Pharma on the hot seat

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act's statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital industry faced when Medicare promulgated major reimbursement modifications. The Article proposes that the pharmaceutical industry, in the face of such intense scrutiny and uncertainty, should implement more rigorous self-regulation. Without more stringent self-regulation, this intense interest in the pharmaceutical industry may result in a regulatory push that establishes unanticipated and cumbersome measures for the industry.     

Nanomanipulation‐Coupled Nanospray Mass Spectrometry Applied to the Extraction and Analysis of Trace Analytes Found on Fibers*

Abstract: This article presents the novel instrumentation of nanomanipulation coupled to nanospray ionization‐mass spectrometry, which is used to directly probe trace analytes found on individual fibers. The low detection limits and sample volumes associated with nanospray ionization‐mass spectrometry make it the ideal instrument to implement for trace analysis. Nanospray ionization‐mass spectrometry, coupled with the nanomanipulator, allows for the direct probing of trace particulates on fibers. The technique is demonstrated by dissolving an electrostatic particle of cocaine from a fiber, collecting the analyte solution in a nanospray tip, and transferring the tip directly to the mass spectrometer to complete analysis. The utility of this technique is evident through the minimal sample preparation and short analysis time. The use of nanomanipulation coupled to nanospray ionization‐mass spectrometry could improve on current trace particulate analysis by reducing both detection limits and sample size required to complete analysis.     

Resolving differing expert opinions

This paper explores procedural mechanisms to resolve differing conclusions when two experts have initially worked independently. These experts can be two human examiners or one of them may be a computer-based model. The resolving process is presented as part of the ACE-V protocol adopted widely in pattern recognition areas (e.g. fingerprints, footwear marks, toolmarks or handwritings/signatures comparisons). It set the conditions of operations and delineates a resolving process that is based on the principles of transparency and detailed argumentations. We predict a gradual but steady introduction of computer-based models in the forensic pattern recognition areas. In our opinion, the rules to resolve differing opinions ought to be articulated and documented in the form of standard operating procedures, before any deployment in casework practice.     

Forensic Imaging‐Guided Recovery of Nuclear DNA from the Spinal Cord*,†

Abstract: Our objective is to document the recovery of DNA from the spinal cord or surrounding dura mater in 11 cases of severely burned human remains. Radiographs established that portions of charred tissue contained spine segments. Multidetector computed tomography (MDCT) revealed that each spine specimen contained an intact spinal cord remnant. A full DNA profile was obtained from seven specimens using spinal cord dura mater in six specimens and spinal cord medulla in one specimen. A partial profile was obtained from four specimens (spinal cord dura mater, 2; spinal cord medulla, 2). Bone and muscle surrounding the spinal cord appear to insulate nucleic acid containing tissue from critical thermal degradation. The spinal cord, which is easily identified by MDCT examination of remains and easily recovered at the postmortem examination, can be a source of DNA with extraction yields comparable with other tissue sources. Specimens of dura mater are preferable as processing time is faster than bone.     

Studying the correlates of fraud victimization and reporting

Little is known about the correlates of white-collar victimization, and even less is known about white-collar crime reporting. In this article, the extent to which predictors of fraud victimization are the same as the predictors of fraud reporting is examined. Using a national sample of fraud victims, these findings were consistent with prior research in that involvement in risky behaviors and age were found to be important predictors of fraud victimization. Additionally, the specific factors that are influential in predicting fraud victimization appear to vary across offense type. Unfortunately, little was revealed regarding the predictors of the official reporting of fraud victimizations. Future research needs to further unravel the importance of risky behavior in both victimization and reporting, as well as to focus on a broader array of white-collar crimes.     

Local Renewable Energy Initiatives in Germany and Japan in a Changing National Policy Environment

Our article explores the contribution of local initiatives to the creation of path dependencies for energy transition in Germany and Japan in the face of resistance from entrenched incumbents at the national level. We use a process‐tracing methodology based partly on interviews with local participants. In particular, we explore the role of local initiatives in securing “socio‐political space” for the expansion of renewable energy (RE) and in embedding themselves in “ecosystems” of public and private institutions. German energy activists were more successful than their Japanese counterparts in expanding this space and creating positive feedback in part because they were able to build horizontal networks that anchored the energy transition firmly in local communities. Although problems with grid technology have led to retrenchment in both cases, Japanese activists' reliance on vertical networks has limited their ability to weather a backlash from national government and utility actors. Our study demonstrates the interaction of political, economic/technological, and legitimation paths to energy transition and highlights the importance of the latter two.     

Accumulation by Dispossession and Its Limits: The Southern Africa Paradigm Revisited

The dispossession of agricultural producers from the land has long been considered a condition of successful capitalist development. The main contention of this paper is that such dispossession has in fact become the source of major developmental handicaps for at least some and possibly many countries of the global South. We develop our argument by focusing on the South(ern) African experience as a paradigmatic outlier case of accumulation by dispossession—that is, as one of its extreme instances capable of highlighting in almost ideo-typical fashion its nature and limits. After reconstructing interpretations of capitalist development in Southern Africa that in the early 1970s established the region as a paradigm of accumulation by dispossession, we discuss how useful these interpretations are for understanding the more recent developmental trajectory of South Africa. We then suggest ways in which these interpretations from the 1970s should be reformulated in light of subsequent developments. We conclude by briefly examining the theoretical and policy implications of the analysis.     

Evaluation of a community-based intervention to enhance road safety

A total of 300 motorists were recruited at public places to answer a self-report questionnaire on a new community-based intervention to enhance road safety. The intervention consisted of a speed-displaying device that was mounted next to the road and was visible to both motorists and the public. The device gives feedback about the current speed of the motorist. The majority of motorists believed these devices influenced compliance with the speed limit. They indicated they approached locations with these devices more slowly than similar locations without such devices. Moreover, they slowed down if they were going faster than the speed limit. They also said that their reaction to the devices was not influenced by whether they were driving in a community where they had friends or in a community where nobody knew them. These results were consistent across gender, age, levels of education, and professions.