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

This study examines a moderated/mediated model of ethical leadership on follower job satisfaction and affective organizational commitment. We proposed that managers have the potential to be agents of virtue or vice within organizations. Specifically, through ethical leadership behavior we argued that managers can virtuously influence perceptions of ethical climate, which in turn will positively impact organizational members’ flourishing as measured by job satisfaction and affective commitment to the organization. We also hypothesized that perceptions of interactional justice would moderate the ethical (...) leadership-to-climate relationship. Our results indicate that ethical leadership has both a direct and indirect influence on follower job satisfaction and affective commitment. The indirect effect of ethical leadership involves shaping perceptions of ethical climate, which in turn, engender greater job satisfaction and affective organizational commitment. Furthermore, when interactional justice is perceived to be high, this strengthens the ethical leadership-to-climate relationship. (shrink)

Alexithymia is associated with emotion processing deficits, particularly for negative emotional information. However, also common are a high prevalence of somatic symptoms and the perception of somatic sensations as distressing. Although little research has yet been conducted on memory in alexithymia, we hypothesized a paradoxical effect of alexithymia on memory. Specifically, recall of negative emotional words was expected to be reduced in alexithymia, while memory for illness words was expected to be enhanced in alexithymia.Eighty-five high or low alexithymia participants viewed (...) and rated arousing illness-related , emotionally positive , negative , and neutral words . Recall was assessed 45 min later.High alexithymia participants recalled significantly fewer negative emotion words but also more illness-related words than low alexithymia participants. The results suggest that personal relevance can shape cognitive processing of stimuli, even to enhance retention of a subclass of stimuli whose retention is generally impaired in alexithymia. (shrink)

ABSTRACT:Regulatory focus theory is proposed as offering an explanation for the influence of ethical leadership on organizational citizenship behaviors and employee commitments. The prevention focus mindset of an employee is argued to be the mechanism by which an ethical leader influences extra-role compliance behavior as well as normative commitment, whereas the promotion focus mindset of an employee is argued to be the mechanism by which an ethical leader influences extra-role voice behavior as well as affective commitment. Moreover, leader-member exchange is (...) proposed as a moderator of the relationship of ethical leadership to regulatory focus mindsets and employee behavior and commitments. Using the data collected in two waves from 250 working adults, we tested the proposed relationships with moderated mediation bootstrap procedures. The findings generally support the hypothesized relationships and point toward important implications for ethical leadership in work settings. (shrink)

Several recent studies have demonstrated context-based, high-confidence misperceptions in hearing, referred to as false hearing. These studies have unanimously found that older adults are more susceptible to false hearing than are younger adults, which the authors have attributed to an age-related decline in the ability to inhibit the activation of a contextually predicted response. However, no published work has investigated this activation-based account of false hearing. In the present study, younger and older adults listened to sentences in which the semantic (...) context provided by the sentence was either unpredictive, highly predictive and valid, or highly predictive and misleading with relation to a sentence-final word in noise. Participants were tasked with clicking on one of four images to indicate which image depicted the sentence-final word in noise. We used eye-tracking to investigate how activation, as revealed in patterns of fixations, of different response options changed in real-time over the course of sentences. We found that both younger and older adults exhibited anticipatory activation of the target word when highly predictive contextual cues were available. When these contextual cues were misleading, younger adults were able to suppress the activation of the contextually predicted word to a greater extent than older adults. These findings are interpreted as evidence for an activation-based model of speech perception and for the role of inhibitory control in false hearing. (shrink)