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)

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)

Post-market pharmaceutical surveillance or ‘pharmacovigilance’ relies on the reporting of suspected adverse drug reactions to regulatory databases. Recently, more ‘active’ methods that directly involve patients in identifying and reporting suspected adverse drug reactions have been suggested. This is different than traditional ‘passive’ methods, e.g., using databases without contacting patients directly. Though there are benefits to active pharmacovigilance, it is not without its potential risks. Here I highlight one of those risks – the nocebo effect. Nocebo effects are harms (...) that are thought to arise by conditioning or negative expectation. If a patient engaged in active pharmacovigilance is improperly motivated to seek out and report suspected adverse drug reactions, nocebo harms can occur. Not only is this a bioethical concern about harm, but it is also an epistemic or data-quality problem. Since nocebo effects are not due to the pharmacological properties of the drugs under investigation, nocebo effects reported as suspected adverse drug reactions constitute false positives in these databases. (shrink)

One of the main challenges in medicine is to guarantee an appropriate drug supply according to the real needs of patients. Closed-loop strategies have been widely used to develop automatic solutions based on feedback variables. However, when the variable of interest cannot be directly measured or there is a lack of knowledge behind the process, it turns into a difficult issue to solve. In this research, a novel algorithm to approach this problem is presented. The main objective of this (...) study is to provide a new general algorithm capable of determining the influence of a certain clinical variable in the decision making process for drug supply and then defining an automatic system able to guide the process considering this information. Thus, this new technique will provide a way to validate a given physiological signal as a feedback variable for drug titration. In addition, the result of the algorithm in terms of fuzzy rules and membership functions will define a fuzzy-based decision system for the drug delivery process. The method proposed is based on a Fuzzy Inference System whose structure is obtained through a decision tree algorithm. A four-step methodology is then developed: data collection, preprocessing, Fuzzy Inference System generation, and the validation of results. To test this methodology, the analgesia control scenario was analysed. Specifically, the viability of the Analgesia Nociception Index as a guiding variable for the analgesic process during surgical interventions was studied. Real data was obtained from fifteen patients undergoing cholecystectomy surgery. (shrink)

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we (...) convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

This article examines the regulation of nonsteroidal anti-inflammatory drugs, with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that (...) these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science, on the other. (shrink)

Arguments in the neuroenhancement debate are sometimes based upon idealistic scenarios involving the assumption of using a drug that has no or negligible side effects. At least it is often implicitly assumed – as technology and scientific knowledge advances - that there soon will be a drug with no or negligible side effects. We will review evidence from neuroscience, complex network research and evolution theory and demonstrate that - at least in terms of psychopharmacological intervention – on the (...) basis of our understanding of brain function it seems inconceivable that there ever will be a drug that has the desired effect without undesirable side effects. We will illustrate this by reference to enhancing edge detection in V2 in monkeys and demonstrate that even for this localised single neuron coded function there would be numerous side effects. Taking the more realistic case of pharmacological enhancement that is inevitably associated with side effects will change consequentialist arguments for neuroenhancement and have implications for the conception of autonomy, specifically in the case of performance enhancement. We conclude that a neuroethics debate that aims to inform policy decisions should take these findings into account. We hope that our article will precipitate more interdisciplinary research in neuroscience and philosophy. (shrink)

This article critically examines current responses to multi-drug resistant tuberculosis and argues that bioethics needs to be willing to engage in a more radical critique of the problem than is currently offered. In particular, we need to focus not simply on market-driven models of innovation and anti-microbial solutions to emergent and re-emergent infections such as TB. The global community also needs to address poverty and the structural factors that entrench inequalities—thus moving beyond the orthodox medical/public health frame of reference.

