Edmund's Newsletter August 5, 2008 Issue: #32 Volume 8 Join Our List In This Issue Follow Up To The January 3, 2008 Communication About An Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Exercise In A Pill? Researchers Find Two Simple Lab Test For Bone Disease Linked To Risk Of Death In Dialysis Patients Drug Has Potential to Prevent Alcoholics From Relapsing The Drug Warfarin May Help Prevent Liver Failure In Thousands Of People With Hepatitis C Impotence Drugs Help Teat Brain Ttumors FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample 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 Follow Up To The January 3, 2008 Communication About An Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) On April 22, 2008, FDA notified the manufacturer of Epogen/Procrit and Aranesp of its decision to require additional safety-related changes to the labeling for these products. Amgen submitted labeling supplements for Epogen/Procrit and Aranesp on May 22, 2008, following the March 13, 2008 Oncologic Advisory Committee's recommendations to make additional safety-related changes to the labeling for these products. Amgen and FDA have agreed on many of these changes, including to replace the existing Patient Package Insert with a Medication Guide and to modify certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of package insert. These changes are intended to clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated. While agreement was reached on the general concepts, Amgen and FDA have not reached agreement on specific wording on two points, including a warning statement that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and statements regarding when to initiate and to discontinue ESA dosing. Labeling discussions concluded on July 15 and FDA issued a letter ordering the additional changes on July 30, 2008. Read more..... Exercise In A Pill? Researchers Find Two Researchers who genetically engineered "marathon mice" that could run for hours have found two pills that can mimic the effects -- and they have already developed a test for the drugs in case athletes try to cheat with them. The drugs reproduce many of the biological benefits of exercise, helping cells burn fat better and boosting endurance, said Ronald Evans, a Howard Hughes Medical Institute researcher at the Salk Institute for Biological Studies in California. One of the pills may some day help people enhance their exercise or training, while the other might be more suited for couch potatoes who need to kick-start themselves, Evans and colleagues reported on Thursday in the journal Cell. "If you like exercise, you like the idea of getting more bang for your buck," Evans said in a statement. "If you don't like exercise, you love the idea of getting the benefits from a pill." Read more..... Simple Lab Test For Bone Disease Linked To Risk Of Death In Dialysis Patients "This large epidemiologic study shows, for the first time, a consistent and robust association between a high blood level of alkaline phosphatase and cardiovascular death in thousands of dialysis patients across the United States," comments Kamyar Kalantar-Zadeh, MD, of the University of California Los Angeles, one of the study authors. "If the association between alkaline phosphatase and mortality has a causal link, treatment strategies that reduce alkaline phosphatase levels may improve survival in patients with CKD, and probably in many other patients with chronic diseases and active bone disorders." The researchers analyzed data on nearly 74,000 hemodialysis patients in DaVita dialysis clinics during a three-year period. Laboratory measurements of alkaline phosphatase level measured in a DaVita laboratory center were analyzed as a possible predictor of mortality risk. In dialysis patients, alkaline phosphatase levels are routinely measured to monitor metabolic bone disease, a common complication of CKD. However, current guidelines do not include specific recommendations or targets for serum alkaline phosphatase in CKD patients. The results showed that patients with higher alkaline phosphatase levels were at higher risk of death during the three-year follow-up period. After adjustment for a wide range of other risk factors, patients with alkaline phosphatase levels above the upper limit of normal (>120 IU/L) had a 25 percent increase in mortality rate. Read more..... Drug Has Potential to Prevent Alcoholics From Relapsing OHSU scientist identifies brain receptor that triggers euphoric feelings from alcohol as well as a drug that blocks the heightened pleasure alcoholics experience when they resume drinking An experimental drug that blocks the euphoric feelings associated with drinking may prevent alcoholics from relapsing. The finding, the result of a mouse study at Oregon Health & Science University, could lead to human clinical trials within the next year. "We showed we could block behavior in mice that resembles this increased euphoria even after the animals had been given a lot of alcohol," said Tamara Phillips, Ph.D., professor and vice chair of the behavioral neuroscience department at OHSU and a research scientist at the Portland Veterans Affairs Medical Center. "That's what you want in a treatment, because we don't get to people until after they become addicted to alcohol." Earlier research has shown that some people's brains become sensitized as a result of chronic exposure to alcohol. This change in the brain does not subside after people quit drinking. So when they begin consuming alcohol again, "they get a bigger jolt," Phillips said. Read more..... The Drug Warfarin May Help Prevent Liver Failure In Thousands Of People With Hepatitis C In a study published tomorrow (1 August) in the Journal of Thrombosis and Haemostasis, researchers show that warfarin reduces the scarring on the liver caused by Hepatitis C. This scarring, or fibrosis, replaces normal liver cells and can lead to cirrhosis of the liver and ultimately liver failure. Following the new