ETHICAL USE OF PLACEBOS IN CLINICAL PRACTICE

To affirm that the use of placebos in clinical practice is ethically acceptable only when patients have been informed of and agree to such use as a component of treatment; further, 

To encourage hospitals and health systems to develop policies and procedures to guide clinicians in making informed decisions regarding the use of placebos; further,

To oppose the use of pharmacologically active substances or medications as placebos.

Rationale

As Tilburt et al. pointed out in 2008, “placebo treatment is an unclear and complicated concept that lacks a standard definition.” Placebos have been defined to include inert agents that have little or no pharmacological activity (e.g., saline injections, lactose pills) given to promote positive expectation, as well as physiologically active agents prescribed solely or primarily to promote positive psychological effects rather than the agent’s recognized physiological effect. (Tilburt JC, Emanuel EJ, Kaptchuk TJ et al. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ 2008;337:a1938. doi: https://doi.org/10.1136/bmj.a1938). 

The American Medical Association (AMA) Code of Medical Ethics Opinion 2.1.4 does not distinguish between inert and active placebos, defining a placebo as “a substance provided to a patient that the physician believes has no specific pharmacological effect on the condition being treated.” The AMA Opinion states that physicians may use placebos for diagnosis or treatment only if they (1) enlist the patient’s cooperation, (2) obtain the patient’s general consent to administer a placebo, and (3) avoid giving a placebo merely to mollify a difficult patient. ASHP concurs with the AMA opinion that the use of placebos in clinical practice is ethically acceptable only when patients have been informed of and agree to such use as a component of treatment. ASHP also concurs that only the patient’s general consent should be required. The informed consent process should be reserved for research and medical interventions, where a consent contract and oral explanation of the patient’s rights are required. Advocating informed consent for placebo use in clinical practice could lead to a mistaken assumption that clinical use requires the review and approval of an institutional review board, which is not the intent of this policy. 

ASHP does not concur with the AMA definition of a placebo, however, preferring that placebos be defined to include only inert substances. ASHP opposes the use of pharmacologically active substances or medications as placebos, because all medication use presents some risk. Due to the complex ethical issues presented by clinical use of placebos, hospitals and health systems should develop policies and procedures to guide clinicians in making informed decisions regarding their use.