Ethical Human Psychology and Psychiatry, Volume 6, Number 1, Spring 2004
The Ethics and Science of
Jacqueline A. Sparks
Barry L. Duncan
Institute for the Study of Therapeutic Change
Prescriptions for psychiatric drugs to children and adolescents have skyrocketed in thepast 10 years. This article presents evidence that the superior effectiveness of stimulantsand antidepressants is largely a presumption based on an empirical house of cards, drivenby an industry that has no conscience about the implications of its ever growing, and dis-turbingly younger, list of consumers. Recognizing that most mental health professionalsdo not have the time, and sometimes feel ill-equipped to explore the controversy regard-ing pharmacological treatment of children, this article discusses the four fatal flaws ofdrug studies to enable a critical examination of research addressing the drugging of chil-dren. The four flaws are illustrated by the Emslie studies of Prozac and children, whichoffer not only a strident example of marketing masquerading as science, but also, giventhe recent FDA approval of Prozac for children, a brutal reminder of the danger inherentin not knowing how to distinguish science from science fiction. The authors argue thatan ethical path requires the challenge of the automatic medical response to medicatechildren, with an accompanying demand for untainted science and balanced informationto inform critical decisions by child caretakers.
During the 1990s, prescriptions for psychiatric drugs to children and adolescents
skyrocketed (Olfson, Marcus, Weissman, & Jensen, 2002; Zito et al., 2003).
Evaluating the records of almost a million Medicaid and HMO youths, one of the
largest and most comprehensive studies to date concluded that child and adolescent psy-chotropic utilization rates nearly tripled from pre-1990s levels (Zito et al., 2003). Totalpsychotropic prevalence for youths reached as high as 6.3%, rivaling adult rates.
According to an IMS Health survey, between 1995 and 1999, the use of antidepressantsincreased 151% in the 7-12 age group and 580% in the under-6-years-old population.
Children under 18-years-old saw a nearly 300% increase in the use of antipsychotic med-ications such as Risperdal (Diller, 2000). Drug Enforcement Administration records andnational physician practice surveys indicate that approximately 4 million children tookstimulants in 1998 (Diller).
Even more alarming rates cluster in certain groups. Zito and colleagues found that chil-
dren in foster care were 16 times more likely to receive a prescription than their non-fostercare counterparts (2003). The Boston Globe
reported that 1 in 8 teens in the state’s Medicaid
2004 Springer Publishing Company
program was taking psychotropic medications, and 1 in 9 aged 6 to 12 years (8% and13%, respectively; Barry, 2003). Between 1991 and 1995, pediatricians and psychiatristswrote record numbers of stimulant, tricyclic antidepressant, clonidine hydrochloride, andSSRI prescriptions for preschoolers (Zito et al., 2000). Prescription rates formethylphenidate (Ritalin) for 2- through 4-year-olds grew by 169%. Zito and associatescalled such dramatic increases “remarkable in light of the limited knowledge base thatunderlies psychotropic medication use in very young children” (2000, p. 1026).
In most major surveys of child and adolescent psychotropic use, stimulants are ranked as
most popular, and antidepressants are ranked second. The research also points to an increas-ingly commonplace trend, polypharmacy, prescribing two or more medications simultane-ously. According to one study, the rate of co-prescription rose significantly from 4.7% to11.6% during 1987-1996 (Olfson, Marcus, Weissman, & Jensen, 2002). Children on stim-ulants for diagnoses of attention-deficit hyperactivity disorder (ADHD) are frequently pre-scribed clonidine, an antihypertensive for adults, to help with insomnia. These childrenoften take an additional antidepressant along with their amphetamine or methylphenidate.
Woolston (1999) remarks:
Unfortunately, the multiple “comorbid” diagnoses may reify the need for multiple med-ications: a different medication to treat each different “disorder.” Almost weekly I amasked to evaluate and treat children who allegedly have 5 or 6 Axis I disorders and whoare receiving as many or more different psychotropic medications to treat each disorder.
Out of these diverse studies, surveys, and anecdotal reports, a consistent picture
emerges. Children and teenagers can hardly be said to live, play, and work in “drug-freezones.” The use of drugs to fix their own, their parents’, or their school’s problems is ram-pant. IMS, the pharmaceutical industry’s own source of information, estimates that asmany as 5 million children are taking some form of psychotropic medication (Diller,2000). Given indisputable trends, widespread marketing, and a growing acceptance ofmedical intervention, current prevalence is likely far greater.
The news of rising psychiatric prescription rates to children has prompted concern
among many. However, reassurance from the medical establishment, including its mas-sive presence in mainstream media, quells much of the public’s uneasiness. Popular Websites, while always advocating therapy interventions, give the most detail for medicationtreatments. The National Institute of Mental Health (NIMH, 2000) Web page reportsthat childhood “mental disease,” contrary to earlier thinking, can begin at very youngages; early diagnosis means a better prognosis. “We used to think children could not bementally ill,” so the line goes, relegating nonmedicating preferences to the uninformeddark ages when children were left to suffer without the benefit of today’s modern medi-cines. The logic and the emotional appeal are compelling. Concerned parents should “seeyour [child’s] doctor.”
In such a climate, legitimate requests for alternatives often meet with formidable
resistance. Reports have surfaced of parents facing accusations of neglect by state childprotection agencies because of their refusal to medicate their child. Some mental healthworkers may fear that openly advocating for nonmedical interventions, especially forwhat are considered severe or chronic conditions, makes them appear ill-informed, rad-ical, or even unethical. Under such conditions, the road to informed consent and freechoice by parents, children, and concerned clinicians becomes more and more perilous.
Until recently, childhood psychiatric medications have largely been used “off-label,”
meaning without the necessary scientific studies to produce FDA approval. Now, this gapis closing, with more and more studies, funded almost exclusively by the medication man-ufacturers, finding their way into journals and granting scientific legitimacy to whatalready seemed just common sense.
