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Abortion Could Prove Divisive For Health Reform, Too
An ultimatum against using federal money for abortion procedures could reopen the politically treacherous rift over the issue, creating yet another obstacle for congressional Democrats to overcome if they are to achieve their health reform goals, Time reports. "While current versions of the [health reform] legislation do not address the abortion issue at all, late last month 19 anti-abortion Democrats in the House sent a letter to Speaker Nancy Pelosi, warning "we cannot support any health care reform proposal unless it explicitly excludes abortion from the scope of any government-defined or subsidized health insurance plan.""
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Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo(R)
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.
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Artificial Liver For Drug Tests
If you have hay fever, headaches or a cold, it"s only a short way to the nearest chemist. The drugs, on the other hand, can take eight to ten years to develop. Until now animal experiments have been an essential step, yet they continue to raise ethical issues. "Our artificial organ systems are aimed at offering an alternative to animal experiments," says Professor Heike Mertsching of the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart. "Particularly as humans and animals have different metabolisms. 30 per cent of all side effects come to light in clinical trials." The test system, which Professor Mertsching has developed jointly with Dr. Johanna Schanz, should in future give pharmaceutical companies greater security and shorten the path to new drugs. Both researchers received the "Human-centered Technology" prize for their work.
Public Health

New Tests For The Investigation Of Patients With Painful Metal-on-metal Resurfacing Arthroplasties

This paper investigates 26 patients with painful metal-on-metal resurfacing arthroplasties and describes three tests for the investigation of the phenomenon. The tests are metal artefact-reduction MRI, 3-D CT measurement of the position of the component and inductively-coupled plasma mass spectrometry. Current techniques for assessing patients with painful MOM hips are the same as for painful non-MOM hips, however, this research demonstrates that hip resurfacing appears to have specific modes of failure which are not detectable using these methods. Therefore, the authors investigated the use of metal artefact-reduction MRI, 3-D CT measurement of the position on the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in the whole blood. As an aseptic lymphocyte-dominated vasculitis-lesion can be a possible cause of unexplained pain in a MOM hip the 26 patients were tested with MRI and 16 hips showed periprosthetic lesions, with 14 collections of fluid and two soft tissue masses. The diagnosis of aseptic lymphocyte-dominated vasculitis-lesion can only be made from tissue samples, usually collected during revision. Therefore, because the lesions were seen in both men and women and in symptomatic and asymptomatic hips the significance of this finding is unclear. It has also been suggested that unexplained hip pain is associated with high levels of metal ions in the blood so the levels of cobalt and chromium may be biomarkers of early failure. In the patients tested, the levels of blood metal ions tended to be higher in painful compared to well-functioning metal-on-metal hips. Specifically the level of cobalt were significantly greater, suggesting that painful hip resurfacings have greater wear rates. However, the levels of chromium were barely raised in patients with unilateral MOM hips and therefore analysis of blood metals ions as a screening test for painful MOM is likely to be sensitive but not specific. The 3-D CT scans showed that the median inclination of the acetabular component was 55° and its positioning was outside the Lewinnk safe zone in 13 of 16 cases. The position of the component may influence the risk of failure of a MOM hip because suboptimal acetabular version may cause impingement, and inclination angles of greater than 50° may cause high rates of wear. The authors protocol for the painful MOM hip demonstrated a high probability of periprosthetic masses on metal artefact reduction sequences, a higher blood metal level than in the well-functioning MOM hip and a position of the component outside the Lewinnek safe zone. Taken together, these observations may help to determine causes of failure, indicate the most appropriate treatment and aid the choice of prosthesis if replacing the contralateral hip. Read the full text article. The Journal of Bone and Joint Surgery


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