Recent studies have explored the effectiveness of open-label placebos for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, (...) I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about (...) intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

Health care providers are expected both to relieve pain and to provide anticipatory guidance regarding how much a procedure is going to hurt. Fulfilling those expectations is complicated by the cognitive modulation of pain perception. Warning people to expect pain or setting expectations for pain relief not only influences their subjective experience, but it also alters how nociceptive stimuli are processed throughout the sensory and discriminative pathways in the brain. In light of this, I reconsider the characterization of placebo analgesia (...) as pharmacologically inert and the use of it as deceptive. I show that placebo analgesia exploits the same physical mechanisms as proven analgesics and argue that it should be utilized to relieve pain. Additionally, I describe factors to help identify situations in which clinicians have the obligation to disclose the potential for pain coupled with ways of mitigating the risk of high-intensity pain by setting positive expectations. (shrink)

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire medication-like (...) effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated. (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)

In a recent article in this Journal, Shlomo Cohen and Haim Shapiro introduce the concept of “comparable placebo treatments” —placebo treatments with biological effects similar to the drugs they replace—and argue that doctors are not being deceptive when they prescribe or administer CPTs without revealing that they are placebos. We critique two of Cohen and Shapiro’s primary arguments. First, Cohen and Shapiro argue that offering undisclosed placebos is not lying to the patient, but rather is making a self-fulfilling prophecy—telling a (...) “lie” that, ideally, will become true. We argue that offering undisclosed placebos is not a “lie” but is a straightforward case of deceptively misleading the patient. Second, Cohen and Shapiro argue that offering undisclosed CPTs is not equivocation. We argue that it typically is equivocation or deception of another sort. If justifiable, undisclosed placebo use will have to be justified as a practice that is deceptive in most instances. (shrink)

In this paper, I argue that deceptive placebo use can be morally permissible, on the grounds that the deception involved in the prescription of deceptive placebos can differ in kind to the sorts of deception that undermine personal autonomy. In order to argue this, I shall first delineate two accounts of why deception is inimical to autonomy. On these accounts, deception is understood to be inimical to the deceived agent’s autonomy because it either involves subjugating the deceived agent’s will to (...) another’s authority or because it precludes the agent from acting effectively in pursuit of their ends. I shall argue that providing an agent with false beliefs is not inimical to their autonomy if they are only able to effectively pursue their autonomously chosen ends by virtue of holding those particular false beliefs. Finally, I show that deceptive placebo use need only involve this latter sort of deception. (shrink)

The American Medical Association's Code of Ethics prohibits physicians from giving substances they believe are placebos to their patients unless the patient is informed of and agrees to use of the substance. Various questions surround the AMA policy, however. One of these has to do with what should be disclosed. The AMA holds that any treatment that the physician believes is a placebo should be identified as such to the patient. But consider a more restrictive policy that requires physicians to (...) defer to the medical community's consensus view about which treatments have a specific effect on the condition being treated. In light of the ethical goals that the AMA identifies—namely, concerns about patient trust, autonomy, and benefit—there are potential advantages to the more restrictive policy. (shrink)

Objectives -/- Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods -/- We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected (...) viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results -/- We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications -/- Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions. (shrink)

The problem is a simple one. A placebo is “a substance provided to a patient that the physician believes has no specific pharmacological effect upon the condition being treated” (AMA 2007). 1 But i...

While a significant body of bioethical literature considers how the placebo effect might introduce a conflict between autonomy and beneficence, the link between justice and the placebo effect has been neglected. Here, we bring together disparate evidence from the field of placebo studies and research on health inequalities related to race and ethnicity, and argue that, collectively, this evidence may provide the basis for an unacknowledged route by which health disparities are exacerbated. This route is constituted by an uneven distribution (...) of placebo effects, resulting from differences in expressions of physician warmth and empathy, as well as support and patient engagement, across racial and ethnic lines. In a discussion of the ethical implications of this connection, we argue that this contribution to health disparities is a source of injustice, consider ways in which these disparities might be ameliorated and suggest that this conclusion is likely to extend to other realms of inequality as well. (shrink)

Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics of placebo controls. Philosophical (...) analysis in each of these areas has the potential to enhance the discussion of EBM methodology and practice. (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)

