Edmund's Newsletter November 11, 2008 Issue: #46 Volume 8 Join Our List In This Issue Type 2 Diabetes Management: Apelin Hormone Injections Powerfully Lower Blood Sugar Novel Leukemia Vaccine for High-Risk Patients Researchers Find New Path To Antibiotics In Dirt New Chemical Key That Could Unlock Hundreds Of New Antibiotics Off-Label Promotion, On-Target Sales Researchers Discover New Risk Factor For Cardiovascular Disease, And A Way To Control It Drinking Milk to Ease Milk Allergy? Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days Drug Shortages Quick Links Edmund's Blog Edmund's Newsletter Edmund's Web Page Past Issues SPECIAL THANKS TO Michael R. Cohen President The Institute for Safe Medication Practices and Dr. Stephen Barrett Quackwatch Some links in Edmund's Newsletter will point to a page that requires registration.  In all cases the most you will have to do is fill out a simple form to enroll as a member.  In no case will I point you to a site that requires payment to view the page. PRAY FOR PEACE © 2001,2002, 2003, 2004, 2005, 2006, 2007 Join Our List Type 2 Diabetes Management: Apelin Hormone Injections Powerfully Lower Blood Sugar By injecting a hormone produced by fat and other tissues into mice, researchers report in the November Cell Metabolism that they significantly lowered blood sugar levels in normal and obese mice. The findings suggest that the hormone known as apelin might be a promising target for managing insulin resistance and type 2 diabetes. Insulin resistance, in which normal amounts of insulin are insufficient to lower blood sugar (glucose) levels, is a precursor to diabetes. "The effects of apelin appear to be similar to insulin," although they operate in different ways, said Isabelle Castan-Laurell of Institut National de la Santé et de la Recherche Médicale and Université de Toulouse. Earlier studies had suggested a link between apelin and insulin, Castan-Laurell said. Apelin levels were shown to parallel insulin levels in mice and humans. Apelin levels in the blood also rise in those who are obese and in those with type 2 diabetes. Those findings led the researchers to suspect that apelin and insulin might have other similarities. Read more..... Novel Leukemia Vaccine for High-Risk Patients Researchers at the Moores Cancer Center at the University of California, San Diego (UCSD) are conducting clinical trials of a novel therapy aimed at revving up the immune system to combat a particularly difficult-to-treat form of leukemia. The experimental therapy is being offered to patients with chronic lymphocytic leukemia (CLL) whose cancer did not respond or was resistant to initial treatment or harbors a particular chromosomal abnormality called a 17p deletion.  In most of these cases, the cancer has failed to respond to further conventional therapy. In this clinical trial, patients will receive a vaccine of an immune-boosting molecule, ISF35 (Immune Stimulatory Factor 35) followed by three courses of rituximab, a monoclonal antibody, and the chemotherapy drugs fludarabine and cyclophosphamide (FCR).  The trial is termed Phase I, meaning that it is aimed at testing the safety of the combination of repeat infusions of ISF35 and FCR, the latter being considered the standard and best possible CLL treatment. "This approach - activating immune cells followed by chemotherapy - may lead to new strategies that could be applied to other cancers," said Januario E. Castro, M.D., assistant clinical professor of medicine at the UC San Diego School of Medicine and the Moores UCSD Cancer Center, who leads the work. The vaccine therapy approach makes it possible to target the cancer cells and activate the immune system by making the cancerous leukemia B cells more visible. The activated immune system can then find and eliminate the cancer cells. Read more..... Researchers Find New Path To Antibiotics In Dirt A teaspoon of dirt contains an estimated 10,000 species of bacteria, but it's only one percent of these microbial bugs - the ones that can be grown easily in a lab - that have brought us antibiotics, anticancer agents and other useful drugs. The odds favor the other 99 percent for clinical promise, too, but scientists have had little success in tapping this unknown majority for new medicines because of the difficulty of analyzing the bugs' DNA. Now researchers at The Rockefeller University have extracted that genetic material from a lump of earth and turned it into an environmental DNA "megalibrary" that may provide access to many previously unknown organic compounds. The library has already led them to the genetic code for two potential antibiotics; the scientists also used enzymes from one set of cloned genes to produce new antibiotic derivatives as powerful as the strongest drugs we have today. The research could recharge interest in the search for new compounds in the environment that has flagged over the past decade because of lackluster results. The new findings suggest that all sorts of useful and unknown products are being manufactured by bacteria in the soil that we routinely trample underfoot. And it shows a promising way to get at them. The work was published online Wednesday in Proceedings of the National Academy of Sciences Early Edition. Read more..... New Chemical Key That Could Unlock Hundreds Of New Antibiotics Chemistry researchers at Warwick and the John Innes Centre, have found a novel signalling molecule that could be a key that will open up hundreds of new antibiotics unlocking them from the DNA of the Streptomyces family of bacteria. With bacterial resistance growing researchers are keen to uncover as many new