A model of the neuropsychology of anxiety is proposed. The model is based in the first instance upon an analysis of the behavioural effects of the antianxiety drugs (benzodiazepines, barbiturates, and alcohol) in animals. From such psychopharmacologi-cal experiments the concept of a “behavioural inhibition system” (BIS) has been developed. This system responds to novel stimuli or to those associated with punishment or nonreward by inhibiting ongoing behaviour and increasing arousal and attention to the environment. It is activity in the (...) BIS that constitutes anxiety and that is reduced by antianxiety drugs. The effects of the antianxiety drugs in the brain also suggest hypotheses concerning the neural substrate of anxiety. Although the benzodiazepines and barbiturates facilitate the effects of γ-aminobutyrate, this is insufficient to explain their highly specific behavioural effects. Because of similarities between the behavioural effects of certain lesions and those of the antianxiety drugs, it is proposed that these drugs reduce anxiety by impairing the functioning of a widespread neural system including the septo-hippocampal system (SHS), the Papez circuit, the prefrontal cortex, and ascending monoaminergic and cholinergic pathways which innervate these forebrain structures. Analysis of the functions of this system (based on anatomical, physiological, and behavioural data) suggests that it acts as a comparator: it compares predicted to actual sensory events and activates the outputs of the BIS when there is a mismatch or when the predicted event is aversive. Suggestions are made as to the functions of particular pathways within this overall brain system. The resulting theory is applied to the symptoms and treatment of anxiety in man, its relations to depression, and the personality of individuals who are susceptible to anxiety or depression. (shrink)

Comparing the phenomenology, neurochemical pathology, and psychopharmacology of hallucinations and dreaming is limited by the available data. Evidence to date reveals no simple correspondence between the two states. Differences in the phenomenology of visual hallucinations and the visual component of dreams may reflect variations in visual context acting on the same underlying mechanism – the minimal visual input during dreaming contrasts with the more substantial perceived context in hallucinations. Variations in cholinergic, dopaminergic and serotonergic neurotransmitter function during sleep and during (...) hallucinations in Lewy body dementias, together with relevant drug effects suggest that, on the whole, different, potentially opposite, changes characterise the two states. A similar analysis of other psychotic features in Lewy body dementia and other disorders suggests that, in contrast to hallucinations, there may be more convincing parallels between dreaming and delusional states. (shrink)

In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

Children who experience well-being are engaging more confidently and positively with their caregiver and peers, which helps them to profit more from available learning opportunities and support current and later life outcomes. The goodness-of-fit theory suggests that children’s well-being might be a result of the interplay between their temperament and the environment. However, there is a lack of studies that examined the association between children’s temperament and well-being in early childhood education and care, and whether this association is affected by (...) ECEC process quality. Using a multilevel random coefficient approach, this study examines the association between toddlers’ temperament and well-being in Norwegian ECEC and investigates whether process quality moderates this association. Results reveal an association between temperament and well-being. Staff-child conflict moderates the association between shyness and well-being, and between activity and well-being. Moreover, high emotional behavioral support moderates the association between activity and well-being. Extra attention should be paid by the staff to these children’s needs. (shrink)

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic (...) of harms and the paucity of benefits. (shrink)

When seriously ill patients reach the end of the standard treatment trajectory for their condition, they may qualify for the use of unapproved, investigational drugs regulated via expanded access programs. In medical-ethical discourse, it is often argued that expanded access to investigational drugs raises ‘false hope’ among patients and is therefore undesirable. We set out to investigate what is meant by the false hope argument in this discourse. In this paper, we identify and analyze five versions of the (...) false hope argument which we call: (1) the limited chance at benefit argument, (2) the side effects outweighing benefits argument, (3) the opportunity costs argument, (4) the impossibility of making informed decisions argument, and (5) the difficulty of gaining access argument. We argue that the majority of these five versions do not provide normative ground for disqualifying patients’ hopes as false. Only when hope is rooted in a mistaken belief, for example, about the likelihood of benefits or chances on medical risks, or when hope is directed at something that cannot possibly be obtained, should it be considered false. If patients are adequately informed about their odds of obtaining medical benefit, however small, and about the risks associated with an investigational treatment, it is unjustified to consider patients’ hopes to be false, and hence, to deny them access to investigational drug based on that argument. (shrink)

Volume 20, Issue 4, May 2020, Page 106-108.

