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In Joint Statement, Industry Groups Reiterate Commitment To Reduce Health Spending Growth
The six industry groups that pledged to reduce health care spending growth by $2 trillion over 10 years on Friday issued a statement reaffirming their commitment to work toward the goal, Roll Call reports (Murray, Roll Call, 5/15). The industry groups in a letter sent to President Obama on May 10 wrote, "We will do our part to achieve your administration"s goal of decreasing by 1.5 percentage points the annual health care spending growth rate. ... This represents more than a 20% reduction in the projected rate of growth." The letter -- which was signed by the American Medical Association, the American Hospital Association, Pharmaceutical Research and Manufacturers of America, the Advanced Medical Technology Association, America"s Health Insurance Plans and the Service Employees International Union -- did not elaborate on what specific measures the groups would take to achieve such reductions (Kaiser Daily Health Policy Report, 5/12). Obama in a May 11 public announcement of the groups" pledge said the coalition"s goal was to cut the growth rate by 1.5 percentage points "each year," which would total $2 trillion over 10 years (Norman, CQ HealthBeat, 5/15).However, industry leaders who attended the meeting with Obama said that they did not promise specific year-by-year savings, but instead agreed to a more incremental approach (Kaiser Daily Health Policy Report, 5/15). Richard Umbdenstock, president of AHA, said, "There"s been a lot of misunderstanding that has caused a lot of consternation among our members." AHA sent its members a bulletin stating that "the groups did not support reducing the rate of health spending by 1.5 percentage points annually," and that the pledge was to eventually reduce the growth rate by 1.5 percentage points (CQ HealthBeat, 5/15).In response to media reports that said they were backing away from their pledge, the groups on Friday in a joint statement reiterated their vow. They wrote, "Our organizations are currently engaged in an intensive process to develop proposals to reduce the rate of increase in future health care costs" (Young, The Hill, 5/15). The statement also said, "We are committed to working together to bend the health care cost curve" and "to doing our part to make reform sustainable and to make the system more affordable and effective for patients and purchasers" (Budoff Brown, Politico, 5/18). It continued that "to be successful, we must take action in public-private partnership. We look forward to offering cost-savings recommendations in the weeks ahead." The Obama administration has requested specifics on the coalition"s cost-cutting plans by June 1. White House Office of Management and Budget Director Peter Orszag on Friday in a blog post wrote that it is "understandable" that the groups need to "ramp up" to the 1.5 percentage point reduction in spending. According to Orszag, "The groups have committed to significant reductions in the growth rate, thereby recognizing that substantial efficiencies can be captured in the health system. Some ramp-up time also does not materially affect the long-term impact from reducing the growth rate, on either national health expenditures or the federal budget" (CQ HealthBeat, 5/15). Orszag"s blog posting is available online. Don't forget to buy zoloft online no prescription.

U.S. To Provide Antiviral Medication To Latin America And The Caribbean For Novel H1N1 Influenza
HHS Secretary Kathleen Sebelius announced today that the United States will provide 420,000 treatment courses of Tamiflu (Oseltamavir) to the Pan-American Health Organization (PAHO) to fight the novel H1N1 influenza in Latin America and the Caribbean.

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IPS Examines Need For New Drugs To Treat Neglected Tropical Diseases
Inter Press Service News Agency examines the shortcomings of treatments for neglected tropical diseases - which, according to the Drugs for Neglected Diseases Initiative (DNDi), account "for 12 percent of the global disease burden," and 1.3 percent of the new drugs developed between 1975 to 2004. "The diseases in question account for the deaths of 500,000 people annually, mostly in sub-Saharan Africa, but drug development is biased towards the prospect of high profits, which diseases of the poor like sleeping sickness and visceral leishmaniaisis are unable to offer," IPS writes.
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Clinical Activity Of Neratinib In Combination With Trastuzumab And In Combination With Paclitaxel In Advanced HER-2 Positive Breast Cancer

