Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation

Abstract

In 1966, Henry Beecher, a professor at Harvard Medical School, published an article in the New England Journal of Medicine describing twenty-two cases of unethical medical research, some of which involved children. In the infamous Willowbrook study, for example, researchers deliberately exposed children who were wards in a state facility to hepatitis to study preventive measures. Public attention to research tragedies led to the passage of federal regulations governing human subjects research, including special protections for children. The regulations restricted the participation of children in research, and, in that sense, they have protected children. However, this effort to protect children "may partly explain the underfunding and understudy of... health issues unique to children" that followed. Consequently, the vast majority of medications prescribed to children today have not been adequately studied in pediatric populations. Since the late 1990s, deploying an array of carrots and sticks, the federal government has sought to increase pediatric research, particularly with respect to pharmaceuticals, to address our lack of knowledge regarding the safety and efficacy of pediatric therapies. Its efforts have worked. Between 1990 and 1997, researchers completed eleven pediatric studies of marketed drugs; since 1997, the Food and Drug Administration (FDA) has requested approximately 800 studies involving 45,000 children in clinical trials. Pediatric research will continue to expand as the President recently signed into law measures to encourage pediatric research regarding medical devices.