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)

It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous “double standard of care” case study in order to (...) offer novel consideration of the placebo orthodoxy that underlies much of the ethical debate. This majority view found in medical research is that placebo-controlled trials are methodologically superior to comparative trials that use active controls. I challenge this orthodoxy and argue that lives were unnecessarily lost in these trials as a result. Furthermore, current HIV research on vaccines and microbicides is now poised to repeat the error of subscribing to the placebo orthodoxy. (shrink)

There is compelling evidence that pain experience is influenced by cognitive states. We explore one specific form of such influence, namely placebo analgesia, and examine its relevance for the cognitive penetration debate in philosophy of mind. We single out as important a form of influence on experience that we termradical cognitive penetration,and argue that some cases of placebo analgesia constitute compelling instances of this phenomenon. Still, we urge caution in extrapolating from this to broader conclusions about cognitive penetration (...) in perceptual experience. Instead, we suggest that the cognitive penetration of pain raises distinctive psychological, epistemological, and ethical issues. (shrink)

The material presented at this conference pointed to a new dimension in the prosecution of activities that seek to relieve people of disease. While the simple instrument of the placebo may show those interested in the efficacy of physiologically active chemicals the extent to which the chemical of interest is actually active, the surprising outcome of such studies is that the placebo per se is worthy of more general study. This, when taken further, points to the ways in (...) which mind can influence the matter of the body. Of course, mind itself is an activity of matter, so we may retain the experimental approach that has told us about the world outside ourselves to examine the world that is inside our brains. New techniques and approaches to these once intractable problems are now in train. Where they will lead us we cannot predict, but as with the emergence of all new tools, we have to adopt those ethics that will carry us forward with the expectation that we will maximise benefits and minimise harms. (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)

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments, rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy (...) have a duty to ‘go open’ to patients about the role of common factors in therapy ; to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works. (shrink)

The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. Results: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo (...) side effect profile was largely similar to the side effect profile of the active treatment. The mechanisms of placebo effects are manyfold and varied (e.g. endorphin release, conditioning), much lacks explanation. Conclusion: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed. (shrink)

Placebos are allegedly used widely in general practice. Surveys reporting high level usage, however, have combined two categories, ‘pure’ and ‘impure’ placebos. The wide use of placebos is explained by the high level usage of impure placebos. In contrast, the prevalence of the use of pure placebos has been low. Traditional pure placebos are clinically ineffective treatments, whereas impure placebos form an ambiguous group of diverse treatments that are not always ineffective. In this paper, we focus on the impure (...) class='Hi'>placebo concept and demonstrate problems related to it. We also show that the common examples of impure placebos are not meaningful from the point of view of clinical practice. We conclude that the impure placebo is a scientifically misleading concept and should not be used in scientific or medical literature. The issues behind the concept, however, deserve serious attention in future research. (shrink)

It is widely believed that medically inert treatments (“placebos”) can bring about therapeutic benefits. There is also evidence that medically active treatments may also have “placebo” effects. Since anything that has the potential to benefit patients ought to be exploited, subject to appropriate ethical standards, it has been suggested that more should be done to investigate and exploit the power of the placebo for therapeutic benefit. I explore the acute epistemic and ethical constraints that such exploitation is likely (...) to face, and conclude that effective exploitation is unlikely. (shrink)

Despite the conceptual problems in identifying the placebo effect, an increasing number of multidisciplinary inquiries rest on the assumption that there is a distinct class of effects, placebo effects. In this chapter, I argue against this assumption. I present cases and characterizations of the placebo effect as offered in the literature, and argue that the latter are subject to insurmountable problems. Moreover, I argue that identification of placebo effects as such is not useful for the three (...) main purposes offered in the literature. I then offer suggestions for why it may remain intuitive that some effects are placebo effects and close by noting the potential benefits of ultimately explaining away these intuitions. (shrink)

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that (...) the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. (shrink)

Abstract. The placebo effect these days is no longer merely the insubstantial, subjective response that some patients have to a sham treatment, like a sugar pill. It has been reconceived as a powerful mind-body phenomenon. Because of this, it has also emerged as a complex reference point in a number of high-stakes conversations about the metaphysical significance of experiences of religious healing, the possible health benefits of being religious, and the feasibility of using double-blind placebo-controlled trials to investigate (...) the efficacy of prayer. In each of these conversations, the placebo effect is always pointing toward some larger issue, serving some larger agenda. The agendas, though, tend to pull in different directions, leading to a situation that feels at once fractured and stalemated. This essay reviews the main areas of interest, and proposes some specific issues where humanistic scholars of religion in particular might be able to introduce constructive and creative new perspectives. (shrink)