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to (...) protect and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments. (shrink)

Dramatic events involving dangerous microbes often focus attention on isolation and quarantine as policy instruments. The incident in May-June 2007 involving Andrew Speaker and drug-resistant tuberculosis joins other communicable disease crises that have forced contemplation or actual application of quarantine powers. Implementation of quarantine powers, which encompasses authority for both isolation and quarantine actions, is important not only for the handling of a specific event but also because the use of such authority provides a window on broader issues of (...) public health and the legal rules, ethical principles, and governance systems that support it. Debates about quarantine powers reflect political and social attitudes about public health that often tell us more about this policy endeavor than acts of isolation and quarantine themselves. (shrink)

This essay argues that policies aimed at suppressing drug use exacerbate the nation's opioid problem. It neither endorses drug use nor advocates legalizing the consumption and sale of all substances in all circumstances. Instead, it contends that trying to suppress drug markets is the wrong goal, and in the midst of an addiction crisis it can be deadly. There is no single, correct drug policy; the right approach depends crucially on the substance at issue, the patterns (...) of use and supply, and the jurisdiction's culture, institutions, and material resources. Decriminalization is no panacea for a nation's drug problems. Nevertheless, either de jure or de facto decriminalization of personal drug possession is a necessary condition for mitigating this crisis. (shrink)

Objective: The dopamine hypothesis is one of the most influential theories of the neurobiological background of schizophrenia (SCZ). However, direct evidence for abnormal dopamine-related subcortical-cortical circuitry disconnectivity is still lacking. The aim of this study was therefore to test dopamine-related substantia nigra (SN)-based striato-thalamo-cortical resting-state functional connectivity (FC) in SCZ. Method: Based on our a priori hypothesis, we analyzed a large sample resting-state functional magnetic resonance imaging (fMRI) dataset from first-episode drug-naïve SCZ patients (n = 112) and healthy controls (...) (n = 82) using the SN as the seed region for an investigation of striato-thalamo-cortical FC. This was done in the standard band of slow frequency oscillations and then in its subfrequency bands (Slow4 and Slow5). Results: The analysis showed in SCZ: (1) reciprocal functional hypo-connectivity between SN and striatum, with differential patterns for Slow5 and Slow4; (2) functional hypo-connectivity between striatum and thalamus, as well as functional hyper-connectivity between thalamus and sensorimotor cortical areas, specifically in Slow4; (3) correlation of thalamo-sensorimotor functional hyper-connectivity with psychopathological symptoms. Conclusions: We demonstrate abnormal dopamine-related SN-based striato-thalamo-cortical FC in slow frequency oscillations in first-episode drug-naive SCZ. This suggests that altered dopaminergic function in the SN leads to abnormal neuronal synchronization (as indexed by FC) within subcortical-cortical circuitry, complementing the dopamine hypothesis in SCZ on the regional level of resting-state activity. (shrink)

Despite recent increasing support for the brain disease model of alcohol and drug addiction, the extent to which the model may clinically impact addiction treatment and client behaviour remains unclear. This qualitative study explored the views of community-based clinicians in Australia and examined: whether Australian community-based clinicians support the BDM of addiction; their attitudes on the impact the model may have on clinical treatment; and their views on how framing addiction as a brain disease may impact addicted clients’ behaviour. (...) Six Australian community-based clinicians participated in semi-structured in-depth interviews that were analysed using thematic analysis. Whilst the BDM was not fully supported by this purposive sample of Australian community-based clinicians, there was acceptance that addiction neuroscience formed a key part of a wider addiction framework. Participants believed the BDM ignored key social, psychological and environmental factors important for successful treatment. The BDM was seen as potentially irrelevant for certain client types, however the model was believed to integrate with particular therapies. Participants believed that for clients viewing their addiction in terms of a brain disease, there were potential positive and negative impacts on client behaviour. Implications for addiction treatment practice and public health policy are discussed. (shrink)

This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous benefit (...) of the sccentific doubt, which is not consistent with the best interests of patients. Interpretative flexibility, the burden of proof falling on regulators and their trust in, and dependence on, industrial scientists facilitates that distribution of the benefit of the scientific doubt. However, regulatory authorities' need for viability and the rationality common to opposing scientific views suggest that it is possible, in principle, to alter this dominant trend. To achieve adequate patient protection, drug regulation in the United Kingdom and the United States requires extensive reform. Some preliminary policy changes are sketched. (shrink)

