- Children return to classrooms this fall amid an increasingly
pitched battle over Ritalin and other drugs used to treat millions with
behavioral and emotional problems in school.
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- Some of Ritalin's competitors are breaking with 30-year-old
international marketing restrictions to advertise directly to parents,
selling the idea that drugs may be the answer to their children's problems
in school. At the same time, state legislatures are moving to prevent schools
from recommending or requiring that parents put their children on medication.
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- Last month, Minnesota became the first state to bar schools
and child protection agencies from telling parents they must put their
children on drugs to treat disorders like attention deficit hyperactivity
disorder, or A.D.H.D. In October, Connecticut will go a step further when
a new law takes effect prohibiting any school staff member from discussing
drug treatments with a parent to assure that such talk comes only from
doctors. Similar bills have been introduced in Arizona, New Jersey, New
York, Utah and Wisconsin.
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- The legislative push is a reaction to what its advocates
call overprescription of the drugs. They say an excessive reliance on Ritalin
and several competing drugs is driving parents away from traditional forms
of discipline and has created a growing, illegal traffic in what are potent
and dangerous speed-like stimulants.
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- Last year, doctors wrote almost 20 million monthly prescriptions
for the stimulants, according to IMS Health, a health care information
company. Most of those prescriptions were written for children, especially
boys. The drugs had sales last year of $758 million, 13 percent more than
in 1999. The political concern comes as producers of the drugs have begun
an advertising campaign that is unparalleled in spending and technique.
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- In the back-to-school section of this month's Ladies'
Home Journal, tucked among the ads for Life cereal, bologna and Jell-O
pudding, are three full-page advertisements for the A.D.H.D. treatments.
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- The ads evoke a sense of Rockwellian calm. Children chat
happily next to a school bus. A child's hand gently touches the hand of
an adult. In one, for the new drug Metadate CD, an approving mother embraces
her beaming son as the drug itself is named and promoted.
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- This is a first. Metadate CD, like Ritalin, Adderall
and similar drugs, are what are known as Schedule II controlled substances,
the most addictive substances that are still legal. (Schedule I drugs like
heroin and LSD are illegal.)
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- In keeping with a 1971 international treaty, such controlled
substances have never been marketed directly to consumers, only to doctors.
There is, however, no federal law to prevent drug companies from doing
it. Yet the new magazine advertisement by Celltech Pharmaceuticals, the
British maker of Metadate CD, states, "Introducing Metadate capsules.
One dose covers his A.D.H.D for the whole school day."
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- Terry Woodworth, deputy director of the Office of Diversion
Control of the Drug Enforcement Administration, said, "We have had
a 30-year agreement with the pharmaceutical industry not to advertise controlled
substances." "Celltech has stepped up and beyond everyone else,"
Mr. Woodworth said, "by advertising a drug with a high potential for
abuse." He said the campaign could have "diplomatic repercussions"
and that Celltech had been recently asked to stop.
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- Ian R. Garland, chief operating officer of Celltech,
would not comment on discussions with drug enforcement officials but said
that the advertisements had been reviewed by regulators at the Food and
Drug Administration and comply with federal regulations. Celltech also
said the ads were aimed at parents whose children had already received
a diagnosis of A.D.H.D. The F.D.A. said the drugs could be advertised as
long as their dangers are described in the ads.
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- McNeil Consumer Healthcare, which makes a drug called
Concerta, and Shire Pharmaceuticals, a British company that makes Adderall,
are also advertising directly to consumers, but they are not naming their
products. Instead, parents are urged to call a toll-free number to request
that brochures be sent to them. That information mentions the drugs by
brand name as one treatment option.
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- Mr. Woodworth of the Drug Enforcement Administration
said such ads - McNeil is running 60-second commercials on cable television
networks like the Discovery Channel and A&E - still violate the spirit
of the international protocols. Officials of both companies say they are
not promoting a brand and are not breaking any law.
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- Some parents and doctors say they welcome the new drugs
and the publicity which, they believe, helps inform parents of new treatments.
Little is known for sure about how the drugs work, but they seem to help
children with attention-deficit disorders to focus.
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- Concerta and Metadate CD work longer than Ritalin, the
best known of these drugs, so children who take them do not have to see
the school nurse at lunch for a booster dose. That avoids embarrassment
and reduces the risks associated with drugs being stored at school.
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- Some physicians who have done research on Ritalin say
the state laws are too severe.
