IS RITALIN A QUICK FIX? POPULAR DRUG IS UNDER ATTACK

WASHINGTON, D.C. -- Those inattentive kids who make constant trouble in
class are getting help these days -- thanks in part to popular drugs such
as Ritalin.

Psychiatric experts, teachers and parents credit these drugs for success
stories in treating youths with attention deficit hyperactivity disorder
(ADHD), an illness that otherwise can open the door to academic and social
failure.

But another faction of experts is not so gung-ho about Ritalin and similar
medications being prescribed for ever-increasing numbers of youths. They
fear that the pills might serve as "gateway drugs" that encourage
experimentation with tobacco, cocaine and other addictive drugs.

Also fueling an intensifying debate in the scientific and medical
communities are concerns that Ritalin is overused and has been inadequately
researched and inappropriately marketed.

Two U.S. House subcommittees are investigating, and at least three class
action suits accuse Ritalin's manufacturer of seeking to broaden the
definition of the behavioral disorder in order to enhance sales. Further,
three state agencies have advised school officials to use caution in
recommending use of the drugs.

In Minnesota, the debate is particularly timely. The U.S. Department of
Education ranked the state No. 1 in the number of youths ages 6 to 21 who
received diagnoses of disabling emotional disturbances in 1998-99, a period
during which the federal Drug Enforcement Administration (DEA) said
Minnesota had the ninth-highest per capita consumption of Ritalin.

ADHD is the most commonly diagnosed childhood disorder, affecting 3 to 5
percent of all school-age children -- or an average of one child per U.S.
classroom -- and the numbers are climbing, according to the National
Institute of Mental Health.

Ritalin, which first hit the market in the 1950s, is the most popular ADHD
drug treatment, stimulating a part of the brain whose sluggish activity is
believed to cause attention deficits and impulsive behavior. Prescriptions
are being written for children as young as 2, although it's difficult to
determine how many children consume the drug. Some of the estimated 2
million to 6 million prescriptions written for Ritalin each year are for
adults.

The DEA says sales of methylphenidate, Ritalin's generic name, skyrocketed
between 1991 and 1999, rising nearly 500 percent.

Ritalin's manufacturer, New Jersey-based Novartis Pharmaceuticals Corp.,
says the drug "has been used safely and effectively in the treatment of
millions of ADHD patients for over 40 years," citing the results of 170
studies.

A gateway drug?

The debate over Ritalin and other behavioral drugs isn't new, but it is
taking new turns -- perhaps most notably because recent research suggests
that it may lead to eventual cocaine use.

"Too often stimulants become gateway drugs to illicit drugs," Dr. Peter
Breggin, director of the International Center for the Study of Psychiatry
and Psychology in Bethesda, Md., told a House education subcommittee in
September.

Most studies to date have found the opposite: that stimulants such as
Ritalin may prevent ADHD children from future substance abuse, according to
Columbia University's Center for the Advancement of Children's Mental Health.

One Ritalin defender, Russell Barkley, director of psychology at the
University of Massachusetts Medical Center, said that ADHD children are
impulsive and thus more prone to make poor decisions, such as experimenting
with drugs or sex. Treatment of their biological disorder, he said, can
lower these risks.

But researchers at the University of California, Berkeley, say their
continuing study, tracking ADHD youths into adulthood, has found a
connection between Ritalin use and later abuse of tobacco, cocaine and
other stimulants.

A yet-to-be-published animal study at the Finch University of Health
Sciences/the Chicago Medical School found that adolescent rats given
repeated doses of Ritalin proportionate to those for children are likelier
to self-administer cocaine as adults.

The results suggest that Ritalin "is likely to make [kids] more sensitive
to cocaine if they ever decide to try that illicit drug later in life,"
said Francis White, chairman of the school's cellular and molecular
pharmacology department.

Few long-term studies

Even though a National Institute of Mental Health study endorsed the
short-term safety and efficacy of the behavioral drugs, concerns persist
over the lack of long-term research.

A 1999 NIMH workshop cited the lack of "controlled studies of the long-term
safety of these drugs beyond two years," despite Ritalin's decades of use.
It called the need for such data critical "given the major developmental
changes that children undergo."

