POSTED: 01:30 a.m. HST, Dec 15, 2013
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 neurobehavioral problem. Doctors and parents have largely accepted drugs like Adderall and Concerta to temper the traits of classic ADHD, helping youngsters succeed in school and beyond.
But Conners did not feel triumphant this fall as he addressed a group of fellow ADHD specialists in Washington. He noted that recent data from the Centers for Disease Control and Prevention show that the diagnosis has been made in 15 percent of high school-age children, and that the number of children on medication for the disorder has 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," 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 ADHD diagnoses and prescriptions for stimulants over the years has 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 ADHD, which could become even more profitable.
Few dispute that classic ADHD, historically estimated to affect 5 percent of children, is a legitimate disability that impedes success at school, at work and in personal lives. 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 ADHD child has led to too many people with scant symptoms receiving the diagnosis and medication. The disorder is the second most frequent long-term diagnosis in children, narrowly trailing asthma, according to a New York Times analysis of CDC data.
Behind that growth has been drug company marketing that has stretched the image of classic ADHD to include relatively normal behavior like carelessness and impatience, and has often overstated the pills' benefits. Advertising on television and in 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 ADHD 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 and 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 ADHD 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 ADHD 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 ADHD 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," 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 ADHD, including safe and effective use of medication."
Now targeting adults, Shire and two patient advocacy groups have recruited celebrities like Maroon 5 musician Adam Levine for their marketing campaign, "It's Your ADHD - 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, ADHD 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."
Many of the scientific studies cited by drug company speakers involved Dr. Joseph Biederman, a prominent child psychiatrist at Harvard University and Massachusetts General Hospital. In 2008, a Senate investigation revealed that Biederman's research on many psychiatric conditions had been substantially financed by drug companies, including Shire. Those companies also paid him $1.6 million in speaking and consulting fees. He has denied that the payments influenced his research.
Conners called Biederman "unequivocally the most published psychopharmacology maven for ADHD," one who is well known for embracing stimulants and dismissing detractors. Findings from Biederman's dozens of studies on the disorder and specific brands of stimulants have filled the posters and pamphlets of pharmaceutical companies that financed the work.
Those findings typically delivered three messages: The disorder was underdiagnosed; stimulants were effective and safe; and unmedicated ADHD led to significant risks for academic failure, drug dependence, car accidents and brushes with the law.
Biederman was frequently quoted about the benefits of stimulants in interviews and company news releases. In 2006, for example, he told Reuters Health, "If a child is brilliant but is doing just OK in school, that child may need treatment, which would result in their performing brilliantly at school."
This year, Biederman told the medical newsletter Medscape regarding medication for those with ADHD, "Don't leave home without it."
Biederman did not respond to requests for an interview.
Most of Biederman's critics said that they believed his primary motivation was always to help children with legitimate ADHD and that risks of untreated ADHD can be significant. What concerned them was how Biederman's high-profile and unwavering promotion of stimulants armed drug companies with the published science needed to create powerful advertisements - many of which cast medications as benign solutions to childhood behavior falling far short of legitimate ADHD.
"He gave them credibility," said Richard M. Scheffler, a professor of health economics and public policy at the University of California, Berkeley, who has written extensively on stimulants. "He didn't have a balance. He became totally convinced that it's a good thing and can be more widely used."
Casola said Shire remains committed to raising awareness of ADHD. Shire spent $1 million in the first three quarters of 2013, according to company documents, to support ADHD conferences to educate doctors. One this autumn found J. Russell Ramsay, a psychologist at the University of Pennsylvania's medical school, who also serves as a consultant and speaker for Shire, reading aloud one of his slides to the audience: "ADHD - It's Everywhere You Want to Be."
"We are a commercial organization trying to bring health care treatments to patients," Casola said. "I think, on balance, we are helping people."
Alan Schwarz, New York Times