Sociological research on moral panics, long understood as “struggles for cultural power,” has focused on the social groups and media conditions that enable moral panics to emerge, and on the consequences of moral panics for the social control systems of societies. In this article I turn instead to modeling the specific cultural process of how the conditions for a moral panic are turned into an actual moral panic, moving the understanding of moral panic away from its Durkheimian origins and towards (...) a process-relational cultural sociology. Drawing on Roland Barthes’ theory of myth and Kenneth Burke’s dramatism, the paper posits the cultural process of resignification via synecdoche and metanarrative as the driver of the disproportion, concern, hostility, consensus, and volatility of moral panics. This process can be carefully traced in the case of the Salem Witch Trials; a retrospective reading reveals the same process at work in the “Mods and Rockers” panic analyzed by Stanley Cohen. Beyond moral panics, theorizing resignification as a non-exclusive counterpoint to framing and ideational embeddedness enriches the theoretical repertoire of cultural sociology. “Deep culture” and mythological signification can, using the schema proposed here, be understood as practical accomplishments—rhetorical responses to particular situations that, when performed successfully, legitimate violence and other forms of domination. (shrink)

This article examines responses from Lutheran pastors, theologians, and physicians to the arguments given by Johann Weyer in 1563 that those women who confessed to a pact with the devil suffered from melancholy and were thus not responsible for their acts. Weyer’s conception of melancholy was a medical one, yet among Lutheran pastors and theologians the concept of a spiritual form of melancholy emerged that came from religious sources. The article clarifies the difference between the concepts of medical and spiritual (...) melancholy within Lutheranism and reviews the respective roles they played in the debates over Weyer’s arguments. (shrink)

In 1590, after Norway’s most famous witch trial, Anne Pedersdotter was burned alive. Resource scarcity and religious competition transformed an old superstition into a witch craze to which Anne fell victim. Her story became a play in 1908 and a film in 1943. The two adaptations attempt to give Anne’s persecution more modern explanations. In the play Anne Pedersdotter, Anne has psychic powers that make her neighbors think she is a Satanic collaborator. In the film Day of Wrath, (...) Anne embodies humanistic aspirations that would have been delusional in her own era and that are perhaps also poorly adapted to human nature in general. The trial and the two fictional versions of the trial all illustrate how thought patterns that evolved for small groups of foragers can be overstimulated in post-agricultural environments. This article identifies cognitive dispositions that, in periods of crisis, can trigger persecution of outsiders, discusses how those universal mechanisms man­ifest themselves in different cultural contexts, and examines the historically specific beliefs and values that animate the two fictional versions of Anne’s story. The article concludes with reflections on how the evolved cognitive mechanisms that led to beliefs in witchcraft often manifest themselves, in the present, as conspiracy beliefs directed at minorities. (shrink)

While contemporary readers may find what appear to be appealing streaks of liberalism in Montaigne's 'Essays', I argue that a more careful analysis suggests that Montaigne's overall stance is quietistic and conservative. To help support this claim I offer a close reading of 'Essays' III.11 ("Of Cripples"), where Montaigne offers his famous critique of the witch trials of early modern Europe. Once Montaigne's objections to the witch trials are properly understood, we see that Montaigne did not (...) seriously or consistently dispute the church's authority in political matters, though certain undeveloped seeds of liberalism do leave an unresolved tension in his writings. (shrink)

The concept of a witch hunt is frequently invoked, in recent times, to describe a kind of procedure for deciding the guilt of a person against whom an accusation has been made. But what exactly is a witch hunt? In this paper, ten conditions are formulated as a cluster of properties characterizing the witch hunt as a framework in which arguments are used: (1) pressure of social forces, (2) stigmatization, (3) climate of fear, (4) resemblance to a (...) fair trial, (5) use of simulated evidence, (6) simulated expert testimony, (7) nonfalsifiability characteristic of evidence, (8) reversal of polarity, (9) non-openness, and (10) use of the loaded question technique. The witch hunt, as characterized by these criteria, is shown to function as a negative normative structure for evaluating argumentation used in particular cases. (shrink)

