The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I (...) focus on three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Among feminist philosophers, there are two lines of argument that sexist values are illegitimate in science, focusing on epistemic or ethical problems. This article supports a third framework, elucidating how value-laden science can enable epistemic oppression. My analysis demonstrates how purported knowledge laden with sexist values can compromise epistemic autonomy and contribute to paternalism and misogyny. I exemplify these epistemic wrongs with a case study of the morning-after pill during its 2006 switch to over-the-counter availability and its new drug (...) label from the US Food and Drug Administration that it “may prevent implantation.” Antiabortion science advisers created this label to protect zygotes based on debated value judgments that were later concealed. This zygote-centric knowledge enabled them to shape potential users by instructing “good mothers” that they ought to protect zygotes and punishing “bad mothers” by refusing their requests for the drug. Therefore, I argue that the sexist values and gender norms of antiabortionists that prioritize zygotic health are illegitimate in this context because they cause epistemic injustices and perpetuate epistemic oppression. Furthermore, I advocate against blanket protections for the “right to conscience” and “religious freedom” of healthcare providers because they reinforce the epistemic oppression of women, especially those on the margins.Content Warning: This article discusses sexual assault and refusals to provide contraception to patients, including survivors. (shrink)

The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner Regulations 1996 and the common law, which require that (...) off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions. (shrink)

In February, the Food and Drug Administration announced a rule imposing new manufacturer labeling requirements for antibiotics. The aim of the new standards is to educate physicians and patients about the dangers of improper antibiotic use. Overprescription of antibiotics, as well as patient failure to comply with treatment regimens, has led to the development of drug-resistant bacteria. “Antibacterial resistance is a serious and growing public health problem in the United States and worldwide,” FDA Commissioner Mark McClellan said in (...) a press release accompanying the rule. “Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike.”The FDA regulates foods, drugs, and cosmetics introduced into interstate commerce for safety and effectiveness. Currently, the agency requires drug labels to provide “adequate directions for use,” including indications, quantity of dose, frequency, duration, route, and preparation. (shrink)

In February, the Food and Drug Administration announced a rule imposing new manufacturer labeling requirements for antibiotics. The aim of the new standards is to educate physicians and patients about the dangers of improper antibiotic use. Overprescription of antibiotics, as well as patient failure to comply with treatment regimens, has led to the development of drug-resistant bacteria. “Antibacterial resistance is a serious and growing public health problem in the United States and worldwide,” FDA Commissioner Mark McClellan said in (...) a press release accompanying the rule. “Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike.”The FDA regulates foods, drugs, and cosmetics introduced into interstate commerce for safety and effectiveness. Currently, the agency requires drug labels to provide “adequate directions for use,” including indications, quantity of dose, frequency, duration, route, and preparation. (shrink)

Although there are exceptions, the principle of primum nil nocere remains the cornerstone of the practice of medicine. In the well known handbook, Goodman and Gilman’s The Pharmacological Basis of Therapeutics1 a case is presented which raises doubts about the permissibility of off-label administration of certain drugs to healthy troops as a preventive measure. The following citation from this handbook gives a clear description of the problem:"Prophylaxis in cholinesterase inhibitor poisoning. Studies in experimental animals have shown that pretreatment with (...) pyridostigmine reduces the incapacitation and mortality associated with “nerve agent” poisoning, particularly for agents, such as soman, that … ". (shrink)

One explanation for drug bans is that regulators know more than consumers about product quality. But why not just communicate the information in their ban, perhaps via a “would have banned” label?Because product labeling is cheap-talk, any small market failure tempts regulators to lie about quality, inducing consumers who suspect such lies to not believe everything they are told. In fact, when regulators expect market failures to result in under-consumption of a drug, and so would not ban (...) it for informed consumers, regulators ex ante prefer to commit to not banning this drug for uninformed consumers. (shrink)

The Food and Drug Administration authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as (...) off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label. (shrink)

Prescribing drugs for uses that the FDA has not approved — off-label drug use — can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. (...) Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers’ conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. (shrink)

