Parents Must Weigh Costs, Benefits of Pediatric Testing
The Los Angeles Times yesterday examined the growing number of clinical trials involving children and the accompanying dilemma that many parents and doctors face: "Test drugs in children or allow untested medications to be given to them." A 1997 law giving drug companies a six-month patent extension if they conduct pediatric testing on a particular drug and an FDA rule issued last year "requiring that new drugs deemed important to children ... include labeling on safe pediatric use" has led to an increase in pediatric clinical trials in the past decade, from 114 in 1990 to 217 last year. With nearly 400 commonly prescribed treatments for children containing no information on pediatric safety and efficacy, the Times reports that most physicians have "long pushed" for pediatric clinical trials. Recent pediatric drug trials have found that some treatments prescribed for children do not work as expected, with many children receiving too low or too high a dosage, the Times reports. Studies also have allowed drug makers to reformulate medications to make them easier for children to take. However, enrolling children in clinical trials raises several ethical questions. The Times reports that a general consensus exists that "early-stage testing to determine if a drug is safe is not justified in children," however, it is "easier for parents of a seriously ill child who has exhausted all other therapeutic options to try an experimental drug." In addition, the issue of drug companies offering incentives for families to enroll their children in clinical trials raises ethical concerns. The federal Office for Human Research Protections is set to issue a report later this month outlining ethical and safety questions regarding pediatric testing (Roan, Los Angeles Times, 4/16).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.