Charland's article suggests that we need to think more about whether decision-making capacity is impaired in severe addiction, working from the idea that drug dealers rely on this understanding of addiction to draw in their clients. Charland argues that it is possible to make a choice without being in control (to make decisions without having decision-making capacity). I argue in support of Charland's ideas by examining the reasons supporting a medical model of addiction and its importance. (For Charland's article (...) and the full set of commentaries, please see the Research Gate link). (shrink)

It is a commonplace of the critical innovation literature that experiment has replaced mass production as the driving force of accumulation. But while many theorists have explored the politics and dynamics of such economies of experiment under the rubric of ‘immaterial’, cognitive or affective labour, few have examined the intersection of labour, experiment and the speculative in the clinic. Taking the clinic as representative of contemporary transformations in the commodity-form, labour and innovation, this article will look at recent attempts to (...) reform the clinical trial, arguing that these developments represent a far-reaching shift in our understanding of medicine. First, I investigate recent efforts (associated with the discourse of ‘translational medicine’) to rethink the interface between experimental lab-based science and the clinic. I also look at closely associated efforts to reintroduce an element of experimental surprise into the clinical trial process itself, through the adoption of novel trial designs. If the randomized controlled trial was conceived essentially along the lines of a product testing procedure, recent efforts have attempted to reintroduce surprise into the testing process itself – in other words, to invent a trial process capable of producing unexpected events as leads for further innovation. I then move from the experimental clinic to what I call the distributed experiment. Here I focus on efforts to outsource pharmacological innovation to a distributed public of patients through the use of social networking software. These platforms allow drug developers to escape the limits of the conventional clinical trial by tracking the experimental practices taking place in the distributed clinic of unregulated drug consumption. (shrink)

Rationale, aims and objectives To compare the pharmacotherapeutic approaches to diabetic hypertension of family physicians (FPs) and general practitioners (GPs). Methods A retrospective prescription-based study was conducted in 15 out of a total of 20 health centres, involving 115 primary care physicians – 77 FPs and 38 GPs, representing 74% of the primary care physicians of Bahrain. Prescriptions were collected during May and June 2000 to comprise a study population of 1266 diabetic-hypertensive patients. Results As monotherapy, angiotensin-converting enzyme (ACE) inhibitors (...) (37.9%) and β-blockers (38.3%) were the most commonly prescribed classes of antihypertensives by FPs and GPs, respectively. Calcium channel blockers (CCBs) were ranked third by both categories of physicians. For two-drug combinations, a β-blocker and an ACE inhibitor was the combination of choice for both physician categories. Patients managed by the FPs were more likely to receive a β-blocker–CCB combination (17.4 vs. 14.9%) or a diuretic–ACE inhibitor combination (16.7 vs. 11.4%) and less likely to receive a β-blocker–diuretic combination (11.8 vs. 16.7%) than those managed by the GPs. The proportion of patients receiving antihypertensive combinations was 40.6 and 38.5% for FPs and GPs, respectively. While the GPs prescribed CCB as a monotherapy to the elderly most often, the FPs choice was a β-blocker. Diuretics were less preferred by both FPs and GPs. β-Blocker–ACE inhibitor was again the most preferred combination of both FPs and GPs. FPs prescribed CCB–β-blocker combinations more often than GPs (P = 0.01), whereas CCB–ACE inhibitor combinations were less preferred (P = 0.09). A trend towards excessive use of short-acting nifedipine as monotherapy for elderly patients, both by FPs and by GPs, was noticed. Glibenclamide, alone or in combination with metformin, was the foremost antidiabetic drug prescribed by FPs and GPs. Middle-aged (45–64 years) patients seen by GPs were more likely to receive glibenclamide than those treated by FPs (P = 0.001) and less likely to receive gliclazide (P = 0.01). Combinations of a β-blocker with either glibenclamide or insulin were prescribed considerably more often by GPs.Conclusions Within the same practice setting, a substantial difference was observed between FPs and GPs in terms of preference for different classes of drugs in the management of diabetic hypertension. The compliance of both FPs and GPs was suboptimal; overall, the compliance of the FPs was closer to the recommended guidelines, however. Educational programmes should specifically address these inadequacies in order to improve the quality of health care. (shrink)