The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an (...) active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the use of placebo may be the cause of the problem pointed to. Scientific, regulatory, ethical and legal advantages of the use of an active control are described. While the use of a placebo control may be acceptable in carefully defined circumstances, in most cases the use of an active control in schizophrenia research is ethically and scientifically preferable. (shrink)

Among medical researchers and clinicians the dominant view is that it is unethical to deceive patients by prescribing a placebo. This opinion is formalized in a recent policy issued by the American Medical Association (AMA [Chicago, IL]). Although placebos can be shown to be always safe, often effective, and sometimes necessary, doctors are now effectively prohibited from using them in clinical practice. I argue that the deceptive administration of placebos is not subject to the same moral objections that face (...) other forms of deception in clinical practice and medical research. Although deception is normally objectionable on the grounds that it limits autonomy and breaches trust, these grounds do not apply to placebos when they are prescribed within appropriate ethical limits. Patients have reason to prefer that doctors can prescribe placebos in ethically responsible ways. Hence, the AMA has an obligation to endorse and to promote the responsible use of deceptive placebos in clinical practice. (shrink)

A humorous short story about a company that tries marketing a placebo as a more expensive drug on the grounds that doing this will both maximize their profits and benefit the greatest number, since research shows the placebo to be highly effective if marketed as something else.

In this paper, Isuggest that placebo effects, as we know them today, should be understood as experimental phenomena, low-level regularities whose causal structure is grasped through particular experimental designs with little theoretical guidance. Focusing on placebo interventions with needles for pain reduction -one of the few placebo regularities that seems to arise in meta-analytical studies- I discuss the extent to which it is possible to decompose the different factors at play through more fine-grained randomized clinical trials. My (...) sceptical argument is twofold. On the one hand, I argue that experiments alone are not enough to standardize interventions, and that it is necessary to include theories. On the other hand, I argue that the social interactions that seem to be part of placebo effects are difficult, if not impossible, to blind. Therefore, the measurement biases arising from the participants’ reactivity to the experimental setup cannot be controlled for. Further decomposition of placebo effects requires a theoretical account of the existing experimental regularities that may guide further tests. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls (...) in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics Committees. (...) Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (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)

Placebo effects raise some fundamental questions concerning the nature of clinical and medical research. This Element begins with an overview of the different roles placebos play, followed by a survey of significant studies and dominant views about placebo mechanisms. It then critically examines the concept of placebo and offers a new definition that avoids the pitfalls of other attempts. The main philosophical lesson is that background medical theories provide the ontology for clinical and medical research. Because these (...) theories often contain incoherent and arbitrary classifications, the concept of placebo inherits the same messiness. The Element concludes by highlighting some impending challenges for placebo studies. (shrink)

Evidence that placebo acupuncture is an effective treatment for chronic pain presents a puzzle: how do placebo needles appearing to patients to penetrate the body, but instead sitting on the skin’s surface in the manner of a tactile stimulus, evoke a healing response? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations suggest an embodied healing mechanism. In this qualitative study, we asked a subset of patients in a singleblind randomized trial in irritable (...) bowel syndrome to describe their treatment experiences while undergoing placebo treament. Analysis focused on patients’ unprompted descriptions of any enhanced touch sensations and any significance patients assigned to the sensations. We found in 5/6 cases, patients associated sensations including “warmth” and “tingling” with treatment efficacy. The conclusion offers a “neurophenomenological” account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices, possibly underlying the phenomenology of placebo acupuncture. (shrink)

The maternal‐fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki – the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the (...) controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow ‘local conditions’ to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta‐ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects. (shrink)

