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Clinical Handover - Critical Communications
The lead article in a special supplement on clinical handover in the Medical Journal of Australia relates a tragic case in which an elderly man died for want of effective handover.

Risk Factors For LRTIs In Inuit Children Identified In First Of Its Kind Study
Inuit children have the highest rate of hospital admission for Lower respiratory tract infections (LRTIs) globally, but new research shows that lowering risk factors though public health interventions and an enhanced immunization program could improve health for Inuit children and lower health care costs significantly. The first-of-its-kind case control research was conducted by Dr. Anna Banerji, a pediatric infectious disease specialist and researcher at St. Michael"s Hospital.
News of the day
Abortion Coverage Likely To Be Next Battle In House Health Reform Legislation
Abortion coverage could become the next "sticking point" in debates over health reform between the House leadership and conservative Democrats, the Los Angeles Times reports. During most of the battle over a health care overhaul, abortion-related issues have taken a "back seat" to clashes between House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) and fiscally conservative Blue Dog Democrats over the cost of the House bill (HR 3200). However, reproductive health issues are increasingly coming into play, with some other conservative Democrats threatening to withdraw support for the bill if coverage of abortion services is not explicitly excluded from receiving federal funding. Rep. Bart Stupak (D-Mich.) and 18 fellow Democrats in June wrote a letter to House Speaker Nancy Pelosi (D-Calif.) stating that they "cannot support any health care proposal unless it excludes abortion from the scope of any government-defined or subsidized health insurance plan." According to the Times, Stupak has "vowed" to press Waxman to include restrictions on abortion coverage in the Energy and Commerce Committee"s version of the House bill. Abortion-rights supporter Rep. Louise Slaughter (D-N.Y.), chair of the House Rules Committee, opposes Stupak"s proposal. Slaughter spokesperson Vincent Morris said, "The starting point for Rep. Slaughter of the health care debate was protecting abortion rights."The Hyde Amendment currently prevents the use of federal Medicaid funds for abortion services. The reach of current law restrictions "grows murkier" if the government forms its own health insurance plan to compete with private insurers or creates a new market that allows the public to choose between various private plans, the Times reports. Both options are under consideration in Congress, and abortion-rights opponents fear that abortion services would be covered unless the language of the bill explicitly forbids it.Abortion-rights supporters argue that the bill would maintain the status quo, as insurance companies already are able to choose whether to cover abortion services. New government restrictions could mean that women seeking abortion coverage would have to choose a more expensive private plan rather than a lower-cost, government-subsidized option, according to abortion-rights advocates. Another concern, they say, is that insurers who currently cover abortion would discontinue that coverage to take advantage of government incentives. In a recent statement, the Planned Parenthood Federation of America said, "Opponents of women"s health and health care reform are exploiting health care reform as a way to push for unprecedented prohibitions on abortion coverage in the private marketplace."The Obama administration is attempting to remain neutral on the issue, the Times reports. White House press secretary Robert Gibbs recently said that "a benefit package is better left to experts in the medical field to determine how best and what procedures to cover." The House bill currently establishes a Health Benefits Advisory Committee to recommend which "essential benefits" should be covered under any government-supported insurance plan. In an interview with CBS News last week, President Obama said that he believes it is "appropriate for us to figure out how to just deliver on the cost savings and not get distracted by the abortion debate."According to the Times, the Obama administration"s silence on the issue is "precisely what worries" antiabortion-rights advocates. Rep. John Fleming (R-La.) said that Obama is "actually making an affirmative statement in favor of" federal funding for abortion services by not taking a stand on the issue (Oliphant, Los Angeles Times, 7/28).
Cardiovascular

GlaxoSmithKline And Genmab Announce Top-line Results For Ofatumumab In Rheumatoid Arthritis

GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures. In the study, 260 patients were treated and included in the analysis. At week 24, the ACR20 response rate was significantly greater for RA patients on ofatumumab (n=129) than on placebo (n=131) with a 50 percent response rate in the patients receiving ofatumumab, compared to 27 percent for patients on placebo (p-value less than 0.001). All key secondary endpoints were significant (p-value less than or equal to 0.001) There were no unexpected safety findings. The most common adverse events in the ofatumumab treated patients (greater than 5 percent) were rash, urticaria, nasopharyngitis, pruritus, throat irritation and hypersensitivity. Other than nasopharyngitis, these events generally occurred within 24 hours of the first infusion. One death, judged by the investigator as unrelated to ofatumumab, was reported in the study during the 24-week study period. "We have always believed in ofatumumab"s potential to make a difference in patients" lives. We are pleased with the results of this study, supporting the further investigation of this antibody"s promise in the treatment of RA" said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "RA can be a highly debilitating disease. It is encouraging to see the reduction in disease symptoms achieved with intravenous ofatumumab, and we look forward to presenting the full study results, " said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. About the study In this 24 week double-blind study, patients with active RA were randomized to receive two 700 mg doses of intravenous ofatumumab or placebo two weeks apart in addition to background methotrexate. Disease status was measured every 4 weeks. Patients for this non-IND study were recruited from Europe, South America and Australia. The primary objective of the study was to determine the efficacy of intravenous ofatumumab in reducing the clinical signs and symptoms in RA patients after two 700 mg doses of ofatumumab compared to placebo. The primary endpoint of the study was ACR20 at 24 weeks. Other key secondary objectives included safety, patient reported outcomes, biomarkers and ACR 50 and ACR 70. ACR Response The ACR 20 response is defined as a 20 percent or greater improvement from baseline in tender and swollen joint counts, and 20 percent or greater improvement in 3 of the 5 following assessments: patient and physician global assessments, pain, disability, and an acute phase reactant (ESR or CRP). About ofatumumab Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. Ofatumumab is being developed for other indications under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country. About GlaxoSmithKline (GSK) GlaxoSmithKline one of the world"s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. GSK"s BioPharm R&D division has a rich early pipeline based on cutting edge molecular biology and genetic technology and a mature late-stage portfolio that will provide important medicines to oncology. GlaxoSmithKline


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