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to (...) compensate and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts’ perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social issues in order to (...) lead to socially responsible innovation. Semi-structured interviews were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers in two contexts of use. Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device, to use, and to user influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees’ judgments of acceptability. Giving consideration to researchers’ perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD. (shrink)

This article explores the claim that how we talk can inspire how we reason and act. Contemporary research suggests that the words militant Christian leaders in the Philippines use shape how they rationalize President Rodrigo Duterte’s war on drugs. Describing drug users as “sinners,” a trope in religious language, is particularly lethal. Using work on pragmatism and philosophy of language by Richard Rorty, Robert Brandom, and Lynne Tirrell, the author examines how the term “sinner” generates pernicious claims in the (...) drug war. It explores how the use of the term inspires hermeneutic uptake, redirects discursive focus, and engenders certain social and political actions in the Philippines. (shrink)

Chance and accidents play important roles in scientific discoveries, but they are not blind luck. Serendipity is not merely stumbling on things unsought for, it is the ability to see significances and find values in the things stumbled upon. Without this ability, accidents do not lead to discoveries, as Pasteur observed: “Chance favors the prepared mind.” What are the characteristics of a prepared mind in science? How do chance and serendipity work in scientific research in general and drug discovery (...) in particular? (shrink)

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current (...) standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school (...) in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

One of the main challenges in group therapy with drug-addicted patients is collective pseudomentalization, i.e., a group discourse consisting of words and clichés that are decoupled from any inner emotional life and are poorly related to external reality. In this study, we aimed to explore the phenomenology of pseudomentalization and how it was addressed by the therapist in an outpatient group for drug-addicted patients. The group was composed of seven members, and the transcripts of eight audio-recorded sessions were (...) rated and studied. The interventions of the therapist were measured with the mentalization-based group therapy adherence and quality scale by independent raters. Two sessions, one with the highest and one with the lowest adherence, were selected, and the clinical sequences of pseudomentalization were analyzed in a comparative way. The findings revealed that pseudomentalization does occur as a collective phenomenon, akin to “basic assumptions” of Wilfred Bion, which we reconceptualized in this study. Any pseudomentalization seemed to be reinforced by the therapist when she was presenting frequent and long interventions, when abstaining from the management of group boundaries, when providing questions focused more on content than on the mental states of the group members, and when not focusing on emotions. However, the ultimate source of collective pseudomentalization seemed to be the fear of the group members of being overwhelmed by painful emotions, mental confusion, and a loss of identity. The findings also indicated that the principles of MBT-G may be a good antidote to pseudomentalization. (shrink)

Non‐genetic forms of antimicrobial (drug) resistance can result from cell‐to‐cell variability that is not encoded in the genetic material. Data from recent studies also suggest that non‐genetic mechanisms can facilitate the development of genetic drug resistance. We speculate on how the interplay between non‐genetic and genetic mechanisms may affect microbial adaptation and evolution during drug treatment. We argue that cellular heterogeneity arising from fluctuations in gene expression, epigenetic modifications, as well as genetic changes contribute to drug (...) resistance at different timescales, and that the interplay between these mechanisms enhance pathogen resistance. Accordingly, developing a better understanding of the role of non‐genetic mechanisms in drug resistance and how they interact with genetic mechanisms will enhance our ability to combat antimicrobial resistance. Also see the video abstract here: https://youtu.be/aefGpdh-bgU. (shrink)

