Subject(s)
Product Recalls and Withdrawals , Retina/surgery , Retinal Diseases/surgery , Visual Prosthesis , Adult , Biomedical Research/economics , Biomedical Research/organization & administration , Biomedical Research/trends , Blindness/epidemiology , Blindness/etiology , Blindness/therapy , Device Approval , France/epidemiology , Fund Raising/standards , Fund Raising/trends , Germany/epidemiology , Humans , Implants, Experimental/adverse effects , Implants, Experimental/economics , Prosthesis Failure/trends , Prosthesis Implantation/adverse effects , Prosthesis Implantation/economics , Prosthesis Implantation/statistics & numerical data , Retina/pathology , Retinal Diseases/economics , Retinal Diseases/epidemiology , Societies, Medical/economics , Societies, Medical/organization & administration , Societies, Medical/standards , Societies, Medical/trends , United States/epidemiology , Visual Prosthesis/adverse effects , Visual Prosthesis/economics , Visual Prosthesis/standards , Visual Prosthesis/supply & distributionABSTRACT
Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.
Subject(s)
Clinical Trials as Topic/adverse effects , Clinical Trials as Topic/legislation & jurisprudence , Compensation and Redress/legislation & jurisprudence , Heart, Artificial/adverse effects , Implants, Experimental/adverse effects , Insurance, Liability/legislation & jurisprudence , Jurisprudence , Liability, Legal , Therapeutic Human Experimentation/legislation & jurisprudence , Clinical Trials as Topic/economics , Conflict of Interest , Contracts/legislation & jurisprudence , Ethics Committees, Research/legislation & jurisprudence , Hospitals , Humans , Implants, Experimental/economics , Industry/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Insurance, Liability/economics , Lawyers , Malpractice/legislation & jurisprudence , Mass Media , Patient Advocacy , Prosthesis Implantation , Research Personnel/legislation & jurisprudence , Research SubjectsABSTRACT
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.