antibiotics as possible. Some of the Streptomyces bacteria are already used industrially to produce current antibiotics and researchers have developed approaches to find and exploit new pathways for antibiotic production in the genome of the Streptomyces family. For many years it was thought that the relatively unstable butyrolactone compounds represented by "A-factor" were the only real signal for stimulating such pathways of possible antibiotic production but the Warwick and John Innes teams have now found a much more stable group of compounds that may have the potential to produce at least one new antibiotic compound from up to 50% of the 1000 or so known Streptomyces family of bacteria. Read more..... Off-Label Promotion, On-Target Sales For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug approved for acne. Government regulatory bodies review laboratory, animal, and human data to confirm that a drug has the claimed efficacy and safety prior to approving its release in the market for specific approved ("labeled") uses. Once a drug is approved for at least one indication, it may be prescribed off-label for a different condition, a different population, or in a different dose than what the drug is approved for. However, off-label uses have not been subject to the testing and review that is a precondition for marketing approval. The scientific review of evidence of effectiveness and safety that regulators weigh prior to approval for a labeled indication protects the patient. With off-label use, this protection often does not exist. Off-label prescription of a drug is generally legal, but promotion of off-label uses by a drug manufacturer is usually illegal. This paper addresses public health issues associated with off-label use, and describes techniques by which pharmaceutical companies covertly promote off-label use even where such promotion is illegal. Read more..... Researchers Discover New Risk Factor For Cardiovascular Disease, And A Way To Control It A team of international researchers - including scientists from the McGill University Health Centre (MUHC) and McGill University - have discovered that having high levels of particular protein puts patients at increased risk of developing cardiovascular disease. The results of the study were so conclusive that the clinical trial had to be stopped before its scheduled completion date. Researchers associated with the international JUPITER Project have demonstrated that high levels of high-sensitivity C-reactive protein (hs-CRP) leads to increased risk of cardiovascular disease. This risk decreases by up to 44% if the patients are treated with statin medications. Dr. Jacques Genest, of the Research Institute of the MUHC and McGill's Faculty of Medicine led the Canadian component of the JUPITER clinical study, which was initiated by Dr. Paul Ridker of the Harvard University Faculty of Medicine. "The risk of cardiovascular disease due to increased hs-CRP levels has been greatly underestimated until now," according to Dr Genest. "Our results show that this is an extremely important indicator that doctors will have to consider in the future." Read more..... Drinking Milk to Ease Milk Allergy? Hopkins Children's oral immunotherapy study shows promise, but do not try this at home Dr. WoodGiving children with milk allergies increasingly higher doses of milk over time may ease, and even help them completely overcome, their allergic reactions, according to the results of a study led by the Johns Hopkins Children's Center and conducted jointly with Duke University. Despite the small number of patients in the trial - 19 - the findings are illuminating and encouraging, investigators say, because this is the first-ever double-blinded and placebo-controlled study of milk immunotherapy. In the study, the researchers compared a group of children receiving milk powder to a group of children receiving placebo identical in appearance and taste to real milk powder. Neither the patients nor the investigators knew which child received which powder, a rigorous research setup that minimizes the chance for error and bias. The findings of the study are reported online ahead of print, Oct. 28, in the Journal of Allergy & Clinical Immunology. Read more..... Believe it or not Ark. woman arrested for huffing asks for can back Police arrested a woman for public intoxication after she reportedly demanded an officer return the can of compressed air she was inhaling "so she could finish getting high." Officers arrested the 46-year-old woman on Monday after officers received a call about a woman "huffing a can of air" inside a car parked at a Wal-Mart store. Police say the woman was slow to react to questions from officers. When the officer again asked her what she was doing, he said "she wouldn't say anything except that she wanted her can back so she could finish getting high," according to police. The woman was booked on the charge and later released. News From MedWatch Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE   Recently Approved Drugs/Indications Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE   FDA Recalls and Safety Alerts in the Past 60 Days: To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE   Drug Shortages: As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE   Recommend Edmund's Newsletter Edmund's Newsletter is published for only one reason and that is expand our knowledge base, join people together with like minds and to disseminate valuable information. If you feel this newsletter is of worth, please pass it along to your friends and colleagues. 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