Effective therapies are now available that can stop the progression of HIV infection and significantly delay the onset of AIDS. The “highly active antiretroviral therapy” (HAART) is a combination of potent antiretroviral drugs such as viral protease inhibitors or nucleoside-analogue reverse-transcriptase inhibitors, that has a variety of serious side effects, including lipodystrophy, a pathology characterized by accumulation of visceral fat, breast adiposity, cervical fat-pads, hyperlipidemia, insulin resistance as well as fat wasting in face and limbs. There is still an open (...) debate that concerns the precise responsibility of HAART as well as metabolic pathways and mechanisms that are involved in the onset of lipodystrophy. The similarities with multiple symmetric lipomatosis (MSL), in which mitochondria impairment plays a crucial role, lead to the hypothesis that drug-induced damages to mitochondrial DNA are able to alter mitochondria functionality to an extent that is similar to what occurs in MSL. In addition, several evidences indicate that HAART is also linked to a deregulated production of tumour necrosis factor-α, which uses mitochondria as intracellular targets. In this paper, we review data concerning the role of mitochondria in the pathogenesis of lipodystrophy, and advance a unifying hypothesis involving either direct or indirect effects of the drugs employed during HAART. BioEssays 23:1070–1080, 2001. © 2001 John Wiley & Sons, Inc. (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)

This paper is a personal account of the events associated with the author’s work at the University of Toronto’s Hospital for Sick Children on a drug, deferiprone, for the treatment of thalassaemia. Trials of the drug were sponsored by the Canadian Medical Research Council and a drug company which would have been able, had the trials been successful, to seek regulatory approval to market the drug. When evidence emerged that deferiprone might be inadequately effective in a (...) substantial proportion of patients, the drug company issued legal threats when the author proposed informing her patients and the scientific community. Until protests were made by international authorities in her field of research, the hospital and university did not adequately support the author’s academic freedom and responsibilities as a medical practitioner. It is argued that underlying cause of this, and of other similar cases, is the political philosophy which is driving the commercialisation of universities and bringing about the deregulation of drug approval procedures. Together these changes constitute a serious threat to the public good. (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)

It is the central hypothesis of this paper that the mental states commonly referred to as altered states of consciousness are principally due to transient prefrontal cortex deregulation. Supportive evidence from psychological and neuroscientific studies of dreaming, endurance running, meditation, daydreaming, hypnosis, and various drug-induced states is presented and integrated. It is proposed that transient hypofrontality is the unifying feature of all altered states and that the phenomenological uniqueness of each state is the result of the differential viability (...) of various frontal circuits. Using an evolutionary approach, consciousness is conceptualized as hierarchically ordered cognitive function. Higher-order structures perform increasingly integrative functions and thus contribute more sophisticated content. Although this implies a holistic approach to consciousness, such a functional hierarchy localizes the most sophisticated layers of consciousness in the zenithal higher-order structure: the prefrontal cortex. The hallmark of altered states of consciousness is the subtle modification of behavioral and cognitive functions that are typically ascribed to the prefrontal cortex. The theoretical framework presented yields a number of testable hypotheses. (shrink)

Osteoporosis (OP) is a bone disease which affects a number of post‐menopausal females and puts many at risk for fractures. A large number of patients are taking bisphosphonates (BPs) to treat their OP and a rare complication is the development of atypical femoral fractures (AFF). No real explanations for the mechanisms underlying the basis for development of where AFF develop while on BPs has emerged. The present hypothesis will discuss the possibility that part of the risk for an AFF is (...) a secondary effect of BPs on a subset of vascular cells in a genetically at‐risk population, leading to localized deregulation of the endothelial cell (EC)‐bone cell‐matrix units in nutrient channels/canals of the femur and increased risk for AFF. This concept of targeting ECs is consistent with location of AFF in the femur, the bilateral risk for occurrence of AFF, and the requirement for long term exposure to the drugs. (shrink)

Lysine methylation has been traditionally associated with histones and epigenetics. Recently, lysine methyltransferases and demethylases – which are involved in methylation of non‐histone substrates – have been frequently found deregulated in human tumours. In this realm, a new discovery has unveiled the methyltransferase SMYD3 as an enhancer of Ras‐driven cancer. SMYD3 is up‐regulated in different types of tumours. SMYD3‐mediated methylation of MAP3K2 increases mutant K‐Ras‐induced activation of ERK1/2. Methylation of MAP3K2 prevents it from binding to the phosphatase PP2A, thereby impeding (...) the impact of this negative regulator on Ras‐ERK1/2 signals, leading to the formation of lung and pancreatic adenocarcinomas. Furthermore, depletion of SMYD3 synergises with a MEK inhibitor, currently in clinical trials, to block Ras‐driven pancreatic neoplasia. These results underscore the importance of lysine methylation in the regulation of signalling pathways relevant for tumourigenesis and endorse the development of drugs targeting unregulated lysine methylation as therapeutic agents in the struggle against cancer. (shrink)