Two days following her arrest, a forty-four-year-old woman died in jail from aspiration pneumonia secondary to Untreated opiate withdrawal. The New York State Commission of Corrections concluded in its final report that had adequate medical evaluation and treatment been afforded, her death would have been prevented. A forty-six-year-old male with a history of alcohol dependence was arrested for trespassing and held in the county jail. Three days later he became agitated and aggressive. Following physician orders, deputies placed him in restraints. (...) He subsequently vomited and seized. Fifteen minutes later, he experienced respiratory arrest and died.These cases highlight a serious, but neglected problem in jails across the country: inadequate assessment and treatment of drug and alcohol withdrawal among arrestees. In this article, we show that untreated drug or alcohol withdrawal is associated with adverse outcomes including needless pain and suffering, medical morbidity, and in some instances, death. (shrink)

This study examines negotiations of motherhood among women in the illegal hard drug economy in Norway. Based on interviews with mothers who are users and dealers, this study analyzes four predominant maternal identities: grieving mothers, detached mothers, motherly dealers, and working mothers. Particularly relevant factors explaining variations in maternal identities include the timing of pregnancy, time spent with children, control over drug use, and place in the drug market hierarchy. By revealing patterns of intra-group variations by gender (...) performances and work situation, the study expands upon previous work on how mothers who are structurally disadvantaged negotiate motherhood ideals. (shrink)

I support the major theme of Heyman's target article that behavioral choice theory can enhance our understanding of drug dependence, but I raise concerns about the critique of the operant model of drug dependence, the underscoring of melioration to the exclusion of other theories of choice, and assertions about the unique effects of drug reinforcement.

This article explores the translation and migration of illegal drugs, humanistic therapies and political ideologies by focusing on China’s first residential community drug treatment center, called Sunlight. I argue that the migration of contemporary treatment therapies from one continent to another initiates certain practices that re-appropriate and remake drug-using bodies that live and work at Sunlight. Reviewing Sunlight ethnographically also allows for broader theoretical exploration. When bodies do not operate under the common trope of possessive individualism different forms (...) of biopolitical and therapeutic power are at play. In keeping with the theme of this special issue, this article begins with a discussion of why migration is a useful rubric for understanding how therapeutics and bodies become global entities and practices through the movement of three things: heroin, humanistic therapy and political ideology. It then presents an ethnographic slice of life at Sunlight to demonstrate how these practices and ideologies play out in the everyday. It finally returns to the question of why these therapies re-appropriate the post-socialist drug user’s body and psyche through a discussion of the term ‘psycho-sociability’. Psycho-sociability can be read as a demand for becoming a good biological citizen, as well as a theoretical rubric for explaining non-Western biopolitics. (shrink)

BackgroundPharmacists as the trustee of pharmacy services must adhere to ethical principles and evaluate their professionalism. Pharmacists may sometimes show different unethical behaviors in their interactions, so it is essential to understand these behaviors. The present study aimed to determine the challenges of ethical behaviors based on a principles-based approach in the area of drug supply in pharmacies.MethodsThis qualitative content analysis was conducted in Kerman in 2018. A number of key players in the field of medication supply were selected (...) using snowball sampling to interview. An effort was made to select samples with maximum variation. Exclusion criteria include having less than 3 years of work experience in pharmacy and supervision, not willing to participate in the interview, and not participating in the interview for 3 times. The participants in this study consisted of pharmacy technicians (n = 5), patients (n = 6), pharmacists (n = 8), inspectors of insurance companies (n = 4), and inspectors of food and drug administration (n = 3). Data were analyzed using directed content analysis by Maxqda software version 10 (VERBI Software, Berlin, Germany). The principles of “Beauchamp and Childress Ethics” theory including autonomy, beneficence, non-maleficence, and justice were selected as the main principles.ResultsAfter data analysis, 8 main categories and 26 subcategories were obtained. The main categories include patient privacy, patient independence, communication principles, patient-centered services, drug supplier, patient harm avoidance, supervision, and distributive, procedural, and interactional justice. The subcategories include increasing patient awareness, culturizing prescription, and rational drug use, confidentiality and privacy, and pharmacist-patient relationship/communication, which were the main ethical challenges in the area of drug supply at pharmacies.ConclusionsAccording to a principle-based approach, the greatest challenges were related to two principles of autonomy and beneficence. The policymakers in the healthcare system should emphasize patient independence, patient privacy, and patient-centered services. The results of this study can be used as a tool to introduce ethical challenges to policymakers and develop educational contents, the chart of professional ethics in pharmacies, and accreditation measures of pharmacies. (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)

