Bioethics @ TIU

Is an RCT of an Ebola drug ethical?

Posted September 4th, 2014 by Jon Holmlund

The title question here is of course over-simplified.  The development of an experimental drug to treat a devastating disease, during an outbreak of that disease, raises many ethical concerns.  Perhaps the most urgent of these is how to make the drug available to as many people with the disease as possible, because the risk of the disease itself makes the risks of the drug more acceptable in light of its potential benefits.  This is “direct” benefit to the patient/experimental subject, not just the “indirect” benefit to society of finding out whether the drug is really effective and safe.

The challenge is, in the urgency to offer the drug with therapeutic intent, it can be hard to tell whether any benefits are due to the drug or other medical care—or just differences in the effects of the disease from person to person.  Pivotal to answering that question is the randomized clinical trial (RCT), in which people with a condition to be studied are randomly designed to get the drug, or not.  Often, “not” means a placebo, especially when there is no standard drug already available to treat the disease.

And such is the case with Ebola.  But why would someone with the disease, and a chance to get an experimental drug that might mean the difference between life and death, agree to risk random assignment to a placebo?  And how could researchers justify a placebo control?  One could argue that every reasonable study candidate within the reach of the trial (and the supply of the drug) should get the drug; results could be compared to historical results taken as a control.  This is the course that I would favor.  But it is not without uncertainty, because the past results of standard care might be worse than what can currently be done.  This is common in medicine; doctors have been practicing medicine, and often getting better.  In the case of Ebola, I read that improvements in “supportive care” (e.g., transfusions and the like) are, where available, improving the survivability of the disease.  And in a properly-designed, placebo-controlled trial, patients on placebo don’t get just placebo, they also (like all patients in the study) get “best supportive care.”

Then there are the issues of actually writing down the data in enough detail to be able to infer, with some confidence, what the effect of the experimental drug is.  And in East Africa, during the current Ebola outbreak, neither the past records nor the current manpower nor, perhaps, state of the art supportive care are readily available.  Clinical drug research is a complex, labor- and resource-intensive undertaking.

There are of course other ethical issues raised by clinical trials of experimental drugs or vaccines against Ebola.  I just picked one for this post.  The World Health Organization apparently is convening a meeting today and tomorrow, September 4 and 5, to address the various challenges.  I for one will watch for the results of that discussion.  In the meantime, Nature offers a handy-dandy graphic of “drugs and vaccines to watch.”

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