THE EFFECT OF FDA'S POLICIES ON THE DECREASING EFFECTIVENESS OF ANTIBIOTICS

This paper will evaluate the effect that the Food and Drug Administration (FDA) has had on the drug resistance problem and will consider how the FDA could tailor its regulatory policies to better safeguard the effectiveness of the American antibiotic supply. The discussion will be divided in two parts. First, we will look at the consequences of FDA's approach to controlling the dissemination of antibiotics. Secondly, we will examine the effect that FDA policies have had on the development of new antibiotics. In both parts, we will consider how the FDA's present approach may be improved upon

Le programme de clercs à la Cour suprême du Canada

Le présent article porte sur les clercs et leur rôle à la Cour suprême du Canada. Le but est de renseigner les clercs éventuels sur la nature du poste et de permettre à tous de mieux comprendre le fonctionnement du processus judiciaire à ce niveau. Les auteurs commencent par étudier l'histoire du programme de clercs à la Cour suprême. Bien que les fonctions du clerc aient peu changé depuis la création du poste en 1968, le programme a évolué au même rythme que la Cour. Les auteurs traitent ensuite du programme de clercs actuel. Ils décrivent d'abord le processus de sélection. En s'inspirant d'un questionnaire envoyé aux clercs des années 1991 à 1993, les auteurs tentent également d'établir, de façon générale, le profil des personnes qui ont été employées par la Cour au cours des dernières années. L'article inclut ensuite une description des tâches. Bien que cette catégorie de personnel assume de nombreuses responsabilités, les auteurs réfutent les critiques habituellement adressées à la Cour suprême des États-Unis en affirmant que les clercs de la Cour suprême du Canada ne jouissent pas d'une autorité excessive. Les auteurs concluent qu'un stage à la Cour profite à la fois aux clercs eux-mêmes et aux procédures de la Cour. Ainsi, les clercs font partie intégrante du processus judiciaire à la Cour suprême du Canada.This article takes an in-depth look at law clerks and the role they play at the Supreme Court of Canada. Such an examination both informs prospective clerks on the nature of the position and promotes a better general understanding of how the judicial process operates at this level. The authors begin their analysis by looking at the history of the law clerks at the Supreme Court. Although the functions of the clerks have changed little since their introduction in 1968, the clerkship program has evolved with a changing Supreme Court, contributing to the institution's « coming of age ». The authors then shift their attention to examining the present clerkship program. The article first reveals the manner in which law clerks are selected by the Court. Using data collected by a questionnaire sent to clerks of the 1991-93 terms, the authors also attempt to convey, in a general way, some sense of the people who have served at the Court in recent years. Next, the major functions performed by the clerks are described. While the clerks do have a great deal of responsibility, the authors dispel much of the criticism directed at the United States Supreme Court clerks by stating that law clerks at the Supreme Court of Canada do not have an improper degree of authority. The authors conclude that the clerking experience benefits both the clerks themselves and Court procedures. As such, law clerks are an entrenched and indispensable part of the judicial process at the Supreme Court of Canada

Exemestane in the Adjuvant Treatment of Breast Cancer in Postmenopausal Women

Exemestane is an irreversible inhibitor of the aromatase enzyme, which is a key component in the production of estrogen. The majority of breast cancers are sensitive to the proliferative effects of estrogen. Exemestane is approved for the adjuvant treatment of postmenopausal women with breast cancer after 2 to 3 years of tamoxifen therapy, based on a 32% improvement in disease-free survival compared with 5 years of tamoxifen alone (P < 0.001). Exemestane has also shown clinical benefits as an upfront therapy. The safety profile of exemestane shares some side effects with tamoxifen (hot flashes and arthralgia), but is not associated with an increased risk of endometrial cancer or thromboembolic events. This review will discuss in detail the efficacy and safety of exemestane in early breast cancer

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis : Fundamentals Of Care for UveitiS (FOCUS) Initiative

Supplemental material available at www.aaojournal.org. Supported by AbbVie, Inc., and the Fundamentals of Care for Uveitis Initiative National Faculty. This manuscript was developed subsequent to an AbbVie-sponsored literature review of noninfectious, nonanterior uveitis. The meeting was conducted to understand the available literature regarding the management of patients with noninfectious, nonanterior uveitis. The program involved a total of 139 experts from 28 countries, who were selected for participation by AbbVie. However, AbbVie was not involved in the development of the manuscript. The authors maintained complete control over the content and this manuscript reflects the opinions of the authors. AbbVie selected the discussion participants and reviewed the final manuscript draft for scientific accuracy, but the authors determined the final content. All authors made substantial contributions to the article or critically revised it for important intellectual content and approved the final manuscript. AbbVie provided funding to invited participants, including honoraria for their attendance at the meetings. Travel to and from the meetings was reimbursed. No payments were made to the authors for the development of this manuscript. Dhinakaran Sambandan, PhD, and Shula Sarner, PhD, of Lucid Partners, Burleighfield House, Buckinghamshire, United Kingdom, provided medical writing and editorial support to the authors in the development of this manuscript; financial support for these services was provided by AbbVie. AbbVie reviewed the manuscript, but was not involved in the methodology, data collection and analysis, or completion of this manuscript.Peer reviewedPublisher PD

Guidance on noncorticosteroid systemic immunomodulatory therapy in noninfectious uveitis: fundamentals of care for uveitis (focus) initiative

Topic: An international, expert-led consensus initiative to develop systematic, evidence-based recommendations for the treatment of noninfectious uveitis in the era of biologics. Clinical Relevance: The availability of biologic agents for the treatment of human eye disease has altered practice patterns for the management of noninfectious uveitis. Current guidelines are insufficient to assure optimal use of noncorticosteroid systemic immunomodulatory agents. Methods: An international expert steering committee comprising 9 uveitis specialists (including both ophthalmologists and rheumatologists) identified clinical questions and, together with 6 bibliographic fellows trained in uveitis, conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol systematic reviewof the literature (English language studies from January 1996 through June 2016; Medline [OVID], the Central Cochrane library, EMBASE,CINAHL,SCOPUS,BIOSIS, andWeb of Science). Publications included randomized controlled trials, prospective and retrospective studies with sufficient follow-up, case series with 15 cases or more, peer-reviewed articles, and hand-searched conference abstracts from key conferences. The proposed statements were circulated among 130 international uveitis experts for review.Atotal of 44 globally representativegroupmembersmet in late 2016 to refine these guidelines using a modified Delphi technique and assigned Oxford levels of evidence. Results: In total, 10 questions were addressed resulting in 21 evidence-based guidance statements covering the following topics: when to start noncorticosteroid immunomodulatory therapy, including both biologic and nonbiologic agents; what data to collect before treatment; when to modify or withdraw treatment; how to select agents based on individual efficacy and safety profiles; and evidence in specific uveitic conditions. Shared decision-making, communication among providers and safety monitoring also were addressed as part of the recommendations. Pharmacoeconomic considerations were not addressed. Conclusions: Consensus guidelines were developed based on published literature, expert opinion, and practical experience to bridge the gap between clinical needs and medical evidence to support the treatment of patients with noninfectious uveitis with noncorticosteroid immunomodulatory agents