Matching Items (19)
Description
Telehealth is the use of information and communications technology by healthcare professionals to provide care to patients. When this technology is being used specifically for genetic services, it is called telegenetics. Previous studies that examine the small-scale use of telegenetics for the field of genetic counseling have shown that the technology may provide a way to address the problem of patient access to genetic counseling services, assuming its efficacy. Patients are satisfied with telegenetics, but genetic counselors hold more reservations. Because of this and the many regulatory barriers in its way, telegenetics was only slowly being adopted when the coronavirus was declared a pandemic in March 2020. The pandemic forced a switch to telegenetics at a scale never seen before. This study begins with a literature review to assess the situation of telegenetics before and during the pandemic. It then surveys practicing genetic counselors in Arizona in order to reveal what they think about telegenetics when it is the encouraged, and sometimes only, modality. Since the literature review revealed that genetic counselors, not patients, are the ones with concerns, it is important to hear their points of view. This study reveals that genetic counselors want telegenetics as an option but not as a replacement for in-person appointments. All respondents agreed that increased patient access is the main benefit of telegenetics. There are reported challenges that must be overcome, but genetic counselors in Arizona overwhelming believe that telegenetics use will be continued in the future.
ContributorsThornton, Gillian Frances (Author) / Hunt Brendish, Katherine (Thesis director) / Frow, Emma (Committee member) / School of International Letters and Cultures (Contributor) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2021-05
Description
This thesis explores and analyzes the emergence of for-profit stem cell clinics in the United States, specifically in the Phoenix metropolitan area. Stem cell therapy is an emerging field that has great potential in preventing or treating a number of diseases. Certain companies are currently researching the application of stem cells as therapeutics. At present the FDA has only approved one stem cell-based product; however, there are a number of companies currently offering stem cell therapies. In the past five years, most news articles discussing these companies offering stem cell treatments talk of clinics in other countries. Recently, there seems to be a number of stem cell clinics appearing in the United States. Using a web search engine, fourteen stem cell clinics were identified and analyzed in the Phoenix metropolitan area. Each clinic was analyzed by their four key characteristics: business operations, stem cell types, stem cell isolation methods, and their position with the FDA. Based off my analysis, most of the identified clinics are located in Scottsdale or Phoenix. Some of these clinics even share the same location as another medical practice. Each of the fourteen clinics treat more than one type of health condition. The stem clinics make use of four stem cell types and three different isolation methods to obtain the stem cells. The doctors running these clinics almost always treat health conditions outside of their expertise. Some of these clinics even claim they are not subject to FDA regulation.
ContributorsAmrelia, Divya Vikas (Author) / Brafman, David (Thesis director) / Frow, Emma (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2016-05
Description
Within the last decade, there has been a lot of hype surrounding the potential medical applications of artificial intelligence (AI) and machine learning (ML) technologies. During the same timespan, big tech companies such as Microsoft, Apple, Amazon, and Google have entered the healthcare market as developers of health-based AI and ML technologies. This project aims to create a comprehensive map of the existing health-AI market landscape for the standard biotech reader and to provide a critical commentary on the existing market structure.
ContributorsWehelie, Sumayah A (Author) / Frow, Emma (Thesis director) / Maynard, Andrew (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2021-05
Description
Homeopathy is a brand of alternative medicine that has enjoyed a unique form of regulation for many years. This work aims to understand the regulation of homeopathic drugs in the United States by performing a literature review focused on three fronts: (i) homeopathy (theory, history in the United States and criticisms), (ii) U.S Food and Drug Administration (history and relationship to homeopathy), and (iii) interpretation of the law through reading guidance documents and the Code of Federal Regulations.
