Lawrence H. Diller

Psych meds for kids: Too much, too soon?

Some psychiatric drugs do help children, but school and family are crucial, too.

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The opposing voices in the “debate” over the use of psychotropic medications in children veer toward hyperbole. One reviewer likened the process to “dueling grade-B movies,” where supporters of drug therapy view doctors as noble knights freeing children and their families from the tyranny of a biologically based mental illness, and the other side has physicians, especially psychiatrists, as evildoers who sedate and control children’s behavior by drugging them at the behest of their parents and teachers.

This dichotomy, while appealing to TV talk shows and tabloid journalism, doesn’t do justice to the motives of nearly everyone involved. Nor does it describe the economic, bureaucratic and social realities that can lead to an 8-year-old boy taking three psychiatric drugs simultaneously.

The discussion is complicated by the fact that children are dependent on their caregivers and are not allowed to make the final decision about their own care. At best, children are offered informed choice but not consent. Also, because children are in a developmental stage, the stakes are higher when they take medication. Parents and doctors are concerned that the medications may affect normal physical and developmental growth, leaving, in essence, permanent side effects.

Doctors genuinely desire to ease suffering. But they are also strongly influenced by economic factors. The profit motive affects whether and in what manner doctors offer treatment. The traditional fee-for-service arrangement encourages interventions. A capitated system of payments to doctors common in health maintenance organizations (HMOs), which sets a limit on how much money physicians receive regardless of what services are offered, discourages interventions that are deemed costly or result in only marginal benefits to the patient.

Our current systems of care and payment for children’s emotional problems, in tandem with often desperate parental expectations that the doctor will supply the “answer” to the problem, place inexorable pressure on the doctor to do something quickly.

Typically today under managed care the doctor must make a judgment about the diagnosis and a decision whether to medicate in a 50-minute meeting with the child and parents (usually just the mother). The doctor is then allowed two follow-up meetings of about 20 minutes each to review the child’s behavior on the medication.

Such was the case with Peter, a 5-year-old I was asked to evaluate. Peter’s developmental milestones were those of a 3-and-a-half-year-old. His language development was that of a 2-year-old. However, no one could be really sure about Peter’s intelligence because he was in constant motion and ignored his parents’ commands.

Peter lived too far away to receive ongoing treatment from me so I called Dr. Murrow, a child psychiatrist who had previously worked with Peter and his family in their community. Murrow had already tried a number of medications with Peter. I thought to offer a couple of ideas on Peter’s medications but also wanted to address his parents’ ineffective approach to limits with Peter.

I asked the doctor if he was doing anything else these days besides prescribing drugs. He sounded resigned and apologetic: “Nope. I see a kid every 15 minutes. It’s the only way I can make an income under managed care.” But he promised that, for Peter, he would try to include some of my ideas about the family the next time he saw the child and his mother.

Parents and schools complete the chain that squeezes the system toward a rapid medication intervention. I’ve never met a parent who, at least initially, wasn’t ambivalent about giving their kid a medication. However, parents today, when pondering their children’s problem behavior, begin to consider medication much sooner than parents did just 10 years ago. These days, after only several weeks of feeling like “We’ve tried everything,” moms and dads think, “Maybe Johnny can’t help what he’s doing. Maybe he does have a ‘chemical imbalance.’”

Imperceptibly at first, people go from believing that a child or parent has influence over a behavior problem to believing that the behavior is involuntary and that something biological is the cause. Medication becomes the reluctantly arrived-at solution. This kind of thinking is powerfully reinforced by much of American psychiatry and the media. Now when I meet parents who strongly believe that their child has “a disorder,” I find that they aren’t interested in considering other interventions unless I also write a prescription for their kid.

Teachers and schools are the final pressure point. Teachers are faced with a broad curriculum that today includes much more than the three Rs. Poorly educated students and social passing have led to increasing use of standardized tests. Not only are students more scrutinized, but so are their teachers. The demands on a teacher’s time and attention in a crowded classroom make managing behaviorally difficult children harder.

Teachers, like parents, consider a medication option much sooner these days. Few teachers come right out and make that suggestion, but the message is unmistakably clear to parents, and to the doctor, when a teacher suggests that the child get a medical evaluation to address problems of behavior and performance at school.

In fact, the Colorado State Board of Education recently passed a resolution urging teachers to first use discipline and educational resources before referring a child for a medical evaluation. They believed that teachers in Colorado were too quick to move to a “medication fix.”

Parents and doctors sometimes have to choose between giving a child medication and having the child attend a more restrictive classroom environment. Steven, 9, still couldn’t write a coherent sentence and instead hid under his desk. Would adding another medication allow him to remain in the regular class? Or should he be sent to “Special Day Class,” where there are fewer children but where they all have similar or more severe problems?

