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Michael Wendell, A 32-year-old software engineer, always had problems in school. He had trouble making friends, couldn't stick to a schedule, and was two to three years behind his classmates in emotional maturity. By third grade, a teacher recommended that he see a therapist, who diagnosed depression. "But I didn't really fit the typical depressive profile," he says.
At 23, he went to see yet another therapist and got what he believes was the first correct diagnosis: attention deficit/hyperactivity disorder (ADHD). He now takes a cocktail of four drugs every day to keep his symptoms in check. "They really improved my ability to function," he says. "I've learned to be patient, I've learned how to listen. My whole development as a person has changed for the better."
Wendell's testimonial helps explain why Eli Lilly & Co. has been running a major advertising campaign for the past six months to promote Strattera. It's the first drug approved by the Food & Drug Administration to treat adults with ADHD. Shire Pharmaceuticals Group PLC hopes to win the same adult designation for its ADHD drug, Adderall XR, this fall. Both companies see a huge untapped market. Over the past 15 years, mental health specialists have realized that a diagnosis long identified with children also applies to 2% to 4% of the adult U.S. population -- possibly as many as 8 million people. But less than 10% of this group is getting treatment. If they started taking medication, the current $2 billion-a-year market for ADHD treatments could easily double."A QUANTIFIABLE DISORDER"
One of the big hurdles in reaching adults with ADHD, however, is overcoming a common perception that the disorder is just a synonym for the frustrations of dealing with fast-paced modern life. Hallmarks of adult ADHD can include difficulty focusing, rapid speech, impulsiveness, excessive irritability, and organizational problems -- behaviors exhibited by, well, lots of people. However, Dr. David W. Goodman, an assistant professor of psychiatry at Johns Hopkins University School of Medicine, notes an important aspect of ADHD: "The symptoms must have started in childhood and persisted into adulthood," he says.
That persistence is not at all unusual. Some 3% to 5% of children have ADHD, according to the National Institutes of Health, and long-term studies have found that up to 66% of those children still suffer from the disorder as adults. These adults tend to change jobs frequently, have substance abuse and gambling problems, commit more crimes, and have a higher divorce rate than the public at large. They often suffer from depression, anxiety, and low self-esteem. "This is not just about being easily bored," says Dr. Leonard A. Adler, director of psychiatry at New York University School of Medicine. "This is a real, quantifiable disorder."
Not all adults with ADHD are struggling. The high energy levels that can accompany the disorder may compensate for the downsides. David Neeleman, the 41-year-old founder of JetBlue Airways Corp., often credits his success to his own ADHD. Indeed, one survey found that about 30% of adults with ADHD become entrepreneurs. But there are plenty of disturbing data as well. Studies have shown that as few as 5% of ADHD sufferers who attend college get a degree, and it is estimated that anywhere from a third to half of the adult prison population has ADHD.FDA OVERSIGHT
No one is sure what causes the disorder, though it clearly has a genetic component, since it runs in families. It also occurs three times more often in boys than in girls. Brain scans of sufferers have noted a deficit of two neurochemicals in the brain's frontal lobes, the center of learning. One, dopamine, improves attention, while the other, norepinephrine, enhances decision-making processes.
Children with ADHD have been treated with stimulants for decades, primarily Novartis' Ritalin, Alza's Concerta, or Shire's Adderall. These drugs raise the level of dopamine in the brain and are effective in 60% to 80% of children.
Stimulants are also effective for adults, but they're trickier to prescribe because the FDA classifies them as abusable drugs. So doctors can't call in prescriptions, and they are likely to have their records scrutinized by drug-enforcement agents if they prescribe stimulants for adults frequently.
Lilly is counting on these difficulties as it promotes Strattera, a nonstimulant that is nonaddictive. Strattera raises the amount of norepinephrine in the brain, and studies have shown that it improves a patient's ability to organize and follow schedules.
Lilly launched Strattera last January and began advertising to consumers in the spring. The ads paid off, with sales of the $3 daily pill totaling $75 million in the second quarter. If Shire wins FDA approval for Adderall XR for adult ADHD sufferers, there are certain to be more ads. "That might serve an important public service by raising awareness of this disorder," says Dr. Goodman. Which, in turn, could sell a lot more pills. By Catherine Arnst in New York