title: "He knows that machine is his mortality": old and new social and cultural patterns in the clinical trial of the AbioCor artificial heart.
abstract: The clinical trial of the AbioCor artificial heart, initiated in July 2001 and still in process, has taken place within a matrix of social and cultural patterns that are both "old" and new. The old patterns--those that have accompanied previous clinical trials of other vital artificial organs and transplantation in the United States--include "experiment perilous," and courage, heroism, and pioneering themes; "right stuff" motifs; "Americana" symbols; allusions to the meaning of the human heart; connections with a for-profit corporation; and the occurrence of moratoriums. New patterns--those more particular and distinctive to the AbioCor trial--involve the restrictions imposed on releasing information about the post-operative clinical status of the implant recipients; the quasi-institutionalization of a patient advocacy system to represent patient-subjects and their families; and the "crises of success" that were encountered when several of the AbioCor recipients survived longer than expected. In certain instances, old and new patterns have been combined--for example, in some of the idiosyncratic features of the AbioCor-associated lawsuit that has resulted in part from the problem of the "therapeutic misconception," the belief that an experimental intervention is actually intended to be a treatment.
authors.affiliation: University of Pennsylvania, USA. rcfox@ssc.upenn.edu
authors.forename: Renée C
authors.initials: RC
authors.lastname: Fox
authors.forename: Judith P
authors.initials: JP
authors.lastname: Swazey
mesh_terms: D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000191:economics; D003132:Commerce / Q000191:economics / Q000941:ethics / Q000458:organization & administration*; D032962:Consent Forms; D003469:Culture; D005380:Financing, Government; D006354:Heart, Artificial / Q000009:adverse effects / Q000191:economics; D006801:Humans; D020007:Implants, Experimental / Q000009:adverse effects / Q000191:economics; D008297:Male; D009316:National Institutes of Health (U.S.); D017063:Outcome Assessment, Health Care; D010351:Patient Discharge; D019452:Terminally Ill; D036302:Therapeutic Human Experimentation / Q000191:economics; D014481:United States; D014486:United States Food and Drug Administration