Edmund's Newsletter January 1, 2008 Issue: #1 Volume 8 Join Our List In This Issue Cardiac Stem Cell Therapy Closer To Reality University of Minnesota Researchers Discover Fast-Acting Cyanide Antidote Physician-Scientist Urges Improved Drug Regulation to Ensure Heart Safety of Non-Heart Drugs Surgery Without Stitches Cell-Death Receptor Link Between Cancer Susceptibility and Inflammation Drug-Eluting Stents -- More Good Than Harm For Heart Patients Men Who Smoke Prone to Impotence Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days 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 Cardiac Stem Cell Therapy Closer To Reality Since the year 2000, much has been learned about the potential for using transplanted cells in therapeutic efforts to treat varieties of cardiac disorders. "Cardiac stem cell therapy involves delivering a variety of cells into hearts following myocardial infarction or chronic cardiomyopathy," says Amit N. Patel, MD, MS, director of cardiac cell therapy at the University of Pittsburgh Medical Center and lead author of an overview and introductory article, Cardiac Stem Cell Therapy from Bench to Bedside. "Many questions remain, such as what types of cells may be most efficacious. Questions about dose, delivery method, and how to follow transplanted cells once they are in the body and questions about safety issues need answers. The following studies, contribute to the growing body of data that will move cell transplantation for heart patients closer to reality." According to Patel, special editor for this issue, suitable sources of cells for cardiac transplant will depend on the types of diseases to be treated. For acute myocardial infarction, a cell that reduces myocardial necrosis and augments vascular blood flow will be desirable. For heart failure, cells that replace or promote myogenesis, reverse apoptopic mechanisms and reactivate dormant cell processes will be useful. "Very little data is available to guide cell dosing in clinical studies," says Patel. "Pre-clinical data suggests that there is a dose-dependent improvement in function." Patel notes that the availability of autologous (patient self-donated) cells may fall short. Determining optimal delivery methods raise issues not only of dose, but also of timing. Also, assessing the fate of injected cells is "critical to understanding mechanisms of action." Will cells home to the site of injury? Labeling stem cells with durable markers will be necessary and new tracking markers may need to be developed. Read more..... University of Minnesota Researchers Discover Fast-Acting Cyanide Antidote University of Minnesota Center for Drug Design and Minneapolis VA Medical Center researchers have discovered a new fast-acting antidote to cyanide poisoning. The antidote has potential to save lives of those who are exposed to the chemical -- namely firefighters, industrial workers, and victims of terrorist attacks. Current cyanide antidotes work slowly and are ineffective when administered after a certain point, said Steven Patterson, Ph.D., principal investigator and associate director of the University of the Minnesota Center for Drug Design. Patterson is developing an antidote that was discovered by retired University of Minnesota Professor Herbert Nagasawa. This antidote works in less than three minutes - meeting the United States Department of Defense "three minute solution" standard. The research will be featured in the Dec. 27, 2007 issue of the Journal of Medicinal Chemistry. "It's much, much faster than current antidotes," Patterson said. "The antidote is also effective over a wider time window. Giving emergency responders more time is important because it's not likely that someone will be exposed to cyanide near a paramedic." Read more..... Physician-Scientist Urges Improved Drug Regulation to Ensure Heart Safety of Non-Heart Drugs Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City. His recommendations include earlier testing of all drugs' cardiovascular effects and giving regulatory bodies the authority to mandate continuing evaluation of drug effects, even after approval for marketing. "The importance of evaluating the cardiovascular safety of new drugs has been highlighted by recent examples of drugs-anti-arthritis drugs and others-that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval," says Dr. Borer. "It is clear that drugs intended for non-cardiovascular problems must be more fully scrutinized than in the past in order to allow doctors and patients to be assured that risks are well defined and that they do not outweigh the benefits provided by the drugs for the individual patient. The primary strategy to achieve this goal is increasing formal observations in both pre- and post-approval studies." Read more..... Surgery Without Stitches A thin polymer film that seals surgical wounds could make sutures a relic of medical history. Measuring just 50 microns, the film is placed on a surgical wound and exposed to an infrared laser, which heats the film just enough to meld it and the tissue, thus perfectly sealing the wound. Known as Surgilux, the device's raw material is extracted from crab shells and has Food and Drug Administration approval in the US. Early test results indicate that it has strongest potential for use in brain and nerve surgery because it can avoid the numerous disadvantages of invasive stictches/sutures, which fail to seal and can act as a source of infection. Up to 11% of brain surgery patients have to return for repeat surgery due to leakage of cerebro-spinal fluid (CSF) and other complications arising from sutures. Surgical sutures date back some 4,000 years, so a new approach is long overdue, according to one of the device's inventors and leader of the Bio/polymer Research Group, UNSW scientist John Foster. Read more..... Cell-Death Receptor Link Between Cancer Susceptibility and Inflammation For over 10 years, Wafik S. El-Deiry, MD, PhD, Professor of Medicine, Genetics, and Pharmacology