The author critiques the expedient application of market valuation principles by the transnational corporations and other large firms in the Indian pharmaceutical industry on a number of issues like patents, pricing, irrational drugs, clinical trials, etc. He contends that ethics in business is chiseled and etched within the confines of particular social structures of accumulation. An ascendant neo-liberal social structure of accumulation has basically shaped these firms' sharp opposition to the Indian Patents Act, 1970, government administered pricing, etc. The author (...) contends that the practice of neo-liberal economics is strongly associated with a "one dimensional" ethics that privileges market valuation principles over all others. This seems to inevitably generate a social counter-movement that struggles for social protections. He critiques neo-liberal business practices from a perspective that derives from the work of the economic anthropologist Karl Polanyi. Before the present phase of liberalization in India, markets were "managed", but without a "welfare state" in place. Moving toward deregulation of the markets without a welfare state in place is unethical. Keeping the debilities of the institutional framework of public policy in mind, the author adopts a Polanyian perspective that places its trust and hope in the growing social legitimacy of the counter-movement in opposition to both neo-liberal business practices and the degenerate behavior of state agencies. (shrink)

The ubiquitin–proteasome system (UPS) is the major proteolytic pathway that degrades intracellular proteins in a regulated manner. Deregulation of the UPS has been implicated in the pathogenesis of many neurodegenerative disorders like Alzheimer's disease, Parkinson's diseases, Huntington disease, Prion‐like lethal disorders, in the pathogenesis of several genetic diseases including cystic fibrosis, Angelman's syndrome and Liddle syndrome and in many cancers. Multiple lines of evidence have already proved that UPS has the potential to be an exciting novel therapeutic target for (...) the treatment of these diseases. Here I review how aberrant functions of various genes have implicated UPS in many human disorders including neurodegeneration and cancers. I also discuss the finding that some proteasome inhibitors possess a therapeutic potential as drugs against many such diseases. BioEssays 30:1172–1184, 2008. © 2008 Wiley Periodicals, Inc. (shrink)

Human chromosome 11p15 comprises two imprinted domains important in the control of fetal and postnatal growth. Novel studies1-3 establish that imprinting at one of these, the IGF2-H19 domain, is epigenetically deregulated (with loss of DNA methylation) in Silver-Russell Syndrome (SRS), a congenital disease of growth retardation and asymmetry. Previously, the exact opposite epigenetic alteration (gain of DNA methylation) had been detected at the domain's ‘imprinting control region’ (ICR) in patients with Beckwith-Wiedemann Syndrome (BWS), a complex disorder of fetal overgrowth. However, (...) more frequently, BWS is caused by loss of DNA methylation at the ICR that regulates the second imprinted domain at 11p15. Interestingly, a similar epigenetic alteration (with loss of methylation) at a putative ICR on human chromosome 6q24, is involved in transient neonatal diabetes mellitus (TNDM), a congenital disease with intrauterine growth retardation and a transient lack of insulin. Thus, fetal and postnatal growth is epigenetically controlled by different ICRs, at 11p15 and other chromosomal regions. BioEssays 28: 453–459, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

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)

Focusing on the issue of the sexual abuse of children, I discuss the question of the relationship between changes in sexual politics and how we think about drives in the context of their relation to neoliberalism. This subject is so emotionally charged that a rational ediscussion of that which goes beyond our comprehension is almost impossible. Any doubt of an easy solution moves the doubter himself or herself into the domain of abuse. The sets of complex interrelated issues associated with (...) child sexual abuse deny any simple description or critique. I therefore approach the topic from three fronts which initially may seem quite separate but which will enable a new perspective and facilitate thinking about it. The first part of this article historicizes the topic. Here I present Ian Hacking’s (1996) work on knowledge, power and truth, which elucidates the crusading nature that the fight against sexual abuse has assumed. I then invoke Foucault’s reconstruction of the production of sexuality in the family in order to replace a position of straightforward moral disgust with the issue of power in the context of sexuality and drive construction. Hacking and Foucault serve as the conceptual bases for reviewing the infamous case of the Belgian child abuser Dutroux. 1 In the third part of the article my analysis is in the first instance focused on a theoretically informed critique of the news media, in particular European and German media. This Eurocentric study has global implications. Its aim is to make a first attempt to demonstrate a relationship between sex scandals and the demands and opportunities of the global free markets. (shrink)

