Edmund's Newsletter March 18, 2008 Issue: #12 Volume 8 Join Our List In This Issue Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) New Drug Holds Promise for Parasitic Worm Disease Researchers Find Cause of Severe Allergic Reaction to Cancer Drug Scientists Shine New Light on Inflammatory Diseases Research Could Put Penicillin Back In Battle Against Antibiotic Resistant Bugs That Kill Millions MRSA Screening At Hospital Admission Not Linked To Reduced Rates Of Infection In Surgical Patients Mayo Clinic Proceedings Contributors Highlight Research Findings About Cardiovascular Benefits Associated With Omega-3 Fatty Acids 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 Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of = 12 g/dL. Read more..... New Drug Holds Promise for Parasitic Worm Disease U.S. researchers have discovered a promising new drug for schistosomiasis -- a parasitic worm disease that affects more than 200 million people in 70 countries. The compound killed worms in the lab, and cured mice infected with the disease, said David Williams of Illinois State University, who reported his findings on Sunday in the journal Nature Medicine. The only existing drug that works against schistosomiasis, praziquantel, is more than 20 years old. "There is nothing else you could go to if the parasite evolves resistance," Williams said in a telephone interview. He said about 100 million people will take the drug this year. Read more..... Researchers Find Cause of Severe Allergic Reaction to Cancer Drug Clinicians have been perplexed by the fact that some patients given the drug cetuximab-an immune-based therapy commonly used to treat persons diagnosed with head and neck cancer, or colon cancer-have a severe and rapid adverse reaction to the drug. Sometimes the reaction includes anaphylaxis, a life-threatening condition characterized by a drop in blood pressure, fainting, difficulty breathing, and wheezing. Now researchers funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have discovered that specific pre-existing antibodies cause the severe reaction to the drug. This discovery in turn has enabled them to explain the unusual geographic pattern of this reaction seen among individuals in the United States. The unusual findings of this investigation appear in a report published in the March 13 edition of the New England Journal of Medicine. "These intriguing research findings not only are potentially important to physicians treating certain cancer patients, but also may have broader implications for the use of immunotherapies for other diseases," notes Anthony S. Fauci, M.D., NIAID director. NIAID grantee Thomas Platts-Mills, M.D., Ph.D., who heads the Division of Allergy and Clinical Immunology at the University of Virginia, led a research study to investigate the cause of the clinical problem with cetuximab. Their newly reported findings are of immediate importance in the care of cancer patients, says Dr. Platts-Mills. "Because of the widespread use of cetuximab in cancer treatment, it may be useful to pre-screen patients for specific IgE antibodies to cetuximab to identify those who are at risk for serious adverse reactions, including anaphylaxis." Cetuximab is a partially humanized mouse monoclonal antibody, which means it is produced by a single cell line and acts against a specific protein. The drug inhibits a growth factor receptor found on the cell surface, thereby controlling the growth of cancer cells. Read more..... Scientists Shine New Light on Inflammatory Diseases Investigators at Hospital for Special Surgery have identified a new mechanism involved in the pathogenesis of inflammatory diseases such as rheumatoid arthritis. The mechanism may also shed some light on why gene therapy experiments that use adenoviruses to deliver genes to humans have run into problems. The study will appear online on March 16 in the journal Nature Immunology. Tumor necrosis factor (TNF) is known to play a role in several important inflammatory diseases including rheumatoid arthritis. While much is known about early signaling pathways activated by TNF, little is known about delayed and chronic TNF responses. In addition, cells called macrophages produce TNF, but little is known about the effects of TNF on the macrophages themselves. In studies using human blood cells and mice, scientists examined the responses of macrophages during a two-day period after being stimulated with TNF. They found that macrophages secreted TNF and that then the TNF activated surface receptors on the macrophages themselves, spurring the cells into a low and sustained production of a protein called interferon-beta. This protein acted synergistically with TNF signals to induce 1) sustained expression of genes encoding inflammatory molecules and 2) delayed expression of genes encoding interferon-response molecules. "The striking thing about many of these genes that came to our attention first was that there were these classic interferon response genes which had previously not been associated with TNF," said Lionel Ivashkiv, M.D., director of Basic Research at Hospital for Special Surgery, who led the study. "It suggests a new mechanism by which TNF can drive and sustain inflammation." Read more..... Research Could Put Penicillin Back In Battle Against Antibiotic Resistant Bugs That Kill Millions Research led by the University of Warwick has uncovered exactly how