Recent research offers good reason to think that various psychedelic drugs—including psilocybin, ayahuasca, ketamine, MDMA, and LSD—may have significant therapeutic potential in the treatment of various mental health conditions, including post-traumatic stress disorder, depression, existential distress, and addiction. Although the use of psychoactive drugs, such as Diazepam or Ritalin, is well established, psychedelics arguably represent a therapeutic step change. As experiential therapies, their value would seem to lie in the subjective experiences they induce. As it is the only (...) way for trainee psychedelic therapists to fully understand their subjective effects, some have suggested that firsthand experience of psychedelics should form part of training programs. We question this notion. First, we consider whether the epistemic benefits offered by drug-induced psychedelic experience are as unique as is supposed. We then reflect on the value it might have in regard to the training of psychedelic therapists. We conclude that, absent stronger evidence of the contribution drug-induced experiences make to the training of psychedelic therapists, requiring trainees to take psychedelic drugs does not seem ethically legitimate. However, given the potential for epistemic benefit cannot be entirely ruled out, permitting trainees who wish to gain first-hand experience of psychedelics may be permissible. (shrink)

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.Although several researchers have examined the regulatory environment and the threat of sanction or harm (...) it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...) if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

In two recent essays, Thomas Pogge addresses the question of how research and development of essential drugs should be incentivized. Essential drugs are drugs for diseases that ruin human lives. The current incentivizing scheme for such drugs is, according to Pogge, a significant causal factor in bringing about a state of affairs in which millions of people die or suffer from lack of access to essential drugs. Pogge, therefore, suggests a reform plan for how to (...) incentivize research and development of these drugs, and he is of the opinion that implementation of this plan will have a significant positive impact on the global disease burden. This paper is a critical examination of Pogge's reform plan. In the first part of the paper, Pogge's reasons for being dissatisfied with the current incentivizing scheme are spelled out. The reform plan is then presented, and in the final part of the paper, it is argued that the reform plan is flawed at a number of levels. (shrink)

Recent research in neurochemistry has shown there to be a number of chemical compounds that are implicated in the patterns of lust, attraction, and attachment that undergird romantic love. For example, there is evidence that the phenomenon of attachment is associated with the action of oxytocin and vasopressin. There is therefore some reason to suppose that patterns of lust, attraction, and attachment could be regulated via manipulation of these substances in the brain: in other words, by their use as 'love (...) drugs'. A growing bioethical literature asks searching questions about this prospect, and especially about the use of such drugs to enhance or reignite attachment in flagging relationships. This Element examines some of the central arguments on the topic, and sounds a note of caution. It urges that there are reasons to think the states of attachment produced or facilitated by the use of such drugs would not be desirable. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence (...) will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

This article proposes a model for regulating use of cognition enhancement drugs for nontherapeutic purposes. Using the method of reflective equilibrium, the author starts from the considered judgment of many citizens that treatments are obligatory and permissible while enhancements are not, and with the application of general principles of justice explains why this is the case. The author further analyzes and refutes three reasons that some influential authors in the field of neuroethics might have for downplaying the importance of (...) justice: (1) Justice applies only to public funds and state action—not to individual choice or corporate actors. (2) “Performance enhancement” does imply questions of justice, while “performance maintenance” does not. (3) There is no sufficient difference between cognition-enhancement drugs and other technologies to warrant the importance of justice for the debate. The challenges are refuted by taking into account the difference between consumption and tool use, and the influence of socioeconomic pressure for widespread use that existing drugs could have on the basic structure of society and equal autonomy of citizens. The analysis of requirements of justice points to a conclusion that introducing economic disincentives for the use of cognition-enhancement drugs would be the most legitimate public policy. With the imposition of taxes, fees, and requirements of additional insurance, the use and indirect coercion to use would be less profitable and less widespread, while additional funds thus created could be allocated to meet basic medical needs and/or education. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, (...) it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

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)

Do pharmaceutical companies have a moral obligation to expand access to investigational drugs to patients outside the clinical trial? One reason for thinking they do not is that expanded access programs might negatively affect the clinical trial process. This potential impact creates dilemmas for practitioners who nevertheless acknowledge some moral reason for expanding access. Bioethicists have explained these reasons in terms of beneficence, compassion, or a principle of rescue, but their arguments have been limited to questions of moral permissibility, (...) leaving for future research the question of whether expanded access is morally obligatory. We take up this further question and argue that pharmaceutical companies have a moral obligation to expand access. Our defense is not based on beneficence, compassion, or rescue, but instead on a reciprocal moral expectation resulting from existing social commitments that help ensure a robust pharmaceutical practice within the broader healthcare system. Our aim is to give this obligation, along with several others, a coherent and plausible structure within the wider clinical trial process so that one might better explain the sources of the dilemmas and their possible resolutions. (shrink)

Review Essay on: Simeon Wade, Foucault in California [A True Story – Wherein the Great French Philosopher Drops Acid in the Valley of Death], foreword by Heather Dundas. (Berkeley, California: Heyday, 2019). 144 pp, ISBN 9781597144636 (hardback).

