Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.     

Recommended Practices for Macerating Human Thyroid Cartilage

Visible abnormalities on the thyroid cartilage may be indicative of perimortem trauma including fractures or sharp force trauma. During autopsy, the thyroid cartilage must be freed of surrounding soft tissue before these abnormalities can be clearly observed. Several processing methods were first experimentally tested on pig ears to narrow down which might work best to process human thyroid cartilage. Several methods in the categories of hot water maceration, chemical/enzyme maceration, and dermestid beetles were then tested on a sample of 37 human thyroid cartilages. An adapted 22-point scoring system was used to score the efficacy of each processing method. Chemical maceration using bleach was found to be the best method for removing surrounding tissue from thyroid cartilage, with Arm & Hammer^TM powdered laundry detergent as a close second. These methods are inexpensive, quick, and easy to implement, making them a simple addition to busy medical examiner’s offices or forensic anthropology laboratories.     

The Application of the Polyvagal Theory to High Conflict Co‐Parenting Cases

Families, litigants, lawyers, advisors embroiled in cases of complex divorce with child contact issues, manage many stressors at once. Participants involved with these types of cases are often exhausted and burned‐out from the long‐term battles of prolonged litigation. The inability to problem‐solve or even communicate effectively reflects the chaos and traumatic stress of the experience and can be seen as a hallmark of this population. When people are consistently stressed, there is a breakdown of communication skills that can create an immunity to receiving help from any direction. Often all parties involved appear to be both hyper‐alert to potential threat, and hyper‐reactive to one another: no one feels safe. Stephen Porges' Polyvagal Theory is premised on the idea that neuroception plays a key role in the nervous system's ability to assess danger in the environment. Neuroception is a neurophysiological response that does not involve cognitive processing. When cognitive processing is not involved, the result may lead to misinterpretation of, and an inability to accurately assess situations: executive functioning including rational thinking and communication skills are lost to physiological response. Rather than evaluating families and individuals involved in the aforementioned complex divorce cases through the lens of pathology, Polyvagal Theory explains their behavior as an adaptive stress reaction. Utilizing Polyvagal Theory offers a promising path to treatment with these families and diminishing the poor communication and the heightened emotion, assisting practitioners in understanding the impact of neurobiological response in managing stress and trauma. Applying Polyvagal Theory to court involved populations can help both litigants and practitioners recognize the role of the autonomic nervous system, providing the opportunity to understand, to self‐regulate, and to improve communication and decision making.     

Social Status and Classroom Behavior in Math and Science during Early Adolescence

Journal of Youth and Adolescence - Social status is a salient feature of the classroom peer ecology in early adolescence, yet research has not examined how it plays out within the domains of math...     

Global Renewable Electricity Policy: A Comparative Policy Analysis of Countries by Income Status

Although the drivers of renewable electricity (RE) are well-established among Western high-income countries, little is known about the factors that encourage RE development elsewhere. This paper analyzes an unprecedented, original dataset of 149 countries from 1990 to 2010 to compare the policy instruments and other factors that influence RE adoption across low-, middle-, and high-income countries. We find the factors driving RE development vary both across income group and between hydroelectric and non-hydro generation. Most notably for environmental concerns, non-hydroelectric RE generation is driven by feed-in-tariffs and renewable portfolio standards in high-income countries, feed-in tariffs alone in middle-income countries, and by subsidies in low-income countries. Non-policy drivers of RE also vary by country income level.     

Public Service Motivation in Ghanaian Civil Service: A Case Study of Ejisu-Juabeng Municipality

Civil servants are perceived to possess altruistic motive known as Civil Service Motivation (PSM) which promotes public interest as confirmed in some developed countries. Using the Ejisu-Juabeng Municipality as a case study, this article assesses the existence of PSM in the Ghanaian public sector and finds that PSM exists in the public service but its existence does not ensure maximum output. The workers professed having motives such as sense of social justice, compassion, commitment to public interest, self-sacrifice, and sense of civic duty but indicated their unwillingness to commit their future to the public sector because of poor working conditions.     

Traumatic Events and Symptoms Among Mexican Deportees in a Border Community

Research on traumatic events experienced among Mexicans deported from the United States is scant. Using clinical interviews, this study assessed the frequency of traumatic events and symptoms of post-traumatic stress disorder (PTSD) among 47 Mexican deportees in a U.S.-Mexico border community. The majority of participants (98%) reported having experienced one or more traumatic events (M = 9, SD = 5) and nearly half met DSM-IV-TR criteria for PTSD. Meeting criteria for PTSD was associated with a higher number of traumatic events. Results suggest that prevention, intervention, and policy efforts are necessary to improve the well-being of this understudied immigrant subgroup.     

Treating Outer Space Like a Place: A Case for Rejecting Other Domain Analogies

The creation and augmentation of the outer space governance regime during the twentieth century was guided by the use of analogies with other planetary domains. These analogies compare the “target” domain of outer space with various “source” domains, especially airspace, the seabed, the high seas, and Antarctica. These analogies, highlighted at different times to provide guidance on the regulation of existing and emerging space activities, shaped the fundamental principles and rules of the Outer Space Treaty. A survey of contemporary literature demonstrates that analogies continue to be used to structure thinking about outer space activities. This paper argues that such analogies are a misleading foundation for constructing a governance regime in outer space. They overlook essential and distinct features of outer space, and misguide the decisions of policymakers by influencing interest formation and problem definition. Six major features of the outer space environment are concealed by other-domain analogies, which helps explain why the use of analogies reduces the chances for effective governance. Scientific activity since the advent of the Space Age makes possible an alternative, non-analogic representation of outer space as a place, which has important implications for space governance.     

“It Was My Understanding That There Would Be No Math”: Using Thematic Cases to Teach Undergraduate Research Methods

Undergraduates frequently approach research methods classes with trepidation and skepticism, owing in part to math-phobia and confusion over how methodology is relevant to their interests. These self-defeating barriers to learning undermine the efficacy of methods classes. This essay discusses a strategy for overcoming these barriers—use of a case study as a thematic framework for the class. In theory, the case study engages students and renders the material less abstract. A research methods class recently taught by the author was organized around political assassinations, with an initial framing focus the assassination of President John F. Kennedy. In an end of semester Qualtrics survey, students reported that they liked this approach and believe that it kept them interested in the material.

“[S]tats are dry. The Kennedys are not dry.” ～A student     

Preface to Yoshimi Shun'ya's Voice Capitalism

Abstract

This article is a translation of the preface to Voice Capitalism by influential sociologist Yoshimi Shun'ya. The chapter ties together a wealth of discourse on the meaning of sound to society and to the individual, and its evolving role as a means of expression and connection to our environments. Yoshimi walks us through Nagai Kafū's reverence for tangible sound, R. Murray Schafer's schizophonic soundscapes, Marshal McLuhan's essays on the impact of the advent of sound recordings and electronic voices, Glenn Gould's theories on the blurring borders between musical performer and audience – amongst numerous other topics and writers.