Edmund's Newsletter September 16, 2008 Issue: #38 Volume 8 Join Our List In This Issue New Drug Hope For Cystic Fibrosis Patients New Cannabis-Like Drugs Could Block Pain Without Affecting Brain Calcium During Pregnancy Reduces Harmful Blood Lead Levels FDA Approves Treatment for Rare Neurologic Disease Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics Study Finds Amount Of Work For Residents--Not Just Hours--Needs Review FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers 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 New Drug Hope For Cystic Fibrosis Patients A new drug therapy may represent a tremendous step forward in the treatment of some 70,000 cystic fibrosis (CF) patients worldwide, Dr David Sheppard from the University of Bristol told an audience at the BA Festival of Science in Liverpool. Speaking at the conference, Dr Sheppard said: 'The early results with VX-770 suggest that drug therapies which target defects at the root of the disease have the potential to improve greatly the quality of life of CF patients.' At the moment there is no cure for CF - a common single-gene disorder in the UK. The disease, which affects about 8,000 people in the UK and 70,000 people worldwide, is due to a defective gene that causes ducts and tubes in the body to become blocked by thick, sticky mucus. This mucus affects the lungs, pancreas, the intestines, the liver and the reproductive organs. One of the most recognisable symptoms of CF is 'salty sweat', caused by the failure of the sweat ducts to reabsorb salt. Existing treatments only alleviate symptoms, for example, physiotherapy to clear the air passages, antibiotics for lung infections and enzymes to aid the digestion of food. The defective gene disables or destroys a protein known as CFTR. To date around 1,500 genetic defects have been found in this protein. In general, genetic defects cause harm in two ways - some stop the protein from travelling to its correct destination in cells, whereas others prevent the protein from working properly. Read more..... New Cannabis-Like Drugs Could Block Pain Without Affecting Brain The research demonstrates for the first time that cannabinoid receptors called CB2 are present in human sensory nerves in the peripheral nervous system A new type of drug could alleviate pain in a similar way to cannabis without affecting the brain, according to a new study published in the journal Pain on Monday 15 September. The research demonstrates for the first time that cannabinoid receptors called CB2, which can be activated by cannabis use, are present in human sensory nerves in the peripheral nervous system, but are not present in a normal human brain. Drugs which activate the CB2 receptors are able to block pain by stopping pain signals being transmitted in human sensory nerves, according to the study, led by researchers from Imperial College London. Previous studies have mainly focused on the other receptor activated by cannabis use, known as CB1, which was believed to be the primary receptor involved in pain relief. However, as CB1 receptors are found in the brain, taking drugs which activate these receptors can lead to side-effects, such as drowsiness, dependence and psychosis, and also recreational abuse. Read more..... Calcium During Pregnancy Reduces Harmful Blood Lead Levels Pregnant women who take high levels of daily calcium supplements show a marked reduction in lead levels in their blood, suggesting calcium could play a critical role in reducing fetal and infant exposure. A new study at the University of Michigan shows that women who take 1,200 milligrams of calcium daily have up to a 31 percent reduction in lead levels. Women who used lead-glazed ceramics and those with high bone lead levels showed the largest reductions; the average reduction was about 11 percent, said Howard Hu, chair of the Department of Environmental Health Sciences at the School of Public Health. Hu is the principal investigator of the study and one of the senior authors on the paper, which is available online in Environmental Health Perspectives, the official journal of the U.S. National Institute for Environmental Health Sciences. Hu, who is also affiliated with the University of Michigan School of Medicine, said this is the first known randomized study examining calcium supplementation on lead levels in pregnant women. Read more..... FDA Approves Treatment for Rare Neurologic Disease The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. The FDA designated Gamunex as an orphan drug to treat CIDP. The orphan drug designation provides manufacturers with financial incentives to develop treatments for rare diseases, those affecting fewer than 200,000 people in the United States. "This approval is part of the FDA's effort to address unmet medical needs in patients who are suffering from rare and serious diseases," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. CIDP, which affects about 25,000 people in the United States, is caused by an immune system attack on the body's peripheral nervous system. The effects of CIDP-progressive muscle weakness, loss of deep tendon reflexes, tingling, and numbness-are caused by damage to the strong, fatty material that covers and protects the nerve fibers, called the myelin sheath. Read more..... Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics Off-label medication use, the clinical application of prescribed drugs for indications other than those approved by the relevant drug regulatory agency (in the US, the Food and Drug Administration-FDA), is widespread in many areas of medicine but is particularly common in psychiatry. While off-label uses are legal and in many instances may be in the best interests of patients, they have not received the same degree of independent scrutiny through randomized clinical trials as have approved indications. A drug approved for marketing may be labeled, promoted and advertised by the manufacturer for only those uses for which the drug's safety and effectiveness have been established by the FDA. In a new paper, published in the online, open-access journal PLoS ONE, David Pickar and colleagues, of Gabriel Sciences, report that 74.5% of 200 community-based schizophrenic patients, who were individually interviewed and evaluated (including a review of clinical records), were treated with off-label medication treatments. Specifically, 42.5% of subjects reported that they were simultaneously treated with more than one antipsychotic drug, an unapproved treatment for schizophrenia. The most common unapproved drug combination was the use of both an antipsychotic drug and a mood stabilizer (45% of patients). This combination of drug classes was predicted by the diagnosis of schizoaffective schizophrenia, history of having physically hurt someone and high symptom ratings. Read more..... Study Finds Amount Of Work For Residents--Not Just Hours--Needs Review First study of its kind finds overloading residents with on-call duties can detract from medical education The number of patients assigned to medical residents and the complexity of care patients require has just as much impact on residents' training as the number of hours they work, according to a study published by researchers at the University of Chicago Medical Center in the September 10 issue of JAMA. The study is believed to be the first of its kind using information gathered objectively from medical residents who work long shifts as part of their training. "A lot of people have been talking about this, but no one had any hard data until now," said study author Vineet Arora, MD, assistant professor of medicine at the University of Chicago Pritzker School of Medicine. "In the past, we have focused on the hours that residents work, but now we also need to focus on the intensity of the work." Read more..... FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. "There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV." The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11. HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year. Read more..... Believe it or not Elephant beats heroin habit with detox A once drug-addled elephant fed heroin-laced bananas by illegal traders will return home after emerging clean from a three-year detox programme on China's tropical island province of Hainan.   The four-year-old bull elephant, referred to alternately as "Big Brother" or "Xiguang" in state media reports, was captured in 2005 in southwest China by traders who used spiked bananas to control him. After police arrested the traders and freed Xiguang a few months later, the elephant was confirmed to be suffering from withdrawal symptoms and sent to a wild animal protection centre in Hainan for rehab, Xinhua news agency said on Thursday. A year of methadone injections at five times the human dosage had helped wean Xiguang off his addiction. Now clean, Xiguang was expected to arrive on Saturday at a wildlife park in Kunming, capital of the elephant's home province of Yunnan on the mainland. Xiguang's return would cap a 1,500-km journey home, Xinhua said, and mark another step in the elephant's triumph over addiction. 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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