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)

Once hematopoiesis is established in the bone marrow, a continuous egress of hematopoietic stem cells (HSCs) to the periphery occurs at a low frequency. It has been proposed that this phenomenon is part of a regenerative homeostatic mechanism that ensures the maintenance of hematopoiesis through the life of the individual. The administration of certain cytotoxic drugs or cytokines can enhance the mobilization of hematopoietic progenitors to the periphery. During the past 15 years, granulocyte‐colony stimulating factor (G‐CSF) has been used (...) as a standard cytokine for mobilization protocols in experimental models and in humans. Despite extensive efforts by multiple groups, a definitive mechanism explaining its role in mobilization has not been provided. In a recent paper, Katayama et al.,1 through a series of clever associations supported by well‐defined experimental systems, proposed that signals through the sympathetic nervous system modify the activity of the hematopoietic niche, acting as regulators of the mobilization of hematopoietic progenitors. This surprising finding adds a new level of complexity to the cellular milieu responsible for generation and maintenance of the hematopoietic niche. BioEssays 28: 687–691, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

Cancer drugs are broadly classified into two categories: cytotoxic chemotherapies and targeted therapies that specifically modulate the activity of one or more proteins involved in cancer. Major advances have been achieved in targeted cancer therapies in the past few decades, which is ascribed to the increasing understanding of molecular mechanisms for cancer initiation and progression. Consequently, monoclonal antibodies and small molecules have been developed to interfere with a specific molecular oncogenic target. Targeting gain‐of‐function mutations, in general, has been productive. (...) However, it has been a major challenge to use standard pharmacologic approaches to target loss‐of‐function mutations of tumor suppressor genes. Novel approaches, including synthetic lethality and collateral vulnerability screens, are now being developed to target gene defects in p53, PTEN, and BRCA1/2. Here, we review and summarize the recent findings in cancer genomics, drug development, and molecular cancer biology, which show promise in targeting tumor suppressors in cancer therapeutics. (shrink)

We formulate a dynamic model of vascular tumor growth, in which the interdependence of vascular dynamics with tumor volume is considered. The model describes the angiogenic switch; thus the inhibition of the vascularization process by antiangiogenic drugs may be taken into account explicitly. We validate the model against volume measurement data originating from experiments on mice and analyze the model behavior assuming different inputs corresponding to different therapies. Furthermore, we show that a simple extension of the model is capable of (...) considering cytotoxic and antiangiogenic drugs as inputs simultaneously in qualitatively different ways. (shrink)

The DNA hypomethylating agents (HMA) azacitidine (AZA) and decitabine (DAC) improve survival and transfusion independence in myelodysplastic syndrome (MDS) and enable a low intensity cytotoxic treatment for aged AML patients unsuitable for intensive chemotherapy, particularly in combination with novel agents. The proposed mechanism of AZA and DAC relies on active DNA replication and therefore patient responses are only observed after multiple cycles of treatment. Although extended dosing may provide the optimal scheduling, the reliance of injectable formulation of the (...) class='Hi'>drug limits it to intermittent treatment. Recently, an oral formulation of AZA demonstrated significantly improved patient relapse free survival (RFS) and overall survival (OS) when used as maintenance after chemotherapy for AML. In addition, both DAC and AZA were found to be highly effective to improve survival in elderly patients with AML through combination with other drugs. These recent exciting results have changed the therapeutic paradigm for elderly patients with AML. In light of this, we review current knowledge on HMA mechanism of action, clinical trials exploring dosing and scheduling, and recent HMA combination therapies to enhance efficacy. (shrink)

Exposure of man to chemical agents can occur intentionally, as in the treatment of disease, or inadvertently because the environment contains a wide range of synthetic or naturally occurring chemicals. The alkylating agents are a diverse group of compounds (Fig. 1) and comprise a good example of such xenobiotics, since much is known about their occurrence, and their biological effects include carcinogenicity, mutagenicity, toxicity and teratogenicity.Exposure to potentially carcinogenic alkylating agents such as nitrosamines may occur occupationally, from cigarette smoke, from (...) certain foodstuffs and even endogenously through the ingestion of the appropriate precursor chemicals.1 At the other extreme, the cytotoxic effects of agents such as the chloroethylating nitrosamides or mustards have been exploited in the design of certain antitumour drugs.2 The effectiveness of antitumour agents and the other, mostly adverse, biological effects of alkylating agents have been ascribed to their ability to damage cellular macromolecules, in particular DNA. This review concentrates on investigations carried out over the past two years on the role of DNA damage in carcinogenesis, but we shall see how recent advances in this area of research have also led to a better understanding of the mechanisms of the cytotoxic effects of alkylating antitumour agents. (shrink)

