Negotiating the Transatlantic Trade and Investment Partnership

Created as part of the 2014 Jackson School for International Studies SIS 495:Task Force. Philip Wall, Task Force Advisor; Shaun Donnelly, Evaluator; Katherine Garbe and Tucker Hoffman, Editors.The Transatlantic Trade and Investment Partnership (TTIP) currently being negotiated between the United States and the European Union stands to be the largest free trade agreement ever created. The comprehensive trade and investment agreement is an opportunity to modernize trade rules and strengthen the strategic partnership between the U.S. and the EU. This can be accomplished through enhancing trade, finance, and investment opportunities that will in turn foster job creation, economic growth, and international competitiveness

Use of IV Iron and Risk of Anaphylaxis: A Multinational Observational Post-Authorisation Safety Study in Europe

PURPOSE: This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from 2.0 to 6.8 per 10 000 first treatments. METHODS: Cohort study of IV iron new users, captured mostly through pharmacy ambulatory dispensing, from populations covered by health and administrative data sources in five European countries from 1999 to 2017. Anaphylaxis events were identified through an algorithm that used parenteral penicillin as a positive control. RESULTS: A total of 304 210 patients with a first IV iron treatment (6367 iron dextran), among whom 13–16 anaphylaxis cases were identified and reported as a range to comply with data protection regulations. The pooled unadjusted incidence proportion (IP) ranged from 0.4 (95% confidence interval [CI], 0.2–0.9) to 0.5 (95% CI, 0.3–1.0) per 10 000 first treatments. No events were identified at first dextran treatments. There were 231 294 first penicillin treatments with 30 potential cases of anaphylaxis (IP = 1.2; 95% CI, 0.8–1.7 per 10 000 treatments). CONCLUSION: We found an IP of anaphylaxis from 0.4 to 0.5 per 10 000 first IV iron treatments. The study captured only a fraction of IV iron treatments administered in hospitals, where most first treatments are likely to happen. Due to this limitation, the study could not exclude a differential risk of anaphylaxis between iron dextran and iron non-dextrans. The IP of anaphylaxis in users of penicillin was consistent with incidences reported in the literature

Skin Examination Practices Among Melanoma Survivors and Their Children

Many professional organizations recommend skin self-examination (SSE) as a tool for early detection of malignancy among melanoma survivors, a growing population that is at increased risk for new or recurrent melanoma. This study examined the frequency and correlates of SSE use among melanoma survivors. Additionally, we assessed skin exam use among children of survivors, who are at elevated lifetime risk for the disease. The California Cancer Registry was used to identify melanoma survivors, who were contacted, screened for eligibility, and invited to participate in a survey. The survey, administered by mail, web, or telephone, assessed a broad range of topics related to melanoma prevention in high-risk families. The present study focuses on skin examination practices of survivors and their children and potential correlates of these practices. Among a sample of 316 melanoma survivors, fewer than one in five participants performed monthly skin self-exams, a lower rate than that observed in previous studies. Although greater family history of melanoma, use of skin protection strategies, and the perceived severity of melanom were associated with more frequent use of skin self-exams, these relationships disappeared in adjusted analyses. Participants reported unexpectedly frequent use of skin examinations for their children despite the lack of professional guidelines for this practice. Interventions are needed to improve skin self-examination practices among melanoma survivors and to counsel parents about optimal melanoma prevention strategies for their children

No clinical utility of KRAS variant rs61764370 for ovarian or breast cancer

Objective. Clinical genetic testing is commercially available for rs61764370, an inherited variant residing in a KRAS 3' UTR microRNA binding site, based on suggested associations with increased ovarian and breast cancer risk as well as with survival time. However, prior studies, emphasizing particular subgroups, were relatively small. Therefore, we comprehensively evaluated ovarian and breast cancer risks as well as clinical outcome associated with rs61764370. Methods. Centralized genotyping and analysis were performed for 140,012 women enrolled in the Ovarian Cancer Association Consortium (15,357 ovarian cancer patients; 30,816 controls), the Breast Cancer Association Consortium (33,530 breast cancer patients; 37,640 controls), and the Consortium of Modifiers of BRCA1 and BRCA2 (14,765 BRCA1 and 7904 BRCA2 mutation carriers). Results. We found no association with risk of ovarian cancer (OR = 0.99, 95% CI 0.94-1.04, p = 0.74) or breast cancer (OR = 0.98, 95% CI 0.94-1.01, p = 0.19) and results were consistent among mutation carriers (BRCA1, ovarian cancer HR = 1.09, 95% CI 0.97-1.23, p = 0.14, breast cancer HR = 1.04, 95% CI 0.97-1.12, p = 0.27; BRCA2, ovarian cancer HR = 0.89, 95% CI 0.71-1.13, p = 034, breast cancer HR = 1.06, 95% CI 0.94-1.19, p = 0.35). Null results were also obtained for associations with overall survival following ovarian cancer (HR = 0.94, 95% CI 0.83-1.07, p = 0.38), breast cancer (HR = 0.96, 95% CI 0.87-1.06, p = 0.38), and all other previously-reported associations. Conclusions. rs61764370 is not associated with risk of ovarian or breast cancer nor with clinical outcome for patients with these cancers. Therefore, genotyping this variant has no clinical utility related to the prediction or management of these cancers. (C) 2015 Elsevier Inc. All rights reserved.Peer reviewe