Scientific backing opens the door to more and stronger arguments in favor of child
pharmocotherapy in both lay and professional press. A recent issue of The Family TherapyMagazine
, the quarterly publication of the American Association of Marriage and FamilyTherapy, is a case in point. This issue devotes itself to exploring family therapists andmedications, with a special article on pediatric psychopharmacology (Walkup, 2003).
Walkup states that the accurate depiction of trends in prescribing practices for childrenfails to “put the increased use in perspective” (p. 35). He argues that many more childrenare being prescribed medications because:
Psychiatric medications work for children’s problems.
De-stigmatizing psychiatric disorders has freed families and communities to seekmedication intervention for troubled children.
Medications have become available during the nineties to serve the needs ofuntreated children.
Our contention is that both common sense and scientific grounding for widespread
psychiatric drugging of children is, at best, unconvincing. Let’s take each point in turn.
First, what evidence do we have for the efficacy of psychotropic medications for safelyalleviating children’s psychological distress?
ANTIDEPRESSANTS AND KIDS: A SAD STORY
What do we know about the efficacy of antidepressants, the second most widely prescribedpsychotropic medication for children and adolescents? The failure of tricyclics (TCAs) toeffectively treat children is well documented (see Fisher & Fisher, 1997). During the1990s, there was great hope for the newer antidepressants, the selective serotonin reuptakeinhibitors (SSRIs). However, before 1997, SSRI efficacy studies found little to be hopefulabout. A comprehensive 10-year review revealed a dearth of evidence that either TCAsor SSRIs were effective for children and adolescents (Birmaher, Ryan, Williamson, Brent,& Kaufman, 1996). In spite of this, with ever staunch optimism, the reviewers concludedthat “psychosocial and pharmacological treatments [for children] are vital” (p. 1581).
Prior to 1997 there was the interesting paradox that at the same time clinicians were
prescribing more and more prescriptions for SSRIs, researchers were unable to prove thatantidepressants were efficacious for children. All of this changed with the publication oftwo studies by Emslie and colleagues. The first study (Emslie et al., 1997) was an 8-week,randomized, placebo-controlled, double-blind trial comparing the efficacy of fluoxetinehydrochloride (Prozac) and placebo. This study found:
• A significant difference in response between medication and placebo groups on one of
five psychometrically sound outcome measures.
• Self-report scores of participating adolescents and their parents indicated no differences
in outcome between the medication and placebo groups.
• Two other clinician-rated measures also showed no difference.
To help guide you though the quagmire of understanding the research jargon, we will
use the Emslie study to illustrate the four fatal flaws (Duncan & Miller, 2000; Duncan etal., in press) of drug research. Setting aside the paltry results of just 1 in 5 measures show-ing superiority over placebo, the four flaws suggest that this study does little to justify theuse of antidepressants for children.
EMSLIE AND THE FOUR FLAWS
Client Versus Clinician Ratings of Improvement
In their provocative tour de force, From Placebo to Panacea
(1997), Seymour Fisher andRoger Greenberg demonstrate that clinicians and clients differ substantially in their read-ing of how much improvement has actually occurred. For example, in 1992, Greenberg,Bornstein, Greenberg, and Fisher published an extensive meta-analysis of 22 antidepres-sant studies involving 2230 persons—and compared the effects of a placebo with both“old” (Elavil, for example) and “new” (Prozac) antidepressants. They found that [both oldand new] antidepressants showed an advantage [about 20%] over the placebo on clinician-rated measures, but none on client-rated measures. In short, when clients rate their ownresponses, they often experience no improvement on antidepressants beyond what can beattributed to hope and expectation. If clients don’t feel better after taking medications,how meaningful is any improvement other raters think they see? The Emslie study foundno difference between the placebo and SSRI groups on the two client-rated measures.
The skepticism researchers have for the perceptions of study participants, even if they
are children and adolescents, reflects the mistrust of client views deeply ingrained in men-tal health discourse. Various explanations have been offered to discount client voices—forexample, clients are too impaired by their “illness” to accurately report their condition, orthey cannot objectively assess improvement or lack of improvement in the way an observ-ing expert can.
Active Versus Inert Placebo
But how objective are expert observers in drug trials? Greenberg and Fisher (1997)demonstrate that the validity of controlled studies, in which a placebo is compared to adrug, depends upon the participants who rate the outcomes not knowing who is gettingthe “real” drug and who is getting the placebo. They note that the use of inert sugar pillsas the placebo in the vast majority of studies actually makes it possible for most partici-pants and clinicians to tell who is getting the real drug. The level of side effects experi-enced tips them off: those taking the active medication are more likely to experience thestandard side effects—dry mouth, weight loss or gain, dizziness, headache, nausea, insom-nia, and so on—clear signals they are taking a powerful drug, while those taking the sugarpill are not. As a result, the “double-blind” study is immediately “unblinded” for those rat-ing outcomes, a fact that seriously compromises any conclusions that can be drawn. Thisis the second fatal flaw, the issue of an active versus inert placebo—whether or not thestudy was truly double blinded and included an active placebo that mimicked the sideeffects of the drug under scrutiny. The Emslie study used a sugar pill placebo and conse-quently the double blind was likely compromised.
So, because of inactive placebos, it is not a stretch for researchers to accurately guess who
is getting a real drug and who isn’t. Along these same lines, many drug trial participants inplacebo groups have previously been on drug regimens, even some just prior to entering the
trial, and are therefore familiar with the effects of active medications. One review of blind-ness in antidepressant trials notes that participants are far from passive—they actively readsubtle cues or attempt to discover their treatment status and do so with remarkable accura-cy (Evan, Siobud-Dorocant, & Dardennes, 2000). This same review notes that simply ask-ing participants to track side effects compromises the blind from the outset.
No active placebo was used in the 1997 Emslie study. The Emslie study researchers,
undoubtedly aware of critiques by many of the double blind, attempted to salvage theintegrity of the 1997 blind (Hughes et al., 2000). In their assessment, Emslie and fellowresearchers determined that the blind “was clearly maintained” (p. 593). When both theProzac and placebo groups were considered together, without regard to client response,there was no trend in the prediction beyond what would be expected by chance.
