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By Shankar Vedantam
Washington Post Staff Writer
Thursday, April 26, 2001; Page A01

Children who are so shy or so attached to their parents that they are afraid to go to school or sleep alone do much better when given a psychiatric drug, according to a major study with profound -- and controversial -- ramifications for millions of children.

The study of 128 children ages 6 to 17 found that the drug Luvox, widely prescribed for adults with depression, alleviated the debilitating symptoms of social phobia, separation anxiety and generalized anxiety -- psychiatric illnesses that afflict as many as 1 in 10 U.S. children.

The effects of the medicine were dramatic, but experts were divided about its appropriateness: The medicine can help children with severe emotional problems, but it might also be abused as a chemical quick fix for normal anxiousness, with lasting effects on growing brains.

"Although the results seem impressive, they nevertheless raise some very important questions about the use of psychotropic medications in children," said Joseph Coyle, chairman of psychiatry at Harvard Medical School, in an article accompanying the findings in today's New England Journal of Medicine.

"Any drug that is effective is not going to be innocuous," he said in an interview. Children and adolescents diagnosed with these disorders should first try a form of therapy known as cognitive behavioral therapy, and turn to medication only if that fails, he said.

An estimated 575,000 children nationwide were diagnosed with anxiety disorders in the 12 months ending in March, including 136,000 under age 10. Doctors recommended 390,000 children be put on medicines such as Zoloft, Paxil and Prozac. Of these, 89,000 were under age 10, according to IMS Health, a private company that tracks the pharmaceutical industry.

Such vast numbers leave critics aghast. Too many children are being put on powerful brain-altering drugs for behaviors that may be merely troublesome, critics say. But other experts point out that many children suffer from distress that, left untreated, can cause impairment well into adulthood.

"Researchers found that anxiety was among the most common problems that kids have," said Daniel Pine of the National Institute of Mental Health. He led the study. "When researchers follow children with anxiety over time, sometimes anxiety developed into more chronic problems. It could be the harbinger of problems with depression, panic attacks and all different kinds of problems."

The study, the first large, well-designed survey to examine the effectiveness of a psychiatric drug for a wide range of anxiety disorders in children, was partly funded by the National Institute of Mental Health and by Solvay Pharmaceuticals, which sells Luvox. The drug, which like Prozac increases levels of the brain chemical serotonin, has been approved for the treatment of obsessive compulsive disorder in children. Luvox sales were more than $2 billion in the United States last year, according to IMS Health.

Scientists at Johns Hopkins University, Columbia University, New York University, Duke University and the University of California at Los Angeles studied the drug over eight weeks in children with anxiety disorders.

An example of a child with severe social phobia would be one who refused to go to school for two weeks, said Mark Riddle of the Johns Hopkins University School of Medicine, one of the study's authors. A milder example, he said, would be a child who went to school and participated in clubs and group events, but with intense discomfort.

Extreme separation anxiety disorder, he said, would be displayed in a child who avoided birthday parties and sleepovers. A medium-grade example would be children who refused to sleep in their own rooms and wanted to get into bed with their parents.

Generalized anxiety disorder, Riddle said, were "the worrywarts."

"A lot of it would be about performance -- getting very preoccupied with a test at school, a lot of fussing about day-to-day things," he said.

"We don't want a Prozac nation," he said about the medication of children. "We want to make sure we are not doing anything to harm youngsters. On the other hand, it can be a huge disservice to children to minimize the true significance of psychiatric impairments that do require treatments. It's the latter that can get lost in the very easy and popular position to take, which is 'Don't drug our kids.' "

Richard Harding, president-elect of the American Psychiatric Association, said clinicians should carefully evaluate anxious children to find out whether their fears are caused by an underlying personality problem -- which would merit psychotherapy or medication -- or by a social problem, such as a bully in school or child abuse at home, in which case medication would be inappropriate.

"A good clinician will not commit a child to a life sentence on medicine," said Riddle. "A good clinician will look to stop medication after the youngster has had a chance to regroup. You want to work with a clinician who says we are going to get John off this medication."

It is unclear what impact this study will have in clinical practice, where doctors are prescribing children such medicines "off-label" -- meaning they have not been approved for such uses by the Food and Drug Administration.

"Given our current medical-economic system in practice, I suspect both doctors and parents will be strongly attracted to the quick-fix nature of this intervention," said Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif., and the author of "Running on Ritalin."

"We have highly effective psychosocial interventions for these problems," he said. But "they are more expensive and take longer."

He said that helping families come up with parenting strategies could ease children's anxieties. "Children are highly responsive to their environments, and the home is the practice arena to deal with life," he said. "This is not parent-blaming -- children are difficult to raise. But when the parent makes changes, you see very rapid changes in the child."

"It doesn't negate the value of the medications," he added. But "with uncertainty on both sides, effective psychosocial treatments -- first do no harm -- take preference."

More extreme critics, such as Bethesda psychiatrist Peter Breggin, said the study was produced by scientists who are part of an "old boys' network of drug pushers." He said the psychiatric drugs cause harm -- some data have shown that the drugs cause lasting alterations in the brains of young animals.

Researchers involved in the new study said the drug was well tolerated and safe.

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