Generation RX

Generation Rx

February 03, 2010
by A.F. Hutchinson, Copywriter
This report originally appeared in the January 2010 issue of DOTmed Business News.

The Medicated Generation? The Centers for Disease Control's National Center for Health Statistics reports that in 2005, 2.9 million children in the U.S. were prescribed medication for "difficulties with [his/her] emotions, concentration, or ability to get along with others." Given those diagnostic criteria, pretty much any parent you stop on the street will tell you that the disorder being medicated is childhood.

What does that number actually mean? Are more cases of mental illness that require medication being identified in kids? Are parents and teachers relying on a convenient alternative to reasoned discipline and behavior management? DOTmed gets up close and personal with the mental health professionals deeply involved in finding the answers to those complex questions.

A is for attention deficit disorder

According to the National Institute on Drug Abuse, Attention-Deficit Hyperactivity Disorder (ADHD) is the most commonly diagnosed behavioral disorder in children and adolescents in the United States. Although stimulants were recognized as a treatment for the symptoms of what is now classified as ADHD as far back as the 1930s, the widespread use of stimulants in the treatment of ADHD in the 1990s sparked a firestorm of controversy.

Prescribing physicians viewed the use of Ritalin (methylphenidate) as a breakthrough that could change the face of pediatric psychopharmacology. Parents, grateful for a remedy that could immediately calm their unruly progeny, readily accepted the break in the battle that the drug promised; in Ritalin, teachers had an antidote for those restless and inattentive charges that disrupted their classes and exhausted their patience.

Critics cited a lack of studies to demonstrate the drug's efficacy, concerns about side-effects as a consequence of long-term use on the developing brain, and viewed Ritalin as a dangerous drug of convenience rather than necessity.

As the debate over Ritalin raged, the class of psychiatric drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs) was gaining popularity in the treatment of depression, anxiety, panic and obsessive-compulsive disorders in adults. (These days, many SSRI compounds have immediate brand recognition, such as fluoxetine (Prozac), paroxetine (Paxil), sertraline hydrochloride (Zoloft), to name a few.)

In 1999, the National Institute of Mental Health sponsored the Multimodal Treatment of ADHD (MTA) study, the first multi-site study of the effect of Ritalin in children with the ADHD. Chief of the National Institute for Mental Health Child and Adolescent Treatment and Intervention Research Branch at the NIMH, Benedetto Vitiello, M.D. co-authored the landmark investigation, which followed 579 children ranging in age from 7-9 for 14 months.

The study examined four approaches to treating ADHD: intensive medication management, intensive behavioral treatment, a combination of both medication management and behavioral treatment, and routine community care. Initial results found that, on average, behavioral therapy coupled with closely managed medication produced 'significantly superior' results than either community care or behavioral treatment alone for reducing ADHD symptoms over a 14-month period.

In March 2009 the study authors presented an important follow-up to the initial study. They found that regardless of treatment, children with ADHD still had a much greater degree of difficulty in school and in social settings, more conduct issues, and higher instances of depression and psychiatric hospitalizations than children without ADHD. Most notably, the success of short-term ADHD treatment -- whether medication, therapy, or a combination of both -- didn't necessarily improve long-term outcomes; in fact, children no longer taking Ritalin at the eight-year follow up were functioning as well as those who were still taking it.

"The reality is that you can't draw too many firm conclusions from the extension of the MTA about the efficacy of treatment," Vitiello cautioned. "What we can say is that, on average, attention deficit disorder is a very impairing condition and even if you treat it intensively for 14 months you are not going to probably change some of the negative outcomes that are related to ADD. There are different patterns and paths within attention deficit disorder. It's very difficult to make a statement that covers them all. That's one of the conclusions that come from this; there's a lot of diversity, heterogeneity in this group that we call attention deficit disorder, and we can't just have one treatment for every group." One striking statistic remains: of the roughly 15% of the country's children prescribed behavioral medication, nine out of ten are given ADHD drugs.

