Step-Wise Repository Licensing-Implementing the Scientific and Legislative Vision for the Next Phase of the Yucca Mountain Project

International scientific consensus backing geologic disposal as the preferred method of long term management of used nuclear fuel and defense high level radioactive waste has existed since the 1950s. Furthermore, many believe that geologic disposal programs should be implemented in a staged or 'step-wise' approach. These principles have also been at the root of US waste management policy for which a regulatory framework for site selection, and the licensing of a site once selected, is set forth in a series of legislation. The US program has now matured to the point where these regulatory components are now in place. Sufficient data has also been gathered and evaluated to support a site recommendation decision. This decision--on whether or not to proceed with a repository site at Yucca Mountain, Nevada - is about to be put before the US President and Congress. If made in the affirmative, the decision would initiate the next phase in the US disposal process as originally envisioned by Congress--a three-step repository licensing process (Construction, Operation, & Closure). This paper explores the many facets of the licensing process that may lie ahead. Approaches that could be deployed to effectively implement this process are discussed and opportunities to optimize the process, by capitalizing on its evolutionary nature to assure that the best available science is always applied to the protection of public health and safety, are identified. Focus is also placed on a key prerequisite to the accomplishment of this goal--the definition of the level to which post closure repository performance must be addressed at each stage of the licensing process

Cross-country comparison of strategies for building consumer trust in food

Consumer trust in the modern food system is essential given its complexity. Contexts vary across countries with regard to food incidents, regulation and systems. It is therefore of interest to compare how key actors in different countries might approach (re)building consumer trust in the food system; and particularly relevant to understanding how food systems in different regions might learn from one another. The purpose of this paper is to explore differences between strategies for (re)building trust in food systems, as identified in two separate empirical studies, one conducted in Australia, New Zealand and the UK (Study 1) and another on the Island of Ireland (Study 2). Interviews were conducted with media, food industry and food regulatory actors across the two studies (n = 105 Study 1; n = 50 Study 2). Data were coded into strategy statements, strategies describing actions to (re)build consumer trust. Strategy statements were compared between Studies 1 and 2 and similarities and differences were noted. The strategy statements identified in Study 1 to (re)build consumer trust in the food system were shown to be applicable in Study 2, however, there were notable differences in the contextual factors that shaped the means by which strategies were implemented. As such, the transfer of such approaches across regions is not an appropriate means to addressing breaches in consumer trust. Notwithstanding, our data suggest that there is still capacity to learn between countries when considering strategies for (re)building trust in the food system but caution must be exercised in the transfer of approaches

A missed orthopaedic injury following a seizure: a case report

Numerous orthopaedic injuries can follow a seizure and are often diagnosed late. This is the first documented case of a missed bilateral anterior shoulder dislocation following a seizure. The possible reasons for the greater incidence of posterior dislocations are examined and why bilateral anterior dislocations following a seizure are so rare. The article discusses the reasons for the delay and highlights potential pitfalls and learning points for junior emergency department doctors

Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial

IMPORTANCE: Secretory phospholipase A2(sPLA2) generates bioactive phospholipid products implicated in atherosclerosis. The sPLA2inhibitor varespladib has favorable effects on lipid and inflammatory markers; however, its effect on cardiovascular outcomes is unknown. OBJECTIVE: To determine the effects of sPLA2inhibition with varespladib on cardiovascular outcomes. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, multicenter trial at 362 academic and community hospitals in Europe, Australia, New Zealand, India, and North America of 5145 patients randomized within 96 hours of presentation of an acute coronary syndrome (ACS) to either varespladib (n = 2572) or placebo (n = 2573) with enrollment between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012). INTERVENTIONS: Participants were randomized to receive varespladib (500 mg) or placebo daily for 16 weeks, in addition to atorvastatin and other established therapies. MAIN OUTCOMES AND MEASURES: The primary efficacy measurewas a composite of cardiovascular mortality, nonfatal myocardial infarction (MI), nonfatal stroke, or unstable angina with evidence of ischemia requiring hospitalization at 16 weeks. Six-month survival status was also evaluated. RESULTS: At a prespecified interim analysis, including 212 primary end point events, the independent data and safety monitoring board recommended termination of the trial for futility and possible harm. The primary end point occurred in 136 patients (6.1%) treated with varespladib compared with 109 patients (5.1%) treated with placebo (hazard ratio [HR], 1.25; 95%CI, 0.97-1.61; log-rank P = .08). Varespladib was associated with a greater risk of MI (78 [3.4%] vs 47 [2.2%]; HR, 1.66; 95%CI, 1.16-2.39; log-rank P = .005). The composite secondary end point of cardiovascular mortality, MI, and stroke was observed in 107 patients (4.6%) in the varespladib group and 79 patients (3.8%) in the placebo group (HR, 1.36; 95% CI, 1.02-1.82; P = .04). CONCLUSIONS AND RELEVANCE: In patients with recent ACS, varespladib did not reduce the risk of recurrent cardiovascular events and significantly increased the risk of MI. The sPLA2inhibition with varespladib may be harmful and is not a useful strategy to reduce adverse cardiovascular outcomes after ACS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01130246. Copyright 2014 American Medical Association. All rights reserved