Often regarded simply as a nuisance in clinical drug trials in which the aim is to separate drug response from placebo response in a statistically significant manner, the placebo response has important implications. These implications relate to the nature of illness, the study of non-specific factors in the treatment setting that are related to clinical improvement, methods of enhancing these non-specific sources of benefit, and the neurobiology that is associated with the placebo response. Specific sources of clinical (...) improvement in medical and psychological treatment generally consist of drugs or clear interventions that appear to directly contribute to the desired treatment. Non-specific factors, on the other hand, include the clinician–patient relationship, installation of hope, relationship with authority, and other such factors that are more implicit to treatment and may contribute to the placebo response. Our understanding of how these non-specific aspects of treatment relate to clinical improvement and ways of enhancing these non-pharmacological elements of therapy may form important aspects of treatment. Furthermore, an important, albeit potentially overlooked element of the placebo response are clinical-trial designs and methodologies, themselves. Specific neurobiological changes also appear to be associated with the placebo response in at least some cases. Finally, it is suggested that the placebo response may in some instances represent a type of brain plasticity in which expectation and desire — agency — can result in specific changes in brain function that either may mirror or differ from the effects of certain drugs. (shrink)

This article considers issues concerning cases where the use of placebo is lawful or is not lawful under aspects of German criminal law. It will differentiate between cases of individual therapy and cases of supervised experiments within the scope of medical tests. Thereby, it reveals that a medication of placebo with regard to an individual patient seems to be lawful if there is no alternative possibility of a better treatment using a chemically effective medicine and if the limits (...) of presumed consent are complied with. On the other hand, in the context of the supervised experiment, the assignment of a patient to a group treated with placebo is only lawful if the patient has been fully informed about the possibilities of a treatment and if the patient has given consent to it. (shrink)

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)

Philosophical debates about how best to explain emotion or placebo are debates about how best to characterise and explain the distinctive form of human responsiveness to the world that is the object of interest for each of those domains of inquiry. In emotion research, the cognitive theory of emotion faces several intractable problems. I discuss two of these: the problem of epistemic deficit and the problem of recalcitrant emotions. Cognitive explanations in Placebo Studies, such as response-expectancy and belief-based (...) explanations, also face the problem of epistemic deficit in addition to the problem of logically self-destructive true belief. While such considerations might motivate a retreat to affect, this brings its own problems. I argue that it is a particular version of cognitivism, representational cognitivism (Rep-Cog), that generates the paradoxes we encounter in emotion and placebo research. I propose that turning to nonrepresentational accounts of cognition will dissolve these paradoxes. As I move toward conclusion, I propose drawing on the ethnomethodological tradition to respecify human responsiveness to loci of significance in the lifeworld by undertaking ethnographies of members’ own situated methods for making intelligible and accountable their attitudinal and nonattitudinal responsiveness to loci of significance in their environment. (shrink)

One of the most successful physicians I have ever known, has assured me, that he used more bread pills, drops of colored water, and powders of hickory ashes, than of all other medicines put together. It was certainly a pious fraud.Clinicians and other health-care practitioners have known for hundreds of years that different procedures with unclear mechanisms of action or efficaciousness can still result in subjective improvement of clinical symptoms. Many scholars have attempted to define the placebo effect. This (...) has resulted in the development of multiple frameworks and models that help explain and further explore placebo effects and responses. After providing some definitions and clarifications of terminology... (shrink)

POHLMAN S, CIBULKA NJ, PALMER JL, LORENZ RA and SMITHBATTLE L. Nursing Inquiry 2013; 20: 71–81 The placebo puzzle: examining the discordant space between biomedical science and illness/healingThe placebo response presents an enigma to biomedical science: how can ‘inert’ or ‘sham’ procedures reduce symptoms and produce physiological changes that are comparable to prescribed treatments? In this study, we examine this puzzle by explicating the discordant space between the prevailing biomedical paradigm, which focuses on a technical understanding of diagnosis (...) and treatment, and a broader understanding of illness and healing as relational and embodied. Although biomedical achievements are impressive, the knowledge resulting from this paradigm is limited by its ontological and epistemological assumptions. When the body and world are objectified, illness meanings, therapeutic relationships, and healing practices are dismissed or distorted. In spite of a robust critique of the tenets of biomedicine for guiding practice, the biomedical paradigm retains a tenacious hold on evidence-based medicine and nursing, downplaying our clinical understanding of the sentient body, patients’ life-worlds, and illness and healing. In reality, skilled nurses rely on multiple forms of knowledge in providing high-quality care to particular patients. Clinically wise nurses integrate their experience and knowledge of patients’ priorities, fears, and illness trajectories along with biomedical findings to make astute judgments and promote health and healing. (shrink)

