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Childbirth-Related Injuries Decline, Linked With Use Of Instruments, AHRQ Report Finds
There were nearly 158,000 potentially avoidable childbirth-related injuries to women and their infants in 2006, a significant decline from 2000, according to a report by the Agency for Healthcare Research and Quality, HealthLeaders Media reports. The report used data submitted for 15 million discharges by 1,900 hospitals in 25 states, including the largest states -- California, New York, Florida and Texas. Between 2000 and 2006, the rate of potentially avoidable injuries during vaginal childbirth without the use of instruments, such as forceps, declined by 30%, according to the report. The injury rate declined by 21.3% for vaginal childbirth using instruments and by 16.7% for women undergoing caesarean sections. Report author Roxanne Andrews of AHRQ said that the report did not examine factors that might have contributed to the declining injury rates but added that it is an area for further study.The report found that rates of injury were higher when instruments were used during childbirth. For instance, trauma to the woman during vaginal delivery with the use of instruments occurred 160.5 times per 1,000 discharges, compared with 36.2 times when instruments were not used. The report said that the most common injuries to women were perineum tears, which are avoidable in many cases. Traumatic injury to infants during childbirth -- such as broken collarbones, head injuries and infections -- occurred 1.6 times per 1,000 discharges.The report also highlighted care disparities between women in low-income areas and those in high-income areas. Women giving birth in high-income areas had 44% more injuries during vaginal delivery than their counterparts in low-income areas. Black and Hispanic women experienced fewer injuries than white women, while Asian American and Pacific Islander women experienced the highest rate of injuries. The report found that women covered by Medicaid were less likely to be injured during childbirth -- 127 injuries per 1,000 deliveries -- compared with women with private insurance plans -- 185 injuries per 1,000 deliveries. However, the rate of injury for infants covered under Medicaid was higher -- 1.7 per 1,000 deliveries -- than those under private plans -- 1.5 per 1,000 deliveries.The report encouraged providers to evaluate their practices to better understand why such complications occur. According to the report, "Identifying which types of patient safety problems exist for different sub-groups of patients is an important first step in developing interventions to reduce disparities and achieve high quality of care for all patients" (Clark, HealthLeaders Media, 6/18).

Parent Project Muscular Dystrophy Holds 15th Annual Connect Conference In Atlanta
Patricia A. Furlong, Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest non-profit organization in the United States focused on finding a cure for Duchenne muscular dystrophy (Duchenne), announced that PPMD will be honoring United States Senator Johnny Isakson and the American Football Coaches Association (AFCA) with "Change It Champion" awards at the 2009 Connect Conference in Atlanta, Georgia on Saturday, June 27. Other award recipients include Darius Weems and Logan Smalley from the acclaimed documentary "Darius Goes West."
News of the day
Administration Could Find Compromise In Co-Op Plan
"With Republicans fighting the idea of a government-run health insurance plan, members of President Barack Obama"s team said Sunday that they are open to a compromise: a cooperative program that would expand coverage with taxpayer money but without direct governmental control," the Associated Press reports. The non-profit, health insurance cooperatives were suggested in Congress by Sen. Kent Conrad, D-N.D., and HHS Secretary Kathleen Sebelius said the concession could be a path to bipartisan health reform legislation (Elliott, 6/15).
Health Insurance

ThromboGenics And BioInvent Start Recruitment Of Second 100 Patient Cohort In Phase II DVT Prophylaxis Study With TB-402

ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have started recruitment of a second cohort of patients for their Phase II trial of TB-402. This follows completion of recruitment of the first cohort of 100 patients ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The decision to move ahead with the second cohort of this trial follows unanimous advice from the external efficacy and safety monitoring board to proceed using a higher dose of TB-402. The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. The study is assessing three different doses of TB-402 given as a single intravenous bolus injection post knee replacement surgery, and will enrol a total of 300 patients across 36 centers, mainly in Europe. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulants. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose after surgery to prevent the development of DVT. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks. Professor Peter Verhamme from the University of Leuven will present additional data from the earlier successful Phase I studies at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) on July 15, 2009 in Boston. Patrik De Haes, CEO of ThromboGenics commented, "We are very happy that this important study with TB-402 is progressing rapidly. TB-402"s profile, including its novel mode of action, could allow it to address the many drawbacks associated with current anticoagulant therapy. We remain confident in the large market potential for TB-402, and believe that the current Phase II study will provide additional data to further highlight the attractive differentiating properties of this novel long-acting anticoagulant." Svein Mathisen, CEO of BioInvent, also commented, "We are pleased that there has been rapid progress in this study and that the efficacy and safety monitoring board unanimously recommended that we proceed to a higher dose of TB-402. It is testament to the strength of our partnership with ThromboGenics and the exciting potential of this product candidate." About Deep Vein Thrombosis (DVT) DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg. DVT is a major public health issue and it is estimated that in the U.S. alone, more than 350,000 individuals are affected by DVT or pulmonary embolism (PE) each year. Moreover, DVT and PE together may be responsible for more than 100,000 deaths in the U.S. each year.(1) It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the U.S. if current trends persist.(2) Patients undergoing hip replacement or knee surgery are particularly at risk of developing DVT and all patients are therefore treated with anticoagulants prophylactically in order to reduce the risks of blood clots. The annual sales of anticoagulants worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with an increased risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a significant unmet need. Legal disclaimer This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. About ThromboGenics ThromboGenics is a biotechnology company focused on the discovery and development of innovative biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. The Company"s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anticoagulant, and TB-403 (anti-PlGF) for cancer. ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. (1) "The Surgeon General"s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism," September 15, 2008, p.1. (2) "Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004," Sunny Kim, Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488. ThromboGenics NV


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