Pharmacy Benefit Managers (PBM) induce drug manufacturers to offer rebates to insurers and employers by denying coverage through formulary exclusions, impeding physician prescription through prior authorization, and reducing patient drug use through cost sharing. As they tighten these access obstacles, PBMs reduce the net prices received by the manufacturers.

A lack of transparency and concerns over patients costs at the pharmacy counter have increased Congressional focus on pharmacy benefits management practices. However, applying regulations without transparency into pharmacy benefits managers practices could do more harm than good.

Recently, Congress has focused on reforms to address pharmacy benefit managers’ (PBMs) role in high drug prices for patients. Congress must not excessively restrict PBMs’ ability to negotiate with manufacturers; alternatively, reforms could be paired with other policies that address the high prices of brand-name drugs.

To improve the value of pharmaceutical spending, some manufacturers and payers have introduced outcomes-based contracts, where rebates are tied to specified outcomes. We reviewed the literature and interviewed key experts to assess these contracts' potential to slow pharmaceutical spending. We found that while outcomes-based contracts are increasingly common in the US, they are still limited by multiple factors — including the lack of meaningful outcomes data. Moreover, there is no evidence to date that they slow pharmaceutical spending or increase (...) access. Experts favored having CMS test and rigorously evaluate this model to achieve a better understanding of the implications. (shrink)

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

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

There is converging evidence that high doses of hallucinogenic drugs can produce significant alterations of self-experience, described as the dissolution of the sense of self and the loss of boundaries between self and world. This article discusses the relevance of this phenomenon, known as “drug-induced ego dissolution (DIED)”, for cognitive neuroscience, psychology and philosophy of mind. Data from self-report questionnaires suggest that three neuropharmacological classes of drugs can induce ego dissolution: classical psychedelics, dissociative anesthetics and agonists of the kappa (...) opioid receptor (KOR). While these substances act on different neurotransmitter receptors, they all produce strong subjective effects that can be compared to the symptoms of acute psychosis, including ego dissolution. It has been suggested that neuroimaging of DIED can indirectly shed light on the neural correlates of the self. While this line of inquiry is promising, its results must be interpreted with caution. First, neural correlates of ego dissolution might reveal the necessary neurophysiological conditions for the maintenance of the sense of self, but it is more doubtful that this method can reveal its minimally sufficient conditions. Second, it is necessary to define the relevant notion of self at play in the phenomenon of DIED. This article suggests that DIED consists in the disruption of subpersonal processes underlying the “minimal” or “embodied” self, i.e., the basic experience of being a self rooted in multimodal integration of self-related stimuli. This hypothesis is consistent with Bayesian models of phenomenal selfhood, according to which the subjective structure of conscious experience ultimately results from the optimization of predictions in perception and action. Finally, it is argued that DIED is also of particular interest for philosophy of mind. On the one hand, it challenges theories according to which consciousness always involves self-awareness. On the other hand, it suggests that ordinary conscious experience might involve a minimal kind of self-awareness rooted in multisensory processing, which is what appears to fade away during DIED. (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)

Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision-making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze (...) these costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions. (shrink)

Regulatory agencies vary widely in their classification of FMT, with significant impact on patient access. This article conducts a global survey of national regulations and collates existing FMT classification statuses, ultimately suggesting that the human cell and tissue product designation best fits FMT's characteristics and that definitional objectives to that classification may be overcome.

The long-standing tradition of phenomenological psychopathology has been historically concerned with the nature of mental disorders, with a special focus on their basic experiential core. In the same way, much of the recent phenomenologically-inspired work in psychopathology consists in providing precise and refined tools for diagnosis, classification, and nosology of mental disorders. What is striking, however, is the lack of therapeutic proposals in this tradition. Although a number of phenomenological approaches refer positively to psychotherapeutic practices, psychopharmacological intervention has been mostly (...) neglected as a relevant field of attention. This work aims to fill this gap. We maintain that the convergence of phenomenological psychopathology and psychopharmacology exhibit a rich potential for mutual enlightenment, which unfolds into a more adequate psychopharmacological practice. Initially, after discussing Joanna Moncrieff’s drug-centered model of drug action we review some of the major findings in phenomenological literature regarding psychopharmacological treatment. Next, we suggest that Moncrieff’s drug-centered model can be seen as an important tool for improving clinical decision-making, by elucidating its inherent epistemic advantage when compared to mainstream models of drug action. As a result, the drug-centered model proves to be also patient-centered, by focusing on experiential alterations and helping to improve treatment outcomes. (shrink)

Why are people interested in money? Specifically, what could be the biological basis for the extraordinary incentive and reinforcing power of money, which seems to be unique to the human species? We identify two ways in which a commodity which is of no biological significance in itself can become a strong motivator. The first is if it is used as a tool, and by a metaphorical extension this is often applied to money: it is used instrumentally, in order to obtain (...) biologically relevant incentives. Second, substances can be strong motivators because they imitate the action of natural incentives but do not produce the fitness gains for which those incentives are instinctively sought. The classic examples of this process are psychoactive drugs, but we argue that the drug concept can also be extended metaphorically to provide an account of money motivation. From a review of theoretical and empirical literature about money, we conclude that (i) there are a number of phenomena that cannot be accounted for by a pure Tool Theory of money motivation; (ii) supplementing Tool Theory with a Drug Theory enables the anomalous phenomena to be explained; and (iii) the human instincts that, according to a Drug Theory, money parasitizes include trading (derived from reciprocal altruism) and object play. (Published Online April 5 2006) Key Words: economic behaviour; evolutionary psychology; giving; incentive; money; motivation; play; reciprocal altruism. (shrink)