The costs and benefits of such choices are often clouded by an inefficient, overworked public education system that pushes parents toward choosing medication over special education. One can’t medicate a school system.

What about the medications themselves and how they are used? Are they effective? What do they do to children? In psychiatry, like the rest of medicine, doctors are supposed to first diagnose a disorder and then treat it. However, the specific psychiatric diagnostic categories for children become less clear in real life situations, and the effects of various medications are neither particularly specific nor reserved for particular diagnoses. ADHD blurs with oppositional defiant disorder, the category used to describe young angry, disobedient children. Ritalin helps treat both. Anxiety disorders merge with depression. Calling Prozac an antidepressant belies its use for obsessive-compulsive disorder or anorexia.

Calls from academic and professional organizations for “proper diagnosis” and adherence to treatment protocols often go unheeded by frontline physicians. And the lack of objective biological or psychological diagnostic markers, such as blood tests or brain scans, leaves psychiatric diagnosis very much within the eye of the beholder.

In the real world, prescription practices are symptom-driven, with doctors trying to use the safest medications with the fewest side effects first and changing or adding medications when old symptoms persist or new ones arise, sometimes from the other medications themselves.

In the schoolyard, Tommy gets into frequent fights with his second-grade classmates; he also hits his mother. He is likely first to receive a stimulant like Ritalin, Dexedrine or Adderall. He is only slightly less impulsive and continues arguing at home, so clonidine or Tenex may be added. If problems persist, the doctor, invoking an underlying “atypical” depressive disorder as his reason, may try Prozac, Paxil, Zoloft or Wellbutrin. There’s not a great deal of difference between the first three drugs except for their length of action.

But if Tommy doesn’t improve or gets worse, especially if he goes after an adult at school or breaks the law, serious consideration will be given to using a “mood stabilizer.” These drugs purport to treat the greatly expanded bipolar diagnosis. The anticonvulsants, Depakote and Neurontin, are often tried first. Some doctors prefer to prescribe lithium carbonate but its reputation as an adult drug that has frequent side effects decreases its popularity for use in children. Ultimately medications initially used to treat psychosis are used. They are categorized as novel or atypical anti-psychotics because their chemical structure is different from the first drugs like Thorazine or Mellaril used for schizophrenia. Risperdal and Zyprexia are the current “hot” anti-psychotics that are now being used to treat bipolar disorder.

Children like Anna, 9, take another medication route. She’s afraid to be alone at night, asks for constant reassurance and insists on wearing the same outfit every day to school. Anna will start with a Prozac-type drug for her anxiety and obsessive behavior. If she doesn’t improve, a Zoloft or Paxil may be tried before another class of drugs is employed. Some doctors continue to prescribe the older antidepressants like imipramine (Tofranil), desipramine (Norpramin) or nortriptyline (Pamelor).

These drugs were not found to be effective in childhood depression but still may be employed for other childhood symptoms. An anti-anxiety agent like Ativan or Klonopin may be offered to Anna especially to help her fall asleep at night. A mood stabilizer or anti-psychotic might be added if she begins talking about death or pulls off all her eyelashes.

All these drugs have side effects. Some are frequent and minor, at least to doctors, while others are quite serious but occur only rarely. The Ritalin-stimulant class has been studied most extensively. The drugs cause temporary loss of appetite and, if given too late in the day, insomnia. In general they are considered relatively safe when used properly. Children do not abuse the stimulants, though teens and adults may. Children under 5 seem to have more side effects on drugs like Ritalin. Clonidine and Tenex are sedating, which may explain their popularity for use in the late afternoon and evening. Children can experience rebound high blood pressure if they are abruptly taken off higher doses of these drugs. Children on Prozac drugs seem to experience a state of “hypomania” far more frequently than their adult counterparts. They act agitated, too happy or bizarre. Mark, 14, had taken Prozac for a week. His father and I had to literally sit on him when he became violent in my waiting room. He had never acted this agitated before.

I was surprised by Claire, a 10-year-old girl I knew, who placed about 10 of her pet salamanders on the sweater she wore as she waited to see me. Claire walked into my office and spent about 20 minutes picking imaginary “warts” off the salamanders as she talked with me. I finally asked her to stop because I thought she was abusing the animals. She had been on Prozac for two months and had never before acted so strangely. Both children’s medications were stopped.

Most of the other drugs cause sedation. In rare cases, Depakote can cause a fatal anemia. In women it causes cysts to form in the ovaries. Lithium commonly causes tremor and requires blood tests every six months to monitor kidney and thyroid function. The newer anti-psychotics are said to be less sedating but do cause significant weight gain for many children. They are touted as causing fewer involuntary muscle movements — called tardive dyskinesia — abnormalities that can persist even after the drug is discontinued.

