Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives.     

Levels of Value Integration in Federal Agencies' Mission and Value Statements: Is Open Government a Performance Target of U.S. Federal Agencies?

The Barack Obama administration advanced open government initiatives to make federal administration more open, accountable, and responsive to citizens. Yet a question remains whether federal administrators took notice. This article examines changes in the extent to which U.S. federal agencies have integrated the three core principles of open government—transparency, public participation, and collaboration—into their performance planning. By analyzing 337 annual performance plans of 24 major federal agencies from fiscal years 2001 to 2016, the authors found that, overall, the level of integration of open government into performance planning has been trending higher since the early 2000s. During the Obama presidency, integration initially rose sharply but later declined. Findings also show that agencies' stated core values regarding open government are not consistently integrated into their performance plans. The implications of these findings for incorporating democratic‐constitutional values into holistic performance management are considered.     

The Effects of Childhood and Adolescent Adversity on Substance Use Disorders and Poor Health in Early Adulthood

Childhood and adolescent adversity have been shown to predict later mental and physical health outcomes. Understanding which aspects and developmental timings of adversity are important, and the mechanisms by which they have their impact may help guide intervention approaches. A large subset of adolescents (N?=?457; Female 68.9?%) from the 10-year longitudinal Youth Emotion Project was examined to better understand the associations among childhood/adolescent adversity, substance use disorder, and later health quality. Adolescent (but not childhood) adversities were associated with poorer health in late adolescence/early adulthood, adolescent adversities were associated with subsequent onset of substance use disorder, and adolescent adversities continued to be associated with poorer health in late adolescence/early adulthood after accounting for the variance explained by substance use disorder onset. These associations were observed after statistically accounting for emotional disorders and socioeconomic status. Specific domains of adversity uniquely predicted substance use disorder and poorer health outcomes. In contrast with current recent research, our findings suggest the association between childhood/adolescent adversity and poorer health outcomes in late adolescence and emerging adulthood are not entirely accounted for by substance use disorder, suggesting efforts to curtail family-based adolescent adversity may have downstream health benefits.     

Adolescent Physical Abuse: Age at Time of Abuse and Adolescent Perception of Family Functioning

The relationship between physical abuse and family functioning was investigated in a comparative study of victims of adolescent physical abuse. The sample consisted of 99 physically abused adolescents and 99 nonabused adolescents who were administered the Parental Bonding Instrument (PBI) and Family Adaptability and Cohesion Evaluation Scale (FACES III). These measures assess family functioning in terms of adolescents' perception of their family's cohesiveness, flexibility, and the degree to which their parents provide care and protection. The relationship between family functioning and physical abuse, severity of abuse, and date of abuse onset was investigated. Abused adolescents perceived their families as significantly less adaptable, less cohesive, and less balanced than the comparison adolescents. Fathers and mothers of abused adolescents were viewed as less caring; abuse group fathers were also viewed as more overprotective. Family functioning was not different when childhood-onset abuse was compared to adolescent-onset abuse. Severity of abuse also did not differ in the childhood and adolescent onset groups. It was concluded that physically abused adolescents view their families as rigid, and their parents as emotionally unavailable. Treatment needs and intervention strategies for these families are outlined.     

sexual assault as trauma: a Foucauldian examination of knowledge practices in the field of sexual assault service provision

This paper examines the deployment of the concept of psychological trauma in the field of sexual assault service provision, a field in which a feminist understanding of sexual violence has achieved a position of ‘truth’. Using a Foucauldian methodological approach, the investigation centred on service provision in New South Wales, Australia, and analysis focused on the everyday practices of workers illuminated through documents collected from the field, in particular the interview texts produced from interviews with thirty sexual assault practitioners. The paper focuses on the adult survivor of child sexual assault who emerged in the study as the most traumatised category of victim. I lay out how ‘trauma’, specifically the concept of ‘complex trauma’, operates as the conceptual (emotional, relational, neurobiological) link between past abuse and current problems, redefining them not as ‘problems’ but as the symptoms or effects of untreated childhood trauma. I argue that in the local field this deployment is simultaneously enabling and problematic. The production of a subject position of ongoing ontological vulnerability has the effect of repositioning the ‘adult survivor’ outside the socio-political context of their current lives and as such appears misaligned with a feminist ‘regime’ centred on enabling practices and structural gender inequality. However, I demonstrate how this same knowledge of the neurobiological, relational and emotional effects of trauma on the survivor self is used by practitioners as part of their established feminist practices of enabling victims to regain a sense of power and control, of interrupting blame and working for victims at a broader systemic level. The research adds to feminist research and commentary that has drawn critical attention to uptake of trauma in sexual assault work by showing the specificity of how trauma operates in a specific location, and illustrating both the potential and the problematic aspects of trauma as a feminist knowledge practice.     

