Naked Price and Pharmaceutical Trade Secret Overreach

Trade secret has drifted from a quiet backwater doctrine to a pervasive force in intellectual property. As always, the risk of distortion is great when a legal arena is developing and expanding rapidly. Nowhere do the theoretical tensions of trade secret law appear in such stark relief as in the modern pharmaceutical debates, where the heart of the theoretical question involves whether pricing is a proper subject for trade secrecy claims. We aim to bring trade secret into greater harmony with broad concepts that reach across all intellectual property regimes. As with other areas of intellectual property law, trade secret law is not a mere contest of private commercial interests. Rather, it embeds substantial dedication to the public interest, reflecting utilitarian balancing of key societal interests. In this context, we develop the concept of “thin” trade secret, looking to the analogous concepts in other intellectual property regimes. Such approaches embody the recognition that intellectual property rights are not solid monoliths, presenting an impenetrable wall through which no party but the rights holder may pass. Rather, they are brilliantly nimble and subtle systems, deftly threading their way among various societal goals. This Article offers the potential of anchoring trade secret more firmly to its theoretical base, as well as bringing trade secret closer to the family of other intellectual property regimes. Although squabbling, chaotic, and somewhat dispersed, all members of this time-honored family can learn from each other, sharing their battleworn wisdom with the newest, young upstart

Scepticaemia: The impact on the health system and patients of delaying new treatments with uncertain evidence; a case study of the sepsis bundle [version 2; referees: 2 approved]

Background: A sepsis care bundle of intravenous vitamin C, thiamine, and hydrocortisone was reported to improve treatment outcomes. The data to support it are uncertain and decision makers are likely to be cautious about adopting it. The objective of this study was to model the opportunity costs in dollars and lives of waiting for better information before adopting the bundle. Methods: A decision tree was built using information from the literature. We modelled the impact of bundle adoption under three scenarios using a simulation in which the bundle was effective as reported in the primary trial, less effective based on other information, and ineffective. The measurements were health services costs, quality-adjusted life years, and transition probabilities. Results: If the bundle proves to be effective under either scenario, it will save billions of dollars and millions of life-years in the United States. This is the opportunity cost of delaying an adoption decision and waiting for better quality evidence. We suggest that hospital decision-makers consider implementing the bundle on a trial basis while monitoring costs and outcomes data even while the evidence base is uncertain. Conclusions: If the decision maker is unwilling to use the best available evidence now, but rather wishes to wait for definitive evidence they are risking incurring large costs for health care systems and for the patients they serve. An explicit analysis of uncertain clinical outcomes is a useful adjunct to guide decision making where there is clinical ambiguity. This approach offers a valid alternative to the default of clinical inactivity when faced with uncertainty

Manure amendments for mitigation of dairy ammonia and greenhouse gas emissions: preliminary screening

 Amendments can be practical and cost-effective for reducing ammonia [NH3] and greenhouse gas [GHG] emissions from dairy manure.  In this study, the effect of 22 amendments on NH3 and GHG carbon dioxide [CO2], methane [CH4] and nitrous oxide [N2O] emissions from dairy manure were simultaneous investigated at room temperature (20℃).  Dairy manure slurry (2 kg; 1:1.7 urine: feces; 12% total solids) was treated with various amendments, representing different classes of product, following the suppliers’ recommended rates.  In this screening of products, one sample of each amendment was evaluated along with untreated manure slurry with repeated measurements over 24 h.  Gas emissions were measured after short (3 d) and medium (30 d) storage duration using a photoacoustic multi-gas analyzer.  Six amendment products that acted as microbial digest, oxidizing agent, masking agent or adsorbent significantly reduced NH3 by >10% (P = 0.04 to <0.001) after both 3 and 30 d.  Microbial digest/enzymes with nitrogen substrate appeared effective in reducing CH4 fluxes for both storage times.  Most of the masking agents and disinfectants significantly increased CH4 in both storage periods (P = 0.04 to <0.001).  For both CH4 and CO2 fluxes, aging the manure slurry for 30 d significantly reduced gas production by 11 to 100% (P<0.001).  While some products reduced emissions at one or both storage times, results showed that the ability of amendments to mitigate emissions from dairy manure is finite and re-application may be required even for a static amount of manure.  Simultaneous measurement of gases identified glycerol as a successful NH3 reduction agent while increasing CH4 in contrast to a digestive-microbial product that significantly reduced CH4 while enhancing NH3 release.Keywords: methane, greenhouse gas, emission, amendment, additive, dairy manure, ammonia, mitigatio

