Edmund's Newsletter September 9, 2008 Issue: #37 Volume 8 Join Our List In This Issue Thank You Cholesterol Drugs Lower Risk Of Stroke For Elderly, Too M. D. Anderson Study Finds Change in HER2 Status After Treatment With Herceptin Free Drug Samples May End Up Costing Uninsured More Study Reveals Promising Method for Reducing MRSA Infections in Hospital Intensive Care Units Study Firmly Shows No Connection Between Measles, Mumps, Rubella (MMR) Vaccine And Autism Tumor Necrosis Factor-Alpha Blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Advertising Prescription Drugs and Medical Devices 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 THANK YOU I just wanted to say THANK YOU to all of you that donated to the American Heart Association. Your donations will help fight our nation's No. 1 and No. 3 killers-heart disease and stroke. Your donations will help make a difference.  Thank you for your support. Cholesterol Drugs Lower Risk Of Stroke For Elderly, Too Elderly people who take a cholesterol drug after a stroke or mini-stroke lower their risk of having another stroke just as much as younger people in the same situation, according to research published in the September 3, 2008, online issue of Neurology®, the medical journal of the American Academy of Neurology. "Even though the majority of strokes and heart attacks occur in people who are 65 and older, studies have found that cholesterol-lowering drugs are not prescribed as often for older people as they are for younger people," said study author Seemant Chaturvedi, MD, of Wayne State University in Detroit, MI, and a Fellow of the American Academy of Neurology. "These results show that using these drugs is just as beneficial for people who are over 65 as they are for younger people." The study involved 4,731 people age 18 and older who had a recent stroke or transient ischemic attack, or mini-stroke. The 2,249 people age 65 and older were in one group, with an average age of 72, and the 2,482 people under age 65 made up the other group, with an average age of 54. Within each group, about half of the people received the cholesterol-lowering drug atorvastatin and about half received a placebo. The participants were then followed for an average of four and a half years. Read more..... M. D. Anderson Study Finds Change in HER2 Status After Treatment With Herceptin Researchers at The University of Texas M. D. Anderson Cancer Center have discovered that when treated with Herceptin prior to surgery, 50 percent of HER2 positive, breast cancer patients showed no signs of disease at the time of surgery. However, of those women who had residual disease, about one-third had tumors that converted from HER2 positive to HER 2 negative status -possibly indicating a resistance to the targeted therapy. The study will be presented today in advance of the American Society for Clinical Oncology Breast Cancer Symposium. Approximately 30 percent of breast cancer cells have an excess amount of the HER2 protein on their surface, which makes the cancer more aggressive. Herceptin, also known as trastuzumab, is a monoclonal antibody that latches on to these proteins and inhibits tumor growth. It was approved in 1998 for women whose advanced, metastatic breast cancer is HER2-positive; it was approved in 2006 for use in the early setting. It's known that a small percentage of HER2 positive patients develop a resistance to Herceptin during treatment, and there have been several described mechanisms for Herceptin resistance, said Elizabeth Mittendorf, M.D., assistant professor in M. D. Anderson's Department of Surgical Oncology. Read more..... Free Drug Samples May End Up Costing Uninsured More Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues. The retrospective study looked at the prescribing habits of more than 70 physicians in a university-affiliated internal medicine practice in the months immediately before and after the closing of their drug sample closet. The results indicate that the availability of free samples from pharmaceutical companies greatly impacts whether an uninsured patient is given a prescription for a generic or a brand-name drug. The complete findings can be found in the September issue of Southern Medical Journal. "It's true that samples can save patients money in the short-run," said David P. Miller, M.D., lead researcher and internal medicine physician at Wake Forest Baptist. "But our study shows that they may end up paying more in the long run when they are given prescriptions for brand-name only drugs." For the study, researchers used a pharmacy database to track all of the prescriptions in four classes of chronic medications given to uninsured and Medicaid patients. Nearly 2,000 prescriptions categorized as antihypertensives (blood pressure medications), oral diabetic agents, peptic ulcer and gastroesophageal reflux medications, and non-narcotic pain medications, were tracked for the nine months leading up to and following the relocation of the practice, at which time the drug sample closet was permanently closed     due to a lack of suitable storage space in the new building. Read more..... Study Reveals Promising Method for Reducing MRSA Infections in Hospital Intensive Care Units Doctors at the University of Virginia Health System have significantly reduced MRSA infections among surgical intensive care patients by using antibiotic cycling, a method of rotating drugs at regular intervals.   