Coronavirus disease 2019 is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, (...) despite a lack of evidence of efficacy in COVID-19. In this review, we highlight the potential ethical issues that should be addressed during the use of investigational drugs with little prior evidence as a treatment options during a pandemic. We discuss the impact of design of randomized clinical trials using LOTUS trial as an example and that of off-label use of drugs like chloroquine/hydroxychloroquine on the safety of patients during COVID-19. We conclude that the adaptive randomized clinical trial designs offer a flexible and efficient approach, enabling patients to quickly switch to successful treatments, while minimizing the number of patients on standard of care. Randomized clinical trial design should consider blinding of investigators and only representative patients who can provide consent should be included. We also conclude the emergency approvals of drugs should be carefully issued and off-label use should be restricted in pandemics. Streamlined regulatory guidelines for emergency drug use in a pandemic can also help in providing benefit and minimizing harm to patients in the future. (shrink)

People have a love/hate relationship with rapidly changing healthcare technology. While consumer demand for medical apps continues to grow as rapidly as does supply, healthcare professionals and safety experts worry about the impact of these apps on the health consumer. In response to the rapidly growing mobile healthcare sector, the Food and Drug Administration has put forth guidelines to regulate ‘mobile medical apps’, those health-related apps that are designated as medical devices. In this article, I argue that this decision, (...) to only regulate apps that bill themselves as medical devices, will create a market for ‘off-label’ app use. Further, I will talk about the oft used analogy between off-label apps and off-label pharmaceuticals, showing that off-labeling apps will provide patients none of the benefits that come with a physician prescribing a drug off-label, while exposing the mobile healthcare consumer to significant risks that go significantly beyond those that we know of from prescription drugs. Recognizing that the Food and Drug Administration is not going to be able to significantly change its policies on oversight, I will suggest specific actions to at least mitigate some of the risks associated with off-label app use. (shrink)

This commentary defends 3 arguments for changing the label of levonorgestrel-based emergency contraception (LNG EC) so that it no longer supports the possibility of a mechanism of action after fertilization. First, there is no direct scientific evidence confirming any postfertilization mechanisms. Second, despite the weight of evidence, there is still widespread public misunderstanding over the mechanism of LNG EC. Third, this FDA label is not a value-free claim, but instead it has functioned like a political tool for reducing (...) contraceptive access. The label is laden with antiabortion values (even though EC is contraception, not abortion), and it imposes these values on potential users, resulting in barriers to access such as with Burwell v. Hobby Lobby. These 3 arguments together provide scientific, social, and ethical grounds for the FDA to take the initiate in changing Plan B's drug label. (shrink)

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration. An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and (...) medical evidence justify off-label uses, physicians promote patients’ interests by prescribing products off label.Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”. (shrink)

While the Value-Free Ideal of science has suffered compelling criticism, some advocates like Gregor Betz continue to argue that science policy advisors should avoid value judgments by hedging their hypotheses. This approach depends on a mistaken understanding of the relations between facts and values in regulatory science. My case study involves the morning-after pill Plan B and the “Drug Fact” that it “may” prevent implantation. I analyze the operative values, which I call zygote-centrism, responsible for this hedged drug (...) label. Then, I explain my twofold account of value-ladenness, involving the constitutive role of value judgments in science and the social function of facts as political tools. Because this drug fact is ineliminably value-laden in both senses, I conclude that hedged hypotheses are not necessarily value-free. (shrink)

Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective (...) treatments. The medical community and federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing. (shrink)

Reports in the popular press suggest that smart drugs or “nootropics” such as methylphenidate, modafinil and piracetam are increasingly being used by the healthy to augment cognitive ability. Although current nootropics offer only modest improvements in cognitive performance, it appears likely that more effective compounds will be developed in the future and that their off-label use will increase. One sphere in which the use of these drugs may be commonplace is by healthy students within academia. This article reviews the (...) ethical and pragmatic implications of nootropic use in academia by drawing parallels with issues relevant to the drugs in sport debate. It is often argued that performance-enhancing drugs should be prohibited because they create an uneven playing field. However, this appears dubious given that “unfair” advantages are already ubiquitous and generally tolerated by society. There are concerns that widespread use will indirectly coerce non-users also to employ nootropics in order to remain competitive. However, to restrict the autonomy of all people for fear that it may influence the actions of some is untenable. The use of potentially harmful drugs for the purposes of enhancement rather than treatment is often seen as unjustified, and libertarian approaches generally champion the rights of the individual in deciding if these risks are acceptable. Finally, whether the prohibition of nootropics can be effectively enforced is doubtful. As nootropics use becomes widespread among students in the future, discussion of this issue will become more pressing in the years to come. (shrink)

