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ARCA Biopharma Receives Complete Response Letter From FDA On The GencaroTM NDA
ARCA biopharma, Inc. (Nasdaq:ABIO) announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA, or the Agency) for its New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure.
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Nursing Shortage Eases With Recession's Help
"The nation"s deep recession is helping to alleviate the decade-long nursing shortage, as workers who had left the field in better times are returning in droves," the Wall Street Journal reports. The paper quotes a study, one of six papers on the nursing workforce published today in the journal Health Affairs, that found "nearly a quarter-million nurses entered the work force in 2007-08, an 18% surge that was the largest two-year increase in at least three decades." Many of them had left nursing, but "re-entered the work force to compensate for a spouse"s lost income or health benefits, the study said." The increase is "particularly remarkable at a time when the U.S. economy has shed more than six million jobs, helping to solidify the profession"s "recession-proof" image." The study found that the surge in new nurses is due to "efforts to expand nursing schools, attract more young people into the field and improve working conditions," along with an increase in the number of foreign-born nurses.
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Do Prevention Programs Save Money? CBO Says 'No'
The Congressional Budget Office has so far "failed to attribute any savings to increased efforts to provide preventive efforts like stop-smoking programs," challenging the notion that preventive care saves money for the health care system, NPR reports. "Former CBO health analyst Joe Antos, now at the American Enterprise Institute, says preventive services often cost more than they save. In screening people for cancer, for example, he says, "you screen literally millions of people, sometimes at fairly high cost per screen. You"ll pick up some true positives, people who really have the disease. You"ll pick up some false positives." Then all those people have to be followed up by the medical system, which costs even more money."
Endocrinology

Increased Risk Of Emphysema Following Childhood Exposure To Tobacco Smoke

Chronic exposure to tobacco smoke in childhood may contribute to early emphysema later in life, according to new research. Environmental tobacco smoke (ETS) is known to be associated with a variety of serious health problems, but it had not previously been associated with the development of emphysema over the life course. The data was presented on Tuesday, May 19, at the 105th International Conference of the American Thoracic Society in San Diego. "Emphysematous "holes" in the lung that begin as small areas of damage or impaired development may expand according to a fractal trajectory after an earlier insult," said Gina Lovasi, M.P.H., Ph.D., of Columbia University. "We hypothesized that environmental tobacco smoke in childhood may be one such early insult, associated with signs of early emphysema detectable on computed tomography (CT) scan in adulthood and perhaps lower lung function detectable by spirometry." Emphysema is an anatomically defined condition that overlaps substantially with chronic obstructive pulmonary disease, the fourth leading cause of death worldwide. Although smoking leads to emphysema in the upper lobes of the lungs, people who have never smoked may also have tissue destruction patterns that indicate emphysema. However, emphysema in people who have never smoked is more likely to appear as diffuse damage throughout the lungs. To determine whether chronic exposure to ETS in childhood could lead to the development of early emphysema later in life, Dr. Lovasi and colleagues analyzed data from a diverse sample of 3,964 relatively healthy adults recruited as part of the Multi-Ethnic Study of Artherosclerosis (MESA) study, focusing on 1,781 adults who had never smoked. The MESA-lung study assessed childhood exposure to ETS by asking each participant "In your childhood, did you live with a regular cigarette smoker who smoked in your home?" The MESA-lung study was also the first large study of healthy adults to collect CT images that show most of the lungs, allowing for the classification of some areas of the lungs as having indications of early emphysema: large contiguous areas of air-like density ("holes", in contrast to lung tissue, which is more dense than air) or the total percentage of lung volume with air-like density. After adjusting for a number of potentially confounding variables, including childhood asthma and living with a smoker as an adult, the researchers found that non-smokers who reported childhood exposure to ETS were more likely to have CT patterns that looked like early emphysema: large holes were relatively more common, and more of the lung volume appeared to have low, air-like density. The association was not detectable among current or former smokers, perhaps due to the relatively strong influence of one"s own smoking history. They did not find an association for childhood ETS exposure and lung function as measured by spirometry. "The take-home message from our analysis is that exposure to tobacco smoke during childhood may be associated with detectable differences in lung structure, and perhaps early emphysema, later in life among people who do not themselves smoke," Dr Lovasi said. "These findings might also help researchers to understand how lung damage develops. However, the observed associations are small and the implications of the novel CT-based measures for long-term health this research needs to be replicated." Keely Savoie American Thoracic Society


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