The great upsurge of witch trials in early modern Europe remains a historical puzzle. Popularly known as the “witch craze”, this eruption of persecution is puzzling because belief in witchcraft had existed for centuries, but large-scale witch-hunting appeared rather abruptly, spread widely, and was remarkably brutal in comparison with the past. We define a theory of ideational diffusion to describe the general process of the emergence and spread of a new idea along with its prescribed behavioral (...) change, in this case the adoption of witch-hunting. Ideational diffusion distinguishes between the adoption of new ideas, which lead social actors to reinterpret the world and thus to change their behavior, and the adoption of behavior alone. We relate how a new theory of witchcraft appeared in the fifteenth century and show that its widespread propagation, owing to the new technology of printing, matches our description of ideational diffusion. We then analyze the diffusion of witch trials in Central Europe by combining data on the publication of demonological treatises alongside climate, state capacity, religious economy, and city network variables. We find that cities adopted persecution after demonological treatises were printed, and that nearby trials induced neighbors to adopt persecution. Tracing the print vectors and social interdependence spurring witch-hunting helps us understand the general mechanisms behind the spread of persecution. (shrink)

The following article begins with my recollection of the only academic conference on Zdziechowski that was organised still under the communist regime in the autumn of 1984 at the Jagiellonian University and ends with a description of the discussion on the genesis and power of evil, with the participation of Czesław Miłosz and Leszek Kołakowski, which was triggered in Poland immediately after the publication of the last edition of On Cruelty in 1993. On Cruelty was first published in 1928 in (...) the journal Przegla̧d Współczesny [Contemporary Review] in Krakow, a second time in 1938 in the volume of articles In the Face of the End, Krakow 1938, and a third – and so far last – time also in Krakow in 1993. On Cruelty, published three times but so far only in Polish, has never been thoroughly analysed or even discussed, which is why this article focuses on discussing it and related questions about the origins and nature of evil, mainly in Europe and Asia, from the earliest times to the present. Zdziechowski was particularly outraged when the cruelty he condemned was justified by religion, especially Christianity (Catholic and Protestant). From these condemnations, he described the activities of the Inquisition, the witch trials, cruelty to animals, and – in the introduction – the “psychology of cruelty.” At the same time, however, he meticulously listed the names of those political and spiritual leaders in Europe and Asia, theologians and thinkers, who, over many centuries, up to the present day, have resolutely spoken out against evil, including cruelty, within and outside the Church. A separate and important issue is Zdziechowski’s attitude to Tsarist Russia and Bolshevism, as outlined in his work On Cruelty. On the one hand, he pointed out that at least two rulers of Russia before 1917 – Ivan the Terrible and Peter the Great – had made major contributions to the history of cruelty in Europe and Asia. But Bolshevism, which Zdziechowski condemned in the strongest terms, was in his eyes not a continuation of pre-1917 Russian despotism, but emanated from the depths of Asia. (shrink)

A thorough and careful report on the variety and extent of offenses prosecuted by the Puritan churches from colonial times into the nineteenth century, with some asides on civil cases, such as the Salem witch trials. The text is lively with verbatim testimony. A large bibliography frankly notes the various reasons why some records are "unavailable."--E. T.

A world in which atheism has replaced religion is the dream of Oxford evolutionary biologist and “New Atheist” activist, Richard Dawkins. He thinks that religious belief is irrational superstition that leads to violence (like the inquisition), intolerance (like homophobia), ignorance (like creationism), and corruption (like red hot Catholic love). In fact, in the episode “Go God Go,” it is the cartoon version of Dawkins himself who pioneered the efforts culminating in religion's demise. First, one has to understand what science is. (...) Science is a method for discovering the truth about the world. Many philosophers argue that science and religion are perfectly compatible. Religion is about ethics and meaning, but science is about explaining the way the world works. Religion has led to a lot of violence—the Crusades, the Spanish Inquisition, witch trials, 9/11, and more. And it's certain that the end of religion wouldn't eliminate all violence. (shrink)

