Identifying Molecular Features Associated with Overall Survival Outcomes in Acute Myeloid Leukemia patients over the age of 60; A Duty Ethics Analysis of the Approval and Withdrawal of the Vioxx Drug

Sahoo, Deepika, School of Engineering and Applied Science, University of Virginia
Garrett-Bakelman, Francine, UPG-MD-INMD Hem-Onc, University of Virginia
Laugelli, Benjamin, EN-Engineering and Society, University of Virginia

In my technical project, my teammate and I performed univariate feature selection on bulk RNA-seq, DNA methylation, and copy number aberration genomic data with the ultimate goal of creating a multivariate prognostic tool for Acute Myeloid Leukemia (AML) patients over the age of 60. The project aims to offer more inclusive care to elderly patients, who are left out of prognostic criteria currently used in medical practice. Consequently, this project necessitates a focus on principles of patient care that are universally applicable and a commitment to respecting the diverse needs of patient populations. To gain insight into how successful patient care can be administered in a healthcare context, my STS research paper examines the case of Merck & Co.’s delayed recall of the Vioxx drug through the lens of Kantian duty ethics.
For the technical report, my capstone team performed univariate feature selection on genomic data from aged Acute Myeloid Leukemia (aAML) patients, those over the age of 60 years, for integration into a multivariate model. We proposed the development of a web-based tool that integrates multiple genomic data types to predict survival outcomes in aAML patients. We utilized data sets from 227 clinically annotated aAML patients, including bulk RNA-seq, DNA methylation, and copy number aberration. The significance of this tool lies in its potential to provide clinicians with a more accurate survival prognosis for aAML patients, assisting in treatment decisions. By incorporating multiple genomic data types, the tool aims to improve survival classification precision and enhance risk assessment for aAML patients. Overall, this web-based tool represents a novel approach to risk assessment in aAML patients, with the potential to improve clinical decision-making and patient outcomes.
My STS research paper examines the case of the delayed recall of the Vioxx drug, evaluating the actions of Merck, the pharmaceutical company responsible for its production, through the lens of Kantian duty ethics. Duty ethics, developed by Immanuel Kant, emphasizes the importance of moral responsibilities and principles in guiding ethical behavior (vande Poel & Royakkers, 2011). The paper analyzes Merck's decisions regarding Vioxx through the two categorical imperative versions: the universalizability of maxims and respect for persons. Under the universalizability of maxims, Merck's actions are evaluated based on whether they could be consistently followed by all pharmaceutical companies facing similar pressures/conditions without contradiction. In terms of respect for persons, Merck's actions are assessed based on whether they respected the autonomy and well-being of patients and healthcare providers. The paper identifies instances where Merck failed to fulfill its duty to accurately present data related to Vioxx's cardiovascular risk profile, remedy conflicts of interest, and attend to patient safety. The paper argues that Merck's actions throughout the Vioxx case were morally wrong due to the company's inability to fulfill both versions of the categorical imperative. The goal of my research is to discuss the responsibilities actors in the healthcare industry have in caring for patients.
Working on these two projects simultaneously has significantly enriched both endeavors. My technical work developed my understanding of genomics data analysis and prognostic tool design. This knowledge provided essential clinical context for my research paper. Similarly, my STS paper research underscored the significance of patient respect and ethical practice in shaping biomedical engineering design. This enhanced my motivation to create a clinical classification tool that would facilitate more inclusive care. Working on both my STS research paper and my technical project together this past year has allowed me to deeply explore administration of considerate patient care and each work improved the quality of the other.

BS (Bachelor of Science)
Acute Myeloid Leukemia, Clinical risk, Survival analysis

School of Engineering and Applied Science

Bachelor of Science in Biomedical Engineering

Technical Advisor: Francine Garrett-Bakelman

STS Advisor: Benjamin Laugelli

Technical Team Members: Mitchell Thomas

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