“Run-in” and “washout” periods involving the withholding of medication are widely used in drug research trials in pursuit of both patient safety and scientific reliability. Such no-medication periods can be justified ethically provided that they are apparent to patients, who can thereby properly consent to undergoing them. Less widespread, but still common, is the practice of “single blinding” no-medication periods, concealing them from patients by means of placebo. Whilst all placebos involve a measure of concealment, their use is typically justified (...) in drug research trials by their preserving the uncertainty generated by the random allocation of different treatments within a drug trial; and by the researchers openly declaring both the randomisation process and the chances of receiving placebo. In the single blind placebo “run-in” or “washout”, neither of these conditions is met.This paper considers three possible defences of the practice of using single blind placebo “run-ins” or “washouts” and finds them all to fail; the practice appears ethically unjustified. (shrink)

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

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. (shrink)