The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
Currently Skimming:
8. Ethical and Societal Issues
8. Ethical and Societal Issues
Pages 135-150
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 135... ...
about research and development funding allocations in the artificial heart program. The first section provides background on the societal issues of justice that are raised by those complex medical technologies designed to sustain life that are here characterized as "incomplete." These technologies reduce the effects of a disease but neither cure nor totally resolve the underlying condition.
|
From page 136... ...
These issues include the informed consent process, use of advance directives, and NHLBI funding as a means of promoting appropriate clinical investigation and use of new mechanical circulatory support systems (MCSSs)
|
From page 137... ...
In determining the appropriate level of federal R&D funding for TAHs, it became necessary to go beyond the issue of resource allocation and consider the societal issues that will arise should TAHs be developed and become available to the public. The NHLBI artificial heart program has been evaluated six times since its inception; it is, perhaps, the most persistently scrutinized program of the National Institutes of Health (NIH)
|
From page 138... ...
Such a decision would indicate that, as a matter of public policy, it is preferable that people die of heart disease than that federal funds be applied to artificially sustaining them at so high a cost. This option, however, raises troubling questions about justice and national priorities for health care.
|
From page 139... ...
As a nation facing increasing economic constraints, we cannot continue to sacrifice optimized and ethical results for the comforts of a pay-as-you-go system. The inadequacies of the decision process for developing and using technologies such as the TAH mean that R&D allocation decisions inappropriately carry some of the weight of decisions about the technology's use.
|
From page 140... ...
Incomplete technologies offer treatment to individuals who can no longer, and in some cases never could, benefit from public health or preventive interventions. Furthermore, they help individuals who are dying now, whereas public health measures help people who do not appear to be in immediate need.
|
From page 141... ...
In the process of answering this question, it calls attention to an issue beyond its scope of work or expertise: the need for developing national priorities for the allocation of resources within the health care system. Conceptualizing Access to Incomplete Technologies The different levels of benefit in health care elicit varied solutions to the problem of equitable and appropriate access to health technologies.
|
From page 142... ...
Conversely, if the limited resources model is applied, current funding of the end-stage renal disease program might militate against the development and provision of TAHs, at least with federal funds, on the grounds that we cannot afford it at this time. Consideration of both models might lead to the establishment of options for reconciling them, such as a comprehensive nationwide or statewide position on access to selected incomplete technologies.
|
From page 143... ...
If basic or adequate care is defined to include access to the TAH for certain individuals in need that is, ethical access is assured within categories of clinical appropriateness or if funding of TAH development continues for other reasons, the interim period before routine availability of the TAH should be used to improve those individuals' procedural access to health care and to facilitate more systematic and consistent third-party decision-making processes. Considerations would include equitable access and use across socioeconomic, ethnic, and racial categories for those with equivalent clinical indications for use, equitable geographic availability, and reduction of nonmonetary restraints on availability such as limited numbers of facilities and personnel able to provide such care.
|
From page 144... ...
Patient use criteria are necessary for investigational clinical trials, and the Stanford University heart transplantation program has established selective criteria that may be relevant for MCSS use (Christopherson, 1982~. Criteria for routine MCSS use, however, will be more exclusionary than selective for two reasons.
|
From page 145... ...
Consideration of the nation's unemployment and underemployment levels is beyond the committee's scope and expertise, but it must note that the prospect of MCSS recipients returning to the work force does not appear great, particularly if they were disabled by heart disease for some time before receiving the MCSS. In concluding this section on societal concerns, a final comment: Clarity about the various goals of TAH development and use is necessary when considering the issues surrounding access and appropriate use.
|
From page 146... ...
Although the concept of informed consent is supported and partially defined by the law, meeting the legal definition of informed consent is a starting point, not an assurance of having conducted the consent process in an ethical and complete fashion. In both clinical trials and routine TAH use, an individual's informed consent must result from a careful, explicit, and accountable process.
|
From page 147... ...
In the case of clinical trials, a mechanism to ensure ethical oversight is the hospital institutional review board. Such an entity should ensure that, even as a last resort in the treatment of seriously ill patients, investigational use of a device or a technique such as xenografting is not undertaken without a legitimate foundation for research, a clear, objective anticipation of benefits, and informed consent for each event in the process of medical care.
|
From page 148... ...
mechanism of NHLBI funding. MCSS, mechanical circulatory support system; NHLBI, National Heart, Lung, and Blood Institute.
|
From page 149... ...
Background paper prepared for the Institute of Medicine Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute. IOM (Institute of Medicine)
|
From page 150... ...
Report of the Working Group on Mechanical Circulatory Support, National Heart, Lung, and Blood Institute. Rockville, Md.: NHLBI.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.