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.
The FDA’s approval for over-the-counter sales of emergency contraception marked a departure from its standard approval process and obstructed access to a safe and effective drug. That departure could set a dangerous precedent for future decisions.
Michael Farias, MD, MS, MBA and Rahul H. Rathod, MD
A distinguishing feature of a SCAMP is its ability to capture knowledge-based diversions from a recommended pathway and to “learn” from such individualized patient management.
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.
Addicts quickly learn the diagnoses that cannot be definitively confirmed or ruled out by examinations or test results but that elicit prescriptions for opioid pain management.