In 2000, testifying before a House of Representatives hearing on "Behavioral Drugs in Schools: Questions and Concerns," child psychiatrist David Fassler, M.D. pointed out that Ritalin was generally well-tolerated by children with minimal side effects, but added this caveat: "Nonetheless, I share the concern that some children may be placed on medication without a comprehensive evaluation, accurate and specific diagnosis or an individualized treatment plan. Let me also be very clear I am similarly deeply concerned about the many children with ADHD and other psychiatric disorders who would benefit from treatment, including treatment with medication, who go unrecognized and undiagnosed, and who are not receiving the help that they need."

In the intervening years since that testimony, SSRIs and other behavioral medications have been widely adopted for use in children, treating the same behavioral issues that adults present, including depression, anxiety disorders, obsessive-compulsive behaviors and panic. With a decade in the rearview since that testimony, DOTmed asked Fassler to comment on the trend of prescribing psychiatric meds in children. "Teachers, pediatricians and parents are all getting better at recognizing the early signs and symptoms of mental illness in children and adolescents," he said. "As a result, we're definitely seeing an increase in the overall rate of diagnosis of child and adolescent psychiatric disorders. More and more young people are also being referred for treatment. We've also seen a significant increase in the use of psychiatric medications in pediatric populations.

"It's true that most of our studies concerning these medications are relatively short term, typically lasting several weeks to months. Very few studies have evaluated the safety or effectiveness of these medications when used to treat children and adolescents over a more extended period of time, which is often the norm in actual clinical practice."
B is for bipolar

According to Charles Barber, author of Comfortably Numb: How Psychiatry is Medicating a Nation, that dearth of research puts too many children at risk. "Medications to address ADHD can be remarkably effective for the children who really need them, but the drugs are highly overused. They are often used as the first-line of treatment without the appropriate probing of more "low tech," social factors that might be contributing to the problematic behavior, such as diet, parenting styles, and lack of consequences for inappropriate behavior," he says. "The last ten years have seen a startling rise in the use of mood stabilizers and antipsychotic drugs for children. This represents a sea change in the use of these medications, which used to be reserved almost entirely for adults. Indeed historically, such illnesses as bipolar disorder were thought not to apply to children at all."

As yet, there's no clear reason why more children are being diagnosed and treated for bipolar disorder. While there have been some studies suggesting a link between ADHD and the development of bipolar disorder, "It's very difficult to figure out what kind of disorder a child is going to eventually develop," Vitiello notes. "Oftentimes kids are just very impulsive and hyperactive and they present with a picture that can fall into the broad category of attention deficit disorder, but then what is the underlying problem? Is it mood disorder? It's true, they are hyperactive, they cannot pay attention, but the problem is the mood dysregulation. They have a problem in maintaining stability of mood that allows them to focus and to pay attention. And so more than just attention deficit disorder, it's really mood disorder that in some cases can develop then toward bipolar disorder. But of course, not for all of them."
Generation RX

Ethan H. Kisch, M.D., Medical Director of Warwick, R.I.-based Quality Behavioral Health, specializes in pediatric psychiatric disorders, including bipolar disorder. "It's well known that many more children are being diagnosed with bipolar disorder than were diagnosed a decade ago," he concurs. "There has been some question as to whether the diagnosis is valid. One of the people that have spoken most fervently about this issue is Gabrielle Carlson, M.D., who is on the faculty at SUNY Stony Brook. She has taken the position that many kids who have problems with mood regulation disorders have been misdiagnosed with bipolar disorder, but in fact, they are diagnostically homeless; they don't fall into any of the categories currently represented in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)."

In an editorial published in the August 2007 edition of the American Journal of Psychiatry, Carlson wrote, "Although most clinicians feel they use DSM-IV criteria for diagnosis, the huge increases in rates of bipolar diagnosis made in the community over the past decade suggest that clinicians may be applying the criteria in ways that are inconsistent." She points to the definition of rages as one example. "Rages are anger episodes called "mood swings" when described by parents and are explosive outbursts clearly out of proportion in both intensity and duration to the precipitant. This symptom is felt to capture the extreme irritability seen in mania. However, the irritability that often characterizes rages may occur in conjunction with many childhood disorders, most notably attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, anxiety disorders, depressive disorders, and autism spectrum disorders."

