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FEDERAL TRADE COMMISSION, CAPITOL HILL EXAMINE ADHD TREATMENTSMay 24, 2000WASHINGTON -- The Federal Trade Commission cracked down earlier this month on two companies marketing dietary supplements as cures for Attention Deficit/Hyperactivity Disorder, one of the most common disabilities diagnosed in American children. The FTC cited the companies for using misleading or false claims to promote their products, pushing them to change their marketing approaches. Meanwhile, members of the U.S. House of Representatives are taking a closer look at Ritalin, the most commonly prescribed drug for treating ADHD in children. The FTC announced consent agreements with Efamol Nutraceuticals Inc., of Boston, and J & R Research Inc., of Massena, Iowa, to stop advertising that their dietary supplements are effective ADHD treatments unless they can provide scientific evidence to back up those claims. Efamol markets Efalex and Efalex Focus, while J&R is a multi-level distribution company that markets Pycnogenol. "The advertisements at issue prey on a vulnerable population of parents who seek a 'natural' alternative to prescription medications," the FTC said. The two companies join New Vision International Inc. and Max James, one of New Vision's chief distributors, as the only four parties the FTC has cracked down on for using misleading marketing tactics for ADHD products. The New Vision/Max James investigations date back to 1998. The FTC's latest consent agreements are not yet final. The Efamol agreement is open to public comment until June 12, while the comment deadline for J&R's agreement is July 12. Parents Bear Responsibility Too According to FTC Bureau of Consumer Protection Director Jodie Bernstein, the agency is worried that "parents who fall for the claims may ignore proven, and perhaps essential, treatments for their child's disorder." While the FTC can push companies to adhere to honest marketing tactics, and can investigate consumer complaints, Bernstein noted parents must also exercise caution when giving their children any supplements. To help parents understand the various claims companies make, the FTC has developed a consumer guide, posted on its web site, called Promotions for Kids' Dietary Supplements Leave Sour Taste. The guide warns parents to be aware that "many dietary supplements, especially herbal products, have not been tested in kids to determine their safety or effectiveness." Such supplements are not required to meet any federal standards in the United States for quality or purity, the FTC says, adding parents should rely on pediatricians or other health care providers for advice on whether to use such products. Even supplements advertised as "natural" are not always safe, and they can have "powerful drug-like effects," the agency says. "Some of these effects can be especially risky for people who take other medicines or have certain medical conditions." Congress Looks At Ritalin
Acknowledging the many questions now arising about Ritalin's growing use, former CHADD president Mary Robertson, of Lexington, Ky., urged Castle and other members of the subcommittee not to "give in to the sensationalism now associated with the name Ritalin." "I welcome expanded governmental support for research on ADHD, on the causes and treatment, as well as barriers to receiving an adequate diagnosis and treatment," she said. "I urge you to resist any effort to demonize people with ADHD." Castle also said he worries about reports that students sell Ritalin at school and that Ritalin under school control during the school day is being stolen. "I also hear that youth find it easy to abuse their own prescribed Ritalin or a friend's Ritalin, such as by snorting it for a better high," Castle said. Though the drug is regulated by the U.S. Drug Enforcement Agency, he noted, some communities report that children have easy access to it. Terrance Woodworth, deputy director of the DEA's Office of Diversion Control, confirmed some of Castle's worries. With the help of CHADD and the American Academy of Neurology, the DEA has studied use of these drugs in detail, he said. Among principal findings by the DEA and various research organizations since 1996, Woodworth said, "Poison control data, emergency room data and high school surveys all indicate that the abuse of methylphenidate [Ritalin's generic name] has increased significantly since 1990." In addition, he said, "A number of questionable practices have contributed to the diversion and abuse of stimulant medication including improper diagnosis, lack of adequate information to youth, parents and schools regarding the abuse potential of these drugs and lax handling of medication." Production and use of both methylphenidate and amphetamines, such as Adderall and Dexedrine, were up dramatically in the 1990s, Woodworth added. In 1999, New