However, over the years, many new anti-psychotics have been introduced with the claim that they have fewer side effects. With time and widespread use, their superiority over the older medications becomes questionable. It remains to be seen how much safer Risperdal will be over Mellaril or Thorazine.

Several drugs that had been frequently prescribed by child psychiatrists and pediatricians plummeted in their use when catastrophic side effects were discovered. Desipramine, imipramine and clonidine have all been associated with episodes of sudden death in children. Even though some researchers, Joseph Biederman among them, have questioned the frequency and association between these tragedies and the drugs involved, many doctors simply stopped prescribing them. Apparently, there are enough alternatives. And doctors found it difficult to tell parents that there existed even a small increased risk of their child dying from these drugs.

Similarly, the stimulant Cylert, once used commonly to treat ADHD, was voluntarily removed from the Canadian market and is hardly used in this country anymore. The manufacturer was compelled by the FDA to announce in a letter to all physicians that 11 cases of severe chemical hepatitis developed in children using the drug leading to their deaths or liver transplants.

This is a short list of only the known side effects of these drugs in children or adults. None of these medications except the stimulants have been studied for more than a few months in any children. The increased theoretical risk of long-term side effects exists especially for young children who continue to develop physically and neurologically and will live for 70 to 80 years after taking the medication. For example it is not known whether drugs like Prozac, which frequently cause sexual dysfunction in adults (decreased sex drive, difficulty with ejaculation or orgasm), will have any negative effects on sexually maturing children and teens.

I believe a child’s symptoms must be severe and the benefits of taking the medication must be quite clear to justify their use. A couple of kids I’ve seen have gotten better while taking a drug other than a stimulant. Timothy, 5, was already in a special kindergarten for emotionally disturbed children and his parents were at their wits’ end in handling his temper outbursts and defiance at home. He had already been on Ritalin, Dexedrine and clonidine without success. I was working with the parents, who were highly stressed by a suit they were pressing against a petrochemical company whose toxic wastes they believed caused their son’s problems. They were going from one doctor to the next.

The parents had Timothy on Zyprexia because of his rage episodes at home. They switched him to Risperdal after a new psychiatrist thought that the better choice. On low-dose Risperdal things did seem to improve for Timmy. His parents reported that his temper tantrums decreased in intensity and frequency and he was more obedient.

As is often the case, however, two other things changed at about the same time. The family finally sold the home they believed was contaminated and moved. Also, I coached the parents, especially the mother, to be more immediate and firm with their discipline of Timmy. It was hard to say if it was only the medicine that made the difference; it’s possible it allowed the other interventions to be more successful. The parents were convinced the medication made a crucial difference. I was content to see the improvement and did not challenge them with the possibility that the other changes had been more important.

Sam’s temper and school defiance improved considerably when he began taking Depakote. Sam previously had tried two stimulants and Prozac to help stop his angry outbursts at home and his defiance at school. At about the same time he started the Depakote the school assigned Sam, who also had severe learning problems, a full-time aide who shadowed him constantly, giving him immediate positive and negative feedback for his actions. The experience in school turned Sam around. However, neither the parents nor I could deny the possibility that the medication had also helped him.

It’s not that I’m against using medication in children. On average, in 1999, I wrote one prescription a day for Ritalin or its equivalent. But I’ve also tried to carefully explore with parents and teachers alternative strategies within the home and school. Many doctors, out of ideological, economic or time constraints, don’t bother. I’m much more worried about all these other drugs being offered to kids these days. Their short-term benefits are far less visible to me. They have the possibility of much more serious immediate side effects, and because none of them have been studied for more than a few months, I’m also uneasy about the unknown long-term side effects.

I resist using more drugs with children, despite the pressures on me, which are at times immense. I suspect I approach children’s problems with a different point of view and emphasis from many of my colleagues. Psychiatry over 30 years has changed in its perspective from the environmental to the biological but its focus remains on the pathological — what’s wrong with the child or family. Evaluations become a widespread and systematic search for symptoms and problems.

I probe with equal vigor for the competencies and strengths of the child and family. Since children do not exist in isolation, I find it impossible to view children’s behavior without considering their families, schools and culture. And it is more effective than considering the child alone. Some children do benefit from some time alone with the doctor. But mostly I work with those who have influence and control over the child’s world. After some weeks or months, if the situation hasn’t improved, I consider prescribing a medication to the child (or to a parent).

