Edmund's Newsletter August 26, 2008 Issue: #35 Volume 8 Join Our List In This Issue Heart Walk Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - May Cause Cancer Addiction Drug Reverses Obesity In Rats Drugs To Inhibit Blood Vessel Growth Show Promise In Rat Model Of Deadly Brain Tumor Silver Is The Key To Reducing Pneumonia Associated With Breathing Tubes Limiting Fructose May Boost Weight Loss Don't Become A Victim Of Medical Marketing FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts 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 HEART WALK Everyone knows someone affected by heart disease or stroke. For those I love, I will be walking in this year's Start! Heart Walk. I have set a personal goal to raise funds for the American Heart Association and need your help to reach my donation goal. We are raising critical dollars for heart disease and stroke research and education. You can help me reach my  goal by making a donation online.  Click on the link below and you will be taken to my personal donation page where you can make a secure online credit card donation. The American Heart Association's online fundraising website has a minimum donation amount of $25.00.  If you prefer to donate less, you can do so by sending a check directly to me. Your donation will help fight our nation's No. 1 and No. 3 killers-heart disease and stroke. You are making a difference.  Thank you for your support. Click Here to View my Heart Walk Web Page   Click Here to Donate Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) May Cause Cancer FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study. FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency. Read more.....  Addiction Drug Reverses Obesity In Rats An epilepsy drug being tested for use in treating addiction can help obese rats shed weight, U.S. government researchers said on Wednesday. Their findings point not only to an easy treatment for obesity, but show it is similar to drug addiction, they said. Even rats bred to be obese lost up to 19 percent of their weight and normal rats lost 12 to 20 percent of their weight after 40 days of injections of the drug, called vigabatrin or GVG, the team at the U.S. Department of Energy's Brookhaven National Laboratory found. "When we gave GVG, they would steadily lose weight, and when we took them off GVG, they would steadily gain weight," Amy DeMarco, who worked on the study, said in a telephone interview. "It was like a roller coaster. It was also dose-dependent. Rats given higher doses would lose more weight." She added that her team saw no side effects in the rats. Read more..... Drugs To Inhibit Blood Vessel Growth Show Promise In Rat Model Of Deadly Brain Tumor In a landmark study, Medical College of Wisconsin researchers in Milwaukee report that drugs used to inhibit a specific fatty acid in rat brains with glioblastoma-like tumors not only reduced new blood vessel growth and tumor size dramatically, but also prolonged survival. "These rat model tumors were developed from human glioblastoma tumor cells and closely mimic human tumors in growth patterns and response to therapy," says lead researcher David Harder, Ph.D., Kohler Co. Professor in Cardiovascular Research. "The concept of targeting blood vessels that feed tumors as an approach to limit tumor growth is not a novel idea," he says. "However, blocking the specific fatty acid described in this study is novel, and holds great promise for use in humans." Malignant gliomas are very aggressive tumors of the central nervous system, resistant to chemotherapy and radiation, and account for about half of the 350,000 brain tumors currently diagnosed in the U.S. Dr. Harder is also professor of physiology, associate dean for research and director of the Medical College's Cardiovascular Research Center. He believes that further studies, demonstrating that such drugs work in humans may reveal that higher concentrations or infusions over longer periods of time may be more effective than the results reported in this study. Read more..... Silver Is The Key To Reducing Pneumonia Associated With Breathing Tube People have long prized silver as a precious metal. Now, silver-coated endotracheal tubes are giving critically ill patients another reason to value the lustrous metal. In a study published in the Aug. 20, 2008 issue of the Journal of the American Medical Association, researchers at Washington University School of Medicine in St. Louis and the NASCENT Investigation Group, report that the silver-coated tubes led to a 36 percent reduction of ventilator-associated pneumonia (VAP). VAP can strike up to 15 percent of people who are intubated to aid breathing and can cause death in an estimated 20 percent to 40 percent of those stricken. "VAP is a relatively common infection and increasingly one caused by antibiotic-resistant bacteria," says the study's lead author, Marin H. Kollef, M.D., a Washington University pulmonary specialist at Barnes-Jewish Hospital. "There have been many attempts to prevent VAP, most of which have revolved around modifying hospital practices. The silver-coated endotracheal tube has an advantage in that it doesn't require any additional effort by nurses, therapists and doctors, who may already be over burdened." Read more..... Limiting Fructose May Boost Weight Loss One of the reasons people on low-carbohydrate diets may lose weight is that they reduce their intake of fructose, a type of sugar that can be made into body fat quickly, according to a researcher at UT Southwestern Medical Center.   