Kisch concurs. "It may be that some of the kids are over-diagnosed with bipolar disorder, but those who don't have bipolar disorder by a variety of schema still have major problems with mood regulations and fall into (the) diagnostically homeless category."

C is for controversy

The American Psychiatric Association produces the DSM, which classifies mental disorders by a system of codes which are used by mental health professionals to submit payment claims to payers. If a code doesn't exist for a particular condition, the clinician attempting to make the diagnosis doesn't get paid. In a joint statement, published in the April 2009 issue of Pediatrics, the American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry agreed that many pediatric developmental and behavioral issues don't meet the criteria for a diagnosis as outlined in the DSM-IV. "The current array of diagnostic codes does not fully capture the wide range of developmental and behavioral problems presenting in children," the statement reads. "Consequently, absent the codes acceptable to payers, primary care clinicians are typically not paid for their time spent identifying, treating, and managing these problems." The manual's current iteration, DSM-IV, is being revised; the updated manual is slated for release in May 2013.

One of pediatric psychiatry's most vocal and enduring critics is Peter R. Breggin, M.D. The former NIMH advisor served as medical consultant in a series of class action suits filed in Texas, California and New Jersey against Ritalin manufacturer Novartis, the APA and advocacy group Children and Adults with Attention Deficit Hyperactivity Disorder that alleged Ritalin's makers "directly affected and caused the APA to make every effort possible to support and confirm a new medical 'diagnosis' for which a stated treatment would be methylphenidate, i.e. Ritalin." The suits were eventually dropped, but ten years-post trial Breggin still has no love for the DSM.

"There is no percentage of the patient population accurately diagnosed (for ADHD). There is no diagnosis," he says. "It's fake, made-up to justify drugging. Everybody who works in the diagnostic panel over the years has been in favor of drugging the kids. That's the whole purpose of it. Impulsivity, inattention and hyperactivity are just categories of what could be normal childhood behavior, or something that reflects anything from a bored kid to a kid who's had a head injury. It's nonspecific. It's meaningless. It's not a diagnosis, and it should never be used as such."

One of Breggin's concerns is the rise and consequences of pediatric polypharmacy - the use of multiple medications to treat mental illness. A 'cocktail' of medications may be assembled to target specific brain chemistry when a single medication is ineffective, or to counteract the effects of other medications. While there are no current clinical trials that demonstrate the efficacy of this approach when it comes to pediatric psychopharmacology, its success in treating certain cancers and HIV/AIDS serves as anecdotal evidence that the idea has merit.

Breggin views polypharmacy as a cause rather than a cure. "Increasingly now I'm seeing children on multiple psychiatric drugs. That's partly because they get adverse reactions to the stimulants. Let's say they have trouble sleeping, so they're put on some form of drug that sedates them, and then when they start to get a little weird on the combination of drugs they're put on an antidepressant or some other medication," he posits. "By the time I get to see them they're on antipsychotics and the parents have forgotten what wonderful kids they were and it all began because he wasn't happy with his kindergarten teacher. Now we've got a kid who's been labeled as psychotic. And he's being labeled with bipolar disorder but he's actually having a manic reaction to antidepressants."

For 35 years, Robert Lehman, M.D. has operated a child and adolescent psychiatry practice in Baltimore. "What I definitively see in the course of the years is that there is an increased severity of symptoms and behaviors in the children that come to my office. I'm treating more difficult, more multi-handicapped, more severely impaired children now then I was at the outset of my practice." He points to an increase in incidence as the cause. "It's not that there is more illness out there. It's recognized more. There is less of a stigma, and there is more willingness for pediatricians to treat ADD and for pediatricians to refer and primary care physicians to treat and to refer, and there's a greater willingness on the part of the parents to go along with it. There is something that has changed, but I don't think incidence of childhood depression has increased; I think it's the idea then of identification, recognition, and diagnosis that has improved." He adds, "There is no question that there are more children on medication. That doesn't mean that there's an increased incidence of ADD. It's an increased recognition and willingness on the part of the provider and on the part of parents to allow pharmacologic intervention."