But once I move beyond Ritalin and the stimulants and think about the other medications employed for children today, I know that the family and I are facing the very difficult choice of dramatically altering a child’s environment or trying a different medication. Typically questions arise like, “Is this the right classroom or school for Joey?” “Maybe Don and I should separate to decrease the tension and fighting at home?” “Should I call the cops the next time Ian breaks something in the house?”

Families deal with these decisions only with great reluctance. The uncertain benefits and risks of a medication begin to seem worth taking. Proponents for children’s psychoactive medication say why not try a medication that may help? Medication is often much cheaper and might work faster.

But medication alone for children’s problems is not the moral equivalent of a better home or school environment for children. I object to the frequent current practice of early and multiple medication interventions because, too often, minimal effort has been made to address the children’s environment.

A 2-year-old boy on three psychiatric drugs, a 5-year-old trying eight different medications — these situations and many others like them leave me feeling confused, inadequate and angry. I continue to question my own competency and instincts about psychiatric drugs for kids. Sometimes I think I’m old-fashioned. But the reassurance I get from colleagues and families helps me believe I’m not alone in my concerns.

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By the time I met Bobby in July 1999, the 8-year-old on three medications, much had changed from when his parents first began fighting. Pierre had always been unhappy about Bobby’s medications, but Carol typically prevailed. After six years of a costly post-divorce battle over finances and custody, the parents had finally settled some of their issues and were getting along better. A new therapist for Bobby also worked closely with each parent and eventually had them meeting together with him about Bobby, whose behavior and performance improved dramatically at school with the help of a private tutor. Bobby now had average grades and a bevy of friends.

Pierre had never had many problems with Bobby. He attributed their getting along to a mutual love of dogs. In fact, in the process of divorcing, Pierre had lost a kennel and training facility he owned. This was without a doubt, Pierre believed, the single greatest loss for him and his son. Pierre also felt he was more direct than Carol with his affection and discipline of his son. Even Carol admitted that things were better at school for Bobby but she still worried about the possibility of problems at home should Bobby stop taking his medications. She fully accepted the hereditary and long-term nature of Bobby’s bipolar diagnosis and was reluctant to stop the medications that she believed had been so helpful. She was a much less confident parent who had battled her own depression and relied quite heavily on trying to talk Bobby through his noncompliance and rages.

I saw Bobby alone and with each parent. He seemed like a pretty normal, cute, lively brown-haired boy to me. He could talk freely about his past problems, his current set of friends and pleasures, his preference for his father’s home but also of his continuing loyalty and caring for his mother. He acted a little bit silly and immature in his mother’s presence. I spoke with his teachers and tutor, who were aware of some of his medications. They said they could not distinguish Bobby’s behavior from that of the other children in the class.

Bobby’s therapist felt that Pierre was finally finding his voice as a parent in the family. He also thought Bobby and his parents overall were working better together.

I met Carol and Pierre together and suggested they try a “tapering trial” — first slowly stopping the Neurontin and then the Anafranil. I was concerned with the sedating effects of both drugs. I tried to acknowledge both parents’ positions on the medication. I said that Carol would need a lot of support from Pierre in parenting Bobby, maintaining similar standards and responses.

Pierre wanted Bobby off all medicines but could accept this compromise. Carol remained apprehensive but was willing to try a trial discontinuation as long as she had backup support from the therapist and Pierre.

Bobby continued to be successful with only the Ritalin and perhaps in the near future could try life without any psychiatric medication.

Was all this medication necessary or useful for Bobby? He didn’t seem much worse off because of the drugs. They may even have helped him through a difficult time in his family’s life. No one knows if the possible benefits outweigh any future harm. Only time will tell.

From my perspective, Bobby’s family — his parents’ battles and relative reconciliation — was the biggest influence on Bobby’s behavior. Was Bobby misdiagnosed by his doctors or were they just “chasing symptoms”? Even if the pills helped, was it really necessary to tag Bobby with a psychiatric label of bipolar disorder that may haunt him and his family the rest of his life?

The only thing I know for sure is there are several million children like Bobby in America taking psychiatric drugs today without much certainty about their present value and long-term consequences.

Kids on drugs

A behavioral pediatrician questions the wisdom of medicating our children.

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Kids on drugs

I‘ve practiced behavioral pediatrics since 1978 in Walnut Creek, Calif., an affluent suburb of San Francisco. I have evaluated and treated more than 2,000 children who struggle with behavior and performance at home or at school. Last year alone, I wrote more than 400 prescriptions for Ritalin or a similar stimulant. I am not against prescribing psychiatric medication to children.

But I’ve become increasingly uneasy with the role I play and the readiness of families and doctors to medicate children.