An exploration of the untamed crossroads where 'the feline' and 'the feminine' mingle and make magic. From ancient Egypt to early modern Venice to Edo Japan, the witch trials to the Women's March, Catwoman to cat ladies, kitten play to cat conventions, this book tracks the cat's circuitous connection to women and femininity through a magical lens. By combining historical research, pop culture and art analyses, and original interviews, this book uncovers what the 'feral feminine' might mean to (...) witches, sluts, feminists, artists, historians, philosophers, cat ladies, and cat lovers today. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Benedict XVI: A Life. Volume 2, Professor and Prefect to Pope and Pope Emeritus 1966–The Present by Peter SeewaldEmil AntonBenedict XVI: A Life. Volume 2, Professor and Prefect to Pope and Pope Emeritus 1966–The Present by Peter Seewald, translated by Dinah Livingstone (London: Bloomsbury Continuum, 2021), viii + 568 pp.What better way to spend Pope Benedict XVI's ninety-fifth birthday (which turned out to be his last) than by (...) visiting his birth house in Marktl am Inn at his birth minute—4.15 AM! In addition to five Finnish pilgrims, twenty or so local grandmas and grandpas attended the now-traditional early morning prayer, which this year fell on Holy Saturday, the very liturgical day on which Joseph Ratzinger was born and baptized. Other destinations on a do-it-yourself Ratzinger pilgrimage included Freising (studies and ordination), Regensburg (professorial years), Altötting (favorite Marian sanctuary), childhood villages and towns (Tittmoning, Aschau am Inn, Hufschlag, Traunstein), and of course Munich (seminary and episcopal years), with beer, good food, and Apfelstrudel at the Augustiner Klosterwirt.Such a trip is highly recommended, even though there were no Ratzinger books in the "Theology" section of University of Regensburg's bookshop, reflecting his persona non grata status in German academia. In Altötting, however, Peter Seewald's magnificent biography was on offer, as well as icon-like pictures of Pope Benedict and candles with his image on them—good for both admirers and critics!In English, Seewald's biography is divided into two volumes (for my review of volume 1, see Nova et Vetera [English] 20, no. 3), the second one comprising three parts: (1) professor, (2) prefect, and (3) Pope. The book was certainly worth the wait and does not disappoint: the research and analysis are excellent, the style is enjoyable, and interesting new details are revealed, such as the "endless outbursts of crying" and "violent quarrels with cardinals" of "popess" (as the housekeeper was called in the curia) Ingrid Stampa, who "kept Ratzinger's diary, edited official speeches and even decided who could meet the Holy Father" (351).As a journalist, Seewald is especially strong on the German press coverage [End Page 285] of Ratzinger. During his time as archbishop of Munich, "Ratzinger took part so frequently in the public debate that the Süddeutsche Zeitung feared that it would be a 'big shock' for millions of Upper Bavarian Catholics if his name did not appear in any edition of the four Munich daily papers" (109). Ratzinger's predominantly negative media image seems to stem to a great extent from the actions of Hans Küng. Asked about the cancellation of Küng's missio canonica at a youth event in 1979, Ratzinger said off the cuff that it was right, since Küng was actively disputing essential doctrines of the Catholic Church (128). The comments were published without authorization, which led to Küng accusing Ratzinger of "falling back on pre-conciliar customs of heresy-hunting, insinuation and defamation" (129). After the publication of Vittorio Messori's The Ratzinger Report in 1985, Küng "crashed in with a sweeping blow in the Hamburg weekly Die Zeit" (170), not failing to bring up his "litany of complaints: the 'case of Galileo,' the 'Chinese rites controversy,' 'putting all the most important European thinkers on the Index (Descartes, Kant, Sartre etc.),' '9 million victims of witch trials'" (171). According to Seewald, this momentous article, ending with the claim that Ratzinger was "afraid of the truth more than anything else," provided the endlessly reproduced media image of the prefect.Seewald singles out the Bild journalist Andreas Englisch as a striking example of the kind of deliberate manipulation typical of so-called expert reporters. After Benedict XVI's election, Englisch admitted with apparent remorse that, in previous reporting, in order to make John Paul II's "light shine more brightly," he had "needed an enemy to make the story more dramatic" (192). Seewald continues: "However, Englisch had no scruples about later applying his business model to books about Pope Francis, whom he raised almost to heaven, in order finally to shove the retired Benedict XVI down to hell" (192... (shrink)

