Below please find a summary and link(s) of new coronavirus-related content published today in Annals of Internal Medicine. The summary below is not intended to substitute for the full article as a source of information. A collection of coronavirus-related content is free to the public at http://go.annals.org/coronavirus.
Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research
There currently is debate regarding whether U.S. institutions and clinicians may or should restrict patient access to COVID-19 drugs and vaccines that have been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration. Authors from the University of Pennsylvania and NYU Grossman School of Medicine discuss their views on the legal, ethical, and clinical ramifications of such restriction. They suggest that, although EUAs expand treatment options, they do not necessarily support a shift in the standard of care - only evidence can do that, and the evidence supporting EUAs varies considerably. Institutions and clinicians are not obligated to offer unproven interventions, but rather they must assess available evidence and treat patients accordingly. As a result, they may permissibly decide not to offer EUA products in clinical care and instead to limit access to EUA products exclusively to participants in clinical trials. Read the full text: https://www.acpjournals.org/doi/10.7326/M20-6703.
Media contacts: A PDF for this article is not yet available. Please click the link to read full text. The lead author, Holly Fernandez Lynch, JD, MBE, can be reached at lynchhf@pennmedicine.upenn.edu.
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Journal
Annals of Internal Medicine