I recently obtained some information from the National Disease and Therapeutic Index of IMS Health that adds to my uneasiness about the number of children taking psychiatric drugs in the United States.

IMS Health is to drug companies what the A.C. Nielsen company is to television networks. The pharmaceutical industry relies on it to report on the latest trends in medication usage. The company recently surveyed changes in doctors’ use of psychiatric drugs on children between 1995 and 1999 and found stimulant drug use is up 23 percent; the use of Prozac-like drugs for children under 18 is up 74 percent; in the 7-12 age group it’s up 151 percent; for kids 6 and under it’s up a surprising 580 percent. For children under 18, the use of mood stabilizers other than lithium is up 40-fold, or 4,000 percent and the use of new antipsychotic medications such as Risperdal has grown nearly 300 percent.

Approximately 5 million American children take a psychiatric drug today. Based on production/use quotas maintained by the Drug Enforcement Administration and national physician practice surveys, it’s possible to say with confidence that nearly 4 million children took the stimulant drug Ritalin, or its equivalent, in 1998.

Stimulants such as Ritalin have been used for more than 60 years to treat hyperactivity and inattentiveness in children. Over the past 10 years, however, psychiatric drug use for children has broadened considerably. There are more drugs and they are being used for more purposes. Ritalin is now prescribed for children as young as 2 and 3. A recent Michigan survey of Medicaid children found a few hundred toddlers taking stimulants and other psychiatric drugs. A study released two weeks ago in the Journal of the American Medical Association confirmed this trend in children of privately insured families.

Medicines originally developed and tested to treat depression in adults, such as the well-known Prozac (now in liquid form for easy pediatric administration), Paxil and Zoloft, but also Wellbutrin, Effexor and Serzone, are now being employed for a wide range of children’s behavioral problems. Medications originally developed to treat blood pressure, such as clonidine (Catapress) and its longer-acting relative, Tenex, are also being used for behavioral management.

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Pierre, 8-year-old Bobby’s father, pleaded with me to evaluate his son. Bobby was on three different psychiatric medications. Pierre and Bobby’s mother, Carol, had bitterly divorced and had been fighting since Bobby was 2. Bobby had had problems at school since kindergarten. Teachers described him as distractible, hyperactive, slow to learn and with few friends.

But his behavior at home, especially with his mother, posed the biggest headaches. He defied Carol and flew into violent rages, hitting and trying to bite her. Time outs were ineffective because he would either escape from his room or completely trash it.

Pierre admitted that he had seen this kind of behavior from Bobby only three or four times over the past three years. But at Carol’s, Bobby had major temper tantrums at least weekly. Carol took Bobby to a child therapist when he was 4. The therapist thought Bobby might have “ADD” — attention deficit disorder or, properly, ADHD (H for hyperactivity). She also thought he was depressed because of the divorce. Weekly play-therapy sessions for Bobby continued for three years and Carol sometimes got advice from the therapist on how to handle Bobby.

Pierre only met the therapist once. He acknowledged he’d never been a big fan of therapy and questioned its value. Carol had been a psychiatric patient for much of their 17-year marriage. She suffered from serious bouts of depression and took Prozac, the well-known antidepressant, and Ativan, a medication for anxiety much like Valium.

Bobby’s pediatrician started him at age 5 on Ritalin, the best-known stimulant for ADHD, because the boy kept getting up from circle time and twice ran out of the classroom at school. Later he was switched to a very similar stimulant medication, Dexedrine. Bobby’s acting out and impulsiveness continued, so Carol took him to a child psychiatrist who added the drug Wellbutrin to his regimen, thinking that Bobby’s irritability might be a sign of depression. (Wellbutrin has been used primarily to treat depression in adults, but has also been employed for a variety of other problems from anorexia nervosa to stopping smoking.) The Wellbutrin did not make much of a difference and after two months was stopped.

Bobby’s problem persisted. At Carol’s his bedtime would begin at 8:30 and at 11 Bobby was still up, getting out of bed, pestering his mother for water or food and driving her “crazy.” Another medication, Anafranil, was prescribed to help him fall asleep. (Anafranil was originally used in adult depression and obsessive-compulsive disorder, a condition of unwanted recurrent thoughts and compulsive behaviors like repetitive hand washing. But it often was too sedating for most people to tolerate.) Bobby fell asleep faster when he took this pill. Pierre, who in general had fewer problems with Bobby, only occasionally gave him this medication.

Bobby was 7 when Carol took him to a private psychiatric clinic well known for its controversial use of brain scans for psychiatric diagnosis and its liberal use of psychoactive medications. Bobby, now getting bigger, had stabbed another child with a pencil. No brain scan was done but the psychiatrist said that Bobby suffered from bipolar disorder, the current name for manic depression, and should take yet another drug. This fifth medication, Neurontin, originally approved as an anticonvulsant, more recently had been categorized felicitously as a “mood stabilizer.” The psychiatrist said this medication would help Bobby control his episodes of rage and prevent a further worsening of his symptoms.