findings in mouse models, the Imperial College London researchers are now embarking on a clinical trial of warfarin as a treatment for people with Hepatitis C, funded by the Medical Research Council (MRC). There are an estimated 300,000 people in the UK with chronic Hepatitis C. The disease progresses much more quickly in some patients than in others and around one in five of those infected will develop cirrhosis. Read more..... Impotence Drugs Help Teat Brain Ttumors Impotence drugs may help carry cancer-fighting drugs through the brain to treat malignant tumors, U.S. researchers reported on Monday. Tests in rats showed two erectile dysfunction drugs -- Schering-Plough's Levitra and Pfizer's Viagra -- helped carry a chemotherapy drug past the blood-brain barrier, the team at Cedars-Sinai Medical Center in Los Angeles said. Rats with brain tumors lived 42 days when injected with the cancer drug adriamycin. But when they also got Levitra, known generically as vardenafil, the rats survived an average of 53 days. Levitra appeared to be more effective, the researchers reported in the journal Brain Research. Read more..... FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors. "The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, which oversees medical diagnostics. "In the past, scientists have classified different types of cancers based on the organs in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells." Read more..... Believe it or not Spanish Bank Notes Contain Highest Traces Of Cocaine Of Any European Currency A study of randomly selected Spanish euro notes carried out by chemists at the University of Valencia (UV) has shown that they contained traces of cocaine at an average concentration of 155 microgrammes, which is the highest rate in Europe, according to an article published in the latest issue of the magazine Trends in Analytical Chemistry. The researchers also carried out a comparative study of the methods currently used in detecting the presence of cocaine on bank notes worldwide. "The latest technology means we can now carry out quantitative analysis of cocaine traces on any bank note, and as a result we can confirm that - at least in Spain - traces of the drug are found not only on notes that have been in direct contact with it, but on nearly all the notes in circulation," said Miguel de la Guardia, co-author of the study and a professor in the Analytical Chemistry Department of the UV, in an interview with SINC. He explained that this was due to "cross contamination" between bank notes, as well as in money counting machines used by banks. The study also analyses previous studies highlighting the concentrations of cocaine found in different currencies around the world, as well as the results of the random sample of Spanish bank notes gathered by the Valencian chemists, which detected concentrations of up to 889 microgrammes of the drug on some notes. In the United States, which has the most highly contaminated bank notes of any country in the world, dollar bills containing more than 1,300 microgrammes of cocaine have been registered, although the average values were between 2.86 and 28.75 microgrammes, varying according to the year and city. The study also reveals that German euro bank notes have a cocaine concentration traces five times lower than that of the Spanish ones. With Irish bank notes, one statistic indicates that of 48 notes studied the highest concentration found was 0.576 microgrammes. Another study, carried out on 356 Swiss franc notes, found that only 6% were contaminated with the drug (at concentrations above one nanogramme per note). The researchers were unable to find any quantitative data in the scientific literature relating to British pounds, but semi-quantitative data from a few years ago suggested that between 40% and 51% of bank notes were contaminated with cocaine, at levels of 0.0011 microgrammes per note. The publication points out that there is an "unequivocal" relationship between the high levels of cocaine found in both American dollar bills and Spanish euro notes and the high consumption of the substance in both countries. Spain, the European point of entry for cocaine The most recent report from the United Nations Office on Drugs and Crime warns that Spain is still the major point of entry of cocaine into Europe. In 2006, 41% of all hauls of the drug made on the continent were made on Spanish soil, where 50 metric tonnes were seized, followed by Portugal, with 35 metric tonnes. The UN also says the rate of cocaine use doubled in Spain between 1999 and 2005, increasing from 1.6% to 3% of those aged between 15 and 64, which is more than twice the rate for western Europe as a whole (1.2%). De la Guardia believes that cocaine "has become rooted in Spanish society, and is playing Russian roulette with the neuronal development of an entire generation", and that for this reason greater efforts must be made to reduce consumption, as well as to destroy the glamorous image of cocaine "which is often portrayed by the media". "I find it profoundly embarrassing that we now all have cocaine in our wallets," the researcher added. The chemist told SINC that the methods used to extract cocaine from the bank notes and to analyse it depended upon whether it was necessary to detect the drug quickly, in which case direct application methods are used (in which the drug is not separated from the bank note), such as thermal dissolution, with detection by mass spectrometry, ionic mobility spectrometry, or immune testing (with an antigen-antibody recognition system). Mass spectrometry is also used if the priority is to determine the exact amounts of cocaine on a note. However, in this case it is necessary to first separate the drug from the notes, using methods such as gas chromatography, liquid chromatography or capillary electrophoresis, using organic solvents. 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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