Does consent make open label placebo research ethical?

By Laura Specker Sullivan

Open label placebo studies hypothesize that placebos can be effective even when there is complete transparency about what participants are given. These studies are being run for conditions such as chronic pain, cancer-related fatigue, and irritable bowel syndrome. Open label placebos have garnered significant interest in the popular imagination, perhaps due to the condemnation of deceptive placebos in clinical care, the ethical debate over the use of placebos in clinical research, and the interest in treatments that highlight the mind-body connection and provide relief without significant expense or side effects.

Open label placebo research has grown in part based on arguments that their use evades the main ethical concern about placebos, which is that they require deception. Open label placebos do not involve deception because patients or subjects are told outright that they are given a placebo, and most ethical discussions of open label placebos focus on this feature.

However, even though open label placebos seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use.

Recent developments of philosophical theories of justice by Iris Marion Young and Miranda Fricker emphasize the importance of pursuing justice by targeting structural injustices, of which epistemic injustices are a particular difficult form. Targeting structural injustices requires drawing attention to (and remediating) practices that privilege some social groups over others based on assumptions about the social value or capabilities of that group. These injustices are epistemic when they involve assumptions about social groups’ capacities as knowers, or as knowledge producers.

Testimonial injustices existed in past deceptive placebo use. Testimonial injustice occurs when individuals’ testimony about their experiences are assumed to be unreliable or imagined, and thus less credible or legitimate. Historically, members of certain social groups have been more liable to be subject to these assumptions by medical providers than others. This can be seen in past descriptions of placebo use, in which “some patients are so unintelligent, neurotic, or inadequate as to be incurable, and life is made easier for them by a placebo.” This entwines testimonial injustice with paternalism, such that the rejection of these patients’ capacities as knowers is used to justify deceptive actions in their best interests.

Even though open label placebos are not deceptive, it may be more difficult to escape these patterns of paternalism and testimonial injustice in placebos than imagined. Currently, women comprise the majority of participants in many studies of open label placebos, and open label placebos are being studied for conditions that predominantly affect women. In the context of an environment in which women’s symptoms are more likely than men’s to be assumed misreported or imagined, investigating open label placebos for conditions that primarily affect women and enrolling a majority of female participants in open label placebo studies risks a vicious cycle in which placebos are thought to be most appropriate and effective for women, a social group who historically have been subject to testimonial injustice in medicine more than men.

To avoid replicating these patterns of injustice that relate to placebo use, open label placebo studies should investigate conditions that affect men and women equally or men predominantly and there should be equal enrollment of male and female participants in open label placebo studies for conditions that affect genders equally. In other words, open label placebo studies need to both acknowledge the problematic history of placebo use and take steps to mitigate this history’s effects.


Paper title: More Than Consent for Ethical Open Label Placebo Research

Author: Laura Specker Sullivan

Affiliations: Fordham University

Competing interests: None

Social media accounts: @SpeckerLaura

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