Hampshire and Vermont led the nation in the amount of methylphenidate prescribed, doling out 5,525 and 5,005 grams per 100,000 residents, respectively, the DEA says. Delaware and Rhode Island were the top users of amphetamines such as Adderall or Dexedrine, prescribing 2,538 and 1,903 grams per 100,000 residents, respectively. The national averages were 3,082 grams of Ritalin and 1,060 grams of Adderall or Dexedrine per 100,000 state residents, the DEA says. The reasons Ritalin use is on the rise are varied and controversial, the panelists said. For example, Rep. Deborah Pryce (R-OH) questioned "the role schools play in diagnosing ADHD and suggesting treatment," based on many letters and calls from parents in her district. "At first blush, you would think that Ritalin is a medical issue, but the input from my constituents reveals that schools are very much involved," Pryce told the subcommittee. "Unfortunately, doctors often cannot observe the behavior that prompts school personnel to suggest that the child may have a medical problem. Even the parents cannot see how their child behaves when he or she is out of their control and in a classroom environment among peers. It seems to me that making this type of health diagnosis is quite difficult and time consuming, yet I am not sure that anyone but the teachers have spent the time observing the behavior in question before children are diagnosed," she said. Pryce's fellow Ohio congressman, Dennis Kucinich, cited similar concerns raised by his constituents after Cleveland NBC television affiliate WKYC aired a multi-part news story on Ritalin use there. "What Channel 3 revealed was a disturbing pattern of abuses, where school teachers and administrators faced with a student with a discipline problem, an unruly student, or a hyperactive student, were using their positions as authority figures in the classroom to encourage parents to seek physicians for the sole purpose of obtaining a Ritalin prescription for their child," Kucinich said. "Well-meaning teachers and counselors, with no real medical background, were unwittingly supplanting the judgment of a trained physician, whose diagnosis should be paramount in determining the cause and the solution for a student who may or may not be suffering from [ADHD]." Defending Teachers However, Arlington, Va., schoolteacher Francisca Jorgensen, who specializes in teaching children with specific learning disabilities, claims most experienced teachers can recognize the clear signs of a student with attention or hyperactivity problems. She stopped short of suggesting these teachers are qualified to offer a formal diagnosis of ADD or ADHD. Rattling off eight common symptoms that often indicate further attention or investigation is needed from the teacher or other school staff, she argued "students who are impacted by Attention Deficit Disorders are some of the most frustrated learners in a classroom. The frustration of these students does not go unnoticed or without close attention by our classroom teachers. A great deal of time, energy and creativity go into modifying the school environment for these students." Like many physicians and psychologists involved in diagnosing and treating children with ADD and ADHD, Jorgensen noted environmental adjustments and behavior management techniques, as well as medication in some cases, must be considered for a child's overall treatment program. "For some students, a teacher's environmental modifications are enough, but for some students, the use of Ritalin is an academic and social necessity," she noted. "Students who are unable to concentrate are unable to learn, and are unable to retrieve information and are unable to communicate in a classroom. The result is a child who lags further and further behind his or her peers, often to a social detriment." In related news, the American Academy of Pediatrics has compiled guidelines for primary care physicians to follow in assessing and diagnosing children with ADHD. The group made the move to try to standardize the approach physicians take to the disorder, which many affect 4 to 12 percent of all school-age children, the AAP says. "Surveys of pediatricians and family physicians nationwide reveal wide variations in both diagnostic criteria and treatment methods for the disorder," the group says. Primarily, the guidelines direct doctors to follow criteria that has already been developed by the American Psychiatric Association, which require that ADHD symptoms be present in two or more of a child's settings before the child is labeled with the disorder. In addition, the psychiatric group says the symptoms must adversely affect the child's academic or social functioning for at least six months. The APA also recommends physicians or other care givers test children for other disorders that commonly accompany ADHD in children, such as anxiety or depression.8 |
