Ethics of Placebo Use in Randomized Trials

Only decades ago, it was common for physicians to prescribe placebos so that patients could benefit from improved expectations. Today such practice is rare, and many would consider it unethical. Placebo use continues in randomized trials, however, where the biggest concern is also an ethical one. According to the 1964 Declaration of Helsinki of the World Medical Association,8 the interests of patients must come before the interests of science and society. Furthermore, every patient in a trial should be assured of getting the equivalent of the best available treatment, even those assigned to the comparison group. Therefore, it is unethical to use a placebo in any trial if there is already an accepted treatment for the condition under study. Instead, an investigator must test a new therapy against the existing standard, to see if it beats the current best treatment.

According to the principles embodied in the Declaration of Helsinki, no researcher should deny a patient the best available treatment solely for the purpose of learning whether a new treatment is better than placebo. Identifying new treatments that are better than placebo but worse than the current best treatment is of less interest than identifying new treatments that are better than the best existing treatment. As medicine progresses, there should be fewer and fewer conditions for which a placebo-controlled study is ethical, because standard therapies that are better than placebo will exist for more and more conditions. Unfortunately, the use of placebos in trials has achieved paradigm status in the minds of many researchers and even official agencies.9 The paradigm should certainly include a comparison, but not necessarily a placebo comparison.8,9

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