The Juvenile Bipolar ‘Juggernaut’

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juggernaut.jpgThat’s what the rate of scrips for antipsychotics written for kids is being called in the wake of a study this week in the Archives of General Psychiatry. The research showed that there’s been a 40-fold increase over nine years in the number of kids diagnosed with bipolar disorder, fueling an explosion in sales of antipsychotic meds made by Johnson & Johnson, AstraZeneca and Pfizer.

The number of scrips written for kids doubled to 4.4 million between 2003 and 2006, according to data provided to Bloomberg New by Wolters Kluwer, a research firm. The expanded use of bipolar disorder as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion US market for antipsychotic drugs. Some experts say the treatments are bringing needed help to troubled kids, while others call it a fad that is exposing children to serious risks, including weight gain and diabetes.

“I call it the juvenile bipolar juggernaut,” Joseph Woolston, chief of child psychiatry at Yale University Hospital in New Haven, Connecticut, tells Bloomberg. “The diagnosis has been broadened considerably, and I think that’s a big problem.”

The new study noted that the number of kids diagnosed with bipolar disorder during outpatient visits to doctors skyrocketed to 800,000 in 2003 from 20,000 in 1994. The data Wolters Kluwer suggest that the numbers have continued to climb in the past three years amid reports that more docs are influenced to prescribe off-label by drug company inducements.

J&J won FDA approval last month to market Risperdal for children over age 9 with bipolar disorder. No other antipsychotic is approved for kids, though Lilly and Bristol-Myers are seeking pediatric clearance for their drugs. Drugmakers say that while they don’t promote the drugs for use in children, doctors prescribe them if they feel their patients need them.

“Doctors can and do prescribe medications for indications beyond those set forth” in the prescribing information, says Jim Minnick, an AstraZeneca spokesman. “It’s common in clinical practice. We don’t promote it.”

Brian Sherry, 13, of Dallas, was diagnosed as bipolar in 2005 after becoming manic while taking antidepressants for irritable bowel syndrome and anxiety. She was prescribed Pfizer’s Geodon and two other pills, which would work “for a few days,” then stop, Brian says, so doctors kept boosting his dose. But his rages grew, as did his weight. The next year, 251,000 Geodon scrips were written for US kids, up from 89,000 in 2003, according to Wolters Kluwer.

Between 2003 and 2006, US pediatrics scrips for Bristol-Myers’ Abilify soared sevenfold to more than 1 million, Wolters Kluwer said. During those same years, sales for J&J’s Risperdal grew 58 percent to 1.9 million scrips, nearly a quarter of all US scrips, and pediatrics scrips for AstraZeneca’s Seroquel doubled to 1 million prescriptions. Only Lilly’s Zyprexa declined, falling to 218,000 in 2006 from 322,000.

Growth was most dramatic in the youngest children. Last year, 20,280 scrips were written for kids ages 4 and younger, a fivefold increase over 2003, Wolters Kluwer said. For 5-to 9-year-olds, scrips rose almost sixfold to 710,937.

Newer antipsychotics, known as atypicals, came on the market in the mid-1990s. They were billed as kinder, gentler drugs that would cause fewer neurological side effects that made users of earlier drugs tremble, doze off and jerk involuntarily. Studies have since suggested the new drugs are neither safer nor more effective than the older meds, while costing 10 to 20 times more.

The decision to prescribe meds comes from a doctor’s desire to help children, says Steven Klotz, a psychiatrist in Harrisburg, Pa. “We see sick kids and we want to help them,” he tells Bloomberg. “Atypical antipsychotics can be highly effective, but they have risks. And a lot of people sometimes resort to medications prematurely.”

Steven Hyman, provost of Harvard University in Cambridge, Massachusetts, and former director of the National Institute of Mental Health, says the growth in use of antipsychotics for kids worries him. “You’re treating a young kid, and it’s a problem if you create obesity and risk of diabetes and metabolic disorders early in life,” Hyman tells Bloomberg.

Drugmakers must walk a fine line in discussing the potential benefits of their meds for kids because they can’t be seen as encouraging their use. Representatives for Lilly, J&J, Bristol-Myers and AstraZeneca all says their companies don’t promote the drugs for use in children, but they’re are funding studies to assess their safety and effectiveness.

“The consensus among the field is that clinicians are obliged to provide something for conditions that leads to such terrible incapacity,” says Robert Findling, a professor of psychiatry at Case Western Reserve University in Cleveland, Ohio, who led a recent study of Bristol-Myers’s Abilify in teenagers. “What’s been lacking are methodologically stringent data that can help clinicians and families make decisions.”

Carol Puls, a Lilly spokeswoman, wrote Bloomberg an e-mail that about one in five bipolar patients experience their first manic episode during adolescence and that “early identification of this disease and initiation of effective treatment may improve long-term outcomes.”

J&J supports “studies that advance the knowledge of what is known about our products, and which can facilitate consistent and informed decision-making by physicians, patients and payers,” spokeswoman Ambre Morley wrote in an e-mail.

Pfizer “doesn’t promote nor encourage” the use of Geodon by children, says spokesman Jack Cox. The company is sponsoring two trials testing the drug in children and teenagers with bipolar disorder and schizophrenia, he said.

Psychiatrists studying bipolar disorder in children said its chief hallmark is explosive anger. “We’re not just talking about typical kinds of mood swings that adolescents have,” says Demitri Papolos, a Connecticut psychiatrist who wrote the popular book “The Bipolar Child.” “When they get really depressed or angry, it’s really extreme, like Dr. Jekyll and Mr. Hyde.”