However, when clients’ responses to treatment were considered, clinicians accurately pre-dicted medication for responders (27 out of 31) and placebo for nonresponders (26 outof 35). These represent approximate 87% and 74% rates of accuracy, respectively, far fromchance predictions! It is more than interesting that the very efforts to bolster claimsabout the integrity of the blind ultimately prove that the blind was undermined. The so-called blind procedures in the Emslie study were at best visually impaired, subject to alle-giance effects and experimenter bias.
Time of Measurement
The 8 weeks of the Emslie study were obviously an inadequate length of time to draw anyconclusions about differences in medication or placebo response. First, antidepressantsare almost never prescribed for short periods of time. Second, and more importantly, tak-ing the last measure at 12 weeks provides an inadequate look at the differential efficacybecause differences between groups tend to dissolve by 16 weeks (Fisher & Greenberg,1997). This major design flaw points to the conclusion that longer-term evaluation wasavoided, as in nearly all drug studies, because of fear that the effects would wash out.
Compromises to the study’s blind and the trial’s short time length are far from trivial
limitations. The fact that only one clinician-rated measure of five outcome scales showeda difference between active medication and placebo is, at best, marginal evidence of med-ication superiority. Nevertheless, Emslie and colleagues concluded, “Fluoxetine treat-ment was superior to placebo in relieving depressive symptoms” (1997, p. 1031).
The importance of the Emslie study as a justification for prescribing SSRIs to juveniles
cannot be underestimated. Keep in mind, until 1997 and Emslie’s publication, there wasvirtually no evidence supporting the increasingly widespread prescription of antidepres-sants for children and adolescents. This study provided enough basis for antidepressantprescription to continue unabated (albeit off-label) for youths and represented the first oftwo needed to accomplish FDA approval of the medication Prozac for this group.
Conflicts of Interest
Emslie and colleagues completed the Prozac approval sweep in 2002 with the publicationof a second placebo-controlled, randomized clinical trial for fluoxetine treatment of childand adolescent depression (2002). The first point of interest is on the first page of thisarticle, which illustrates the fourth fatal flaw of drug studies, namely, who is funding thestudy and with whom are the authors affiliated.
In May 2000, the editor of the New England Journal of Medicine
called attention to the
problem of “ubiquitous and manifold . . . financial associations” authors of drug trials hadto the companies whose drugs were being studied (Angell, 2000, p. 1516). Since this
time, there has been increasing pressure for medical journals to publicize funding sourcesand author ties to those sources to alert readers to potential conflicts of interest. It is illus-trative to note that in the 1997 Emslie article, no author affiliations to drug companieswere noted nor was the study’s funding source identified. However, under the title of the2002 Emslie study, readers can note that Drs. Emslie and Wagner were paid consultantsfor Eli Lilly and Company, who funded the research. The remaining six authors were list-ed as employees of Eli Lilly and “may own stock in that company” (p. 1205).
Beyond that—same study, different day. Eli Lilly and Company pronounced Prozac to
be “well tolerated and effective for acute treatment of major depressive disorder (MDD) inchild and adolescent outpatients” adding that “Fluoxetine is the only antidepressant thathas demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatricdepression” (Emslie et al., 2002, p. 1205). The primary measure of the study failed to showa significant difference in response; all client-rated and two clinician-rated scales showedno difference. Out of seven, three clinician-rated measures showed significant differencesbetween the experimental drug and placebo. As a 9-week trial, the study did not assesslonger-term outcomes. Once again, no active placebo was used, seriously calling into ques-tion whether the investigators, either employees or consultants of the company whosedrug was under investigation, could, with so much at stake, reasonably remain objective.
Nevertheless, the deed was done—two studies allegedly proving efficacy of Prozac for
children and adolescents. Shortly after the second publication, the FDA granted legitima-cy to an already well-entrenched prescribing practice. The January 3, 2003, edition of FDATalk Paper
prepared by the FDA Press Office announced FDA approval for Prozac for pedi-atric use to treat depression (Food and Drug Administration, 2003a). The report noted thatstudies have found side effects similar to those in adult trials. The paper also acknowledgedthat, after 19 weeks of treatment with fluoxetine, youths in one clinical trial gained an aver-age of 1.1 cm less in height (about 0.5 of an inch) and about 1 kg less in weight (about 2lb.) compared to youths taking placebo. The FDA report added that, although long-termeffects on growth are not known, Lilly had agreed to conduct a Phase IV postmarketingstudy to evaluate this concern. Unfortunately, the track record for pharmaceutical compa-nies’ completion of Phase IV follow-up studies is dismal. For example, of 107 new drugsapproved between January 1995 and the end of 1999, not one had been classified by theFDA as having completed Phase IV commitments (Sasich, Lurie, & Wolfe, 2000).
What difference does FDA approval make if child and adolescent antidepressant pre-
scription is already a well-established and growing fact of life? FDA blessing allows theunfettered marketing of these drugs to those who may be concerned about the drug’s impactin children’s lives. Bestowing the governmental seal of approval quells real fears of parents,clinicians, and clients. It allows the matter of efficacy to be put finally to rest. In an era ofevidence-based practice, it can now be said that indeed there is evidence, regardless of howslight, that at least this particular compound works. This “fact” is now repeated in futureresearch articles, mental health Web sites, promotional materials, workshops, classrooms,popular and professional books, ads, and more—media saturation reinforces truth.
For example, Brent and Birmaher (2002), in their most recent review of adolescent
depression, unequivocally state the case for SSRIs for adolescent depression: “SSRIs arethe most commonly used treatment for adolescent depression, because of the proven effi-cacy of fluoxetine, citalopram, and paroxetine in placebo-controlled trials, with aresponse rate of approximately 60% and a favorable side-effect profile” (p. 668). And this“truth” virtually halts inquiry into the actual soundness of the evidence that undergirds amassive child and adolescent pharmaco-mental health industry.