When I first met Bobby he took Dexedrine in the morning, Neurontin three times a day and Anafranil at night only before bedtime. He took 12 pills a day when he stayed with his mother. At his father’s, he usually skipped the Dexedrine and Anafranil, especially on weekends. Pierre was afraid to stop the Neurontin because he had been told that Bobby might experience headache and irritability if that medication were abruptly discontinued.

Bobby was a very unhappy, angry boy caught in a web of strained emotions and loyalties between his parents. He was not an easy child to raise, especially for his mother, who had her own problems with depression. Bobby’s story is disturbing not for its uniqueness but for how it represents a growing trend in the U.S. — young children are being given essentially untested and potentially dangerous psychotropic drugs alone and in combination in greater volume than ever before.

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Diagnosing bipolar disorder in children as young as 3 has become the latest rage. It justifies using a host of meds to treat very difficult-to-manage, unhappy children. The old-line drug, lithium, has been replaced by newer, untested (in children) mood stabilizers like Neurontin or Depakote as a first-choice intervention for pediatric “manic depression.” Finally, a new class of anti-psychotic medications — the most popular these days is Risperdal — is heralded as the ultimately effective treatment for a number of diagnoses whose common features are not hallucinations or psychosis, but severe acting-out behaviors.

No one knows precisely how many children are taking these non-stimulant medications. The most recent survey of physicians’ practices had 1.5 million children taking an anti-depressant in 1996. Most were teenagers (girls are the majority), but more than 200,000 children under 12 are also prescribed an antidepressant. Other data tells us that rates of antidepressant use since 1996 continue to rise. For example, 150,000 prescriptions for clonidine were written for children in 1996. More than 100,000 children take “mood-stabilizing” drugs for purported bipolar disorder. Again, most are teens (here boys predominate) but it’s being advised that children as young as 3 take these drugs. More than 200,000 children receive anti-psychotic medications, mostly to control unruly behavior rather than to treat hallucinations or other symptoms of schizophrenia.

The number of children combining two or more psychoactive drugs is unknown. Combined pharmacotherapy (known pejoratively as polypharmacy) has been strongly endorsed by leading research groups as the sensible approach to treating the co-morbid, or multiple occurring, diagnoses common in “high problem resistant behavior” children. Some doctors call it prescribing by “symptom chasing.”

No other society prescribes psychoactive medications to children the way we do. We use 80 percent of the world’s stimulants such as Ritalin. Only Canada comes close to our rates, using half, per capita, the amounts we do. Europe and industrialized Asia use one-10th of what we do. Psychiatrists in those countries are perplexed and worried about trends in America. The use of psychoactive drugs other than Ritalin for preteen children is virtually unheard of outside this country.

In my practice of behavioral pediatrics I regularly meet children under 13 on two psychiatric medications. A 5-year-old girl troubled by fears had tried eight different psychoactive drugs over the year before she saw me. I met the mother of a 29-month-old boy who wanted me to prescribe medication. I didn’t, but later I learned the boy was getting lithium, Zoloft and Risperdal from another doctor.

Is this cutting-edge treatment or an outrage? I’m not sure. But with three or four exceptions, none of these drugs, alone or in combination, has been shown to be effective for a specific psychiatric condition in children. Outside of the stimulants and old-line anti-psychotic group, only two of the most frequently prescribed medications, Luvox and Zoloft, have been studied sufficiently to obtain the Food and Drug Administration’s approval for psychiatric use in children. Only a handful more have been examined systematically to eliminate the placebo effect, which has a particularly powerful influence in psychiatric conditions and in children. None of the newer medications has been studied beyond a few months for efficacy or side effects, and no one has looked at their effects on children’s growth and development.

Until recently the recondite and rarified worlds of academic child psychiatry and psychology have largely supported the increased use of these medications. Joseph Biederman, chief of Harvard’s pediatric psychopharmacology clinic, hails the increased use of psychiatric drugs in children as evidence “that child psychiatry is finally catching up to adult psychiatry” in psychopharmacological practice.

Other leaders in the field of child psychiatry are not as sanguine. Michael Jellinek, who as the head of child psychiatry at Harvard is effectively Biederman’s boss, and Peter Jensen, who recently stepped down as director of child and adolescent research of the National Institutes of Mental Health, have both publicly worried whether physicians’ prescribing practices for children have outstripped their scientific substantiation. They are also concerned that not enough is being done about the world these troubled children live in.

