The last two decades have witnessed intense debate over the ethical legitimacy of placebo controlled trials. Most of the arguments for and against the use of PCTs turn on one of the following issues: the compatibility of the obligations of clinicians and researchers with PCTs, the scientific merit of PCTs, and the influence of patients' and subjects' perceptions, ability to consent, expectations, and rights on the permissibility of PCTs. I introduce each of these categories and assess the principal arguments in (...) each group. I argue that, although some of the arguments against PCTs have limitations, they do inform the debate in significant ways by pointing to important constraints on PCTs. Those concerning patients' and subjects' perceptions, capacity to consent, expectations, and rights are particularly instructive. They do not, for the most part, sustain an absolute prohibition of PCTs, but they do suggest types of PCTs that are inappropriate and they indicate issues that must be addressed when PCTs are conducted. I argue that we should look to the reasonableness and permissibility of informed refusals of care to evaluate the extent to which a trial is a legitimate PCT ; to determine which potential subjects should be considered eligible to enroll in a PCT ; and to inform the language that should be used in describing the study as part of the informed consent process. (shrink)

Placebo treatments, like sugar pills and saline injections, are effective in treating pain and perhaps a host of other conditions. To use placebos most effectively, however, doctors must mislead patients into believing that they are receiving active medications. While placebo deception is surprisingly common, its legality has rarely been tested. In November 2006, the American Medical Association (AMA) adopted a new ethics provision categorically prohibiting doctors from using placebos deceptively. In so doing, the AMA shifted the legal landscape, making it (...) almost certain that courts will decide that placebo deception violates informed consent requirements. I argue that the AMA's new policy is overbroad, insensitive to patient preferences, and likely to have unforeseen consequences. While deception is often exploitative, placebo deception can genuinely benefit patients. Absent stronger evidence to justify a ban than we currently have, deceptive placebos should be treated as scarce medical resources--used sparingly but not categorically prohibited. (shrink)

While discussions of the ethics of the placebo have usually dealt with their use in a research context, the authors address here the question of the placebo in clinical practice. It is argued, firstly, that the placebo can be an effective treatment. Secondly, it is demonstrated that its use does not always entail deception. Finally guidelines are presented according to which the placebo may be used for clinical purposes. It is suggested that in select cases, use of the placebo may (...) even be morally imperative. The argument is illustrated by three case vignettes. (shrink)

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the (...) therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. (shrink)