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FDA Requests Labeling Change For Leukotriene Modifiers
The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
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Tragic Death Highlights Perils Of Binge Drinking, UK
Commenting on the tragic death of 22-year-old Gary Reinbach, who died as a result of binge drinking since the age of 13, Dr Peter Carter, Chief Executive of the Royal College of Nursing (RCN), said:
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Opinion Pieces, Editorials Comment On Obama's Notre Dame Commencement Speech
Several newspapers recently published opinion pieces and editorials regarding President Obama"s commencement address at the University of Notre Dame on Sunday. Summaries appear below.~ Austin Hill, U.S. News and World Report: A "careful look" at the controversy surrounding Notre Dame"s invitation to Obama "suggests that ... the Catholic Church in America is neither communicating very clearly to the broader American society, nor is it communicating very clearly among its own members," columnist Hill writes. Hill asks, "[I]f Catholics need to criticize a political figure even when he is "right" on the abortion issue, can they, or should they, praise a political figure even when he is "wrong" on the abortion issue" but "right" on other moral issues? He adds, "The bishops need to answer this question, in no uncertain terms, and they need to do so with clarity" (Hill, U.S. News and World Report, 5/20).~ William Saletan, Slate: Abortion is "the classic multidimensional issue," and "Obama"s acknowledgment of the issue"s complexity is important for two reasons," author and Slate correspondent Saletan writes. The first reason is that Obama is "dropping the pretense of a conclusive answer," and the second is that "even strategic symbolic dialogue can bring unforeseen consequences," Saletan writes (Saletan, Slate, 5/20).~ Julia Duin, Washington Times: A number of things "did not seem right" about Obama"s speech,"[e]specially about "common ground" on an issue that has none" -- abortion rights, columnist Duin writes. Duin asks, "Does this "common ground" idea really work? On peripheral issues, yes. On life-and-death issues, no." According to Duin, "It seems that one side of the debate is always told it needs to move to the center on a given issue, while the other side is told it needs to stand firm." She adds that Obama"s speech highlighted "a huge disconnect," possibly "that some issues don"t have a common ground" (Duin, Washington Times, 5/21).~ Marybeth Hicks, Washington Times: In his speech, Obama "shared a world view that people of all strongly held beliefs must consider: While we will never agree on certain matters of principle, we should still find ways to lift up mankind through cooperation and service and love," columnist Hicks writes. Hicks says that she would like "Obama to send a copy of that speech to Harry Knox" -- director of the religion and faith program at the Human Rights Campaign and a member of Obama"s White House Council on Faith-based and Neighborhood Partnerships -- because Knox "must learn to respect the right of Catholics and of our church to hold principled beliefs of our own" (Hicks, Washington Times, 5/20).~ Dallas Morning News: Obama "[o]nce again ... displayed his gift for making his most strident opponents marginalize themselves" by "com[ing] across as the kind of politician who genuinely sees those who disagree with him as opponents, not enemies," a Morning News editorial says. "When a strong abortion-rights supporter like Obama is not only honored at the nation"s most important Catholic university (in terms of cultural symbolism), but enthusiastically embraced, times are changing," it adds (Dallas Morning News, 5/18).~ Kansas City Star: Most Americans "have more in common with the 12,000 graduates, families and friends who were inside the Notre Dame arena than with the demonstrators outside" and "are willing to listen to different views and ... seek a middle ground that would lessen the [abortion] issue"s grip on political discourse," a Star editorial states. It continues, "Instead of ostracizing those of different views, Americans would do better to follow the path suggested by Obama: Reduce unintended pregnancies, make adoption more available and provide "care and support for women who do carry their children to term"" (Kansas City Star, 5/18).~ Baltimore Sun: Obama "met the challenge head-on" of speaking at Notre Dame amid the protests through "his faith in the ability of reasonable people to disagree and still find common gro
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New Statistical Method Shows Importance Of Dialysis Dose

A new approach to statistical analysis may be better suited to study the relationship between higher "dose" of dialysis and survival time for patients with advanced kidney disease, according to an upcoming paper in the Journal of the American Society of Nephrology (JASN). Some studies have shown longer survival times for patients receiving a higher dose of dialysis, while others show no such relationship. Thus, Christos Argyropoulos, MD, PhD (University of Pittsburgh Medical Center) and colleagues analyzed data from a large group of U.S. dialysis patients using the new statistical technique as well as conventional methods. The "accelerated failure time" model (inspired by considerations of what happens when kidneys cease working and many unidentified toxins start building up in the patient"s bloodstream) showed longer survival times at a higher dose of dialysis, compared to no significant effect with the conventional model. Upon analysis using this technique, patient survival increased steadily along with dialysis dose, after adjustment for other risk factors (age, heart disease, diabetes, comorbid conditions, etc). The results suggest that the conflicting results of previous studies may be related to the limitations of the statistical methods used. Small to moderately sized clinical trials may be particularly sensitive to this effect, adds Argyropoulos. "From a public health perspective, it may be reasonable to re-examine the clinical trial data with unconventional, yet scientifically valid statistical techniques and encourage relevant basic research in statistics and epidemiology to facilitate future clinical studies in this area." The study was limited by the lack of follow-up information on the dose of dialysis the patients received at multiple clinic visits. "Consequently, no conclusions could or should be drawn about the validity of existing national and international guidelines concerning an adequate dialysis dose," says Argyropoulos. He also stresses that the findings cannot be generalized to non-U.S. patients. Co-authors included Chung-Chou H. Chang, PhD, and Mark Unruh, MD (University of Pittsburgh); Nancy Fink, MPH (John Hopkins University, Baltimore); and Laura Plantinga, MSc, and Neil Powe, MD (University of California, San Francisco). The research was supported by an unrestricted grant through the Renal Discoveries Baxter Extramural Grant program from Baxter Healthcare International to the authors and by grants from the Agency of Healthcare Research and Quality (AHRQ), the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung and Blood Institute (NHLBI). American Society of Nephrology


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