Drug development: EU paediatric legislation,the European Medicines Agency and its Paediatric Committee—adolescents’ melanoma as a paradigm

The European Medicines Agency (EMA) website lists all diseases that officially exist in adults only. The class waiver for juvenile melanoma was revoked in 2008 referring to US SEER statistics. This statistical justification is misleading. Melanoma in adolescents is much rarer than claimed by EMA/Paediatric Committee; < 1 ∕ 4 of adolescents with melanoma need systemic treatment; separate efficacy studies are neither medically justified nor feasible. The scarce adolescent patients should be allowed to participate in adult trials. To force companies to investigate them separately turns them into paediatric hostages, to adapt the term therapeutic orphans coined in 1968 by Shirkey. There are now five melanoma Paediatric Investigation Plans (PIPs). Probably none of the PIP‐triggered clinical studies will ever be completed; we propose to call them ghost studies. An oncology research network considering a reasonable trial in melanoma, including adolescents, will compete for recruitment with the PIP‐triggered trials designed by regulatory tunnel vision and sponsored by companies under EMA‐imposed pressure. EMA/Paediatric Committee's territorial enthusiasm (“our patients”) damages oncology research. Copyright © 2014 John Wiley & Sons, Ltd.     

A Note on the Best Linear Unbiased Estimation Based on Order Statistics

The appropriateness of replacing the term regression to the mean with regression to the mode is discussed.     

Benchmarking: the key to influencing physicians

Managing physicians to achieve cost reductions can seem impossible, especially when managed care penetration is low. Physicians feel little pressure to change when asked merely to cut costs, especially when their boat is not rocking. But physicians will respond to benchmarking data on CPT-coded procedures that are directly comparable to their own practices. When surgeons see that others take less time to perform a procedure and/or use fewer and lower cost supplies, their competitive spirits are aroused. They become inquisitive about why this is so and then are eager to change by trying new methods and improving their techniques. Science is the key motivator, not savings. When benchmarking recommendations are implemented in a facility, better practice and substantial cost savings are the positive results.     

Human facial expression judgment in a conversational context

Two hundred eighty male and female college students scaled thirty-five human face photographs for the degree of annoyance, interest, understanding, and spontaneity expressed. An individual differences analysis of the scaling data indicated independence of these expression dimensions and resulted in 11 like-perceiving subgroups of subjects. These homogeneous subgroups were characterized on the basis of their differential use of facial features within as well as between expression dimensions and on their differences in a test of figural creativity.The authors are grateful to Dr. Dina Anselmi and Dr. Michael Tirrell for their contributions to the Phase II data collection.     

Targeting occupations with varying reputations to increase tax revenue

If the government's goal is to raise tax revenue in a cost-effective manner, which (if any) occupation categories could be targeted with a higher probability of an audit to yield increased revenue? Looking beyond mere opportunity to evade (e.g., self-employment) and starting from the premise that taxpayers in certain occupations evade more than others, the issue is whether these taxpayers respond to a change in the audit rate. Theory suggests that compliance increases in response to higher audit rates; the occupations with the higher evaders could therefore be targeted. This theory is tested by drawing a connection between occupation, reputation, and tax compliance. We assume that taxpayers in occupations with high need for reputation respond to a lower extent to increased tax audits than taxpayers whose achievement does not depend on reputation. The results support the effectiveness of raising tax revenue by targeting specific occupations, non-managers, with a higher probability of an audit.     

Marriage Advantage in Subjective Well-Being: Causal Effect or Unmeasured Heterogeneity?

I investigate whether the marriage advantage in subjective well-being is a true protective effect vs. being attributable to self-selection into (or out of) marriage based on pre-existing mental health. I utilize 1,240 respondents from the GSS panel, a three-wave longitudinal survey collected from 2010–2014. I use a pseudo-treatment approach to informally test for the presence of self-selection. This is followed by a fixed-effect regression analysis to eliminate its influence when estimating the marriage effect. Results support the existence of self-selection: the currently married who in later waves will be exiting marriage are already more distressed than other married respondents in wave 1. And the currently not married who in later waves will be entering marriage are not more distressed in wave 1 than those remaining continuously married. A protective effect is also supported: at any given time, net of self-selection, the currently married are less distressed than the unmarried.     

Till Discord Do Us Part: The Role of Physical and Verbal Conflict in Union Disruption

The focus of this study was the extent to which physical aggression and, to a lesser extent, verbal conflict predict relationship dissolution in a national sample. Data were from a 5‐ to 7‐year follow‐up of 3,508 married and cohabiting couples in the National Survey of Families and Households. Controlling for demographic factors and verbal conflict, male violence significantly elevated the risk of disruption between waves. Female violence was not a predictor of disruption. Much of the effect of male violence was accounted for by its association with reduced relationship quality. The impact of male violence did not appear to differ according to the female partner's socioeconomic resources or whether couples were in formal or informal unions.     

Demographic aspects of climate change mitigation and adaptation

This paper addresses the contribution of changes in population size and structures to greenhouse gas emissions and to the capacity to adapt to climate change. The paper goes beyond the conventional focus on the changing composition by age and sex. It does so by addressing explicitly the changing composition of the population by level of educational attainment, taking into account new evidence about the effect of educational attainment in reducing significantly the vulnerability of populations to climatic challenges. This evidence, which has inspired a new generation of socio-economic climate change scenarios, is summarized. While the earlier IPCC-SRES (Intergovernmental Panel on Climate Change—Special Report on Emissions Scenarios) scenarios only included alternative trajectories for total population size (treating population essentially as a scaling parameter), the Shared Socio-economic Pathways (SSPs) in the new scenarios were designed to capture the socio-economic challenges to climate change mitigation and adaptation, and include full age, sex, and education details for all countries.