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Stretch Mark

House Committee Approves Reform Bill; Full House Debate Scheduled For After August Recess
The House Energy and Commerce Committee on July 31 approved its health care reform bill (HR 3200) by a 31-28 vote that was mostly along party lines, the AP/Seattle Times reports. Among the many amendments considered during the markup, the committee rejected an amendment offered by Reps. Joe Pitts (R-Pa) and Bart Stupak (D-MI) to prohibit government subsidies to any insurance plans that offers abortion coverage, effectively prohibiting abortion coverage for customers eligible for public premium assistance. The amendment was rejected by a 27-31 vote. Another provision approved on July 30 would neither require nor prohibit insurance companies from providing coverage for abortion services.The approved bill includes provisions limiting how much insurers can increase premiums and gives the federal government the power to negotiate with drug companies for lower prices under Medicaid. The provisions were part of an effort by Democrats on the committee to reconcile the demands of liberals and conservatives, the AP/Times reports. The bill also would require insurance companies to sell coverage to anyone seeking it, regardless of pre-existing conditions. The government would provide subsidies to lower-income families to help them afford policies. In addition, the legislation would establish health insurance exchanges offering a variety of insurance plans, where consumers with or without subsidies could purchase health insurance (Espo/Werner, AP/Seattle Times, 8/1).Five of the committee"s Democrats joined all 23 Republicans in opposing the measure, the Washington Post"s "Capitol Briefing" reports. The five Democrats who voted against the bill were Reps. John Barrow (Ga.), Rick Boucher (Va.), Jim Matheson (Utah), Charlie Melancon (La.) and Bart Stupak (Mich.) (Kane, "Capitol Briefing," Washington Post, 7/31).The committee was the last of three House panels to take action on the legislation, although the vote comes several weeks after the White House and Democratic leaders originally wanted, the AP/Times reports. The full House is expected to vote on the bill after policymakers return from their August recess.Although the House"s agenda has moved slower than party leaders had hoped, it still was faster than the action in the Senate, according to the AP/Times (AP/Seattle Times, 8/1). Senate Finance Committee Chair Max Baucus (D-Mont.) on July 30 announced that the panel will not mark up a health care reform bill this week after Republican negotiators urged that the speed of discussion in the Senate be slowed, the Post"s "44" reports. The announcement means that health care reform legislation will not be out of committee in both chambers before the summer recess (Pershing, "44," Washington Post, 7/31).Catholic Bishops Say That House Bill Could Expand Abortion Coverage In related news, the U.S. Conference of Catholic Bishops in a letter to members of the House Energy and Commerce Committee voiced its opposition to the reform bill, arguing that it could be used to require private health insurance plans to cover abortion services, the Post reports. The bill has been opposed by conservative Christian groups for weeks, with the groups arguing that it could be used to expand abortion rights, the Post reports.In the letter, Cardinal Justin Rigali -- chair of the Committee on Pro-Life Activities -- said the bill could increase federal funding for abortion services because some government funding would not be covered by the Hyde Amendment, which currently bans the use of federal Medicaid funds for abortion services. Rigali also said the bill could overturn state laws that restrict access to abortion services, such as parental notification laws. In addition, Rigali said the bill should continue to ensure provider conscience rights to protect Catholic health care workers who refuse to provide abortion services based on their religious or moral beliefs (Washington Post, 8/1).
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Does Preoperative Biliary Drainage Influence The Outcome Of Resectional Surgery For Ampullary Carcinoma?
A research article published in the World Journal of Gastroenterology addresses this question. This is believed to be the first study to investigate the effect of PBD in ampullary cancer. A team of gastroenterologists led by Dr Steven Joseph Mesenas and hepatobiliary surgeons at Singapore General Hospital divided 82 patients with ampullary cancer planned for surgical resection into those with PBD (n = 35) and those without (n = 47). The authors looked into various outcomes after surgery, such as pancreatic leakage, wound infection, bile leakage, infectious morbidity, intra-abdominal or gastrointestinal bleeding, intra-abdominal abscess, delayed gastric emptying and mortality. They found that the PBD group had a significantly reduced wound infection rate compared to the non-PBD group. More studies should be conducted to assess this benefit, especially in ampullary cancer patients.
News of the day
Data From Clinical Study Of BioTheranostics Molecular Diagnostic Test Presented At American Society Of Clinical Oncology Annual Meeting
bioTheranostics, a bioMerieux company that discovers, develops and commercializes new molecular diagnostic tests in oncology, announced that a recent study demonstrated the company"s THEROS CancerTYPE ID(R) molecular diagnostic test predicted cancer origin with 75 percent accuracy in patients whose primary cancer was initially "unknown" using traditional diagnostics. Findings were presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fl.
Medical Devices

POZEN Submits New Drug Application For VIMOVO™ (PN 400)

POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. The NDA submission is based on data from a comprehensive clinical trials program. POZEN conducted two pivotal studies (301/302) under a special protocol assessment agreed with the FDA, which met their primary endpoints. In the 301/302 studies, significantly fewer subjects taking VIMOVO experienced endoscopically confirmed gastric ulcers compared to subjects receiving EC naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either VIMOVO or EC naproxen (500 mg), twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. Upon the FDA"s acceptance for filing of the NDA, a $10 million milestone payment from AstraZeneca will be payable to POZEN. About Osteoarthritis Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 140 million individuals worldwide,1 and impacting approximately 18% of women and 9.6% of men aged 60 and above.2,3 A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness.4 Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.5 In the U.S., the average direct cost of osteoarthritis is about $2,600 per year out-of-pocket expenses. Total annual disease costs are $5,700 (2000) and job-related osteoarthritis costs are $3.4 to $13.2 billion per year.6 POZEN


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