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.
An undercurrent in all debates about allocation of health care resources to the poor is the matter of access to and coverage of health care for immigrants, particularly low-income and undocumented ones.
The legal definition of a patient and the corresponding duties of the physician have been debated in state courts for over a century, and many aspects of the question are still unresolved.
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.
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.