In recent years, the postulation that deception is necessary for placebos to have an effect on pain relief or increased well-being has come into question. Latest studies have shown that an openly administered mock drug works just as well as a deceptively administered placebo on certain complaints. This open-label placebo effect has primarily been used in the area of pain treatment so far. This study is the first to examine the effect of such placebos on healthy individuals with (...) the use of drinking water. In two experiments, participants were required to use certain specified water bottles for their daily drinking water consumption. At the beginning of Experiment 1, all participants received one bottle of water, which they were asked to refill themselves each day during a 2-week intervention period. In Experiment 2, participants received a new sealed water bottle every day. In both experiments, participants were randomly assigned to one of four groups: no treatment, open-label placebo without rationale, open-label placebo with rationale, and open-label placebo with additional rationale in a suggested relaxed state. We conducted baseline and post-treatment measurements of the subjective perceived physical and mental well-being of the participants. In Experiment 1, only the OPR++ group reported enhanced vitality at the post-treatment level compared to the other groups. In Experiment 2, post-treatment measurements showed improvements for the OPR++ group in the Physical Performance Capability, Mental Performance Capability, Emotional Balance, Overall Recovery, Negative Emotional State, and Overall Stress categories compared to the other groups. Our results support the idea that placebos with an additional rationale in a suggestive relaxed state are more effective than with just a rationale in a normal state. Furthermore, our study shows the tendency that OLP++ in the form of water with health claims may be more effective when the water is given in several sealed bottles separately than in one sealed but refillable bottle. (shrink)

Objectives Potentially life-shortening medical end-of-life practices ) remain subject to conceptual vagueness. This study evaluates how physicians label these practices by examining which of their own practices they label as euthanasia or sedation.Methods We conducted a large stratified random sample of death certificates from 2007 . The physicians named on the death certificate were approached by means of a postal questionnaire asking about ELDs made in each case and asked to choose the most appropriate label to describe (...) the ELD. Response rate was 58.4%.Results In the vast majority of practices labelled as euthanasia, the self-reported actions of the physicians corresponded with the definition in the Belgian euthanasia legislation; practices labelled as palliative or terminal sedation lack clear correspondence with definitions of sedation as presented in existing guidelines. In these cases, an explicit life-shortening intention by means of drug administration was present in 21.6%, life shortening was estimated at more than 24 h in 51% and an explicit patient request was absent in 79.7%.Discussion Our results suggest that, unlike euthanasia, the concept of palliative or terminal sedation covers a broad range of practices in the minds of physicians. This ambiguity can be a barrier to appropriate sedation practice and indicates a need for better knowledge of the practice of palliative sedation by physicians. (shrink)

Attention deficit hyperactivity disorder is a developmental disorder with an age onset prior to 7 years. Children with ADHD have significantly lower ability to focus and sustain attention and also score higher on impulsivity and hyperactivity. Stimulants, such as methylphenidate, have remained the mainstay of ADHD treatment for decades with evidence supporting their use. However, recent years have seen emergence of newer drugs and drug delivery systems, like osmotic release oral systems and transdermal patches, to mention a few. The (...) use of nonstimulant drugs like atomoxetine and various other drugs, such as a-agonists, and a few antidepressants, being used in an off-label manner, have added to the pharmacotherapy of ADHD. This review discusses current trends in drug therapy of ADHD and highlights the promise pharmacogenomics may hold in the future. (shrink)

Until recently, the medical community assumed that placebos required either concealment in randomized controlled trials or deception in clinical practice to elicit placebo effects. Henry Beecher emphasized this orthodoxy, when he stated that placebo pills only work "as long as it is not detected as a placebo by the subject or the observer" and therefore, patients "believe it [is a drug] and consequently the expected results occurs". The time was ripe for such ideas: Norman Vincent Peale's The Power of (...) Positive Thinking was already in its fourth year on the bestseller list when Beecher published his landmark paper. As time went on, the use of placebo pills became trapped in an... (shrink)

