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Washington Post Examines Focus On Abortions Later In Pregnancy After Tiller Murder
The Washington Post on Friday examined the renewed attention on abortion procedures performed later in pregnancy following Kansas provider George Tiller"s shooting death on Sunday. Tiller was one of the few physicians in the U.S. who performed late abortions. The Post reports that these abortions make up a small portion of the 1.2 million abortions performed each year -- more than 88% of abortions are performed in the first trimester and less than 1% are performed after 21 weeks" gestation. Data published in 2001 from 15 states and New York City show that as many as 2,400 abortions after 24 weeks" gestation were performed in the U.S. that year, according to Stanley Henshaw, a senior fellow at the Guttmacher Institute. He added that most of those abortions likely were performed in the 25th or 26th week.Henshaw said that little is known about the circumstances surrounding third trimester abortion procedures and that "information just isn"t available." The government does not collect detailed data regarding the number of such procedures, who is performing them and under what circumstances. In addition, abortion providers who perform the procedure later in pregnancy supply very little published information, the Post reports. According to the Post, most abortion providers will not perform the procedure after 22 or 24 weeks" gestation because of legal and other concerns, social stigma, or inadequate training and lack of experience. A 2001 survey of 1,819 abortion providers indicated that 18 clinics and 12 hospitals performed abortions at 26 weeks" gestation. However, the Post reports that the number of providers offering abortions later in pregnancy likely has declined in correlation with the decreasing number of overall providers. Henshaw said the number of providers offering the procedure later in pregnancy also likely has declined.Abortion-rights supporters say that third-trimester abortions are performed only when medically necessary, such as when a fatal abnormality is detected in the fetus or a life-threatening complication in the woman is discovered. Other circumstances include cases when the woman suffers serious emotional issues or is undergoing cancer treatment, the Post reports. Vicki Saporta, president of the National Abortion Federation, said that women who experience such pregnancies have "no good choice" and "nee[d] to terminate their pregnancies to protect their own health." Tiller "provided both the emotional and physical care for women in that situation," she said (Stein, Washington Post, 6/5).Los Angeles Times Profiles Abortion Provider Hern The Los Angeles Times on Friday profiled Warren Hern, a Colorado-based abortion provider who performs the procedure later in pregnancy and was a close friend of Tiller"s. Hern has provided abortions since 1973 when the Supreme Court legalized the procedure with Roe v. Wade. He said he "felt doing abortions was the most important thing I could do with my life." Hern opened the Boulder Abortion Clinic in 1975, and in the 1980s authored and self-published a textbook, Abortion Practice. He said that he eventually began to focus on abortion procedures later in pregnancy, which currently make up the majority of his practice. Such abortions usually are performed because of medical complications in the woman or abnormalities in the fetus. Patients at Hern"s clinic receive counseling to explain the procedure and to ensure the woman wants it, although he said many women have already made their decision with their own physician. Hern said that although Tiller"s death has been an emotional situation, his clinic is "pretty busy taking care of people who said they couldn"t find anyone else" to perform abortions later in pregnancy (Correll, Los Angeles Times, 6/5).Bond Set for Tiller Shooting Suspect Sedgwick County, Kan., District Judge Warren Wilbert on Thursday set a $5 million bond for Scott Roeder, the man charged with shooting and killing Tiller, the AP/Yahoo! News reports. A preliminary hearing for Roeder is scheduled for June 16. If convicted, Roeder face
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Sen. Tom Daschle, Rep. Jason Altmire, Healthcare Experts Tout Homecare As Cost-Effective Solution In The Healthcare Reform Process
During a roundtable discussion on Capitol Hill on Tuesday, former Senate Majority Leader Tom Daschle and Blue Dog Democrat Rep. Jason Altmire (D-Pa.) stressed the cost-effective role that homecare can play in the reform of the U.S. healthcare system. The roundtable also addressed the controversial competitive bidding program for home medical equipment and services. The American Association for Homecare hosted the event, which was attended by congressional staff and media.
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Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase IIb Study
Valeant Pharmaceuticals International (NYSE: VRX) reported final results for its Phase IIb dose-finding clinical trial for taribavirin, a prodrug of ribavirin which is in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon. The study in treatment naive genotype 1 infected subjects was of standard design, consisting of 48 weeks of treatment with a 24-week follow-up period. It explored three weight-based doses of taribavirin: 20 mg/kg, 25 mg/kg and 30 mg/kg vs. ribavirin 800-1400 mg/day. Throughout the 72-week trial, all doses of taribavirin demonstrated comparable efficacy (sustained virologic response (SVR)) to ribavirin with consistently lower levels of anemia. In addition, relapse rates in the 25 mg/kg and 30 mg/kg arms were comparable with the ribavirin arm; supporting the premise that higher dose weight-based taribavirin may be as effective as weight based ribavirin. Valeant plans to present the full final data at the American Association for the Study of Liver Disease (AASLD) later this year.
Cardiovascular

BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System

BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000. Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the company"s strong desire to bring the BSD-2000 to market as quickly as possible, the company has been working closely with FDA to seek the most expeditious pathway that can lead to marketing approval for the BSD-2000. FDA recommended that BSD pursue a Humanitarian Device Exemption (HDE) marketing approval and BSD followed FDA"s recommendation. The HDE approval of the BSD-2000 Hyperthermia System will authorize the commercial sale of the BSD-2000 in the United States. In addition, a product can have multiple HDE approvals and the company may decide to pursue additional HDE approvals for the BSD-2000 in the future. Cervical cancer is the second-most common cancer in women worldwide and a leading cause of death. It is the leading cause of death from cancer among women in developing countries. Researchers have predicted that developing countries could face a 75% increase in the number of cervical cancer cases in the next two decades due to growth and aging of the population. BSD is increasing the company"s representation in countries throughout the world, including the developing countries. BSD Medical


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