Controversy Erupts Over Ads for ADHD Drugs

As the traditional school year began this fall, parents across the country found themselves awash in advertising for medications promising a wide array of benefits for their children. One particular ad, touting the advantages of Metadate CD, a long-acting form of methylphenidate, led many industry watchdogs—and a good number of parents—to cry foul.

In mid-August, drug companies launched new ads in what is nearly a billion-dollar-a-year market for medications aimed at alleviating the symptoms of attention deficit/hyperactivity disorder (ADHD). The makers of regular and long-acting forms of the stimulant methylphenidate started with new direct-to-consumer ads in leading women’s magazines and on cable TV channels like Lifetime, Discovery, and A&E.

In what one industry watchdog called “the biggest and boldest step outside the box,” drugmaker Celltech Pharma began a print ad in the September issue of nearly a dozen women’s magazines featuring a smiling young boy in the arms of his also-smiling mother, with the caption “One dose covers his ADHD for the whole school day.”

The appearance of the Celltech ad ended nearly 30 years of observance by the industry of an international treaty that discouraged consumer advertising of controlled psychotropic substances. All forms of methylphenidate are classified as Schedule II controlled substances, considered highly addictive but having defined medically accepted uses.

While the United Nations treaty was signed by the United States in 1971, the U.S. Congress never passed legislation to outlaw the type of advertising banned by the treaty. As such, Celltech maintains that the company is not doing anything illegal.

Celltech is certainly not alone. Both Adderall (made by Shire Pharmaceuticals) and Concerta (McNeil Consumer HealthCare) are being advertised directly to consumers by their makers through ads in women’s magazines. However, neither pharmaceutical company is using the name of its respective ADHD product; rather, their ads are in the “help-seeking” category. The ads include toll-free phone numbers and mail-in cards so that consumers can get more information about ADHD and the medications available to treat the disorder. These “help-seeking” types of ads have appeared before, but the Celltech ad is believed to be the first to name the specific ADHD medication being advertised directly to the consumer.

Many popular women’s magazines carried ads for more than one of the three products in their September issues. A few magazines ran ads for all three.

The U.S. Drug Enforcement Administration and the Food and Drug Administration are also concerned by the ads. “This is just an icebreaker,” Terry Woodworth, deputy director of the DEA, told USA Today in September. “These advertisements are counter to the whole international treaty.”

In late August, the DEA sent Celltech a cease-and-desist letter after seeing the new Metadate CD ads in Ladies’ Home Journal and Parade. Although Celltech did not respond to several requests from Psychiatric News for comment, company representatives told USA Today and Time that the company was “not doing anything wrong.”

The FDA is also reviewing the Celltech ad. Regulations do grant the agency oversight of ads that market a medication by name and stipulate that if a drug is specifically named in promotional materials, all risks and side effects must be included in the ad.

The Celltech ad does include “Important Safety Information for Patients,” including notations that Metadate CD should not be used in children under the age of 6 or in patients with anxiety, agitation, tics, Tourette’s syndrome, or glaucoma. It is also contraindicated for patients taking an MAO inhibitor. The ad states that the “most common side effects are headache, stomachache, decreased appetite, and sleeplessness.” The ad does not directly identify Metadate CD as a controlled substance, nor does it mention any risk of abuse or dependence. The “CII” symbol does appear after the drug’s name.

The FDA, however, does not have authority to treat ads for controlled substances differently from ads for noncontrolled substances. Also, the FDA does not have authority to oversee the “help-seeking” ads because no specific drug is named in the ad.

During 2000, the pharmaceutical industry spent $2.5 billion on direct-to-consumer advertising. A spokesperson for the Pharmaceutical Researchers and Manufacturers of America, a trade organization that lobbies for and represents the industry, said in a press release that help-seeking ads like those for Concerta and Adderall help to “empower” patients by informing them of treatment options.

Members of APA’s Council on Children, Adolescents, and Their Families discussed these issues at APA’s fall component meetings in September. They see that “empowerment” as having both risks and benefits. The ads do tend, council members said, to help increase awareness of mental health issues in children. However, the ads also tend to drive up parental demands for specific drugs, regardless of whether they are the best treatment option for a particular child. Moreover, council members are concerned that the ads may create the impression that medication is an “easy, quick fix” for the often very confusing and frustrating behavior of children with ADHD.

Council members stressed that an important message parents need to understand is that children with signs and symptoms of psychiatric illnesses need a thorough evaluation by a trained and qualified psychiarist before any decisions about treatment are even considered. ▪