The antidepressant debate and ethically defensible placebo-controlled trials.

A basic tenet of biological psychiatry is that place bo-controlled, randomized drug trials under double blind have shown that antidepressants exert pharmacological efficacy-in other words, that they induce specific and measurable drug effects on research subjects. But there is ongoing dissention about whether pharmacological efficacy has been established reliably by these trials. The antidepressant debate indicates a split in the expert clinical community about the size of the drug/placebo difference and whether the mechanisms that produce it stem from the subjects' expectation of benefit or from the intervention's pharmacological prop erties. A basic tenet of research ethics is that if standard effective treatments exist, then clinical equipoise requires their use as active controls against which novel, nonvali dated treatments are tested. Substituting a placebo for an effective treatment in the control arm of a trial does not maintain this duty, as it exposes research subjects to an intervention that is known to be inferior. Defenders of clinical equipoise argue that conducting a trial is not an invitation to practice substandard medicine.' They have also argued that legal liability concerns might be raised about placebo-controlled trials of antidepressants.2 These ethical and legal concerns can be assessed with reference to cases in which clinical equipoise permits placebo-controlled trials. Given the recurring questions about whether the drug/placebo difference results from specific biological effects of antidepressants or from fac tors introduced by placebo response that have not been adequately excluded, I think a plausible argument can be made that clinical equipoise would permit the use of active placebo controls in the clinical trials that test them. This argument can be abbreviated to three premises and a conclusion. The first premise is that placebo con trols for drug trials are ethically defensible and scientifi cally justified when we have evidence leading to a rea sonable concern that a standard treatment might only work because of expectancy enhanced by side effects i.e., by enhanced placebo effects. The second premise is that this evidence must be endorsed by at least a respectable minority of the expert clinical community. Premise three asserts that a respectable minority of the expert clinical community endorses evidence leading to a reasonable concern that standard antidepressants might only work by enhanced placebo effects. If these premises are sound, then one can conclude that placebo controls for antidepressant trials are ethically defensible and sci entifically justified.

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