The Patient Assistance Problem

Implemented in January 2006 as a voluntary enrollment supplement to standard Medicare plans, Medicare Part D coverage subsidizes the cost of prescription drugs for participants. However, significant gaps in coverage exist for those suffering from rare diseases that require costly drugs. Pharmaceutical companies seek to remove the powerful market force of patient price sensitivity by directly sponsoring or substantially funding “patient assistance programs” that help cover out-of-pocket costs. While pharmaceutical donors insist that their goal is strictly altruistic, the reality is that many of these programs offer a financial windfall for drug makers because they help funnel patients towards new pharmaceuticals with generic alternatives while collecting the drug’s market price at the expense of taxpayers. This Note argues that industry-sponsored patient assistance programs violate the anti-kickback statute and should be outlawed. To preserve a safety net of assistance while discouraging illegal activity, an industry-sponsored, CMS-administered fund should be established for the appropriate disbursement of pharmaceutical industry charity, opening access to costly, life-saving medications to a broader population of needy patients in a manner uninfluenced by corporate bottom lines

Variation in Specificity of HIV Rapid Diagnostic Tests over Place and Time: An Analysis of Discordancy Data Using a Bayesian Approach

BACKGROUND Recent trends to earlier access to anti-retroviral treatment underline the importance of accurate HIV diagnosis. The WHO HIV testing strategy recommends the use of two or three rapid diagnostic tests (RDTs) combined in an algorithm and assume a population is serologically stable over time. Yet RDTs are prone to cross reactivity which can lead to false positive or discordant results. This paper uses discordancy data from Médecins Sans Frontières (MSF) programmes to test the hypothesis that the specificity of RDTs change over place and time. METHODS Data was drawn from all MSF test centres in 2007-8 using a parallel testing algorithm. A Bayesian approach was used to derive estimates of disease prevalence, and of test sensitivity and specificity using the software WinBUGS. A comparison of models with different levels of complexity was performed to assess the evidence for changes in test characteristics by location and over time. RESULTS 106, 035 individuals were included from 51 centres in 10 countries using 7 different RDTs. Discordancy patterns were found to vary by location and time. Model fit statistics confirmed this, with improved fit to the data when test specificity and sensitivity were allowed to vary by centre and over time. Two examples show evidence of variation in specificity between different testing locations within a single country. Finally, within a single test centre, variation in specificity was seen over time with one test becoming more specific and the other less specific. CONCLUSION This analysis demonstrates the variable specificity of multiple HIV RDTs over geographic location and time. This variability suggests that cross reactivity is occurring and indicates a higher than previously appreciated risk of false positive HIV results using the current WHO testing guidelines. Given the significant consequences of false HIV diagnosis, we suggest that current testing and evaluation strategies be reviewed.The authors have no funding or support to report

A grounded theory analysis of the experience of therapy in the context of negative change

Negative change occurring during psychotherapy is relatively underresearched and current theories take little account of social context. Eight clients and four therapists were interviewed about their therapy experience when reliable score deterioration on an outcome measure was observed, with the aim of generating a Grounded Theory model of negative change. The emerging model identified three major themes: a context of adversity, the therapeutic experience, and help withdrawn (within the context of positive outcomes). Difficulties included wanting therapy to provide more advice, talking about distressing issues, relationship difficulties, ambivalence, and a wish for support instead of change. Client context merits increased attention. Changes in outcome measures used, more diverse supervision models, training to use outcome measures constructively, and sensitive, routine analysis of negative change are indicated. Increased availability of therapies able to address clients’ interpersonal and social context and a wider choice of therapy type would allow interventions to better fit the individual in context

Self-organized global control of carbon emissions

There is much disagreement concerning how best to control global carbon emissions. We explore quantitatively how different control schemes affect the collective emission dynamics of a population of emitting entities. We uncover a complex trade-off which arises between average emissions (affecting the global climate), peak pollution levels (affecting citizens' everyday health), industrial efficiency (affecting the nation's economy), frequency of institutional intervention (affecting governmental costs), common information (affecting trading behavior) and market volatility (affecting financial stability). Our findings predict that a self-organized free-market approach at the level of a sector, state, country or continent, can provide better control than a top-down regulated scheme in terms of market volatility and monthly pollution peaks.Comment: 4 pages, 4 figure

Tailoring of the resonant mode properties of optical nanocavities in two-dimensional photonic crystal slab waveguides

