Toddlers On Drugs -- The Lilly Solution To Health

Prescriptions of mood-altering drugs to curb unruly behavior in toddlers rose significantly in the 1990s, a trend one psychiatrist described as "very disturbing."

A study of thousands of American children enrolled in two Medicaid programs and an HMO group found that in 1995 nearly 1.5% of children two to four years of age were prescribed a psychotropic -- or mind-altering -- drug to control hyperactivity, depression, mania or psychosis.

The study, published in Wednesday's edition of the Journal of the American Medical Association, found prescriptions for children of clonidine, a heart drug that also is used to calm anxiety, jumped 28-fold between 1991 and 1995 in one of the groups studied. That increase came despite the fact that there aren't any conclusive clinical trials showing that clonidine or other mind-altering drugs -- such as Eli Lilly & Co.'s Prozac or Novartis AG's Ritalin -- are safe or effective in children so young. Clonidine is sold by several drug makers.

¹Ritalin's Role Produces Contradictory Findings (May 17, 1999)

Essentially, many doctors are guessing drugs that work in disturbed older children and adults can also work in very young children. The study's principal author said in an interview studies should be done to determine if the doctors are correct.

"We need to find out what is the validity of the use of medication in these children, and did they deserve the medication they got?" Julie Magno Zito, an associate professor at the School of Pharmacy at the University of Maryland, said.

Dr. Zito was especially skeptical of the use of Ritalin to combat attention-deficit disorder in two-year-olds. "What is 'abnormally inattentive' in a two-year-old?" Dr. Zito asked. "ADHD is a disorder of school-age children, and somehow we've gotten it down to preschool children."

One prominent psychiatrist who wrote an editorial accompanying the study in JAMA said he doesn't have to wait for any more studies. The use of such powerful medications in so many children so young is wrong, Joseph Coyle, chairman of the department of Psychiatry at Harvard Medical School, said.

Dr. Coyle wrote that the brains of children between the ages of two and four are still undergoing rapid and important biological development that can be impeded or transformed by the use of mind-altering drugs.

Dr. Coyle noted few experts in child psychiatry recommend children so young receive these medications. There are extremely unusual cases in which some very disturbed children between the ages of two and four might need a psychotropic drug such as Ritalin, but certainly not 1.5% of all children that age, he said. Dr. Coyle said kids may be getting these drugs because doctors are too busy and health-maintenance organizations too tight-fisted with their spending to offer therapies that might include counseling.

Judith Rapoport, chief of the child psychiatry branch of the National Institute of Mental Health in Bethesda, Md., said parents may be motivated by concerns about legitimate behavioral problems.

On the other hand, Dr. Rapoport said, some of these drugs aren't effective in young children, and the drugs' side effects often are worse in children than in adults. "Based on what I know, I am skeptical of what fraction of these kids are actually getting a benefit," she said. "But have I seen kids in that age range where it has made a difference? Yes."

Health Journal

Ritalin's Role Produces
Contradictory Findings

RITALIN, THE embattled stimulant drug prescribed to millions of young people with attention deficit hyperactivity disorder, is at the center of a new debate.

Whirlwinds in perpetual motion, children with ADHD have trouble with focus and impulse control, disrupting their home and school life. But they are also at high risk for drug abuse.

Now a controversial study from the University of California at Berkeley contends that Ritalin and other stimulants further raise the risk of drug abuse. Nadine Lambert, a professor of education, followed almost 500 children for 26 years. She argues that exposure to Ritalin makes the brain more susceptible to the addictive power of cocaine and doubles the risk of abuse.

"This reinforces an old stereotype," retorts David Smith, founder of the Haight-Ashbury Free Clinic in San Francisco. "It's one of the reasons people haven't treated children, for fear it would turn them into addicts."

"I very much doubt Ritalin predisposes children to take other drugs of abuse unless they were abusing it," adds Nora Volkow, a psychiatrist at the Brookhaven National Laboratory on Long Island. While Ritalin is addictive if snorted or injected, oral Ritalin taken in the proper dose "doesn't produce a pleasurable high."

