An analysis of common ethical justifications for compassionate use programs for experimental drugs

BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. MAIN BODY: The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT’s through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk (as they are already dying). Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. SHORT CONCLUSION: In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy

Enacting New Nordic terroir as rootless American innovation or soiled European tradition?

The governing of food quality and food security is often intertwined with regional development and the notion of terroir pivotal - not least when considering cheese production. Terroir, however, is primarily understood in a strictly European sense, accentuating soil and tradition. Drawing on readings of ‘dairy produce strategies’ and deploying a possible world induced STS attitude, a crude model for differentiating American and European enactments of terroir is investigated in this paper. I claim that in the US, geographical claims are ‘uprooted’ and generally highlight alethic modalities – centerstaging individual competence and innovation. Geographical claims in EU, on the other hand, steers towards communal practices and deontic modalities grounded in soil and tradition. Both food systems make use of sustainable claims, but render their authority from different institutions of legitimacy. In Europe the concept of collective regional enterprises or consortiums flourishes. In the US collective patrimony is less propagated, whereas privately owned farms and production facilities secure personal recognition through intellectual property

Dimensional reduction of dual topological theories

We describe the reduction from four to two dimensions of the SU(2) Donaldson-Witten theory and the dual twisted Seiberg-Witten theory, i.e. the Abelian topological field theory corresponding to the Seiberg--Witten monopole equations.Comment: LateX, 6 page

Symmetry protected topological phases of spin chains

Symmetry protected topological (SPT) phases are characterized by robust boundary features, which do not disappear unless passing through a phase transition. These boundary features can be quantified by a topological invariant which, in some cases, is related to a physical quantity, such as the spin conductivity for the quantum spin Hall insulators. In other cases, the boundary features give rise to new physics, such as the Majorana fermion. In all cases the boundary features can be analyzed with the help of an entanglement spectrum and their robustness make them promising candidates for storing quantum information. The topological invariant characterizing SPT phases is strictly only invariant under deformations which respect a certain symmetry. For example, the boundary currents of the quantum spin Hall insulator are only robust against non-magnetic, i.e. time-reversal invariant, impurities. In this thesis we study the SPT phases of spin chains. As a result of our work we find a topological invariant for SPT phases of spin chains which are protected by continuous symmetries. By means of a non-local order parameter we find a way to extract this invariant from the ground state wave function of the system. Using density-matrix-renormalization-group techniques we verify that this invariant is a tool to detect transitions between different topological phases. We find a non-local transformation that maps SPT phases to conventional phases characterized by a local order parameter. This transformation suggests an analogy between topological phases and conventional phases and thus give a deeper understanding of the role of topology in spin systems

Unwrapping The Northern Sea cheese - Enacting place in the Danish dairy food sector

The Nordic foodscape has changed radically over the last decade. In Scandinavia there is massive focus on a Nordic gourmet food evolution in general and in Denmark specifically also a cheese revolution. Notions of terroir and place specific foodstuffs are rapidly gaining interest in the Nordic countries. In the fall of 2008 Thise Mejeri won an annual Danish gourmet dairy prize with their speciality cheese ‘Vesterhavsost’. The judges noted that: “The cheese has character, and it has the “terroir” that we search for. It means that it is characterized by the origin of the milk, as well as the area of production and maturing. It has a good story” . The Vesterhavsost (Eng. ‘The Northern Sea cheese’) was thus inscribed in an (it seems) ever-growing trend towards food related site-specificity

The culture of market oriented organisations

This paper investigates the relationship between corporate culture and market orientation using a different methodology to those usually found done in empirical studies on this topic. Conventionally, one or two key informants provide information on the firm’s marketing practices in large scale quantitative cross-sectional studies; these few respondents provide their opinion on the firm’s actual marketing practices which are then considered as a reliable representation of both the (whole) firm’s culture and its market orientation. We have taken a different approach. Firstly, we chose to do multiple case studies in stead of cross sectional research. These case studies were small scale and qualitative; next a large(r) scale quantitative study was done within those organisations. Secondly, all employees in an organisation were invited to participate in the study: only then is it possible to measure culture as the shared beliefs in the company. Corporate culture itself as well as the marketing practices have been investigated as two separate constructs in our case studies. Both are measured via employee perceptions. Thirdly, we are looking at the possible configuration of market orientation and corporate culture. Almost all of the propositions generated are supported. The degree of openness appeared to be crucial to an organisation’s market orientation. Moreover, such a culture is also resultsoriented, employee-oriented and professional. It also has a balanced position on the two other dimensions: pragmatic/normative and loose/tight control. From the marketing perspective, the essential building blocks of a market oriented culture include: the internal cooperation, internal communication, drive to be the best, lack of pursuing self interest, learning from mistakes and from experiences in the market place, clarity about customer needs and better relative quality than competitors’. Because market orientation and corporate culture were measured as two distinct constructs, this study offers new insights in both domains as to what organisations should change to be(come) market oriented.Strategy;

The geometrical origin of the strain-twist coupling in double helices

The geometrical coupling between strain and twist in double helices is investigated. Overwinding, where strain leads to further winding, is shown to be a universal property for helices, which are stretched along their longitudinal axis when the initial pitch angle is below the zero-twist angle (39.4 deg). Unwinding occurs at larger pitch angles. The zero-twist angle is the unique pitch angle at the point between overwinding and unwinding, and it is independent of the mechanical properties of the double helix. This suggests the existence of zero-twist structures, i.e. structures that display neither overwinding, nor unwinding under strain. Estimates of the overwinding of DNA, chromatin, and RNA are given.Comment: 8 pages, 4 figures; typos fixed; added ref. and acknowledgemen