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FDA Urges Consumers Not To Purchase Or Use Certain Gel-Filled Teethers
Luv N" Care Ltd. of Monroe, La., is initiating a nationwide recall of gel-filled teethers with the brand names "Nuby," "Cottontails" and "Playschool," because the liquid inside the gel-filled teethers has been found to contain Bacillus subtilis and Bacillus circulans bacteria in the gel.
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House Rejects Amendment To HHS Bill To Limit Funding To Planned Parenthood Clinics
The House on Friday voted 264-153 to approve its fiscal year 2010 Labor-HHS-Education spending bill (HB 3293) after voting on five amendments addressing price and policy issues, CQ Today reports. The bill would appropriate $730.5 billion. The Senate Appropriations Committee is scheduled to begin markup of its version of the bill on July 28.The House voted 183-247 to reject an amendment offered by Rep. Mike Pence (R-Ind.) that would have prohibited family planning funding through the Title X program to Planned Parenthood clinics. The House also voted 211-218 to reject an amendment by Rep. Mark Souder (R-Ind.) that would have stripped language to lift the ban on federal funding for needle-exchange programs. Lawmakers did approve an amendment offered by Rep. Darrell Issa (R-Calif.) to strip $5 million in funding for three NIH grants to study the HIV/AIDS risks associated with alcohol and substance use among sex workers in Asia and alcoholics in Russia (Wolfe, CQ Today, 7/24).
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NICE Guideline Helps End Regional Variation Of Access To Fertility Treatment, UK
The number of local health services implementing NICE"s fertility guideline and offering three cycles of IVF treatment to couples who are unable to conceive naturally has increased significantly in the past year, according to a new survey published by the Department of Health. According to these new figures, more than a quarter of primary care trusts now offer the full number of cycles recommended by NICE- this figure is up from five per cent in 2007.
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Drug-Eluting Stents More Effective Than Bare-Metal Stents In Heart Attack Patients

NewYork-Presbyterian Hospital and Columbia University Medical Center, together with the Cardiovascular Research Foundation (CRF), announced that its landmark study comparing the safety and efficacy of drug-eluting stents and bare-metal stents was published in the May 7 New England Journal of Medicine. The study, HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction), showed that in heart attack patients undergoing angioplasty, the use of paclitaxel-eluting stents reduces rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of bare-metal stents after one year. Additionally, the primary safety measure of major adverse cardiovascular events (MACE), including death, reinfarction, stent thrombosis and stroke established the non-inferiority of drug-eluting stents with respect to safety through one year. The study was led by Dr. Gregg W. Stone, director of cardiovascular research and education in the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center; and professor of medicine at Columbia University College of Physicians and Surgeons. The research was sponsored and managed by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company. In the trial, the use of paclitaxel-eluting stents resulted in a significant reduction of ischemia-driven target-lesion revascularization (TLR) at 12 months (4.5% vs. 7.5%). TLR, which was the primary efficacy endpoint of the trial, refers to the rate at which a particular lesion re-narrows following stent implantation severely enough to require either a repeat angioplasty or bypass surgery operation. The use of paclitaxel-eluting stents also resulted in a significant reduction in binary restenosis after 13 months, which is the rate at which the artery re-narrows at least 50 percent following implantation of the stent, and was the secondary efficacy endpoint of the trial. The paclitaxel-eluting stent had a rate of 10.0 percent and the bare-metal stent had a rate of 22.9 percent. "Outcomes from prior registry and randomized trials of drug-eluting stents compared with bare-metal stents in heart attack patients have been conflicting. These results now provide definitive evidence that paclitaxel-eluting stents are superior in efficacy to bare-metal stents and have a comparable safety profile at one year," says Dr. Stone. "The findings from the HORIZONS-AMI trial will have a major impact on how decisions are made regarding drug-eluting and bare-metal stents in the highest-risk patients, those in the early hours of a heart attack. This study removes much of the uncertainty and concern about the efficacy and safety of drug-eluting stents in this clinical setting. Moreover, all of the patients in this trial will be followed long-term to ensure that these favorable results are maintained." The HORIZONS-AMI trial, a prospective, open-label, multicenter, controlled study, enrolled 3,602 heart attack patients at 123 centers in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting stents versus otherwise identical bare-metal stents. Co-authors include Drs. Alexandra J. Lansky, George Dangas and Roxana Mehran, Ms. Alison Kellock and Ms. Helen Parise of NewYork-Presbyterian/Columbia; Dr. S. Chiu Wong of NewYork-Presbyterian Hospital/Weill Cornell Medical Center; Dr. Stuart J. Pocock of the London School of Hygiene and Tropical Medicine, London; Dr. Bernard J. Gersh of Mayo Clinic, Rochester, Minn.; Dr. Bernhard Witzenbichler of Charitç© Campus Benjamin Franklin, Berlin; Dr. Martin Mç¶ckel of Charitç© Campus Virchow-Klinikum, Berlin; Dr. Giulio Guagliumi of Ospedali Riuniti di Bergamo, Bergamo, Italy; Dr. Jan Z. Peruga of Medical University, Lodz, Poland; Dr. Dariusz Dudek of Jagiellonian University, Krakow; Dr. Andrzej Ochala of the Silesian Medical Academy, Katowice, Poland; Dr. Bruce R. Brodie of LeBauer Cardiovascular Research Foundation and Moses Cone Hospital, Greensboro, N.C. Jennifer Homa New York- Presbyterian Hospital/Columbia University Medical Center


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