Biomedical subjects
Publications and source records attributed to Renée C Fox.
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Although the application of major biomedical advances has yielded spectacular results for individual health, there has been little improvement in the health of whole populations. There is a "back to the future" irony in the fact that at the inception of the 21st century, the eruption and spread of a multitude of "old" and "new" infectious diseases has become the most serious global threat to the health of humankind. At this historical juncture, the United States is the country with the most potential for favorably influencing global health and health care. Although there are historical, cultural, economic, and political factors that impede the United States from rising to this challenge, there is both a moral imperative and a rational long-term self-interest basis for the U.S. medical profession and government to exercise leadership in facing the health challenges of tragic and genocidal proportions that threaten everyone in an increasingly interdependent world.
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.
The period from the end of World War II to the early 1960s has been characterized as the "golden years" of patient-oriented clinical research in the United States, a period catalyzed and fostered by advances in biology and medicine, changes in the organization and financing of research units, and strong moral and political convictions growing out of the war about the importance and possibilities of the scientific enterprise. This account of some of the salient themes, phenomena, and issues in clinical research during that era draws primarily on the proceedings of an oral history conference whose core participants were a number of emeritus physician-investigators who had played major roles in shaping patient-oriented research. The topics that they and the other conferees discussed included the factors that had led the emeritus physician-investigators into clinical research; the organizational attributes of the units where they had trained and worked, focusing particularly on Boston's Peter Bent Brigham Hospital; the vital role played by private and federal funding for research and training; and some of the changes in the nature of clinical research, research training, and their relationships to the care of the sick in the decades since the golden years.
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It seems commendable that Michael A. DeVita and James V. Snyder, and the physicians, nurses, and Ethics Committee of the University of Pittsburgh Medical Center (UPMC) on whose behalf they write, continually and publicly reflect on the policy they have enacted to obtain organs from non-heartbeating cadaver donors, and that they are willing to change their procedures in the light of their experiences with their protocol for this type of transplant, and the criticisms of it they have invited. It is also disquieting because, in effect, the Medical Center is engaged in trial-and-error experimentation with some features of the protocol that, from the outset, should not have been a part of it, and with certain revisions of the protocol that are as questionable as what has been modified. Is it really as virtuous as it appears, then, for UPMC health professionals and Ethics Committee members to constantly reevaluate and alter their policy for non-heartbeating organ donation, and for their spokespersons to issue one report after another containing their latest thoughts and actions in this regard?
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