Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned with the interests of their providers and drug developers. Second, we focus on the resource constraints facing providers, funders, and patients and conclude that they often counsel against the use of unproven interventions against EVD.     

Motivation to Pursue Genetic Testing in Individuals with a Personal or Family History of Cardiac Events or Sudden Cardiac Death

Genetic testing is becoming increasingly available for cardiac channelopathies, such as long QT syndrome and Brugada syndrome, which can lead to sudden cardiac death. Test results can be used to shape an individual’s medical management and to identify at-risk family members. In our qualitative study, all participants had a personal or family history of a diagnosed cardiac arrhythmia syndrome or sudden cardiac death. Open-ended interviews were conducted individually and in focus groups. Interviews were audio recorded, transcribed verbatim, and analyzed using a qualitative grounded-theory approach. Of 50 participants, 37 described their motivations for pursuing genetic testing for long QT syndrome or another cardiac channelopathy. Participants’ motivations included: to find an explanation for a family member’s sudden death, to relieve uncertainty regarding a diagnosis, to guide future medical management, to allay concern about children or other family members, and to comply with recommendations of physicians or family members. Perceived reasons not to pursue genetic testing included denial, fear, and lack of information. The genetic counseling and informed consent process can be enhanced by understanding and addressing an individual’s internal and external motivations either for or against pursuing genetic testing.     

The development of a greeting signal in wild chimpanzees

Adult chimpanzees produce a unique vocal signal, the pant-grunt, when encountering higher-ranking group members. The behaviour is typically directed to a specific receiver and has thus been interpreted as a 'greeting' signal. The alpha male obtains a large share of these calls, followed by the other adult males of the group. In this study, we describe the development of pant-grunting behaviour from the first grunt-like calls of newborn babies to the fully developed pant-grunts in adults. Although babies produce grunts from very early on, they are not directed to others until about 2 months of age. Subsequently, socially directed grunting steadily increases in frequency to peak around 7 months of age, but then decreases again to reach a nadir in older infants and juveniles, while the specificity in use increases. During adolescence, grunt production increases again with grunts given most frequently to socially relevant individuals. As young chimpanzees are closely affiliated to their mothers for the first decade of their lives, we also compared the grunting patterns of mothers and their offspring, which revealed some influences in pant-grunt production. In conclusion, the acquisition of pant-grunting behaviour in chimpanzees is a long-lasting process with distinct developmental phases in which social influences by the mother and other group members are likely to play a role.     

The relation of maternal emotional and cognitive support during problem solving to pre‐academic skills in preschoolers

Using a sample of 263 mother–child dyads, we examined the extent to which maternal emotional and cognitive support during a joint problem‐solving task when children were 3‐years‐old predicted children's academic skills 1 year later independent of each other, the quality of the home learning environment, and maternal emotional responsiveness. When all parenting measures were examined simultaneously, only maternal emotional support during problem solving and the quality of the home learning environment predicted unique variation in gains in pre‐academic skills from 3 to 4 years of age. The positive effect of emotional support during problem solving was especially apparent for children whose pre‐academic skills were low at the age of 3 years. These findings are discussed in light of the changing demands placed on young children and their parents as they prepare for entry to the formal school system. Copyright © 2011 John Wiley & Sons, Ltd.     

Shock,Adjust, Decide: Reproductive Decision Making in Cystic Fibrosis (CF) Carrier Couples—A Qualitative Study

Cystic fibrosis (CF) is the most common recessive condition affecting the White British population. Facilitating reproductive decision making for couples at genetic risk for CF is an important aspect of genetic counseling practice in the UK. The purpose of this study was to explore the reproductive decision making process for 31 members of CF carrier couples (15 men and 16 women) with or without an affected child. The design involved a qualitative approach consisting of semi-structured interviews and data analysis informed by grounded theory methodology. Sex and personal experience of CF were identified as factors that may influence reproductive decision making. Findings suggest these hypotheses: (1) CF carrier couples who have an affected child/pregnancy, are more likely to embark on another pregnancy than couples who have a healthy child from an at-risk pregnancy, and (2) men and women play different roles in the reproductive decision making process. Data analysis resulted in development of a structured framework modeling the reproductive decision making process, which may be helpful in guiding genetic counseling with CF carrier couples and other at risk couples making reproductive decisions.     

An examination of gender-moderated test bias on the Levenson Self-Report Psychopathy Scale

In this investigation, we examined the validity of Levenson's Self-Report Psychopathy Scale (LSRP; Levenson, Kiehl, & Fitzpatrick, 1995) in a sample of undergraduate students (n = 403). Utilizing a step-down hierarchical multiple regression procedure (e.g., Arbisi, Ben-Porath, & McNulty, 2002), we used LSRP scores to predict psychopathic personality traits to determine the presence of gender-moderated test bias. Results indicate similar correlational magnitudes for men and women. However, systematic over- and underprediction of scores (i.e., differential intercepts) was found for external criteria measuring key affective (i.e., low empathy) and behavioral (i.e., aggression, antisocial behavior) components of the psychopathic personality, although these effects were generally small.     

Migranten in sozial schwachen Stadtteilen von Berlin

Background

The aim of the present study was to compare psychological distress and substance use between migrant and non-migrant populations in a socially deprived area of Berlin.

Methods

A population-based random sample stratified for age (18?C57?years) and gender (50% female) was retrieved from the registration office. A total of 143 persons were included in the study. The participation rate was 48.5% when contact was established. Psychological distress was assessed using the General Health Questionnaire (GHQ-28) with its four subscales, somatic symptoms, anxiety/insomnia, social dysfunction and severe depression. Substance use was quantified using the Alcohol Use Identification Disorder Test (AUDIT) and the Fagerstr?m Test for Nicotine Dependence (FTND).

Results

Of the study population 51.3% were first or second generation migrants and lived more often in single households. Migrants had lower educational levels and lower employment rates. The mean scores of migrants and non-migrants did not differ on any of the subscales somatic symptoms, anxiety/depression, social dysfunction or severe depression of the GHQ-28. Non-migrants showed significantly higher risks regarding alcohol use.

Discussion

The present study did not reveal any differences regarding symptom profiles in the spectrum of anxiety and depression between non-migrants and migrants who lived in a socially deprived area. Migrants may compensate higher social risk profiles with lower risks regarding alcohol use. Larger samples have to inform on possible differences regarding smoking and other substances.