Clinical end points in coronary stent trials: a case for standardized definitions

BACKGROUND: Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS: The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. CONCLUSION: Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.

Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis

Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. Design Collaborative network meta-analysis. Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. Conclusion In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.

Report from the National Institute of Allergy and Infectious Diseases workshop on drug allergy

Allergic reactions to drugs are a serious public health concern. In 2013, the Division of Allergy, Immunology, and Transplantation of the National Institute of Allergy and Infectious Diseases sponsored a workshop on drug allergy. International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology, and pharmacogenomics discussed the current state of drug allergy research. These experts were joined by representatives from several National Institutes of Health institutes and the US Food and Drug Administration. The participants identified important advances that make new research directions feasible and made suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy. The workshop summary and recommendations are presented herein.

Foodborne illness - An age old problem requiring contemporary solutions

Foodborne illness has always been with us, and food safety is an increasingly important public health issue affecting populations worldwide. In the United States of America, foodborne illness strikes millions of people and kills thousands annually, costing our economy billions of dollars in medical care expense and lost productivity. The nature of food and foodborne illness has changed dramatically in the last century. The regulatory systems have evolved to better assure a safe food supply. The food production industry has invested heavily to meet regulatory requirement and to improve the safety of their products. Educational efforts have increased public awareness of safe food handling practices, empowering consumers to fulfill their food safety role. Despite the advances made, none of the Healthy People 2010 targets for reduction of foodborne pathogens has been reached. There is no single solution to eliminating pathogen contamination from all classes of food products. However, irradiation seems especially suited for certain higher-risk foods such as meat and poultry and its use should advance the goal of reducing foodborne illness by minimizing the presence of pathogenic organisms in the food supply. This technology has been studied extensively for over 50 years. The Food and Drug Administration has determined that food irradiation is safe for use as approved by the Agency. It is time to take action to educate consumers about the benefits of food irradiation. Consumer demand will compel industry to meet demand by investing in facilities and processes to assure a consistent supply of irradiated food products. ^

Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Immigration and labor: the economic aspects of European immigration to the United States

by Isaac A. Hourwich.

Manuscript on United States relations with England and France,

Untitled and undated manuscript written by Tudor offering his opinions on political and commercial relations between the United States, England, and France, and the causes of American animosity toward those countries. Topics and events referenced include the slave trade, Napoleon, and the Little Belt Affair. Introduction and parts one through three.

Birth and mortality statistics of the Virgin Islands of the United States. 1901-1919.

On t.-p., seal of Department of the navy, Bureau of medicine & surgery.

Comparison of radiation exposures from panoramic dental X-ray units /

"Dec. 1976."

Quality control practices for compliance with the Federal Laser Product Performance Standard.

"March 1976"--P. [i].

Drug registration and listing instruction booklet.

Mode of access: Internet.

Procedures for field testing microwave ovens /

Mode of access: Internet.

Evaluation of commercially available laser protective eyeware /

Mode of access: Internet.