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Experts warn that hasty treatment designs could harm Ebola patients
In a commentary published in Annals of Internal Medicine, experts warned that the hasty distribution of experimental Ebola treatments could do more harm than good.
The perspective, written by Andrew Hantel, MD, and Christopher Olusola Olopade, MD, MPH, both of the University of Chicago Medicine, joins the debate on how best to fight the Ebola outbreak that has spread across West Africa and now reached the US.
Andrew Hantel
Hantel and Olopade countered arguments for swifter trial designs, and suggested that the inability to properly distribute a limited, unstudied treatment could lead to poorer outcomes for those given experimental drugs, missed opportunities for those who are treatable, and the beginnings of antibiotic resistance.
“Triage in scarce, established treatments is often possible when the natural history of the disease, medication effects and status of the patient are taken into account,” they wrote. “Yet, with experimental treatments, few of these factors can be determined vis-à-vis the effect of the drug —one loses the ability to discern the patients likely to benefit.”
Citing the guidelines laid forth when a WHO advisory panel declared the use of experimental Ebola treatments ethical in August, Hantel and Olopade argued that the requirement of informed consent loses its meaning in an epidemic scenario.
“Participants consent to early-stage trials — which are done primarily for toxicity and dosing assessment rather than treatment — under the pretext that the trial is a rigorous, stepwise process to benefit future persons,” they wrote. “When this paradigm is applied to the epidemic context, problems arise.
“The belief that informed consent is understood by patients naïve to advanced health care, especially in an epidemic, is cavalier. It belies participants’ perceived risk and physicians’ duty to abide by primum non nocere,” they wrote.
Christopher Olusola Olopade
The “celebrity status” of these investigational drugs distracts from the standard critical care that is still needed in urban centers at the heart of the outbreak, Hantel and Olopade wrote. Along with meeting hygiene necessities that would greatly reduce new cases, supportive care to combat the cardiovascular collapse and multi-organ failure that come with Ebola should be the medical community’s priority.
“Novel treatments can add little to the underfunded areas that are bereft of standard critical care,” they wrote. “Combined with public health efforts to stem disease transmission and provide public education, implementing routine hemodynamic support must be the focus of all involved organizations … an influx of health care personnel adequately supplied with intravenous fluids, catheters, safety needles and personal protective equipment is the intercession most likely to curb the epidemic.”
Disclosure: The authors report no relevant financial disclosures.