A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Editorial fellow Dr Ariel Wampler describes what few know about material and device regulation, and Dr Adriane Fugh-Berman explains why we should ask more questions about device representatives’ intraoperative roles during implantations.
Jeffrey Bedard joins Ethics Talk to discuss his article: "What Should Patients Be Told About Device Representatives’ Roles at the Point of Surgical Care?"
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.
Pharma has long marketed opioids in ways that contribute to opioid use disorder and deaths by overdose. Regulatory mistakes in approving and labeling new analgesics by the FDA didn’t make us safer.
AMA J Ethics. 2020;22(8):E743-750. doi:
10.1001/amajethics.2020.743.
Joel T. Wu, JD, MPH, MA and Jennifer B. McCormick, PhD, MPP
False health-related speech can cause harm, but it’s not restricted unless it’s obscene. Physicians are obliged not only to correct patients’ false beliefs, but to engage digital spaces in which false claims thrive.
AMA J Ethics. 2018;20(11):E1052-1058. doi:
10.1001/amajethics.2018.1052.