Are open‐Label Placebos Ethical? Informed Consent and Ethical Equivocations

Abstract

The doctor-patient relationship is built on an implicit covenant of trust yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebearers physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified.. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect AND SUCH EFFECTS NECESSARILY INVOLVE A BINARY DISTIINCTION BETWEEN AUTONOMY AND BENEFICIENCE. In this paper we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus

“…Importantly, there are compelling ethical arguments for informing patients about placebo treatments in clinical contexts [27]. Related to these findings, the majority of the experts strongly agreed that deception is not necessary for placebo effects to occur (B2).…”

Placebos Without Deception: Outcomes, Mechanisms, and Ethics

“…A handful of studies have shown that long-term placebo effects can also be elicited under open-label conditions, in which patients are explicitly informed that they will receive a placebo (Blease, Colloca, & Kaptchuk, 2016; Charlesworth et al, 2017). This is counterintuitive since placebos supposedly work because people believe they do, but (presumably) knowing a treatment is a mere sugar pill makes it difficult to believe they will work.…”

Placebo disclosure does not result in negative changes in mood or attitudes towards health care or the provider

“…Furthermore, a recent study found educating patients about placebo could enhance its acceptability [58]. Subsequently, 'pure' placebo treatments may be a viable and ethically acceptable [59] option for patients with pain conditions.…”