Brian Sherry, the Dallas 13-year-old, had a manic episode after a school band trip in May 2005 that left him “talking real fast, unable to control the flood of thoughts coming into his head,” recalls his father, Duane Sherry. The Sherrys were contacted through a patient advocacy organization and plan no legal action in connection with Brian’s treatment.

Arnold Mech, a psychiatrist in Plano, Texas, diagnosed Brian with bipolar, obsessive-compulsive, social anxiety, generalized anxiety and attention-deficit hyperactivity disorders. Mech prescribed Geodon and the Pfizer antidepressant Zoloft, along with Lilly’s Straterra, a stimulant. To counteract the sedating effect of Geodon, he added Cephalon’s Provigil, a drug that promotes wakefulness.

Over the next seven months, Brian had only fleeting relief from anxious, angry moods and rages, he says. The drugs made him so tired he could barely function, his father says. Duane decided to wean his son off the meds and start him on a regimen of vitamins and herbal supplements. Since the switch, Brian says his moods and his relationships with schoolmates are better.

“The biggest thing was it kind of slowed down my thinking process,” he says. While on the meds, “I would make very rash decisions and get in trouble at school. When you slow down and think things through more rationally, it really helps.”

Mech, citing patient confidentiality, declined to discuss the Sherry case, but says bipolar disorder has been underdiagnosed in the past and that more doctors, including primary-care physicians, now recognize it. “It’s good they’re looking for it rather than ignoring symptoms and being unaware that depressive symptoms may be a phase of bipolar disease,” he tells Bloomberg.

Mech says he helped conduct a pediatric study of Geodon on behalf of Pfizer and has done research sponsored by 11 other drug companies and serves on the advisory boards or speakers’ bureaus of 18 drug and medical device makers, according to records he provided.

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  1. Dear Ed,

    You definitely know how to drive traffic ;)

  2. This is “DISCUSTING”

    Eventually, every American child and adolescent will be diagnosed as BIPOLAR.

    If there is an increase in suicide in “CHILDREN AND ADOLESCENTS” as Dr. Fassler professes,( DURING FDA MED GUIDE HEARING)then he and his fellow collegues are responsible for the harm and death these drugs have bestowed upon children and their families,and should be held accountable.

    “Voluntary Manslaughter” and “Criminal Negligence” comes to mind.

  3. I will be using this case in an upcoming course since it promises to combine a lot of key issues that connect “big academic medicine” (Harvard), big pharma, and the fragility of reliable science.

    Biederman of Harvard - who has been the point guy on expanding the bipolar dx - has COIS, consultancies, and speakerships with every relevant company (Harvard limits capital investments but not much else). That, in itself, does not prejudge the science. But it will be interesting for my students to compare (I haven’t done it yet) the results of studies that are independently funded on this issue and those that are not.

    Also, it’s striking how cynical are the voices even within mainstream psychiatric pharamcology ont his question.

    Harvard has put itself “out there.” We’ll see what the consequences are - first for our kids; second for them.

  4. Regardless of how the medical profession may feel about medicating juvenile bipolar disorder, there is no denying that children are born with this!! There’s a genetic component that’s associated with this disorder, and, without treatment, both the patient and society in general pays for the folly of having ignored it until the teen years - when it often bursts out in violent behavior and suicides. Let’s get rational here, and admit this exists.

  5. Meryl…

    Just because you have a gene for something, doesn’t necessarily mean you’re going to get it. Let’s use identical twins as an example. They share the same genes. If one twin has schizophrenia, the other only has a 50% chance of getting it.
    There must be a social/viral/bacterial aspect to this.

  6. Ed,

    TOUCHE’

    Meryl,
    Parents really dont care about your so called “STAR TREK THEORY” They just want the facts,something that Industry, and their “FOR HIRE PSYCHIATRISTS” clearly dont want them to know.

    “CHEMICAL IMBALANCE THEORY” show me the science!!!

    If you cant,Than, PLEASE, let me suggest that “SILENCE IS GOLDEN”.

  7. Meryl,

    When a Mistake is made,SOCIETY PAYS!!…
    When a Mistake is made a child suffers…
    When a mistake is made,Parents are left with the ultimate pain of loosing a child……

    When a mistake is made, their is a loss of Human Life…

    “Justice”, Just a thought…..

  8. Along the lines of some other comments - there is a “genetic component” for a lot of things. That does not mean:

    (1) It will necessarily _ever_ “break out.”
    (2) That pharmacologic therapy is necessarily the best treatment. The best tx requires a far more complex view of the situation of individual patients.
    (3) That, at this point, we have much more than conjecture about whether there is, or is not, a childhood form of bipolar disorder. Rather, at this point, it’s not about the science. It is about reframing the “phenomenology” of the illness in order to suggest tthat there is, indeed, a childhood form.

    Let’ts “get rational here” and acknowledge what we know and what we don’t.

    That may or may not be true. But the evidence, as it stands, has nothing to do with genes.

  9. Bathroom Remodeling Fallbrook Ca…

    As cyberspace continues to pile up What Is Bipolar 1 Disorder guidance, we’ll try to show them to you….

  10. Thank you for posting this.

    My son Brian is the adolescent featured in the Bloomberg piece.

    He has been symptom-free from bipolar for over two years - without medication.

    Is recovery from this ‘life-long’ illness possible?
    Without medication?

    You bet it is!

    Duane Sherry, M.S., CRC
    http://discoverandrecover.wordpress.com

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