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Senate Bill To Protect Patients' Healthcare By Amending Medicare Coverage
The U.S. Senate has introduced a bill, S. 1221, "The Medicare Prompt Pay Correction Act," a companion bill to H.R. 1392, which was introduced in the U.S. House of Representatives and currently has 45 co-sponsors.
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World Leaders Must Take Action To Support Commitments To Lower Maternal Mortality, Opinion Piece Says
"I stood up and applauded for women everywhere when I heard the news" that the United Nations Human Rights Council, including the U.S., "recognized maternal death as a human rights issue," CARE President and CEO Helene Gayle writes in an Atlanta Journal-Constitution opinion piece. Gayle writes that governments for the past 15 years "have failed to meet the commitments made and targets set to reduce the more than half a million maternal deaths every year."According to Gayle, preventing maternal death "requires three well-coordinated actions: sustain political leadership, secure adequate res and strengthen health systems." She adds that the resolution "is a positive step" but that it is "only effective if it translates into action." She continues, "It"s great to see the Obama administration places women and girls high on the agenda," adding that many members of Congress also support these issues.Reducing maternal mortality "requires significant res," Gayle writes. She adds, "To be blunt, an estimated global commitment of $39 billion over 10 years is needed to make significant progress." Such a commitment would be "an investment in women, their families and the economic productivity of nations," according to Gayle."The cost of not investing is far greater," Gayle continues. She notes that women "do two-thirds of the world"s work and produce nearly 60% of the world"s food." In addition, "children who lose their mothers are 10 times more likely to die in childhood than children with mothers," and maternal and newborn deaths "represent an estimated annual loss of $15.5 billion in productivity," according to Gayle. "Clearly, other development goals cannot be met without healthy mothers," she adds.She continues that the "most tragic and infuriating point" is that the "death of a woman in childbirth is one of the most inexcusable deaths on earth." Because high maternal mortality is a "barometer of weak health systems, often reflecting the low status of women," strengthening health systems to improve maternal health will therefore enable the system to "address other health needs," Gayle writes. She adds that countries such as Bangladesh, Ethiopia and Peru have improved mortality rates "through four lifesaving programs: family planning, skilled and culturally sensitive care during pregnancy and childbirth, emergency care for complications and postpartum care."Gayle writes, "The U.S. can spearhead a comprehensive maternal health action plan and, by doing so, set an example for world leaders to join and invest in." She concludes, "The actions we take now can make maternal death a problem of the past and not one of our children"s future" (Gayle, Atlanta Journal-Constitution, 7/10).
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Supreme Court Should Be 'Reined In' To Return Power To Legislative Branch, NYT Columnist Writes
Although Supreme Court nominee Sonia Sotomayor"s confirmation hearings are more than a month away, "it"s easy to predict how they will go," New York Times columnist Ross Douthat writes. Douthat predicts that Senate Judiciary Committee members "will attempt to divine Sotomayor"s position on a variety of controversial topics," such as abortion rights, and in "a series of polite, evasive answers, the nominee will feign a studious neutrality on almost every issue that could come before her during what"s likely to be decades as one of the most powerful women in the world." According to Douthat, the "deeper stakes" that likely will be ignored are that "Sotomayor will be joining a high court that"s gradually become a kind of extra legislative body." He cites research from Harvard Law School professor Jed Shugerman showing that the court over roughly the past 50 years has invalidated both state and federal statutes at an unprecedented rate. Douthat also points to data from Evan Caminker of the University of Michigan showing that in one eight-year period, the court invalidated 16 federal laws in 5-4 votes, something that occurred only 25 times in the previous two centuries. Douthat writes that "settling so many vexing controversies with 5-to-4 votes -- effectively making Anthony Kennedy the nation"s philosopher king -- is an awfully poor way to run a republic."Douthat continues that the "modern court"s most enduringly controversial power grabs -- with Roe v. Wade leading the way -- were usually the work of liberal justices" but that "in practice, the main divide between liberal and conservative judges tends to be over the responsibilities of the federal government, not judicial activism per se." He writes, "There are bipartisan ways that the Court could be reined in, and the legislative branch reinvigorated," including the idea of a supermajority rule that would require a 6-3 vote to overturn federal legislation. This idea "might spur the court toward greater consensus, and perhaps greater modesty as well," according to Douthat. Another possibility would be to implement 12-year term limits, he says. Douthat concludes that these suggestions would not "reduce the Supreme Court"s power directly, but it would help us see the court for what it has become -- a deeply political institution, as fallible as any other, and answerable, when all is said and done, to us" (Douthat, New York Times, 6/2).
