpublished trials of Of interest, peer ratings concurred investigation in the MTA. SSRIs for the under-18 age group with this assessment. The fact that When practitioners know what to reveal that, as far as how well they neither blinded classroom observers, look for—does the study have a true work, these drugs, plain and simple, the children themselves, or their peers double blind, are outcome measures do not deserve a blank cheque. An found that medication was better than clinician or client rated, how long did the study last, who funded the study and what are the authors’ The notion of stable, fixed psychiatric industry affiliations—they realize that medication should not be privileged syndromes does not fit the fluctuations over other psychosocial options (Sparks & Duncan, in press). Equipped of child development and adaptation to with this information, therapists also have a powerful method for evaluating social environments—children change future studies without having to take the word of the latest headline or sound continually with age and context. byte on the evening news. Kyle and his family are at a crossroads. It would not be hard analysis by researcher Jon Jureidini behavioural interventions suggests that to start down a path that saw his found that, out of 42 reported measures stimulant drugs offer no advantages difficulty as the early signs of mental in six published trials, only 14 showed over non-medication alternatives. illness. Through this lens, a proactive a statistical advantage. None of the With regard to time frames, the approach might make sense, warding youth and parent measures in this MTA surpassed its predecessors off a potential downward spiral before sample indicated any advantage of because it evaluated outcomes at 14 it becomes entrenched and intractable. the drug over a sugar pill—only the months instead of the customary 8–12 However, knowing also that such an doctors reported improvement. They weeks. The assessment occurred at approach most likely means medication also discovered that the effect size for the 14-month endpoint while subjects with its attendant risk and unproven the drug over placebo was quite modest were actively medicated. However, efficacy, it also makes sense to explore (0.26), amounting to only a 3 to 4 point behavioural intervention had long since other ways to understand and to resolve difference on scales which had ranges stopped—endpoint measures were his and his family’s dilemma. from 17 to 113 as possible scores. This taken four to six months after the last Therapist: I can certainly see that you may be statistically significant, but fails face-to-face contact. Thus, the endpoint have some concerns here. I really appreciate the test of clinical significance—that MTA comparison was between how you’re trying to make sure that you is, fails to tells us anything meaningful active medication and withdrawn know what’s going on so that you can take about the client sitting in front of us, behavioural intervention. This made action sooner rather than later. Usually, much less serve as a mandate, or ‘best the comparison hardly a head-to-head it’s a lot easier to head things off at this practice’. Unpublished trials fared contest, making the slight superiority age, rather than wait until the child is 8 or much worse—only one in nine showed of medication (on 3 of 19 unblinded 9 when it is a lot harder. a statistical advantage for the drug over measures) a foregone conclusion. A Mother: Exactly! That’s what we [with placebo (Jureidini, Doecke, Mansfield, 24-month follow-up of the MTA Kyle’s dad] thought too. That’s why I Haby, Menkes & Tonkin, 2004). shows that the improvements of wanted to speak to you. You know, since The Multimodal Treatment Study children on medication deteriorated (up we moved here, and the new baby came, of Children with ADHD (MTA), to 50 per cent) while the behavioural and starting the business and all, we the major trial supporting the intervention group retained their gains. hardly have time to sleep. superiority of ADHD medication, All advantage of the combined group Therapist: Well, it says a lot about you not only didn’t use an active placebo, over the behavioural intervention also that you could make the time to get in it lacked a pill placebo control group dissipated (MTA, 2004a). here today! altogether (MTA Cooperative Group, Finally, consider the conflicts of Mother: Thanks. What you said about 1999). As a consequence, it relied on interest. For those studies conducted doing something now rather than later, evaluations made by teachers, parents, before the disclosure requirement, a did you think we should have him see a and clinicians who were not blinded to little sleuthing can help. An online doctor, or have some kind of evaluation, the intervention conditions. The only database published by a non-profit maybe some medication or something? double-blind measurement (made by health advocacy group (Integrity in Therapist: Well, that is certainly classroom raters) found no difference Science, www.cspinet.org/integrity/) something that could be done. But, we among any of the intervention groups. reveals that lead MTA investigator don’t really know if that will be needed In fact, the subjects themselves Peter Jensen and at least five other at this point. Most of the time, we can PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007 37