For all its problems, the microeconomic theory had the appeal of making clear predictions about the effects of various drug policies. The emerging picture of the and of addiction is far more complex. Addiction scientists might help bridge the sciencewhomwhen” of addiction.

Chloroquine-resistant plasmodium falciparum malaria is a serious public health threat that is spreading rapidly across Sub-Saharan Africa. It affects over three quarters (80%) of malarial endemic countries. Of the estimated 300-500 million cases of malaria reported annually, the vast majority of malarial-related morbidities occur among young children in Africa, especially those concentrated in the remote rural areas with inadequate access to appropriate health care services. In Liberia, in vivo studies conducted between 1993 and 2000 observed varying degrees of plasmodium falciparum (...) malaria infections that were resistant to chloroquine, including sulfadiazine-pyrimethamine. As the country emerges from a prolonged civil war, the health care delivery system may not be adequately prepared to implement an effective nation-wide malarial control strategy. As a result, the management of uncomplicated malaria in Liberia poses a significant public health challenge for the government-financed health care delivery system. Therefore, based on extensive literature review, we report the failure of chloroquine as an effective first-line drug for the treatment of uncomplicated plasmodium falciparum malaria in Liberia and recommend that national health efforts be directed at identifying alternative drug(s) to replace it. (shrink)

Recent research shows that a faulty or sub‐optimally operating metabolic network can often be rescued by the targeted removal of enzyme‐coding genes – the exact opposite of what traditional gene therapy would suggest. Predictions go as far as to assert that certain gene knockouts can restore the growth of otherwise nonviable gene‐deficient cells. Many questions follow from this discovery: What are the underlying mechanisms? How generalizable is this effect? What are the potential applications? Here, I approach these questions from the (...) perspective of compensatory perturbations on networks. Relations are drawn between such synthetic rescues and naturally occurring cascades of reaction inactivation, as well as their analogs in physical and other biological networks. I specially discuss how rescue interactions can lead to the rational design of antagonistic drug combinations that select against resistance and how they can illuminate medical research on cancer, antibiotics, and metabolic diseases. Editor's suggested further reading in BioEssaysThe evolutionary context of robust and redundant cell biological mechanisms AbstractReprogramming cell fates: reconciling rarity with robustness Abstract. (shrink)

The article identifies a problem in socio-cultural-historical activity theory (SCHAT) with ignoring how hope and power constitute the theory itself, and suggests that this is why the tradition faces a bad choice between functionalist or utopianist reductions of its own social relevance. Currently, remedies for this kind of (perhaps shammed) innocence can be found in Foucauldian and Latourian approaches to knowledge. However, since these appear to presuppose the (often feigned) cynicism of a purely negative standpoint that fits all too smoothly (...) into the neoliberal management it describes, this presents us with an impossible choice or oscillation at another level. To get beyond it, we need the frankly self-reflected standpoint of ideology critique and the articulation of ‘concrete utopia’, i.e. real possibilities for social transformation. The approach is then realized and exemplified as part of an emergent practice research in the field of drug treatment. The field is broadly described as moving toward certain kinds of recognition of users’ standards, but also as filled with paradoxes that allow us to intervene with theory. One of these (sets of) paradoxes concerns the relations between state and civil (bourgeois) society that are played out in drug treatment. Contrary to the doxa of New Public Management, the (welfare) state’s normative power has not dissolved, only hides from itself. An immanent critique of practices and ideas in the field leads to the suggestion that its forms of recognition imply both submission of users, and the creation of positive standards and collectives. To intervene in this set of issues, we must expand the SCHAT reading of its own Hegelian-Marxist legacy, against the dominant liberal and scientistic trend, to engage with theories of recognition. A contemporary, participatory concept of recognition is sketched, which seeks to sublate (include and supersede) submission into the building of the generalizing ethics of a collective. (shrink)