A mathematical model of the dynamics of the immune system is considered to illustrate the effect of its response to HIV infection, i.e. on viral growth and on T-cell dynamics. The specific immune response is measured by the levels of cytotoxic lymphocytes in a human body. The existence and stability analyses are performed for infected steady state and uninfected steady state. In order to keep infection under control, roles of drug therapies are analyzed in the presence of efficient (...) immune response. Numerical simulations are computed and exhibited to illustrate the support of the immune system to drug therapies, so as to ensure the decay of infection and to maintain the level of healthy cells. (shrink)

© Copyright 2015, Mary Ann Liebert, Inc..Signal transducer and activator of transcription factor 3 is hyperactivated in head and neck squamous cell carcinomas. Cumulative evidence indicates that IL-6 production by HNSCC cells and/or stromal cells in the tumor microenvironment activates STAT3 and contributes to tumor progression and drug resistance. A library of 94,491 compounds from the Molecular Library Screening Center Network was screened for the ability to inhibit interleukin-6 -induced pSTAT3 activation. For contractual reasons, the primary high-content screening campaign (...) was conducted over several months in 3 distinct phases; 1,068 primary HCS actives remained after cytotoxic or fluorescent outliers were eliminated. One thousand one hundred eighty-seven compounds were cherry-picked for confirmation; actives identified in the primary HCS and compounds selected by a structural similarity search of the remaining MLSCN library using hits identified in phases I and II of the screen. Actives were confirmed in pSTAT3 IC50 assays, and an IFNγ-induced pSTAT1 activation assay was used to prioritize selective inhibitors of STAT3 activation that would not inhibit STAT1 tumor suppressor functions. Two hundred three concentration-dependent inhibitors of IL-6-induced pSTAT3 activation were identified and 89 of these also produced IC50s against IFN-γ-induced pSTAT1 activation. Forty-nine compounds met our hit criteria: they reproducibly inhibited IL-6-induced pSTAT3 activation by ≥70% at 20 μM; their pSTAT3 activation IC50s were ≤25 μM; they were ≥2-fold selective for pSTAT3 inhibition over pSTAT1 inhibition; a cross target query of PubChem indicated that they were not biologically promiscuous; and they were ≥90% pure. Twenty-six chemically tractable hits that passed filters for nuisance compounds and had acceptable drug-like and ADME-Tox properties by computational evaluation were purchased for characterization. The hit structures were distributed among 5 clusters and 8 singletons. Twenty-four compounds inhibited IL-6-induced pSTAT3 activation with IC50s ≤20 μM and 13 were ≥3-fold selective versus inhibition of pSTAT1 activation. Eighteen hits inhibited the growth of HNSCC cell lines with average IC50s ≤ 20 μM. Four chemical series were progressed into lead optimization: the guanidinoquinazolines, the triazolothiadiazines, the amino alcohols, and an oxazole-piperazine singleton. (shrink)

In recent years, a debate has emerged on whether bodily sensations are typically accompanied by a sense of body ownership, namely a distinctive experience of one's body or body part as one's own. Realists about the sense of body ownership heavily rely on evidence from experimentally-induced bodily illusions (e.g., the rubber hand illusion) and pathological disownership syndromes (e.g. somatoparaphrenia). In this chapter, I will introduce novel evidence regarding body disownership syndromes induced by psychoactive drugs rather than pathological conditions, and discuss (...) its relevance to the debate on the sense of body ownership. (shrink)

Most people who are regular consumers of psychoactive drugs are not drug addicts, nor will they ever become addicts. In neurobiological theories, non-addictive drug consumption is acknowledged only as a “necessary” prerequisite for addiction, but not as a stable and widespread behavior in its own right. This target article proposes a new neurobiological framework theory for non-addictive psychoactive drug consumption, introducing the concept of “drug instrumentalization.” Psychoactive drugs are consumed for their effects on mental states. Humans (...) are able to learn that mental states can be changed on purpose by drugs, in order to facilitate other, non-drug-related behaviors. We discuss specific “instrumentalization goals” and outline neurobiological mechanisms of how major classes of psychoactive drugs change mental states and serve non-drug-related behaviors. We argue that drug instrumentalization behavior may provide a functional adaptation to modern environments based on a historical selection for learning mechanisms that allow the dynamic modification of consummatory behavior. It is assumed that in order to effectively instrumentalize psychoactive drugs, the establishment of and retrieval from a drug memory is required. Here, we propose a new classification of different drug memory subtypes and discuss how they interact during drug instrumentalization learning and retrieval. Understanding the everyday utility and the learning mechanisms of non-addictive psychotropic drug use may help to prevent abuse and the transition to drug addiction in the future. (shrink)