Dr. Elizabeth Parks, associate professor of clinical nutrition and lead author of a study appearing in a current issue of the Journal of Nutrition, said her team's findings suggest that the right type of carbohydrates a person eats may be just as important in weight control as the number of calories a person eats. Current health guidelines suggest that limiting processed carbohydrates, many of which contain high-fructose corn syrup, may help prevent weight gain, and the new data on fructose clearly support this recommendation. "Our study shows for the first time the surprising speed with which humans make body fat from fructose," Dr. Parks said. Fructose, glucose and sucrose, which is a mixture of fructose and glucose, are all forms of sugar but are metabolized differently. "All three can be made into triglycerides, a form of body fat; however, once you start the process of fat synthesis from fructose, it's hard to slow it down," she said. Read more..... Don't Become A Victim Of Medical Marketing Linda Lewis says that when she had back surgery two years ago, her surgeon didn't do what was best for her health; he did was best for his bank account. If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion. If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion. Lewis, a graduate student who lives in Sherman Oaks, California, says Dr. John Regan, a surgeon in Beverly Hills, put in an artificial disc to help relieve her lower back pain. "He said my back would be better than ever," said Lewis, 45. "I'm thinking, 'Wow, disc replacement is the best thing since sliced bread.' " But after the surgery, Lewis says, she ended up in debilitating pain, could walk only with the assistance of a walker and had to have a second procedure to correct the first one. "I couldn't take enough drugs for the pain," she said. "Having that surgery was the worst decision of my life." Lewis said she was "livid" when she later found out that Regan had financial ties to the company that makes the disc, saying she believes that those ties prompted Regan to recommend the disc over other treatment options. Read more..... FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for this loss. "This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. The estimated 140,000 people with chronic ITP are prone to bruising and at risk for life-threatening bleeding. Current medical treatment includes corticosteroids and immunoglobulin. Surgery to remove the spleen, a procedure known as a splenectomy, may help some patients. Nplate is approved only for patients with chronic ITP who do not respond sufficiently to current treatments. Read more..... Believe it or not Dying for a salad? Try a dash of this... Celebrity chef Antony Worrall Thompson has apologized after accidentally recommending a potentially deadly plant in organic salads. The chef and TV presenter said in a magazine article that the weed henbane, also known as stinking nightshade, made an excellent addition to summertime meals. There was plenty of it, it grew locally and was used by the ancient Greeks and the Arabs for its anesthetic properties. Er, not quite. Henbane, or Hyoscyamus niger, is toxic and can cause hallucinations, convulsions, vomiting and in extreme cases death. Worrall Thompson, who was discussing his passion for organic foods, had confused the plant with another of a similar name. The magazine "Healthy & Organic Living" printed an urgent warning: "Henbane is a very toxic plant and should never be eaten. As always, check with an expert when foraging or collecting wild plants." Henbane, a close relative of deadly nightshade, was used by Dr Crippen to kill his wife in 1910, and is thought to have been the main ingredient in the poison Romeo took in Shakespeare's play "Romeo and Juliet." The chef had intended to refer to fat hen, a weed rich in vitamin C, that is edible, media reports said. It too can be harmful because of its high level of nitrates, but cases of poisoning are rare, Garden Organic said on its website. Worrall Thompson was reported in the media as saying the confusion had been "a bit embarrassing." "There have been no reports of any casualties," he said. "Please do pass on my apologies." 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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