Edmund's Newsletter December 23, 2008 Issue: #51 Volume 8 Join Our List In This Issue Preventing A Broken Heart: Research Aims To Reduce Scarring From Heart Attacks Joslin Research Finds Nearly Three-quarters of Youths with Diabetes Insufficient in Vitamin D Better Patient Outcomes With Drug Eluting Stents Persistent Imminent Orgasms In Women Are Associated With Restless Legs Vitamin B1 Could Reverse Early-Stage Kidney Disease In Diabetes Patients Unintentional Overdose Deaths Associated With Nonmedical Use Of Prescription Pain Relievers FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes 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 Preventing A Broken Heart: Research Aims To Reduce Scarring From Heart Attacks A heart damaged by heart attack is usually broken, at least partially, for good. The injury causes excessive scar tissue to form, and this plays a role in permanently keeping heart muscle from working at full capacity. Now researchers have identified a key molecule involved in controlling excessive scar tissue formation in mice following a heart attack. When they stopped the scarring from occurring, the scientists found that the animals' heart function greatly improved following the injury. The study, by scientists at the University of Wisconsin-Madison and Cornell University, appears in the current Nature Cell Biology online. The findings offer heartening news for the millions who have heart attacks each year and suffer from the resulting poor heart function. The study raises the hope that the outlook for people with this major disability might be markedly improved. Read more..... Joslin Research Finds Nearly Three-quarters of Youths with Diabetes Insufficient in Vitamin D Three-quarters of youths with type 1 diabetes were found to have insufficient levels of vitamin D, according to a study by researchers at the Joslin Diabetes Center - findings that suggest children with the disease may need vitamin D supplementation to prevent bone fragility later in life.   "To our surprise, we found extremely high rates of vitamin D inadequacy," said Lori Laffel, M.D., M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section at Joslin, Investigator in the Section on Genetics and Epidemiology, and senior author of the paper. "We didn't expect to find that only 24 percent of the study population would have adequate levels."   The study, which appears in the January 2009 issue of The Journal of Pediatrics, measured levels of serum 25-hydroxyvitamin D in 128 youths with type 1 diabetes ranging in age from 1.5 to 17.5 years. The study sample included subjects with recent onset of diabetes as well as those who had long-established diabetes.   It found 24 percent had sufficient levels, 61 percent with insufficient levels and 15 percent to be deficient or having the lowest levels. Generally, those with deficient levels were the oldest of the subjects. In fact, 85 percent of the adolescents in the sample demonstrated inadequate vitamin D levels. Read more..... Better Patient Outcomes With Drug Eluting Stents Patients receiving drug eluting stents (DES) - stents coated with medication to prevent narrowing of the artery - as part of an angioplasty had better outcomes one year later than patients with bare metal stents, according to a new study to be published in the Canadian Medical Association Journal. Mortality in the first 30 days for people with drug eluting stents was significantly lower than for those with bare metal stents. However, in this prospective cohort study of 6440 patients, there was an increased risk of repeat revascularization procedures or death in the DES group after 3 years. Patients with drug eluting stents were more likely to be female, with higher rates of kidney disease, diabetes, high cholesterol and hypertension. "Our study findings suggest that drug eluting stents, despite recent concerns surrounding drug eluting stent safety, the long-term survival (to 3 years) of patients receiving drug eluting stents remains globally favourable, and certainly not measurably worse than that of patients treated with bare metal stents," state Dr. William Ghali, coauthors from the University of Calgary and Dr. Andrew Philpott. "However, we did observe a concerning risk trend toward accelerating adverse events in the DES group late in the follow-up period - a finding that underlines the need for ongoing surveillance of longer-term outcomes," write the authors. Read more..... Persistent Imminent Orgasms In Women Are Associated With Restless Legs Persistent imminent orgasms in women are associated with restless legs and overactive bladder. This is the result of research by the Utrecht University and The Hague's HagaHospital. Neuropsychiatrist Dr. Marcel Waldinger and his colleagues studied 18 Dutch women with Persistent Sexual Arousal Syndrome (PSAS) and published their results this week in the renowned International scientific Journal of Sexual Medicine. Women affected by this rare and mysterious syndrome experience persistent genital sensations as if they are continuously on the verge of an orgasm. All participants received in depth interviews and various medical examinations such as MRI-scans of the brain and pelvis. The study showed that most women in this research also had restless legs, symptoms of an overactive bladder and pelvic varicosis. "These results are a very important breakthrough in the research of this syndrome and show that this is a real