Philosophical and empirical research on bodily awareness has mostly focused so far on bodily disorders – such as anorexia nervosa, somatoparaphrenia, or xenomelia (body integrity dysphoria) – and bodily illusions induced in an experimental setting – such as the rubber hand illusion, or the thermal grid illusion. Studying these conditions can be illuminating to investigate a broad range of issues about the nature, function, and etiology of bodily experience. However, a number of psychoactive compounds can also induce a remarkably wide (...) variety of bodily effects that have received little attention despite their relevance to these issues. Some of these effects are similar to those associated with bodily disorders or experimental bodily illusions, while others appear to be unique. The purpose of this chapter is to provide an overview of these lesser known bodily effects of psychoactive compounds, and outline some ways in which they can bear on recent debates regarding bodily awareness and bodily ownership. (shrink)

Objectives: The aim of this study was to investigate the actual condition of the students of University of Rajshahi (RU) regarding drug abuse and addiction. Using case study method the research was conducted with four objectives: (a) to find out how respondents began drug abuse; (b) to discover the causes of their drug addiction; (c) to understand the process of their drug abuse; and (d) to find out the economic, social and health effects of drug (...) abuse. Methods: Case study method was used in this research. Through snowball sampling 18 drug- addicted students of RU were selected as respondents. In-depth interview with a schedule was used to collect data from the respondents in January 2019. Results: Findings of the study show that the causes of drug addiction included curiosity, frustration, friends’ request, neglect from family and friends etc. The drugs which they usually abused were Yaba, Phensydyle, Ganja (Weed), Chuani etc. Their average monthly expenditure for collecting drugs was in between Taka 8,000-10,000. They collected those drugs from rickshaw pullers at different points within the campus and from Mizaner Mor, Budhpara slum and other places outside the campus. The respondents opined that drugs were available if sufficient money could be spent. The respondents had senior and junior fellow students and local boys as companions while taking drugs. Most of them faced physical problems after taking drugs, and some of them tried to get rid of this curse of drug addiction. Conclusion: The findings of this research show that the rate of drug addiction among the students of RU was quite alarming. Therefore, all stakeholders including the students, guardians, teachers, university authority, the law makers and law enforcing agencies, researchers, civil society, NGO’s and the state must come forward together to combat this formidable foe. (shrink)

Drug exceptional access programs (DEAPs) exist across Canada to address gaps in access to pharmaceuticals. These programs circumvent standard procedures, raising epistemic, economic, social and political issues. This commentary provides insights into these issues by revealing the context and procedures on which these programs depend.

Cytotoxic lymphocytes play a central role in immune inflammatory responses against tumour cells, viruses and cells transplanted or infected with intracellular bacteria. The pivotal importance of lymphocytes in each of these immune responses has justified our continued interest in their cytotoxic function. Recent studies of cytotoxic lymphocytes have involved the characterisation of recognition structures on cytotoxic lymphocytes and the definition of two mechanisms of cytotoxicity. In contrast to normal cell death, which occurs during embryonic development and (...) the formation and death of hematopoietic cell lineages, lymphocyte‐mediated cytotoxicity occurs in the context of an inflammatory response and the dying cells are lysed into the surroundings rather than phagocytosed. The roles of the two different forms of lymphocyte‐mediated cytotoxicity are quite distinct; however they both involve induction of an endogenous pathway of apoptosis in the targeted cell, and they do share features with all other forms of physiological cell death. (shrink)

The “hijacking” and “drug instrumentalization” models of psychoactive drug use predict opposite outcomes in terms of adaptive behavior and fitness benefits. Which is the range of applicability of each model? To answer this question, we need more data than those reported by studies focusing on medical, psychiatric, and legal problems in addicted users. An evolutionary analysis requires a much wider focus.

