title: Calculating risk/benefit in X-linked severe combined immune deficiency disorder (X-SCID) gene therapy trials: the task of ethical evaluation.
abstract: In response to adverse events in retroviral gene therapy clinical trials conducted in France to correct for X-linked severe combined immune deficiency disorder (X-SCID), an advisory committee of the Food and Drug Administration convened in October 2002, February 2003, and March 2005, to deliberate and provide recommendations for similarly sponsored research in the United States. A similar National Institutes of Health committee met in February 2003. In this article, I review the transcripts and/or minutes of these meetings to evaluate the extent to which the ethical dimension of the research was engaged even as the molecular and clinical evidence was reviewed. I then provide representative ethical arguments to demonstrate the sort of ethical reasoning that should be included as part of the agenda of such committee meetings.
authors.affiliation: University of Alaska Fairbanks, Fairbanks, Alaska 99775, USA. ffnks@uaf.edu
authors.forename: Norman K
authors.initials: NK
authors.lastname: Swazo
mesh_terms: D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000941:ethics*; D026690:Ethics, Clinical; D032984:Ethics, Research; D015316:Genetic Therapy / Q000941:ethics*; D006801:Humans; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration; D053632:X-Linked Combined Immunodeficiency Diseases / Q000628:therapy*