Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
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.
How can clinicians respond to the alarmingly high rates of maternal mortality in the U.S., and address racial disparities between black and white mothers? This month on Ethics Talk, we discuss how clinicians can improve maternal outcomes.
Developing drugs for profit is challenged in Parasites!, a patient education comic that highlights the need for unprofitable drugs for tropical diseases.
AMA J Ethics. 2018;20(2):167-175. doi:
10.1001/journalofethics.2018.20.2.msoc1-1802.
Medical education must acknowledge the problematic use of race as a biological or epidemiological risk factor in research and the controversy over race.
AMA J Ethics. 2017;19(6):518-527. doi:
10.1001/journalofethics.2017.19.6.peer1-1706.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.
AMA Journal of Ethics editor Audiey Kao, MD, PhD, interviewed Richard Pan, MD, MPH, about how, as a physician and legislator, he seeks to protect public health in light of recurrent outbreaks of vaccine-preventable infectious diseases.