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Insurers Refuse To Stop Canceling Some Sick Patients' Policies
Members of Congress grilled executives from the insurance industry"s big three - UnitedHealth Group, WellPoint, and Assurant - for canceling coverage of more than 20,000 paying policy holders at a hearing Tuesday, the Los Angeles Times reports. The executives responded that they would continue the practice, known as rescission, which has saved them an estimated $300 million over a five-year period.
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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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New Tool To Improve Patient Understanding Of Long-Acting Injectable Antipsychotic Therapies
A new instrument for improving patient understanding and acceptance of long-acting injectable antipsychotic therapy (LAT) has been published in the April edition of Psychiatry 2009.1 This novel, psychosocial approach encompasses Goal setting, Action planning, Initiating treatment, and Nurturing motivation (GAIN) through the use of a clinical discussion tool.
Public Health

'Invading' Bacteria In DNA

Call it advanced warfare on the most elemental of levels. Researchers at Texas A&M University"s Artie McFerrin Department of Chemical Engineering have discovered how certain types of bacteria integrate the DNA that they have captured from invading enemies into their own genetic makeup to increase their chances of survival. To be more accurate, the genetic material isn"t really captured as much as it is simply utilized after it"s injected into the bacteria by an invading virus, says Professor Thomas K. Wood, who along with colleagues Xiaoxue Wang and Younghoon Kim has published the findings in Nature"s 2009 International Society for Microbial Ecology Journal. Wood"s findings shed light on a millions-of-years-old battle between bacteria and bacteria-eating viruses known as "phages." Locked in an epic struggle, the two life forms, Woods explains, are constantly developing new ways to win the war. One such approach undertaken by a phage is to attach to a bacterial cell and, using a syringe-like tail apparatus, inject its genetic material into the bacterial cell. Once inside, the phage replicates itself and eventually exits the cell to find new bacteria to infect. But as is the case with men, the best-laid plans of phages can also go astray. Examining E. coli bacteria, Wood found that the bacteria developed a means of not allowing the phage to replicate and leave the cell of its own volition. Once the phage was effectively "captured," the bacteria incorporated the phage"s DNA material into its own chromosomes. This new diverse blend of genetic material, Wood says, has helped the bacteria not only overcome the phage but also flourish at a greater rate than similar bacteria that have not incorporated the phage DNA. "The bacteria are alive and doing well, and in fact the bacteria are doing better because it captured its enemy," Wood said. "Our research shows that if these bacteria didn"t have this particular set of 25 genes that belonged to the old phage it wouldn"t be able to grow as fast. If you removed the phage remnant, the bacteria grows five times slower on some carbon s." This distinct advantage is helping scientists understand why bacteria carry about 10-20 percent of genes that aren"t their own. Simply put, carrying the virus DNA allows bacteria to increase their chances of survival by producing diverse progeny - something Wood says is extremely important when the bacteria choose to move to a new environment through a process known as dispersal. Dispersal occurs, Woods says, when the bacterium can no longer glean the nutrients it needs from its surroundings or when other environmental conditions, such as temperature, have become unfavorable. Wood found that through an elaborate regulation method, the bacteria are able to retain the virus DNA or expel it. It"s an interesting trade off, as retaining the virus DNA helps the bacteria grow faster but reduces its motility, which is needed when seeking out new environments, Wood explains. Further exploring this dynamic, Wood and his research group were able to link this regulation process to the formation of bacterial communities called biofilms. A biofilm, Wood says, is a protective, adhesive slime created by bacteria that have joined together to form a community and reap the benefits of a "strength-in-numbers" approach. Biofilms can grow on a variety of living and nonliving surfaces, including submerged rocks, food, teeth (as plaque) and biomedical implants such as knee and hip replacements. The National Institutes of Health estimate that about 90 percent of infections in humans are caused by biofilms, and the Centers for Disease Control estimate biofilm to be present in 65 percent of hospital-acquired (nosocomial) infections. Biofilms typically are the cause of fatal infections that develop post surgery. More commonly, they are the of persistent ear infections among children. In addition to finding that biofilm formation relies heavily on virus genes present within the bacteria, Wood"s research has shown the mechanism for how this takes place. A protein within the bacterium called Hha has the ability to control whether virus genes are kept within the bacterium or jettisoned. When Hha is basically "turned on," the bacteria expel the virus genes, opting for motility over the ability to form biofilms. Likewise, when Hha is not expressed, the bacteria move slower but grow biofilms at a much faster rate, Wood explains. It"s a finding that could impact everything from health care to research into alternative fuel production. "If we can understand how biofilms are formed, we can begin to manipulate forming them where we want and getting them to not form where we don"t want them," Wood says. "We have found a regulator - this Hha - that controls the genes related to biofilm formation. Now we can begin to envision ways to turn on that Hha gene if we want to get rid of biofilms, and that is what we are working on. That"s the long-term goal - as engineers to make biofilms where we want them. "For example, if we want to remediate soil, we"d form a biofilm on the roots of plants, plant the tree, and wherever the tree root goes we clean the soil. That"s a beneficial biofilm. If I want to make hydrogen with E. coli, I"ll probably want to do it in a biofilm, so I would want to promote the growth of the biofilm. "We"re one of the first labs in the world that has begun to not only try to understand how biofilms form but to control them." Thomas Wood Texas A&M University


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