臨床研究と生命倫理ジャーナル

概要

Review of the Ethical Literature on Surgical Placebos in Parkinson’s Disease Treatment

Dante J. Clementi

In clinical trials of neurosurgical interventions for the treatment of Parkinson’s disease, the ethicality of using placebo surgeries as a control in trial design is disputed. A primary issue in this dispute is the risk-benefit profile associated with such surgeries, whether the benefits of the surgery justify exposing trial participants to the potential risks. Proponents argue that the risks to trial participants are sufficiently minimized such that the surgery is ethical justifiable, while critics argue both that those risks are not minimized when compared to a no-surgery trial design and when the “basic interests” of trial participants are potentially endangered by the procedure. After considering the respective merits of the arguments advanced by both proponents and critics, this analysis finds the position of those against the ethical permissibility of sham surgery in clinical trials for PD treatment more tenable. In defense of the critics’ position, this analysis develops and defends two reasons adduced by critics: first, that the risks to trial participants are not in fact minimized when compared to a no-surgery trial design and second, that the magnitude of the risks associated with the sham procedure directly endangers the “basic interests” of trial participants. Given these two reasons adduced by critics, this analysis further develops this line of argument and concludes that sham surgery in this context violates the principle of beneficence.