Studies have shown that both serotonin and glutamate receptor systems play a crucial role in the mechanisms underlying drug-induced synesthesia. The specific nature of these mechanisms, however, continues to remain elusive. Here we propose two distinct hypotheses for how synesthesia triggered by hallucinogens in the serotonin-agonist family may occur. One hypothesis is that the drug-induced destabilization of thalamic projections via GABAergic neuronal circuits from sensory areas leads to a disruption of low-level, spontaneous integration of multisensory stimuli. This sort (...) of integration regularly occurs when spatial and temporal attributes match. Destabilization of feedback loops, however, can result in incongruent experiences or binding of random thalamus activation with sensory input in a particular sensory modality. The second hypothesis builds on embodied cognition, cases in which visual images of external stimuli activate task-related neural regions. On this proposal, binding processes that do not normally generate awareness become accessible to consciousness as a result of decreased attentional discrimination among incoming stimuli. (shrink)

Science has needed a dispassionate valuation of psychoactive drugs, but a motivational analysis should be conducted with respect to long-term reward rather than reproductive fitness. Because of hyperbolic overvaluation of short-term rewards, an individual's valuation depends on the time she forms it and the times she will revisit it, sometimes making her best long-term interest lie in total abstinence.

Despite their centrality to medicine, drugs are not easily defined. We introduce two desiderata for a basic definition of medical drugs. It should: (a) capture everything considered to be a drug in medical contexts and (b) rule out anything that is not considered to be a drug. After canvassing a range of options, we find that no single definition of drugs can satisfy both desiderata. We conclude with three responses to our exploration of the drug concept: maintain (...) a monistic concept, or choose one of two pluralistic outcomes. Notably, the distinction between drugs and other substances is placed under pressure by the most plausible of the options available. (shrink)

We often get evidence concerning the reliability of our own thinking about some particular matter. This “higher-order evidence” can come from the disagreement of others, or from information about our being subject to the effects of drugs, fatigue, emotional ties, implicit biases, etc. This paper examines some pros and cons of two fairly general models for accommodating higher-order evidence. The one that currently seems most promising also turns out to have the consequence that epistemic akrasia should occur more frequently than (...) is sometimes supposed. But it also helps us see why this might not be a bad thing. (shrink)

Periodic and unexpected shortages of drugs, biologics, and even medical devices have become commonplace in the United States. When shortages occur, hospitals and clinics need to decide how to ration their available stock. When such situations arise, institutions can choose from several different allocation schemes, such as first-come, first-served, a lottery, or a more rational and calculated approach. While the first two approaches sound reasonable at first glance, there are a number of problems associated with them, including the inability to (...) make fine, individual patient-centered decisions. They also do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others. In this article I outline an ethically acceptable procedure for rationing drugs during a shortage in which demand outstrips supply. (shrink)

Intensive research is carried out to develop a disease-modifying drug for Alzheimer’s disease. The development of drug candidates that reduce Aß or tau in the brain seems particularly promising. However, these drugs target people at risk for AD, who must be identified before they have any, or only moderate, symptoms associated with the disease. There are different strategies that may be used to identify these individuals. Each of these strategies raises different ethical challenges. In this paper, we analyse (...) these challenges in relation to the risk stratification for AD necessary for using these drugs. We conclude that the new drugs must generate large health benefits for people at risk of developing AD to justify the ethical costs associated with current risk stratification methods, benefits much larger than current drug candidates have. This conclusion raises a new set of ethical questions that should be further discussed. No data are available. (shrink)

Each of the antiretroviral drugs that are currently used to stop the progression of HIV infection causes its own specific side effects. Despite the expansion, multiplication, and simplification of treatment options over the past decade, side effects continue to affect people living with HIV. Yet, we see a clear disconnect between the way side effects are normalized, routinized, and framed in clinical practice and the way they are experienced by people living with HIV. This paper builds on the premise that (...) new approaches are needed to understand side effects in a manner that is more reflective of the subjective accounts of people living with HIV. Drawing on the work of Deleuze and Guattari, it offers an original application of the theory of ‘assemblage’. This theory offers a new way of theorizing side effects, and ultimately the relationship between the body and antiretroviral drugs (as technologies). Combining theory with examples derived from empirical data, we examine the multiple ways in which the body connects not only to the drugs but also to people, things, and systems. Our objective is to illustrate how this theory dares us to think differently about side effects and allows us to originally (re)think the experience of taking antiretroviral drugs. (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)