Alan Sroufe, a University of Minnesota child psychology professor who says
that Ritalin "is way overused," concedes that myriad studies show that
beneficial effects last weeks. But, he says: "There's no evidence that ...
ADHD children treated with Ritalin are more likely to be successful in
school than ADHD children not treated with Ritalin."

At a separate hearing in May before a House education subcommittee, Dr.
Lawrence Diller, author of "Running on Ritalin," said he's written plenty
of Ritalin prescriptions himself. But in the early 1990s, he said, he was
startled by the soaring number of children being referred to his office,
including many who "seemed far less impaired by their personalities
compared to the previous generation of patients."

Barkley, the author of 14 books on behavioral disorders, contends that the
disorder is actually underdiagnosed. "We're not even reaching half the
people," he said. "The fact that we're seeing a rise is not bad news, it's
good news ... 20 to 30 years ago we didn't pay attention."

Norm Miskowiec of Columbia Heights knows firsthand about dealing with a
child who has attention deficit disorder, and condemns Ritalin opponents.

"I've lived it, I've seen it firsthand," he said, recalling that his son
couldn't do schoolwork for more than 15 minutes and was constantly at risk
of getting expelled from school.

Half an hour after he gave his son his first Ritalin pill as a
ninth-grader, Miskowiec said, the youth sat down and did algebra homework
for four hours. His grades improved from barely passing to nothing lower
than a C, he said.

'Chicken or egg?'

Arguments over the merits of Ritalin could ricochet across U.S. courtrooms
in coming months.

Class-action suits filed in California, New Jersey and Texas accuse
Novartis, the American Psychiatric Association (APA) and an ADHD support
group of conspiring to broaden the definition of the disorder and promote
Ritalin as the "drug of choice" for treatment -- an allegation that all
three defendants deny.

"What came first, the chicken or the egg?" asked San Diego attorney Donald
Hildre, who is pursuing one of the suits. "If you don't have a disease, you
can't have a drug for it. If you've got a drug and you want to give it to a
certain group of people, there has to be a disease."

The San Diego suit alleges that Ciba-Geigy Corp., which first brought
Ritalin to market and merged with Novartis in 1997, conspired beginning in
the 1970s with the psychiatric association "to create, develop, promote and
confirm the diagnoses of Attention Deficit Disorder and Attention Deficit
Hyperactivity Disorder in a highly successful effort to increase the market
for its product Ritalin."

The APA, in a statement, dismissed the suits as "ludicrous and totally
false" and said it would present "a mountain of scientific evidence to
refute these meritless allegations." Novartis said the suits have no merit
and defended its award of educational grants to the two groups.

Concerned that the drug is being abused recreationally by non-ADHD
children, U.S. Rep. Henry Hyde, R-Ill., has asked the General Accounting
Office to investigate its illegal use in schools.

U.S. Rep. Bob Schaffer, R-Colo., said he is worried that federal programs
that offer increased benefits to families and schools with ADHD children
may be creating financial incentives to put kids on the drugs. Schaffer
said he wants Congress to explore whether federal Medicaid and disability
benefits are contributing to spiraling prescription numbers.

Schaffer got interested after the Colorado Board of Education last year
adopted a resolution discouraging schools from using Ritalin and similar
drugs to deal with "essentially problems of discipline."

Texas' state school board and the Rhode Island Department of Education also
have formally urged school officials to search out Ritalin alternatives and
abstain from influencing parents in medical matters.

In Minnesota, State Rep. Barb Sykora, R-Excelsior, said she was alarmed by
reports from teachers about surging numbers of ADHD diagnoses and children
being placed on Ritalin. She unsuccessfully pushed legislation last year to
fund a $40,000 study to determine how many ADHD children are taking
behavioral drugs. She says she will try again in 2001.

"It isn't trying to say Ritalin is all bad," Sykora said. "It's a
relatively new thing and it's being embraced very quickly, and I'm not sure
we know what the long-term effects are going to be. I'm hoping that 20
years from now, we don't look back and say, 'Oh, my God, look what we
created here.'