Edmund's Newsletter January 6, 2009 Issue: #1 Volume 9 Check Out My Book Check Out My Book Join Our List In This Issue Reduced Hospitalizations for Acute Myocardial Infarction After Implementation of a Smoke-Free Ordinance FDA Approves Drug for Patients with Advanced Prostate Cancer Another Reason To Avoid High-Fat Diet - It Can Disrupt Our Biological Clock Fewer Deaths With Preventive Antibiotics From Rare Bugs To Test Tube Drugs Grape Seed Extract Kills Laboratory Leukemia Cells, Proving Value of Natural Compounds A Diet High in Vegetables,Fruit and Fiber May CutRisk of Breast Cancer Recurrence in Women Without Hot Flashes 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 Reduced Hospitalizations for Acute Myocardial Infarction After Implementation of a Smoke-Free Ordinance Exposure to secondhand smoke (SHS) has immediate adverse cardiovascular effects, and prolonged exposure can cause coronary heart disease. Nine studies have reported that laws making indoor workplaces and public places smoke-free were associated with rapid, sizeable reductions in hospitalizations for acute myocardial infarction (AMI. However, most studies examined hospitalizations for 1 year or less after laws were implemented; thus, whether the observed effect was sustained over time was unknown. The Pueblo Heart Study examined the impact of a municipal smoke-free ordinance in the city of Pueblo, Colorado, that took effect on July 1, 2003. The rate of AMI hospitalizations for city residents decreased 27%, from 257 per 100,000 person-years during the 18 months before the ordinance's implementation to 187 during the 18 months after it (the Phase I post-implementation period).* This report extends that analysis for an additional 18 months through June 30, 2006 (the Phase II post-implementation period). The rate of AMI hospitalizations among city residents continued to decrease to 152 per 100,000 person-years, a decline of 19% and 41% from the Phase I post-implementation and pre-implementation period, respectively. No significant changes were observed in two comparison areas. These findings suggest that smoke-free policies can result in reductions in AMI hospitalizations that are sustained over a 3-year period and that these policies are important in preventing morbidity and mortality associated with heart disease. This effect likely is mediated through reduced SHS exposure among nonsmokers and reduced smoking, with the former making the larger contribution (4,6,7). Two control sites were selected for comparison with the city of Pueblo: 1) the area of Pueblo County outside the city of Pueblo limits and 2) El Paso County, including Colorado Springs, the most populous city in this county. The city of Pueblo and Colorado Springs are located approximately 45 miles apart (Figure 1). Neither of the control sites had smoke-free laws in place before or during the study periods. Based on data from the Behavioral Risk Factor Surveillance System, the adult smoking prevalence for Pueblo County (including the city of Pueblo) and El Paso County during 2002--2003 was 25.9% (95% confidence interval [CI] = 20.2%--31.6%) and 17.4% (CI = 14.5%--20.2%), respectively. The corresponding prevalences for 2004--2005 were 20.6% (CI = 15.4%--25.8%) and 22.3% (CI = 19.3%--25.4%). Separate smoking prevalence estimates were not available for the city of Pueblo. Persons with recognized AMIs that occur in the city of Pueblo and Pueblo County receive care at two hospitals, Parkview Medical Center and St. Mary-Corwin Medical Center, both located within the city of Pueblo. Persons with recognized AMIs that occur in El Paso County receive care at two other hospitals, Penrose Hospital and Memorial Hospital, both located in Colorado Springs. Data on AMI hospitalizations were drawn from electronic Colorado Hospital Association administrative data. These data included admission date, primary diagnosis code (based on International Classification of Diseases, Ninth Revision codes 410.0--410.9), sex, age, postal code of residence, and hospital name. No other patient-level data, including smoking status, were available. U.S. Census Bureau population data for 2006 were used as denominators in calculating AMI hospitalization rates. A more extensive description of the study's methodology has been published previously (3). AMI hospitalization rates among residents of the city of Pueblo, the area of Pueblo County outside the city of Pueblo limits, and El Paso County were compared across three periods: 0--18 months before the smoke-free law took effect (pre-implementation period), 0--18 months after this date (Phase I, post-implementation period), and 19--36 months after this date (Phase II, post-implementation period), for a total of 54 months. Rates were compared between periods using a chi-square test. Relative rates (RRs) were calculated as the ratios of AMI rates between two periods. Data presented in this report were not adjusted for seasonality because a season-adjusted analysis of Phase I versus the pre-implementation period found that the adjustment did not significantly change the findings. Read more..... FDA Approves Drug for Patients with Advanced Prostate Cancer The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer. Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this. "Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. Read more..... Another Reason To Avoid High-Fat Diet - It Can Disrupt Our Biological Clock Indulgence in a high-fat diet can not only lead to overweight because of excessive calorie intake, but also can affect the 24-hour biological clock.     