Evaluation of odor emissions from amended dairy manure: preliminary screening

Manure amendments have shown variable effectiveness in reducing odor.  Twenty-two amendments were applied to dairy manure then evaluated for odor reduction efficacy after storage at 20℃ for 3 d and 30 d.  Amendments represented differing primary modes of action including: microbial digestive, oxidizing, disinfecting, masking, and adsorbent.  Each amendment was added to 2 kg dairy manure (1:1.7 urine:feces; 12% total solids) following recommended rates.  In this preliminary screening, one sample (n=1) of each amendment was evaluated along with untreated manure (Control).  Odor emission from each treated manure and Control was estimated twice by five or six qualified odor assessors (n=10 or 12) after each storage duration, using an international standard for triangular forced-choice olfactometry.  Odor quality was defined using hedonic tone, Labeled Magnitude Scale and ASTM methods for supra-threshold odor intensity, and an odor character wheel for descriptors.  For selected treatments, odor emissions were significantly reduced relative to Control at 30 d versus 3 d incubation (P<0.0001).  However, no amendment was significantly effective for both incubation times.  Likewise, for all amendments tested, aging the manure slurry for 30 d significantly reduced odor emission and odor intensity (P<0.0001).  A proprietary microbial amendment (Alken Enz-Odor + Clear Flo: aerobic/ facultative microbes with growth factors), disinfectant (hydrogen peroxide), and masking agent (Hyssopus officinalis essential oil) provided significant short-term control of odor (P <0.06).  However, after 30 d seven amendments significantly increased odor emission (P<0.02) while only two amendments offered a significant efficacy (P<0.0001): a proprietary microbial aerobic/facultative product (Bio-Regen) and a proprietary mix of chemicals (Greaseater), both with weekly re-application.  Hedonic tone observations suggested an improvement to “slightly to moderately unpleasant” smell versus untreated manure for all amendments except clinoptilolite zeolite adsorbent.  Hedonic tone improvement was correlated with reduced manure odor supra-threshold intensity.Keywords: odor, hedonic tone, odor strength, amendments, additives, dairy manure, United States of Americ

Diffusion kurtosis MRI as a predictive biomarker of response to neoadjuvant chemotherapy in high grade serous ovarian cancer

Abstract: This study assessed the feasibility of using diffusion kurtosis imaging (DKI) as a measure of tissue heterogeneity and proliferation to predict the response of high grade serous ovarian cancer (HGSOC) to neoadjuvant chemotherapy (NACT). Seventeen patients with HGSOC were imaged at 3 T and had biopsy samples taken prior to any treatment. The patients were divided into two groups: responders and non-responders based on Response Evaluation Criteria In Solid Tumours (RECIST) criteria. The following imaging metrics were calculated: apparent diffusion coefficient (ADC), apparent diffusion (Dapp) and apparent kurtosis (Kapp). Tumour cellularity and proliferation were quantified using histology and Ki-67 immunohistochemistry. Mean Kapp before therapy was higher in responders compared to non-responders: 0.69 ± 0.13 versus 0.51 ± 0.11 respectively, P = 0.02. Tumour cellularity correlated positively with Kapp (rho = 0.50, P = 0.04) and negatively with both ADC (rho = −0.72, P = 0.001) and Dapp (rho = −0.80, P < 0.001). Ki-67 expression correlated with Kapp (rho = 0.53, P = 0.03) but not with ADC or Dapp. In conclusion, Kapp was found to be a potential predictive biomarker of NACT response in HGSOC, which suggests that DKI is a promising clinical tool for use oncology and radiology that should be evaluated further in future larger studies

Haptic Guidance with a Soft Exoskeleton Reduces Error in Drone Teleoperation

Haptic guidance has been shown to improve performance in many fields as it can give additional information without overloading other sensory channels such as vision or audition. Our group is investigating new intuitive ways to interact with robots, and we developed a suit to control drones with upper body movement, called the FlyJacket. In this paper, we present the integration of a cable-driven haptic guidance in the FlyJacket. The aim of the device is to apply a force relative to the distance between the drone and a predetermined trajectory to correct user torso orientation and improve the flight precision. Participants (n=10) flying a simulated fixed-wing drone controlled with torso movements tested four different guidance profiles (three linear profiles with different stiffness and one quadratic). Our results show that a quadratically shaped guidance, which gives a weak force when the error is small and a strong force when the error becomes significant, was the most effective guidance to improve the performance. All participants also reported through questionnaires that the haptic guidance was useful for flight control

EUROfusion-theory and advanced simulation coordination (E-TASC): programme and the role of high performance computing

The paper is a written summary of an overview oral presentation given at the 1st Spanish Fusion HPC Workshop that took place on the 27th November 2020 as an online event. Given that over the next few years ITER will move to its operation phase and the European-DEMO design will be significantly advanced, the EUROfusion consortium has initiated a coordination effort in theory and advanced simulation to address some of the challenges of the fusion research in Horizon EUROPE (2021-2027), i.e. the next EU Framework Programme for Research and Technological Development. This initiative has been called E-TASC that stands for EUROfusion-Theory and Advanced Simulation Coordination. The general and guiding principles of E-TASC are summarized in the paper. In addition, an overview of the scientific results obtained in a pilot phase (2019-2020) of E-TASC are provided while highlighting the importance of the required progress in computational methods and HPC techniques. In the initial phase, five pilot theory and simulation tasks were initiated: 1. Towards a validated predictive capability of the L-H transition and pedestal physics; 2. Electron runaway in tokamak disruptions in the presence of massive material injection; 3. Fast code for the calculation of neoclassical toroidal viscosity in stellarators and tokamaks; 4. Development of a neutral gas kinetics modular code; 5. European edge and boundary code for reactor-relevant devices. In this paper we report on recent progress made by each of these projects.</p

An Experimental Analysis Of the Demand For Payday Loans

The payday loan industry is one of the fastest growing segments of the consumer financial services market in the United States. We design an environment similar to the one that payday loan customers face and then conduct a laboratory experiment to examine what effect, if any, the existence of payday loans has on individuals\u27 abilities to manage and to survive financial setbacks. Our primary objective is to examine whether access to payday loans improves or worsens the likelihood of financial survival in our experiment. We also test the degree to which people\u27s use of payday loans affects their ability to survive financially. We find that payday loans help the subjects to absorb expenditure shocks and therefore survive financially. However, subjects whose demand for payday loans exceeds a certain threshold level are at a greater risk than a corresponding subject in the treatment in which payday loans do not exist