Target Article What Makes Placebo-Controlled Trials Unethical? What Makes Placebo-Controlled Trials Unethical?

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. Randomized controlled trials (RCTs) became the leading method of testing treatment efªcacy in the 1940s. From the beginning, ethical concerns were voiced about clinical trials involving control groups not receiving proven effective or standard treatment. Debate over the use of placebo controls intensiªed following the publication in 1994 of