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- All Subjects: governance
- All Subjects: Biomedical Technology
- Creators: Hurlbut, James B
Description
Corporations in biomedicine hold significant power and influence, in both political and personal spheres. The decisions these companies make about ethics are critically important, as they help determine what products are developed, how they are developed, how they are promoted, and potentially even how they are regulated. In the last fifteen years, for-profit private companies have been assembling bioethics committees to help resolve dilemmas that require informed deliberation about ethical, legal, scientific, and economic considerations. Private sector bioethics committees represent an important innovation in the governance of emerging technologies, with corporations taking a lead role in deciding what is ethically appropriate or problematic. And yet, we know very little about these committees, including their structures, memberships, mandates, authority, and impact. Drawing on an extensive literature review and qualitative analysis of semi-structured interviews with executives, scientists and board members, this dissertation provides an in-depth analysis of the Ethics and Public Policy Board at SmithKline Beecham, the Ethics Advisory Board at Advanced Cell Technology, and the Bioethics Committee at Eli Lilly and offers insights about how ideas of bioethics and governance are currently imagined and enacted within corporations. The SmithKline Beecham board was the first private sector bioethics committee; its mandate was to explore, in a comprehensive and balanced analysis, the ethics of macro trends in science and technology. The Advanced Cell Technology board was created to be like a watchdog for the company, to prevent them from making major errors. The Eli Lilly board is different than the others in that it is made up mostly of internal employees and does research ethics consultations within the company. These private sector bioethics committees evaluate and construct new boundaries between their private interests and the public values they claim to promote. Findings from this dissertation show that criticisms of private sector bioethics that focus narrowly on financial conflicts of interest and a lack of transparency obscure analysis of the ideas about governance (about expertise, credibility and authority) that emerge from these structures and hamper serious debate about the possible impacts of moving ethical deliberation from the public to the private sector.
ContributorsBrian, Jennifer (Author) / Robert, Jason S (Thesis advisor) / Maienschein, Jane (Committee member) / Hurlbut, James B (Committee member) / Sarewitz, Daniel (Committee member) / Brown, Mark B. (Committee member) / Moreno, Jonathan D. (Committee member) / Arizona State University (Publisher)
Created2012
Description
In the past century, a number of technological projects have been undertaken as grand solutions to social problems. In the so called century of biology, this technological world view focuses on biomedical advances. The President of the United States, who once called for nuclear weapons and space exploration, now calls for new biotechnologies, such as genomics, individualized medicine, and nanotechnology, which will improve the world by improving our biological lives. Portrayed as the Manhattan Project of the late 20th Century, the Human Genome Project (HGP) not only undertook the science of sequencing the human genome but also the ethics of it. For this thesis I ask how the HGP did this; what was the range of possibilities of goods and evils imagined by the HGP; and what, if anything, was left out. I show that the Ethical, Legal, and Social Implications (ELSI) research program of the HGP was inscribed with the competencies of the professional field of bioethics, which had lent itself useful for governing biomedical science and technology earlier in the 20th century. Drawing on a sociological framework for understanding the development of professional bioethics, I describe the development of ELSI, and I note how the given-in-advance boundaries between authorized/unauthorized questions shaped its formation and biased technologically based conceptualizations of social problems and potential solutions. In this sense, the HGP and ELSI served both as the ends of policy and as instruments of self-legitimation, thus re-inscribing and enacting the structures for these powerful sociotechnical imaginaries. I engage the HGP and ELSI through historical, sociological, and political philosophical analysis, by examining their immediate context of the NIH, the meso level of professional/disciplinary bioethics, and the larger context of American democracy and modernity. My argument is simultaneously a claim about how questions are asked and how knowledge and expertise are made, exposing the relationship between the HGP and ELSI as a mutually constitutive and reciprocally related form of coproduction of knowledge and social structures. I finish by arguing that ELSI is in a better position than bioethics to carry out the original project of that field, i.e., to provide a space to elucidate certain institutionally authorized questions about science and technology. Finally, I venture into making a prophecy about the future of ELSI and bioethics: that the former will replace the latter as a locus for only formally rational and thin ethical debates.