The classical liberal approach to deregulation is based on the consecutive elimination of state regulatory activities and their substitution by competitive market structure. Increasing competition accompanied with decreasing arbitrary state agencies’ interventions will undoubtedly cultivate the behaviour of market agents and bring benefits to consumers.The classical liberal approach to deregulation is incompatible with the EU deregulation model, which in case of network industries is still based on the permanent existence of regulatory agencies, Third-Party-Access, public service liability, centralized (...) control of investments and the negative reciprocity. The adoption of these principals will at least delay deregulation process in transition economies but will likely preserve the cartel structure on the utility markets.Economics of regulation and implicitly economics of deregulation is a product of the Chicago School of Economics. Since current “deregulation process” leads to tighter regulation, the adequate term for it should be the reregulation.L’approche libérale classique de la réglementation repose sur l’élimination de la réglementation étatique et leur substitution par des structures marchandes concurrentielles. Une concurrence accrue et une diminution des interventions arbitraires de l’état ne pourront que modifier le comportement des agents sur le marché et engendrer des bénéfices pour les consommateurs.L’approche de la déréglementation du libéralisme classique est incompatible avec le modèle de déréglementation de l’Union Européenne : dans le cas des industries en réseau, ce dernier demeure fondé sur l’existence continue d’agences de réglementation, la responsabilité du service public, le contrôle centralisé des investissements et la réciprocité négative. L’adoption de ces principes aura pour effet au moins de retarder le processus de déréglementation dans les économies en transition et probablement aussi de préserver la structure cartellisée des marchés de services publics.L’économie de la réglementation, et par implication, l’économie de la déréglementation est une contribution émanant de l’Ecole d’Economie de Chicago. Parce que les “processus de déréglemen- tation” en vigueur induisent des réglementations plus drastiques, l’expression appropriée devrait plutôt être la re-réglementation. (shrink)

Robert Nozick, in what is surely one of the most intriguing and provocative footnotes in modern philosophical writing, referred in Anarchy,StateandUtopia to the notion of a In keeping with the central arguments of that text, his suggestion was that choices about the genetic composition of future generations should, as far as possible, be left in the hands of private individuals, and should not be determined or restricted by the state. This free market in genetic screening would meet and would possess (...) In short, prospective parents would be allowed, to whatever extent was rendered possible by current technology, to choose the genetic traits of their future children. (shrink)

Mutations in enhancer‐associated chromatin‐modifying components and genomic alterations in non‐coding regions of the genome occur frequently in cancer, and other diseases pointing to the importance of enhancer fidelity to ensure proper tissue homeostasis. In this review, I will use specific examples to discuss how mutations in chromatin‐modifying factors might affect enhancer activity of disease‐relevant genes. I will then consider direct evidence from single nucleotide polymorphisms, small insertions, or deletions but also larger genomic rearrangements such as duplications, deletions, translocations, and inversions (...) of specific enhancers to demonstrate how they have the ability to impact enhancer activity of disease genes including oncogenes and tumor suppressor genes. Considering that the scientific community only fairly recently has begun to focus its attention on “enhancer malfunction” in disease, I propose that multiple new enhancer‐regulated and disease‐relevant processes will be uncovered in the near future that will constitute the mechanistic basis for novel therapeutic avenues. (shrink)

Mutations in enhancer‐associated chromatin‐modifying components and genomic alterations in non‐coding regions of the genome occur frequently in cancer, and other diseases pointing to the importance of enhancer fidelity to ensure proper tissue homeostasis. In this review, I will use specific examples to discuss how mutations in chromatin‐modifying factors might affect enhancer activity of disease‐relevant genes. I will then consider direct evidence from single nucleotide polymorphisms, small insertions, or deletions but also larger genomic rearrangements such as duplications, deletions, translocations, and inversions (...) of specific enhancers to demonstrate how they have the ability to impact enhancer activity of disease genes including oncogenes and tumor suppressor genes. Considering that the scientific community only fairly recently has begun to focus its attention on “enhancer malfunction” in disease, I propose that multiple new enhancer‐regulated and disease‐relevant processes will be uncovered in the near future that will constitute the mechanistic basis for novel therapeutic avenues. (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)

Early research on the cell cycle revealed correlations between protein accumulation and cell proliferation. In this review, I describe the data showing that abnormality of cell growth and tumor development are dependent upon oncogene‐induced increases in the levels and activity of factors that determine the rate of protein synthesis. It is proposed that the establishment of a vicious circle, namely oncoproteins → increase in translation → oncoproteins, is a major biological mechanism that fuels neoplastic growth. The constitutively high rates of (...) protein synthesis and accumulation of proteins, including those necessary for DNA replication and mitosis, would drive cells to excessive proliferation. (shrink)

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)

This is an issue of our quarterly journal Hume Papers on Public Policy - the journal of the David Hume Institute.

