Edmund's Newsletter November 25, 2008 Issue: #48 Volume 8 Join Our List In This Issue Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions More Than Half Of US Chronically Ill Adults Skip Needed Care Due To Costs New Hope For HIV Treatment: Cells Exhausted From Fighting HIV Infection Can Be Revitalized Hospital "Superbugs" On The Rise Despite Prevention Efforts Can Vitamins And Minerals Prevent Hearing Loss? Researchers Use Chemical From Medicinal Plants To Fight HIV Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates 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 Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions A 9-year-old with cerebral palsy received an injection of the neurotoxin "Botox" to relieve muscle spasms. This off-label use was legal but not approved by the US Food and Drug Administration (FDA) for this indication. People with headaches have also received Botox injections as a legal, but unapproved, treatment-in this case the FDA is investigating whether the manufacturer actually promoted the drug for this indication. In fact, the drug has some significant dangers leading to hospitalizations and deaths. A more familiar instance of off-label drug use would be the example of a 47-year-old male presenting to his doctor with lower back pain. The doctor, having previously suggested over-the-counter medications, prescribes a drug to ease the pain. The doctor tells the patient to take the drug three times a day, but provides no other information. In this case, a reasonable person might wish to be told: that the prescribed drug gabapentin was approved by the FDA only to treat seizures in epilepsy-not for back pain; and (2) that no reliable research supports using the drug for back pain. These examples are not uncommon, yet current practice does not require or even suggest that doctors disclose any of these facts to their patients. This article argues that as an extension of the legal doctrine of informed consent and the ethical duty of shared decision-making (SDM), patients should be told when a drug is being prescribed "off-label;" that is, it has not been approved for the indication and is being used experimentally. Read more..... More Than Half Of US Chronically Ill Adults Skip Needed Care Due To Costs The U.S. has highest rates among 8 nations of patient-reported medical errors, wasteful or poorly coordinated care and high out-of-pocket costs; Dutch often fare best in affordable, accessible care, low rates of medical errors. Compared to patients in seven other countries, chronically ill adults in the United States are far more likely to forgo care because of costs; they also experience the highest rates of medical errors, coordination problems, and high out-of-pocket costs, according to a new study from The Commonwealth Fund. Published today as a Web Exclusive in the journal Health Affairs, the eight-country survey finds that U.S. patients are significantly more likely to call for fundamental change in their country's health care system, with a third saying the system needs to be rebuilt completely. The 2008 survey of 7,500 chronically ill patients in Australia, Canada, France, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States included adults who had a diagnosis of at least one of seven chronic conditions. Read more..... New Hope For HIV Treatment: Cells Exhausted From Fighting HIV Infection Can Be Revitalized Researchers at the University of Toronto and the University of California, San Francisco, have revealed new hope for HIV treatment with the discovery of a way to 'rescue' immune cells that are exhausted from fighting off HIV infection. The team lead by Drs. Mario Ostrowski, of the University of Toronto's Faculty of Medicine, and Douglas Nixon, of the Division of Experimental Medicine at the University of California, San Francisco, has discovered that a molecule called Tim-3 is present at high levels on poorly functional immune system cells which are 'exhausted' from fighting HIV infection. The researchers found that blocking the activity of Tim-3 on these cells improved their function and allowed them to rejoin the battle against HIV. "In the typical course of HIV infection, an initial burst of very high levels of the HIV virus is brought partially under control by the infected person's immune system, specifically by an immune system cell called a CD8+ killer T cell. In the majority of cases without antiretroviral drug treatment, the immune system is eventually overwhelmed and progression to AIDS occurs," said co-principal author Brad Jones, a PhD candidate in Immunology at the University of Toronto. Read more..... Hospital "Superbugs" On The Rise Despite Prevention Efforts Although infection control has been substantially ramped up in Canadian hospitals since the SARS crisis of 2003, resistant bacterial infections post-SARS are multiplying even faster, a new Queen's University study shows. Led by Queen's epidemiologist Dr. Dick Zoutman, the national survey is a six-year follow-up to a study that was undertaken in 1999, prior to the outbreak of SARS (Severe Acute Respiratory Syndrome). The original, groundbreaking study, funded by the Public Health Agency of Canada, showed that most Canadian hospitals fell seriously short in preventing patients from getting hospital infections. The researchers estimated then that about 250,000 patients a year experience infected surgical wounds, blood infections, and antibiotic-resistant organisms while in hospital - and that 8,000 of these patients will die. Findings from the new Queen's study - which draws on data from 2005 - will be published in the December issue of the American Journal of Infection Control. Read more..... Can Vitamins And Minerals Prevent Hearing Loss? About 10 million people in the United States alone-from troops returning from war to students with music blasting through headphones-are suffering from impairing noise-induced hearing loss. The rising trend is something that researchers and physicians at the University of Michigan Kresge Hearing Research Institute are hoping to reverse, with a cocktail of vitamins and the mineral magnesium that has shown promise as a possible way to prevent hearing loss caused by loud noises. The nutrients were successful in laboratory tests, and now researchers are testing whether humans will benefit as well.   "The prevention of noise induced hearing loss is key," says Glenn E. Green, M.D., assistant professor of otolaryngology at the U-M Health System and director of the U-M Children's Hearing Laboratory.   "When we can't prevent noise-induced hearing loss through screening programs and use of hearing protection, then we really need to come up with some way of protecting people who are still going to have noise exposure. My hope is that this medication will give people a richer, fuller life." Read more..... Researchers Use Chemical From Medicinal Plants To Fight HIV Like other kinds of cells, immune cells lose the ability to divide as they age because a part of their chromosomes known as a telomere becomes progressively shorter with cell division. As a result, the cell changes in many ways, and its disease fighting ability is compromised.   But a new UCLA AIDS Institute study has found that a chemical from the Astragalus root, frequently used used in Chinese herbal therapy, can prevent or slow this progressive telomere shortening, which could make it a key weapon in the fight against HIV.   "This has the potential to be either added to or possibly even replace the HAART (highly active antiretroviral therapy), which is not tolerated well by some patients and is also costly," said study co-author Rita Effros, a professor of pathology and laboratory medicine at the David Geffen School of Medicine at UCLA and member of the UCLA AIDS Institute.   The study, to be published in the Nov. 15 print edition of the Journal of Immunology. Read more..... Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa) This information reflects FDA's current analysis of available data concerning these drugs. On October 1, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased risk for atrial fibrillation in patients treated with a bisphosphonate drug (http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm).   An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine described increased rates of serious atrial fibrillation in two different studies of women ages 65 to 89 years old with osteoporosis treated with the bisphosphonates, Reclast and Fosamax.  Data available to FDA at that time, including data from the NDA approval of Reclast for osteoporosis, showed an increased risk of serious atrial fibrillation and this risk was reflected in the Reclast labeling. After our review, based on the data available at this time, healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.   On October 1, 2007, FDA began requesting placebo-controlled clinical trial information from the sponsors of alendronate, ibandronate, risedronate, and zoledronic acid in order to explore the potential risk for atrial fibrillation in male and female patients treated with these bisphosphonate drugs. The data submitted by the four sponsors included data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. Read more..... Believe it or not Purified urine to be astronauts' drinking water As NASA prepares to double the number of astronauts living aboard the International Space Station, nothing may do more for crew bonding than a machine being launched aboard the space shuttle Endeavour on Friday. It's a water-recycling device that will process the crew's urine for communal consumption. "We did blind taste tests of the water," said NASA's Bob Bagdigian, the system's lead engineer. "Nobody had any strong objections. Other than a faint taste of iodine, it is just as refreshing as any other kind of water." "I've got some in my fridge," he added. "It tastes fine to me." Delivery of the $250 million wastewater recycling gear is among the primary goals of NASA's 124th shuttle mission, which is due to launch at 7:55 p.m. EST on Friday (0055 GMT on Saturday) from the Kennedy Space Centre in Florida. Meteorologists predicted a 70 percent chance the weather would be suitable for launch. With no technical issues, NASA managers told the launch team on Friday morning to fuel the shuttle for liftoff, a three-hour operation to pump 500,000 gallons (1.9 million litres) of liquid hydrogen and liquid oxygen into the spaceship's tank for the 8.5-minute climb into orbit. If the shuttle lifts off on time, it would arrive at the space station on Sunday so astronauts could begin 11 to 12 days of home improvements. In addition to the water recycler, Endeavour carries two small bedrooms, the station's first refrigerator, new exercise gear, and perhaps most important for a growing crew -- a second toilet. "With six people you really do need to have a two-bathroom house. It's a lot more convenient and a lot more efficient," said Endeavour astronaut Sandra Magnus, who will take over as a space station flight engineer from Greg Chamitoff. Chamitoff has been aboard the outpost since the last shuttle flight in June. NASA wants to make sure the water recycling system is working well before adding another three astronauts to the station's crew. SHUTTLE SUPPLIES DRYING UP Reusing water will become essential once NASA retires its space shuttles, which produce water as a byproduct of their electrical systems. Rather than dumping the water overboard, NASA has been transferring it to the space station. But the shuttle's days are numbered. Only 10 flights remain, including a final servicing call to the Hubble Space Telescope. NASA is preparing to end the program in 2010, after which Russian Soyuz spacecraft will be the only way to ferry crew to the space station. "We can't be delivering water all the time for six crew," said space station flight director Ron Spencer. "Recycling is a must." NASA expects to process about six gallons (23 litres) of water per day with the new device. The goal is to recover about 92 percent of the water from the crew's urine and moisture in the air. The wastewater is processed using an extensive series of purification techniques, including distillation -- which is somewhat tricky in microgravity -- filtration, oxidation, and ionization. The final step is the addition of iodine to control microbial growth, Bagdigian said. The device is intended to process a full day's worth of wastewater in less than 24 hours. "Today's drinking water was yesterday's waste," Bagdigian said. 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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