This paper scrutinizes the tension between individuals’ rights and paternalism. I will argue that no normative account that includes rights of individuals can justify hard paternalism since the infringement of a right can only be justified with the right or interest of another person, which is never the case in hard paternalism. Justifications of hard paternalistic actions generally include a deviation from the very idea of having rights. The paper first introduces Tom Beauchamp as the most famous contemporary hard paternalist (...) by outlining his moral theory (principlism) and showing why it, as it stands, has to allow for hard paternalism. Secondly, the paper focuses on the notion of rights within principlism. I will employ traditional theories of rights to make sense of rights in principlism. Unfortunately, this attempt fails. In the third part, then, I claim that rights can only be limited with reference to the rights or interests of others. This structure is the very point of rights, it is their bite. I will argue for this claim and show its implications. The most important implication is that not only principlism, but every normative theory that includes rights of individuals, has to abolish hard paternalism. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider (...) the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining informed consent and communicating intervention risks with patients. There are no data in this work. (shrink)

This paper offers a critical analysis of several accounts of the placebo effect that have been put forward. While the placebo effect is most often thought of as a control in research and as a deceptive tool in practice, a growing body of research suggests that it ought to be thought of as a powerful phenomenon in its own right. Several accounts that aim to draw boundaries around the placebo effect are evaluated in relation to current evidence and it is (...) argued that none of them adequately capture the variability and potency of the phenomenon. Two accounts, however, that point towards the underlying mechanisms of the placebo effect, are shown to offer promise in terms of developing a more comprehensive account of the placebo effect. (shrink)

Is it ever right to prescribe placebos to patients in clinical practice? The General Medical Council is ambivalent about the issue; the American Medical Association asserts that placebos can be administered only if the patient is (somehow) ‘informed’. The potential problem with placebos is that they may involve deception: indeed, if this is the case, an ethical tension arises over the patient's autonomy and the physician's requirement to be open and honest, and the notion that medical care should be the (...) primary concern. This paper examines the case of depression as an entry point for understanding the complexities of the prescription of placebos. Recent important meta-analyses of antidepressants claim that they are not significantly more effective in a clinical setting than placebos. Given that antidepressants have numerous adverse side effects and are hugely expensive, this provocative research has serious potential ethical and practical implications for patients and medical providers. Should placebos be prescribed in place of antidepressants? The case of depression highlights another important issue which medical ethical codes have hitherto overlooked: well-being is not synonymous with being realistic about oneself, one's circumstances and the future. While severely depressed individuals are unduly pessimistic about themselves and the world around them, treatment of depressed individuals can be deemed successful when patients have successfully attained those positive illusions that are indicative of psychological health. This is exactly what successful psychological treatments of depression seem to achieve. It is therefore possible that there may be a limited unavoidable role for deception in medicine. (shrink)

Debates about the ethics and effects of placebos and whether ‘placebos’ in clinical trials of complex treatments such as acupuncture are adequate rage. Yet there is currently no widely accepted definition of the ‘placebo’. A definition of the placebo is likely to inform these controversies. Grünbaum’s characterization of placebos and placebo effects has been touted by some authors as the best attempt thus far, but has not won widespread acceptance largely because Grünbaum failed to specify what he means by a (...) therapeutic theory and because he does not stipulate a special role for expectation effects. Grünbaum claims that placebos are treatments whose ‘characteristic features’ do not have therapeutic effects on the target disorder. I show that with four modifications, Grünbaum’s definition provides a defensible account of placebos for the purpose of constructing placebo controls within clinical trials. The modifications I introduce are: adding a special role for expectations, insisting that placebo controls control for all and only the effects of the incidental treatment features, relativizing the definition of placebos to patients, and introducing harmful interventions and nocebos to the definitional scheme. I also provide guidance for classifying treatment features as characteristic or incidental. (shrink)

Advertisements for pharmaceuticals may promote placebo responses by generating an expectation of therapeutic success. Some cite this as reason to favour Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA). Against this, I show placebo responses to emanate from beliefs rendered unjustified by the influence of a conditioning process. I argue that drug safety and efficacy are material properties and that unjustified beliefs in these domains entail costs to autonomy that outweigh any prudential gains attending a placebo response. I conclude that (...) its placebogenic potential ought not to count as reason to favour DTCA. (shrink)

Placebos are arguably the most commonly prescribed drug, across cultures and throughout history. Nevertheless, today many would consider their use in the clinic unethical, since placebo treatment involves deception and the violation of patients’ autonomy. We examine the placebo's definition and its clinical efficacy from a biopsychosocial perspective, and argue that the intentional use of the placebo and placebo effect, in certain circumstances and under several conditions, may be morally acceptable. We highlight the role of a virtue-based ethical orientation and (...) its implications for the beneficent use of the placebo. In addition, the definitions of lying and deception are discussed, clarified and applied to the clinical placebo dilemma. Lastly, we suggest that concerns about patient autonomy, when invoked as a further argument against administering placebos, are extended beyond their reasonable and coherent application. (shrink)

