This article presents and defends an integrated view of the placebo effect, termed “affective-meaning-making” model, which draws from theoretical reflection, clinical outcomes, and neurophysiological findings. We consider the theoretical limitations of those proposals associated with the “meaning view” on the placebo effect which leave the general aspects of meaning unspecified, fail to analyze fully the role of emotions and affect, and establish no clear connection between the theoretical, physiological, and psychological aspects of the effect. We point out that a promising (...) way to overcome these limitations is given by grounding the placebo effect on Peirce’s theory of meaning, in which the role of the meaning constitution and change is placed in logical and objective structures. We also show the connection between our theoretical proposal and the appraisal theory and integrate it with emotion regulation. (shrink)

The beliefs involved in the placebo effect are often assumed to be self-fulfilling, that is, the truth of these beliefs would merely require the patient to hold them. Such a view is commonly shared in epistemology. Many epistemologists focused, in fact, on the self-fulfilling nature of these beliefs, which have been investigated because they raise some important counterexamples to Nozick’s “tracking theory of knowledge.” We challenge the self-fulfilling nature of placebo-based beliefs in multi-agent contexts, analyzing their deep epistemological nature and (...) the role of higher-order beliefs involved in the placebo effect. (shrink)

Next SectionThere has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting (...) the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. (shrink)

Despite their centrality to medicine, drugs are not easily defined. We introduce two desiderata for a basic definition of medical drugs. It should: (a) capture everything considered to be a drug in medical contexts and (b) rule out anything that is not considered to be a drug. After canvassing a range of options, we find that no single definition of drugs can satisfy both desiderata. We conclude with three responses to our exploration of the drug concept: maintain a monistic concept, (...) or choose one of two pluralistic outcomes. Notably, the distinction between drugs and other substances is placed under pressure by the most plausible of the options available. (shrink)

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed (...) consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)

Nursing knowledge stems from a dynamic interplay between population‐based scientific knowledge (the general) and specific clinical cases (the particular). We compared the ‘cascade model of knowledge translation’, also known as ‘classical biomedical model’ in clinical practice (in which knowledge gained at population level may be applied directly to a specific clinical context), with an emergentist model of knowledge translation. The structure and dynamics of nursing knowledge are outlined, adopting the distinction between epistemic and non‐epistemic values. Then, a (moderately) emergentist approach (...) to nursing knowledge is proposed, based on the assumption of a two‐way flow from the general to the particular and vice versa. The case of the ‘placebo effect’ is analysed as an example of emergentist knowledge. The placebo effect is usually considered difficult to be explained within the classical biomedical model, and we underscore its importance in shaping nursing knowledge. In fact, nurses are primarily responsible for administering placebo in the clinical setting and have an essential role in promoting the placebo effect and reducing the nocebo effect. The beliefs responsible for the placebo effect are as follows: (1) interactive, because they depend on the relationship between patients and health care professionals; (2) situated, because they occur in a given clinical context related to certain rituals; and (3) grounded on higher order beliefs concerning what an individual thinks about the beliefs of others. It is essential to know the clinical context and to understand other people's beliefs to make sense of the placebo effect. The placebo effect only works when the (higher order) beliefs of doctors, nurses and patients interact in a given setting. Finally, we argue for a close relationship between placebo effect and nursing knowledge. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment (...) and informed consent. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 30-31, March 2012.

The American Journal of Bioethics, Volume 12, Issue 3, Page 31-33, March 2012.

This paper introduces the 2011 number of the Journal on Clinical Ethics. Philosophical critical appraisal is essential for the success of philosophical analysis and argument in clinical ethics. To clear away conceptual underbrush, papers in this Clinical Ethics number of the Journal address genetic engineering, conscience-based objections to forms of health care, placebos, and preventing exploitation of patients to be recruited to become research subjects.

Recent discourses about the legitimacy of homeopathy have focused on its scientific plausibility, mechanism of action, and evidence base. These, frequently, conclude not only that homeopathy is scientifically baseless, but that it is “unethical.” They have also diminished patients’ perspectives, values, and preferences. We contend that these critics confuse epistemic questions with questions of ethics, misconstrue the moral status of homeopaths, and have an impoverished idea of ethics—one that fails to account either for the moral worth of care and of (...) relationships or for the perspectives, values, and preferences of patients. Utilitarian critics, in particular, endeavour to present an objective evaluation—a type of moral calculus—quantifying the utilities and disutilities of homeopathy as a justification for the exclusion of homeopathy from research and health care. But these critiques are built upon a narrow formulation of evidence and care and a diminished episteme that excludes the values and preferences of researchers, homeopaths, and patients engaged in the practice of homeopathy. We suggest that homeopathy is ethical as it fulfils the needs and expectations of many patients; may be practiced safely and prudentially; values care and the virtues of the therapeutic relationship; and provides important benefits for patients. (shrink)

EBM, and the hierarchy of evidence it prescribes, is a controversial model when it comes to research into the effectiveness of psychotherapeutic treatments. This is due in part to the so-called ‘Dodo Bird verdict’, which claims that all psychotherapies are equally effective, and that their effectiveness is largely due to the placebo effect. In response to this controversy, I argue that EBM can nevertheless be made to fit research into the effectiveness of psychotherapy, once a piecemeal approach to conducting RCTs (...) is taken. Such an approach involves studying the contributions made by individual treatment components. (shrink)

Philosophical Investigations, Volume 45, Issue 4, Page 414-429, October 2022.