Other critics contend the study participants who got medication probably had more severe ADHD to begin with than the untreated group -- a factor that could explain their higher rates of drug abuse. For her part, Dr. Lambert says, "I stand by our results."

But stay tuned. Studies heading for publication later this year will reach exactly the opposite conclusion, finding that Ritalin and other drug treatments actually reduce the risk of drug abuse. Untreated kids are more prone to self-medicate and abuse chemicals, they conclude.

Harvard psychiatrist Tim Wilens and his colleagues at Massachusetts General Hospital studied 500 children from age 10 to age 15 and exonerate Ritalin.

"The unmedicated group [of ADHD patients] clearly was at risk for substance-abuse disorder in mid-adolescence," Dr. Wilens says. By contrast, kids who were treated with stimulants such as Ritalin had lower drug-abuse rates, much like those of a control group who didn't have the disorder.

"Drug therapy," he concludes, "was protective." Dr. Wilens's study is scheduled to be published in the August issue of the journal Pediatrics.

The Harvard study parallels findings by psychologist Jan Loney of the State University of New York at Stonybrook. She tracked 300 Iowa youths who were diagnosed with the disorder in the late '60s and '70s. By their 20s, she says, "we found the medicated kids were less involved with substances [of abuse], less antisocial and generally better off than unmedicated kids were."

James Swanson, professor of pediatrics and cognitive science at the University of California, Irvine, says ADHD may be rooted in the receptor for the neurotransmitter dopamine. Ritalin is a dopamine reuptake inhibitor -- meaning it keeps more of the substance in circulation.

Dr. Swanson says Ritalin, while effective for many, fails to help 20% to 30% of patients. Moreover, it wears off in two hours, requiring children to take medicine at school. A newer stimulant, Adderal, is active longer, and Dr. Swanson says a half dozen companies are searching for new and better medications.

Other conventional drug treatments include the stimulants Dexedrine and pemoline (Cylert), the drug clonidine (Catapres) and a variety of antidepressants from older tricyclics to the newer Wellbutrin.

Soon, the National Institute of Mental Health will air results of a study comparing drugs, behavioral therapy and a combination of the two. Peter Jensen, associate director for child and adolescent research at NIMH, says the study examined 600 children.

Drugs alone -- Ritalin, Dexedrine, Cylert or the antidepressant imipramine -- worked well for simple ADHD, he says. But for many children suffering from related social problems, anxiety or depression, the combination was superior. The behavioral therapy combined a system of rewards for meeting goals with parental education, classroom support and a special summer camp devoted to building skills.

As the mother of a son with ADHD, Sheila Anderson of Renton, Wash., knows the value of a comprehensive treatment program.

Past president of Children and Adults with Attention Deficit Disorders, an advocacy group based in Landover, Md., Mrs. Anderson says medication for ADHD "is a personal decision. It doesn't work for all children. If it happens to work, that's great. But you need to look at other areas of a child's need. We've had tutoring, therapy, social-skills training -- lots of interventions."

Diagnosed in first grade, her son Neil is now 17 and finishing his junior year of high school. "I wouldn't tell you he's perfect," Mrs. Anderson says. "It's always going to be difficult for him. But he gives it his best shot."

While Ritalin is often criticized as a crutch or tool to boost performance, Harvard's Dr. Wilens says he sees few cases of parents misusing Ritalin for sheer enhancement. "This is not the Viagra of cognition," he cautions.

Children on Ritalin should be carefully monitored and undergo a trial discontinuation once a year to see if they can end treatment, he says: "If they're struggling, it's not the proper course" to end treatment. "If they're confident, OK."

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Toddlers On Drugs

Health

Use of Mood-Altering Drugs to Control Toddlers' Behavior Jumped in the '90s

Health Journal

Ritalin's Role Produces Contradictory Findings

Use of Mood-Altering Drugs to Control
Toddlers' Behavior Jumped in the '90s

Ritalin's Role Produces
Contradictory Findings