In contrast, but not supported by multibillion dollar corporate entities, psychotherapy
for children and adolescents has a strong tradition of proven efficacy (Asarnow, Jaycox,& Tompson, 2001; Curry, 2001; Lewinsohn & Clarke, 1999; Michael & Crowley, 2002;Mufson, Weissman, Moreau, & Garfinkle, 1999). Nevertheless, the political and eco-nomic clout of medical psychiatry has allowed childhood psychopharmacology to take itsplace at the head of the treatment table.
STIMULANTS AND KIDS: THE WRONG KIND OF ATTENTION
ADHD is arguably the most controversial topic in recent mental health history becausethe ADHD diagnosis is not defined by a biological marker (Leo & Cohen, 2003); it is quitesubjective, and is not easily distinguished from the everyday behavior of children (i.e., thediagnosis lacks reliability and validity [Duncan, Miller, & Sparks, 2004]); despite theguidelines of diagnostic prevalence of 3%-5% established by the 1998 National Instituteof Health (NIH) consensus panel, diagnostic rates are as high as an astounding 33% insome locations (LeFever, Arcona, & Antonuccio, in press); and despite the lack of evi-dence for long-term safety and effectiveness, stimulant medication treatment for ADHDhas increased significantly in the 1990s (Zito et al., 2003).
Without consideration of design flaws, stimulants, primarily Ritalin, have unequivo-
cally established their efficacy over placebo in small, short-term, randomized clinical tri-als on narrowly defined ADHD symptoms (not on social or academic measures). Toaddress the criticism that short-term efficacy studies do not address the more importantissue of effectiveness—or the success of stimulants on a wider range of outcome measuresin real settings over a longer period of time—the Multimodal Treatment Study ofChildren with ADHD (MTA Cooperative Group, 1999) was conducted. It comparedfour treatments for ADHD: behavioral treatment (BT), medication management (MM),combined BT and MM, and a community comparison treatment control group. TheMTA already has been touted, in both popular and professional publications, as provingthat stimulants are more effective than behavioral intervention. Similar to the Emsliestudies, and given the impact of the study on prescription practices, it is important toscratch a little below the surface to understand its conclusions.
First, on the positive side, the most unique element of the study is its large sample.
Previous studies of ADHD treatment have generally been small, with 1 to 20 participantsin each condition. With 144 participants in each group, the MTA was far superior innumbers alone. The MTA also surpassed its predecessors because it evaluated treatmentfor 14 months instead of the customary 12-16 weeks. Another impressive aspect is thecomprehensive nature of the assessments conducted. Rather than the simple clinician-rated outcome measures that characterize most studies, the MTA selected a total of 19measures from multiple sources (parents, teachers, child, peers, objective tests, and obser-vations) in multiple domains of functioning (ADHD symptoms, peer, and parent-childrelationships, classroom behavior, and academic achievement).
Before looking at the specific problems with the MTA, consider the results collect-
ed at the 14-month endpoint, as summarized by Pelham (1999), one of the principalinvestigators:
•All four groups showed dramatic improvement.
•MM was superior to BT on parent and teacher ratings of inattention, and on teacher rat-
ings of hyperactivity, but not on any of the other 16 measures.1
•Combined treatment and MM did not differ on any dependent measure; combined treat-
ment was better than BT on parent and teacher ratings of inattention, and on parent rat-ings of hyperactivity and oppositional behavior, and reading achievement.
•Both MM and combined treatments were superior to community treatments on parent
and teacher symptom ratings and on teacher-rated social skills, whereas BT was equiva-lent to community treatments; the two conditions with BT were superior to communitytreatment on parent-child relationships. (p. 982)
Let’s examine these results in light of the usual design flaws of drug studies. First, as
Breggin (2000b) articulates, the study was not placebo controlled or double blinded.
The MTA not only lacked a pill placebo control group, but also relied only on evalu-ations made by teachers and parents who were not blinded to the treatment condi-tions. Adding emphasis to this criticism, Breggin suggests, is the fact that the onlydouble blind measure (blinded classroom raters) found no difference among any of thetreatment groups.
Next, consider the issue of client versus other ratings. Neither the participants them-
selves (the 7-9-year-old children) nor their peers rated the children as more improvedwhen using medication than when using behavioral or community alternatives.
Breggin suggests that the negative findings from the blinded classroom observers, thechildren themselves, and their peers indicate that stimulant drugs offer no advantagesover nonmedication alternatives (2000b).
Finally, recall that the time of measurement is a crucial factor to consider. Here is
the key flaw of this study: Assessment occurred at the 14-month endpoint while sub-jects were actively medicated, but after the fading of therapy. Endpoint measures weretaken 4 to 6 months after the last, face-to-face, therapeutic contact! Thus, the end-point MTA treatment comparison was for active MM treatment versus withdrawn BT.
The study’s slight drug-favoring results were a foregone conclusion based on the veryway it was designed (Pelham, 1999).
Given that the results reflect medication versus withdrawn therapy, the lack of differ-
ence on 16 of 19 measures (when MM was compared with BT) and on 19 of 19 measures(when community treatment of mostly medicated children was compared with BT) iseven more telling. Also impressive, given the withdrawal, is that 75% of the children inthe BT condition were maintained without medication for 14 months, including one halfof those who were medicated at study entry (Pelham, 1999).
Two papers addressing the 24-month, follow-up data are under review (W. Pelham,
personal communication, April 21, 2003). They show that the group differences areeven smaller because the MM and combined groups have lost much of their effect,while the BT and community groups have retained their gains. Further, at 24 months,the majority of parents in the BT group thought their youths were doing well enoughthat they did not medicate them even after the study had ended (W. Pelham, person-al communication, April 21, 2003).