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- "To argue that these treatments are inappropriate
or ineffective just flies in the face of a scientific knowledge base that
is impossible to ignore," said Howard Abikoff, director of research
at the Child Study Center at New York University. "You can't close
your eyes to this. It's made differences that are monumental in the lives
of these kids and their parents." He was one of the principal researchers
in a National Institute of Mental Health study of Ritalin that found that
medication was more effective than behavioral therapy in treating A.D.H.D.
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- Dr. Lawrence H. Diller, a behavioral pediatrician in
Walnut Creek, Calif., who wrote a book called "Running on Ritalin,"
said that as the ads have appeared, parents have begun asking for the drugs
by name.
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- Celltech has created a Superman- like character with
"CD" emblazoned on his chest. "A new hero for ADHD patients
is here!" pronounces the company's brochure. Dr. Diller said a Celltech
sales representative gave him such a brochure that seemed intended to be
passed on to parents. But the company said the brochures were meant only
for doctors and pharmacists.
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- Evelyn Green, a teacher in Chicago and the president
of CHADD, Children and Adults with Attention- Deficit/Hyperactivity Disorder,
a nonprofit group that represents people with the disorder, said that one
of her sons has been taking medication - first Ritalin and now Adderall
- for eight years.
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- Some parents may not be aware of the new longer-acting
drugs, Concerta and Metadate CD, which have genuine benefits for many chidren,
Ms. Green said. "The danger of the ads," she said, "is that
parents could get the message that medication is all there is."
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- The problems associated with these drugs have escalated.
The Drug Enforcement Administration says Ritalin and other stimulants are
among the most frequently stolen prescription drugs. Some students are
crushing and snorting pills for a speed-like high; in Orem, Utah, an elementary
school principal was sentenced to 30 days in jail after he stole his students'
Ritalin pills and replaced them with sugar pills.
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- The Journal of the American Medical Association last
year noted a "disturbing" rise in prescriptions for stimulants
and anti-depressants for children under 5, most of whom are too young,
according to the drugs' labels, to take them.
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- "Before they came out with these, how did we grow
up?" asked Lenny T. Winkler, a nurse and state representative who
sponsored Connecticut's new law. "If a child has a problem and it's
diagnosed properly, I support that. But I think teachers are far too quick
to blame the problem on attention deficit, and say to parents, `This is
what needs to be done.' "
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- Children who take medication for emotional or learning
problems in school tend to be labeled "learning disabled" under
special education laws, and now account for over half of those in special
education.
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- The diagnoses for many of the problems have long been
controversial, in part because there are no blood or lab tests for attention-deficit
disorders, or even for schizophrenia or depression.
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- Sales of Ritalin, which was approved in 1955, have been
declining for years as doctors prescribe lower- cost, generic versions.
In 1999, Adderall overtook Ritalin. Adderall was first sold in the 1960's
as a weight loss drug. Its success has changed Shire from a small company
with offices in a farmhouse into an international pharmaceutical firm.
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- Now McNeil's Concerta has captured 16 percent of the
market. Metadate CD was approved in April. Mr. Garland said the company
felt forced to advertise to parents after the other companies did so.
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- Novartis, the maker of Ritalin, has not advertised the
drug directly to consumers. It is, however, preparing two new drugs similar
to Ritalin that it hopes the F.D.A. will approve in the next month. Regina
Moran, a spokeswoman, said the company did not know yet how it would market
those drugs.
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- The Connecticut legislation began with Ms. Winkler's
work as an emergency room nurse, where she said she saw more and more children
coming in who were on psychotropic drugs, from stimulants to antidepressants
and anti-anxiety medications, and requiring metabolic tests and cardiograms.
"Why, unless these drugs have some impact on the other body systems,
would we have to do these tests?" she said. Then she began receiving
calls from constituents who complained that schools had encouraged them
to put their children on drugs, even, in some cases, making it a condition
of attending class or after-school.
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- In Millbrook, N.Y., Patricia Weathers said her son's
school told her to put him on Ritalin in first grade. By fourth grade,
he was showing signs of severe anxiety, she said, chewing his clothes and
paper. When Mrs. Weathers took him off the drugs, she said, the school
called the state's office of child protective services and accused her
of medical neglect.
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- "You have the school psychologist, the teachers,
the principal, all bombarding you, saying this is the only way to go,"
she said. "I fell for it, and I believe most parents fall for it.
They want to do what's right for their child, and if the professionals
are telling them this is right, you think, `They must be right.' "
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- She, like many parents who think Ritalin is overprescribed,
complain that there is no scientific basis for the diagnosis of the disorders
for which it is prescribed.
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- "You can't tell me they all have this brain disorder
during the school year, when during the summer they're fine," said
Mrs. Weathers, who now instructs her son at home.
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