[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]
By Carl H. Coleman
With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments. Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska. Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.
As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls. Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections. In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.
From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos. Placebo-controlled trials are widely considered the “gold standard” of clinical research. Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”). Read More