October 27, 1998
Although an estimated 8 million American children suffer from behavioral and emotional problems, more than 80 percent of the psychiatric drugs on the market have not been tested and approved for use in children and adolescents. As a result, clinicians are routinely faced with the difficult choice of either treating pediatric disorders with adult medicine or withholding treatment altogether.
In an attempt to level the playing field, researchers at the Johns Hopkins Children's Center are studying psychotropic drugs already approved for adults to determine whether they are safe and effective for children. Leading child psychiatrists from the Research Unit of Pediatric Psychopharmacology (RUPP) at the Children's Center will discuss their ongoing studies as well as some of the controversies surrounding this issue on Wednesday, Oct. 28, at the annual meeting of the American Academy of Child and Adolescent Psychiatry in Anaheim, Cal.
According to unit director Mark Riddle, M.D., an estimated 10 percent of children have medication-responsive psychiatric disorders, but the majority are not treated medicinally. Riddle, director of the Division of Child and Adolescent Psychiatry at the Children's Center, and his colleagues linked a reluctance to prescribe psychotropics for children in part to the paucity of data on their safety and efficacy.
Critics of pediatric psychopharmacology often cite the lack of clinical trials and studies of the long-term effect of medications in developing children as the best reason not to treat children pharmacologically. By conducting thorough examinations of these drugs, Hopkins' RUPP researchers hope to help change this attitude and enable physicians and psychiatrists to take advantage of the best medications available, when indicated, Riddle and his colleagues, John Walkup, M.D., and Michael LaBellarte, M.D., report.
Although the FDA requires that all new drugs be tested for safety in their given populations, social, financial and clinical obstacles historically have impeded drug research in children. Given the relatively small size of the pediatric population, in this instance, pharmaceutical companies have had little financial incentive to conduct tests. Private and public funders, in general, have been uncomfortable with activities that place children in experimental situations. Sensationalized media coverage of pediatric psychopharmacology, such as the use of Ritalin for attention deficit hyperactivity disorder (ADHD), has fostered misconceptions about clinical trials and medication use in children, the Hopkins researchers add.
Beginning in 1996, the National Institute of Mental Health (NIMH) responded to the need for data on the safe and effective use of psychotropics in children and adolescents by establishing national research units, of which Johns Hopkins is one. "Good clinical practice must be based on sound research data," says Benedetto Vitiello, M.D., of NIMH. "Research on the effect of medications in children requires a specialized setting that integrates psychiatric, pharmacological and pediatric expertise," he adds.
As psychiatric disorders in children are increasingly better understood and diagnosed, the number of children receiving medication has rapidly increased. Ironically, this increase has prompted public concern that children are being over-medicated and skepticism of psychotropic use and research, at the very time many promising new drugs are appearing in the adult market.
The Hopkins Children's Center researchers hope that model clinical programs, such as their own RUPP, will increase in number and help take the mystery out of psychiatric disorders in children and the treatments available. Medications used in the treatment of anxiety disorders, depression, obsessive compulsive disorder, ADHD and autism in children are among those being studied at Hopkins.