Edmund's Newsletter August 12, 2008 Issue: #33 Volume 8 Join Our List In This Issue FDA Approves 2008-2009 Flu Vaccines FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees Researchers Find Cancer-Inhibiting Compound Under The Sea Why Dopamine Freezes Parkinson Patients And Drives Drug Addicts Spices May Protect Against Consequences Of High Blood Sugar NYU Researchers Demonstrate That Widely Prescribed Anti-Parasite Drug Targets Cancer-Causing Protein Stony Brook University Collaborative Study of New HIV Drug Shows Significant Viral Load Reduction For Patients Resistant To Therapy 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 FDA Approves 2008-2009 Flu Vaccines The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. Approval information and specific indications can be found at http://www.fda.gov/cber/flu/flu2008.htm. This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Read more..... FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.   The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance.  The FDA announced the availability of the guidance documents in today's Federal Register; copies of all of the guidances are available on FDA's website.  Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days. "The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum," said Randall Lutter, Ph.D., deputy commissioner for policy.  "It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. Today's announcement strengthens our processes."   FDA advisory committees are panels of independent, outside experts -- often the world's leading authorities in their fields -- who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues.  Last year FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children. Read more..... Researchers Find Cancer-Inhibiting Compound Under The Sea University of Florida College of Pharmacy researchers have discovered a marine compound off the coast of Key Largo that inhibits cancer cell growth in laboratory tests, a finding they hope will fuel the development of new drugs to better battle the disease. The UF-patented compound, largazole, is derived from cyanobacteria that grow on coral reefs. Researchers, who described results from early studies today (Aug. 7) at an international natural products scientific meeting in Athens, Greece, say it is one of the most promising they've found since the college's marine natural products laboratory was established three years ago. An initial set of papers in the Journal of the American Chemical Society also has garnered the attention of other scientists, and the lab is racing to complete additional research. The molecule's natural chemical structure and ability to inhibit cancer cell growth were first described in the journal in February and the laboratory synthesis and description of the molecular basis for its anticancer activity appeared July 2. "It's exciting because we've found a compound in nature that may one day surpass a currently marketed drug or could become the structural template for rationally designed drugs with improved selectivity," said Hendrik Luesch, an assistant professor in UF's department of medicinal chemistry and the study's principal investigator. Read more..... Why Dopamine Freezes Parkinson Patients And Drives Drug Addicts Parkinson's disease and drug addiction are polar opposite diseases, but both depend upon dopamine in the brain. Parkinson's patients don't have enough of it; drug addicts get too much of it. Although the importance of dopamine in these disorders has been well known, the way it works has been a mystery. New research from Northwestern University's Feinberg School of Medicine has revealed that dopamine strengthens and weakens the two primary circuits in the brain that control our behavior. This provides new insight into why a flood of dopamine can lead to compulsive, addictive behavior and too little dopamaine can leave Parkinson's patients frozen and unable to move. "The study shows how dopamine shapes the two main circuits of the brain that control how we choose to act and what happens in these disease states, " said D. James Surmeier, lead author and the Nathan Smith Davis Professor and chair of physiology at the Feinberg School. The paper is published in the August 8 issue of the journal Science. These two main brain circuits help us decide whether to act out a desire or not. For example, do you get off the couch and drive to the store for an icy six-pack of beer on a hot summer night, or just lay on the couch? Read more..... Spices May Protect Against Consequences Of High Blood Sugar Herbs and spices are rich in antioxidants, and a new University of Georgia study suggests they are also potent inhibitors of tissue damage and inflammation caused by high levels of blood sugar. Researchers, whose results appear in the current issue of the Journal of Medicinal Food, tested extracts from 24 common herbs and spices. In addition to finding high levels of antioxidant-rich compounds known as phenols, they revealed a direct correlation between phenol content and the ability of the extracts to block the formation of compounds that contribute to damage caused by diabetes and aging. "Because herbs and spices have a very low calorie content and are relatively inexpensive, they're a great way to get a lot of antioxidant and anti-inflammatory power into your diet," said study co-author James Hargrove, associate professor of foods and nutrition in the UGA College of Family and Consumer Sciences. Read more..... NYU Researchers Demonstrate That Widely Prescribed Anti-Parasite Drug Targets Cancer-Causing Protein Researchers at the NYU Cancer Institute and the Ronald O. Perelman Department of Dermatology have identified mebendazole, a drug used globally to treat parasitic infections, as a novel investigational agent for the treatment of chemotherapy-resistant malignant melanoma. Because most patients with metastatic melanoma fail to respond to available therapies, the discovery of a viable investigational treatment with an established safety profile could address a serious unmet need in oncology. Effectively sidestepping the prohibitive costs and long lead times typically required to discover new cancer medicines, the NYU team screened a library of already approved drugs for activity against the most deadly form of skin cancer. Their report, which was selected for advance online publication by Molecular Cancer Research, is published in the August issue of the journal. Since submitting the article for publication, the authors have conducted additional pre-clinical studies of mebendazole in an in vivo model of chemotherapy-resistant melanoma and are now preparing a phase I clinical trial, expected to begin next year at NYU Cancer Institute. Read more..... Stony Brook University Collaborative Study of New HIV Drug Shows Significant Viral Load Reduction For Patients Resistant To Therapy A study led by Roy T. Steigbigel, M.D., Professor of Medicine, Pathology, Microbiology and Pharmacological Sciences at Stony Brook University Medical Center, and colleagues worldwide demonstrated that raltegravir, a new medication to treat HIV infection, combined with other anti-HIV medications, provided superior suppression of HIV-1 in patients with highly resistant virus compared to placebo used with other anti-HIV medications. The results, reported in the July 24 edition of the New England Journal of Medicine, are for 48 weeks of therapy from two pivotal Phase III studies of 699 patients. Resistance to antiretroviral therapies against HIV infection remains a problem for millions worldwide being treated for the infection. In fall 2007, the U.S. Food and Drug Administration granted approval of raltegravir for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with HIV-1 strains resistant to multiple antiretrovial agents. The approval was based on analyses of viral load reductions and CD4 cell count increases from the start of treatment to 24 weeks in Phase III studies of the drug, which are ongoing. The 48-week data, reported in NEJM, adds to those studies. "HIV disease is very complex and is especially difficult to manage in patients whose virus has become resistant to therapy," says Dr. Steigbigel, Principal Investigator. "This new drug and approach, however, offers enormous hope for patients living with and being treated for HIV infection for many years." Read more..... Believe it or not Babies born 8/8/08 at 8:08; 8 pounds, 8 ounces Meet Hailey Jo Hauer and Xander Jace Riniker, both born at 8:08 a.m. on 8/8/08, weighing 8 pounds, 8 ounces, in neighboring states. Xander, born at St. Luke's Hospital in Cedar Rapids, Iowa, is the eighth grandchild for his mother's parents. And he's not the only one in his family with an unusual birthday: His 2-year-old brother, Kael, was born on 4/5/06. Lindsey Hauer thought staff at Lake Region Hospital in Minnesota were joking when they told her the time of her daughter's birth. And then she got a call from the birthing suite noting Hailey's weight. Nurse Jenny Harstad joked that she tried to shrink the baby to 18 inches from her actual 19.5 inches. Several hospital staff members in Minnesota pledged to buy lottery tickets. And Chad Riniker, Xander's father, said that eight hadn't been his lucky number before, but that now he was thinking about buying a lottery ticket. "I just might," he said. "If nothing else, with four children I should probably play the lottery." 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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