In 2015, the FDA began a process to reevaluate and update the regulations surrounding homeopathic products to better fit their present risk-based model. Past regulations were set in 1938; and as the world evolved, these have been found to set inadequate standards. By reviewing the agency’s guidance drafts and core regulatory documents, we come to understand that these changes are motivated by a desire for homeopathic remedies to follow high standards that apply to other products for the benefit of the U.S. consumers. FDA has made significant advances by proposing new Guidances on homeopathic products, listening to homeopathic community and consumers, and withdrawing the Compliance Policy Guide 400.400 issued in 1988.
We recommend for homeopathic manufacturers and practitioners to see the FDA as an ally and cooperate fully with the proposed changes for the regulation the agency gives out. Doing so will give the homeopathic community the best chance at continuing to sell their products and reach their consumers in the United States. In the same token, the FDA should do their best to involve homeopathic professionals in some way in this regulatory process, to encourage participation and compliance by the broader homeopathic community. Doing so ensures a climate of teamwork among different facets of the medical community in the United States.
In 2015, the FDA began a process to reevaluate and update the regulations surrounding homeopathic products to better fit their present risk-based model. Past regulations were set in 1938; and as the world evolved, these have been found to set inadequate standards. By reviewing the agency’s guidance drafts and core regulatory documents, we come to understand that these changes are motivated by a desire for homeopathic remedies to follow high standards that apply to other products for the benefit of the U.S. consumers. FDA has made significant advances by proposing new Guidances on homeopathic products, listening to homeopathic community and consumers, and withdrawing the Compliance Policy Guide 400.400 issued in 1988.
We recommend for homeopathic manufacturers and practitioners to see the FDA as an ally and cooperate fully with the proposed changes for the regulation the agency gives out. Doing so will give the homeopathic community the best chance at continuing to sell their products and reach their consumers in the United States. In the same token, the FDA should do their best to involve homeopathic professionals in some way in this regulatory process, to encourage participation and compliance by the broader homeopathic community. Doing so ensures a climate of teamwork among different facets of the medical community in the United States.
ContributorsRobayo, Juan Pablo (Author) / Pizziconi, Vincent (Thesis director) / Feigal, David (Committee member) / Frow, Emma (Committee member) / School of International Letters and Cultures (Contributor) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
Genetic engineering, a development in science and technology that has enabled the genetic modification of crops among other organisms since the 1970s, has stirred heated debate among various stakeholders in the issue. This struggle is one consisting of two sides set in their own beliefs, refusing to even consider the validity of any opposition. As a result, it is difficult to establish common ground and attempt to develop policies and practices that can best suit all members involved while still being able to utilize a breakthrough technology in beneficial ways to society. This research project was conducted upon one particular case in the timeline of genetic modification of crops: the introduction of the Rainbow papaya in Hawaii in 1998 and its subsequent ramifications. The goal was to establish a more detailed understanding of the landscape of a debate that can appear to be based mainly upon the science of genetic engineering. Upon analysis of 22 news articles spanning the years 1999-2019 it was determined that the types of arguments themselves, both in favor of and against GM, fall into a wide range of categories that span much more than simply the science. Arguments both in favor and in opposition are nuanced and actually often seek similar end goals. There is potential to utilize these common goals and priorities in productive ways once stakeholders in the debate are aware of them. Finding commonalities will enable progress in the safe, effective implementation of a technology that has the potential to provide immense benefit in various ways in a manner that considers all perspectives involved.
ContributorsCartwright, Avery (Author) / Frow, Emma (Thesis director) / Bowman, Diana (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
In this paper, I aim to assess the ethical and policy issues at the forefront of developmental biology, mainly, the 14-day guideline dictating human embryo research. Ever since the invention of in vitro fertilization in the 1970s, the research landscape of human embryo research has been well explored. Now, there are new embryonic technologies and human embryonic stem cell based models that many believe do not fit into current guidelines. This paper analyzes four of these new technologies-- stem cell derived gametes, embryoids, 3D printed embryos and synthetic embryos-- in order to explore the impetus for reopening the debate on the 14-day guideline. The paper then explores current research and research projects while comparing and contrasting science as well as the potential for moral status and how that impacts regulation. Current United States policies and regulations as well as current professional society guidelines are broken down to fully grasp the political landscape surrounding human embryo research. Notably, current policies include the complete lack of a federal definition of an embryo as well as the Dickey-Wicker Amendment which restrict funding for human embryo research. It is thus advised that these, along with the 14 day guideline, are updated in order to encapsulate the early human developmental research landscape and promote research. This paper ends with an in depth policy recommendation including (but not limited to) bill language, suggested definitions and potential strategies.