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Celera Presents Data Replicating Its Immunodiagnostic Assay To Detect Lung Cancer From Blood Serum

Celera Corporation (NASDAQ:CRA) announced yesterday the presentation of data replicating its novel mass spectrometry-based approach to identify and validate circulating protein biomarkers that detect non-small cell lung cancer (NSCLC) in an independent cohort of individuals with lung cancer. This study was performed in collaboration with scientists at NYU Langone Medical Center, NY. A key outcome of the study was the validation of a 9 biomarker immunoassay on a cohort of samples that is enriched for stage I disease, important for screening of early stage disease. The assay detected lung cancer with 92% sensitivity at 93% specificity. The panel also accurately distinguished malignant cases from benign lung disease. The data is being presented at the 13th World Conference on Lung Cancer as part of the International Association for the Study of Lung Cancer (IASLC) in San Francisco, CA. This study confirms the performance of a 9 member biomarker panel previously presented at the 100th Annual American Association for Cancer Research (AACR) Conference in April 2009. In addition, the authors report the high performance of a 6 marker panel derived from the 9 marker panel which distinguishes malignant cases with 92% sensitivity at 88% specificity. Celera expects to continue the evaluation of the clinical utility of both the 6 and 9 marker panels in an effort to determine which panel would offer optimal performance in a broad clinical setting. "This is one of the most promising assays I"ve seen as a predictor of non-small cell lung cancer," said Harvey I. Pass, M.D., Professor of Cardiothoracic Surgery and Director of Thoracic Surgery and Oncology at the New York University Langone Medical Center and its NYU Cancer Institute. "Such a test with this accuracy, if validated prospectively in other larger cohorts, may impact the management of individuals with presumed or diagnosed non-small cell lung cancer in the future." "The Early Disease Research Network initiative of National Cancer Institute is committed to identifying a biomarker test for early detection of lung cancer that demonstrates robust performance," said William N. Rom M.D., M.P.H., the Sol and Judith Bergstein Professor of Medicine and Environmental Medicine at the New York University Langone Medical Center. "The work from this collaboration has resulted in a very promising set of biomarkers that warrant continued study. Such a test could potentially provide clinically useful information for physicians and their patients." "We"re pleased to see the performance confirmed in an independent cohort since we believe this assay presents a robust test to detect lung cancer using a simple blood test," said Steve Ruben, Ph.D., Vice President of Proteomics at Celera. "We believe the ability to identify a collection of biomarkers, which we have subsequently shown to be elevated in the blood of non-small cell lung cancer patients relative to appropriate controls, presents an opportunity to detect the disease earlier, enabling more effective intervention and monitoring. This test in combination with helical CT imaging may increase the predictive value of these tests over CT alone. We"re exploring the commercial opportunities for this program as we continue our efforts to validate these findings in a clinical setting." A panel of 9 candidate biomarkers capable of distinguishing lung cancer serum samples from normal samples was previously identified. In the current study, these biomarkers were measured in an independent collection of samples that included: 39 subjects with NSCLC; 33 of which are stage I or II; 38 non-cancer smoking controls; 20 COPD (Chronic Obstructive Pulmonary Disease, emphysema and/or chronic bronchitis) subjects, which is one group of several benign lung diseases often seen in smokers; and 20 subjects with Ground Glass Opacity who continue to be followed to determine which of these patients may progress to malignant disease. The 9 marker panel demonstrated a significantly high level of performance in distinguishing malignant lesions from a control population that included smokers and patients with COPD, showing 92% sensitivity at 93% specificity. Study details The study included 13 candidate biomarkers from a larger set of markers that had been selected from approximately 500 proteins previously identified by a proteomic discovery effort. These biomarkers were used to test serum specimens using ELISA (Enzyme Linked Immunosorbent Assay) methods in a preliminary validation set of sera comprising 103 patients with NSCLC and 104 healthy smoker controls who were matched for age, gender and smoking history. This set of markers includes examples novel to the mass spectrometry discovery effort that have not previously been reported to be elevated in the blood of lung cancer patients. Markers that showed elevated disease expression were then validated in sera from 39 individuals with NSCLC, 38 non-smoking controls and 20 subjects COPD. The test panels that were configured detected lung cancer with favorable sensitivity and specificity to those previously reported (J Clin Onc. 2007, 25: 5578-5582; J Thorac Oncol. 2006, 1: 513-519; Clin Cancer Res. 2008, 14: 1355-1362). This panel and others described in the study are expected to provide the flexibility to design tests with performance specifications suitable for a variety of diagnostic applications, such as screening individuals at risk for lung cancer and for monitoring of disease following diagnosis and treatment. Biomarkers and Lung Cancer Lung cancer is the leading cause of cancer mortality in the U.S. accounting for about 29% of all cancer deaths that occurred in 2008 (Cancer J Clin, 2008; 58:71-96). Currently, there are no guidelines for screening of individuals at risk for lung cancer, and current biomarkers are used only for monitoring of disease following diagnosis and treatment. Novel biomarker panels with improved performance, such as the one described in the current study, may have value at various stages in the detection and diagnosis of lung cancer, which includes independent screening for high risk individuals, and/or for subsequent CT analysis used in combination with imaging technologies to improve resolution of malignant nodules. Such a panel could also be used to improve the monitoring of lung cancer progression by enhancing the management of pulmonary nodules that are identified through CT scanning. Celera


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