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Patients In St. Jude Medical Deep Brain Stimulation For Depression Pilot Study Demonstrate Sustained Improvement In Depression Symptoms
According to the latest data in a clinical study supported by St. Jude Medical, Inc. (NYSE:STJ), deep brain stimulation (DBS) therapy for depression may provide sustainable improvement in depression symptoms among patients with major depressive disorder. Study results will be presented at the American Psychiatric Association (APA) meeting in San Francisco.

Researchers Discover Key To Malaria Susceptibility In Children
A team of researchers from Case Western Reserve University School of Medicine have solved the mystery of why some children are more susceptible to malaria infection and anemia. These novel findings suggest that some children who are exposed to Plasmodium falciparum (P. falciparum) malaria before birth become tolerant to the malaria parasites, or their soluble products. This tolerance, which persists into childhood, reduces the ability of the immune system to attack and destroy parasites and increases the susceptibility of these children to develop a malaria infection. It also increases their risk for anemia. The study, published in this week"s issue of the open access journal, PLoS Medicine, is led by Indu Malhotra, Ph.D., and Christopher King, M.D., Ph.D., professor of international health, medicine, and pathology, with their colleagues at the Center for Global Health and Diseases at the Case Western Reserve University School of Medicine and their Kenyan colleagues at the Kenya Medical Research Institute and Division of Vector Borne Diseases.
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Unjust Stigma, Lack Of Physician Training Hinder Market For IUDs, Opinion Piece Says
Intrauterine devices "seem like the perfect form of contraception: simple to use, long-lasting, reversible, hormone-free, economical," Slate columnist Kate Klonick writes. She asks, "So why are American women so late to this party? Perhaps the better question is: Why did they leave the party to begin with?"Klonick explains the benefits of IUDs, calling them a "foolproof method of birth control" and noting that they are 99% effective and "can last up to 10 years." Although IUDs can cost between $300 and $500, it is a one-time expense that is often covered by insurance, according to Klonick. She notes that although efficacy studies show that birth control pills, patches and vaginal rings can be "99% effective in a clinical setting, real-life compliancy -- like forgetting to take the pill at the same time every day -- reduces its success rate." Klonick adds that the availability of hormone-free IUDs makes them an "ideal" option for "women prone to some of the negative effects of hormonal birth control, like weight gain, mood swings, acne or high blood pressure."According to Klonick, IUDs were used by almost 10% of U.S. women taking birth control in the late 1970s but are now used by less than 2% of such women. She writes that Katharine O"Connell, a gynecologist at Columbia University who specializes in contraception, believes IUDs still carry a stigma "due to the erroneous belief that they"re highly dangerous" partly due to a number of deaths that occurred in the early 1970s tied to a specific brand of IUD known as the Dalkon Shield. Because of bad publicity surrounding the devices, "the U.S. pharmaceutical industry abandoned the research and manufacturing of IUDs in the mid-1980s, claiming the devices were no longer profitable," Klonick states. According to O"Connell, most experts now agree that the Dalkon Shield"s problems were related to its design, which made users more susceptible to infection, and a lack of testing for sexually transmitted infections before insertion.There are now two major brands of IUDs -- Mirena and ParaGard -- on the U.S. market, but physican training remains a problem, according to Klonick. She writes that studies show that premedical students are not educated regarding IUDs to the extent they are about oral contraceptive pills. O"Connell also noted that many medical schools limit classes on contraception to one lecture, which often omits IUDs. Klonick writes, "This lack of training can leave many doctors feeling uncomfortable recommending the once-controversial devices to their patients." She adds that many physicians who know how to insert and remove IUDs "still refuse to recommend it to childless patients because of the device"s checkered history." She concludes, "With Mirena advertising on television, the downturn in the economy forcing people to economize, and more women concerned about the long-term effects hormones have on their bodies, perhaps the IUD"s stigma will finally become a thing of the past" (Klonick, Slate, 7/29).
Mental Health

Osiris Therapeutics Reports Interim Data For COPD Stem Cell Study

Therapeutics, Inc. (NASDAQ:OSIR) announced six-month interim data from a Phase II clinical trial evaluating Prochymal, the Company"s proprietary formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). Sixty-two patients were enrolled and are being followed for two years in the placebo-controlled study. At the six-month time-point, the data revealed several important findings. Important Findings: - The trial met its primary goal of demonstrating the safety of Prochymal in patients with compromised pulmonary function at the six-month evaluation point. - Prochymal significantly decreased systemic inflammation in patients when compared to those receiving placebo, as determined by C-reactive protein (CRP). - Despite the reduction in inflammation, pulmonary function in patients receiving Prochymal was not significantly improved compared to those receiving placebo. "We are very pleased with the interim outcome of this study and that the data continues to support the strong safety profile of this therapy, particularly given the severity of these patients" pulmonary disease," said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. "Importantly, we are gratified to obtain clear, objective data that helps bolster our understanding of the anti-inflammatory effects of these remarkable cells. Short-term, these anti-inflammatory effects did not appear to improve pulmonary function in patients with advanced destructive changes of the lung. Collectively however, these findings add to our confidence about the safety and effectiveness of the drug." Six-Month Interim Data Prochymal was evaluated in a total of 62 patients, 58% of them male. The patients ranged in age from 47 to 80 years and suffered from moderate (n=23) to severe (n=39) COPD. Patients had been suffering with COPD for an average of 7.8 years. Patients with asthma were excluded from the trial. All patients in the trial completed the planned course of four infusions without any evidence of infusional toxicity. Oxygen saturation levels were measured throughout each infusion and showed no adverse effects of the infusion. Adverse event rates were comparable for patients receiving Prochymal and placebo. There were no signs of adverse immune reaction after any of the four infusions and no differences in the reported incidence of infection of any kind. Prochymal significantly decreased the levels of CRP compared to placebo in those patients with elevated CRP (>4 mg/L) at the time of study entry (pAbout the Phase II Chronic Obstructive Pulmonary Disease Trial The Phase II trial is evaluating the safety of Prochymal in conjunction with standard of care in patients with moderate to severe COPD. The clinical trial is a double-blind, placebo-controlled study. A total of 62 patients were randomized to either Prochymal or placebo at a 1:1 ratio. In order to explore potential improvements in pulmonary function, several evaluations including pulmonary function tests, exercise capability, and quality of life assessments are being conducted. In addition, exacerbations and hospitalizations due to COPD will be monitored for both safety and efficacy. Patients will be evaluated over the course of two years following initial Prochymal or placebo infusion. About Prochymal Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors, avoiding the controversy surrounding embryonic and fetal cell s. Prochymal is currently being evaluated in three, double-blind, placebo-controlled Phase III studies, including steroid refractory GvHD, acute GvHD, and Crohn"s disease. Prochymal has been granted Fast Track status by FDA for all three of these indications. Prochymal also obtained Orphan Drug status by FDA and the European Medicines Agency for GvHD. Prochymal is also being studied in Phase II trials for the treatment of acute myocardial infarction and type 1 diabetes. Additionally, the Department of Defense awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome. Osiris Therapeutics


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