It’s Johnny’s Brain: The Triumph of Biological Psychiatry in America

What makes America so different from the rest of the world in how it views and treats children’s emotional and behavioral problems? Perhaps no other profession fell so completely under the sway of Freudian ideas as American psychiatry and psychology did in the first 60 years of the 20th century. Yet by the late 1960s critics both within and outside of American psychiatry had doubts about psychoanalysis as a science and as an effective treatment. In the 1950s drugs like lithium, Thorazine and Elavil, found to be useful in alleviating psychiatric symptoms, further challenged the Freudian hegemony on psychiatric thinking and practice in this country.

By the 1970s research and academic psychiatrists fomented an internal revolution culminating in 1980 with the publication of the third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III). The DSM III replaced the old Freudian diagnoses, which were based on traumatic childhood experience, with etiologically neutral lists of symptoms collected into supposedly definable syndromes. DSM III was meant only to be descriptive and used primarily for research. Few outside of an inner circle of research psychiatrists knew of a paragraph in the introduction, deleted at the last moment (ostensibly to maintain etiological neutrality), that said the presumptive cause of most of the disorders listed was biological, that is, the result of heredity or a chemical imbalance.

It really didn’t matter what was written, because over the next 10 years American academic psychiatry shifted 180 degrees from blaming Johnny’s mother for all his problems to blaming Johnny’s brain and genes.

The introduction of Prozac in the late 1980s cemented America’s belief in the biological basis for abnormal behavior. Prozac was no more effective than earlier antidepressants but had less severe side effects, which allowed greater numbers of less severely disabled people to continue to take the drug. A logic developed that if a drug improved behavior, the problems must be biologically based. No one speaks of headache as an “aspirin deficiency” even though the drug relieves the symptoms. Nevertheless terms like “chemical imbalance” became increasingly fashionable in explaining problem behavior.

Media exaggeration of scientific findings contributed to the revolution. The acceptance of Prozac made taking a psychotropic drug no longer taboo; it became the topic of dinner-party conversation. Nearly one in 10 Americans has taken Prozac or one of its close drug relatives. With so many adults taking a drug for mood, it didn’t take long for the primary drug for children’s behavior, Ritalin, to zoom in use.

Ritalin production and use for the treatment of ADHD rose by more than 700 percent between 1991 and 1998. Amphetamine production also used for ADHD initially lagged but has tripled in use since 1996. Trade amphetamine (primarily Adderall) surpassed trade Ritalin prescriptions in 1998, a testament primarily to the marketing success of the manufacturers of Adderall.

As Prozac opened the door for Ritalin use in children, Ritalin itself ushered in a new “better children through chemistry” age in our country. At least Ritalin had been the most studied of pediatric drugs, though only a handful of the thousands of studies look at patients other than boys or monitor the children beyond a couple of weeks. Meanwhile research on other psychotropic drugs for use in children has been limited. Until recently, funding for studies of psychiatric medication in children was meager by adult comparisons. Questions about children’s rights and consent to participate in studies raised thorny ethical issues, and the pharmaceutical industry did not believe there was much of a market for these drugs in children and so it did not fund studies.

Ironically, the new belief in a robust market for psychotropics in children has fueled a host of pending studies of different drugs for different child psychiatric conditions.

The community of pediatric psychopharmacology researchers is rather small; Biederman’s Harvard program has been arguably the most productive and influential. His work stands as prototypic of children’s psychiatric research under the DSM (now in its fourth edition) and demonstrates how a drug becomes established in the pediatric psychiatric pharmacopea. His research has won awards and his professional publications are prolific.

Biederman’s group demonstrated in the late 1980s that the tricyclic antidepressants (their chemical structure contains three “rings”) imipramine and desipramine, abandoned as a treatment for childhood depression because studies had shown them to be ineffective, could be used in high doses to successfully treat children with ADHD who had failed to respond to stimulants. In 1996, the Harvard clinic published a paper that said that 23 percent of their ADHD children also “had” bipolar disorder. (Most child psychiatrists believed manic depression to be a rare disorder in children.)

The Harvard group had always found higher rates of co-occurrence or “co-morbidity” of other disorders in their ADHD patients, but this rate of bipolar disease in children astonished the world of academic child psychiatry.

Biederman further claimed he could diagnose manic depression in children as young as 3. Few of these children demonstrated the classic signs of mania, euphoria or grandiosity. They did not have distinct periods of several weeks or months between their highs and lows. These children could cycle on a daily basis. They were very angry, very irritable kids.

