Expand Drug Studies’ Scope
First Lady and New York senatorial candidate Hillary Rodham Clinton’s media event Monday to discuss the sharp rise in the number of young children using Ritalin, Prozac and other powerful psychiatric drugs addressed an urgent and legitimate problem. The number of children on Ritalin, for instance, nearly tripled in the mid-1990s. Ultimately, however, the event had a hollow feel, for Clinton’s proposed solutions barely touched the underlying problems.
The Clinton administration reforms center on two soon-to-be-launched studies--one at the National Institute of Mental Health, the other at the Food and Drug Administration.
The NIMH study would spend about $5 million over the next five years looking at three groups of preschoolers who have been diagnosed with the impulsive, aggressive traits that are known as attention deficit hyperactivity disorder. The first group would receive Ritalin, a drug commonly prescribed for ADHD that is thought to increase the ability to pay attention by stimulating the central nervous system. The second group would get counseling and behavior therapy, while the third would receive some combination of the two.
The NIMH research, however, needs to do more than merely study whether Ritalin is effective. It should try to answer the question that Clinton herself raised on Monday: Are all of the 4 million children who now take Ritalin really in need of a daily drug? Or is normal childhood behavior sometimes being diagnosed as an illness?
The second study, to be overseen by the Food and Drug Administration, will look at the safety and efficacy of antidepressants used by children 7 to 18 years old. Sounds good, until you look at the process. FDA Commissioner Jane E. Henney is asking seven drug companies to conduct the studies, in effect to decide whether or not their own drugs are effective.
True, U.S. drug companies have long funded studies of their own drugs in a collaboration with the federal government, subject to peer review--the critical eye of other scientists. But the exposure of conflicts of interest in peer-reviewed medical journals has cast doubt on the process. For an issue as critical as children’s health, greater independence and public accountability need to be assured.
The number of psychiatric medications prescribed to children continues to soar, and drug companies have more than 100 new psychiatric drugs for children in the pipeline. But to answer these questions adequately, federal agencies will have to broaden the scope of their studies and ensure that parents, doctors and others have full access to their findings.
