Edmund's Newsletter August 19, 2008 Issue: #34 Volume 8 Join Our List In This Issue FDA To Hold Meeting On Baby Bottle Chemical Personalized Immunotherapy To Fight HIV/AIDS. Treatment With Anti-anemia Drugs May Not Be Safe For Multiple Myeloma Patients Blood Pressure Response To Daily Stress Provides Clues For Better Hypertension Treatment Aspirin, Acid Blocker A-Day Keeps GI Bleeding At Bay Adverse Reactions To Antibiotics Send Thousands Of Patients To The ER Low Vitamin D Levels Pose Large Threat To Health 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 FDA To Hold Meeting On Baby Bottle Chemical The U.S. Food and Drug Administration said on Friday it will hold a public meeting next month about the safety of a chemical found in baby bottles and many other products. Environmental groups say the chemical, bisphenol A, can hurt children and animals. But the FDA and European regulators, as well as the plastics industry, say it is safe. The National Toxicology Program, part of the U.S. government's National Institutes of Health, has issued a draft report expressing concern that bisphenol A could cause neural and behavioral problems in fetuses, infants and children. The FDA said its meeting would focus on this. The chemical, commonly known as BPA, is used in polycarbonate bottles, including water bottles and baby bottles, as well as the lining of cans including infant formula cans. Read more..... Personalized Immunotherapy To Fight HIV/AIDS. An MUHC team, in collaboration with the Université de Montréal, adopts an innovative approach to fight the virus responsible for AIDS. For a long time, the main obstacle to creating an AIDS vaccine has been the high genetic variability of the HIV virus. Dr. Jean-Pierre Routy and his team from the Research Institute of the McGill University Health Centre (MUHC), in collaboration with Dr. Rafick Sékaly from the Université de Montréal, have overcome this difficulty by designing a personalized immunotherapy for HIV-infected patients. The team's findings were presented on August 5 at the XVII International AIDS Conference in Mexico City. "Our approach is unique in the world: no one else has yet developed customized immunotherapy using the virus from individual patients," said Dr. Routy. "This experimental technique remains long and costly for the moment, but we're hoping it will hold the promise of a completely innovative and widely available treatment in the future." This immunotherapy is based on the properties of dendritic cells, whose role is to present specific proteins from infectious organisms at their surface, thereby alerting the rest of the immune system. In collaboration with Argos Therapeutics, the researchers designed a study in which the dendritic cells of nine study patients were multiplied in vitro and then treated with the RNA (ribonucleic acid) from the virus that had infected each patient. A virus sample was taken before the administration of any antiretroviral treatment. The surfaces of these manipulated dendritic cells present an increased number of HIV proteins, which allows them to stimulate the cytotoxic response of a certain type of immune cell called CD8+ lymphocytes. After receiving multiple subcutaneous injections of these dendritic cells, eight of the nine patients involved experienced a significant increase in CD8+ lymphocyte activity. "At this stage, we have shown that the technique doesn't cause side effects or an undesirable auto-immune response," said Dr. Routy. "Health Canada has approved a multicentre clinical trial across the country that will let us further assess the technique's effectiveness at controlling HIV reproduction. We're hoping that the FDA in the United States will also give us the go-ahead soon so that our pharmaceutical partner, Argos Therapeutics, can begin testing in the United States." Read more..... Treatment With Anti-anemia Drugs May Not Be Safe For Multiple Myeloma Patients A recent study published in American Journal of Hematology demonstrated that Erythropoiesis-stimulating agents (ESAs), a widely used drug to treat anemia, may have a negative impact on the survival of myeloma patients. In the study, 323 multiple myeloma patients were evaluated over a 20 year period in Greece from 1988 to 2007. The investigators reviewed their medical records and observed an association between ESA exposure and a reduction in progression-free and overall survival. The study demonstrated that ESA administration may influence the course of the disease, in that people who received ESA may progress earlier than those who did not receive ESA. The median survival rate was 31 months for patients who were administered ESAs, compared to 67 months in those who were not exposed to ESAs. The median progression-free survival for patients in the ESA group was 14 months, and 30 months for those without ESA exposure. For the past 15 years, erythropoiesis-stimulating agents have been used in the management of cancer-related anemia, but researcher Eirini Katodritou stresses the possible harmful effects ESAs may have on cancer patients. "Physicians should use ESAs with caution, based on the International Guidelines for ESA administration in cancer and on certain prognostic indicators to guide their use. Physicians need to identify the appropriate group of cancer patients who will benefit from ESA administration, while avoiding possible detrimental effects," said Katodritou. Read