Developing technologies for personalized medicine may be misused to popularize the idea that one can infer a person’s genetic makeup from observer-defined or self-reported assignment to a race or ethnic group.
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.
Measuring outcomes alone is not the answer. There should be a way to reward the doctor for educating a patient about lifestyle modifications and then documenting that the care provided followed patient preferences.
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.
Nisha Quasba joins Ethics Talk to discuss her article, coauthored with Elliot Vice: “What Should Prescribers and Policy Makers Know About US Drug Importation?”