Back to school for ADHD drugs

By Karen Thomas, USA TODAY

Moms accustomed to being sold lunchbox notions and cold remedies are starting to see ads for powerful drugs to control their children's behavior in an escalating marketing push that has some child advocates and government officials twitching.

As the school year gets underway, drug companies are launching an aggressive battle to win the beefiest slice of what is shaping up to be a billion-dollar industry for treating attention deficit/hyperactivity disorder (ADHD) with stimulants such as Adderall, Concerta and Ritalin. Brand-name ads for ADHD drugs appearing in September issues of women's magazines and on cable TV are the first break from a 30-year-old agreement between nations and the pharmaceutical industry not to market controlled drugs to consumers.

"This is an icebreaker," says Terry Woodworth, deputy director at the Drug Enforcement Administration.

The ad campaign "has the mentality of 'mother's little helpers' from the '60s," adds DEA's Patricia Good, of the policy division.

• The makers of Metadate CD, introduced in April, launched a direct-to-consumer print ad in nearly a dozen women's magazines this month, introducing the drug by name in an ad featuring a smiling son and mother that reads, "One dose covers his ADHD for the whole school day."
• Adderall and Concerta advertise directly to consumers with print ads in September women's magazines. Called "help-seeking" ads, they don't use the drug's brand name, and include toll-free phone numbers and mailing cards so consumers can get more information about the medications.
• The makers of Concerta began airing 60-second ads this month on cable TV channels, including Discovery and A&E, urging parents to talk to their doctor about medical options. According to the Food and Drug Administration, which was not aware of the ads and is eager to review them, this is a first: No TV ads for this class of drugs (highly addictive but legal) have ever before aired.

Drug research and technology have fueled the commercial drug war. Not only is the use of ADHD drugs up 37% over the past five years — more than 20.5 million prescriptions were written during the 12 months ending in June — but competition in that group is greater than ever.

Five years ago, the best-known brand, Ritalin, and its generic form dominated the group.

Today, more than a half-dozen drugs are used to treat ADHD, which is characterized by behaviors such as inattentiveness, fidgetiness, not listening, being easily distracted, making careless mistakes and excessive talking. Those drug treatments with new single-dose formulas — pills taken once a day, instead of two or three times a day — are rising quickest. Prescriptions for Adderall have increased 1,017% since 1997. In less than a year since becoming available, Concerta, also a single-dose drug, captured 11% of the market.

The use of Ritalin, which requires two or three doses daily, is declining quickly and steadily.

Enter a reinvented Ritalin.

Novartis, the maker of Ritalin, hopes the FDA next month will approve Ritalin LA, a long-acting formula that lasts for six hours — the length of a typical school day.

Like other companies that market long-lasting stimulants for schoolchildren, Novartis says it wants to avoid giving kids medicines during the school day.

"It should be supervised by parents, and it can eliminate drug diversions," says Rama Seshamani, medical director at Novartis, referring to Ritalin theft or other misuse. Also, a single morning dose "avoids the stigma and embarrassment for those kids who go to the nurse's office."

Novartis can't talk extensively about the new drug's side effects or studies before the FDA completes its review. The FDA's decision, Novartis says, is expected Sept. 28, and the company plans to get it to pharmacies before the end of the year. The FDA does not talk about drugs being reviewed.

Once this new Ritalin enters the game, though, ad campaigns that already are at unprecedented levels will be pushed even further.

"The truth in distinguishing between the drugs is they all work," says psychologist Lawrence Diller, author of 1998's Running on Ritalin, among the first books to suggest there is too much prescription of stimulants for kids. "You'll see furious advertising to distinguish one from the other."

Federal agencies that regulate drugs are watching carefully as pharmaceutical companies push the limit on a 30-year-old international practice in which the industry agreed not to advertise controlled substances that have high potential for abuse.

The new ads are "counter to the whole international treaty," says DEA's Woodworth.

The DEA last week sent a cease-and-desist letter after seeing the new Metadate CD ads in Ladies' Home Journal and Parade. The manufacturer, Celltech, declines to discuss the DEA's move and maintains it is breaking no laws.

Even less publicly visible marketing gimmicks aimed at physicians have come under fire. Celltech circulated pamphlets and magnets to doctors' offices this summer that feature a blue-suited cartoon superhero with the letters CD — a reference to Metadate CD — on his chest. Celltech's explanation is that the superhero was intended to grab the attention of doctors, not parents and young patients in the waiting room.

"Give me a break," says Diller. "The superhero was intended for the doctor?"

Last November, the FDA sent a letter to the makers of Adderall, which aggressively "made unsubstantiated comparison claims" to health professionals that the drug was better than Ritalin or its generic form. That attempt to compare the long-acting Adderall with Ritalin was patently unsound, Diller says.

"Everyone knows Ritalin was never intended to last more than three to four hours. But those who are interested in selling a product can stretch these results as far as the FDA will allow. In this case, they went too far."

Stimulants used to treat ADHD are classified by the DEA as Schedule II drugs, the most highly addictive drugs that are still legal. According to the DEA, drugs to treat ADHD rank among today's most-stolen prescriptions and most-abused legal drugs. Most abusers, DEA officials say, are kids. Most dealers are kids who are prescribed the drugs to treat ADHD.

"There already is not the oversight we'd like to see of this drug, and ads can only make it worse," says DEA pharmacologist Gretchen Feussner. In some U.S. communities, 20% of kids are taking stimulants.

"That should be a wake-up call that something isn't right," Feuss ner says.

States are beginning to step in:

Thursday, Connecticut's governor signs off on a first-of-its-kind law banning teachers, counselors and other school officials from recommending psychiatric drugs for students.

• A Minnesota law this year bars schools from forcing parents to use drugs on students diagnosed with ADHD.
• In Texas and Colorado, recent non-binding resolutions say educators must consider non-medical solutions to behavior problems.

A dozen more states have proposals on the table about psychiatric drugs in schools.

According to the FDA, it's not unusual for drug companies to suddenly start spending money on advertising when new formulations are developed. Four drugs to treat ADHD were introduced in the past five years, two in the past 12 months. At least two more, including reformulated Ritalin, are expected this year, with many more being developed.

"They presumably fill a niche, and manufacturers believe it's to their advantage to have professionals know about it," says Nancy Ostrove, deputy director of the FDA's drug marketing division. "They don't put money to market unless they see a benefit."

The FDA reviews most drug promotions — about 32,000 a year — after they become public. Those that advertise a drug by name must include all risks involved.

But the lines delineating hype and helpful are not completely clear. "You have to live in a cave not to know about ADHD," says Diller, who objects to the new ads that oversimplify ADHD as a "brain problem" or "homework issue" and make no mention of family, school and behavioral management models.

And the "help ads" are not regulated by the FDA. "Does that make that ad somehow volatile?" Ostrove asks. "We don't feel we can legally take action. We're not the good-taste police."