Behrendt & Young (B&Y) propose that a dysfunction in the reticular thalamic nucleus contributes to disinhibition of specific thalamic nuclei, allowing cortical attention mechanisms to engage thalamic relay neurons, causing underconstrained activation of the cortex and hallucinations. The following hypothesis challenges the notion of impaired sensory gating by providing the alternative view that hypofrontality reduces the power of incoming stimuli, causing internal drives to override consciousness, resulting in hallucinations.

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)

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.

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)

The weaponizing of scientific expertise to oppose regulation has been extensively studied. However, the relevant studies, belonging to the emerging discipline of agnotology, remain focused on the analysis of empirical corruption: of misinformation, doubt mongering, and other practices that cynically deploy expertise to render audiences ignorant of empirical facts. This paper explores the wrongful deployment of expertise beyond empirical corruption. To do so, I develop a broader framework of morally subversive expertise, building on recent work in political philosophy (Howard, 2016). (...) Expertise is subversive if it sets up its audience to fail morally, either intentionally or negligently. I distinguish three modes of subversive expertise: empirical subversion (the focus of agnotology), normative subversion and motivational subversion. Drawing on these distinctions, I offer a revisionary account of the Trump Administration’s regulatory science as a case study. I show that the Trump Administration’s use of expertise to dismantle climate regulation, contra the standard charge, cannot be explained using the resources of agnotology alone: the Administration produced highly reliable climate assessments, detailing the risks of climate change, candidly admitting the harms of its proposed policies, and still successfully deployed these findings to justify massive climate deregulation. The lesson of the analysis is that dismissing the expertise that underpins climate deregulation as empirically corrupt ‘anti-science’ both obscures its actual role in the politics of climate change and understates its wrongfulness: it misses the breadth of the assault on moral agency that sustains climate injustice. (shrink)

Against a wider background of rationales for deregulation within a modern economy, and as an exercise of subjecting a theory to the hard discipline of a particular case, a detailed analysis is given of a recent proposal for a form of deregulation for engineering in Ontario. The proposal of the Staff Study of the Professional Organizations Committee set up by the Ontario Government is analyzed in terms of its Posnerian foundations, and is critized theoretically, empirically and normatively. Attention (...) is drawn to two wider issues: the protection by self-regulating professionals of third parties against negative externalities, and the adverse effects of the proletarianization of professionals in large organizations. (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)

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 profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how (...) organized psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

A deregulation of medicines is currently underway in the U.K. and France. Emergency contraception has become available over the counter in pharmacies in both countries. This might constitute a further step in the liberalisation of contraception, something which has always received support from women’s organisations and from women themselves. It also forms part of a current revolution in patient behaviour. This article examines the law governing the deregulation of emergency contraception in the U.K. and France and assesses how (...) far this might serve to empower women to take control of their own reproductive health care provision. It considers some of the British feminist critiques of the limit to patient’s autonomy put forward by Sheldon(1998), Foster (1998), and Murphy (1998). (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we (...) show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (shrink)

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

Brian Earp and colleagues argue that the major harms associated with the use of illicit drugs largely arise from, or are at least exacerbated by, the fact that their use attracts criminal pe...

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)

Electricity deregulation was meant to improve the quality of people’s lives by lowering the cost of a critical commodity. In every state that has chosen deregulation, however, power companies, free from the oversight of state regulators, have increased prices and, in California’s case, have driven a utility to bankruptcy. It is clear that deregulation was intended to benefit the energy industry more than consumers by removing cost-based regulations that restricted corporate profits but guaranteed low prices and reliable (...) service to consumers. Deregulation proponents argued that California’s commitment to strong air quality standards prevented development of adequate power plant construction and that not a single power plant was constructed in California in the 1990s. This claim is refuted through an examination of California Energy Commission data. Although other states’ experiences are not as dramatic as California’s, serious problems will emerge if deregulation continues to dominate the policy agenda. (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)