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AlphaRx Reports Positive Preclinical Data On GAI-122 Against Liver Disease
AlphaRx Inc. (OTCBB: ALRX) reported positive preclinical results on GAI-122 injectable nano-emulsion in multiple models of acute hepatitis, an inflammatory liver disease.
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Groups Want NJ To Restore Immigrant Outreach Funds
"Immigrant and health-care advocacy groups" are calling on New Jersey to "restore $1 million in funding that has been eliminated in the latest round of budget tightening," the AP/Philadelphia Inquirer reports. "The money was earmarked for community-outreach efforts to educate legal immigrants on available state health programs." A report released yesterday by Rutgers University concluded that "New Jersey"s percentage of uninsured immigrant children is higher than the national average, and the state has a poor track record of making sure those children receive health coverage."
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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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The Cost Of Smoking In The UK

A study available ahead of print in Tobacco Control reports that the cost of tobacco illnesses to the National Health Services in The United Kingdom is five times the accepted figure, resulting in more than 5 billion pounds a year. The most up to date data is based on information dating back to 1991. It demonstrates that the direct cost estimates to the healthcare system ranged from 1.4 to 1.7 billion pounds a year, and an astonishing death toll in excess of 105,000 people up to 2002. The authors mention that the studies concerning tobacco illness are not carried out on a regular basis and most of them, if not all, are somewhat incomplete prompting confidence on information that is rapidly outdated. This is mainly due to the reason that it is extremely difficult to calculate the direct expenditures of this disease. For the purpose of this study, the authors revised and gathered information from the following s. ò€¢ An analysis on the currently accepted figures on three s of data up to 2005/06 when at the time, one in four UK adults were smokers. ò€¢ A detailed revision on published research dating between 1997 and 2007. ò€¢ The gathering of information from a 2002 study by the WHO"s Global Burden of Disease Project evaluating the disease proportions credited to a particular risk factor by gender and region. ò€¢ The routine data of the monthly death toll for the year 2005 related to smoking in The United Kingdom. Based on the conclusions on the figures gathered above, the authors determined that in 2005, approximately 110,000 people died as a direct result of smoking. Therefore concluding that one in every five of all deaths (19 percent) was smoking related. And out of this smoking related percentage, one in four deaths was among men (27 percent), compared to only one in ten among women. These figures are similar to previous estimates, say the authors, and "suggests that the overall numbers of deaths attributable to smoking have not changed much in the past 10 years." Another important conclusion the authors outlined is that according to the composite measure of Disability Adjusted Life Years Lost (DALY), smoking has always been directly accountable for a significantly large amount of disability and premature deaths. Of all DALYs lost in the UK, twelve were directly attributed to smoking. Finally the authors concluded that since 1990 an unchanged 5.5 percent of the total NHS budget accounting for 5.2 billion pounds is considered an adequate estimate for the direct impact of smoking for the year 2005/06. This percentage proportion hat has not changed since the early 1990"s. They also consider this annual expenditure perhaps as an underestimate, since many issues still have not been taken into consideration, such as few indirect costs like lost productivity and informal care, the cost of passive smoking, or the full range of conditions linked to smoking. "The burden of smoking-related ill health in the United Kingdom" S Allender, R Balakrishnan, P Scarborough, P Webster, M Rayner doi:10.1136/tc.2008.026294 Tobacco Control Written by Stephanie Brunner (B.A.) Copyright: Medical News Today Not to be reproduced without permission of Medical News Today


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