David Townend

Worldwide Prevalence of Fetal Alcohol Spectrum Disorders: A Systematic Literature Review Including Meta‐Analysis

BACKGROUND Although fetal alcohol spectrum disorders (FASD) affect communities worldwide, little is known about its prevalence. The objective of this study was to provide an overview of the global FASD prevalence. METHODS We performed a search in multiple electronic bibliographic databases up to August 2015, supplemented with the ascendancy and descendancy approach. Studies were considered when published in English, included human participants, and reported empirical data on prevalence or incidence estimates of FASD. Raw prevalence estimates were transformed using the Freeman-Tukey double arcsine transformation so that the data followed an approximately normal distribution. Once the pooled prevalence estimates, 95% confidence intervals and prediction intervals were calculated based on multiple meta-analyses with transformed proportions using random effects models, these estimates were transformed back to regular prevalence rates. Heterogeneity was tested using Cochrans Q and described using the I(2) statistic. RESULTS Among studies that estimated prevalence in general population samples, considerable differences in prevalence rates between countries were found and therefore separate meta-analyses for country were conducted. Particularly high-prevalence rates were observed in South Africa for fetal alcohol syndrome (55.42 per 1,000), for alcohol-related neurodevelopmental disorder (20.25 per 1,000), and FASD (113.22 per 1,000), For partial fetal alcohol syndrome high rates were found in Croatia (43.01 per 1,000), Italy (36.89 per 1,000), and South Africa (28.29 per 1,000). In the case of alcohol-related birth defects, a prevalence of 10.82 per 1,000 was found in Australia. However, studies into FASD exhibited substantial heterogeneity, which could only partly be explained by moderators, most notably geography and descent, in meta-regressions. In addition, the moderators were confounded, making conclusions as to each moderators relevance tentative at best. CONCLUSIONS The worldwide pooled prevalence estimates are higher than assumed so far, but this was largely explained by geography and descent. Furthermore, prevalence studies varied considerably in terms of used methodology and methodological quality. The pooled estimates must therefore be interpreted with caution and for future research it is highly recommended to report methodology in a more comprehensive way. Finally, clear guidelines on assessing FASD prevalence are urgently needed, and a first step toward these guidelines is presented.

Health inequalities and regional specific scarcity in primary care physicians: ethical issues and criteria

ObjectivesA substantial body of evidence supports the beneficial health impact of an increase in primary care physicians for underserved populations. However, given that in many countries primary care physician shortages persist, what options are available to distribute physicians and how can these be seen from an ethical perspective?MethodsA literature review was performed on the topic of primary care physician distribution. An ethical discussion of conceivable options for decision makers that applied prominent theories of ethics was held.ResultsExamples of distributing primary care physicians were categorised into five levels depending upon levels of incentive or coercion. When analysing these options through theories of ethics, contrasting, and even controversial, moral issues were identified. However, the different morally salient criteria identified are of prima facie value for decision makers.ConclusionsThe discussion provides clear criteria for decision makers to consider when addressing primary care physician shortages. Yet, decision makers will still need to assess specific situations by these criteria to ensure that any decisions they make are morally justifiable.

Data protection and consent to biomedical research: a step forward?

1 European Parliament. Legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). 2 Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458–61. 3 Di Iorio CT, Carinci F, Oderkirk J. Health research and systems’ governance are at risk: should the right to data protection override health? J Med Ethics 2014; 40: 488–92. 4 Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534. 5 McCall B. European Parliament supports data protection reforms. Lancet 2014; 383: 1115. 6 Mascalzoni D, Knoppers BM, Ayme S, et al. Rare diseases and now rare data? Nat Rev Genet 2013; 14: 372. 7 Protecting health and scientifi c research in the Data Protection Regulation (2012/0011(COD)): Position of non-commercial research organisations and academics– July 2014. http://www.wellcome. ac.uk/stellent/groups/corporatesite/@ policy_communications/documents/web_ document/WTP055584.pdf (accessed Aug 7, 2014). 8 Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). June 30, 2014. http://register.consilium. europa.eu/doc/srv?l=EN&f=ST%2011028%2

