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AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths
AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH® for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation. The 90 minute molecular diagnostic test enables rapid and highly sensitive detection of Group B Strep from Lim Broths to help detect colonization in pregnant women.
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Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets
Procter & Gamble Pharmaceuticals (P&GP) announced the availability of Asacol HD (mesalamine) delayed-release tablets, which are indicated for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involves inflammation of the lining of the colon and rectum and is typically characterized by flares followed by periods of remission. Moderately active UC is characterized by tougher symptoms than mildly active UC. Asacol HD is proven to help treat these tougher flares of moderately active UC. Asacol HD was approved by the U.S. Food and Drug Administration (FDA) based on evaluations from the ASCEND studies [Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA (4.8 g/day 800 mg tablet)].
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Lobbyists Swarm Around Health Reform Activity
NPR began a series of reports on the health care lobbyists who attend Congressional sessions as part of their campaign. Richard Miller, a "longtime lobbyist for the American Chiropractic Association, says it"s important that the chiropractors keep on top of the health care overhaul legislation - and also take pains to make sure that senators and staff see them doing that, because the chiropractors are small dogs in a big fight." President Barack Obama "certainly sees Washington"s lobbyists as an obstacle to change. He"s tried limiting their access to the executive branch, but that runs into the constitutional question." Lobbying is on the rise: "Between 1998 and 2008, the number of registered lobbyists on health care more than doubled, to 3,627, according to the Center for Responsive Politics." Spending also increased: "Organizations lobbying on health care spent $484.4 million in 2008, more than two and a half times the spending in 1998." The project includes an interactive panoramic photo of lobbyists in the Senate HELP Committee hearing room and asks readers to help identify the players (Overby and Seabrook, 6/25).
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New York Times Examines Trend Of Posting Childbirth Videos On YouTube

The New York Times on Thursday examined how thousands of women have posted videos on YouTube showing themselves giving birth. According to the Times, the women believe the videos help "demystify" childbirth by candidly presenting the process in a manner that pregnant women and their partners otherwise might not see. Along with YouTube, Web sites like Internet chat rooms and pregnancy blogs are helping to shift dynamics between pregnant women and their care providers, the Times reports. Eileen Ehudin Beard, an adviser for the American College of Nurse-Midwives, said, "The more information you have, the more s you have, the more informed you are, the better questions you ask." However, she added that the videos could have negative effects, particularly if they make women more fearful of childbirth. The childbirth videos are relatively controversial because of their graphic nature, which has challenged some of YouTube"s rules and raised issues of propriety. Victoria Grand, the head of policy for YouTube, said that nudity generally is banned from YouTube but that the site "make[s] exceptions for videos that are educational, documentary or scientific." Most childbirth videos on YouTube are age restricted to ages 18 and older. A majority of them show home births because most U.S. hospitals prohibit patients from recording births due to liability concerns, the Times reports. Although childbirth education classes have shown edited videos of births since the 1970s, the Internet and YouTube could change the way such classes are taught, according to Jeanette Schwartz, president of the International Childbirth Education Association. She noted that most videos currently used in childbirth classes are heavily edited and out of date, adding that the YouTube videos "create a wonderful opportunity to show free, real life, candid videos in a classroom setting." Eugene Declercq, a professor at the Boston University School of Public Health, said, "A hundred and fifty years ago, women viewed birth on a pretty regular basis -- they saw their sisters of neighbors give birth." He said that changed with a trend toward hospital births beginning in the late 19th century. "But now, with YouTube, we"ve come back around and women have this opportunity to view births again," Declercq said (Wollan, New York Times, 6/11). Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women"s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women"s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company. © 2009 The Advisory Board Company. All rights reserved.


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