Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture

Since the 1980s, successive White House Administrations have shaped federal policy on genetically modified food and agriculture to (1) be product-based, (2) presume low risk from genetic modification, and (3) review GM products under existing federal standards. For two decades, the FDA, USDA, and EPA have erected a regulatory framework for GM products based on these three principles. This Article reviews the history and structure of this framework and the challenges that it has faced as more GM products have entered the market. The Article concludes that the three basic principles of federal GM policy may have to be reconsidered and redirected as genetic modification continues to grow as a force in world commerce

International agreements and the plant genetics research community: A guide to practice

Plant genetic resources (PGR), including collections held in national and international gene banks, provide access to a wide array of genetic diversity and are critical to genomics research, conservation efforts, and applied breeding. Yet, there is a general lack of awareness in the research community about the rules and treaties that govern the use of PGR, about access and benefit sharing obligations contained in international treaties and/or national laws, and about how best to comply with potentially applicable requirements. This article provides a brief history and overview of three key international agreements, namely the Convention on Biological Diversity, the Nagoya Protocol, and the International Treaty on Plant Genetic Resources for Food and Agriculture, which collectively address responsibilities and obligations related to the use of much of the world’s PGR. By highlighting the coverage and key considerations of each agreement, the article provides a guide for those who use PGR in plant genetics research to better understand when and how international agreements apply, and—where the rules are unclear—to suggest best practices for compliance with existing agreements

Creating an Online CME Module: Early Detection and Diagnosis of Dementia and Alzheimer’s Disease

Introduction. The number of individuals living with dementia and Alzheimer’s disease (AD) in the United States is growing annually; only 40% are properly diagnosed. Primary care providers should identify individuals with cognitive impairment and provide options for care; early diagnosis of dementia and AD helps patients and families plan for the future, increases quality of life, and allows for treatment options.https://scholarworks.uvm.edu/comphp_gallery/1192/thumbnail.jp

A response to Rome: lessons from pre- and post-publication data-sharing in the C. elegans research community

<p>Abstract</p> <p>Background</p> <p>In recent years numerous studies have undertaken to measure the impact of patents, material transfer agreements, data-withholding and commercialization pressures on biomedical researchers. Of particular concern is the theory that such pressures may have negative effects on academic and other upstream researchers. In response to these concerns, commentators in some research communities have called for an increased level of access to, and sharing of, data and research materials. We have been studying how data and materials are shared in the community of researchers who use the nematode <it>Caenorhabditis elegans </it>(<it>C. elegans</it>) as a model organism for biological research. Specifically, we conducted a textual analysis of academic articles referencing <it>C. elegans</it>, reviewed <it>C. elegans </it>repository request lists, scanned patents that reference <it>C. elegans </it>and conducted a broad survey of <it>C. elegans </it>researchers. Of particular importance in our research was the role of the <it>C. elegans </it>Gene Knockout Consortium in the facilitation of sharing in this community.</p> <p>Results</p> <p>Our research suggests that a culture of sharing exists within the <it>C. elegans </it>research community. Furthermore, our research provides insight into how this sharing operates and the role of the culture that underpins it.</p> <p>Conclusions</p> <p>The greater scientific community is likely to benefit from understanding the factors that motivate <it>C. elegans </it>researchers to share. In this sense, our research is a 'response' to calls for a greater amount of sharing in other research communities, such as the mouse community, specifically, the call for increased investment and support of centralized resource sharing infrastructure, grant-based funding of data-sharing, clarity of third party recommendations regarding sharing, third party insistence of post-publication data sharing, a decrease in patenting and restrictive material transfer agreements, and increased attribution and reward.</p

Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial.

BACKGROUND: Staphylococcus aureus bacteraemia is a common cause of severe community-acquired and hospital-acquired infection worldwide. We tested the hypothesis that adjunctive rifampicin would reduce bacteriologically confirmed treatment failure or disease recurrence, or death, by enhancing early S aureus killing, sterilising infected foci and blood faster, and reducing risks of dissemination and metastatic infection. METHODS: In this multicentre, randomised, double-blind, placebo-controlled trial, adults (≥18 years) with S aureus bacteraemia who had received ≤96 h of active antibiotic therapy were recruited from 29 UK hospitals. Patients were randomly assigned (1:1) via a computer-generated sequential randomisation list to receive 2 weeks of adjunctive rifampicin (600 mg or 900 mg per day according to weight, oral or intravenous) versus identical placebo, together with standard antibiotic therapy. Randomisation was stratified by centre. Patients, investigators, and those caring for the patients were masked to group allocation. The primary outcome was time to bacteriologically confirmed treatment failure or disease recurrence, or death (all-cause), from randomisation to 12 weeks, adjudicated by an independent review committee masked to the treatment. Analysis was intention to treat. This trial was registered, number ISRCTN37666216, and is closed to new participants. FINDINGS: Between Dec 10, 2012, and Oct 25, 2016, 758 eligible participants were randomly assigned: 370 to rifampicin and 388 to placebo. 485 (64%) participants had community-acquired S aureus infections, and 132 (17%) had nosocomial S aureus infections. 47 (6%) had meticillin-resistant infections. 301 (40%) participants had an initial deep infection focus. Standard antibiotics were given for 29 (IQR 18-45) days; 619 (82%) participants received flucloxacillin. By week 12, 62 (17%) of participants who received rifampicin versus 71 (18%) who received placebo experienced treatment failure or disease recurrence, or died (absolute risk difference -1·4%, 95% CI -7·0 to 4·3; hazard ratio 0·96, 0·68-1·35, p=0·81). From randomisation to 12 weeks, no evidence of differences in serious (p=0·17) or grade 3-4 (p=0·36) adverse events were observed; however, 63 (17%) participants in the rifampicin group versus 39 (10%) in the placebo group had antibiotic or trial drug-modifying adverse events (p=0·004), and 24 (6%) versus six (2%) had drug interactions (p=0·0005). INTERPRETATION: Adjunctive rifampicin provided no overall benefit over standard antibiotic therapy in adults with S aureus bacteraemia. FUNDING: UK National Institute for Health Research Health Technology Assessment