Info Sheet-10
Attention Focuses on New ADHD Drugs

SAN ANTONIO, Apr 04 - Every weekday around noon in schools across America, the nurse's office becomes a very busy place. Children and adolescents line up for their midday dose of stimulant medication, usually Ritalin, a drug that helps control the symptoms of attention deficit hyperactivity disorder, or ADHD. Believed to affect 3 percent to 5 percent of school-age children -- with boys diagnosed three to four times more than girls -- ADHD is a biologically-based brain disorder marked by higher-than-average levels of impulsivity, inattention and sometimes, hyperactivity.

What many parents may not know is that alternatives now exist for Ritalin
(known generically as methylphenidate), which stays in the system only four hours and thus usually requires two to three doses a day.

Frequent doses present problems. It means kids have to remember to go to the nurse at lunch. It means everyone in class knows who has to go to the nurse at lunch. It means extra work for already burdened school nurses.

Two drugs on the market may offer solutions. Adderall, which has been around for about five years, is a stimulant medication that lasts five to eight hours, depending on the individual. One study found that Adderall not only lasted longer but also was more effective in controlling the symptoms of ADHD than methylphenidate among a group of 58 children. (Given in low doses stimulants have the paradoxical effect of focusing children with ADHD, as opposed to "stimulating" them.),

And now comes Concerta, a drug approved by the Federal Drug Administration last August that provides extended relief from the symptoms of ADHD. The first time-released form of methylphenidate, Concerta uses the pill structure found in common over-the-counter time-released drugs to deliver smooth, controlled doses of the drug for 12 hours.

Not only does Concerta eliminate the need for in-school dosing, it helps
children get through after-school activities and homework without having to take another pill. "And it reduces the stigma" of having to take medication for ADHD, says Dr. Tim Wilen of Massachusetts General, principal researcher in a one-year study of 400 children that led to the FDA's approval of Concerta.

While schoolchildren of any age can feel stigmatized by the singling-out
that goes along with trips to the nurse for stimulant medication, he says,
the issue often grows particularly pointed as children enter adolescence. At an age when kids hate to be singled out, embarrassment over needing to take pills for ADHD can lead to problems with "compliance" to a drug regimen.

Studies have shown that children and adolescents with ADHD who go untreated are at heightened risk for social and academic problems, criminal activity, dropping out and substance abuse.

"Yes, it's quietly replacing Ritalin," says Wilen of Concerta. "Frankly, the
time for a once-a-day stimulant is long overdue."

Because of its subtle, time-released method of delivery, studies show levels of the drug in the blood don't vary as widely as they do in traditional
four-hour methylphenidate. There's no dramatic onset or "rush" when the drug starts to work, and no precipitous drop-off when it quits.

"What we heard is (children) don't realize they're on the medication," says
Wilen. "They don't get that rush, they don't know it's peaking, and it also
doesn't have the dramatic wear-off. It basically eliminates rebound, which
is a huge issue."

"Rebound" is an effect some children experience in which their ADHD symptoms temporarily worsen as the drug wears off.

Concerta, which is approved for children olden than 6, carries the same
general side effects as Ritalin: a decrease in appetite, headache, stomach pains and/or insomnia, all of which are usually temporary.The pill can be taken with or without breakfast and must be swallowed whole
with a liquid such as water or juice. Because of the pill's time-released
structure, it must not be chewed, divided or crushed.

Like Ritalin, Concerta is "very safe," says Wilen. The use of
methylphenidate in children has been researched for 40 years. It's one of
the most widely studied medications in pharmaceutical history, he says.

Another benefit of Concerta that seems pertinent in light of recent news
stories detailing the illicit "recreational" use of Ritalin among
teen-agers: You can't abuse it.

Not only is Concerta kept at home away from snitching hands at school
medicine cabinets; its time-released form makes abuse difficult.

"It won't do you any good to take a hammer to it, because all you'll get is
a gooey mess," says John Liu, director of corporate communications for Alza Corp., the company that makes Concerta. "If you tried to snort it,
you'd just get a big glob up your nose."

What's more, he says, the extended-release form of the drug makes attaining a "rush" also moot.

First observed in the 1900s, ADHD has been studied for more than 50 years. There is no easy blood test or simple diagnosis to determine if a child truly has ADHD, although recent studies involving brain imaging point to a strong biochemical basis for the disorder.

Other elements in a child's life -- recent divorce or a move, depression,
anxiety, child abuse -- can evoke symptoms that mimic ADHD, so it's
important for families to seek a physician's advice, say experts. Teachers
alone cannot diagnose ADHD, although their input is key in any evaluation.

For a true diagnosis, symptoms must have appeared before age 7, cause a child difficulty in more than one setting, have persisted for at least six months and be more severe than what is expected at the child's developmental level.

Studies suggest a fair number of children diagnosed with ADHD will continue to have symptoms into adolescence and adulthood. About 70 percent to 80 percent of adults and children with ADHD respond well to stimulants. The use of stimulants indeed, the very existence of ADHD as a disorder is controversial, although medical experts who study the syndrome say the condition is actually undertreated, despite media stories suggesting the opposite.

Treatment, at least optimally, involves not just stimulant medication but
also a combination of school-based behavioral interventions and counseling,
if necessary. Interestingly, drugs such as Concerta and Adderall mean a
child's medical history can now remain a private matter, a plus to parents
worried that their child's ADHD diagnosis will automatically bias teachers
and other school officials against the child.

"Still, you don't want to not include the school if a child has ADHD and is
having academic problems," advises Wilen.

Of the three stimulant medications now available -- Adderall, Concerta and Ritalin -- it is impossible to predict which drug will work best for each
child. It's very much an individual thing.

Cost is also a factor: Newer drugs like Concerta tend to be more expensive, although many insurance plans cover stimulant medication for ADHD. Finding a pharmacy that stocks newer drugs also can be a challenge.

Finally, not all children require 12 hours of medication, or even eight
hours, say experts. Families should work with physicians in finding the
right stimulant, a process that sometimes involves trial and error.

"The important thing is we have three stimulant medications that are all
very effective," says Dr. Steven Pliszka, chief of child and adolescent
psychiatry at the University of Texas Health Science Center and lead
investigator in the Adderall study.

"These drugs are effective, so you shouldn't settle for a mediocre
response."

By: The Associated Press Copyright: 2001 by The Associated Press. All rights Reserved.

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