RITALIN'S REPLACEMENT? NEW NONSTIMULANT DRUG STRATTERA BEING TOUTED AS TREATMENT FOR ADHD, BUT MANY DOCTORS WAIT FOR MORE DATA.

Byline: Mariko Thompson Staff Writer

THE FIRST new nonstimulant medication for attention-deficit/hyperactivity disorder to win FDA approval in three decades hit the market with an impressive list of selling points - fewer annoying side effects, less stigma.

Despite the excitement that surrounded Strattera's release in January, Los Angeles-area doctors and psychiatrists specializing in ADHD are preaching caution to their patients. Though maker Eli Lilly did extensive testing on Strattera, whether the drug proves to be as effective and safe as gold-standard stimulants Ritalin and Dexedrine remains to be seen.

``The studies look good, but we don't have the long-term history,'' said Dr. Robert Moss, chief of pediatrics and director of the Children's Center for Attention Problems at Kaiser Permanente in Woodland Hills. ``We have a totally new drug without the safety profile of Ritalin and Dexedrine, which have been around for 40 or 50 years. My hope is (Strattera) will turn out to be as good as it's marketed. But like any new medication, you approach it with caution.''

Local ADHD specialists say they will start by prescribing Strattera for patients who either don't respond to stimulants or who suffer from severe side effects.

``Most of my patients on stimulant medications are doing really well with them,'' said Dr. Sloane Sevran of Tarzana Pediatrics. ``You don't want to fix something that's not broken.''

Real disorder or bad parenting?

ADHD has become the most common - and most controversial - behavioral disorder in American children. In some corners, ADHD has been dismissed as either the medical diagnosis for routine childhood antics or the result of poor parenting. But researchers say the disorder is very real and can be damaging to family, schooling and career.

Children can suffer from one of three forms, hyperactive/impulsive, inattentive or a combination of the two. To make the diagnosis, doctors gather information about the child's behavior at home and at school. They also check for other behavioral and learning disorders that resemble ADHD. For an estimated 60 percent, the symptoms will continue to interfere with their ability to function throughout adulthood.

``There are a lot of kids described as on the go, energetic, flighty, dreamy or spacy, but who adapt,'' said Dr. James McCracken, UCLA professor of child psychiatry. ``We don't or shouldn't give these kids the diagnosis.''

A study released in May by the Centers for Disease Control and Prevention in Atlanta found that 7 percent of children between the ages of 6 and 11 had been diagnosed with ADHD. Despite concerns the disorder has been overdiagnosed, the CDC study noted that ADHD may actually be underdiagnosed, particularly in areas where access to health care is limited.

ADHD is one of the best-studied childhood psychiatric disorders, McCracken said. Not only do the behavioral problems remain stable over time, but ADHD has a predictable response to treatment, he said. Studies have confirmed a strong genetic risk for the disorder. While the biology of ADHD is not fully understood, researchers have found differences in the brain areas that control attention.

``That it's a condition is indisputable,'' McCracken said. ``This is a view not just held by psychiatrists but by medicine in general.''

Multipart treatment

When it comes to treatment, medication is only one piece of the puzzle. ADHD specialists emphasize behavioral techniques to create more structure and organization. Tutoring, specialized classroom settings and therapy also may be needed, McCracken said.

Only about 3 percent of children take medication for ADHD, which suggests that many go untreated, said Moss of Kaiser Permanente. Girls are more likely to be missed than boys. Children with the inattentive form of ADHD are more likely to be overlooked, since they tend to daydream rather than disrupt.

For many parents, the decision to try medication isn't an easy one. Suz- Anne Weggesser, a single mother, was overwhelmed by the nonstop energy of her 5-year-old son, Noah Soltero.

``From the minute he started walking, he's been running,'' said Weggesser, a Ventura resident. ``From the minute he started talking, he hasn't stopped.''

Weggesser recently enrolled in a multicenter National Institutes of Health-supported study testing the safety and effectiveness of Ritalin in preschoolers. Ritalin has only been tested on children ages 6 and up, but a number of physicians and psychiatrists prescribe the drug to preschool-age children anyway. McCracken runs the study at UCLA, which begins with a 10-week behavior management seminar before moving into the medication phase.

``I love that it's a blind study so we can really determine the right dose for him,'' Weggesser said. ``He's been on the pills for a week. We don't know what's in them. He seemed to respond OK. No side effects.''

Common side effects for stimulants include insomnia and loss of appetite - side effects that Strattera is said to reduce. Because Ritalin, Dexedrine and other psycho-stimulants are considered controlled substances by the Drug Enforcement Administration, the prescription process is far more arduous. To avoid abuse, physicians are required to fill out special prescription forms. Refill guidelines are strict. By contrast, as a nonstimulant, Strattera prescriptions can be filled like any other medication.

``There's less stigma involved,'' said Dr. Marilyn Kroplick, a Calabasas psychiatrist who served as a consultant for Strattera. ``Parents might be more likely to give their child something like this rather than something that's called speed in the streets.''

