Marisa De Andrade

Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

Abstract Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising. Methods Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues. Results Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post‐hoc sample refinement and the use of inappropriate comparators. Despite this, evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful. Conclusions Problems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base.

Teenage perceptions of electronic cigarettes in Scottish tobacco-education school interventions: co-production and innovative engagement through a pop-up radio project:

Aims: This article thematically analyses spontaneous responses of teenagers and explores their perceptions of electronic cigarettes (e-cigarettes) with a focus on smoking cessation from data collected for research exploring Scottish secondary school students’ recall of key messages from tobacco-education interventions and any influence on perceptions and behaviours. Methods: E-cigarettes were not included in the research design as they did not feature in interventions. However, in discussions in all participating schools, e-cigarettes were raised by students unprompted by researchers. Seven of 19 publicly funded schools in the region opted to participate. Groups of 13- to 16-year-olds were purposely selected to include a range of aptitudes, non-smokers, smokers, males and females. A total of 182 pupils took part. Data were generated through three co-produced classroom radio tasks with pupils (radio quiz, sitcom, factual interviewing), delivered by a researcher and professional broadcast team. All pupils were briefly interviewed by a researcher. Activities were recorded and transcribed verbatim and the researcher discussed emerging findings with the broadcast team. Data were analysed using NVivo and transcripts making reference to e-cigarettes examined further using inductive thematic analysis. Results: Key themes of their impressions of e-cigarettes were easy availability and price; advertising; the products being safer or healthier, addiction and nicotine; acceptability and experiences of use; and variety of flavours. Conclusions: This was a qualitative study in one region, and perception of e-cigarettes was not an a priori topic. However, it provides insights into youth perceptions of e-cigarettes. How they discerned e-cigarettes reflects their marketing environment. The relative harmlessness of nicotine, affordability of e-cigarettes, coolness of vaping, absence of second-hand harms and availability of innovative products are all key marketing features. Conflicting messages on safety, efficacy, potential ‘gateway’ to smoking and nicotine may be contributing to teenagers’ confusion. The allure of ‘youthful cool’ to vaping offers no public health gain, so children should be protected from misleading promotion. Consistent tobacco-education initiatives need to account for this popular trend.

The Ethics of Pharma–Physician Relations in Pakistan: “When in Rome”

This article investigates the pervasive influence of the pharmaceutical industry in Pakistan and primarily the attitudes of the medical community toward such interactions. We used an inductive approach informed by grounded theory principles to analyze interviews and focus groups with consultants, residents, medical students, and a pharmaceutical industry representative in Karachi and Lahore (n = 27), and participant-observation data from two biomedical conferences. Data were then analyzed through a deontological and teleological ethical theoretical framework. Findings highlight the reasons leading to the continuation of norms including weak regulations, physicians’ expectations of receiving favors, and limited exposure to bioethics education. Recommendations for practice, policy, and research are discussed.

Culture and Values

There is increasing recognition of the importance of culture and values in the running and improvement of health, care and wider community services. Culture, or ‘the way we do things round here’, has been connected to the quality and safety of such services both positively and negatively. An enabling and learning culture is seen to promote opportunities for identifying, reflecting and acting on any concerns, whilst a controlling and blaming culture is seen to stifle such concerns being raised and so responded to appropriately. In turn values, both those expressed by an organization within its mission and strategy and those which practically underpin the everyday decisions made by teams are a key component of institutional culture. Personal values based on professional standards and individual beliefs further influence the choices and priorities of practitioners. Any organization seeking to achieve effective change must take account of these multi-layered and multi-dimensional factors. Integrated care initiatives, which commonly bring together professionals, practitioners and services from established silos add yet more complexity. The clashes in values and culture which can emerge through their new arrangements can be a powerful obstacle as the parties involved are exposed to alternative ways of seeing and interpreting the world. Inter-professional learning and inter-professional teams provide a means to positively respond to diversity in culture and values, and enable professionals to collaborate successfully together.