DECEMBER 14, 2013
By ALAN SCHWARZ
After more than 50 years leading the fight to legitimize attention deficit hyperactivity disorder, Keith Conners could be celebrating.
Severely hyperactive and impulsive children, once shunned as bad seeds, are now recognized as having a real neurological problem. Doctors and parents have largely accepted drugs like Adderall and Concerta to temper the traits of classic A.D.H.D., helping youngsters succeed in school and beyond.
But Dr. Conners did not feel triumphant this fall as he addressed a group of fellow A.D.H.D. specialists in Washington. He noted that recent data from the Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder had soared to 3.5 million from 600,000 in 1990. He questioned the rising rates of diagnosis and called them “a national disaster of dangerous proportions.”
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”
The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.
Few dispute that classic A.D.H.D., historically estimated to affect 5 percent of children, is a legitimate disability that impedes success at school, work and personal life. Medication often assuages the severe impulsiveness and inability to concentrate, allowing a person’s underlying drive and intelligence to emerge.
But even some of the field’s longtime advocates say the zeal to find and treat every A.D.H.D. child has led to too many people with scant symptoms receiving the diagnosis and medication. The disorder is now the second most frequent long-term diagnosis made in children, narrowly trailing asthma, according to a New York Times analysis of C.D.C. data.
Behind that growth has been drug company marketing that has stretched the image of classic A.D.H.D. to include relatively normal behavior like carelessness and impatience, and has often overstated the pills’ benefits. Advertising on television and in popular magazines like People and Good Housekeeping has cast common childhood forgetfulness and poor grades as grounds for medication that, among other benefits, can result in “schoolwork that matches his intelligence” and ease family tension.
A 2002 ad for Adderall showed a mother playing with her son and saying, “Thanks for taking out the garbage.”
The Food and Drug Administration has cited every major A.D.H.D. drug — stimulants like Adderall, Concerta, Focalin and Vyvanse, and nonstimulants like Intuniv and Strattera — for false and misleading advertising since 2000, some multiple times.
Sources of information that would seem neutral also delivered messages from the pharmaceutical industry. Doctors paid by drug companies have published research and delivered presentations that encourage physicians to make diagnoses more often that discredit growing concerns about overdiagnosis.
Many doctors have portrayed the medications as benign — “safer than aspirin,” some say — even though they can have significant side effects and are regulated in the same class as morphine and oxycodone because of their potential for abuse and addiction. Patient advocacy groups tried to get the government to loosen regulation of stimulants while having sizable portions of their operating budgets covered by pharmaceutical interests.
Companies even try to speak to youngsters directly. Shire — the longtime market leader, with several A.D.H.D. medications including Adderall — recently subsidized 50,000 copies of a comic book that tries to demystify the disorder and uses superheroes to tell children, “Medicines may make it easier to pay attention and control your behavior!”
Profits for the A.D.H.D. drug industry have soared. Sales of stimulant medication in 2012 were nearly $9 billion, more than five times the $1.7 billion a decade before, according to the data company IMS Health.
Even Roger Griggs, the pharmaceutical executive who introduced Adderall in 1994, said he strongly opposes marketing stimulants to the general public because of their dangers. He calls them “nuclear bombs,” warranted only under extreme circumstances and when carefully overseen by a physician.
Psychiatric breakdown and suicidal thoughts are the most rare and extreme results of stimulant addiction, but those horror stories are far outnumbered by people who, seeking to study or work longer hours, cannot sleep for days, lose their appetite or hallucinate. More can simply become habituated to the pills and feel they cannot cope without them.
Tom Casola, the Shire vice president who oversees the A.D.H.D. division, said in an interview that the company aims to provide effective treatment for those with the disorder, and that ultimately doctors were responsible for proper evaluations and prescriptions. He added that he understood some of the concerns voiced by the Food and Drug Administration and others about aggressive ads, and said that materials that run afoul of guidelines are replaced.
