"He knows that machine is his mortality": old and new social and cultural patterns in the clinical trial of the AbioCor artificial heart.
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.
Fox
Renée C
RC
University of Pennsylvania, USA. rcfox@ssc.upenn.edu
Swazey
Judith P
JP
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