Moreover, the MTA reported that parents significantly preferred the behavioral and
combined treatments over medication alone. Even when a preference for medicationexists, most parents desire not to medicate their children for the long-term since mostADHD individuals stop taking stimulant medication during late childhood or adolescence(Pelham, 1999). This makes nonmedical intervention particularly important becauseeffects of stimulant medication, though beneficial in the short term, do not last beyondmedication termination. This is, of course, why the endpoint measure in the MTA was ofactive medication and withdrawn BT and not vice versa.
Perhaps parental concern about long-term stimulant use is most fueled by adverse drug
reactions (ADRs). In the MTA, an alarming 64% of the children were reported to havesome ADRs; 11% of the ADRs were rated as moderate, and 3% as severe, with the lattercategory representing largely “depression, worrying, and irritability.” In his review of thestimulant medication research, Breggin (1998) reports that these troubling reactions tostimulant medications are common across clinical trials.
Finally, emphasizing the importance of parental preference, consider the recent reve-
lation made by one of the principal investigators of the MTA, psychiatrist Peter Jensen.
Jensen has been traveling the globe extolling the virtues of stimulants over behavioralinterventions. With an audience at a recent APA meeting, Jensen shared that his son isdiagnosed with ADHD, and that he and Mrs. Jensen opted for behavioral treatmentinstead of medication (O’Connor, 2001).
The MTA, as well as all the available evidence regarding stimulants, say nothing
that indicates that medication should be privileged over any other option, especiallyas guided by client preferences. Moreover, and more troubling, the overuse of stimu-lants is a stopgap measure that locates the problem exclusively in the child (LeFeveret al., in press); it creates an “attention deficit” in professionals to responding morecreatively to behaviorally demanding children and their less-than-perfect learningcontexts. Mental health professionals need to challenge business as usual and encour-age a broader discussion of the socioeconomic and cultural issues affecting childrenand their success in the schools.
On balance, given the less than overwhelming empirical support and apparent med-
ical risks, as well as the nebulousness of the ADHD diagnosis itself (Leo, 2002), the judi-cious use of stimulants seems warranted. LeFever and associates (in press) make thefollowing (edited) recommendations:
Before any treatment, a suspected case of ADHD requires a thorough evaluationthat establishes that the symptoms cannot be better explained by other factors,and are inconsistent with developmental level.
If a child receives a diagnosis of ADHD during the preschool years, stimulantsshould be avoided because many problems are resolved by the first or second grade.
Behavioral interventions ought to be tried first because of their comparable effica-cy and lower medical risks than drug treatment.
If the child has not responded adequately after 6 months of therapy, then drugtreatment may be considered.
Psychotropic medications should not be combined until data from controlled stud-ies support the safety and efficacy of the combination in children. (p. 12)
DE-STIGMATIZATION AND TREATING THE UNTREATED
Putting aside the underwhelming efficacy of both stimulants and antidepressants, Walkup(2003) also argues that de-stigmatization has freed caretakers to use medical means toaddress children’s psychological needs. De-stigmatization would be a good thing, but wefind the logic that mental illness is not stigmatizing a bit hard to swallow. Breggin (2000a)states it well:
Nothing is more stigmatizing than carrying the label of “mental illness” for the rest of yourlife. It is especially unfair and demoralizing to tell children that they suffer from “brain dis-eases,” “biochemical imbalances” or “crossed wires” when they simply don’t. (p. 27)
How benign is a psychiatric label when it means a child must take medicine and must
rely on experts rather than on his or her own resources to solve problems? How harmlessis it when a diagnosis means a child can forget pursuing a job or career in the armedforces, or may be ineligible to run for political office in the future? Instead, we concurwith Breggin that psychiatric diagnosis and its sidekick, medication, create stigma. Weprefer to understand children’s problems from almost any other frame—lack of maturity,individual temperament, life trauma, or difficulties with relationships—situations thatare amenable to time or to the effort of the child guided by those closest to him or her.
We also prefer to take into consideration the impact of social conditions beyond thechild, family, or school that inhibit the best efforts of all. What might be seen as a braindisease may, in fact, be better described as diseases of poverty, racism, or other forms ofmarginalization.
Walkup and others, often by omission, paint a relatively benign picture of the side
effects of child psychiatric medications. One parent we know questioned the possibleeffects of Geodon, an antipsychotic, combined with Zoloft (an antidepressant) for her 15-year-old son. The prescribing psychiatrist responded by suggesting that she not read thewarnings on the drug insert because “it would just make you crazy.” While most profes-sional organizations, including the NIMH, encourage parents to read and to be informedwhen considering medication for their child, we wonder how often adverse events get lostin the discourse of drug efficacy and benefit?
In reality, the side effects of psychotropic medications for children warrant serious
examination. Primarily, the impact of earlier and longer chemical intervention on yet-developed brains represents a significant concern (Vitiello, 1998). There is evidence thatthe use of neuroleptic and other psychotropic medications makes long-term, if not per-manent, changes in brain structure (Breggin & Cohen, 1999). Secondly, too many warn-ing signals point toward an increased risk of mania and suicide brought about bypsychotropic medications, specifically the SSRIs (e.g., see Breggin, 2000a). Emslie failedto discuss the implications of the 6% dropout rate due to manic reactions in his 1997 ado-lescents and Prozac study. If extrapolated to the general population (as are the study’s effi-cacy claims), for every 100,000 children on Prozac, 6,000 would likely experience thisserious adverse effect.
Moreover, in a study of paroxetine hydrochloride (Keller et al., 2001), 21 out of 93
(23%) Paxil-takers reported manic-like symptoms, including hostility, emotional lability,and nervousness. (Ten in the Paxil group reported tremor, none in the placebo group.) Inreal practice, when these medications are taken for much longer periods of time than inclinical trials, rates of serious adverse responses are likely to be even more pronounced.
Nevertheless, both of the above mentioned studies proclaim the investigated drugs are“well tolerated” and safe. Meanwhile, reports of children becoming either more violentor more depressed due to medications designed to produce the opposite are abundant(e.g., see Breggin, 2000a; Breggin & Cohen, 1999; Fisher & Fisher, 1997)).