Various historical sources from the Renaissance--including transcripts of trials for witchcraft, writings on demonology and textbooks of pharmaceutical botany--describe vegetal ointments prepared by women accused of witchcraft and endowed with marked psychoactive properties. Here, we examine the botanical composition and the possible pharmacological actions of these ointments. The results of our study suggest that recipes for narcotic and mind-altering salves were known to Renaissance folk healers, and were in part distinct from homologous preparations of educated medicine. In addition, our (...) study reveals an unexpected connection of these vegetal psychotropes with archaic chtonic beliefs, confirming the tight association between rituals and cults entered on the Underworld and the image of the Medieval witch. (shrink)

Denounced by neighbors and scrutinized by demonologists, the early modern French witch also confessed, self-identified as a witch and as the author of horrific deeds. What led her to this point? Despair, solitude, perhaps even physical pain, but most decisively, demonology's two-pronged prosecutorial and truth-seeking confessional apparatus. This book examines the systematic and well-oiled machinery that served to extract, interpret, and disseminate witches' confessions in early modern France. For the demonologist, confession was the only way to find out (...) the truth about the clandestine activities of witches. For the witch, however, trial confessions opened new horizons of selfhood. In this book, Virginia Krause unravels the threads that wove together the demonologist's will to know and the witch's subjectivity. By examining textual and visual evidence, Krause shows how confession not only generated demonological theory but also brought forth a specific kind of self, which we now recognize as the modern subject. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Bleed: Destroying Mythsand Misogyny in Endometriosis Care by Tracey LindemanSarah Seabrook (bio)Bleed: Destroying Myths and Misogyny in Endometriosis Care by Tracey Lindeman. Toronto: ECW Press, 2023Endometriosis—a complex and painful health condition in which tissue similar to the endometrium tissue that normally lines the inside of a person's uterus grows outside—has gained considerable attention over the last few years. Because endometriosis patients' concerns about their reproductive health and menstrual (...) experiences are often dismissed by healthcare professionals (Wahl 2021; Alberta Women's Health Foundation 2022), there has been a groundswell of conversations about abnormal menstruation and endometriosis, not by government or medical professionals but rather by patients who validate each other's experiences and relate to one another's struggles in seeking access to care (EndoAct Canada 2024). Experiences about the trials and tribulations endometriosis patients endure seeking medical care and diagnosis are shared through op-eds and Facebook support groups and have appeared on special feature segments on the local news. With increased attention around endometriosis, there remains a lot of work to do around dispelling what endometriosis truly is and why people are not being adequately treated.In BLEED: Destroying Myths and Misogyny in Endometriosis Care, author and endometriosis patient Tracey Lindeman (2023), takes on the work of that dispelling. With a focus on the North American context (largely Canada and the United States), Lindeman shines a light on the deeply embedded systemic discrimination that shapes experiences of endometriosis and other gendered health conditions that prevent women, trans, and non-binary people from receiving a diagnosis and/or adequate treatment. This compelling part memoir, part investigation of the systemic barriers to care for endometriosis patients, reveals the long-standing and ongoing history of misogyny in contemporary gynecology and healthcare (Davis-Floyd 1997; Wetherell, Taylor, and Yates 2001; Young, Fisher, and Krikman 2019), including how pharmaceutical funding and interests are prioritized at the expense of endometriosis patients' health and well-being, and how sexism and racism, among other markers of discrimination, are [End Page 181] institutionalized features in healthcare systems that strip women, trans, and non-binary people of their agency over their bodies and decision-making capacity.BLEED is a particularly timely and important contribution to feminist health scholarship because it offers an intimate account of how the historical medicalization of female-specific health issues has normalized power asymmetries between patients and medical professionals. She demonstrates how the contemporary dynamics in healthcare settings leave women and gender-nonconforming people to navigate the intersections of misogyny and myths surrounding endometriosis. Lindeman does so by discussing her own experiences, including being asked by medical professionals to provide a written letter of support from her male partner indicating his approval of her requested hysterectomy.As both a researcher and someone with endometriosis, Lindeman is able to take the narrative of BLEED in several directions. She offers readers the intimacy of her perspective and experiences with endometriosis in Canada's health system while also offering readers a broader view of how age, race, gender identity, sexual orientation, and geography inform the experiences of others who have endometriosis. Her ability to situate her experiences as a cis-white woman as the focal point of her analysis provides readers with a strong reference point to recognize and understand the heightened systemic discrimination experienced by her nonwhite, non-cis interviewees. In particular, the contrast between Lindeman's experiences of being prescribed sixty-tablet refills of the painkiller naproxen for endometriosis pain and the experiences of her interviewee, Denise, a black cis-woman who was only given five naproxen pills a month provides insight into racialized dimensions of endometriosis care (39).Recognizing that a history unlearned results in history being repeated, Lindeman opens BLEED by situating the painfully paternalistic and misogynistic experiences of endometriosis patients in the healthcare system in the context of the evolution of gynecology as a subfield. Lindeman highlights how the medicalization of endometriosis as a condition went hand in hand with the professionalization of gynecology, which has since created and perpetuated a power asymmetry between patients and their care providers. Whereas gynecological care was historically provided by women—witches, midwives, and healers—the long male-dominated... (shrink)

