Word: fda
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Dates: during 2000-2009
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...curb consumption of sugared soda, the Center for Science in the Public Interest (CSPI) last week urged the FDA to slap cigarette-style warning labels on these drinks, citing statistics like this: in 2004 the average American drank 37 gal.--60,000 calories--of what CSPI calls "liquid candy...
...nearly eight years for the new heart drug BiDil to win approval from the Food and Drug Administration--and it won that approval only after its maker, a small company called NitroMed, repositioned it as a treatment earmarked for African Americans. But if NitroMed thought getting BiDil past the FDA was hard, wait until it tries marketing the drug to its target group. Even during its clinical trials, BiDil ran into resistance. Says Dr. Theodore Addai of Nashville's Meharry Medical College, who had to enlist black patients for a 2001 trial: "We had to try to persuade them that...
...BiDil--the first drug approved for a specific race--has been controversial from the start. The drug is actually a combination of two older, generic medicines. When it was first tested on the general population as a treatment for congestive heart failure--a gradual weakening of the heart--the FDA ruled that the results were not statistically significant. It was only when the drug was retested on patients who identified themselves as African Americans that tangible benefits emerged: a 43% reduction in the death rate and a 39% reduction in hospitalizations...
...caused irritation and minor nasal bleeding about 10% of the time, the main drawback of the treatment is likely to be price. Schering will not discuss the current cost of its interferon, but according to a spokesman, the company hopes "to have the product at an affordable level after FDA approval," which could take months or even years to obtain. Unless the price of interferon drops substantially, its most practical use may be to protect those most endangered by colds: people with asthma, cancer patients whose resistance is low and the elderly...
...government is leading this charge into the medical information age--robustly and, by most accounts, effectively--because it pays 46% of the nation's medical bills. Dr. Mark McClellan, former head of the FDA and now director of the Centers for Medicare and Medicaid Services, is making paperless medicine mandatory for physicians who want to participate in the agency's potentially remunerative pay-for-performance scheme. The aim, sensibly enough, is to pay doctors for keeping their patients healthy, as opposed to the current fee-for-service basis that simply rewards patient throughput. A priority for McClellan is to improve...