In addition to private practice and his role as Clinical Assistant Professor in the psychiatry department at the University of Maryland, Lehman is a founder of Pharmasite Research, a clinical trial management firm. He's candid about the influential role of the pharmaceutical industry in academic research. What does he think of Big Pharma's influence on pediatric psychiatry? "That's the price you pay for progress," he asserts. "You try to be an intellectual and thinking person when you read clinical trials, and when you read about the medications coming out, and you have to be intellectually honest with yourself about trying to make as good a diagnosis (as possible). But I would challenge any one of these people who say we're over-medicating to deny some of the claims of responses that I'm able to establish relatively easily with children. There are people that will be critical of multi-medicine use in children with no clinical trial evidence to support it. Polypharmacy in children is very common now, particularly in very disruptive children who get labeled as bipolar children. I've done three or four bipolar child trials; if every person was labeled bipolar, I'd have no trouble recruiting for those trials. It's very difficult to make an accurate diagnosis of bipolar, but if you have a kid that somebody's labeled as bipolar who is six years old and is running out of the house impulsively in downtown Baltimore where the distance between the front stoop and the street is about four feet, that's dangerous."

D is for debate

Prior to becoming a board-certified child and adolescent psychiatrist, Elizabeth J. Roberts, M.D. taught elementary school kids in the Chicago public school system. The experience informed her ensuing psychiatry practice; today she is a vociferous critic of the use of behavioral medications in children. While she is careful to make the distinction between behavioral problems and biologically-based psychiatric illnesses, she sees a disturbing trend of convenience on the part of prescribing physicians and amenable parents. "It's easier, sadly, to tell a parent your child has a chemical imbalance rather than to have to confront the parent with the idea that perhaps their parenting hasn't been up to par. No parent wants to hear that; no clinician wants to confront a parent. It's just easier to go along with the party line." From Roberts' perspective, the wide availability of self-diagnostic information on the Internet is a double-edged sword. "Parents will come in and say, "my child is bipolar, I'm sure. Six people in my family have been diagnosed with it." So that means every drunk in your family that blows up at Thanksgiving has been diagnosed with bipolar disorder." She predicts that parents' current fascination with bipolar disorders will be short-lived.

"It's not like the ADHD craze. ADHD got popular and will continue to be popular because the treatment for ADHD is a prescription of speed. Everybody loves speed," she says. "If you have any question about that, drive by any Starbucks on any morning and see the line out the door... people love their speed. It keeps you trim, you don't gain a lot of weight, don't become a fat American and all that fear that we have in our society." Conversely, atypical antipsychotics used to treat bipolar disorder have been shown to cause a variety of side effects, including rapid weight gain.

Roberts paints a dispiriting picture of the overmedication issue. "You have a profession driven by [researchers] who've taken millions of dollars from Risperdal and Seroquel, promoting this idea that every child has a tantrum is bipolar. Parents that are on the Internet researching, parents that don't want to have you tell them that you're parenting is terrible and the reason your kid is a brat is because you cannot parent well, they want to hear that he is chemically imbalanced, and an insurance system that drives docs to see a kid in five minutes and doesn't want to have a fight with parent [encourages overmedication]. 'You think he has bipolar disorder? Here's your script. Next!' And now you have a whole country full of medicated children."

Deciphering the Disorder Alphabet

Clearly, there are more questions than definitive answers when it comes to determining if today's kids are indeed the Medicated Generation. David Fassler sums up the situation this way: "On the positive side, we're seeing more kids make it through high school and into college despite significant psychiatric problems, in part as a result of effective and appropriate treatment. We've also seen a significant drop in the adolescent suicide rate over the past decade, which may well reflect increased recognition and access to treatment. But there's no question that we need more information about the safety and efficacy of all treatment alternatives including, but not limited to, medication. We also need more well designed, large scale, long term studies to provide the information parents and physicians need in order to make fully informed decisions about treatment options."