Issues in Protecting Privacy in Medical Research Using Genetic Information and Biobanking: The PRIVILEGED Project

PRIVILEGED was an EC FP6 project exploring the protection of the interests of citizens in relation to medical research using genetic information and biobanks, particularly in relation to privacy and its protection through data protection. It did this through: (stage one) a literature review assessing the concepts of privacy used, and the interests expressed by citizens, in this area; (stage two) by compiling and studying the relevant European and national law already in place, especially assessing its congruence with the issues identified in stage one; and (stage three), considering areas of particular difficulty for the law and the nature of future regulation. This introduction first presents the project and contextualises the selected PRIVILEGED papers in this edition.

Fetal Alcohol Spectrum Disorders (FASD): an Approach to Effective Prevention

Purpose of ReviewThe objective of the current contribution is to propose an evidence-based, six-step approach to develop effective programs for prevention of fetal alcohol spectrum disorders.Recent FindingsDespite widespread campaigns aimed to reduce prenatal alcohol exposure, the number of affected children continues to be high. Current strategies to reduce prenatal alcohol exposure may be ineffective or counterproductive. However, proven principles of health promotion could be applied to reduce drinking in pregnancy. One such approach is Intervention Mapping (IM), a six-step procedure based on proven principles to change behaviors.SummaryFASD affects all communities and is an underestimated problem worldwide. Programs based on proven principles of behavior change are warranted. Program developers can use pre-existing protocols and strategies from evidence-based practice, such as Intervention Mapping. Developers who plan their preventive programs in a systematic and evidence-based manner increase the chances of success in reducing prenatal alcohol exposure and FASD.

Protecting animals and enabling research in the European Union: an overview of development and implementation of Directive 2010/63/EU

In 1986, European Directive 86/609/EEC, regulating the use of animals in research, was one of the first examples of common legislation to set standards for animal protection across the Member States of the former European Economic Community, now the European Union, with the aim of securing a level European playing field. Starting in 2002, a process of revising European animal experimentation legislation was undertaken, with one of its key aims being to ensure high standards of welfare for laboratory animals across Europe. This resulted in Directive 2010/63/EU, which has regulated this activity in Europe since 2013. Since this is a European Union Directive, transposition into national legislation is a necessary and important part of the implementation of the new legislation. This paper gives an overview of the transposition process followed by an analysis of the potential to reach the different objectives of the directive, particularly with a focus on securing the same high standards of animal protection across member countries. The analysis focuses on three separate issues: (1) minimum standards for laboratory animal housing and care, (2) restrictions on the use of certain animal species, and (3) project review and authorization.

EU Laws on Privacy in Genomic Databases and Biobanking.

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be “fair and lawful” and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data.

Streamlining ethical review of data intensive research

Unfounded concerns about local liability should not delay urgent reform

Permitting patients to pay for participation in clinical trials: the advent of the P4 trial

In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

The Influence of Intellectual Property Protection on drug development for neglected Tropical diseases

Neglected tropical diseases (NTDs) are a group of 17 tropical diseases designated by the World Health Organization (WHO). These diseases affect a billion of the poorest people worldwide, which is one-sixth of the world’s population. They usually have high morbidity rates but do not often result in death, thereby posing an urgent public health concern. In high-income countries, these diseases affect a small number of patients; this limits the market for drug sales to a very small population and makes it impossible to recover research and development (R&D) costs, making pharmaceutical responses to these diseases commercially unattractive. In 2010, the WHO published their first report on NTDs, suggesting they are also “policy neglected” (Crompton 2010). NTDs are strongly associated with poverty, flourishing in poor environments such as remote rural areas, urban slums, and shantytowns. Sufferers are without financial means to seek treatment, making them invisible. Stigmatization that comes with infection produces a vicious circle: disability that further locks sufferers into poverty. NTDs kill people, but not in the same quantity as malaria, tuberculosis, and HIV/AIDS. NTDs are less prominent and, because they do not travel from their low-income locations, they pose no (immediate) threat to high-income countries (Crompton 2010).