Despite its lack of conceptual clarity and uniform definition, the term drug‐seeking is used frequently by nurses from a variety of practice environments. The drugs patients are referred to as seeking are often pain medications. This is important because nursing has widely adopted a patient‐centric definition of pain. Nursing also has a robust ethical code that places high value on human dignity and nurses’ role in patient advocacy. A review of literature was conducted with the aims of describing whether/how (...) the term drug‐seeking has changed over time and to determine whether the use of the term in nursing literature is consistent with nursing values. Use of the term has shifted from objective counts of patient requests for medication to a confusing mixture of observable patient behavior and subjective interpretations of patient motivation. Its use is not consistent with nursing values. It is, in fact, a good illustration of stigmatization in nursing. Stigmatization is contrary to nursing values. Nurses in practice, research, education, authors, reviewers, and editors all have a role in ending this stigmatization. (shrink)

Why is the American policy debate not focused more intensely on the relative merits or demerits of our current approach to drugs and of possible alternatives to it? The lack of discussion of this issue is rather striking, given that America has the most serious drug problem in the world, that alternatives to a prohibitionist approach are under serious consideration in other countries, and that the grounds for reconsidering our current approach are, I shall argue, so weighty. -/- One (...) consideration that tells against our present approach to drugs is that prohibition simply does not work. For we have, after all, been pursuing this approach in the case of heroin since the Harrison Narcotic Act of 1914, and what has been the outcome? We have the worst heroin problem in the world. Moreover, our brief experiment in banning the consumption of what is undoubtedly our most harmful drug, alcohol, during Prohibition, turned out to be an utter failure. -/- A second consideration, often noted is the striking difference in our treatment of drugs such as alcohol and nicotine, on the one hand, and drugs such as marijuana, heroin, and LSD, on the other. This difference is so familiar that it may no longer seem strange. If so, it is worth asking the following question. If you were on a desert island, with a plentiful supply of both tobacco plants and opium poppies, and you knew that your son or daughter was going to wind up addicted either to nicotine or to heroin, which would you prefer? If your choice is nicotine you have chosen a drug that, according to the testimony of most heroin addicts, is the more addictive of the two drugs. In addition, given access to heroin that has not been combined with dangerous chemicals, your son or daughter could be a lifelong addict without suffering serious organ damage. But a lifelong addiction to tobacco is often, of course, a very different story. -/- In this article, then, I consider in detail perhaps the two most important reasons for reconsidering our current drug policy: first, the difficulty of providing any adequate justification for the restrictions that prohibitive laws place on people's liberty, and secondly, the enormous social and personal cost associated with a prohibitionist approach. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

A critical survey of arguments for and against the morality and the legality of recreational drug use, deploying Feinberg's analysis of liberty-limiting principles.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light (...) of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and (...) efficacy of the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions. (shrink)

The legalization of cannabis in Canada instantiates principles of harm-reduction and safe supply. However, in-depth understanding of values at stake and attitudes toward legalization were not part of extensive democratic deliberation. Through a qualitative exploratory study, we undertook 48 semi-structured interviews with three Canadian stakeholder groups to explore opinions and values with respect to the legalization of cannabis: (1) members of the general public, (2) people with lived experience of addiction and (3) clinicians with experience treating patients with addiction. Across (...) all groups, participants tended to be in favor of legalization, but particular opinions rested on their viewpoint as stakeholders. Clinicians considered the way legalization would affect an individual’s health and its potential for increasing rates of addiction on a larger scale. People with lived experience of addiction cited personal autonomy more than other groups and stressed the need to have access to quality information to make truly informed decisions. Alternatively, members of the public considered legalization positive or negative in light of whether one’s addiction affected others. We elaborate on and discuss how scientific evidence about drug use impact values relates and how can different arguments play in democratic debates about legalization. (shrink)

Through the 1960s, many people claimed that drug advertising was educational and physicians often relied on it. Continuing Medical Education (CME) was developed to provide an alternative. However, because CME relied on grants, industry funders chose the subjects offered. Now policymakers worry that drug firms support CME to promote sales and that commercial support biases prescribing and fosters inappropriate drug use. A historical review reveals parallel problems between advertising and industry-funded CME. To preclude industry influence and improve (...) CME, we should ensure independent funding by taxing medical industries, facilities and physicians. Independent public and professional authorities should create CME curricula. An independent agency should allocate all funds to educational institutions for approved curricula. (shrink)