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Celgene Announces Positive Top Line Data From Randomized Controlled Phase II Study Of Apremilast In Psoriatic Arthritis
Celgene Corporation (NASDAQ: CELG) announced the preliminary results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast - a novel, orally available small molecule that exhibits anti- inflammatory activities through the suppression of multiple pro-inflammatory mediators and cytokines - in adult patients with psoriatic arthritis (CC-10004-PSA-001). The study met its primary objective of assessment of ACR20 at 12 weeks. ACR20 is defined as the percentage of patients achieving a 20% or better improvement according to the American College of Rheumatology (ACR) criteria. ACR20 is the primary assessment utilized by the U.S. Food and Drug Administration for assessment of efficacy in psoriatic arthritis, as well as rheumatoid arthritis.
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Washington Times Opinion Piece, Editorial Discuss DOJ Nominee Johnsen
The Washington Times recently published an opinion piece and an editorial discussing President Obama"s nomination of Indiana University law professor Dawn Johnsen to head the Office of Legal Counsel in the Justice Department. Summaries appear below. ~ Mickey Edwards/William Sessions, Washington Times: The Senate should "act expeditiously to approve" Johnsen"s nomination because "her views on the limits of presidential power are precisely what the Constitution envisions and conservatives have long championed," Edwards, vice president of the Aspen Institute and author of "Reclaiming Conservatism," and Sessions, a partner at the law firm Holland & Knight, write in a Times opinion piece. According to the authors, Johnsen "made her views clear" on the limits of presidential power when she joined a bipartisan group of lawyers that declared that the Office of Legal Counsel should promote "presidential adherence to the rule of law." Edwards and Sessions write that Johnsen is being criticized for "being blunt, unserious and critical of presidential policies." However, these attacks are unwarranted, they write, noting that in the legal profession, "a little blunt talk to a client -- in this case, the president of the United States -- might be required." Edwards and Sessions continue, "What is needed in the Office of Legal Counsel is a person with the constitutional understanding to know that even presidents with whose politics she agrees must obey both the Constitution and federal statutes and who has the gumption to say so, even if the advice won"t be well received" (Edwards/Sessions, Washington Times, 5/21).~ Washington Times: The editorial states that Johnsen "is so radical" that 31 Republican Indiana state senators on Monday sent a letter to Sens. Evan Bayh (D-Ind.) and Dick Lugar (R-Ind.) asking them to oppose her confirmation. The Republican senators called Johnsen"s views supporting abortion rights "extremely radical" and said she often uses "harsh, sensationalizing rhetoric" in her writings on Supreme Court cases, the editorial states. According to the editorial, Johnsen"s "political advocacy shows a profound disregard for the courts" proper role" because she considers the courts "as making up just another political, policymaking branch of government, not as bodies restrained by the Constitution or existing laws." The editorial continues that Johnsen is "guilty" of "asking judges to impose their own policy preferences" in favor of abortion rights "against the dictates of existing constitutional law." The editorial concludes, "Someone with such contemptuous views of the Constitution should not be the Obama administration"s chief constitutional interpreter" (Washington Times, 5/21).
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'Complacency,' 'Stigma' Hindering Efforts To Reduce HIV/AIDS In Black Communities, Opinion Piece Says
"Nearly 30 years after the discovery of HIV and AIDS, the epidemic is still ravaging black neighborhoods in Baltimore and across the nation," Kevin Fenton -- director of CDC"s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention -- writes in a Baltimore Sun opinion piece. Fenton writes that "complacency about HIV and the continued stigma associated with the disease are hindering progress by preventing too many African-Americans from seeking either HIV testing and treatment or support from their friends and family," adding that "this is a challenge that can be overcome."According to Fenton, the Obama administration last month "took an important step in confronting the United States" HIV epidemic" when CDC and White House officials announced a five-year campaign called Act Against AIDS, which is "designed to refocus the nation"s attention on the HIV crisis here at home." Fenton notes that 14 black civic organizations -- including the NAACP, the National Urban League, the Southern Christian Leadership Conference and the National Council of Negro Women -- are "joining the CDC to increase knowledge, awareness and action within black communities across the country." He adds that the campaign "will harness the strength and reach of these organizations by enhancing their ability to make HIV prevention a core component of their daily activities." "By raising the visibility of HIV and AIDS, the new campaign also aims to confront and overcome the fear and stigma that help keep HIV alive in black communities," Fenton says. He adds that he has "been encouraged in recent years to see black leaders, including black faith leaders, speak out more openly across the nation about the need to confront HIV and the stigma that persists surrounding this disease." Fenton writes that "[e]nding this epidemic will require not only frank and difficult discussions about HIV but also a shared sense of responsibility and commitment," concluding, "All of us can and must be part of the solution" (Fenton, Baltimore Sun, 5/27).
Public Health

Critical Appraisal Of Continuous Glucose Monitoring Technology Is Focus Of Diabetes Technology & Therapeutics Supplement

Continuous Glucose Monitoring (CGM) devices represent a critical step toward achieving automated glucose measurement, offering people with diabetes a promising new tool for maintaining optimal glucose control. A comprehensive review of this rapidly changing field, featuring the most recent research findings and critical analysis, is the focus of a special supplement of Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. The supplement is available free online at http://www.liebertonline.com/dia "CGM is still in its infancy, yet this technology is already becoming the standard of care," writes Satish K. Garg, MD, Editor-in-Chief of Diabetes Technology & Therapeutics, and Professor of Medicine and Pediatrics from the University of Colorado Denver, in an editorial introducing the supplement. Over the past decade, "The annual healthcare costs related to diabetes care in the United States have increased significantly by 32%...to $174 billion," despite improvements in glucose control, Garg notes. Better methods are needed to prevent the long- and short-term complications associated with diabetes. This in-depth supplement provides a detailed presentation of the need for better glucose monitoring techniques, describes state-of-the-art CGM technology, and looks to the future and the ultimate goal of integrating CGM with an artificial pancreas to simulate normal blood glucose control systems in the body. Several articles focus on the challenges that CGM must still overcome, whether technical, practical, or economic. In the editorial, "Do We Really Need Continuous Glucose Monitoring?" Anne Peters, MD, from the University of Southern California Keck School of Medicine (Los Angeles), points out some of the drawbacks of current CGM technology: for example, the devices are "finicky and require care and calibration leading patients to use them infrequently"; "few physicians know how to interpret the data"; and "CGM devices have not been shown to reduce rates of severe hypoglycemia." Associate Editor Jay S. Skyler, MD, from the University of Miami Miller School of Medicine (Florida), reviews the history of CGM in an editorial entitled, "Continuous Glucose Monitoring: An Overview of Its Development." Eric Orzeck, MD, from Endocrinology Associates (Houston, TX), describes the need for better documentation, coding, and appeal procedures for use of CGM to improve insurance coverage, in the article, "Maximizing Reimbursement through Correct Coding Initiatives." In the commentary entitled, "Continuous Glucose Monitoring: Understanding Our Current Culture," Irl Hirsch, MD, from the University of Washington School of Medicine (Seattle), concludes that CGM, "is only a tool to help patients make better decisions about insulin and food. Until we have a closed-loop system or islet cell transplant, human behavior will continue to dictate the success of a patient with his or her diabetes control." Vicki Cohn Mary Ann Liebert, Inc./Genetic Engineering News


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