Indulgence in a high-fat diet can not only lead to overweight because of excessive calorie intake, but also can affect the balance of circadian rhythms - everyone's 24-hour biological clock, Hebrew University of Jerusalem researchers have shown. The biological clock regulates the expression and/or activity of enzymes and hormones involved in metabolism, and disturbance of the clock can lead to such phenomena as hormone imbalance, obesity, psychological and sleep disorders and cancer. While light is the strongest factor affecting the circadian clock, Dr. Oren Froy and his colleagues of the Institute of Biochemistry, Food Science and Nutrition at the Hebrew University's Robert H. Smith Faculty of Agriculture, Food and Environment in Rehovot, have demonstrated in their experiments with laboratory mice that there is a cause-and-effect relation between diet and biological clock imbalance. Read more..... Fewer Deaths With Preventive Antibiotics Administering antibiotics as a preventive measure to patients in intensive care units (ICUs) increases their chances of survival. This has emerged from a study involving nearly sixthousand Dutch patients in thirteen hospitals. Researchers at University Medical Center (UMC) Utrecht have published their findings in an article in The New England Journal of Medicine. During the study, a team of researchers compared the effect of two kinds of antibiotic treatments with the standard ICU care. They divided into three groups nearly six thousand patients hospitalized in ICUs between 2004 and 2006. The patients in question were expected to be on a ventilator for at least two days and/or to be admitted to the ICU for at least three days. One of the groups received an oral antibiotic paste four times a day. The second group, in addition to being given the oral paste four times daily, received antibiotics through a gastric tube in the intestinal tract and by intravenous drip. The third group was the control group and received the standard ICU care. After four weeks, fewer people had died in the groups that received antibiotics than in the control group. Preventive use of antibiotics reduced the number of deaths by 3.5 percent (oral antibiotic paste, and antibiotics in the intestinal tract and by intravenous drip) and 2.9 percent (oral antibiotic paste). The difference between the two groups treated with antibiotics was not significant. The number of antibiotic-resistant bacteria did not increase in these patients. Although the patients in the control group were in general slightly less sick, the statistical data were adjusted to reflect this. Read more..... From Rare Bugs To Test Tube Drugs Scientists at the University of St Andrews have created exotic biological compounds in a test tube by uncovering some of Nature's chemical secrets. The development for preparing fluorinated chemicals, an important group of compounds which comprise commercial entities such as Teflon and Prozac, could help the multibillion dollar industry which currently makes the materials by hazardous methods. The discovery by the researchers in the School of Chemistry demonstrates, for the first time, that fluorinated molecules can be made in the laboratory but under mild biological conditions. Professor David O'Hagan, who led the team, is excited by the breakthrough. He explained, "Fluorinated chemicals are big in pharmaceutical chemistry, and they also play an important role in medical imaging. Read more..... Grape Seed Extract Kills Laboratory Leukemia Cells, Proving Value of Natural Compounds An extract from grape seeds forces laboratory leukemia cells to commit cell suicide, according to researchers from the University of Kentucky. They found that within 24 hours, 76 percent of leukemia cells had died after being exposed to the extract. The investigators, who report their findings in the January 1, 2009, issue of Clinical Cancer Research, a journal of the American Association for Cancer Research, also teased apart the cell signaling pathway associated with use of grape seed extract that led to cell death, or apoptosis. They found that the extract activates JNK, a protein that regulates the apoptotic pathway. While grape seed extract has shown activity in a number of laboratory cancer cell lines, including skin, breast, colon, lung, stomach and prostate cancers, no one had tested the extract in hematological cancers nor had the precise mechanism for activity been revealed. "These results could have implications for the incorporation of agents such as grape seed extract into prevention or treatment of hematological malignancies and possibly other cancers," said the study's lead author, Xianglin Shi, Ph.D., professor in the Graduate Center for Toxicology at the University of Kentucky. Read more..... A Diet High in Vegetables,Fruit and Fiber May CutRisk of Breast Cancer Recurrence in Women Without Hot Flashes A secondary analysis of a large, multicenter clinical trial has shown that a diet loaded with fruits, vegetables and fiber and somewhat lower in fat compared to standard federal dietary recommendations cuts the risk of recurrence in a subgroup of early-stage breast cancer survivors - women who didn't have hot flashes - by approximately 31 percent. These patients typically have higher recurrence and lower survival rates than breast cancer patients who have hot flashes. The study team, led by researchers at the Moores Cancer Center at the University of California, San Diego, along with six other sites, including the University of California, Davis, reported its results online December 15, 2008, in the Journal of Clinical Oncology. The results come on the heels of a report last year on the findings of the original study, the Women's Healthy Eating and Living Trial (WHEL), which compared the effects of the two diets on cancer recurrence in more than 3,000 early-stage breast cancer survivors. That study showed no overall difference in recurrence among the two diet groups. "Women with early stage breast cancer who have hot flashes have better survival and lower recurrence rates than women who don't have hot flashes," said Ellen B. Gold, Ph.D., professor and chair of the UC Davis Department of Public Health Sciences and first author of the study. "Our results suggest that a major change in diet may help overcome the difference in prognosis between women with and without hot flashes." Read more..... Believe it or not NY judge: Religion aside, monkey meat needs permit A federal judge in Brooklyn has rejected a Liberian woman's religious reasons for smuggling endangered monkey meat into the country. U.S. District Judge Raymond J. Dearie ruled Wednesday that Mamie Manneh's faith didn't preclude her from applying for permits to import exotic food or explain why she misled officials. Manneh was charged with smuggling the meat three years ago after customs agents seized a shipment of primate parts as it passed through Kennedy Airport on the way to her home in Staten Island. Manneh's lawyers claimed a First Amendment right, arguing that some Liberian Christians eat monkey meat for spiritual reasons. Her lawyer didn't respond to phone messages Saturday. She faces up to five years in prison and deportation if convicted. 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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