Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021;23(9):E745-749. doi:
10.1001/amajethics.2021.745.
Dr Charles Binkley joins Ethics Talk to discuss his article, coauthored with Michael Politz and Dr Brian Green: "Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices?"
In the 1910s, the American Medical Association fought quackery promoted in pamphlets for drugs and treatments for everything from teething to epilepsy.
AMA J Ethics. 2018;20(11):E1082-1093. doi:
10.1001/amajethics.2018.1082.
Targeted dosing to treat pediatric inflammatory bowel disease is challenging because dosing guidelines are based on data gathered from adult subjects of clinical trials. Patients’ families and health care organizations also incur high costs and must try to balance potential benefits against risks of ongoing monitoring.
AMA J Ethics. 2018;20(9):E841-848. doi:
10.1001/amajethics.2018.841.
Dr Jamaji C. Nwanaji-Enwerem joins Ethics Talk to discuss his collection of images: Intentionally Retained, Intentionally Fragmented, Accidentally Retained, and Accidentally Fragmented.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.