In a study published in the September 3, 2008 issue of Surgical Infections, UVA researchers report that switching between two antibiotics, linezolid and vancomycin, every three months in the surgical ICU decreased the MRSA infection rate from 1.9 to 1.4 patients per 100 admissions. In-hospital mortality from surgical ICU-acquired MRSA infections fell from 3.8 patients per year to none. Study data spanned six years, including the period before cycling began (1997 to 2001) and the period after it was instituted (2002 to 2003). The study's key focus was resistant gram-positive cocci, a subgroup defined as MRSA (which stands for methicillin-resistant Staphylococcus aureus) and VRE (which is an acronym for vancomycin-resistant Enterococcus). "Before we began cycling, 67 percent of the Staphylococcus aureus infections in our surgical ICU were caused by MRSA," notes the study's lead author, Dr. Robert Sawyer, a professor of surgery and co-director of UVA's Surgical Trauma Intensive Care Unit. "Cycling reduced MRSA cases to 36 percent of that total." Read more..... Study Firmly Shows No Connection Between Measles, Mumps, Rubella (MMR) Vaccine And Autism In a case-control study, the presence of measles virus RNA was no more likely in children with autism and GI disturbances than in children with only GI disturbances. Furthermore, GI symptom and autism onset were unrelated to MMR vaccine timing. Study findings are reported online in the Public Library of Science on September 4. Prior to the implementation of measles vaccines in 1963, three to four million people were newly infected each year, 400-500 died, 48,000 were hospitalized, and 1,000 developed chronic disability from measles encephalitis. From January 1 through July 2008 the Centers for Disease Control and Prevention received 131 reports of confirmed measles virus infection in the U.S., the highest number for the same time period since 1996. Of these 131 cases, 91% occurred in individuals who had not been vaccinated or had unknown vaccination status. In 1998, a report of the presence of measles virus RNA in intestinal tissue from children with autism spectrum disorders and GI disturbances (Wakefield et al.) resulted in public concern over the safety of MMR vaccine. Although epidemiological investigations found no associations between MMR vaccine and autism, no subsequent studies tested for the presence of viral RNA in GI tissues of children with autism and GI disturbances or examined the temporal relationship of MMR, GI disturbances, and autism. Failure to have done so may have contributed to persistent concerns that have influenced vaccine acceptance rates, resulting in outbreaks of measles. Read more..... Tumor Necrosis Factor-Alpha Blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-a blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. Read more..... Advertising Prescription Drugs and Medical Devices The Food and Drug Administration (FDA) enforces the laws regulating advertisements made or distributed by sponsors of certain new medical products, which include:     * prescription drugs for humans and animals     * vaccines and blood products     * certain medical devices, such as laser-guided eyesight correction equipment The laws generally require that such advertising materials and activities be truthful and reasonably complete, and do not mislead people. FDA believes that accurate and balanced information can help to inform healthcare providers and the general public, thus enabling them to make better health decisions. The information at the following link will help you to be more informed about the basic rules that regulate this advertising. Read more..... Believe it or not Doctor fired for allegedly drinking on the job A Massachusetts doctor has been fired and lost the right to renew his medical license for allegedly trying to give a pregnant woman an epidural while drunk. The state Board of Registration in Medicine says 39-year-old Robert Dolan was drinking from a bottle of bourbon he brought to work when he was called to perform the procedure at Caritas St. Elizabeth's Medical Center last November. Dolan, an anesthesiologist, called another resident for help, who noticed he appeared drunk. The attending physician then called security. He was fired by the hospital a few days later. Dolan's license to practice medicine lapsed in January and he will not be allowed to renew it unless he can stay sober for 18 months. The board said Dolan accepted its version of events. 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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