In this short essay I intent to discuss the moral standing of autonomy in the field of Medical Ethics and the way it affects individual decision making as well as health care policies. To this purpose I will employ a real life scenario, namely administering placebo medication to a patient without letting him know, by means of which I will challenge not only the effectiveness and the feasibility of autonomy in the Kantian sense, but also its desirability. I will (...) argue that the Kantian notion of autonomy when it comes to Medical Ethics is in some cases self-defeating and, therefore, confusing and misleading. I will conclude with the view that, at least as Medical Ethics is concerned, we should rethink and, maybe, revise the meaning we usually assign to autonomy, so as to take into account the particular nature of the doctor-patient relationship. (shrink)

The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. Results: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo (...) side effect profile was largely similar to the side effect profile of the active treatment. The mechanisms of placebo effects are manyfold and varied (e.g. endorphin release, conditioning), much lacks explanation. Conclusion: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical (...) and scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

A placebo is an intervention that is believed to lack specific pharmacological or physiological efficacy for a patient’s condition. While placebo-controlled trials are considered the gold standard when it comes to researching and testing new pharmacological treatments, the use of placebos in clinical practice is more controversial. The focus of this case study is an undisclosed placebo trial used as an attempt to diagnose a patient’s complex and unusual symptomology. In this case, the placebo was used (...) not just as a treatment, but as a diagnostic intervention in order to determine the best course of treatment for a patient. Could the deceptive use of a placebo be justified in clinical practice on the grounds of beneficence? (shrink)

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: the presence of equipoise, defined as a lack of unbiased evidence for efficacy of (...) an intervention; clinically important research question; the risk to patients is minimised and reasonable; there is uncertainty about treatment allocation rather than deception; there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial should be sufficiently powered and standardised so that its results are valid, consent should be valid, the standard treatment or rescue medication should be provided if possible, and after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association. (shrink)

Robin Nunn has argued that we should stop using the terms ‘placebo’ and ‘placebo effect’. I argue in support of Nunn’s position by considering the logic of why we perform placebo comparisons. Like all comparisons, placebo comparison is just a case of comparing one thing with another, but it is a mistake, I argue, to think of placebo comparison as a case where something is compared to ‘a placebo’. Rather, placebo comparison should be (...) understood as a situation which sets-up the treatment and control groups in a particular way; not as a case involving objects or procedures called ‘placebos’ employed in order to control for ‘placebo effects’. (shrink)

Kihlbom has recently argued that a system of seeking negatively informed consent might be preferable in some cases to the ubiquitous informed consent model. Although this theory is perhaps not powerful enough to supplant informed consent in most settings, it lends strength to Evans’ and Hungin’s proposal that it can be ethical to prescribe placebos rather than "active" drugs. This paper presents an argument for using negatively informed consent for the specific purpose of authorising the use of placebos in clinical (...) contexts. (shrink)

The achievement of optimal therapeutic results presupposes the use of appropriate treatment combined with maximal utilization of placebo effects. These aims may sometimes be difficult to satisfy in randomized clinical trials (RCTs). The question thus arises whether there is a conflict between the goals of therapy and those of experimental research; and if so, to what extent, and how is it handled in practice by clinicians and researchers. Various ethical problems have been discussed in several reports connected with RCTs. (...) But we have found no discussion concerning the conflict between obtaining informed consent and promoting optimal placebo effects. Information about RCTs can be given in various ways. Sometimes appropriate information about RCTs to patients involves non-optimal utilization of placebo effects. This gives rise to ethical and methodological problems, which are discussed in this article. (shrink)

Recent research, especially with functional brain imaging, demonstrated cases where the administration of a placebo produces objective effects in tissues that are indistinguishable from those of the real therapeutic agents. This phenomenon has been shown in treatments of pain, depression, Parkinsonism, and more. The main ethical complaint against placebo treatment is that it is a kind of deception, where supposedly we substitute what works just psychologically for a real drug that actually works on the tissue level. We claim (...) that the scientific findings bring to a new level the seeming deconstruction of the distinction between “placebo” and “real” drugs, and that instances of placebo treatment which fulfill this criterion should be recognized as a unique category—we call it “comparable placebo treatment” (CPT). The paper uses an analysis of the notion of deception to argue that CPT does not amount to deception; that it can preserve patient autonomy; and that it is therefore morally legitimate. (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)

