Physicians are cautioned that the two obstacles to reforming post-marketing clinical trials are the FDA's reluctance to revisit past approvals and its inability to enforce pharmaceutical companies' commitment to conduct Phase IV trials.
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.
Viewing dementia as a distinct disease promotes funding for research but may stigmatize those who have dementia and lead to disinvestment in caregiving.
AMA J Ethics. 2017;19(7):713-719. doi:
10.1001/journalofethics.2017.19.7.mhst1-1707.
Michael J. O’Brien, MD and William P. Meehan III, MD
It is unclear whether the decreased risk of injury associated with prohibiting a teenage boy from playing football outweighs the benefits to his health and well-being of allowing him to participate.
Clinical equipoise—the idea that the community of medical experts is uncertain about the relative therapeutic merits of the arms of a clinical trial at its outset—mitigates physicians’ responsibility for patients’ poor outcomes when patients are assigned to the control arm or are harmed by an investigational agent.
AMA J Ethics. 2015;17(12):1108-1115. doi:
10.1001/journalofethics.2015.17.12.ecas1-1512.
Distinctions between treatment and enhancement, and between supposedly authentic and inauthentic tools, often inform judgments about what is morally acceptable in sport.
When deciding whether to offer deep brain stimulation earlier than usual for Parkinson disease, it is important to consider not only the patient’s autonomy but also the validity of the evidence and concepts of harm that are being used to form practice policies.