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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
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Vitamin D And Calcium Supplements Help Prevent Bone Fracture In The Elderly
We all know that vitamin D and calcium are good for bones, but research teams in Europe and USA have shown that both taken daily reduces the rate of hip fracture in older people by 20%.
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Liver Transplantation After Drug Induced Acute Liver Failure Examined By Study
Liver transplantation offers a good chance for survival for patients with drug induced acute liver failure, however, certain pre-transplant factors are associated with worse outcomes. Patients who are on life support, who have elevated serum creatinine, and children whose liver failure was caused by antiepileptic drugs did not fare as well after transplantation. These findings are in the July issue of Liver Transplantation, a journal published by John Wiley & Sons. The article is also available online at Wiley Interscience.
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The Pressure Is On For African Americans With Hypertension

Nearly two-thirds (63 percent) of African Americans with high blood pressure (also known as hypertension) say they worry more about their finances than their personal health, according to a new "My Pressure Points"(TM) national survey commissioned by Daiichi Sankyo, Inc., in collaboration with the Association of Black Cardiologists.(1) In addition, almost half (48 percent) are stressed about their work and careers. Everyone juggles many external pressures in everyday life like jobs, finances and family care. But while those African Americans surveyed have increased their focus on the external pressures, have they lost sight of a critical internal pressure -- one that can impact every facet of their lives? The survey was designed to test this hypothesis. High blood pressure affects about 73 million adults (age 20 and older) in the U.S. and is often called the "silent killer," with African Americans being more likely to develop the condition than any other racial or ethnic group, and often to a more severe extent, though scientists have yet to determine the exact reason why this is true.(2)(3)(4) The continued high prevalence within the African American community is of great concern to the medical community. Equally concerning is the potential consequence they may face if they allow the ordinary external pressures people face daily, to take precedence over their high blood pressure. To address this concern, the Association of Black Cardiologists and Daiichi Sankyo, Inc. are launching the "My Pressure Points" national consumer education campaign. The goal of the campaign is to draw attention to this important health issue, and encourage African Americans to focus on their high blood pressure in addition to their external pressures. "Elevated blood pressure in the African American community has been prevalent for quite some time, and minimized such that this treatable condition continues to result in catastrophes such as stroke and endstage renal disease," said ABC Board member Icilma Fergus, M.D., Chief of Cardiology at Harlem Hospital Center in Harlem, New York. "The survey findings reaffirm the critical need for African Americans to work with their doctors and focus attention on their heart health, making sure it remains a priority in their lives. That"s why we"re partnering with Daiichi Sankyo to launch this campaign and ignite the high blood pressure conversation within the African American community." As part of the "My Pressure Points" campaign, the Association of Black Cardiologists and Daiichi Sankyo, Inc. have unveiled new res at www.mypressurepoints.com which may help African Americans take a more proactive approach to controlling their blood pressure. The web site has practical advice for controlling and delaying the onset of high blood pressure as well as culturally relevant tips for eating healthier and increasing physical activity. Results from the My Pressure Points national online survey conducted in 2009 of over 500 African Americans with high blood pressure (age 18 and older) and 150 doctors who treat African Americans with hypertension, are also available. Additionally, people can log on to take the survey and see how their responses compare to the national results. "As a leader in global cardiovascular health, Daiichi Sankyo is committed to providing the most up-to-date, comprehensive educational res for people who are at increased risk for high blood pressure and cardiovascular disease, such as African Americans," said Jonathon Jaffe, M.D., FACC, Senior Medical Director, Hypertension - Therapeutic Area Head, Medical Research and Strategy at Daiichi Sankyo, Inc. "Helping patients manage chronic diseases more effectively -- whether that entails adopting a healthier lifestyle recommended via their physician and/or taking appropriate medication when prescribed -- will benefit both patients and physicians. We"re pleased to be partnering with such a recognized leader in cardiovascular health, the Association of Black Cardiologists, on this important health awareness campaign." My Pressure Points National Survey Highlights Juggling life"s pressure points More than half (55 percent) of the African Americans with hypertension surveyed report that they are more "stressed" about their financial situation now than they were a year ago, compared to just 28 percent who are feeling more anxiety about their health than 12 months ago. More than half (52 percent) admit they aren"t giving their health and well-being as much attention as they would like. Interestingly, though 73 percent are worried about what their condition can lead to, they aren"t taking proactive steps; perhaps this is due in part to their viewpoint on how big an issue they think it is -- 29 percent don"t consider their condition to be a big problem. Family history not enough to encourage action Of the 75 percent of African Americans with high blood pressure surveyed who were aware of a family history of blood pressure before they were diagnosed, almost three in five (59 percent) did not take any steps to keep their blood pressure down before their own diagnosis. "Unfortunately, for some, it takes a serious personal health scare to get them to take a closer look at their condition," said Dr. Fergus. "It is dangerous for high blood pressure and other cardiac risk factors to take a backseat to so many other life stresses." Interestingly, more men than women surveyed (46 percent vs. 38 percent) who were aware of a family history made an effort to keep their blood pressure down before their own diagnosis. African American women more stressed than men -- yet LESS proactive The African American women with high blood pressure surveyed are slightly more likely than their male counterparts to stress about the many pressure points in their lives, including their family (52 percent vs. 43 percent), personal health (57 percent vs. 48 percent) and their finances (77 percent vs. 67 percent). Despite these concerns, African American women are still less proactive than men (56 percent vs. 47 percent) and admit their health doesn"t receive the attention it should. "Women tend to pay more attention to their family"s health and not focus on their own," said Dr. Fergus. "But women need to become more proactive about taking care of themselves, and promoting health from within their families." Survey Methodology Kelton Research conducted the online survey within the U.S. between January 29 and March 6, 2009. The survey sample included 506 African Americans, aged 18 and over, who have been diagnosed with hypertension. Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. In this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 4.4 percentage points from the result that would be obtained if interviews had been conducted with all persons in the universe represented by the sample. More comprehensive survey highlights can be found on www.mypressurepoints.com. Association of Black Cardiologists Daiichi Sankyo, Inc.


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