Schools' Backing of Behavior Drugs Comes Under Fire

By KATE ZERNIKE and MELODY PETERSEN

hildren 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.

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.

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.

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.

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.

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.

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.

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.)

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."

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.

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.

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.

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.

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.

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.

Some physicians who have done research on Ritalin say the state laws are too severe.

"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.

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.

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.

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."

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.

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.

"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.' "

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.

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.

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.

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.

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.

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.

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.

"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.' "

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.

"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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