Treating physicians have key roles to play in expanded access to investigational drugs, by identifying investigational treatment options, assessing the balance of risks and potential benefits, informing their patients, and applying to the regulatory authorities. This study is the first to explore physicians’ experiences and moral views, with the aim of understanding the conditions under which doctors decide to pursue expanded access for their patients and the obstacles and facilitators they encounter in the Netherlands. In this mixed-methods study, semi-structured (...) interviews and a questionnaire were conducted with medical specialists across the country and analysed thematically. Typically, our respondents pursue expanded access in “back against the wall” situations and broadly support its classic requirements. They indicate practical hurdles related to reimbursement, the amount of time and effort required for the application, and unfamiliarity with the regulatory process. Some physicians are morally opposed to expanded access, with an appeal to safety risks, lack of evidence, and “false hope.” Some of these moral concerns and practical obstacles may be essential targets for change, if expanded access to unapproved drugs is to become available for wider groups of patients for whom standard treatment options are not—or no longer—available, on a more consistent and equal basis. (shrink)

While pharmaceutical industry involvement in producing, interpreting, and regulating medical knowledge and practice is widely accepted and believed to promote medical innovation, industry-favouring biases may result in prioritizing corporate profit above public health. Using diabetes as our example, we review successive changes over forty years in screening, diagnosis, and treatment guidelines for type 2 diabetes and prediabetes, which have dramatically expanded the population prescribed diabetes drugs, generating a billion-dollar market. We argue that these guideline recommendations have emerged under pervasive (...) industry influence and persisted, despite weak evidence for their health benefits and indications of serious adverse effects associated with many of the drugs they recommend. We consider pharmaceutical industry conflicts of interest in some of the research and publications supporting these revisions, and in related standard-setting committees and oversight panels. We raise concern over the long-term impact of these multifaceted involvements. Rather than accept industry conflicts of interest as normal, needing only to be monitored and managed, we suggest challenging that normalcy, and ask: what are the real costs of tolerating such industry participation? We urge the development of a broader focus to fully understand and curtail the systemic nature of industry’s influence over medical knowledge and practice. (shrink)

Many people have been enraged lately by the enormous increases in certain generic prescription drugs. But free marketeers defend these prices by arguing that they simply represent what the market will bear, and in a capitalist society there is accordingly nothing wrong with charging them. This paper argues that such a defense is actually contrary to the very principles that free marketeers claim to embrace. These prices are not only unjust and exploitative, but government interference with them would not (...) render the market less free, at least if what it means for a market to be “free” is properly understood. Everyone, even free marketeers with a libertarian or neoliberal bent, should accordingly be against this kind of profiteering. (shrink)

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of access (...) to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate. (shrink)

How do our brains make choices? How do factors such as Alzheimer's or depression impair decision-making? Presenting the latest research on 'hot' and 'cold' decision-making, Barbara Sahakian and Jamie Nicole LaBuzetta look at the therapeutic smart drugs now available, and raise concerns about their unregulated use to enhance mental performance.

In a recent study, Lantian and colleagues (2024) measured public attitudes toward the use of ‘love drugs’ as introduced through the work of Earp, Savulescu, and their collaborators. Use of a “revol...

This article seeks to provide insights into appropriate FDA oversight of nanotechnology. This commentary identifies limitations in the methodology employed and concludes that the analysis would be stronger with a more in-depth institutional dimension based on administrative law and political science research.

Too little has been written about the biology of joy. Most of the articles in the medical literature about brains and emotions are devoted to explaining how we feel fear, anger, anxiety and despair. This is understandable, because we don't go to doctors when we are feeling optimistic, happy and joyful. Most of what we know about the chemistry of our emotions has been learned from the disorders and the treatments of people who are sad and depressed. -/- But we (...) can't just accept this and say, ‘Why bother?’, because too many of us are seeking to find joy by taking chemicals. We need to ask, ‘What happens inside our brains when we experience happiness? Is there a way to stimulate pleasure in our brains, and what really happens when we do that?’. (shrink)