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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold

Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure"s oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.
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Survey Examines Health Outcomes Of American Indians In Alabama

American Indians in Alabama have better outcomes than the rest of the state"s population in some health indicators but are less healthy in other areas, according to a survey released by the Alabama Department of Public Health, the Montgomery Advertiser reports.The report -- titled "Health Survey of American Indians of Alabama 2008: Keeping the Circle Healthy" -- surveyed 3,000 people from the nine recognized tribes in the state. The study found that overall American Indians in Alabama had lower levels of obesity than the rest of the state and nation. The report also found that American Indians exercise more and eat more fruits and vegetables than the state"s general population. American Indians also reported that they smoke and binge drink less than the rest of the state. In addition, the report found lower rates of hypertension and arthritis among American Indians when compared with state and national populations. However, the report found that American Indians in Alabama consume more alcohol and have more strokes and heart attacks than other state residents. American Indians in the state also are less likely to undergo recommended screenings, such as Pap tests, mammograms and prostate exams, the report found. The report found that a high percentage of people in the state"s Piqua Shawnee and Ma-Chi"s Lower Creeks tribes lack health insurance. The report also found that two tribes have the capability to monitor health trends and provide preventive care. According to the Advertiser, the Poarch Band Creek is the tribe statewide that is federally recognized and has access to health services through the Indian Health Service. In addition, one tribe -- the MOWA Band of Choctaw Indians -- is recognized by the state and has a health clinic on its reservation. Ben Moreira, planning and economic development strategist for the Alabama Indian Affairs Commission, said American Indians represent about 1% of Alabama"s population. Moreira said he hopes the report will help American Indian tribes make decisions about health care res. "One of our primary goals is to get this survey into the hands of people who make the decisions about the allocation of health res in the state," he said, adding, "There is also a lot of information that is tribal specific that could be used to develop programs internal to each tribe" (Ricks, Montgomery Advertiser, 5/28).