J&J, Pfizer Profit on “Juvenile Bipolar Juggernaut” — (Bloomberg)

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Bloomberg

By Rob Waters

Sept. 5, 2007

(Bloomberg) — Sales for children of antipsychotic medicines made by Johnson & Johnson, AstraZeneca Plc and Pfizer Inc. have exploded, fueled by a 40-fold increase over nine years in the number of children diagnosed with bipolar disorder.

The number of prescriptions for children doubled to 4.4 million between 2003 and 2006, according to data provided to Bloomberg by Wolters Kluwer NV, a drug-tracking company. The sales added to revenue for J&J, the world’s largest producer of health supplies; Pfizer, the world’s biggest drugmaker; London- based AstraZeneca and Bristol-Myers Squibb Co. of New York.

The expanded use of bipolar disorder as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. 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,” says Joseph Woolston, chief of child psychiatry at Yale-New Haven Hospital, affiliated with Yale University in New Haven, Connecticut. “The diagnosis has been broadened considerably, and I think that’s a big problem.”

Researchers reported yesterday in the Archives of General Psychiatry that the number of children diagnosed with bipolar disorder during outpatient visits to doctors skyrocketed to 800,000 in 2003 from 20,000 in 1994. The data from Netherlands- based Wolters Kluwer suggest that the numbers have continued to climb in the past three years.

Broadened Definition

J&J won U.S. regulatory approval Aug. 22 to market Risperdal for children over age 9 with bipolar disorder. No other antipsychotic medicine is cleared for children, 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 drugs’ official prescribing information, said Jim Minnick, a spokesman for AstraZeneca. “It’s common in clinical practice. We don’t promote it.”

Johnson & Johnson declined 33 cents to $61.55 at 4 p.m. in New York Stock Exchange composite trading and has lost 6.6 percent this year. Pfizer fell 37 cents, or 1.5 percent, to $24.71. The stock has dropped 4.6 percent in 2007.

Bipolar disorder, once known as manic-depression, used to be seen as a serious, enduring condition that kept adults mired for weeks or months in a deep depression, then sent them flying into a manic phase of similar length. In 1994, researchers began broadening the definition and including children.

Thirteen-Year-Old’s Diagnosis

Thirteen-year-old Brian Sherry of Dallas was diagnosed as bipolar in 2005 after becoming manic while taking antidepressants for irritable bowel syndrome and anxiety. Doctors prescribed the antipsychotic drug Geodon and two other pills. The regime would work “for a few days,” then stop, Brian says, so doctors kept boosting his dose. His rages grew, as did his weight.

The next year, 251,000 Geodon prescriptions were written for children in the U.S., up from 89,000 in 2003, according to Wolters Kluwer. Geodon is made by New York-based Pfizer.

Between 2003 and 2006, U.S. prescriptions of Bristol-Myers’s Abilify for children 18 years and younger soared sevenfold to more than 1 million, Wolters Kluwer said.

During those same years, sales for children of New Brunswick, New Jersey-based Johnson & Johnson’s best-selling drug, Risperdal, grew 58 percent to 1.9 million orders, nearly a quarter of all U.S. prescriptions. Pediatric sales of AstraZeneca’s Seroquel doubled to 1 million prescriptions.

Only Zyprexa, made by Indianapolis-based Eli Lilly & Co., declined, falling to 218,000 in 2006 from 322,000, the data showed.

Children 4 and Younger

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

Antipsychotic drugs reduce levels of dopamine, a brain chemical that, in excess, is thought to cause symptoms of psychosis and mania. Newer antipsychotics, known as atypicals, came on the market in the mid-1990s. They were billed as kinder, gentler drugs that would cause fewer of the neurological side effects that made users of earlier drugs like Haldol and Thorazine tremble, doze off and jerk involuntarily.

Studies have since suggested that the new drugs are neither safer nor more effective than the older medications, while costing 10 to 20 times more.

The decision to prescribe medications comes from doctors’ desire to help children, says Steven Klotz, a psychiatrist in Harrisburg, Pennsylvania.

Obesity, Diabetes Effects

“We see sick kids and we want to help them,” he says. “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, said the growth in use of antipsychotics for children 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 said in an interview.

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

Methodology Lacking

“The consensus among the field is that clinicians are obliged to provide something for conditions that leads to such terrible incapacity,” said 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.”

Carole Puls, a spokeswoman for Eli Lilly, said in 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 said in an e-mail.

Pfizer Comments

Pfizer “doesn’t promote nor encourage” the use of Geodon by children, said 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” and has discussed it in magazine articles and on ABC television’s “20/20.” “When they get really depressed or angry, it’s really extreme, like Dr. Jekyll and Mr. Hyde.”

Brian’s Manic Episode

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,” said 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 Strattera, a non-stimulant attention-deficit drug. To counteract the sedating effect of Geodon, he added Cephalon Inc.’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 medicines 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. On the medications, “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.”

Bipolar Underdiagnosed

Mech, citing patient confidentiality, declined to discuss the Sherry case. He said 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 said in an interview last week.

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

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
Last Updated: September 5, 2007 17:02 EDT