Anti-vascular endothelial growth factor therapy has revolutionised the treatment of a variety of ophthalmic conditions and has become the first-line therapy for a range of retinal diseases. Bevacizumab, a VEGF inhibitor first approved for the treatment of colorectal cancer, has been shown to be nearly or virtually as effective and safe as other anti-VEGF therapies in the treatment of certain retinal diseases but is not approved or registered by the Food and Drug Administration or European Medicines Agency. While other (...) anti-VEGF options are approved and registered, they are generally more expensive and less accessible. Accordingly, despite its off-label status, bevacizumab is frequently used for a variety of disabling retinal diseases. Indeed, bevacizumab is included on the World Health Organization’s list of essential medicines. However, its use in some parts of the world remains restricted due to its off-label status. How, then, should healthcare authorities approach this situation? What are the ethical and societal implications of adhering to a standard and generally effective evaluation and approval system while restricting access to a potentially cost-saving therapy? In countries where its use is not restricted, how should providers approach off-label treatment with bevacizumab? By examining the evidence behind bevacizumab’s efficacy and safety and evaluating the individual and societal implications of off-label use and restriction, this paper illustrates the ethical factors providers and policy makers must consider in the off-label use of bevacizumab and ultimately argues for increased access to bevacizumab in the treatment of retinal disease. (shrink)

Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in paediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children. This paper briefly reviews the factors associated with the lack of paediatric clinical trials. We advocate a shift toward increasing paediatric trials with psychotropic drugs through a combination of adequate safety controls, additional reimbursement/compensation, a more organised and large-scale effort to (...) collate results and outcomes across researchers and studies and additional public education about the importance of this research. In addition, we encourage the re-examination of the ethical standards for children's participation in phase 1 clinical trials as well as argue for longitudinal developmental studies on children who are prescribed off-label psychotropic drugs. (shrink)

BackgroundDepressive disorders are a common form of psychiatric illness and cause significant disability. Regulation authorities, the medical profession and the public require high safety standards for antidepressants to protect vulnerable psychiatric patients. Ketamine is a dissociative anaesthetic and a derivative of a hallucinogen. Its abuse is a major worldwide public health problem. Ketamine is a scheduled drug and its usage is restricted due to its abuse liability. Recent clinical trials have reported that ketamine use led to rapid antidepressant effects (...) in patients suffering from treatment-resistant depression. However, various flaws in study designs, and possible biased reporting of results, may have influenced those findings. Further analyses of ketamine use are needed to ensure patient safety.DiscussionThe use of ketamine in research and treatment of depressive disorders is controversial. Recently, mental health professionals raised ethical concerns about an ongoing ketamine trial in the UK. Also, a Canadian agency reviewed the existing evidence and did not recommend prescribing ketamine to treat depressive disorders. Findings obtained from tightly controlled research settings cannot be easily translated to clinical practice as substance abuse is commonly comorbid with depressive disorders. An effective antidepressant should reduce severity of depressive symptoms without liability problems. Although the US FDA has not approved the use of ketamine to treat depressive disorders, some psychiatrists offer off-label repeat prescription of ketamine. Prescribing ketamine for treating depressive disorders requires substantial empirical evidence. Clinicians should also consider research findings on ketamine abuse. Depressive disorders can be chronic conditions and the current evidence does not rule out the risk of substance abuse after repeat prescription of ketamine. Off-label ketamine use in treating depressive disorders may breach ethical and moral standards, especially in countries seriously affected by ketamine abuse. This article presents two real-world clinical vignettes which highlight ethical principles and theories, including autonomy, nonmaleficience, fidelity and consequentialism, as related to off-label ketamine use.ConclusionWe urge clinicians to minimise the risk of harming patients by considering the empirical evidence on ketamine properties and attempting all standard antidepressant therapies before considering the off-label use of ketamine. (shrink)

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients’ assignment at the point of entry into the open label (...) phase, on the grounds that this may introduce ascertainment bias in the main study.It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons. (shrink)

The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. (...) The new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times. The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. (shrink)

In the United States, while it is legal for physicians to prescribe drugs for “off-label” indications (uses for which the drugs do not have Food and Drug Administration approval), it is largely—though not entirely—illegal for drug manufacturers to promote off-label uses of their drugs to physicians. In recent months, the rules against off-label marketing have been rigorously enforced: in October, Allergan reached a $375 million settlement over off-label promotion of Botox; in September, Novartis settled (...) an off-label marketing dispute for $422.5 million, and Forest Laboratories settled one for $313 million. These were only the latest in a series of criminal and civil settlements on off-label promotion, the most .. (shrink)

We wish to point out an additional consequence of the Catch-22 described by Andreae and colleagues (Andreae et al. 2016). The decades-long research gridlock of controlled drugs has unintentionally...

