Genetic epidemiological study of schizophrenia: two modes of sampling

The ascertainment of probands according to place of residence in hospitals or in the community has enabled our sampling to be representative of whole subpopulations of patients. Probands from psychiatric hospitals are characterized by biased clinical parameters. Our sampling procedure provides important preliminary results which appear to be contradictory to those produced by conventional sampling methods.     

Extrapolation: Experience gained from original biologics

Biologicals undergo modifications throughout their commercial lifecycle. Major changes can unintentionally magnify their inherent physicochemical variability. Although trials comparing the pre- and the post-change versions have been requested occasionally, analytical comparison is the most sensitive approach to anticipating clinical equivalence. Therefore, it may be concluded, by means of ‘extrapolation’, that non-identical versions of a given biologic will behave equally in all indications. Despite the lessons learned with original biologics, there are still controversies around the approval of biosimilars through extrapolation. Here, a comprehensive analysis of scattered information allows for an account of cases of original biologic versions approved in some indications with no patient trials involved. Healthcare professionals can be reassured that inasmuch as extrapolation has proven valid for new versions of original biologics, the same holds for biosimilars.     

Beyond a Cross-Cultural Definition of Child Maltreatment: Comparing Immigrants From the Caucasus and European Countries of the Former Soviet Union

A major barrier to accurate assessment and effective intervention in situations of children at risk among immigrant families could be lack of knowledge what they consider to be the boundaries for inappropriate child rearing practices, their rationale for these beliefs and their help seeking patterns in situations of maltreatment. To acquire knowledge about this subject among immigrant parents from different regions of the Former Soviet Union, a study was conducted in Israel with 53 immigrants from the European countries of this region and 52 immigrants from the Caucasus. A low level of willingness to request help from formal networks was found in both samples. Differences were found in the underlying rationale of the participants' perceptions of inappropriate parental behaviors. Immigrants from the Caucasus were concerned with the inappropriateness of the parents' behaviors by relating to what is normative and what is not while immigrants from the European countries were concerned with the potential harm to the child. The comparison between the two groups of immigrants illuminates the significance of adopting a differentiated approach when assessing and intervening in situations of child maltreatment among immigrants who speak the same language and could be considered as coming from the same nonwestern culture.     

Early awareness of emerging risks associated with food and feed production: Synopsis of pertinent work carried out within the SAFE FOODS project

This introduction to the journal’s supplement on emerging food and feed safety issues summarizes the objectives and activities of the EU-funded SAFE FOODS project in general and its work package focusing on the early identification of emerging food safety risks, in particular. Within this work package, a number of studies have been carried out on methods enabling the early awareness, identification, and prevention of emerging issues before they can become real risks. The various reviews in this supplement explore the background of the emergence of known food safety risks, both of microbial and chemical/biochemical nature, as well the methods that can be used to identify such risks. Another review identifies a number of chemical and microbiological hazards that are likely to be affected by a changing climate. A major conclusion from these explorative reviews is that monitoring and information exchange systems or procedures are in place to detect, in an early phase, the emergence of potential food safety risks linked to known hazards. Additional systems are needed to predict the development of new potential food safety risks, which are linked to either new hazards or known hazards to which exposure has been altered.     

Safety assessment of a novel ingredient for removable chewing gum

Rev7™ is an indigestible gum polymer used for the manufacturing of chewing gum. It allows for the formulation of chewing gum with low adhesion; thus can be readily removed from surfaces such as sidewalks, clothing, carpets and furniture. In a toxicological safety assessment, Rev7™ was found to be non-mutagenic in the AMES assay. The highest concentration tested in a mouse lymphoma thymidine kinase locus gene mutation assay induced a slight but biologically relevant increase in mutations under non-metabolic activation conditions after 24 h. Because of this finding, a mouse micronucleus assay was performed, and the test article was found to be negative for inducing chromosomal damage. A 28-day repeated oral toxicity study resulted in a NOAEL of 80,000 ppm; the highest concentration tested. Rev7™ was found to be free from contaminants such as heavy metals, monomers, and solvents. Lastly, Rev7™ did not demonstrate skin-sensitizing properties in the murine local lymph node assay.     

An anthropological analysis of European Union (EU) health governance as biopolitics: The case of the EU tissues and cells directive

Healthcare in Europe is increasingly influenced by European Union (EU) regulation enacted to harmonise heterogeneous practices through common safety standards. In many instances directives on safety issues evade public debate because they are seen as merely ‘technical matters’. In this paper I analyse the implications at a national level in Denmark of one such piece of legislation: the EU Tissues and Cells Directive. The analysis is based on participant observation, interviews and document analysis conducted in the period from May 2007 to June 2009. I follow translations of the Directive from the level of the EU text into national legislation and further into everyday practices. From a biopolitical perspective, I explore the implications of this so-called technical directive that appear necessary for policymakers and yet remain strangely detached from the everyday experiences of people for whom and on whom it is supposed to work. The Directive has serious implications for the allocation of funds, for patients and for healthcare professionals. These implications need to be discussed. Even more basically, the analysis points to a need for discussing what makes so-called technical directives necessary. This article is intended to facilitate this type of debate.