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In Rare Disorder, A Familiar Protein Disrupts Gene Function
An international team of scientists studying a rare genetic disease discovered that a bundle of proteins with the long-established function of keeping chromosomes together also plays an important role in regulating genes in humans.

Federal Funding Should Be Available For Abortion Services, Opinion Piece Says
"The current debate over government funding for abortion in the health care plan is a reminder of how we have failed poor women," Frances Kissling writes in a Salon opinion piece. According to Kissling, the 32-year-old Hyde Amendment, which prohibits federal funding for abortion services, has played a large role in denying impoverished women access to the procedure. "Restoring those funds has not been a top priority for pro-choice advocates, who sadly concluded that because the public does not care about poor women and is actually hostile to poor women who have sex and become pregnant, it would be futile to put too much capital into reversing Hyde," Kissling writes.However, "we have an opportunity to make amends" by reversing the Hyde Amendment and restoring federal funding for abortion services, according to Kissling. "But the portents are not promising," she writes, adding that a group of "pro-life" Democrats in the House in a recent letter to House Speaker Nancy Pelosi (D-Calif.) "laid down the first major antiabortion challenge to health care reform." In addition, the Obama administration "has refused to rule out including abortion in the health care package, but President Obama is already signaling that the status quo on abortion is likely to endure," Kissling writes."The longer it takes to pass a plan, the more momentum against including coverage for abortion -- and possibly contraception -- will build," Kissling writes, adding that "there is a good chance there will be limits on government funding for abortions in the health care package, if not outright exclusion." A compromise being considered by the House Energy and Commerce Committee would not prohibit or require private insurers offering government plans from covering abortions but would prohibit the use of federal funds to pay for them. "Whether this would result in a reduction of coverage in such plans is unclear, but it is possible," she continues."The timing is critical. The need is great, and growing," Kissling writes, adding, "If abortion services are excluded from the health care reform package, the number of women who will not be able to afford abortions is bound to rise and the number of unwanted children will increase." Kissling concludes, "One hears over and over again that we all agree that the health care system is broken; the status quo is not acceptable. The status quo on coverage for abortion is especially unacceptable" (Kissling, Salon, 7/27).
News of the day
Ontario Women Live Longer But Don't Prosper: Study
While Ontario women live longer than men, a majority are more likely to suffer from disability and chronic conditions, according to a new women"s health study by St. Michael"s Hospital researcher Dr. Arlene Bierman. What"s more, low-income women have more chronic conditions, greater disability and a shorter life expectancy than women in high-income groups.
Cardiovascular

Regulatory Update: Mepolizumab For The Treatment Of Hypereosinophilic Syndrome (HES)

GSK announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES). GSK took the decision to withdraw the submission for mepolizumab based on feedback from the Committee for Medicinal Products for Human Use (CHMP) that additional data would be required to further demonstrate clinical benefit and support the application for approval. GSK continues to believe that the evidence supports mepolizumab as a treatment option for patients with HES but accepts the CHMP"s recommendation that the medicine cannot be approved at this time without further data. David Gordon, VP, Biopharm R&D, GSK said: "Research and development in HES is tremendously challenging. It is a disease with very limited treatment options and this decision has been extremely difficult to take. Nevertheless, we are committed to exploring new options to develop mepolizumab as a treatment for HES and we will continue to make it available to patients who are currently benefiting from mepolizumab through our compassionate use programme." The intended use of mepolizumab was for the treatment of FIP1 negative HES, to reduce or eliminate the need for corticosteroid therapy and to reduce eosinophil (a type of white blood cell) count. There is a significant need among HES patients for new treatment options as there are no currently approved therapies in the EU for FIP1 negative HES. Developing a new treatment for such a rare orphan disease as HES and establishing a favourable benefit to risk profile is a significant challenge: small numbers of patients make recruitment for clinical trials difficult and there are no recognised clinical endpoints for HES as this disease affects patients in many different ways and in many different body organs. In recognition of the severity of the disease and currently limited treatment options GSK will continue, where permitted, to support access to mepolizumab for patients with life-threatening HES through its ongoing compassionate use programme. Patients will receive the medicine for as long as they and their treating physicians believe they are benefiting from continued treatment. GSK will explore future options for development of mepolizumab as a treatment of HES and withdrawal of the EU application does not preclude GSK from making a new application at a later stage. Development programmes for the other potential indications will continue as planned, including for use to treat severe asthma. HES patients without the FIP1L1-PDGFRA fusion gene. About HES Hypereosinophilic syndrome (HES) is a group of disorders characterised by persistent and marked build-up in the blood and organs of a type of white blood cell, known as an eosinophil, in the absence of a recognised cause. Depending on which organs are affected, the overabundance of eosinophils can lead to complications ranging from fever and malaise to blood abnormalities, respiratory and cardiac problems, or death in some patients with advanced disease. About mepolizumab Mepolizumab is an investigational, humanised monoclonal antibody that binds to and inactivates a protein cell messenger called interleukin-5, which is the main controller of eosinophils in the blood. The antibody treatment reduces the accumulation of eosinophils in the blood.1,2 Mepolizumab has been granted orphan drug status for the HES indication by regulatory authorities in the US and the European Union. 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. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK" s operations are described under "Risk Factors" in the "Business Review" in the company" s Annual Report on Form 20-F for 2008. References 1. Ames RS, Tornetta MA, McMillan et al. Neutralizing murine monoclonal antibodies to human IL-5 isolated from hybridomas and a filamentous phage Fab display library. J Immunol 1995; 6355-6564. 2. Hart TK, Cook RM, Zia-Amirhosseini P, et al. Preclinical efficacy and safety of mepolizumab (SB-240563), a humanized monoclonal antibody to IL-5, in cynomolgus monkeys. J Allergy Clin Immunol 2001; 108:250-7. GlaxoSmithKline


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