Recently, the United Kingdom’s Medicine and Healthcare Products Regulatory
Agency (MHRA) stated that Seroxat (paroxetine, also called Paxil in the US) must notbe prescribed for anyone under the age of 18 years (Boseley, 2003). According to theMHRA, clinical trials have failed to demonstrate the compound’s efficacy for childhoodand adolescent depression. More importantly, these trials indicate harmful outcomes asmuch as 3.2 times greater in the paroxetine group compared to children and adolescentstaking placebo, including increased agitation, aggression, self-harm, and suicidality.
Glaxo, the drug’s manufacturer, denied covering up studies suggesting the drug might
cause damage to youths under 18 years old. Earlier in the year, The Guardian
revealed thatmembers of the first working group investigating the safety of SSRIs held shares in Glaxo,leading to the group’s eventual disbanding.
Nine days later, the FDA issued a similar warning. Stating that it was reviewing reports
of possible increased risks of suicide thinking and suicide attempts in children and ado-lescents being treated with Paxil, the FDA recommended that Paxil not be used by thisage group (Food and Drug Administration, June 19, 2003). The FDA’s announcementalso noted that three well-controlled trials in pediatric patients with MDD failed to showthat the drug was more effective than placebo. Once again, how does this sit with the fol-lowing claim made by the authors of one highly touted trial: “[Paxil] is generally well tol-erated and effective for major depression in adolescents” (Keller et al., 2001, p. 762). TheKeller and associates’ study was funded by GlaxoSmithKline.2
The final argument Walkup and others make is that instead of questioning current
prescription rates, we should in fact be asking if enough children are “receiving treat-ment.” Fretting over design flaws or even a few unpleasant side effects is missing thebigger picture. This argument cites the Surgeon General’s 2001 National ActionAgenda for Children’s Mental Health (NAACMH), claiming a virtual epidemic ofchild mental disorders. According to NAACMH, 1 in 10 children or adolescents in theUS suffers from mental illness severe enough to impair their life functioning. Sadly, thisinitiative proclaims, only about one half of these “receive necessary treatment” (Mitka,2001, p. 398).
In light of these messages, parents and other caretakers are understandably anxious,
nervously watching for telltale signs that their child might be the next to succumb.
According to Walkup, the most relevant question here is “not the increased use per se,but what percentage of children and adolescents with pharmacologically responsive con-ditions are actually getting medication treatment” (Walkup, 2003, p. 35). In other words,if only half are being treated, and if evidence now indicates responsiveness for the largestcategories of disorders, then current prescription rates for children should practicallydouble. Instead of the 5 million plus children taking psychotropic medications, thereshould be as many as 10 million or more “receiving treatment.”
Missing in the explanations offered by Walkup and others, besides the questionable
efficacy of these drugs, are several key questions. How do we know that so many chil-dren are “sick”? Have these disorders been hidden from view in past generations, andonly now are we able to locate, diagnose, and treat them? If increases in childhood“mental disorders” are a more recent phenomenon, how might we make sense of this?Why are poor children—those on Medicaid, in the foster care system, or in residentialsettings—more often diagnosed and medicated? What role do simple cultural differ-ences make when the psychiatric establishment is comprised mostly of White,American men (Zito, Safer, dosReis, & Riddle, 1998)? Finally, instead of diagnosableillnesses, are we seeing reasonable reactions to oppressive conditions by those mostlikely to be under the gaze of “the system”? If so, should we be putting our time, ener-gy, and resources toward larger social agendas, rather than into pills that subdue andstigmatize the very victims of these conditions?
One thing we do know. Pharmaceutical marketing took on new life in the 1990s, and,
at the same time, so did a host of mental disorders. With the population “educated” to thesymptoms of silent epidemics, the everyday business of living, with its diversity of tempera-ments and emotional cycles, became subject to “disordering.” Who stands to gain the mostfrom promoting a medical versus nonmedical story for children in trouble? We believe that
an ethical path requires posing this question and those raised earlier to the scientific andbroader communities in ways that invite clarification of the true options available to chil-dren and their families.
ETHICAL CONCLUSION: FIRST DO NO HARM
With all this largesse and publicity raining benevolently down, is it any wonder thatpeople become hypnotically fixated on the brouhaha about a “revolution” in pharma-ceuticals and overlook the boring fine print of the drug studies with their more nega-tive implications? Is it any wonder that mental health professionals, who do not havethe time to sift through the doublespeak, become beguiled into believing that privileg-ing drugs is a matter of scientific fact? And consequently, how many will know that inthe Emslie studies Prozac only outperformed placebo on a few clinician-rated measures,or the sleight of hand presentation of the integrity of the double blind; or the interest-ing design choice of withdrawing behavior therapy long before endpoint measurementin the MTA?
The time has come to take a long and critical look at the rapid encroachment of drug
money and drug marketing influence on those who have the least power to just say no—children. Given that drugs are essentially foisted upon youths without their consent, andthe efficacy and safety of drugs for youths has yet to be established, we consider the prac-tice of prescribing drugs to youths as clearly the last resort, and in many cases, unethical,until other options have been discussed. The problem is, in the current pharmaceutical-saturated climate, it becomes increasingly difficult to have other options. The tale ofdrugs’ magical powers to solve life’s dilemmas is so compelling, so ubiquitous, there is lit-erally no room for anything else. When faced with the difficult decisions about how bestto help, parents, child professionals, and significant caretakers, with all the best inten-tions, too easily go for the medicine cabinet.
What is required is a shift, or, more likely, a reconnection with what parents and ther-
apists know and have experienced over and over—that most people can and will devel-op solutions to even the most daunting dilemmas given support and encouragement, thatthe impetus to health has many avenues and sometimes takes unorthodox routes, andthat change will and does occur naturally and universally. At its core is a faith in changeand the human tendency to find a way even out of the heart of darkness. Children are noexception. We should not discount the abilities of children to rise to the occasion and toconquer difficult situations in their lives, particularly with the love and support of keyadults. Nor should we discount the accuracy of the youngest voices to tell us what is work-ing or what might help. We can protect children, and we can allow them into the equa-tion, giving them a say in their lives (Duncan & Sparks, 2002).
