Warning about Warnings: Weighing Risk and Benefit When Information Is in a State of FluxLaventhal N.T. · Shuchman M. · Sandberg D.E.
aDepartment of Pediatrics and Communicable Diseases, and bCenter for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Mich., USA; cDepartment of Psychiatry, University of Toronto, Toronto, Ont., Canada
In 2010, new data about the safety of recombinant human growth hormone (rhGH) resulted in warnings and subsequent pronouncements by the US Food and Drug Administration (FDA) and its European counterpart [the European Medicines Agency (EMA)] regarding its use in children and adolescents as an elective treatment for short stature. However, opinions about these new data are divergent: the FDA did not change the label of the drug and experts have argued for further research on the safety of rhGH. In this situation of an evolving scientific controversy, it is unclear how questions about benefit and risk are communicated to patients and their parents. Social biases and misperceptions about the deleterious effects of short stature and the benefits of added height influence decisions to prescribe rhGH and may affect discussions of the warnings by regulators. Fully supporting a model of shared decision-making involving children and adolescents requires sharing risk-benefit information, including evolving information from drug regulators, with patients and parents.
8-621 C&W Mott Hospital
1540 E. Hospital Dr., SPC 4254
Ann Arbor, MI 48109-4254 (USA)
Received: December 10, 2012
Accepted: December 10, 2012
Published online: January 23, 2013
Number of Print Pages : 5
Number of Figures : 0, Number of Tables : 0, Number of References : 43
Hormone Research in Paediatrics (From Developmental Endocrinology to Clinical Research)
Vol. 79, No. 1, Year 2013 (Cover Date: February 2013)
Journal Editor: Czernichow P. (Paris)
ISSN: 1663-2818 (Print), eISSN: 1663-2826 (Online)
For additional information: http://www.karger.com/HRP