Media actors' perceptions of their roles in reporting food incidents

Background: Previous research has shown that the media can play a role in shaping consumer perceptions during a public health crisis. In order for public health professionals to communicate well-informed health information to the media, it is important that they understand how media view their role in transmitting public health information to consumers and decide what information to present. This paper reports the perceptions of media actors from three countries about their role in reporting information during a food incident. This information is used to present ideas and suggestions for public health professionals working with media during food incidents. Methods: Thirty three semi-structured interviews with media actors from Australia, New Zealand and the United Kingdom were conducted and analysed thematically. Media actors were recruited via purposive sampling using a sampling strategy, from a variety of formats including newspaper, television, radio and online. Results: Media actors said that during a food incident, they play two roles. First, they play a role in communicating information to consumers by acting as a conduit for information between the public and the relevant authorities. Second, they play a role as investigators by acting as a public watchdog. Conclusion: Media actors are an important source of consumer information during food incidents. Public health professionals can work with media by actively approaching them with information about food incidents; promoting to media that as public health professionals, they are best placed to provide the facts about food incidents; and by providing angles for further investigation and directing media to relevant and correct information to inform such investigations. Public health professionals who adapt how they work with media are more likely to influence media to portray messages that fit what they would like the public to know and that are in line with public health recommendations and enable consumers to engage in safe and health promoting behaviours in response to food incidents

National Outbreak of Salmonella Serotype Saintpaul Infections: Importance of Texas Restaurant Investigations in Implicating Jalapeño Peppers

BACKGROUND: In May 2008, PulseNet detected a multistate outbreak of Salmonella enterica serotype Saintpaul infections. Initial investigations identified an epidemiologic association between illness and consumption of raw tomatoes, yet cases continued. In mid-June, we investigated two clusters of outbreak strain infections in Texas among patrons of Restaurant A and two establishments of Restaurant Chain B to determine the outbreak's source. METHODOLOGY/PRINCIPAL FINDINGS: We conducted independent case-control studies of Restaurant A and B patrons. Patients were matched to well controls by meal date. We conducted restaurant environmental investigations and traced the origin of implicated products. Forty-seven case-patients and 40 controls were enrolled in the Restaurant A study. Thirty case-patients and 31 controls were enrolled in the Restaurant Chain B study. In both studies, illness was independently associated with only one menu item, fresh salsa (Restaurant A: matched odds ratio [mOR], 37; 95% confidence interval [CI], 7.2-386; Restaurant B: mOR, 13; 95% CI 1.3-infinity). The only ingredient in common between the two salsas was raw jalapeño peppers. Cultures of jalapeño peppers collected from an importer that supplied Restaurant Chain B and serrano peppers and irrigation water from a Mexican farm that supplied that importer with jalapeño and serrano peppers grew the outbreak strain. CONCLUSIONS/SIGNIFICANCE: Jalapeño peppers, contaminated before arrival at the restaurants and served in uncooked fresh salsas, were the source of these infections. Our investigations, critical in understanding the broader multistate outbreak, exemplify an effective approach to investigating large foodborne outbreaks. Additional measures are needed to reduce produce contamination

In the interest of food safety: a qualitative study investigating communication and trust between food regulators and food industry in the UK, Australia and New Zealand

Background Food regulatory bodies play an important role in public health, and in reducing the costs of food borne illness that are absorbed by both industry and government. Regulation in the food industry involves a relationship between regulators and members of the industry, and it is imperative that these relationships are built on trust. Research has shown in a variety of contexts that businesses find the most success when there are high levels of trust between them and their key stakeholders. An evidence-based understanding of the barriers to communication and trust is imperative if we are to put forward recommendations for facilitating the (re)building of trusting and communicative relationships. Methods We present data from 72 interviews with regulators and industry representatives regarding their trust in and communication with one another. Interviews were conducted in the UK, New Zealand, and Australia in 2013. Results Data identify a variety of factors that shape the dynamic and complex relationships between regulators and industry, as well as barriers to communication and trust between the two parties. Novel in our approach is our emphasis on identifying solutions to these barriers from the voices of industry and regulators. Conclusions We provide recommendations (e.g., development of industry advisory boards) to facilitate the (re)building of trusting and communicative relationships between the two parties

Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)