physical disorder", Waldinger emphasizes. Read more..... Vitamin B1 Could Reverse Early-Stage Kidney Disease In Diabetes Patients  Researchers at the University of Warwick have discovered high doses of thiamine - vitamin B1 - can reverse the onset of early diabetic kidney disease. Kidney disease, or diabetic nephropathy, develops progressively in patients with type 2 diabetes. Early development of kidney disease is assessed by a high excretion rate of the protein albumin from the body in the urine, known as microalbuminuria. The research is led by Dr Naila Rabbani and Professor Paul J Thornalley at Warwick Medical School, University of Warwick, in collaboration with researchers at the University of Punjab and Sheik Zaid Hospital, Lahore, Pakistan. The team has discovered taking high oral doses of thiamine can dramatically decrease the excretion of albumin and reverse early stage kidney disease in type 2 diabetes patients. In a paper published online in the journal Diabetologia, the team show 300 mg of thiamine taken orally each day for three months reduced the rate of albumin excretion in type 2 diabetes patients. The albumin excretion rate was decreased by 41% from the value at the start of the study. The results also showed 35% of patients with microalbuminuria saw a return to normal urinary albumin excretion after being treated with thiamine. Read more..... Unintentional Overdose Deaths Associated With Nonmedical Use Of Prescription Pain Relievers An examination of unintentional overdose deaths in West Virginia, a state that has experienced one of the highest increases in the rate of drug overdose deaths, finds that the majority of these were associated with the nonmedical use and diversion of pharmaceuticals, primarily pain relievers, according to a study in the December 10 issue of JAMA. In 1997, two expert panels in the United States introduced clinical guidelines for management of chronic pain, including encouraging expanded use of opioid pain medications after careful patient evaluation and counseling when other treatments are inadequate. In the 10 years since the guidelines were first published, per capita retail purchases of the pain relievers methadone, hydrocodone, and oxycodone in the United States increased dramatically, according to background information in the article. Along with the increase in legitimate sales of opioids, rates of emergency department visits and deaths attributable to opioid analgesic overdoses have also increased. Aron J. Hall, D.V.M., M.S.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues conducted a study to determine the risk characteristics and other factors associated with persons dying of unintentional pharmaceutical overdose in West Virginia in 2006. During 1999-2004, West Virginia experienced the nation's most substantial increase (550 percent) in death from unintentional poisoning. The researchers used data from medical examiner, prescription drug monitoring program, and opiate treatment program records. Of 295 persons who died (decedents), 198 (67.1 percent) were men and 271 (91.9 percent) were age 18 through 54 years. Among all decedents, 63.1 percent had used pharmaceuticals that contributed to their death without documented prescriptions (i.e., diversion), and 21.4 percent had 5 or more clinicians prescribe them controlled substances in the year prior to death (i.e., doctor shopping). Women were significantly more likely to have evidence of doctor shopping than men (30.9 percent vs. 16.7 percent). Prevalence of diversion was greatest among the group age 18 through 24 years. Relative to all other age groups, the group age 35 through 44 years was associated with a significantly greater rate of doctor shopping (30.7 percent vs. 18.2 percent). Of the 295 persons who died, 94.6 percent had at least 1 indicator of substance abuse. Read more..... FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development. "We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment." More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia. Read more..... Believe it or not Doctors find body parts in newborn's brain Doctors operating on a newborn Colorado boy discovered the apparent tumor in his brain was actually a tiny, almost perfectly formed foot and other body parts. Dr. Paul Grabb, a pediatric neurosurgeon, told The (Colorado Springs) Gazette that in addition to the foot found in 3-day-old Sam Esquibel's brain, doctors also found what looked like the formations of another foot, a hand, a thigh and possible intestines. "It looked like the breech delivery of a baby coming out of the brain," Grabb said. Sam was born by Caesarean section Oct. 1 after an ultrasound showed abnormalities in his brain. Two days later, he went through surgery at Memorial Hospital for Children in Colorado Springs. Tiffnie Esquibel, his mother, said Grabb advised the parents to get the boy baptized before the operation. If Sam had had a cancerous tumor, death would have been almost certain. The Esquibels said Sam has made a good recovery from the surgery. They waited for weeks to go public about their son's unusual condition. Grabb called the appendages he found "extremely unique, unusual, borderline unheard of," The Denver Post reported. Doctors say that very rarely newborns have a "fetus in fetu," a twin developing inside the body, but in previous cases that has involved the torso, not the brain. 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