Genetic Revolutions & Moral Crossroads: Navigating the Moral Landscape of CRISPR’s Debut FDA Approval for Sickle Cell Disease
Thursday, September 19, 2024
10:45 AM – 11:45 AM CT
Location: Midway 10 (First Floor)
Abstract: Casgevy, a cell-based gene therapy, represents a significant milestone as the first FDA-approved therapy for sickle cell disease (SCD) utilizing CRISPR. SCD, characterized by a point mutation in the beta globin chain, is an ideal target for CRISPR intervention due to the feasibility of correcting this mutation. Casgevy also decreases morbidity and mortality rates. However, as CRISPR-based treatments advance, they bring forth a myriad of ethical concerns. The moral landscape surrounding FDA approval for SCD explores the complex interplay between disorder and population selection. Sickle cell disproportionately affects individuals of African descent. Additionally, over 60% of SCD hospitalizations are covered by Medicaid, demonstrating further marginalization of individuals who suffer from SCD. While Casgevy offers hope for the few SCD patients who can access it, there is concern that the treatment is neither affordable nor accessible to the population it was designed for. Approving Casgevy underscores the urgency of addressing systemic barriers to care and ensuring equitable distribution of innovative therapies. I aim to argue that drug developers and health officials have a moral responsibility to understand and evaluate barriers between the intervention and the population it is designed for to increase innovation equity. Recent Medicaid negotiations by the Biden administration demonstrate a reactive approach in increasing accessibility, but this could be evaluated proactively for future CRISPR-related approvals. Through normative inquiry, I argue that the FDA ought to require consideration of population selection and disparities prior to drug approval to bring attention to disparities and make systemic efforts to decrease them.
Learning Objectives:
After participating in this conference, attendees should be able to:
Evaluate the complex interplay between disorder and population selection in terms of Casgevy approval.
Analyze the moral responsibility to proactively consider population-specific disparities when approving innovative treatment options.