A case study is presented of the development of computer-based support tools for power engineers in the electricity supply industry. The objective was to develop an expert system to support witching schedule production. A user-centred approach was followed which led the user community to conclude that a switching schedule production assistant (SSPA) was required which would leave control with the power engineer. Prototype systems were developed and evaluated in user trials which revealed that a significant and more general purpose (...) tool would be a computer generated electricity network display that the engineers could manipulate. The paper concludes that the process of enabling users to evaluate alternative forms of technology can facilitate the development systems that are useful, acceptable and usable. (shrink)

Pragmatic clinical trials (PCTs) seek to show the effectiveness of treatments in routine, clinical practice (MacPherson 2004). However, a number of ethical challenges come to the fore when collater...

: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle (...) of nonexploitation. This framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose (...) a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We (...) examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated. (shrink)

BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then (...) elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.ConclusionThe fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. (shrink)

First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns (...) on claims about future events like harms, therapeutic response, and clinical translation. Recurrent failures in clinical translation, like Eli Lilly's Alzheimer candidate semagacestat, highlight the severe limitations of current methods of prediction. In this case, patients in the active arm of the placebo-controlled trial had earlier onset of dementia and elevated rates of skin cancer [2]. Various authoritative accounts of human research ethics state that decision-making about risk and benefit should be careful, systematic, and non-arbitrary [3]–[5]. Yet, these sources provide little guidance about what kinds of evidence stakeholders should use to ensure their estimates of such events ground responsible ethical decisions. In this article, we suggest that investigators, oversight bodies, and sponsors often base their predictions on a flawed and inappropriately narrow preclinical evidence base. (shrink)