more..... Blood Pressure Response To Daily Stress Provides Clues For Better Hypertension Treatment How the body regulates blood pressure in response to daily stress is the focus of a study geared toward helping people whose pressure is out of control. "Research shows that two-thirds of patients' high blood pressure is not controlled despite the best efforts of their doctors. That is terrible," says Dr. Gregory Harshfield, director of the Georgia Prevention Institute at the Medical College of Georgia. "We are trying to identify the mechanisms through which blood pressure is regulated under normal everyday conditions -  which is what stress is - and take that information back to the clinic to better determine what sort of therapy is going to be most effective at treating your blood pressure or your grandfather's." More than a dozen researchers have teamed up to do parallel studies in animal models and young adults to learn more about what factors like genes, stress and obesity contribute, their synergy and novel ways to control them. Read more..... Aspirin, Acid Blocker A-Day Keeps GI Bleeding At Bay For patients with clogged heart arteries who take long-term, low-dose aspirin to prevent a cardiac event, adding a stomach acid-blocking drug to their daily routine has been shown to reduce their risk for upper gastrointestinal bleeding - an infrequent, but serious side-effect of regular aspirin use. But do the benefits of these acid blockers - called proton pump inhibitors, or PPIs - outweigh their long-term costs?   In a new study, researchers at the University of Michigan Health System reveal that, from the perspective of a long-term payer, over-the-counter PPIs are worth the price for coronary heart disease patients taking low-dose aspirin as a preventative measure. At prescription costs, however, PPIs are cost-effective only for elderly patients and patients at high risk for upper GI bleeding.   "Our study was also able to demonstrate that, for patients at an average risk for GI bleeding, starting PPI cotherapy at a younger age was marginally cost-effective, while starting PPI cotherapy at an older age was highly cost effective," says Sameer Dev Saini, M.D., M.S.,clinical lecturer in the Division of Gastroenterology at the U-M Medical School. "Ultimately, physicians should discuss the gastrointestinal risks of low-dose aspirin with their patients and consider PPI cotherapy." Study results appear in the Aug. 11/25 issue of Archives of Internal Medicine. Read more..... Adverse Reactions To Antibiotics Send Thousands Of Patients To The ER Adverse events from antibiotics cause an estimated 142,000 emergency department visits per year in the United States, according to a study published in the September 15, 2008 issue of Clinical Infectious Diseases. "This number is an important reminder for physicians and patients that antibiotics can have serious side effects and should only be taken when necessary," said study author Daniel Budnitz, M.D., at the Centers for Disease Control and Prevention (CDC). Prior to this study, detailed data on the scope and burden of antibiotic adverse events in the U.S. were not available. This investigation is the first to use timely, nationally representative surveillance data to estimate and compare the numbers and rates of adverse events from systemic antibiotics by class, drug, and event type. Read more..... Low Vitamin D Levels Pose Large Threat To Health Researchers at Johns Hopkins are reporting what is believed to be the most conclusive evidence to date that inadequate levels of vitamin D, obtained from milk, fortified cereals and exposure to sunlight, lead to substantially increased risk of death. In a study set to appear in the Archives of Internal Medicine online Aug. 11, the Johns Hopkins team analyzed a diverse sample of 13,000 initially healthy men and women participating in an ongoing national health survey and compared the risk of death between those with the lowest blood levels of vitamin D to those with higher amounts. An unhealthy deficiency, experts say, is considered blood levels of 17.8 nanograms per milliliter or lower. Of the 1,800 study participants known to have died by Dec. 31, 2000, nearly 700 died from some form of heart disease, with 400 of these being deficient in vitamin D. This translates overall to an estimated 26 percent increased risk of any death, though the number of deaths from heart disease alone was not large enough to meet scientific criteria to resolve that it was due to low vitamin D levels. Read more..... Believe it or not Man accused of stealing ambulance outside hospital Police have charged a suburban Philadelphia man with swiping an ambulance from outside a hospital. Authorities say the crew of the Lafayette Ambulance & Rescue squad was in Montgomery Hospital in Norristown dropping off a patient about 3:30 p.m. Tuesday when someone drove off with the ambulance.   About 7:30 p.m., state police spotted the vehicle westbound on Interstate 76, the Schuylkill Expressway, and pulled it over at the Route 202 exit in Upper Merion Township. Police say they charged the man driving the ambulance, 22-year-old Justin Janaitis, of Norristown, with receiving stolen property and driving under the influence. Police say it was not immediately clear why Janaitis had taken the ambulance. It also was unclear whether he had a lawyer. 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