PLoS medicine
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European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. ⋯ The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.
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Randomized Controlled Trial
Intimate Partner Violence and Depression Symptom Severity among South African Women during Pregnancy and Postpartum: Population-Based Prospective Cohort Study.
Violence against women by intimate partners remains unacceptably common worldwide. The evidence base for the assumed psychological impacts of intimate partner violence (IPV) is derived primarily from studies conducted in high-income countries. A recently published systematic review identified 13 studies linking IPV to incident depression, none of which were conducted in sub-Saharan Africa. To address this gap in the literature, we analyzed longitudinal data collected during the course of a 3-y cluster-randomized trial with the aim of estimating the association between IPV and depression symptom severity. ⋯ In this secondary analysis of data from a population-based, 3-y cluster-randomized controlled trial, IPV had a statistically significant association with depression symptom severity. The estimated associations were relatively large in magnitude, consistent with findings from high-income countries, and robust to potential confounding by time-invariant factors. Intensive health sector responses to reduce IPV and improve women's mental health should be explored.
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Randomized Controlled Trial
Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.
Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information. ⋯ A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence.
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In this month’s editorial, the PLOS Medicine editors note recent progress towards data sharing as the community norm in medical research and the barriers that remain.