Physicians commonly recommend ?placebo treatments?, which are not believed to have specific efficacy for the patient's condition. Motivations for placebo treatments include complying with patient expectations and promoting a placebo effect. In this article, we focus on two key empirical questions that must be addressed in order to assess the ethical legitimacy of placebo treatments in clinical practice: 1) do placebo treatments have the potential to produce clinically significant benefit? and 2) can placebo treatments (...) be effective in promoting a therapeutic placebo response without the use of deception? We examine evidence from clinical trials and laboratory experiments bearing on these two questions. The conclusion is reached that based on currently available evidence, it is premature to judge whether placebo treatments are ethically justifiable, with the possible exception of acupuncture for pain relief. (shrink)

Placebos are commonly defined as ineffective treatments. They are treatments that lack a known mechanism linking their properties to the properties of the condition on which treatment aims to intervene. Given this, the fact that placebos can have substantial therapeutic effects looks puzzling. The puzzle, we argue, arises from the relationship placebos present between culturally meaningful entities, our intentional relationship to the environment and bodily effects. How can a mere attitude toward a treatment result in appropriate bodily changes? We argue (...) that an ‘enactive’ conception of cognition accommodates and renders intelligible the phenomenon of placebo effects. Enactivism depicts an organism’s adaptive bodily processes, its intentional directedness, and the meaningful properties of its environment as co-emergent aspects of a single dynamic system. In doing so it provides an account of the interrelations between mind, body and world that demystifies placebo effects. (shrink)

The Helsinki Declaration is the ‘gold standard’ — a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use “the best treatment” excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments in general. (...) The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component. (shrink)

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)

The conceptual and ethical challenges regarding clinical placebo are interwoven with each other, so that one's definition of clinical placebo influences the moral reasoning with regard to its use i...

What’s so bad about the placebo effect? John Worrall discusses the recent Nurofen labelling “scandal”.

This paper considers the ethics of placebo‐controlled trials in developing countries, where a treatment already exists but is not available due to the low local standard of care. Such trials would not be permitted in more developed nations where a higher standard of care is available. I argue that there are moral intuitions against such trials, but a further intuition that if the trials were aimed at producing treatment options for the developing world, that would be more permissible than (...) if the trials were designed with the benefit of rich world people in mind. An approach based upon GA Cohen's work on interpersonal justifiability is suggested to allow us to explain these intuitions. Cohen's framework shows that these trials are ethically problematic because the inequality in healthcare provision between developing and developed nations that allows them to take place is at least partly the pharmaceutical corporations’ fault. Following Cohen's argument, this means the trials are non‐comprehensively justified. This allows for a more complete explanation of our intuitions than to consider such trials as cases of exploitation, because intuitions on the ethicacy of research can vary even when the exploitation relation remains the same. It is then established that there is good empirical evidence to believe that pharmaceutical corporations do fail the interpersonal justifiability test. The policy implications of this judgement are then considered, and it is suggested that the framework might be equally applicable to examining the permissibility of research conducted on vulnerable people within more developed nations. (shrink)

American orthodox medicine consolidated its professional authority in the early 20th Century on the basis of its unbiased scientific method. The centerpiece of such a method is a strategy for identifying truly effective new therapies, i.e., the randomized clinical trial (RCT). A crucial component of the RCT in illnesses without established treatment is the placebo control. Placebo effects must be identified and distinguished from pharmacological effects because placebos produce actual but unexplained therapeutic successes. The blinding necessary for a (...) proper placebo-controlled RCT therefore introduces an epistemic bias into orthodox medicine: therapeutic successes that rely upon a direct link between knowing and healing, such as placebo effects, are discarded in favor of therapeutic successes that rely upon an indirect link between knowing and healing, such as pharmacological interventions. Where the capacity to produce therapeutic results once validated the method of clinical medical science, now method validates results. The clinical consequences of this method of testing therapies include a diminished vision of the therapeutic potential of the doctor-patient relationship and of the potential human resources available for healing. Keywords: doctor-patient relationship, epistemology, placebo effect, professionalization, randomized clinical trials CiteULike Connotea Del.icio.us What's this? (shrink)