It is widely agreed that deception of the enemy can be morally permissible in war. However, the question of the morally acceptable limits to deception in war has barely been explored in contemporary ethics. This paper defends the thesis that there are no moral limits on military deception per se, that is, no limits based on the ethics of truthfulness. Rather, all moral restriction against deception in war is based on another moral principle: military deception is morally unacceptable only when (...) it violates the principle of not harming those who do not intend to harm us. (shrink)

A growing body of cross-cultural survey research shows high percentages of clinicians report using placebos in clinical settings. One motivation for clinicians using placebos is to help patients by capitalising on the placebo effect’s reported health benefits. This is not surprising, given that placebo studies are burgeoning, with increasing calls by researchers to ethically harness placebo effects among patients. These calls propose placebos/placebo effects offer clinically significant benefits to patients. In this paper, we argue many findings in this highly cited (...) and ‘hot’ field have not been independently replicated. Evaluating the ethicality of placebo use in clinical practice involves first understanding whether placebos are efficacious clinically. Therefore, it is crucial to consider placebo research in the context of the replication crisis and what can be learnt to advance evidence-based knowledge of placebos/placebo effects and their clinical relevance (or lack thereof). In doing so, our goal in this paper is to motivate both increased awareness of replication issues and to help pave the way for advances in scientific research in the field of placebo studies to better inform ethical evidence-based practice. We argue that, only by developing a rigorous evidence base can we better understand how, if at all, placebos/placebo effects can be harnessed ethically in clinical settings. (shrink)

Increasing numbers of health organisations are offering some or all of their patients access to the visit notes housed in their electronic health records. In some countries, including Sweden and the USA, this innovation is advanced with patients using online portals to access their clinical records including the visit summaries written by clinicians. In many countries, patients can legally request copies of their records; however, open notes are different because this innovation offers patients rapid, real-time access via electronic devices. In (...) this brief report, we explore what open notes might mean for placebo use in clinical care. Survey research into patient access to their clinical notes shows that increased transparency enhances patients’ understanding about their medications and augments engagement with their care. We reflect on the consequences of access for placebo prescribing, particularly for the common practice of deceptive placebo use, in which patients are not aware they are being offered a placebo. In addition, we explore how open notes might facilitate placebo and nocebo effects among patients. Bridging placebo studies with medical ethics, we identify a range of empirical research gaps that now warrant further study. (shrink)

The use of ‘placebos’ in clinical practice is a source of continued controversy for physicians and medical ethicists. There is rarely any extensive discussion on what ‘placebos’ are and how they work. In this paper, drawing on Louhiala and Puustinen's work, the author proposes that the term ‘placebo effect’ be replaced in clinical contexts with the term ‘positive care effect’. Medical treatment always takes place in a ‘context of care’ that encompasses all the phenomena associated with medical intervention: it includes (...) the particular method of treatment, the interpersonal relationships between medical staff and the patient and other factors, including physicians' and patients' beliefs in the power of the treatment. Together, these phenomena can result in a full spectrum of therapeutic effects to the patient—from no effects, to small effects, to large effects. In cases where there are significant therapeutic benefits to the patient, ‘positive care effects’ may be spoken of. Since the ethical codes of the General Medical Council and the American Medical Association demand transparency with respect to patient treatment and insist on complete openness in ‘placebo’ usage, the author argues that, as a matter of conceptual rigour and consistency, if the term ‘placebo effect’ is replaced by ‘positive care effect’, these ethical codes appear to insist on transparency about all such beneficial components of treatment. Given that this appears to be a counterintuitive obligation, the author concludes the paper with some comments on the clinical consequences of this conceptual revision, including a brief discussion of how this important debate might develop. (shrink)

Clinical use of placebos is controversial among bioethicists. While placebos have been shown to provide benefit for patients with some conditions, offering placebos to patients without disclosing that they are placebos raises ethical concerns, including the concern that this lack of transparency about the nature of placebos amounts to deceiving patients. Some have proposed open-label placebos as an ethically preferable alternative: patients are offered placebos and told that the treatment being offered is a placebo. To contribute to the ongoing discussion (...) about the ethics and feasibility of clinical use of placebos, we conducted focus groups to explore physician attitudes about clinical use of placebos, including non-disclosed and OLPs, and physician attitudes about the underlying ethical issues. We found that while the non-transparency and deceptiveness of offering non-disclosed placebos was a concern for some physicians, their primary focus when considering both non-disclosed and OLPs was identifying and weighing potential harms and benefits to patients. Some participants also felt further research and training in prescribing OLPs would be needed before they would be willing to use them in their practice. Data are available upon request. (shrink)