Nationwide, almost 11% of women abuse drugs during their pregnancy. In some communities, these numbers are as high as 25–30%. Drug abuse is not limited to the poor or to African Americans, but is seen among affluent and white Americans as well. It is widespread, irrespective of race or social class. Annually, nearly 375,000 infants are exposed to drugs in America. Because of the terrible suffering caused by these births, and the conflicts caregivers experience in the treatment of these (...) infants, Trollope's quote is very apropos. Although caregivers have good motives in trying to rescue these babies and helping place them in a nurturing environment, despair about this objective is always close to the surface. (shrink)

Introducción: Se presenta un análisis cualitativo del acompañamiento psicosocial a jóvenes en condiciones de vulnerabilidad desde la ecología humana durante 12 meses entre 2010 a 2011; utilizando técnicas pedagógicas evaluativas participativas. Éstas, son una alternativa para crear espacios reflexivos con el propósito de potenciar la resiliencia en las relaciones comunicativas y formar en el respeto. Objetivo: Generar bienestar, prevenir la farmacodependencia y contribuir a la promoción de la salud. Material y Métodos: Se revisaron los antecedentes temáticos, fueron seleccionados 100 estudiantes (...) entre 11 y 19 años de dos instituciones educativas públicas en condiciones vulnerables;se desarrollaron cuatro talleres reflexivos y cuatro prácticas lúdicas y se realizaron tres grupos focales con estudiantes, profesores y padres de familia. Resultados y Discusión: El contexto social de la población intervenida, revela problemas de abuso sexual, violencia intrafamiliar y eventos violentos en el vecindario por grupos armados ilegales, entre otros, que constituyen factores de riesgo importantes para la farmacodependencia. Conclusión: Se infiere que lo psicosocial incide en la farmacodependencia, afectando la convivencia de la población estudiada por múltiples causas del orden psicoafectivo, sociocultural, económico y político que van desde el consumo cultural hasta la seguridad alimentaria. Introduction: A qualitative analysis of the psycho-social support to young people in situations of vulnerability from human ecology is presented for 12 months between 2010 to 2011; using participatory evaluative pedagogical techniques. These are an alternative to create reflective spaces with the purpose of enhancing resilience in communicative relationships and working in respect. Objective: to generate well-being, prevent drug abuse and contribute to the health promotion. Material aids and methods: the thematic background was reviewed, 100 students between 11 and 19 years of two public schools in vulnerable conditionswere selected; four reflective workshops and four playful practices were developed and three focus groups with students, teachers and parentswere conducted. Results and discussion: the social context of the manipulated population reveals sexual abuse problems, domestic violence and violent events in the neighborhood by illegal armed groups, among others, which constitutemajor risk factors for drug abuse. Conclusion: It can be inferred that the psychosocial factors impact on drug dependence, affecting the coexistence of the population studied by multiple causes of the psychological, socio-cultural, economic and political order, ranging from cultural consumption to food security. (shrink)

A novel data-driven model-free adaptive control approach is first proposed by combining the advantages of model-free adaptive control and data-driven optimal iterative learning control, and then its stability and convergence analysis is given to prove algorithm stability and asymptotical convergence of tracking error. Besides, the parameters of presented approach are adaptively adjusted with fuzzy logic to determine the occupied proportions of MFAC and DDOILC according to their different control performances in different control stages. Lastly, the proposed fuzzy DDMFAC approach is (...) applied to the control of particle quality in drug development phase of spray fluidized-bed granulation process, and its control effect is compared with MFAC and DDOILC and their fuzzy forms, in which the parameters of MFAC and DDOILC are adaptively adjusted with fuzzy logic. The effectiveness of the presented FDDMFAC approach is verified by a series of simulations. (shrink)