Signaling complexes and networks are being intensely studied in an attempt to discover pathways that are amenable to therapeutic intervention. A challenge in this search is to understand the effect that the modulation of a target will have on the overall function of a cell and its surrounding neighbors. Protein‐interaction mapping reveals relationships between proteins and their impact on cellular processes and is being used more widely in our understanding of disease mechanisms and their treatment. The review discusses challenges and (...) breakthroughs in this new and evolving area and its impact on medicine. BioEssays 27:958–969, 2005. © 2005 Wiley Periodicals, Inc. (shrink)

Rebate has long been a crucial tool that has attracted researchers from a diverse range of fields including marketing and supply chain management. When a manufacturer uses a retailer for reaching end customers, the rebate strategy undertakes an additional dimension. Here we show whether the two rebate strategies, manufacturer rebate and channel rebate, can be the optimal choice for the manufacturer and the retailer. And we aim at full coordination with rebate. Game theory is exploited to identify the equilibrium rebate (...) decisions, which are fully characterized with two rebate strategies considering rebate sensitivity. Furthermore, we demonstrate how the decisions depend on parameters, such as market size, rebate redemption rate, and competition intensity in monopoly and duopoly supply chain systems. Our work also coordinates the supply chain with two coordination policies and examines if they can achieve full coordination. Counterintuitive findings suggest that the channel rebate with sensitivity and discrimination is not effective and the manufacturer rebate is the unique optimal option. Besides, the coordination can be realized with a centralized rebate in monopoly setting when the manufacturer forgoes her own interest. Then full coordination can be achieved in duopoly setting with a new coordination policy, rebate combination, given the redemption rate for the channel rebate is lower compared with the manufacturer rebate. Managerial insights are suggested that offering rebates with discrimination can have significant inventory and coordination policy implications and can lead to a double win under a well-controlled redemption rate. (shrink)

Volume 20, Issue 4, May 2020, Page 102-103.

The ambiguities and overspecificities of prescription semantics along with their lack of standardization hinders the adoption of electronic prescriptions in some countries, limit data interoperabil...

Medical professionals often deny patients who inject opioids a second or third heart valve replacement, even if such a surgery is medically indicated. However, such a position is not well defended. As this paper demonstrates, the ethical literature on the topic too often fails to develop and apply an ethical lens to analyse the issue of multiple valve replacements. This paper addresses this lacuna by analysing the case of Mr Walsh, a composite case which protects the identity of any one (...) patient, through the principlist approach of Beauchamp and Childress. It argues that the hospital should offer Mr Walsh, a second valve replacement because the procedure is: medically indicated, autonomously requested, non-maleficent, beneficent and does not violate a formal account of justice. The paper concludes with clinical ethical guidelines for valve surgery for patients with opioid use disorder. (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)

This essay outlines the moral dilemma of funding orphan drug research and development. To date, ethical aspects of priority setting for research funding have not been an issue of discussion in the bioethics debate. Conflicting moral obligations of beneficence and distributive justice appear to demand very different levels of funding for orphan drug research. The two types of orphan disease, rare diseases and tropical diseases, however, present very different ethical challenges to questions about allocation of research funds. The (...) dilemma is analysed considering utilitarian and rights based theories of justice and moral obligations of non-abandonment and a professional obligation to advance medical science. The limitations of standard economic evaluation tools and other priority setting tools used to inform health policy decision makers on research funding decisions are outlined. (shrink)

The unprecedented outbreak of Ebola virus disease in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on (...) the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics. (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)

The American Journal of Bioethics, Volume 12, Issue 7, Page 23-25, July 2012.

This article probes the advisability of regulating U.S. food and drug safety according to the precautionary principle. To do so, a precautionary regulatory regime is formulated on the basis of the beliefs that motivate most proponents of this initiative. That hypothetical regime is critically analyzed on the basis of an actual instantiation of a similarly stylized initiative. It will be argued that the precautionary principle entails regulatory constraints that are apt to violate basis tenets of political legitimacy. The modifications (...) that would change this finding would also change precautionary regulation to the point that it would be indistinguishable from orthodox safety protocols. It is concluded on the basis of its impoverished content that the precautionary principle should not be taken seriously as a formal approach to the regulation of U.S. food and drug safety. (shrink)

We examined amygdala subregion volumes in patients with a first episode of major depression and in healthy subjects. Covariate-adjusted linear regression was performed to compare the MD and healthy groups, and adjustments for age, gender, and total estimated intracranial volume showed no differences in amygdala subregion volumes between the healthy and MD groups. Within the MD group, we examined the association between amygdala subregion volume and the 17-item Hamilton Rating Scale for Depression score and the HAMD subscale score, and found (...) no association in the left amygdala. In the right amygdala, however, there was an inverse linear association between the HAMD total and the HAMD core and lateral nucleus and anterior-amygdaloid-regions. Furthermore, an inverse linear association was seen between the HAMD psychic and the lateral nucleus, anterior-amygdaloid-regions, transition, and whole amygdala. The findings of this study suggest that the severity of MD and some symptoms of MD are associated with right amygdala volume. There have been few reports on the relationship between MD and amygdala subregional volume, and further research is needed to accumulate more data for further validation. (shrink)

Tieu, Matthew The main results of the reports published on the efficacy and achievements of the Medically Supervised Injecting Centre in Kings Cross over the last decade of its operations are discussed. The reports do not provide any substantive evidence that the MSIC has achieved its objectives.

Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be (...) considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT. (shrink)

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...

The American Journal of Bioethics, Volume 12, Issue 1, Page 16-18, January 2012.