“Shire — and I think the vast majority of pharmaceutical companies — intend to market in a way that’s responsible and in a way that is compliant with the regulations,” Mr. Casola said. “Again, I like to think we come at it from a higher order. We are dealing with patients’ health.”
A spokesman for Janssen Pharmaceuticals, which makes Concerta, said in an email, “Over the years, we worked with clinicians, parents and advocacy groups to help educate health care practitioners and caregivers about diagnosis and treatment of A.D.H.D., including safe and effective use of medication.”
Now targeting adults, Shire and two patient advocacy groups have recruited celebrities like the Maroon 5 musician Adam Levine for their marketing campaign,“It’s Your A.D.H.D. – Own It.” Online quizzes sponsored by drug companies are designed to encourage people to pursue treatment. A medical education video sponsored by Shire portrays a physician making a diagnosis of the disorder in an adult in a six-minute conversation, after which the doctor recommends medication.
Like most psychiatric conditions, A.D.H.D. has no definitive test, and most experts in the field agree that its symptoms are open to interpretation by patients, parents and doctors. The American Psychiatric Association, which receives significant financing from drug companies, has gradually loosened the official criteria for the disorder to include common childhood behavior like “makes careless mistakes” or “often has difficulty waiting his or her turn.”
The idea that a pill might ease troubles and tension has proved seductive to worried parents, rushed doctors and others.
“Pharma pushed as far as they could, but you can’t just blame the virus,” said Dr. Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif. “You have to have a susceptible host for the epidemic to take hold. There’s something they know about us that they utilize and exploit.”
Selling to Doctors
Modern marketing of stimulants began with the name Adderall itself. Mr. Griggs bought a small pharmaceutical company that produced a weight-loss pill named Obetrol. Suspecting that it might treat a relatively unappreciated condition then called attention deficit disorder, and found in about 3 to 5 percent of children, he took “A.D.D.” and fiddled with snappy suffixes. He cast a word with the widest net.
All.
For A.D.D.
A.D.D. for All.
Adderall.
“It was meant to be kind of an inclusive thing,” Mr. Griggs recalled.
“It was meant to be kind of an inclusive thing,” Mr. Griggs recalled.
Adderall quickly established itself as a competitor of the field’s most popular drug, Ritalin. Shire, realizing the drug’s potential, bought Mr. Griggs’s company for $186 million and spent millions more to market the pill to doctors. After all, patients can buy only what their physicians buy into.
As is typical among pharmaceutical companies, Shire gathered hundreds of doctors at meetings at which a physician paid by the company explained a new drug’s value.
Such a meeting was held for Shire’s long-acting version of Adderall, Adderall XR, in April 2002, and included a presentation that to many critics, exemplifies how questionable A.D.H.D. messages are delivered.
Dr. William W. Dodson, a psychiatrist from Denver, stood before 70 doctors at the Ritz-Carlton Hotel and Spa in Pasadena, Calif., and clicked through slides that encouraged them to “educate the patient on the lifelong nature of the disorder and the benefits of lifelong treatment.” But that assertion was not supported by science, as studies then and now have shown that perhaps half of A.D.H.D. children are not impaired as adults, and that little is known about the risks or efficacy of long-term medication use.
The PowerPoint document, obtained by The Times, asserted that stimulants were not “drugs of abuse” because people who overdose “feel nothing” or “feel bad.” Yet these drugs are classified by the government among the most abusable substances in medicine, largely because of their effects on concentration and mood. Overdosing can cause severe heart problems and psychotic behavior.
Slides described side effects of Adderall XR as “generally mild,” despite clinical trials showing notable rates of insomnia, significant appetite suppression and mood swings, as well as rare instances of hallucinations. Those side effects increase significantly among patients who take more pills than prescribed.
Another slide warned that later in life, children with A.D.H.D. faced “job failure or underemployment,” “fatal car wrecks,” “criminal involvement,” “unwanted pregnancy” and venereal diseases, but did not mention that studies had not assessed whether stimulants decreased those risks.