Much of the day-to-day of bioethics involves specific decisions about the ethics of human subject research. This week brings three items—ranging from a standard “bread and butter” issue that is particularly topical, on the one hand, to the incredibly bureaucratic and arcane on the other.
The “bread and butter” issue is, under what circumstances is it ethical to use a placebo in clinical research? The issue is timely with regard to some clinical trials about to start to test experimtal drugs to treat Ebola. With the outbreak seemingly waning everywhere but Sierra Leone, there is particular urgency to prioritize and test some experimental new drugs in the people who do have the disease. The problem: should the people with the disease be randomly assigned to new experimental drug plus current standard of care (SOC), or to SOC plus a placebo? Or should they all just get experimental drug plus SOC (no placebo arm)? Ordinarily, a concurrent control is essential, because it makes it easier to tell whether the new drug is safe and effective, and because different people respond to drugs differently. And this kind of design is normally ethical because everyone gets the best current standard of medical care. But what if 70% of people still die with SOC, as is the case with Ebola in West Africa? Just how badly do we need the scientifically “purest” study? Can we still learn what we want without the concurrent control? Such is the debate demanding an immediate decision by physicians and scientists running the trials.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.