the bacterium Streptococcus pneumoniae has become resistant to the antibiotic penicillin. The same research could also open up MRSA to attack by penicillin and help create a library of designer antibiotics to use against a range of other dangerous bacteria. Worldwide Streptococcus pneumoniae causes 5 million fatal pneumonia infections a year in children. In the US it causes 1 million cases a year of pneumococcal pneumonia in the elderly of which up to 7% are fatal. This new research has completely exposed how Streptococcus pneumoniae builds its penicillin immunity and opens up many ways to disrupt that mechanism and restore penicillin as a weapon against these bacteria. The research was led by Dr Adrian Lloyd of the University of Warwick's Department of Biological Sciences along with other colleagues from the University of Warwick, the Université Laval, Ste-Foy in Quebec, and The Rockefeller University in New York. The research was funded by Welcome Trust and the MRC. Penicillin normally acts by preventing the construction of an essential component of the bacterial cell wall: the Peptidoglycan. This component provides a protective mesh around the otherwise fragile bacterial cell, providing the mechanical support and stability required for the integrity and viability of cells of Streptococcus pneumoniae and other bacteria including MRSA. Read more..... MRSA Screening At Hospital Admission Not Linked To Reduced Rates Of Infection In Surgical Patients New findings do not support the recommendation for universal screening on hospital admission for methicillin-resistant Staphylococcus aureus (MRSA) to reduce the rate of hospital-acquired infections in surgical patients. Individuals who carry antimicrobial-resistant disease-producing agents such as MRSA places patients at high risk of infection. Early identification of patients with MRSA and subsequent prevention of patient-to-patient spread through infection control measures are believed to be important interventions to control MRSA. "Experts and policy makers, nationally and internationally, recommend universal admission screening as a means to control MRSA. However, no controlled trial has tested the hypothesis that rapid MRSA screening may improve patient outcome by decreasing MRSA cross-transmission and increasing the adequacy of pre-operative prophylaxis [disease prevention]," the authors write. Stephan Harbarth, M.D., M.S., and colleagues with the University of Geneva Hospitals and Medical School, Geneva, Switzerland, conducted a study to evaluate the effect of a early MRSA detection strategy on MRSA infections acquired in a hospital (nosocomial ) among 21,754 surgical patients at a Swiss teaching hospital. There were two MRSA control strategies: rapid screening on admission plus standard infection control measures vs. standard infection control alone. Read more..... Mayo Clinic Proceedings Contributors Highlight Research Findings About Cardiovascular Benefits Associated With Omega-3 Fatty Acids Thousands of research studies have documented how the oils known as omega-3 fatty acids can benefit the cardiovascular system, particularly among people diagnosed with coronary artery disease. The incredible volume of research on this topic creates difficulty for many physicians and patients to stay current with findings and recommendations related to these oils. In the March issue of Mayo Clinic Proceedings, contributors briefly summarize current scientific data on omega-3 fatty acids and cardiovascular health, focusing on who benefits most from their protective effects, recommended guidelines for administration and dosing, and possible adverse effects associated with their use. Two omega-3 fatty acids that have been associated with cardiovascular benefit, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), are found in fish oils. The best source for DHA and EPA are fatty coldwater fish such as herring, mackerel, salmon and tuna. Fish oil supplements or algae supplements also can provide omega-3 fatty acids. Author James O'Keefe, M.D., a cardiologist from the Mid America Heart Institute in Kansas City, Mo., cites the results of several large trials that demonstrated the positive benefits associated with omega-3 fatty acids, either from oily fish or fish oil capsules. Read more..... Believe it or not French mayor tells locals not to die The mayor of a village in southwest France has threatened residents with severe punishment if they die, because there is no room left in the overcrowded cemetery to bury them.   In an ordinance posted in the council offices, Mayor Gerard Lalanne told the 260 residents of the village of Sarpourenx that "all persons not having a plot in the cemetery and wishing to be buried in Sarpourenx are forbidden from dying in the parish". It added: "Offenders will be severely punished". The mayor said he was forced to take drastic action after an administrative court in the nearby town of Pau ruled in January that the acquisition of adjoining private land to extend the cemetery would not be justified. Lalanne, who celebrated his 70th birthday on Wednesday and is standing for election to a seventh term in this month's local elections, said he was sorry that there had not been a positive outcome to the dilemma. "It may be a laughing matter for some, but not for me," he said. 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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