Most often, children trust that adults know and do what is best for them. We must not
betray this trust. We simply cannot be blasé about accepting the increasingly automaticmedical response, but must demand high quality, untainted science and accurate, bal-anced information to inform critical decisions by child caretakers. Our ethical position isthat families should make the decisions they believe will be most helpful for theiryoungest members. At the same time, we believe professionals are duty bound, by theethics of our various professions, to ferret out the good science from the bad and to learnto critically analyze claims in Web sites, brochures, press releases, and scientific studiesregarding medications for children. We recommend a vigorous critique of what has come
to be everyday understanding of what works for children and teenagers as they navigatesometimes difficult paths to adulthood. We are obligated to be purveyors of this informa-tion to those who must make the final choice, the families themselves.
Finally, we believe therapists are obligated to not take the easy road by abandoning
tried and true counseling skills in favor of a “quick fix.” Being up-to-date on the latestpediatric psychopharmacology at the expense of adding to or strengthening other prac-tices only bolsters medical dominance and diminishes the choices we can offer. Whenconcerned parents approach us, we should be ready and willing with a range of nonmed-ical strategies. We assert that heroic youths and heroic parents should have a full rangeof options for making this journey on their own terms. Only then can we claim that wefirst do no harm.
Although Pelham reports that MM was superior to BT on parent and teacher ratings of
hyperactivity, the table on page 1082 in the 1999 MTA paper says that according to the teachersthe students were better off in terms of inattention but not hyperactivity. This has been pointedout by authors not affiliated with the MTA study (Leo, 2003, personal communication), but hasnever been clarified in print by any of the MTA researchers.
The lead author of the study, Martin Keller, according to The Boston Globe
(Kong & Bass,
1999), earned over one half million dollars in consulting fees in 1998, mostly from pharmaceuticalcompanies whose drugs he touted in medical journals. The story reported that neither BrownUniversity, where Keller is a professor, nor Keller reported these payments to the government asrequired of grantees under federal regulations designed to prevent research bias.
Angell, M. (2000). Is academic medicine for sale? The New England Journal of Medicine, 342
Asarnow, J. R., Jaycox, L. H., & Tompson, M. C. (2001). Depression in youth: Psychosocial inter-
ventions. Journal of Clinical Child Psychology, 30
Barry, E. (2003, March 9). Guidelines pushed on child medication—Romney aide questions use of
psychiatric drugs in Mass Health program. Boston Globe,
Birmaher, B., Ryan, N. D., Williamson, D. E., Brent, D. A., & Kaufman, J. (1996). Childhood and
adolescent depression: A review of the past 10 years (Pt. II). Journal of the American Academyof Child Psychiatry, 35
Bosely, S. (2003, June 10). Seroxat warning over risk to young. The Guardian.
Retrieved July 23,
2003, from www.guardian.co.uk/uk_new/story/0,3604,974175/00.html
Breggin, P. (1998). Talking back to Ritalin.
Monroe, MA: Common Courage Press.
Breggin, P. (2000a). Reclaiming our children: A healing plan for a nation in crisis.
Breggin, P. (2000b). The NIMH multimodal study of treatment for attention-deficit/hyperactivity
disorder: A critical analysis. International Journal of Risk & Safety in Medicine, 13,
Breggin, P., & Cohen, D. (1999). Your drug may be your problem: How and why to stop taking psychi-
Cambridge, MA: Perseus.
Brent, D. A., & Birmaher, B. (2002). Adolescent depression. The New England Journal of Medicine,
Curry, J. F. (2001). Specific psychotherapies for childhood and adolescent depression. Biological
Diller, L. H. (2000). Kids on drugs—A behavioral pediatrician questions the wisdom of medicating
. Retrieved May 20, 2003, from http://www.salon.com/health/feature/2000/03/09/kid_drugs/
Duncan, B., & Miller, S. (2000). The heroic client: Doing client directed, outcome informed therapy.
Duncan, B., Miller, S., & Sparks, J. (2004). The heroic client: A revolutionary way to improve effec-
tiveness through client-directed, outcome informed therapy
. San Francisco: Jossey Bass.
Duncan, B., Miller, S., Sparks, J., Jackson, G., Greenberg, R. P., & Kinchin, K. (in press). The myth
of the magic pill. In B. Duncan, S. Miller, & J. Sparks, The heroic client: Becoming client direct-ed and outcome informed
(2nd ed.). San Francisco: Jossey Bass.
Duncan, B., & Sparks, J. (2002). Heroic clients, heroic agencies: Partners for change.
Emslie, G. J., Heiligenstein, J. H., Wagner, K. D., Hoog, S. L., Ernest, D. E., Brown, E., et al.
(2002). Fluoxetine for acute treatment of depression in children and adolescents: A placebo-controlled, randomized clinical trial. Journal of the American Academy of Child and AdolescentPsychiatry, 41
Emslie, G. J., Rush, A. J., Weinberg, W. A., Kowatch, R. A., Hughes, C. W., Carmody, T., et al.
(1997). A double-blind, randomized, placebo-controlled trial of fluoxetine in children andadolescents with depression. Archives of General Psychiatry, 54
Evan, C., Siobud-Dorocant, E., & Dardennes, R. M. (2000). Critical approach to antidepressant
trials: Blindness protection is necessary, feasible and measurable. The British Journal ofPsychiatry, 177,
Fisher, R. L., & Fisher, S. (1997). Are we justified in treating children with psychotropic drugs? In
S. Fisher & R. P. Greenberg (Eds.), From placebo to panacea: Putting psychiatric drugs to the test
(pp. 307-322). New York: Wiley.
