Clinical Trials Of Medications In Children Fall Short
Federal regulators in recent years have "enticed or forced pharmaceutical companies to conduct hundreds of studies that have produced vital results about more than 200 drugs," but physicians "still have scant information to guide them when they administer many medications to kids," the Washington Post reports. About two-thirds of medications administered to children remain untested in young age groups.
According to the Post, the "alarming gap" in drug testing for children stems from many factors: clinical trials involving children were "shunned for decades as unnecessary and unethical; Congress and the pharmaceutical industry did not provide adequate funding; and conducting medical experiments on children is difficult." Drug companies and physicians for many years assumed that medical providers could safely extrapolate study results in adults and scale down the dosage levels for children.
However, more recently, researchers have "started to realize that children react to many drugs in surprising ways," the Post reports. Gregory Kearns, professor of pharmacology and pediatrics at the University of Missouri-Kansas City, said, "Children are different; they are not just small adults."
To address this problem, Congress in 1997 passed legislation that offers six additional months of market exclusivity for products that drug makers study in children. In 2002, Congress renewed that provision and also passed a measure that directed FDA and NIH to collaborate on drug studies that pharmaceutical companies have little incentive to conduct. However, that measure has remained largely unfunded.
Richard Gorman of the American Academy of Pediatrics said, "We're chipping away at the problem, but we still have a long way to go."
Wayne Snodgrass, professor of pediatrics at the University of Texas Medical Branch, said, "When's the next dangerous drug going to be found? That's what keeps me up at night," adding, "It's what we can't predict that worries me" (Stein, Washington Post, 11/23).