With her own patients, Kroplick is taking a wait-and-see attitude. Concern over long-term side effects and safety aren't the only reasons for the delay. Strattera went through six placebo-controlled trials but did not go up against Ritalin. It also was not tested in children under the age of 6.

``There's no direct head-to-head comparison,'' said Dr. Skip Baker, founder of the Descanso Medical Center for Development and Learning in La Canada. ``We've had an unbelievable volume of calls, and we're having to temper people's desire.''

Peter Gregory, assistant coordinator for the Children and Adults with Attention-Deficit/Hyperactivity Disorders (CHADD) San Fernando Valley branch, has no problems being patient. Gregory was just diagnosed last year at age 44.

``I'm going to wait a year before considering it,'' he said. ``I'm not so impressed that I need to be a guinea pig.''

Combination of behavior management, Ritalin being tested on preschoolers

SOME NIGHTS, your mind races so fast you can't fall asleep. No matter how hard you try to still your mind, the thoughts and impressions swirl like snowflakes.

Imagine feeling that way all the time.

That's what Suz-Anne Weggesser envisioned four months ago as she grappled with her son's diagnosis of attention-deficit/hyperactivity disorder.

``I'd taught him to calm down, to go shhhh from his head to his body,'' said Weggesser, a 27-year-old Ventura resident. ``Sometimes it works and sometimes it doesn't. His mind is racing 24 hours a day, and he's only 5. That's when I started thinking how exhausting (it would be) if he really cannot control this and it goes on all day long.''

Not long after the diagnosis, Weggesser enrolled Noah in a clinical trial at UCLA testing the safety and effectiveness of Ritalin in preschool- age children. UCLA is one of several sites around the country participating in the National Institutes of Health study. For Weggesser, a single mother of two, part of the appeal was the 10-week behavior management workshop included in the study.

About 50 families have gone through the workshop so far. About 25, including Weggesser and Noah, have since moved into the medication phase. Many of the remaining 25 felt the workshop gave them the strategies they needed and decided to drop out, said James McCracken, professor of child psychiatry who is directing the UCLA study.

``If the behavior has improved so much, then we wish them on their merry way,'' McCracken said. ``It's interesting and encouraging. It suggests preschoolers will benefit from a combination of approaches.''

Every Thursday, the parents gather around a table at UCLA's Neuropsychiatric Institute to learn such tactics as when to praise, when to ignore, when to call time-outs and how to use voice, touch and eye contact. Cynthia Whitman, associate director of UCLA's Parenting and Children's Friendship Program, teaches the class and also makes weekly phone calls to answer any questions and give pep talks.

``We understand the importance of parent training and how effective it is in changing bad habits,'' Whitman said. ``That's what we call bad behaviors - bad habits. It won't erase the symptoms of ADHD. It's genetic, and it's there all of your life.''

At a recent workshop, Whitman plays a video and has the parents comment on various scenarios. In one, a mother pauses in her telephone conversation and yells at her daughter to turn down the volume on the television. Whitman stops the tape and asks for reactions.

The parents are quick to respond. The mother shouldn't have yelled. She should have set the receiver down and walked into the TV room. She didn't explain to her daughter beforehand that she was expecting an important call. She didn't thank the daughter when she complied.

``It's an easy one,'' Whitman agrees.

The parents also share their difficulties and triumphs from the previous week. Weggesser tells them about the rewards chart that she created. Noah receives stars for completing tasks such as brushing his teeth, getting dressed and sitting up straight at the table. The stars earn him both daily and long-term rewards.

``This is another form of positive attention,'' Whitman says. ``A star chart with tangible rewards.''

``There were a couple of times I wanted to take away a star so bad,'' Weggesser jokes, adding, ``So far we've earned chocolate milk and a movie with mom.''

Much of what the parents learn in the workshop sounds like common sense, Weggesser said. But it helps to receive reassurance from Whitman and support from other parents learning to cope with children with ADHD.

``They've taught me about getting the household under control,'' Weggesser said. ``I'm telling all my friends about it. I think every parent, with or without (a child with) ADHD, could benefit from a parenting class.''

- Mariko Thompson

CAPTION(S):

4 photos, box

Photo:

(1 -- cover -- color) BEYOND RITALIN

New nonstimulant drug get a cautious welcome in treatment of ADHD

(2) Noah Soltero, 5, at right and on the cover, with his brother Jackson Weggesser, 18 months, and mother Suz-Anne Weggesser, is participating in a UCLA study on the use of Ritalin and behavior modification for preschoolers with ADHD.

(3) ``From the minute he started walking, he's been running. From the minute he started talking, he hasn't stopped,'' is the way Noah Soltero is described by his mother.

(4) The pills Noah Soltero is taking in the UCLA study may be Ritalin or a placebo. So far he has suffered no side effects.

Andy Holzman/Staff Photographer

Box:

Combination of behavior management, Ritalin being tested on preschoolers (see text)