Fisher, S., & Greenberg, R. P. (Eds.). (1997). From placebo to panacea: Putting psychiatric drugs to the
Food and Drug Administration. (2003, January 3). FDA approves Prozac for pediatric use to treat
depression and OCD. FDA Talk Paper.
Retrieved February 2, 2003, from www.fda.gov/bbs/topics/ANSWERS/2003/ANSO1187.html
Food and Drug Administration. (2003b, June 19). FDA statement regarding the anti-depressant Paxil
for pediatric population. FDA Talk Paper. A
Greenberg, R. P., Bornstein, R. F., Greenberg, M. D., & Fisher, S. (1992). A meta-analysis of anti-
depressant outcome under “blinder” conditions. Journal of Consulting and Clinical Psychology,60,
Greenberg, R. P., & Fisher, S. (1997). Mood-mending medicines: Probing drug, psychotherapy,
and placebo solutions. In S. Fisher & R.P. Greenberg (Eds.), From placebo to panacea: Puttingpsychiatric drugs to the test
(pp. 115-172). New York: Wiley.
Hughes, C. W., Emslie, G., Kowatch, R., Weinberg, W., Rintelmann, J., & Rush, A. J. (2000).
Clinician, parent, and child prediction of medication or placebo in double-blind depressionstudy. Neuropsychopharmacology, 23
Keller, M. B., Ryan, N. D., Strober, M., Klein, R. G., Kutcher, S. P., Birmaher, B., et al. (2001).
Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, con-trolled trial. Journal of the American Academy of Child & Adolescent Psychiatry, 40
Kong, D., & Bass, A. (1999, October 8). Case at Brown leads to review: NIMH studies tighter rules
on conflicts. Boston Globe,
LeFever, G., Arcona, A., & Antonuccio, D. (in press). ADHD among American school children:
Evidence of overdiagnosis and misuse of medication
Leo, J. (2002). American preschoolers on Ritalin. Society, 39
Leo, J., & Cohen, D. (2003). Broken brains or flawed studies? A critical review of ADHD neu-
roimaging research. The Journal of Mind and Behavior, 24,
Lewinsohn, P. M., & Clarke, G. N. (1999). Psychosocial treatments for adolescent depression.
Clinical Psychology Review, 19
Michael, K. D., & Crowley, S. L. (2002). How effective are treatments for child and adolescent
depression? A meta-analytic review. Clinical Psychology Review, 22
Mitka, M. (2001). Mental health agenda now set for US children. Journal of American Mecical
MTA Cooperative Group. (1999). A 14-month randomized clinical trial of treatment strategies for
attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56
Mufson, L., Weissman, M. M., Moreau, D., & Garfinkel, R. (1999). Efficacy of interpersonal psy-
chotherapy for depressed adolescents. Archives of General Psychiatry, 56
National Institute of Mental Health. (2000). Treatment of children with mental disorders.
July 10, 2003, from http://www.nimh.nih.gov/publicat/childqa.cfm
O’Connor, E. (2001, December). Medicating ADHD: Too much? Too soon? Monitor on Psychology,
Olfson, M., Marcus, S. C., Weissman, M. M., & Jensen, P. S. (2002). National trends in the use of
psychotropic medications by children. Journal of the American Academy of Child and AdolescentPsychiatry, 41
Pelham, W. (1999). The NIMH multimodal treatment study for attention-deficit hyperactivity dis-
order: Just say yes to drugs alone. Canadian Journal of Psychiatry, 44
Sasich, L. D., Lurie, P., & Wolfe, S. M. (2000). The drug industry’s performance in finishing post-
marketing research (Phase IV) studies: A Public Citizen’s Health Research Group report. TheHealth Research Group
. Retrieved June 6, 2003, from http://www.citizen.org/publications/release.cfm?ID=6721
Vitiello, B. (1998). Pediatric psychopharmacology and the interaction between drugs and the
developing brain. Canadian Journal of Psychiatry, 43
Walkup, J. T. (2003, June 11). Pediatric psychopharmacology update. Family Therapy Magazine,
Woolston, J. L. (1999). Combined pharmacotherapy: Pitfalls of treatment. Journal of Child &
Adolescent Psychiatry, 38
Zito, J. M., Safer, S. J., dosReis, S., Gardner, J. F., Boles, M., & Lynch, F. (2000). Trends in the pre-
scribing of psychotropic medications to preschoolers. Journal of the American MedicalAssociation, 283
Zito, J. M., Safer, S. J., dosReis, S., Gardner, J. F., Magder, L., Soeken, K., et al. (2003). Psychotropic
practice patterns for youth: A 10-year perspective. Archives of Pediatric & Adolescent Medicine,157
Zito, J., Safer, D., dosReis, S., & Riddle, M. (1998). Racial disparity in psychotropic medications
prescribed for youths on Medicaid insurance in Maryland. Journal of the Academy of ChildAdolescent Psychiatry, 37,
. This article is adapted from The Heroic Client: Doing Client Directed, Outcome
by B. Duncan, S. Miller, and J. Sparks, in press, San Francisco: Jossey-Bass.
Adapted with permission.
. Requests for offprints should be directed to Jacqueline A. Sparks, PhD, 2750 NE 28th
Court, Lighthouse Point, FL 33064. E-mail: [email protected]
G E B R A U C H S I N F O R M AT I O N : I N F O R M AT I O N F Ü R D E N A N W E N D E R Jatrosom® 20 mg Filmtabletten Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme/Anwendung dieses Arzneimittels beginnen. • Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen. • Wenn Sie weitere Fragen haben, wenden Sie sich
MEGA D Vit. D3 1,000 I.U. DESCRIPTION: One softgel provides 1000 IU of vitamin D3 100 count bottle of easily swallowed light beige softgels. FORMULA: One softgel provides Vitamin D3 of 1000 IU (250% daily value). Other ingredients: rice bran oil, gelatin, glycerin and purified water. DIRECTIONS: One capsule per day; recent investigations into the safety and efficacy of vit