Edmund's Newsletter March 25, 2008 Issue: #13 Volume 8 Join Our List In This Issue Treatment Promising for Alcohol Dependence Treatment Gives Lung Cancer Patients With Inoperable Tumors Two Years Or More, Study Shows Joslin Researchers Discover New Effect for Insulin Plays Previously Unknown Role in Aging and Lifespan Only Two Percent of Pediatric Drug Trials Have Independent Safety Checks Inhaled Tuberculosis Vaccine May Be More Effective Than Injected Vaccine Neuronal Regulators Offer Potential Targets for Cancer Soy Compound May Halt Spread of Prostate Cancer 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 Treatment Promising for Alcohol Dependence An extended-release version of the anti-addiction medicine naltrexone reduces drinking in alcohol-dependent patients within two days of being injected, according to a new study. Naltrexone blocks opioid receptors and is approved for use in alcohol-dependent patients. To improve adherence, "an intramuscular, injectable, extended-release formulation of naltrexone has been developed," Dr. Domenic A. Ciraulo, of Boston University School of Medicine, and colleagues explain in the Journal of Clinical Psychiatry. The researchers tested injectable naltrexone XR in some 600 actively drinking, alcohol-dependent men and women who were given one of two doses of the drug or an inactive placebo every 4 weeks for 24 weeks. The participants also received 12 sessions of standardized, low-intensity psychosocial therapy. Compared with the placebo patients, patients given the higher dose of naltrexone had a significant reduction in the average daily number of drinks consumed by the second day. By the third day, fewer naltrexone patients reported heavy drinking compared with those on placebo (20 percent versus 35 percent, respectively). This reduction was maintained throughout the study. Read more..... Treatment Gives Lung Cancer Patients With Inoperable Tumors Two Years Or More, Study Shows   Radiofrequency ablation (RFA)-an interventional treatment that "cooks" and kills lung cancer tumors with heat-greatly improves survival time from primary or metastatic inoperable lung tumors, according to a new study. Of the 244 patients suffering from lung metastases (195 patients) or primary non-small cell lung cancer (49 patients), 70 percent were still alive at two years, including 72 percent for lung metastases and 64 percent for primary lung cancer. These survival results are similar to surgical results from other studies, but the interventional treatment is less invasive and has far fewer side effects and less recovery time. The researchers found that RFA often can completely destroy the primary tumor and, therefore, extend a patient's survival and greatly improve his or her quality of life. Survival thus becomes dependent on the extent of disease elsewhere in the body. Of the 49 patients (ages 27-85) with non-small cell primary lung cancer who were treated with RFA, 85 percent had no viable lung tumors after one year on imaging, and 77 percent had no viable lung tumors after two years, which indicates a cure. This study was conducted in tumors four centimeters in diameter or smaller, and even better results were obtained for tumors smaller than two centimeters. Read more..... Joslin Researchers Discover New Effect for Insulin Plays Previously Unknown Role in Aging and Lifespan Researchers at the Joslin Diabetes Center have shown that insulin has a previously unknown effect that plays a role in aging and lifespan, a finding that could ultimately provide a mechanism for gene manipulations that could help people live longer and healthier lives.   The paper, published in the March 21st issue of Cell, reports that insulin inhibits a master gene regulator protein known as SKN-1, and that increased SKN-1 activity increases lifespan.  SKN-1 controls what is called the Phase 2 detoxification pathway, a network of genes that defends cells and tissue against oxidative stress - damage caused by elevated levels of free radicals (byproducts of metabolism) - and various environmental toxins. The new finding was demonstrated in experiments on the digestive system of C. elegans, a microscopic worm often used as a model organism.   "We've found something new that insulin does and it has to be considered when we think about how insulin is affecting our cells and bodies," said Dr. T. Keith Blackwell, senior investigator at Joslin and author of the paper. "This has implications for basic biology since under some circumstances insulin may reduce defense against the damaging effects of oxidative stress more than we realize." Read more..... Only Two Percent of Pediatric Drug Trials Have Independent Safety Checks Only two per cent of paediatric drug trials reported using independent safety monitoring committees that can help lead to the early detection of adverse drug reactions, according to a major review published in the journal Acta Paediatrica. Child health researchers from The University of Nottingham carried out a detailed analysis of 739 international drug trials published between 1996 and 2002, to see what safety measures were in place to monitor levels of adverse drug reactions. While 74 per cent of the drug trials described how safety monitoring was performed during the study, only two per cent - 13 studies out of 739 - had independent safety monitoring committees. Lead author Dr Helen Sammons, an Associate Professor of Child Health in the University's Academic Division of Child Health, based at Derbyshire Children's Hospital, said: "We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children. "It is essential that drugs are developed for use in children and clinical trials need to continue. They are vital because they increase the chance of picking up adverse reactions before drugs are introduced into general clinical practice." Read more..... Inhaled Tuberculosis Vaccine May Be More Effective Than Injected Vaccine A novel aerosol version of the most common tuberculosis (TB) vaccine, administered directly to the lungs as an oral mist, offers significantly better protection against the disease in experimental animals than a comparable dose of the traditional injected vaccine, researchers report this week (March 12) in the Proceedings of the National Academy of Sciences (PNAS). The aerosol vaccine - under development through a collaboration between Harvard University and the international not-for-profit Medicine in Need (MEND) - could provide a low-cost, needle-free TB treatment that is highly stable at room temperature. "Rising rates of tuberculosis and drug-resistant disease in developing countries have amply illustrated the need for more effective vaccines," says David Edwards, the Gordon McKay Professor of the Practice of Biomedical Engineering in Harvard's School of Engineering and Applied Sciences. "While most new TB vaccines continue to call for needle injection, our vaccine could provide safer, more consistent protection by eliminating these injections and the need for refrigerated storage. We see great promise for this new treatment." Read more..... Neuronal Regulators Offer Potential Targets for Cancer Being too brainy can be a bad thing in a junior high cafeteria, where the social hierarchy favors other traits. "Braininess" also causes problems for cells. When a breast cell begins making the proteins normally produced in neurons, for example, it can acquire cancerous properties. Now, researchers in Stephen Elledge's laboratory at Harvard Medical School (HMS) have identified some of the cellular switches that control this transformation, providing promising new therapeutic targets in some types of cancer. Their results appear in the March 20 issue of Nature. "These switches play an important physiologic role in neural development and pathologic role in cancer," says first author and former Elledge lab postdoc Thomas Westbrook, who is now an assistant professor at Baylor College of Medicine. "I'm optimistic that we can use small molecules to control them." In a previous study, Westbrook showed that a protein called REST-which keeps neural programs silent in most parts of the body-serves as a tumor suppressor in these same parts of the body. "He's now identified a protein that promotes tumor growth by tagging REST for destruction, thereby activating neural programs," says Elledge, who holds primary appointments in the HMS Department of Genetics and at Brigham and Women's Hospital. Read more..... Soy Compound May Halt Spread of Prostate Cancer A compound found in soybeans almost completely prevented the spread of human prostate cancer in mice, according to a study published in the March 15 issue of Cancer Research, a journal of the American Association for Cancer Research. Researchers say that the amount of the chemical, an antioxidant known as genistein, used in the experiments was no higher than what a human would eat in a soybean-rich diet. Investigators from Northwestern University found that genistein decreased metastasis of prostate cancer to the lungs by 96 percent compared with mice that did not eat the compound in their chow - making the study the first to demonstrate genistein can stop prostate cancer metastasis in a living organism. "These impressive results give us hope that genistein might show some effect in preventing the spread of prostate cancer in patients," said the study's senior investigator, Raymond C. Bergan, MD, director of experimental therapeutics for the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Read more..... Believe it or not Hawaii hospital turns away horse visitor A man hoping to cheer up an ailing relative at Wilcox Memorial Hospital hadn't considered one of the visitation rules: No horses allowed. The man thought the patient would enjoy seeing his stallion, said Lani Yukimura, a spokeswoman at the hospital. He and the horse entered the hospital earlier this month and rode an elevator up to the third floor, where they were met and stopped by security personnel, Security managed to get the man and the horse out of the hospital, with "just a few scuff marks," she said. The hospital has a pet visitation policy, but it's for dogs and cats, not horses. "On Kauai, we have a very warm inviting atmosphere at Wilcox," Yukimura said. "We just hope people understand this is not a place for a horse." The man's good intentions were further dashed when his relative was brought out to see the horse. "That's not my horse," the patient said to hospital staff. 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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