In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and (...) the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation. (shrink)

The first Volkskalender, according to Ernst Zinner, is found in an early-fifteenth-century manuscript in Augsburg. Written by Johannes Wissbier of Gmünd, or translated or copied by him, the text contains a Kalendarium and treatises on Aristotelian cosmology, the twelve signs of the zodiac, and the seven planets.

The nature of moral action versus moral judgment has been extensively debated in numerous disciplines. We introduce Virtual Reality (VR) moral paradigms examining the action individuals take in a high emotionally arousing, direct action-focused, moral scenario. In two studies involving qualitatively different populations, we found a greater endorsement of utilitarian responses–killing one in order to save many others–when action was required in moral virtual dilemmas compared to their judgment counterparts. Heart rate in virtual moral dilemmas was significantly increased when compared (...) to both judgment counterparts and control virtual tasks. Our research suggests that moral action may be viewed as an independent construct to moral judgment, with VR methods delivering new prospects for investigating and assessing moral behaviour. (shrink)

ABSTRACT In this article, we first document the virtually complete absence of infectious disease examples and concerns at the time bioethics emerged as a field. We then argue that this oversight was not benign by considering two central issues in the field, informed consent and distributive justice, and showing how they might have been framed differently had infectiousness been at the forefront of concern. The solution to this omission might be to apply standard approaches in liberal bioethics, such as autonomy (...) and the harm principle, to infectious examples. We argue that this is insufficient, however. Taking infectious disease into account requires understanding the patient as victim and as vector. Infectiousness reminds us that as autonomous agents we are both embodied and vulnerable in our relationships with others. We conclude by applying this reunderstanding of agency to the examples of informed consent and distributive justice in health care. (shrink)