Few of these kids were crazy. They could distinguish reality as long as they weren’t enraged. They were very unhappy and very difficult to control. But Biederman felt that children diagnosed as bipolar could be saved from a lifetime of antisocial behavior and substance abuse by aggressively treating them with medication.

The presumed hereditary and biochemical nature of bipolar disorder would justify the use of a new class of drugs known as mood stabilizers: lithium, Depakote, Neurontin — all drugs with far more serious short- and long-term side effects than Ritalin.

The response from other academic researchers was mixed. Debate goes on in the professional journals over the definition and frequency of bipolar disorder in children. One psychiatrist commented cynically that “Ritalin is for irritable and irritating children while lithium is for very irritable and very irritating children.” The practical effect, though, of the announcement of this new interpretation of pediatric bipolar disorder, was that these medications began to be used in very young children without even short-term evidence of their effectiveness and safety.

Of late, the new anti-psychotic drug, Risperdal, has been touted by the Biederman group as more effective than mood stabilizers in controlling the symptoms of bipolar children. Risperdal’s ascendancy as the drug of choice has not been slowed by a different set of more serious disabling side effects.

How should drugs properly be studied for use in children? Only two of the newer psychotropic drugs have been approved by the FDA for the treatment of a psychiatric condition in children. Paxil and Luvox, both variations of Prozac, have proved effective in clinical trials required by the FDA for the treatment of pediatric obsessive compulsive disorder (OCD). No other medication, as yet, has met FDA approval. Several drug trials in children, actively supported by the pharmaceutical industry, are under way.

Once a drug is approved for use by the FDA for the treatment of a specific medical condition, a doctor can legally prescribed it “off label” for any purpose. Virtually every other med used to treat children’s behavior is prescribed this way. Off-label use of medicines in pediatrics is common, but nowhere more so than in psychiatric medications. Physicians are constrained only by their own judgment and ethics. Local hospital and medical boards usually do little to interfere with doctors’ preferences for treatment.

Most of the drugs used to treat children’s emotional problems first became available after they met the FDA’s standards for approval in psychiatric clinical trials in adults. A few were initially approved for use in adults for other medical conditions: Depakote and Neurontin for control of seizures, clonidine for blood pressure.

The typical path to the widespread use of any of these drugs for children begins with a report of a single child’s response to a drug, usually as a letter in one of the professional journals. Journal editors explicitly state their openness to these kinds of “case” reports and more critical peer review scrutiny is omitted. The report will generate other letters until a series of cases are reported in which everyone — the kids, parents and doctors — knows what drug the child is taking.

Such studies are notorious for creating expectations of both positive and unwanted placebo effects. In the only study demonstrating the effectiveness of Prozac in children when the patients and doctors didn’t know which pill was taken, 60 percent of the improvement in depressive symptoms was attributed to the placebo effect.

The Super Bowl of drug testing, which supposedly can distinguish between the actual effects of the active ingredients of a medication and placebo, is called the double-blind randomized control study (DBRCS). In a DBRCS neither the family nor doctor knows whether the child is getting the medication or an identical capsule filled with an inert ingredient. Only the pharmacist who prepares the medication knows which capsule contains the drug to be tested.

Patients are carefully screened for the psychiatric condition to be treated and then are randomly selected to receive either the real drug or the placebo. The children are monitored by their parents and doctors for improvements and side effects; along with benefits coming from placebo, many children complain of unwanted effects like headache and stomachache while taking placebos. After a pre-determined period it is revealed who took the drug and who took the the placebo. Only then does one learn the “real” vs. “believed” effects of the drug.

Such DBRCS are expensive; until recently, pediatric psychopharmacology researchers have been limited by low funds for their studies. Those few DBRCSs that had been run usually included only enough children, usually fewer than 100, to generate the likelihood of a statistically significant difference between drug and placebo required for scientific journal publication, but not enough for FDA approval.

But with only scores of children assessed, drugs like Prozac, imipramine, clonidine and Wellbutrin have come to be prescribed for hundreds of thousands of children. Research with imipramine demonstrated that adult drug studies do not necessarily correspond to effects in children. Nonetheless, adult medication trials are regularly invoked to justify the use of those same agents in children.

Calls for increased funding for pediatric psychopharmacology research are ubiquitous within the child mental-health community. The pharmaceutical industry, which now sees a children’s market large enough to justify the expense, is funding several large studies, hoping to obtain FDA approval for the tested drugs.

On the other hand, studies on psychosocial interventions provide no similar profit-driven initiative for investigation. The much lower funding for this kind of research comes primarily from government. However, with the profit-motive incentive to develop new drugs and the real-life pressures to medicate children these days, there is ever-increasing pressure to medicate.

When all you’ve got is a hammer, everything starts to look like a nail.

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