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FDA Approved Spiriva Inhaler The U.S. FDA has expanded approval for the Spiriva Handihaler to include reducing symptoms during flares of chronic obstructive pulmonary disease (COPD), makers Boehringer Ingelheim Pharmaceuticals and Pfizer said. The Spiriva Handihaler, first FDA-approved in 2004, is already sanctioned as a once-daily maintenance treatment for COPD-related problems, including cough, wheezing, or difficulty breathing. COPD is a broad term for respiratory disorders that include chronic bronchitis and emphysema. COPD leads to the deaths of an estimated 120,000 Americans annually. Source: Associated Press, December 27, 2009 Pros and Cons of Electronic Medical Records Studies show U.S. physicians support the use of electronic medical records, but widespread concerns exist about privacy problems. A study showed that 86% believed electronic health information exchange (HIE) would improve patient quality of care, 70% thought it would reduce costs and 76% said it would save time. However, 16% said they were very concerned about possible privacy breaches, while 55% were somewhat concerned. The study also found that none of the doctors wanted to pay the suggested $150 monthly fee for HIE and about half said they were not willing to pay any fee. The researchers concluded, “Designers of future systems will need to enhance electronic file security and simultaneously maintain legitimate accessibility in order to preserve confidence in psychiatric and other electronic health record systems.” Source: Health Day News, December 16, 2009 Study Questions FDA Approvals of Cardiac Devices The U.S. FDA may not be as stringent in evaluating devices as it is in approving drugs. According to a report, approval of cardiovascular devices often sails through based on studies that are not randomized or blinded and sometimes even on the basis of one study alone. Dr. Rita Redberg, a professor of medicine at the University of California, said, “While we did not expect that all studies would be or should be randomized and blinded, we were surprised that the numbers of such studies were as low as they were and that there were many devices approved on the basis of a single study.” The FDA issued a statement in which it said the study presented an “inaccurate picture” of the clinical trials used in the agency’s heart device review process, noting that devices and drugs are not the same thing and require different processes for approval. Dr. Kirk Garrat, clinical director of interventional cardiovascular research at Lenox Hill Hospital in NYC, said, “I have been through the device approval process often enough with the FDA to know that these types of criticism don’t reflect the typical standard of FDA behavior.” The problem with this study may be that the authors tried to look at too many different types of devices, not all of which have the same impact on the patient and not all of which can be randomized or blinded. Dr. Charles Lowenstein, head of cardiology at the University of Rochester Medical Center, said, “The FDA has a tough job, and they do a pretty good job. This article is concerning because the results suggest that the FDA sometimes accepts studies that aren’t as rigorous as possible...The FDA should rely on the best studies possible, not the best studies available. According to the study authors, device safety has largely slipped through the cracks, even as attention on drug safety months. Source: Health Day News, December 29, 2009
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Life Expectancy Hits High in U.S. Federal health officials said the average life expectancy in the United States has reached almost 78 years. According to the report from the U.S. Centers for Disease Control and Prevention, from birth in 2007, women can expect to live to 80.4 years on average and men to 75.3 years. However, even though Americans can expect to live longer than their parents, life expectancy in the United States is still lower than in many other industrialized countries, including Canada and Japan. Along with increased life expectancy, the report notes the death rate has dropped to an all-time low of 760.3 deaths per 100,000 people, continuing a long-term trend. Arialdi M. Minino, a statistician at the CDC’s Center for Health Statistics, said, “The risk of dying has dropped to a record low level, and life expectancy has reached a record high. Ever since the 1960s, the death rate has been decreasing in the United States. Fewer deaths from heart disease, stroke and cancer are driving the trend.” According to the report, life expectancy in 2007 increased to 77.9 years up from 77.7 years in 2006. Since 2000, life expectancy has increased 1.4 years. Other findings include:
Dr. William O’Neill, executive dean for clinical affairs at the University of Miami Miller School of Medicine, said, “This is great news. Many people say the U.S. health care system is broken. But, this is kind of great evidence to show there has actually been some dramatic improvements in the health of Americans over the last 20 years. We are going to have many people 80 to 90 years old. So how is the U.S. going to handle this huge increase?” People living 20 years or more than their predecessors will have to rethink retirement planning. Increased life expectancy is largely the result of better treatment for heart disease. Source:: Business Wire, December 16, 2009 |
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