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced preliminary data from two ongoing studies, one evaluating neratinib (HKI-272) in combination with trastuzumab (Herceptin(R), Roche) in HER-2 positive (ErbB-2 positive) breast cancer, and a separate study investigating neratinib safety and efficacy when given with paclitaxel (Taxol(R), Bristol-Myers Squibb) in patients with HER-2 dependent solid tumors. The data gathered from both trials are scheduled to be presented at the 45th Annual Meeting of the American Society of Clinical Oncology Annual Meeting in Orlando, Florida, from May 29 to June 2, 2009. Neratinib is an investigational orally administered irreversible inhibitor of the HER-2 and EGFR kinases. "The data gathered from these studies provide additional evidence suggesting that neratinib, when combined with these therapies, is an active agent in HER-2 positive breast cancer," says Ramona Swaby, M.D., Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA. "While improvements have been made in treating HER-2 positive breast cancer, there remains an unmet medical need for more therapies for patients with metastatic breast cancer. These data warrant ongoing and future investigations to further understand and evaluate the utility of neratinib against this aggressive disease." Neratinib (HKI-272) in Combination with Trastuzumab for the Treatment of Advanced Breast Cancer This ongoing phase 1/2 study of neratinib in combination with trastuzumab evaluated patients with advanced ErbB-2 positive breast cancer that progressed following therapy with trastuzumab, the standard of care in this disease setting. The primary endpoint of the two-part study is 16-week progression-free survival (PFS). The first part of the study includes patients being administered neratinib (160 mg or 240 mg) daily plus weekly trastuzumab (4 mg/kg IV loading dose then 2 mg/kg). In the second part of the study, patients receive a weekly dose of trastuzumab with daily neratinib (240 mg). To date, 45 patients have been enrolled and 28 patients were evaluable for efficacy. The 16-week PFS rate (for part 2) was 45 percent (95 percent CI, 26 percent to 62 percent); median PFS was 16 weeks (95 percent CI, 15 to 31 weeks). The complete response rate was 7 percent, while 21 percent of evaluable patients showed partial response. The objective response rate was 29 percent (95 percent CI, 13 percent to 49 percent). In this study, adverse events of any grade were diarrhea, nausea, anorexia, vomiting, asthenia, rash and fatigue. In the 45 patients enrolled in this study, diarrhea was the most common adverse event, observed in 91 percent of patients, and was the most significant grade 3 or 4 adverse event, occurring in 16 percent of patients. Two patients receiving neratinib 240 mg reported adverse events leading to discontinuation of therapy. Safety and Efficacy of Neratinib (HKI-272) in Combination with Paclitaxel in Patients with Solid Tumors In a separate phase 1/2, open-label, 2-part study, ascending multiple daily oral doses of neratinib (160 mg, 240 mg) were administered in combination with IV paclitaxel 80 mg/m2, if tolerable, or 70 mg/m2 on days 1, 8 and 15. Patients with solid tumors (endometrial, cervical, colorectal and esophageal cancers) were entered in the phase 1 portion (part 1), and only patients with metastatic ErbB-2 positive breast cancer were enrolled in part 2. Safety and efficacy were investigated in patients with ErbB-2 positive metastatic breast cancer. A total of 102 patients were enrolled in part 2 of the study and 97 patients were evaluable for efficacy. The overall response rate at 16-weeks (for part 2) was 63 percent (80 percent CI, 55.9 percent to 69.4). In this preliminary analysis, the adverse event profile of the combination of neratinib (240 mg) plus paclitaxel (80 mg/m2) was similar to that reported with both agents as monotherapy. Adverse events of any grade were diarrhea, alopecia, infection, peripheral neuropathy, leucopenia, anemia, nausea, rash, fatigue and vomiting. The most common adverse event was diarrhea, observed in 89 percent of the 102 patients enrolled in part 2 and was the most significant grade 3 or 4 adverse event, occurring in 25 percent of patients. Fourteen patients had dose reductions and one patient withdrew from the study due to an adverse event. "Emerging clinical data continue to suggest that neratinib, in combination with these therapies is tolerable and active in treating HER-2 positive disease, even in those women who have progressed while on other targeted therapies," says Gary L. Stiles, M.D., Chief Medical Officer, Wyeth Pharmaceuticals. "These additional data build upon results presented at the 2008 San Antonio Breast Cancer Symposium, and Wyeth is committed to evaluating further the potential of this investigational therapy." In 2008, the American Cancer Society estimated that more than 182,000 women in the United States would be diagnosed with breast cancer, and more than 40,000 would die from the disease. The HER-2 receptor is over-expressed in 25 percent to 30 percent of patients with breast cancer. Wyeth Pharmaceuticals


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