Research Ethics Committees (RECs) play a critical gatekeeping role in clinical trials. This role is meant to ensure that only those trials that meet certain ethical thresholds proceed through their gate. Two of these thresholds are that the potential benefits of trials are reasonable in relation to risks and that trials are capable of producing a requisite amount of social value. While one ought not expect perfect execution by RECs of their gatekeeping role, one should expect (...) routine success in it. This article reviews a range of evidence showing that substantial numbers of ethically tainted trials are receiving REC approvals. Many of the trials are early phase trials that evidence shows have benefits that may not be reasonable compared with their risks and many others are later trials that evidence shows may lack sufficient social value. The evidence pertains to such matters as methodologically inadequate preclinical studies incapable of supporting the inferences that REC members must make about the prospects for potential benefit needed to offset the risks in early phase trials and sponsorship bias that can cause improperly designed, conducted, analysed and reported later phase trials. The analysis of the evidence makes clear that REC practices need to be strengthened if they are to adequately fulfil their gatekeeping role. The article also explores options that RECs could use in order to improve their gatekeeping function. (shrink)

Those researching HIV prevention measures for people who inject drugs face a dilemma. Regions where baseline HIV prevalence and onward transmission via injecting is sufficiently high to power HIV prevention trials are also those where repressive laws, policies and practices raise concerns about the ethics of research subject protection. Dawson et al, outlining criteria to address ethical challenges in HIV prevention research among PWID, recommend that all trial participants be offered sterile injecting equipment and urge additional strategies to limit (...) research and background risks.1 In light of ethical questions opened by recent clinical trials involving PWID, including several the authors cite favourably, these cautions are timely. Dawson et al urge weighing of costs and benefits of PWID participation in research trials as an essential part of the ethical calculus. Overdose is a particular risk in any trial that uses abstinence from opioids as a precondition for participation or as an outcome of interest, and a risk that institutional review boards and researchers frequently ignore. Given the increased likelihood of fatal overdose for those who return to injection following a period of abstinence, provision to all trial participants of naloxone—the overdose antidote …. (shrink)

David Sackett and Jack Wennberg have each introduced and developed ideas and methods that have had major impacts on how we think about and perform clinical research. Sackett is best known for his work in Evidence-Based Medicine (Sackett et al. 1997); Wennberg, upon noting wide geographic (and other) variations in best practices for the same conditions, stressed the importance of comparative effectiveness in clinical decision-making (Wennberg et al. 1993). When these two collaborated in an editorial about the current state of (...) the art and science of clinical research, it comes as no great surprise that they produced some truly memorable guidance. And, as is so often the case for inspired—and inspiring—advice, their .. (shrink)

The principle of clinical equipoise requires that, aside from certain exceptional cases, second generation treatments ought to be tested against standard therapy. In violation of this principle, placebo-controlled trials (PCTs) continue to be used extensively in the development and licensure of second-generation treatments. This practice is typically justified by appeal to methodological arguments that purport to demonstrate that active-controlled trials (ACTs) are methodologically flawed. Foremost among these arguments is the so called assay sensitivity argument. In this paper, I (...) take a closer look at this argument. Following Duhem, I argue that all trials, placebo-controlled or not, rely on external information for their meaningful interpretation. Pending non-circular empirical evidence that we can trust the findings of PCTs to a greater degree than the findings of ACTs, I conclude that the assay sensitivity argument fails to demonstrate that placebo-controlled trials are preferable, methodologically or otherwise, to active-controlled trials. Contrary to the intentions of its authors, the fundamental lesson taught by the assay sensitivity argument is Duhemian: the validity of all clinical trials depends on external information. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, (...) and the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in (...) the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

Background: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what “adequately informed” might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in such (...) trials feel they have been given adequate information, or whether they feel able to understand that information.Objectives: To explore trial participants' views on the amount of information provided, and of their own understanding of that information.Design: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition.Findings: Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given outwith the research setting, patients generally felt they received more information when participating in a clinical trial.Conclusions: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate. (shrink)

This afterword extends and refines the arguments presented in Cohen and Jacobs . The main point made by the authors is that the antidepressant randomized controlled trial world is a make-believe world in which researchers act as if a bona fide medical experiment is being conducted. From the assumed existence of the “disorder” and the assumed homogeneity of the treatment groups, through the validity of rating scales and the meaning of their scores, to the presentations of researchers’ ratings as the (...) genuine outcome of interest — all aspects of such trials are make-believe. The continued acceptance of randomized controlled trials as appropriate mechanisms to ascertain the actual effects of psychoactive drugs on human beings in distress confirms that researchers are inextricably dependent on large-scale organizational and financial interests that require the sustained production of make-believe results about psychoactive drugs. (shrink)

