Calculating risk/benefit in X-linked severe combined immune defieciency disorder (X-SCID) gene therapy trials: the task of ethical evaluation
Swazo, Norman K.
Journal of Medicine and Philosophy 2006 October; 31(5): 533-564
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.
Showing items related by title, author, creator and subject.
French gene therapy group reports on the adverse event in a clinical trial of gene therapy for X-linked severe combined immune deficiency (X-SCID). Position statement from the European Society of Gene Therapy European Society of Gene Therapy [ESGT] (2003-01)
Case of Leukaemia association with X-linked severe combined immunodeficiency gene therapy trial in London European Society of Gene and Cell Therapy. Board Clinigene Network of Excellence. Executive Committee; CONSERT Integrated Project. Executive (2008-01)
Hacein-Bey-Abina, Salima; Le Deist, Francoise; Carlier, Frederique; Bouneaud, Cecile; Hue, Christophe; De Villartay, Jean- Pierre; Thrasher, Adrian J.; Wulffraat, Nicolas; Sorensen, Ricardo; Dupuis-Girod, Sophie; Fischer, Alain; Cavazzana-Calvo, Marina (2002-04-18)