Imagine you are a patient that is seriously ill and the standard clinical treatment is not working for you. You may want to try experimental drug products, still being investigated and not yet approved by the US Food and Drug Administration (the FDA)…what are your options? There are currently a couple of pathways: First, you could enroll as a participant in a controlled clinical research drug trial. These drug trials are reviewed by institutional research boards or IRBs. A key focus of an IRB is to review how well participants are being fully informed of the risks and benefits of the drug trial.
But maybe you don’t meet all the criteria and don’t qualify for the drug trial. Then, there are two other pathways you might pursue – the Food and Drug Administration has an expanded access program and now, there exists Federal “Right to Try” legislation that was signed into law by President Trump in May of 2018. Both pathways are attempting to create more access and also navigate between ensuring patient safety and the ability of a patient with a life-threatening condition to have access to not yet approved approaches by the FDA. This change begs the question, “What level of patient safety is appropriate and what is unhelpful bureaucracy?” What are the risks and benefits of these different approaches to increasing patient access?
Ashley Snyder, our Summer intern at EthicsLab in 2019, will be interviewing our guests. Ashley completed her Masters in Public Health in Epidemiology at the Colorado School of Public Health, University of Colorado and in the Fall will be pursuing her PhD in Public Health at the University of Utah.
Our guests in this episode include:
- Carolyn Chapman, faculty affiliate of the Division of Medical Ethics in the Department of Population Health in the NYU School of Medicine
- Kelly McBride Folkers, Senior Research Associate at the Division of Medical Ethics in the NYU School of Medicine at NYU Langone Health, and a member of the Working Group on Compassionate Use and Pre-approval access
Additional resources relating to or referenced in this episode:
Are you a graduate or post graduate student interested in the EthicsLab Podcast intern program? If so, contact us here.