work with the schools and also recommend children are prescribed ‘off label’. participants receiving Prozac in this things at home, that can move things in This means that the majority of drugs study attempted suicide (FDA, 2001, a better direction. Children of Kyle’s age prescribed frequently do not have the June 25). typically respond well to behaviour plans. requisite two clinical trials that show After a review of published We can observe what’s working for him they are safe and effective. Included and unpublished trials, the FDA and what we can do to build in some in off label medications are the new issued a black box warning for rewards for when things are going well. antipsychotics and all anticonvulsants. all antidepressants for children, It would be helpful if you could do the Additionally, there are no studies alerting consumers and providers same—see what is working or what isn’t to support the efficacy or safety of to increased risk of suicidality and at home. Would you note the times that Kyle is getting along with his sister and when things are going well? (Mother nods in agreement) If we can meet again In both clinical trials that resulted in FDA next week, we might have some better ideas of what’s going on and where to go approval of Prozac, no client-rated measures with things. Does that make sense? indicated superiority of the drug over Mother: Yes, it does. Problem is, his dad and I are so busy, and the baby takes up placebo. However, both studies concluded so much of my time, we hardly pay much attention to Kyle these days except to tell that Prozac outperformed placebo. him to do things, like get ready for bed or to stop doing things. Come to think of it, we don’t even have time to get him in prescribing multiple medications. All clinical worsening (FDA, October, 15, bed like we used to, with his favorite antidepressants, with the exception of 2004). The Medicines and Healthcare game and story. Prozac, are prescribed off label for child Products Regulatory Authority Kyle’s mother and the therapist and adolescent depression. The window (MHRA) in the United Kingdom took detailed concrete steps that could of approved drugs for children is very it further, banning all antidepressants be implemented at school and home. narrow—more narrow than what (except Prozac, which can only be used A follow-up meeting was scheduled might justify the robust prescription with children over eight years when to review progress and develop a rates. Even approved medications often talk therapies have failed). Growth behavioural plan based on the mother’s have risks that are minimized in the suppression and adverse cardiac effects and the teacher’s observation of decision-making process. have been noted as well (FDA, 2001, what was working. Diagnosis and As the APA report noted, a June 25; FDA, 2003, January 3). medication, while not discounted, thoughtful weighing of risk versus ADHD drugs also have troubling were not the primary discussion benefit is at the heart of any medication records when it comes to side effects. topics. Instead, other ways to view decision. Much of the data that has Sixty four percent of the children and address the problem emerged been collected raises concern. A in the MTA reported adverse drug from a therapeutic partnership to systematic evaluation of 82 medical reactions: 11 per cent were rated explore options. charts of children and adolescents as moderate and three per cent as treated with SSRIs found that 22 severe. In March of 2006, an FDA Safety per cent experienced some type of safety advisory committee called for Jess’s mother was torn. On one psychiatric adverse event (PAE), stronger warnings on ADHD drugs, hand, she feared for her daughter’s typically a disturbance in mood citing reports of serious cardiac risks, life and would do whatever it took to (Wilens, Biederman, Kwon, Chase, psychosis or mania, and suicidality. protect her. On the other, she was leery Greenberg & Mick , 2003). Estimates Stimulant medications have also been of medications and, in particular, ones of PAEs in child and adolescent associated with increased emergency not approved for children. Michael studies is complicated by inconsistent room visits. A recent study conducted was placed on an antipsychotic and an collection methods for side effects by the U. S. Centers for Disease anticonvulsant. All he knew was that data, and benign or misleading Control and Prevention found he didn’t feel right. His teacher noted assessments of data actually reported. that thousands of children taking that Michael no longer disrupted class, In the first Emslie study, six per cent stimulants wind up in the ER with but instead put his head on the desk a of participants taking Prozac dropped chest pain, stroke, high blood pressure, good portion of the day. Many popular out due to manic reactions compared fast heart rate, and overdose (Johnson, drugs are viewed as safe for children. with two per cent in the placebo 2006, May 25). Finally, the MTA However, safety is often tied to a group. If extrapolated to the general also revealed that the average height lesser-of-two-evils argument. Many are population, for every 100,000 children suppression for older children was willing to accept certain risks when the on Prozac, as many as 6,000 might about 1 cm per year, while younger possible alternative is a child’s school be expected to experience this serious children averaged 1.4 cm per year failure, drug abuse, crime or suicide. adverse effect. In addition, according height loss with a 20 per cent reduction Most psychiatric medications for to FDA documents, at least two in growth rate. 38 PSYCHOTHER APY IN AUSTR ALIA • VOL 13 NO 4 • AUGUST 2007