The growth of esports as a recognized, organized, competitive activity in North America and Europe has evolved steadily from one of the most prominent sport industries in several Asian countries. Esports, which is still pursuing a widely accepted governance structure, has struggled to control the factors that typically act as a breeding ground for sport corruption. Within the esports industry, there is alleged widespread use of both prescription and off-label use of stimulants, such as modafinil, methylphenidate, and dextroamphetamine. Anti-doping (...) policy implementation in this environment may result in either the abuse of the Therapeutic Use Exemptions system or excluding too many competitors who have a legitimate need for these medications. In this paper, we contextualize esports and substance use within this emerging industry. Subsequently, we outline the specific challenges faced by esports organizations in crafting policies to address PEDs—one of the industry’s most pressing issues. Furt... (shrink)

According to several recent studies, a big chunk of college students in North America and Europe uses so called ‘smart drugs' to enhance their cognitive capacities aiming at improving their academic performance. With these practices, there comes a certain moral unease. This unease is shared by many, yet it is difficult to pinpoint and in need of justification. Other than simply pointing to the medical risks coming along with using non-prescribed medication, the salient moral question is whether these practices are (...) troubling in and of themselves. In due consideration of empirical insights into the concrete effects of smart drugs on brain and behavior, our attempt is to articulate wherein this moral unease consists and to argue for why the authors believe cognitive enhancement to be morally objectionable. The authors will contend that the moral problem with these practices lies less in the end it seeks, than in the underlying human disposition it expresses and promotes. Some might ask, what is wrong with molding our cognitive capacities to achieve excellence, get a competitive edge, or, as the whim takes us? In all of these occasions, the usage of smart drugs serves a certain goal, a telos. The goal is, broadly speaking, this: outsmarting opponents in an arms race for limited resources and thereby yielding a competitive edge. In plain words: competition is valued higher than cooperation or solidarity. What is wrong with striving for this goal? The authors submit that the question whether people really want to live in a society that promotes the mentality ‘individual competition over societal cooperation' deserves serious consideration. In developing their answer, the authors draw on an ‘Ethics of Constraint' framework, arguing that widespread off-label use of smart drugs bears the risk of negative neural/behavioral consequences for the individual that might, in the long run, be accompanied by changing social value orientations for the worse. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges (...) associated with the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

Providing in-utero treatments to target specific conditions in the fetus is a relatively new approach in perinatal care, with the vast majority of these treatments being used off-label. The high degree of off-label medication use in the perinatal and neonatal settings raises concern for the safety of both the fetuses and expectant mothers. This report presents two examples of intra-amniotic drug administration based on reported clinical cases. From the ethical framework of medical principlism, we examine the competing (...) ethical duties of autonomy, beneficence, and non-maleficence in this setting. We then lay out three fundamental ethical principles for obtaining informed consent and maximizing clinical benefit. (shrink)

This paper is about a drug called misoprostol and its controversial clinical and social lives. Although originally developed as a prevention for gastric ulcers, in the 1980s, it developed an off-label reputation as an abortifacient. The drug’s association with clandestine abortion has profoundly shaped its social life as a marginal and suspect character in the realm of global maternal and reproductive health where it has the potential to prevent two major causes of maternal death––postpartum hemorrhage and unsafe (...) abortion. The social life of misoprostol has also been shaped by the question of authoritative practice, that is, the question of who can deliver medicine. Both issues are about the specters of misuse of misoprostol: off-label, illegal, immoral, or by unlicensed providers. In this paper, I focus ethnographically on two women’s health nongovernmental organizations that have been conducting clinical testing and advocacy for the use of misoprostol for reproductive indications in global maternal health settings. Drawing on the notions of pharmaceutical activism and protocol feminism, I describe and analyze how the tools of evidence and authoritative practice have been reassembled in new networks of expertise toward the social justice goals of life, access, and dignity for women. (shrink)

This study investigates the engagement of family firms in corporate social responsibility. We first compare their corporate social performance to non-family firms. Then, following recent evidence on the heterogeneity of family firms, we examine two factors that may influence CSP within family firms: the level of family control and the governance orientation of the country in which they operate. This research is based on a theoretical framework which considers both agency and socioemotional wealth influences on family firms CSR engagements. Overall, (...) we find that family firms exhibit lower CSP than non-family firms. But when focusing on family firms, our analyses show a curvilinear relationship between family control and CSP. At lower levels of control, family owners invest more in social initiatives to protect their SEW. Beyond a threshold level of control that we estimate at 36 % in our sample, economic considerations prevail over SEW and social performance starts decreasing. We also find that family firms operating in stakeholder-oriented countries are more attentive to social concerns than those operating in more shareholder-oriented countries. (shrink)