ContributorsCarvalho, Tito (Author) / Robert, Jason S (Thesis advisor) / Ellison, Karin D (Committee member) / Hurlbut, James B (Committee member) / Arizona State University (Publisher)
Created2012
Description
Atrial fibrillation (AF) is the most common abnormal heart rhythm, affecting
nearly 2% of the world’s population at a cost of $26 Billion in the United States annually, and incalculable costs worldwide. AF causes no symptoms for some people. However, others with AF experience uncomfortable symptoms including palpitations, breathlessness, dizziness, and fatigue. AF can severely diminish quality of life for both AF sufferers and their loved ones. Beyond uncomfortable symptoms, AF is also linked to congestive heart failure and stroke, both of which can cause premature death. Medications often fail to control AF, leading patients and healthcare providers to seek other cures, including catheter ablation. To date, catheter ablation has yielded uneven results, but garners much attention in research and innovation in pursuit of a cure for AF. This dissertation examines the historical development and contemporary practices of AF ablation to identify opportunities to improve the innovation system for the disease. First, I trace the history of AF and AF ablation knowledge from the 2nd century B.C.E. through the present. This historical look identifies patterns of knowledge co-development between science, technology, and technique, as well as publication patterns impacting knowledge dissemination. Second, I examine the current practices of AF ablation knowledge translation from the perspective of clinical practitioners to characterize the demand-side of knowledge translation in real-world practice. Demand-side knowledge translation occurs in nested patterns, and requires data, experience, and trust in order to incorporate knowledge into a practice paradigm. Third, I use social network mapping and analysis to represent the full AF ablation knowledge-practice system and identify
opportunities to modify research and innovation practice in AF ablation based on i
measures of centrality and power. Finally, I outline six linked recommendations using raw data capture during ablation procedures and open big data analytics, coupled with multi-stakeholder social networking approaches, to maximize innovation potential in AF ablation research and practice.
nearly 2% of the world’s population at a cost of $26 Billion in the United States annually, and incalculable costs worldwide. AF causes no symptoms for some people. However, others with AF experience uncomfortable symptoms including palpitations, breathlessness, dizziness, and fatigue. AF can severely diminish quality of life for both AF sufferers and their loved ones. Beyond uncomfortable symptoms, AF is also linked to congestive heart failure and stroke, both of which can cause premature death. Medications often fail to control AF, leading patients and healthcare providers to seek other cures, including catheter ablation. To date, catheter ablation has yielded uneven results, but garners much attention in research and innovation in pursuit of a cure for AF. This dissertation examines the historical development and contemporary practices of AF ablation to identify opportunities to improve the innovation system for the disease. First, I trace the history of AF and AF ablation knowledge from the 2nd century B.C.E. through the present. This historical look identifies patterns of knowledge co-development between science, technology, and technique, as well as publication patterns impacting knowledge dissemination. Second, I examine the current practices of AF ablation knowledge translation from the perspective of clinical practitioners to characterize the demand-side of knowledge translation in real-world practice. Demand-side knowledge translation occurs in nested patterns, and requires data, experience, and trust in order to incorporate knowledge into a practice paradigm. Third, I use social network mapping and analysis to represent the full AF ablation knowledge-practice system and identify
opportunities to modify research and innovation practice in AF ablation based on i
measures of centrality and power. Finally, I outline six linked recommendations using raw data capture during ablation procedures and open big data analytics, coupled with multi-stakeholder social networking approaches, to maximize innovation potential in AF ablation research and practice.
ContributorsRoss, Heather M (Author) / Hackett, Edward J (Thesis advisor) / Hurlbut, James B (Thesis advisor) / Sarewitz, Daniel (Committee member) / Miller, Clark A. (Committee member) / Arizona State University (Publisher)
Created2016
Description
This dissertation investigates and describes the concept of precision medicine from historical, conceptual, capital investment, industry strategic, regulatory oversight, and medicalization perspectives. The study examines the various current and ongoing challenges, impacts, assimilations, and actual adaptive measures occurring within each of these areas as a result of the emergence and continued evolution of precision medicine as a medical discipline, as well as the technosocial advancements characteristic of precision medical products, such as companion diagnostics and targeted therapeutics, seeking market entry in the United States. The dissertation argues that there is a disjunction between precision medicine and historical governance, oversight, and medical practice mechanisms. Through case studies of two case products, Foundation Medicine’s F1CDx companion diagnostic and Novartis’ Kymriah CAR-T Cell therapeutic, the dissertation illustrates the impacts, destabilization and destandardization effects, and re-standardization efforts around a precision medicine diagnostic and therapy. As a central contribution, this dissertation demonstrates and illustrates the impact(s) that precision medicinal technologies are having on the technoscientific network involved in the creation, development, evaluation, governance, and implementation of medical products in the United States. Results revealed an emerging precision medical innovation model between and among member components of a precision medical ecosystem comprised of the above-mentioned focal areas and that, to fully understand the emerging precision medical innovation model, it is critical to understand not only the impacts of precision medical technologies on the individual components of the precision medicine ecosystem, but also the impacts, adaptations, assimilations, and occlusions inherent to the ecological relations within and across the ecosystem itself. Findings include the destabilization of the traditional drug development process across all stakeholder areas, characterized by the development of non-linear adaptive processes at both the premarket and post-market phases. Although the findings from this study are significant, it is likely that they are temporary in nature and will continue to evolve in accordance with the further advancement of precision medicine, ultimately re-stabilizing the precision medical development ecosystem.
ContributorsSeabrooke, Lee (Author) / Hurlbut, James B (Thesis advisor) / Miller, Clark (Thesis advisor) / Robert, Jason (Committee member) / Arizona State University (Publisher)
Created2021