Ethox and WEH Seminar - The ethics and epistemology of nocebo effects in trials, and what to do about it
A recent systematic review found that almost half of participants who take placebos in clinical trials experience drug related adverse events (AEs), with 5% of participants dropping out due to ‘drug related’ intolerance. However the placebo per se cannot be the cause of these adverse events. Instead, there are two overlapping likely explanations:

1. Misattribution
A patient may have an underlying condition whose natural history produces some event (such as a headache), then the patient misattributes the event to the placebo.

2.Nocebo effects
Having been warned about side effects in the patient information sheets, the patient may expect an adverse event. This negative expectation could then produce the event.

Nocebo effects may be caused—at least partly—by sharing information about AEs in the wrong way. This causes a tension between the ethical requirements of autonomy and non-maleficence. On the one hand, autonomy demands that patients be fully informed about treatment (adverse events). On the other hand, non-maleficence demands that patients be informed about AE’s in the right way. Ethical discussions of informed consent have focused almost exclusively on autonomy and may therefore been violating the requirement to do no harm. I will discuss ways in which autonomy and non-maleficence can be balanced in future clinical trials and ethical debates.
Date: 24 October 2018, 11:00 (Wednesday, 3rd week, Michaelmas 2018)
Venue: Big Data Institute (NDM), Old Road Campus OX3 7LF
Venue Details: Seminar Room 0
Speaker: Dr Jeremy Howick (Nuffield Dept. of Primary Care Health Sciences, University of Oxford.)
Organising department: Ethox Centre
Part of: Ethox Centre Seminars
Booking required?: Not required
Audience: Members of the University only
Editor: Hannah Freeman