Edmund's Newsletter April 15, 2008 Issue: #16 Volume 8 Join Our List In This Issue Nose Spray Anthrax Vaccine Effective in Early Tests Diabetes Drug May Hold Potential As Treatment For Epilepsy, Using Same Mechanism As Ketogenic Diet Pepper Compound Could Aid Millions With Vitiligo JAMA Article Looks at Data-Sharing in Clinical Trials for Heart Disease - Discussion of When and How to Share Data, and When to Suspend a Study Landmark Study Shows Combination Therapy Of No Benefit to Heart Patients and Should Be Avoided Anti-Cancer Compounds: The Good And The Bad Side Breast Cancer Vaccine Works Against Deadlier Form of Disease 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 Nose Spray Anthrax Vaccine Effective in Early Tests Early studies show that a new mucosal vaccine against anthrax has the potential to provide military personnel with more effective and efficient protection against a "popular" bioweapon, according to a study published today in the journal Clinical and Vaccine Immunology (CVI). With the new vaccine, researchers sought to take two steps at once, fine-tuning its ingredients and delivering it by nose spray instead of injection. Anthrax is caused by Bacillus anthracis, a bacterium that forms seed-like structures called spores capable of reproducing the organism despite tremendous punishment. In recent years, anthrax has become a top choice as a biological warfare agent, according to the U.S. Department of Defense (DOD), because its spores can easily become airborne. It can be spread by mailed packages, missiles or crop-dusting planes. It can travel downwind for hundreds of miles and stay lodged in soil for decades. Following the Sept. 11, 2001, attacks, terrorists mailed letters coated with anthrax spores to 22 U.S. men and women, five of whom died. Saddam Hussein developed anthrax spore-filled weapons, and Boris Yeltsin said the former Soviet Union had a biological weapons program that dwarfed that of pre-war Iraq. The U.S. military requires personnel in high-risk areas to be vaccinated with the only FDA-licensed human anthrax vaccine, BioThraxTM, produced by BioPort Corporation/Emergent Defense Operations. It was approved by the U.S. Food and Drug Administration in 1998, and about 1.8 million U.S. personnel have been vaccinated since then, according the Department of Defense. Those vaccinated are intended to receive a series of six shots, and then an annual booster shot. While 1.8 million have been vaccinated since 1998, just seven million doses have been handed out. Read more.... Diabetes Drug May Hold Potential As Treatment For Epilepsy, Using Same Mechanism As Ketogenic Diet Two years ago, University of Wisconsin-Madison scientists reported they had suppressed epileptic seizures in rats by giving them a glycolytic-inhibitor, inhibiting the brain's ability to turn sugar into excess energy and blocking the expression of seizure-related genes. The discovery was greeted with excitement and hope for a new class of drugs for epilepsy, which afflicts more than 50 million people worldwide. Now, in a presentation at Experimental Biology 2008 in San Diego,* Dr. Avtar Roopra describes a next step in this research that may mean a drug already widely used by people with diabetes could also be an effective and safe therapy for epilepsy, especially for that one third of patients who have recurrent seizures despite therapy with the best available antiepileptic drugs. Although the earlier work by Dr. Roopra and his colleagues marked the first time a compound had been used for metabolic regulation of neuronal genes, epilepsy patients had been attempting to achieve the same goal - fewer seizures - for centuries through severe dietary restriction, in some cases with near starvation, more often with a high-fat, high-protein diet completely free of starches and sugars. Half of all drug-resistant people with epilepsy experience seizure control with this kind of severe ketogenic diet (although even a mild lapse can sometimes result in seizures). Read more...... Pepper Compound Could Aid Millions With Vitiligo Oregon Health & Science University announced collaboration to develop promising topical agent for vitiligo, a skin pigmentation disorder that afflicts as many as a 100 million people worldwide Oregon Health & Science University has licensed a family of compounds derived from black pepper extract - on which it owns the patents - to AdPharma, Inc. for potential pharmaceutical development. The compounds have shown potential in animal studies to be effective in treating vitiligo, a skin pigmentation disorder. Vitiligo, which afflicts an estimated 100 million people worldwide, is characterized by the loss of pigment in affected areas of skin. It is the disease pop star Michael Jackson has publicly disclosed that he has. It is neither life-threatening nor contagious. But the sometimes unsightly white patches it causes produce emotional distress for many and often lead to social ostracism because of a widespread misperception that the condition is infectious. An estimated 1 percent to 2 percent of the world's population suffers from the malady. Current treatments, which rely on immunosuppression or ultraviolet radiation to stimulate repigmentation, are only partially effective, often producing a mottled appearance. Excessive ultraviolet (UV) radiation also poses the risk of skin cancer. Read more..... JAMA Article Looks at Data-Sharing in Clinical Trials for Heart Disease - Discussion of When and How to Share Data, and When to Suspend a Study How and when to share