This article proposes and empirically tests a theoretical framework incorporating Reidenbach and Robin’s (J Bus Ethics 10(4):273–284, 1991 ) conceptual model of corporate moral development. The framework is used to examine the relation between governance and business ethics, as proxied by diversity management (DM), and financial reporting quality, as proxied by the magnitude of earnings management (EM). The level of DM and governance quality are measured in accordance with the ratings of Jantzi Research (JR), a leading provider of social and (...) governance research for institutional investors. This DM score is part of an index developed by JR that investment managers use to integrate DM criteria into their investment decisions. As expected, a negative relation between corporate DM development and financial reporting quality is found while controlling for other factors known in the literatures on governance and accounting choices to affect earnings quality. Despite some caveats presented in conclusion, this study contributes to the ethics, governance, and financial reporting literatures by studying the dynamics between governance and ethics in the prevention of EM. (shrink)

In this paper I examine two theories of democracy that can be found in contemporary French philosophy. Both Cornelius Castoriadis and Jacques Rancière offer a critique of modern democracy with the purpose of refounding it. The ‘refoundation narratives’ they propose are both based on an account of the origins of democracy in ancient Greece. According to Castoriadis, ancient democracy is grounded in a ‘magma’ of ‘social imaginary significations’ in which ‘autonomy’ is considered the correct response to Being defined as an (...) insurmountable ‘Chaos’. On the contrary, modern democracy defines Being as a determinacy and consequently fails to grasp the notion of autonomy. According to Rancière, the origins of democracy are to be found in the invasion of the public space by ‘those without a part’ who consequently have no title to govern. The problem with the ‘domesticated’ modern democracy is that it denies the existence of Otherness; that is, of non-citizens excluded from the public space. Therefore it appears incapable of letting the ‘dis-agreement’ manifest itself and consequently incapable of transforming the ‘police’ order. After examining the meaning of both theories, I attempt to elucidate the difficulties encountered by each author in the attainment of his goal, which is that of refounding modern democracy. (shrink)

The book proposes a multi-dimensional understanding on sound and listening as capacities for challenging social and political structures of inequality and domination, supporting interpersonal exchange and modes of community-building based on empathy, care and compassion.

L’antéposition d’un verbe non conjugué (participe passé, infinitif) en ancien et en moyen français a été assimilée à l’antéposition stylistique de l’islandais. Nous montrons que dans le cas du français, ces antépositions illustrent trois constructions différentes, toutes distinctes de l’antéposition stylistique de l’islandais. Dans la construction la plus fréquente, étiquetée déplacement stylistique à gauche, l’expression antéposée s’insère dans une position interne à la proposition plutôt que dans la périphérie gauche, à la droite immédiate de la position canonique du sujet, qui (...) peut y être réalisé, contrairement à ce que l’on observe en islandais. La même analyse est étendue aux cas où le sujet est nul ou déplacé plus à gauche. Les deux autres cas sont ceux où 1) l’expression antéposée est l’élément initial d’une construction V2, une situation rare, ou 2) il y a mise en relief du verbe non fini à la gauche immédiate de la position canonique du sujet. (shrink)

Authored by leading sound studies scholar Brandon LaBelle, this book focuses on questions of acoustics as the basis for challenging normative structures.

The starting point of this article is that there is a kind of ‘hidden dialogue’ that Claude Lefort is trying to conduct with Leo Strauss on the theologico-political problem. If Strauss claims this problem to be ‘irresolvable’, Lefort seeks to show that the ‘permanence of the theologico-political’ in modernity is only an appearance, as democracy has, in the last instance, succeeded in ‘cutting’ the knot tied between the theological and the political in pre-modern societies. Moreover, while Strauss associates recognition of (...) the irresolvable character of the theologico-political problem with moderation, Lefort takes the exact opposite view, insisting on the lack of moderation, even excess, that weighs particularly on modern politics consequent to any attempt to amalgamate the theological with the political. (shrink)

Si les publics improbables sont, fondamentalement, des publics faibles, ils nous surprennent aussi – et c’est leur principal cadeau, leur caractère exemplaire. Par un art de la transgression, ils rappellent combien la vie publique est une affaire commune, façonnée par les gens à certains moments, en certains lieux, animés par la lutte et l’imagination, et par la joie de se découvrir les uns les autres. Cet article identifie quatre figures d’agentivité sonique pratiquées par ces improbables publics : l’invisible, l’entendu par-dessus (...) l’épaule, l’itinérant et le faible. (shrink)