University at Buffalo - The State University of New York

Published: February 23, 2006

By JOHN DELLACONTRADA
Contributing Editor

William E. Pelham Jr., an expert on attention deficit hyperactivity disorder, says he agrees with a recent Federal Drug Administration panel recommendation that Ritalin and other stimulant drugs used to treat ADHD should carry a warning about a possible link to an increased risk of death and injury.

William Pelham agrees with a recommendation by an FDA panel that Ritalin and other stimulant drugs used to treat ADHD carry a "black box warning."
PHOTO: DOUGLAS LEVERE

The FDA's Drug Safety and Risk Management voted in favor of a "black box" warning—the FDA's strongest form of warning—for ADHD stimulant drugs after hearing testimony about the deaths of 25 people, including 19 children, who had taken the drugs.

Pelham, a UB Distinguished Professor of psychology, pediatrics and psychiatry and director of UB's Center for Children and Families, is an outspoken critic of the overuse of ADHD drugs. His nationally regarded Summer Treatment Program for ADHD children has provided evidence-based behavioral treatments for thousands of children with ADHD and their families.

Pelham's research has shown that behavioral therapy, when used by itself or in combination with small doses of medication, is more effective and carries lower risks of long-term side effects than ADHD medication when used alone. Use of behavioral therapy also can reduce by two-thirds the amount of medication needed to effectively treat an ADHD child, Pelham's research has shown.

The FDA is not required to follow the recommendations of its advisory committees, but usually does. The recommendation was a surprise for many in the mental-health profession and pharmaceutical industry, and it is a source of concern and confusion for the parents and caregivers of an estimated 2.5 million children who take ADHD drugs.

In an interview with The New York Times, Pelham said that it "would be a very good outcome for kids with ADHD and their families" if the warning led families to consider behavioral treatments as an alternative to prescription drugs. Pelham's expertise also was a source for CBS Evening News coverage of the FDA panel's warning.

Pelham has done a lot of work with stimulant drugs and ADHD, including the first trials of Concerta, Adderall and the new methylphenidate patch. However, he "remains concerned that the medications are used too frequently (nearly 5 percent of children in the U.S. are medicated with one of these drugs), at doses that are unnecessarily high (three times higher than needed) and for much too long a duration for most children (years rather than months)."

According to Pelham, a "safety-first" approach to treating ADHD children would argue that behavioral therapies—parent training, social-skills training and classroom management by teachers—should be used as the first-line intervention. Pelham's research, and the work of other researchers, has produced solid evidence that behavioral therapies are effective for ADHD and provide children with effective, long-term strategies for coping with the disorder into adulthood.

Drug therapies, on the other hand, offer only a temporary solution for the disorder, Pelham says. Their effect wears off as soon as the child stops taking the drug, which many children do against the advice of parents and physicians once they become adolescents. What's more, Pelham says, the side effects of ADHD drugs have not been sufficiently studied, nor are parents told of studies showing that ADHD drugs slow a child's growth rate and may increase the risk of experimentation with illicit drugs.

According to Pelham, most parents would choose behavioral therapy over drug therapy for their children if they were told about the health risks of stimulant drugs and if their physicians told them about effective alternative treatments, such as behavioral therapy.

"We know nothing about the long-term safety of the drugs," Pelham cautions. "We do know that when used alone, they have no long term efficacy—that is, they don't improve an ADHD child's outcome in adolescence and adulthood.

"In my opinion, that means that they should be used as adjunctive treatments for children for whom behavioral treatments are insufficient, they should be used at the lowest possible dose and they should be administered only as long as necessary."

In addition to his research and treatment efforts in Buffalo, Pelham is consulting with mental-health experts and physicians in Japan who are developing the country's first programs for children with ADHD. His Summer Treatment Program was implemented last year at Japan's Kurume University and this year will start up in locations throughout the city of Kurume. He said he hopes his work there will help create a more balanced approach to ADHD treatment in Japan than what is currently practiced in the U.S.