Pediatric Drug Testing: Is It at Risk?

H arry Shirkey could not have guessed what he started when, in 1963, he first coined the phrase "therapeutic orphans" to describe the plight of a population for whose use few drugs had been tested and approved. His expression drew attention to pediatric therapeutics, a field not merely neglected but until then virtually ignored. Physicians were often forced to guess at drug dosages for children on the basis of a percentage of adult body weight. A breakthrough came when pediatric pharmacologists such as Dr. Shirkey pointed to skin surface area as a more rational way to calculate pediatric doses. Unfortunately, that method did not work for all drugs either: some drugs were absorbed and metabolized more efficiently in children than in adults, others stayed in the blood stream for longer periods of time and had longer half lives than in adults, and still others produced in children responses quite different from those in adults. In the mid-1960s pharmacologists realized that drugs would have to be adequately tested in children from the beginning, as if children were another species, before appropriate directions could be given for their use.