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Fertility Treatments Becoming More Common, Costly To Health Care System, CDC Says
The number of assisted reproduction procedures, such as in vitro fertilization, continues to increase at a rapid pace, with half of the 54,656 infants born in 2006 being twins, triplets or higher multiples, according to a series of Centers for Disease Control and Prevention reports, HealthLeaders Media reports. Since 2001, the number of live-birth deliveries -- which includes those in which at least one infant was born -- as the result of assisted reproductive technology increased by 41%, and the number of infants born as a result increased by 34%, according to CDC. ART services are offered at 483 medical centers, compared with 421 in 2001.According to CDC, ART procedures are more likely to result in multiple births, which produce higher rates of complication in the infants, such as prematurity, low birthweight and disability. CDC said that the cost of treating complications resulting from ART pregnancies totaled $1 billion in 2005, presenting an economic burden to hospitals and payers. The American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology recommend that doctors transfer one embryo in women younger than age 35, one or two in women ages 35 to 37, no more than three embryos in women ages 38 to 40 and up to five in older women and "extraordinary circumstances." However, CDC reported that about 16% of ART procedures since 2001 involved four or more embryos, and 5% involved five or more embryos, indicating that these guidelines were not widely followed. According to CDC, "In certain states, ART procedures are not covered by insurance carriers, and patients might feel pressured to maximize the opportunity for live-birth delivery by transferring multiple embryos." The report also noted that physicians might be implanting more embryos to increase the percentage of total live-birth deliveries by their patients. The report said that to "minimize the adverse maternal and child health effects associated with multiple pregnancies, ongoing efforts to limit the number of embryos transferred in each ART procedure should be continued and strengthened."Many hospitals consider ART a lucrative field because most patients undergoing the procedures have private insurance or pay out of pocket. However, health plans pass on the costs of complications to employers and the insured in the form of higher premiums, HealthLeaders Media reports. Thomas Moore, director of Obstetrical Services at the University of California-San Diego, said, "Even though private insurance pays a large percentage of the cost of caring for these newborns, it can be expensive for the health insurance industry overall," adding, "At $2,000 to $3,000 a day for intensive care, which can continue three and four months, that"s a cost that raises premiums across the board" (Clark, HealthLeaders Media, 6/12).
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Small Businesses, Doctors Voice Concerns About Health Reform
"Small business is suddenly playing a big role in negotiations over health care," NPR reports. "Supporters and opponents of various plans to overhaul the system are all trying to paint themselves as champions of mom and pop entrepreneurs." The National Federation of Independent Business is "not happy with the health care bill taking shape in the House this week - especially its requirement for all but the smallest employers to provide health insurance or pay a penalty." Meanwhile, "the Democratic National Committee quickly lined up its own panel of small business owners to defend the House plan."
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UK Watchdog Calling For Clearer Labelling Compared A Supermarket Salad To A Big Mac
A UK consumer watchdog that is campaiging for clearer food labelling analysed a selection of pre-packed salads from high street supermarkets
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Transcept Pharmaceuticals Presents Data From Studies Of Two Product Candidates At Annual Meeting Of The American Psychiatric Association

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today the presentation of two posters at the 2009 annual meeting of the American Psychiatric Association in San Francisco, California. The first poster, titled "Low-Dose Zolpidem Tartrate Sublingual Tablet Safely and Effectively Treats Insomnia Following MOTN Awakening," was presented on May 20, 2009 by Russell Rosenberg, PhD, D.ABSM, Founder and Director of NeuroTrials Research and the Atlanta School of Sleep Medicine. The intent of the study was to evaluate the safety and efficacy of 3.5 mg zolpidem tartrate sublingual tablet (ZST) when taken on an as-needed (prn) basis for the treatment of middle-of-the-night (MOTN) awakenings. In the study, 294 adults (aged 18 to 64 years) with DSM-IV primary insomnia characterized by MOTN awakenings were randomized to four weeks of prn double-blind treatment with either ZST 3.5 mg or placebo, after a two-week interactive voice response system (IVRS) single-blind placebo screening. Results indicated that compared to placebo, 3.5 mg ZST significantly reduced latency to sleep onset after MOTN awakenings and improved sleep quality and next-day alertness ratings throughout the treatment period. Furthermore, ZST significantly improved the post-MOTN sleep maintenance parameters of wake after sleep onset and number of awakenings versus placebo. The 3.5 mg zolpidem tartrate sublingual tablet was well tolerated and no safety issues were identified. The second poster, titled "Ondansetron Augmentation in Treatment Resistant OCD: A Preliminary Single-Blind Prospective Study," was presented on May 20, 2009 by Eric Hollander, M.D., Director, Neuropharmacology Services, LLC and former Esther and Joseph Klingenstein Professor and Chair of Psychiatry at the Mount Sinai School of Medicine. The pilot study, which involved 14 patients with a DSM-IV diagnosis of treatment resistant obsessive compulsive disorder (OCD) and under stable treatment with selective serotonin reuptake inhibitors (SSRIs) and neuroleptic augmentation, aimed to evaluate the potential of ondansetron augmentation as an alternative treatment for OCD. Following a 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for six weeks, and titrated to 0.5 mg twice daily for six weeks, results demonstrated that nine of 14 subjects (65 percent) experienced a treatment response at 12 weeks based on a score of greater than or equal to 25 percent reduction in the Yale Brown Obsessive Compulsive Scale (YBOCS). The average reduction in YBOCS-rated symptoms of the whole group was 23.2 percent. According to the researchers, the results suggested that low-dose ondansetron may have promise as an alternative treatment strategy for some patients suffering from OCD resistant to SSRIs and antipsychotic augmentation. None of the treated patients experienced symptom exacerbation or significant side effects. Glenn Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals, commented, "The posters presented by Dr. Rosenberg and Dr. Hollander lend further support to the Transcept strategy of deriving significant new patient benefits from proven drugs to address significant unmet medical needs. We are honored to have the opportunity to collaborate with such renowned researchers as Drs. Russell Rosenberg and Eric Hollander." About Transcept Pharmaceuticals Transcept Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. On January 30, 2009, Transcept completed a merger with Novacea, Inc. As part of the transaction, Novacea changed its name to "Transcept Pharmaceuticals, Inc." and its NASDAQ ticker symbol to "TSPT." The combined company res resulting from the merger are expected to enable Transcept to successfully commercialize its lead product candidate, Intermezzo(R). If approved as anticipated, Intermezzo(R) would be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Intermezzo(R) Phase 3 clinical trials have been completed and, on September 30, 2008, Transcept submitted a New Drug Application (NDA) for Intermezzo(R) to the U.S. Food and Drug Administration (FDA), which was accepted for filing on December 15, 2008. The FDA has assigned a PDUFA date of July 30, 2009 to the Intermezzo(R) NDA. Transcept Pharmaceuticals, Inc


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