Optically thin dielectric slabs, in which a fully etched-through two-dimensional patterning is applied, are used to form high-Q optical cavities with modal volumes approaching the theoretical limit of a cubic half-wavelength. Resonant cavities are formed from local defect regions within the photonic lattice. Simple group theoretical techniques are developed to design cavities which support resonant modes with a particular polarization and radiation pattern. Numerical simulations using the finite-difference time-domain method are then used to study the detailed emission and loss properties of these modes. The cavities are probed spectroscopically through photoluminescence measurements, which when compared with numerical results show the presence of both donor and acceptor type modes. These experimental results show the predictive power of the modest symmetry analysis presented here in describing highly localized defect states within photonic crystals

Effects of BPA in Snails

It is an ethical requirement that new findings be presented in light of and in conjunction with a balanced evaluation of the current knowledge and published literature. We believe that Oehlmann et al. (2006) violated this general principle in several ways. For example, the authors inferred that prosobranch snails have a functional estrogen receptor and therefore a much higher sensitivity to estrogens and endocrine-disrupting compounds (EDCs) than other species previously reported in the literature. We found several other problems in their article..

Determination of reference intervals for fluid analysis and cytologic evaluation variables in synovial fluid samples obtained from carpal and tarsal joints in commercial nonlame growing swine

OBJECTIVE To determine reference intervals for total nucleated cell count, total protein concentration, pH, RBC count, and percentages of neutrophils, lymphocytes, and large mononuclear cells in synovial fluid samples (SFSs) obtained from the carpal and tarsal joints of healthy swine. ANIMALS 54 healthy commercial finisher pigs that had no evidence of lameness or gross joint swelling. PROCEDURES Each pig was anesthetized, and SFSs were collected from 1 carpal and 1 tarsal joint for fluid analysis, cytologic evaluation, bacterial culture, and PCR analyses for common swine joint pathogens. Each pig was euthanized after SFS collection, and synovial tissue samples were collected for histologic assessment. If necessary, postmortem SFSs were collected. RESULTS Overall, 37 of 50 tarsal and 46 of 53 carpal SFSs met inclusion criteria of sufficient volume, no gross blood contamination, and negative results of bacterial culture and PCR analyses, and were from joints with histologically normal synovial tissues. For the carpal and tarsal joints, upper reference limits were as follows: total nucleated cell count, 3,281 cells/μL and 2,368 cells/μL, respectively; total protein concentration, 3.6 g/dL and 3.6 g/dL, respectively; pH, 7.2 and 7.0, respectively; RBC count, 0.8 X 106 cells/μL and 0.1 X 106 cells/μL, respectively; and percentage of neutrophils, 46.5% and 33.7%, respectively; percentage of lymphocytes, 40.6% and 56.3%, respectively; and percentage of large mononuclear cells, 92.0% and 95.3%, respectively. CONCLUSIONS AND CLINICAL RELEVANCE Results have provided reference intervals for selected variables in SFSs obtained from the carpal and the tarsal joints of healthy swine, which should be useful in diagnostic investigations of swine lameness and arthritis

Lanthanum halide nanoparticle scintillators for nuclear radiation detection

Nanoparticles with sizesscintillators, in order to determine the viability of using scintillators employing nanostructured lanthanum trifluoride. Preliminary results of this investigation are consistent with the idea that these materials have an intrinsic response to nuclear radiation that may be correlated to the energy of the incident radiation

From data to draught: Modelling and predicting mixed-culture beer fermentation dynamics using autoregressive recurrent neural networks

The ascendency of the craft beer movement within the brewing industry may be attributed to its commitment to unique flavours and innovative styles. Mixed-culture fermentation, celebrated for its novel organoleptic profiles, presents a modelling challenge due to its complex microbial dynamics. This study addresses the inherent complexity of modelling mixed-culture beer fermentation while acknowledging the condition monitoring limitations of craft breweries, namely sporadic offline sampling rates and limited available measurement parameters. A data-driven solution is proposed, utilising an Autoregressive Recurrent Neural Network (AR-RNN) to facilitate the production of novel, replicable, mixed-culture fermented beers. This research identifies time from pitch, specific gravity, pH, and fluid temperature as pivotal model parameters that are cost-effective for craft breweries to monitor offline. Notably, the autoregressive RNN fermentation model is generated using high-frequency multivariate data, a departure from intermittent offline measurements. Employing the trained autoregressive RNN framework, we demonstrate its robust forecasting prowess using limited offline input data, emphasising its ability to capture intricate fermentation dynamics. This data-driven approach offers significant advantages, showcasing the model’s accuracy across various fermentation configurations. Moreover, tailoring the design to the craft beer market’s unique demands significantly enhances the model’s practicable predictive capabilities. It empowers nuanced decision-making in real-world mixed-culture beer production. Furthermore, this model lays the groundwork for future studies, highlighting transformative possibilities for cost-effective model-based control systems in the craft beer sector.</jats:p