Medication reconciliation for pediatric oncology patientparticipants enrolled in clinical trials often reveals the use of chemical complementary medicine alongside protocol therapeutic agents. Considering the blurry delineation between clinical ethics and research ethics, this paper demonstrates how complementary medicine-related protocol violations introduce ethical questions of who should be included and excluded from clinical trials and offers recommendations on how to manage physician-patient-family interactions around these challenging issues.

Within the world of pharmacology, the male body has traditionally been taken as the biological norm. Coupled with this, concern about danger to the unborn foetus has meant that, until very recently, ‘women of childbearing potential’ were routinely excluded from most of the early phases of clinical drug testing. Consequently, most drugs tested during Phase I trials were initially carried out on healthy male volunteers. During subsequent phases when drugs were tested on patients, women remained largely under-represented. As a (...) result, some drugs prescribed for women have later been discovered to be lacking in efficacy, and women are more likely to suffer adverse drug reactions than men. The exclusion of women during the early phases of clinical drug trials has now been lifted and drugs are currently being more widely tested on women. This paper examines the differing political and ethical positions adopted by the pharmaceutical industry, drug regulators, pharmacologists, women's groups and patient activists in relation to the exclusion and inclusion of women in clinical drug trials. (shrink)

Garland and colleagues provide many compelling reasons for why clinicians ought to participate in pragmatic clinical trials (Garland et al. 2023), also known as effectiveness trials (Thorpe et al....

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...) The European Medicines Agency reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. (shrink)

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose (...) a penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. (shrink)

Unregulated patient treatments and approved clinical trials have been conducted with haematopoietic stem cells and mesenchymal stem cells for children with autism spectrum disorder. While the former direct-to-consumer practice is usually considered rogue and should be legally constrained, regulated clinical trials could also be ethically questionable. Here, we outline principal objections against these trials as they are currently conducted. Notably, these often lack a clear rationale for how transplanted cells may confer a therapeutic benefit in ASD, and (...) thus, have ill-defined therapeutic outcomes. We posit that ambiguous and unsubstantiated descriptions of outcome from such clinical trials may nonetheless appeal to the lay public as being based on authentic scientific findings. These may further fuel caregivers of patients with ASD to pursue unregulated direct-to-consumer treatments, thus exposing them to unnecessary risks. There is, therefore, a moral obligation on the part of those regulating and conducting clinical trials of stem cell-based therapeutic for ASD minors to incorporate clear therapeutic targets, scientific rigour and reporting accuracy in their work. Any further stem cell-based trials for ASD unsupported by significant preclinical advances and particularly sound scientific hypothesis and aims would be ethically indefensible. (shrink)

BackgroundEarly in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns about equipoise pose a barrier to the ethical conduct of (...) COVID-19 RCTs?MethodsGoogle Scholar and Pubmed were searched for articles containing substantial discussion about equipoise and COVID-19 RCTs. 347 article titles were screened, 91 full text articles were assessed, and 48 articles were included. Uses of equipoise were analyzed and abstracted into seven categories.Results and discussionApproximately two-thirds of articles used equipoise in a way that is consistent with the concept. They invoked equipoise to support RCTs of specific therapies, RCTs in general, and the early termination of RCTs after achieving the primary outcome. Approximately one-third of articles used equipoise in a manner that is inconsistent with the concept. These articles argued that physician preference, widespread use of unproven therapies, patient preference, or expectation of therapeutic benefit may undermine equipoise and render RCTs unethical. In each case, the purported ethical problem can be resolved by correcting the use of equipoise.ConclusionsOur findings highlight the continued relevance of equipoise as it supports the conduct of well-conceived RCTs and provides moral guidance to physicians and researchers as they search for effective therapies for COVID-19. (shrink)

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (shrink)