Experimental Tx Shouldn't Replace Critical Care for Ebola
Docs say unregistered meds, vaccines add little in underfunded areas that lack standard critical care
TUESDAY, Oct. 14, 2014 (HealthDay News) -- Use of medications and vaccinations that have yet to be formally approved should not be a replacement for standard critical care, according to an ideas and opinions piece published in the Oct. 14 issue of the Annals of Internal Medicine.
Andrew Hantel, M.D., and Christopher Olusola Olopade, M.D., M.P.H., from the University of Chicago, discuss the recent statement of the World Health Organization relating to the use of experimental medications and vaccines that have not been formally approved or tested in humans to treat people with Ebola virus.
The authors note that this position corresponds with the expanded access regulations of the U.S Food and Drug Administration, known as "compassionate use," which allow access to unapproved medications in conditions without alternative treatments. The panel mandates three ethical norms that raise difficulties with expanded access: fairness in scarcity, informed consent, and physician nonmaleficence. In addition, misguided attention and funding garnered by unregistered medications and vaccines add to the difficulties in the application of expanded access. Novel treatments add little to underfunded areas, which lack standard critical care. In countries with overwhelming infection rates and low physician-patient rates, the focus should be on providing experienced personnel and supplies.
"Moving forward, the medical community must focus on implementing the current standard of care fairly and with maximum benefit while maintaining principled experimentation to provide a better future standard," the authors write.