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London Surgeon Pioneering Scarless Abdominal Surgery Using Belly Button
A London surgeon is pioneering a new way to remove abdominal organs through the belly button using an approach called single incision
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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).
Medical Devices

Sucampo Reports Top-Line Results Of Phase 2 Clinical Trial Of Cobiprostone For Prevention Of NSAID-Induced Gastrointestinal Injuries

Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), today reported top-line results from its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). A total of 124 patients with osteoarthritis and/or rheumatoid arthritis at 12 sites in the U.S. were enrolled in this 12-week, double-blinded, randomized, dose-ranging and placebo-controlled phase 2 trial. All patients in the trial received 500 mg of naproxen twice a day. There were four treatment cohorts: one cohort received placebo while the other three cohorts received 18 mcg of cobiprostone either once, twice or three times a day (daily totals of 18, 36 or 54 mcg, respectively). Efficacy endpoints that were evaluated included: the overall incidence of gastric ulcers during the 12-week treatment period; overall incidence of duodenal ulcers; change in the number of ulcers and/or erosions (gastric and duodenal) by patient; time-to-onset analysis of ulcer and/or erosion development; and the severity of overall gastrointestinal injury measured on a standardized grading scale. A top-line analysis of data from the trial indicates that patients receiving cobiprostone experienced a lower overall incidence of ulcers: at Week 12, patients receiving the 54 mcg dose experienced a 50.0% reduction in the overall incidence of gastric ulcers when compared to patients taking placebo. Cobiprostone patients experienced an overall statistically significant reduction in the number of gastric erosions through the treatment period of twelve weeks compared to placebo patients. The reduction of gastric erosions through Week 12 was dose dependent, with 36 mcg and 54 mcg demonstrating statistical significance. The time-to-onset of all ulcer or erosion development was delayed in the cobiprostone cohorts with overall statistical significance across the 12 week treatment period. The retention rates of patients taking naproxen with cobiprostone at Week 12 were statistically significant when compared to patients taking naproxen with placebo and increased in a dose-dependent manner. The rates were 40% for placebo vs. 47%, 52% and 77% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The median number of days in the treatment period was 55.0 days for patients taking placebo compared to 60.0, 82.0, and 83.0 days for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. Overall, the data showed cobiprostone was well tolerated in patients receiving NSAID therapy. The related overall adverse event rates were 66.7% for placebo, compared to 60.0%, 71.0% and 67.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The most common related adverse events were: diarrhea, at 13.3% for placebo compared to 13.3%, 32.3% and 35.5% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively; nausea, at 10.0% for placebo vs. 10.0%, 16.1% and 16.1% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively; and gastritis, at 13.3% for placebo vs. 13.3%, 6.5% and 9.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. The drug-related gastrointestinal adverse event rates were 66.7% for placebo vs. 60.0%, 67.7%, and 67.7% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively, which suggest that gastrointestinal adverse events other than diarrhea and nausea may be related to the naproxen therapy. Withdrawal rates from the trial due to an adverse event were: 21.9% for placebo vs. 13.3%, 16.1% and, 16.1% for cobiprostone 18 mcg, 36 mcg and 54 mcg, respectively. Ryuji Ueno, M.D., Ph.D., Ph.D., Chair and CEO of Sucampo Pharmaceuticals, Inc., said, "I am pleased with these results. We believe cobiprostone may have the potential to offer patients a new treatment strategy for the prevention of gastrointestinal injuries associated with NSAID therapy. We look forward to working with our investigators to determine the next steps in clinical development. We also intend to initiate contact with potential commercialization partners to understand the possible commercial alternatives if cobiprostone succeeds in further clinical development." About cobiprostone Cobiprostone is a functional fatty acid and a member of a class of compounds called prostones. It is a locally acting chloride channel activator that Sucampo believes has potent activities in the gastrointestinal tract. In pre-clinical cellular assays, cobiprostone dose-dependently activated type-2 chloride channels in a protein kinase A independent fashion. In animal studies, cobiprostone protected against formation of ulcers induced by indomethacin, an NSAID, and ulcers induced by stress and demonstrated an acceptable safety profile at what Sucampo believes are clinically relevant doses. Sucampo Pharmaceuticals, Inc. holds exclusive worldwide rights to develop and commercialize cobiprostone for all indications. About NSAID-Induced Gastric Ulcers Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used drugs worldwide. Although the analgesic, anti-pyretic and anti-inflammatory properties of NSAIDs are very effective for the treatment of pain and inflammation, long-term use can cause gastrointestinal injury ranging from upset stomach to ulcer formation and gastrointestinal bleeding. Sucampo Pharmaceuticals, Inc


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