ContributorsNadone, Haley (Author) / Robert, Jason (Thesis director) / Frow, Emma (Committee member) / School of Life Sciences (Contributor) / School of Politics and Global Studies (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
The direct-to-consumer (DTC) stem cell industry is a novel industry in the United States offering experimental stem cell treatments to patients with little regulatory oversight. The rapid expansion of this industry over the last decade has drawn attention from a number of stakeholders, and there is heated debate about how the industry should be regulated in order to maintain patient safety and treatment efficacy while also promoting innovation. Since 2009, the U.S. Food and Drug Administration (FDA) has been the main regulatory agency within the DTC stem cell industry, but it has been criticized for not taking stricter action. To develop a better understanding of the regulatory landscape in the DTC stem cell industry, this study provides a thorough analysis of five effective regulatory pathways: Food & Drug Administration (FDA), Federal Trade Commission (FTC), litigation, state legislation, and state medical boards. The operation of these pathways as regulatory agencies separately and together provide a clearer picture of future regulation in the DTC stem cell industry.
ContributorsWilliams, Paige (Author) / Frow, Emma (Thesis director) / Bowman, Diana (Committee member) / School of International Letters and Cultures (Contributor) / School of Human Evolution & Social Change (Contributor) / Barrett, The Honors College (Contributor)
Created2019-05
Description
the project led by Professor Emma Frow, researching of stem cell clinics focused on stem cell applications, adherence to FDA guidelines, and characterization of information available and physician credentials. Regenerative medicine clinics commonly offered stem cell therapy, but introduced platelet rich plasma (PRP) and prolotherapy as regenerative therapies.
PRP and Prolotherapy are individual treatments that were even suggested and used in combination with stem cell therapies. Prolotherapy predates PRP as a chemical irritant therapy originally used to sclerose tissues. Prolotherapy is meant to stimulate platelet derived growth factors release to improve tissue healing response. Prolotherapy shows negligible efficacy improvements over corticosteroids, but may have underlying side effects from being an irritant. PRP is a more modern therapy for improved healing. Speculations state initial use was in an open heart surgery to improve healing post-surgery. PRP is created via centrifugation of patient blood to isolate growth factors by removing serum and other biological components to increase platelet concentration. PRP is comparable to corticosteroid injections in efficacy, but as an autologous application, there are no side effects making it more advantageous. Growth factors induce healing response and reduce inflammation. Growth factors stimulate cell growth, proliferation, differentiation, and stimulate cellular response mechanism such as angiogenesis and mitogenesis. The growth factor stimulation of PRP and prolotherapy both assist stem cell proliferation. Additional research is needed to determine differential capacity to ensure multipotent stem cells regenerate the correct cell type from the increased differential capacity offered by growth factor recruitment. The application of combination therapy for stem cells is unsubstantiated and applications violate FDA ‘minimal manipulation’ guidelines.