The Secret of West Indian Success

For nearly a century, black immigrants from the West Indies have enjoyed greater economic success than African Americans. Several explanations have been proposed for this trend, but until now, none of these explanations have been subjected to systematic scrutiny. Recent efforts to adjudicate among them indicate that West Indian success can be attributed entirely to the “selectivity of migration”. This phrase refers to the tendency of people who migrate to be more talented and determined than the compatriots they leave behind. One implication of this discovery is that sympathetic observers should stop exhorting African Americans to behave more like West Indians. Such pleas are inappropriate because West Indian success is a consequence of choosing to move, not a consequence of Caribbean birth. A second implication is that persons of West Indian background remain vulnerable to racism. The new findings provide no evidence that positive selection protects West Indians from the negative stereotypes that Americans associate with black skin.

Reassessing Privatization Strategies 25 Years Later: Revisiting Perry and Babitsky's Comparative Performance Study of Urban Bus Transit Services

Privatization appeals to citizen and politician desires for more cost-effective methods of service delivery. For this reason, it is important for public administrators to know when gains can be made by contracting out or privatizing services and when it is better to keep service provision in house. This article assesses the viability of contracting out and privatization of transit services. Following up on the 1986 work of James Perry and Timlynn Babitsky, which used data from the early 1980s, the authors revisit whether certain service delivery arrangements are more efficient and effective than others in the provision of transit services. Twenty-five years later, they find results similar to those of Perry and Babitsky's original study. Neither the type of government nor whether an agency contracts out has much impact on the efficiency and performance of urban bus services. The main difference between the two studies is that private transit agencies are no longer more efficient or effective than public providers.     

Application of a pyroprobe to simulate smoking and metabolic degradation of abused drugs through analytical pyrolysis

Smoking of illicit drugs can produce unique metabolic biomarkers. Smoking conditions can be partially modeled via pyrolysis, a process that decomposes a chemical compound by extreme heat. Pyrolytic decomposition was found to be useful as a limited metabolic mimic in that analytical pyrolysis can be used to generate some of the same compounds produced by metabolic degradation. This project focused on the pyrolysis of cocaine and methamphetamine using a pyroprobe coupled with a GC/MS and more generally, potential applications of pyrolysis to forensic toxicology. Common diluents including lidocaine, caffeine, and benzocaine were pyrolyzed in mixtures with cocaine and methamphetamine. Correlations between pyrolytic and metabolic degradations revealed that this method has the capability to produce some of the reported metabolites such as norcocaine and cocaethylene for cocaine, and amphetamine for methamphetamine. The results demonstrate that analytical pyrolysis has the potential to identify some metabolic products and to supplement in vivo and enzymatic studies.     

Physical components of soft-tissue ballistic wounding and their involvement in the generation of blood backspatter*

Gunshot backspatter comprises biological material expelled backward through bullet entry holes. Crime scene investigators analyze backspatter patterns to infer wounding circumstances. An understanding of the mechanism of backspatter generation, and the relationship between spatter patterns and bullet and tissue characteristics, would enhance the predictive value of such analysis. We examined soft-tissue ballistic wounding responses to determine the underlying components and how these might be relevant to the generation of backspatter. We identified five mechanistic components to ballistic wounding (elastic, viscous, crushing, cutting, and thermal), each related to mechanical disciplines (respectively, solid mechanics, fluid mechanics, fracture mechanics, rheology, and thermodynamics). We identified potential roles for these five components in backspatter formation and provide a scenario whereby a sequence of events incorporating these components could lead to backspatter generation and expulsion. This research provides a framework for the mathematical representation, and subsequent computational predictive modeling, of backspatter generation and pattern formation.     

Exploring the age of onset and recurrence of childhood animal cruelty: can animal cruelty be learned from witnessing others commit it?

Despite recent research, few studies have examined the specific social contexts in which animal cruelty may be learned. Using data collected from 180 inmates at a medium- and maximum-security prison in a southern state, the authors seek to replicate findings from the Hensley and Tallichet study that examined the potential for the onset and recurrence of childhood animal cruelty to become a learned behavior, specifically in terms of demographic characteristics and childhood experiences with witnessing animal abuse. In the current study, those who were younger when they first witnessed animal cruelty initially hurt or killed animals themselves at a younger age. Respondents who had witnessed a family member hurt or kill animals reported engaging in recurrent animal cruelty and were older when they committed their first act of animal cruelty.