clinical trial data for heart studies - including when to suspend a study - is vitally important to physician-scientists and regulators as an increasing number of clinical trials evaluate new treatments. This issue is explored in the April 9 Journal of the American Medical Association (JAMA) in a commentary article authored by Dr. Jeffrey S. Borer of NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Drs. David J. Gordon and Nancy L. Geller - both of the National Heart, Lung and Blood Institute (NHLBI). Treatment decisions are based on findings from scientific studies called clinical trials that can sometimes involve many thousands of patients. Several of these studies - such as those involving the drugs Avandia, Vytorin and, earlier, Vioxx - have been the subject of recent controversies in the media. Increasingly, clinical trials are monitored by independent, external groups called Data and Safety Monitoring Committees (DSMCs), charged with protecting the safety of trial participants and preserving trial integrity and credibility. These committees are the only groups that can know results of blinded trials (trials in which participants and investigators are not aware of treatment assignments) while the trials are ongoing. The proper function of DSMCs is subject to discussion and debate. The JAMA article addresses one aspect of this debate. Read more..... Landmark Study Shows Combination Therapy Of No Benefit to Heart Patients and Should Be Avoided Results from the ONTARGET study, the world's largest cardiovascular study in high risk patients, has shown that combination treatment with commonly used blood-pressure lowering drugs, ARBs and ACE-inhibitors, does not provide extra protective benefit for patients at high risk heart disease, stroke, and heart failure. In fact, the treatment increases the risks of dizziness, blackouts and kidney problems. The findings were announced today by Australian researchers from The George Institute for International Health and the Baker Heart Research Institute at the American Congress of Cardiology in Chicago, coinciding with publication in the New England Journal of Medicine. The landmark study compared the effectiveness of two types of anti-hypertensive drug treatments: the ACE-inhibitor (angiotensin-coverting enzyme inhibitor) ramipril, and the ARB (angiotensin receptor blocker), telmisartan. The study had two aims, to determine whether telmisartan was equivalent to ramipril, and that the combined treatment was superior to ramipril alone, in the prevention of cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure in people at high-risk of cardiovascular disease on the basis of being aged over 55 years and having a history of heart attack, angina, stroke, peripheral vascular disease, or diabetes with complications. Read more..... Anti-Cancer Compounds: The Good And The Bad Side   Compounds known as "HDAC inhibitors" exhibit cancer-killing activities in cultured cells. While they are currently being tested as anti-cancer agents in clinical trials, just how they execute their effects is unclear. In a pair of recent papers, Vanderbilt-Ingram Cancer Center investigators provide a potential mechanism by which HDAC inhibitors specifically damage cancer cells and offer clues about possible adverse effects of these compounds - findings with important implications for their clinical use as cancer therapies. Scott Hiebert, Ph.D., professor of Biochemistry and Medicine, and colleagues initially set out to study how chromosomal translocations - which happen when chromosomes break and rejoin, creating new genes at the breakpoints - cause acute leukemias. Read more..... Breast Cancer Vaccine Works Against Deadlier Form of Disease A breast cancer vaccine significantly reduced the risk of recurrence for patients who have a high expression of the protein HER2-neu. This type of breast cancer, representing about one-quarter of all cases, tends to be deadlier than other forms of the disease. In this group, the vaccine reduced mortality by 50 percent. Even better, however, the vaccine lowered mortality by 100 percent in women with breast cancer and low or intermediate expression of HER2/neu. Currently, these women have no therapies other than conventional cancer treatments such as surgery and chemo. "We now have something we think works in the majority of women with breast cancer who are currently underserved," said Dr. George Peoples, senior author of the study, which is expected to be presented at the American Association for Cancer Research annual meeting, in San Diego. "It's also very, very well-tolerated, like a flu shot." Read more...... Believe it or not Firefighter saves Claws the cat with CPR Thanks to firefighter Jared Brister, Claws the cat has an extra life. The firefighter used cardiopulmonary resuscitation for 5 minutes after the cat passed out due to smoke inhalation. Barbara Simmons had already lost one cat, Booger, during the Monday morning house fire and thought for sure Claws was a goner. "He was not breathing," Brister said. But Brister used the regulator from his air tank to feed the cat oxygen and started doing chest compressions with fellow firefighter Donnie Hodges assisting. After a stay at the animal hospital, Claws, still smelling of smoke, was returned to Simmons on Tuesday. "I can't thank him enough," Simmons said of Brister. "It's one thing to lose your possessions, but my animals are like a member of my family." 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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