119 research outputs found
Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA
This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after those drugs have passed through phase 1 clinical testing and have received FDA approval to enter additional clinical trials as a basis for eventual FDA approval for marketing. We make three arguments: (1) FDA staff face strong incentives to be too cautious in approving new drugs. As demonstrated by experience in cancer drug testing, patients often face a situation in which high-quality data from phase 1 clinical trials strongly indicate that a drug's benefits probably exceed its risks. (2) Permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs still in testing will not unduly discourage patient participation in additional trials or inhibit post-phase- randomized clinical trials needed to obtain FDA approval. This is evident from the widespread and growing phenomenon of post-approval randomized clinical trials of approved drugs. (3) For similar reasons, it is clear that permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs in testing will not discourage manufacturers from conducting additional randomized clinical trials.Health and Safety, Other Topics
Kinetic Energy and Complementary Kinetic Energy in Gyrodynamics
Fundamental Concepts Following Crandall (1957) and Tabarrok (1981), we adopt the concepts of kinetic energy T, and complementary kinetic energy T*, as analogies to potential energy V and complementary potential energy V*. Using generalized coordinates q, and generalized momenta p, of analytical mechanics, the kinetic energy of a scleronomic (i.e., where the time t does not appear explicitly) system with n-degrees-of-freedom is defined by while its complementary kinetic energy is with / = 1, 2, 3, ..., n. For a point mass m on a straight path q, as an example, Generalized velocities and generalized momenta are obtained by partial differentiation and defined by q T{ p) dp/ Pi = ^-T*(q,q
Voting and the Cardinal Aggregation of Judgments
The paper elaborates the idea that voting is an instance of the aggregation of judgments, this being a more general concept than the aggregation of preferences. To aggregate judgments one must first measure them. I show that such aggregation has been unproblematic whenever it has been based on an independent and unrestricted scale. The scales analyzed in voting theory are either context dependent or subject to unreasonable restrictions. This is the real source of the diverse 'paradoxes of voting' that would better be termed 'voting pathologies'. The theory leads me to advocate what I term evaluative voting. It can also be called utilitarian voting as it is based on having voters express their cardinal preferences. The alternative that maximizes the sum wins. This proposal operationalizes, in an election context, the abstract cardinal theories of collective choice due to Fleming and Harsanyi. On pragmatic grounds, I argue for a three valued scale for general elections
Progress in Classical and Quantum Variational Principles
We review the development and practical uses of a generalized Maupertuis
least action principle in classical mechanics, in which the action is varied
under the constraint of fixed mean energy for the trial trajectory. The
original Maupertuis (Euler-Lagrange) principle constrains the energy at every
point along the trajectory. The generalized Maupertuis principle is equivalent
to Hamilton's principle. Reciprocal principles are also derived for both the
generalized Maupertuis and the Hamilton principles. The Reciprocal Maupertuis
Principle is the classical limit of Schr\"{o}dinger's variational principle of
wave mechanics, and is also very useful to solve practical problems in both
classical and semiclassical mechanics, in complete analogy with the quantum
Rayleigh-Ritz method. Classical, semiclassical and quantum variational
calculations are carried out for a number of systems, and the results are
compared. Pedagogical as well as research problems are used as examples, which
include nonconservative as well as relativistic systems
Deriving and critiquing an empirically-based framework for pharmaceutical ethics.
Background: The pharmaceutical industry has been responsible for major medical advances, but the industry has also been heavily criticized. Such criticisms, and associated regulatory responses, are no doubt often warranted, but do not provide a framework for those who wish to reason systematically about the moral dimensions of drug development. We set out to develop such a framework using Beauchamp and Childress’s “four principles” as organizing categories. Methods: We conducted a qualitative interview study of people working in the “medical affairs” departments of pharmaceutical companies to determine: (1) whether our data could meaningfully be organized under the headings of “autonomy,” “beneficence,” “nonmaleficence,” and “justice”; (2) how principles might be expressed in this particular commercial setting; and (3) if these principles are expressed, whether and how competing principles are balanced. We then critiqued these findings using existing normative theory. Results: Our interviews demonstrated that three of Beauchamp and Childress’ four principles were salient to our participants: beneficence, non-maleficence, and justice. Within each of these principles, participants had two broad ethical orientations: an altruistic public focus (“other-ness”) and a commitment to their companies (“firm-ness”). Our participants also demonstrated efforts to balance these principles and highlighted the importance of phronesis (or practical wisdom) in balancing and enacting principles. Notably, however, our participants did not spontaneously emphasize the importance of autonomy. Conclusions: It is possible to use qualitative empirical research, together with normative analysis, to derive a framework for pharmaceutical ethics. We suggest that our framework would be useful for those who wish to reason ethically within, or in collaboration with, the pharmaceutical industry. Keywords: Empirical ethics, principle-based ethics, pharmaceutical industry, pharmaceutical ethics, qualitative researchNHMRC Career Development Fellowship APP106356
A New Triangular Hybrid Displacement Function Element for Static and Free Vibration Analyses of Mindlin-Reissner Plate
A new 3-node triangular hybrid displacement function Mindlin- Reissner plate element is developed. Firstly, the modified variational functional of complementary energy for Mindlin-Reissner plate, which is eventually expressed by a so-called displacement function F, is proposed. Secondly, the locking-free formulae of Timoshenko’s beam theory are chosen as the deflection, rotation, and shear strain along each element boundary. Thirdly, seven fundamental analytical solutions of the displacement function F are selected as the trial functions for the assumed resultant fields, so that the assumed resultant fields satisfy all governing equations in advance. Finally, the element stiffness matrix of the new element, denoted by HDF-P3-7β, is derived from the modified principle of complementary energy. Together with the diagonal inertia matrix of the 3-node triangular isoparametric element, the proposed element is also successfully generalized to the free vibration problems. Numerical results show that the proposed element exhibits overall remarkable performance in all benchmark problems, especially in the free vibration analyses
Dynamic analysis of an axially translating viscoelastic beam with an arbitrarily varying length
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