Parents shopping for pencils, book bags and new clothes for their kids may be tempted by recent advertisements to add yet another item to their back-to-school cart -- a prescription for an ADHD drug.
So say critics of back-to-school themed ads for attention deficit hyperactivity disorder (ADHD) drugs sponsored by companies that market the medications.
"Given that parents obviously are anxious about their kids' school performance, these ads really exploit these parents' concerns," said Dr. Sidney Wolfe, director of the consumer advocacy group Public Citizen's Health Research Group.
"This kind of ad is obviously not pushing for better teaching, better schools or more counseling, but it is pushing for the easy fix, the drug solution."
But a number of child and adolescent psychiatrists counter that the ads may not be all bad -- and may even give children access to beneficial treatment options of which their parents would not otherwise be aware.
Children with ADHD often have trouble sitting still and paying attention. They may also act out at home and, more problematically, in the classroom.
On Monday, an editorial in the Los Angeles Times took drug makers to task for advertisements featuring drugs used to treat the condition, which routinely feature the medicines' branding splashed amid a background of back-to-school imagery.
"Powerful psychotropic medications should be an option of last resort and uninfluenced deliberation, not another brand-name product to add to the back-to-school shopping list," the editorial reads.
The article points a finger at U.S. regulatory agencies for lax oversight of such ads, some of which market candy-flavored versions of the powerful drugs.
Industry representatives have already come out in defense of the advertisements, which they say educate the public about a commonly undertreated condition among children.
"[W]hat the author failed to mention is that while more Americans are seeking treatment for mental illnesses, most of them fail to get adequate care," said Ken Johnson, senior vice president of the industry group Pharmaceutical Research and Manufacturers of America (PhRMA) in a statement issued Wednesday.
"DTC advertising can help bridge this information gap by empowering patients, improving patient understanding of disease and available treatments, and fostering strong relationships between patients and their health care providers," the statement continues.
And some psychiatrists say that while ethical considerations do exist with regard to the ads, they could be more beneficial than the public realizes.
"While the drug companies may be advertising their products, there is a piece of this that could be educational," said Dr. John Walkup, associate professor of child and adolescent psychiatry at Johns Hopkins Children's Center in Baltimore, Md.
"It's an advertisement. No question, they're trying to sell their product," he said. "On the other hand, this is the time of year when kids start to benefit from these products."
"It's a double-edged sword," said Dr. Sharon Hirsch, professor of child and adolescent psychiatry at the University of Chicago Comer Children's Hospital.
"Certainly they're out there to promote their medicines. But I think the positive side of advertisements, especially for psychological medications, is that you decrease some of the stigma of some of these conditions."
Overprescribed vs. Underserved
For anyone who has been paying any attention at all, it should come as little surprise that drugs for ADHD are big business.
Psychological professionals who work with children and adolescents say there is a notable spike in office visits for the condition -- and hence, ADHD drug prescriptions -- at the beginning of the school year.
"We certainly see an increase," said Jennifer Kurth, adolescent psychiatrist at Northwestern Memorial Hospital's Warren Wright Adolescent Center in Chicago. "Usually our field in general starts to see a lot of kids throughout the first few months of school."
ADHD is thought to affect anywhere from 3 to 12 percent of school-age children -- a figure that works out to as many as 3.8 million kids. This makes it one of the most common childhood disorders in the country.
And it is possibly also one of the most lucrative. Medicines to treat the disorder -- such as Ritalin, manufactured by Novartis Pharmaceuticals Corp., Concerta by Johnson & Johnson and Adderall by Shire U.S. Inc. -- are estimated to rake in more than $1 billion annually in sales.
So while researchers continue to point to a wide range of possible ADHD causes ranging from prenatal alcohol exposure to genetics, some parents and doctors suspect that the drugs for the condition may be overprescribed.
"If a child, after a proper diagnostic evaluation actually has ADHD, then the drug may make sense," Wolfe said. "But it is always a poor balancing of benefits and risks to prescribe a drug that is unnecessary, taking the risks of the drug, which can be substantial, while getting no benefit."
Many physicians in the field, however, say that this is a dangerous misapprehension.
"I think there were a couple of reports in early 2000 that showed a dramatic rise in the prescription rates of these drugs. These reports, while accurate, do not convey the whole picture," said Walkup, who added that up to half of the children who have ADHD go untreated.
"I certainly think that it's important to remember that ADHD affects 8 to 10 percent of school-aged children," Kurth said. "We're prescribing the drug more frequently because we are catching those who hadn't been treated in the past."
To Advertise or Not to Advertise?
It's the fact that these drugs are advertised so heavily and in a targeted way that has some researchers and regulators concerned. Currently, the United States and New Zealand stand alone as the only nations that allow drug companies to advertise their prescription-only products directly to consumers.
And the very nature of ADHD drugs -- some which have been shown in the past to have rare but potentially deadly side effects on the heart and significant abuse potential -- may beg for stricter regulation.
Julie Donohue, assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health, published a study in the New England Journal of Medicine on Aug. 16 of this year that found that drug companies spending on advertising since such marketing became legal in 2001 has more than tripled. Her research also suggests that regulatory efforts by the FDA have decreased over time.
"Some people might have ethical issues with advertising prescription drugs for children in the first place," she said. "My whole point is that the rules that we have on the books are adequate, they just need to be enforced."
But even with the enforcement of current drug advertising laws, she said ADHD drugs may present a unique conundrum.
"This is a classic example of a class of drugs that is plagued by the problems of both overuse and underuse," Donohue said. "It's hard to fix one of these problems without exacerbating the other."
Even psychiatrists who view drug ads favorably note that there is a possibility that they could be a source of confusion for some parents.
"There is obviously a lot of controversy in our using psychotropic medications in children, and I think that the pharmaceutical industry can make that a little more confusing for parents through advertising," Kurth said.
Balancing Publicity with Need
Yet some say the controversy over the advertisements may provide a surrogate form of regulation by putting the pressure on doctors to truly scrutinize their scripts.
"Public attention to this issue forces physicians to maintain their integrity in prescribing these drugs," Kurth said.
And Walkup added that in light of the undertreatment rate of kids with ADHD, public concern should be aimed at the disorder itself, rather than the marketing that promotes its treatments.
"I understand the concern of drug companies hitting a vulnerable population at one time or another," he said. "But in this case they are targeting the real concern of something that will happen to real kids this September.
"Over and over again studies have shown that this stuff is enormously helpful."
Kurth agreed. "We would hope that it wouldn't be marketed to the equivalent of a candy bar, and we hope that the pharmaceutical industry is not making this seem like something everyone should check in with their doctor about," she said.
But she added, "I still see parents mostly coming in as a result of problematic behavior on the part of their child, rather than as a result [of drug ads]... I have not seen too many parents coming in and saying, 'You must put my kid on this medicine.'"