at the University of Pennsylvania School of Medicine, has been pursuing a cancer-targeting molecule called TRAIL and its molecular partners. TRAIL is normally produced by immune cells and curtails tumor spread by binding to a specialized receptor on a tumor's surface. "However, in cancer patients who often have suppressed immunity, and for reasons we still don't understand, there isn't enough TRAIL being produced, so tumors are not suppressed," explains El-Deiry, who is also Co-Program Leader of the Radiation Biology Program for the Abramson Cancer Center at Penn. Most recently, El-Deiry and colleagues demonstrated for the first time a link between TRAIL's receptor and cancer susceptibility, as reported online December 13, 2007 in the Journal of Clinical Investigation in advance of the January 2008 print issue. Unexpectedly, they also found a connection - via Trail - between inflammation and cancer susceptibility. Mice engineered without the TRAIL receptor on their cells versus healthy controls developed larger and more tumors in their livers and other organs after being challenged with a chemical carcinogen or radiation. The team also bred TRAIL receptor knock-out mice with mice genetically engineered to get B-cell lymphomas that metastasize to the liver. Their offspring displayed more liver tumors compared to controls. "This is the first direct in vivo evidence that loss of the tumor death-inducing TRAIL receptor confers cancer susceptibility," says El-Deiry. Read more..... Drug-Eluting Stents -- More Good Than Harm For Heart Patients Clinical evidence suggests that drug-eluting stents in patients undergoing coronary artery revascularization procedures relieve obstructive coronary artery disease, provide durable mechanical results, and do more good than harm. This is the conclusion reached by Allen Jeremias, M.D., Assistant Professor of Medicine and Director, Vascular Medicine and Peripheral Intervention, Division of Cardiovascular Medicine at Stony Brook University Medical Center, in an article published online in the Annals of Internal Medicine (print edition: February 5, 2008).  The use of stents coated with drugs, which are slowly released to help keep blood vessels from reclosing, is one of the most recent advancements in interventional cardiology. This type of stent was developed to address the problem of the re-narrowing or blockage of an artery (restenosis) after bare-metal stent implementation. Yet, clinical reports of increased incidence of blood clot formation - defined as late stent thrombosis occurring more than 30 days after drug-eluting stent implementation - has raised concerns about the safety of the devices. Dr. Jeremias and co-author Ajay Kirtane, M.D., Assistant Professor of Clinical Medicine, Center for Intervascular Therapy, Division of Cardiology at Columbia University Medical Center in New York, analyzed current clinical data to provide a perspective on the benefits and risks of drug-eluting stents compared to bare-metal stents in "Balancing Efficacy and Safety of Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention." "There appears to be a slightly higher risk with drug-eluting stents, namely late stent thrombosis, but our analysis of the clinical evidence suggests that the net clinical benefit of drug-eluting stents may outweigh their risks," says Dr. Jeremias, adding that studies show a remarkably consistent benefit of these devices in the reduction of repeat revascularization. Read more..... Men Who Smoke Prone to Impotence If heart disease, stroke and certain cancers haven't been reason enough for men to quit smoking, consider this: The habit also increases the risk of erectile dysfunction. In fact, emerging research shows that men with a pack-a-day habit are almost 40 percent more likely to struggle with erectile dysfunction than men who don't smoke. "Smoking delivers nicotine and other vasoconstrictors that close down the blood vessels" of the penis, explained Dr. Jack Mydlo, chairman of urology at Temple University School of Medicine and Hospital in Philadelphia. Erectile dysfunction -- also called "ED" or impotence -- is the inability to achieve or sustain an erection on repeated occasions. It's estimated that about two of every 100 American men have erectile dysfunction serious enough to warrant a doctor's visit, according to the U.S. National Institute of Diabetes and Digestive and Kidney Disorders. As men age, the risk of erectile dysfunction increases. Read more..... Believe it or not Funeral director charged with ashes fraud A former funeral home owner has been charged with fraud for allegedly giving families cremated ashes that were not the remains of their loved ones, Canadian police said on Wednesday. Police began investigating a defunct funeral home in Princeton, British Columbia, in 2006 after receiving complaints from families in the small town, who said they believed they had received -- and in some cases buried -- the wrong cremated remains. The families discovered the problem when contacted by another funeral home that had received 56 urns of cremated human remains from the Princeton-Similkameen Funeral Services after it shut down in 2005 for operating without a license. The urns were labelled as being unclaimed by the families who had paid for cremations and thought they already had the ashes. Police spent 19 months investigating the case and determining which remains went to which family. The former funeral home's owner has been charged with 34 counts of fraud, and two counts each of neglect of duty and "offering an indignity" to human remains, the Royal Canadian Mounted Police said. Most of the 56 urns have been reunited with the proper families, but some still remain unclaimed. "We don't know if that's because there aren't any family members around any more to claim them or what," said RCMP Constable Julie Rattee. "It's a tragic case." 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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