PRP and Prolotherapy are individual treatments that were even suggested and used in combination with stem cell therapies. Prolotherapy predates PRP as a chemical irritant therapy originally used to sclerose tissues. Prolotherapy is meant to stimulate platelet derived growth factors release to improve tissue healing response. Prolotherapy shows negligible efficacy improvements over corticosteroids, but may have underlying side effects from being an irritant. PRP is a more modern therapy for improved healing. Speculations state initial use was in an open heart surgery to improve healing post-surgery. PRP is created via centrifugation of patient blood to isolate growth factors by removing serum and other biological components to increase platelet concentration. PRP is comparable to corticosteroid injections in efficacy, but as an autologous application, there are no side effects making it more advantageous. Growth factors induce healing response and reduce inflammation. Growth factors stimulate cell growth, proliferation, differentiation, and stimulate cellular response mechanism such as angiogenesis and mitogenesis. The growth factor stimulation of PRP and prolotherapy both assist stem cell proliferation. Additional research is needed to determine differential capacity to ensure multipotent stem cells regenerate the correct cell type from the increased differential capacity offered by growth factor recruitment. The application of combination therapy for stem cells is unsubstantiated and applications violate FDA ‘minimal manipulation’ guidelines.
ContributorsKrum, Logan (Author) / Frow, Emma (Thesis director) / Brafman, David (Committee member) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2017-05
Description
Malaria is a disease that has plagued human populations throughout history. Malaria is cause by the parasite Plasmodium, which uses mosquitoes as a vector for transfer. Current methods for controlling malaria include issuing bed nets to citizens, spraying home with insecticides, and reactive medical care. However, using Clustered Regularly Interspaced Short Palindromic repeats (CRISPR) in conjunction with the Cas9 protein found in bacteria, the genomes of mosquitoes can be edited to remove the ability of mosquitoes to host Plasmodium or to create sex bias in which the birth rate of males is increased so as to make reproduction near impossible. Using CRISPR, this genome edit can be ‘driven’ through a population by increasing the likelihood of that gene being passed onto subsequent generations until the entire population possesses that gene; a gene drive can theoretically be used to eliminate malaria around the world. This paper identifies uncertainties concerning scientific, environmental, governance, economic ,and social aspects of researching and implementing gene drives and makes recommendations concerning these areas for the emerging technology of gene drives concerning the eradication of malaria using Sub-Saharan Africa as a case study
ContributorsSacco, Elena Maria (Author) / Frow, Emma (Thesis director) / Maynard, Andrew (Committee member) / School of Politics and Global Studies (Contributor) / School of International Letters and Cultures (Contributor) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2017-05
Description
This dissertation investigates the relationship between the universal aspirationsof technology and the particularity of place, by way of close participant observation with biotechnology companies in the San Francisco Bay Area. Its central claim is that the aspiration to placelessness in the development of science and technology operates as material configurations, modes of subjectivation, and historical conditions particular to places. Following Foucault’s late work in ethics, I conduct a series of sustained investigations into the reflective modes of critique biotechnologists make in thinking of and being in the San Francisco Bay Area. I show the ways the aspiration to placelessness exists in place at four different vantage points: the organization, the city, the broader cultural history of the region, and the practices of self-cultivation undertaken by technologists. Within biotechnology organizations, biological work is digitized and automated only through an intensification of bespoke material infrastructures, physical labor, and tacit institutional knowledge. Biotechnology organizations have come into existence through a history of settler colonial erasure, industrial devastation, post-war industrial decay, and urban renewal in Bay Area industrial suburbs and neighborhoods. A nostalgic imagination of the broader San Francisco Bay Area and its history of counterculture become mobilized as an antidote to the felt lifelessness of these forms of urban renewal and technological order and incorporated back into engineering practice. Finally, the technologist themselves must aspire to placelessness, in ways critiqued by local landless people’s movements who offer an alternative ethic to place in their imperative to gentrifiers to “move home with your parents.” I conclude by reflecting on the ways interlocutors at each of these vantage points are actively exploring the creation of more enduring relationships to place in the face of the unintended but intensified forms of social suffering in zones of technological innovation.
ContributorsHammang, Anne (Author) / Bennett, Gaymon (Thesis advisor) / Hurlbut, J. Benjamin (Committee member) / Frow, Emma (Committee member) / Arizona State University (Publisher)
Created2022