Children like Michael, diagnosed systematic feedback on an outcome C. L., Walter, J. M., Zijdenbos, A., Evans, with pediatric bipolar disorder, are measure that is understood easily A. C., Giedd, J. N. & Rapoport, J. L. (2002). Developmental trajectories of brain volume taking antipsychotic medications in by all (like the Child Outcome abnormalities in children and adolescents record numbers (Duffy et al., 2005; Rating Scale—free download with attention-deficit/hyperactivity disorder. Staller, Wade, & Baker, 2005). Side at www.talkingcure.com.) If JAMA, 288(14), 1740––1748. effects for these drugs in adults are medication is part of the plan, dosReis. S., Zito, J. M., Safer, D. J., well known, including irreversible invite the youth and others to Gardner, J. F., Puccia, K. B., Owens, movement disorders, obesity and the monitor the effects and use the P. L. (2005). Multiple psychotropic risk of diabetes. Given that one in five results as a basis for discussion medication use for youths: a two-state visits to a psychiatrist by a young person with medical professionals. Invite comparison. Journal of Child & Adolescent Psychopharmacology, 15(1), 6877. results in an antipsychotic prescription, the youth and others to view a six-fold increase in recent years, it’s positive change as resulting from Duncan, B., Miller, S., & Sparks, J. (2004). hard not to be alarmed at what these their efforts—‘Given that some The Heroic Client. San Francisco: Jossey-Bass. risks might mean for children (Olfson, take meds and they don’t work, how Blanco, Liu, Moreno & Laje, 2006). is it that you made them work for Duffy, F. F., Narrow, W. E., Rae, D. S., & West, J. C., Zarin, D. A., Rubio-Stipec, you?’ These kinds of questions Conclusion M., Pincus, H. A. & Reiger, D. A. (2005). encourage people to take ownership Concomitant pharmacotherapy among The decision of whether or not for successful outcomes. youths treated in routine psychiatric to medicate a child is one of the Lack of critical awareness takes practice. Journal of Child and Adolescent most difficult any family can face. A on greater weight where children Psychopharmacology, 15(1), 12–25. medical path is always a choice, and are concerned because children trust Emslie, G. J., Heiligenstein, J. H., its pros and cons can be explored with adults to make good decisions on Wagner, K. D., Hoog, S. L., Ernest, D. E., medical and non-medical professionals. their behalf. We hope that knowing Brown, E., Nilsson, M. & Jacobson, J. G. Therapists can feel free to shed their about the APA recommendations, (2002). Fluoxetine for acute treatment of timidity and discuss openly the risks depression in children and adolescents: the lackluster empirical support for A placebo-controlled, randomized clinical and benefits of medication, with the drugging children as a first-line trial. Journal of the American Academy of knowledge that there is empirical intervention, and the attendant safety Child and Adolescent Psychiatry, 41(10), support for psychosocial intervention risks has bolstered your confidence to 1205–1215. as a first line approach. The following talk about medication, raise concerns Emslie, G.J., Rush, A.J., Weinberg, W. A., are recommendations for engaging about robotic prescription practices and Kowatch, R. A., Hughes, C. W., Carmody, clients as central partners in developing side effects, and offer alternatives. An T. C. & Rintelmann, J. R. (1997). A double- solutions—medical or non-medical— awareness of the relationship between blind, randomized, placebo-controlled trial that fit each child and each situation. of fluoxetine in children and adolescents a profit-driven industry and science, with depression. Archives of General • Gather input from multiple sources and what that science actually reveals, Psychiatry, 54(11), 1031–1037. including the child, parents, enables therapists to assist families teachers, school records, and Fisher, S., & Greenberg, R. P. (1997). From to make intervention decisions—not Placebo to panacea: Putting psychiatric other community care-givers. only permitting a fuller picture from drugs to the test. New York: Wiley. • Develop multiple frameworks which to construct solutions, but also of understanding the problem Heres, S., Davis, J., Maino, K., Jetzinger, an appreciation that a child constantly E., Kissling, W., & Leucht, S. (2006). Why based on the perspectives of the changes with the ebb and flow of life, Olanzapine beats Risperidone, Risperidone youth, parents, teachers, and and is indeed like a river. You cannot beats Quetiapine, and Quetiapine beats significant others. Include step in the same river twice. Olanzapine: An exploratory analysis developmental, familial and of head-to-head comparison studies environmental explanations. References of second-generation antipsychotics. American Journal of Psychiatry, 163(2), • Develop a concrete plan of action. American Psychological Association 185–194. Working Group on Psychoactive If medication is part of the plan, Medications for Children and Adolescents. Johnson, L. A. (2006, May 25). ADHD make sure that all involved, (2006). Report of the working group on drugs linked to scores of ER visits. Chicago including the youth, are aware of psychoactive medications for children & Tribune, p. 6. potential risks, adverse events, the adolescents. 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