FDA Warns on Beverages
A maker of one of the now-notorious, high-potency, caffeine-and-alcohol drinks said it would remove the stimulant from its product as the Food and Drug Administration warned other makers that they must do the same or face action such as seizure of their products. The FDA cautioned Charge Beverages Corp., New Century Brewing Co. LLC, Phusion Projects LLC, and United Brands Company Inc. that the caffeine represents an “unsafe food additive” that can mask sensory cues individuals normally rely on to determine their level of intoxication. The result can be risky behaviors and life-threatening situations, the agency said. Phusion Projects, which makes the drink Four Loko, announced the day before the FDA warning that it would remove caffeine and two other stimulants, taurine and guarana, from its beverages. Wake Forest University's Dr. Mary Claire O'Brien, who has researched caffeinated alcoholic products, said that they allow drinkers to stay awake to drink more, “well beyond the amount they would otherwise be able to tolerate if they were only drinking alcohol.”
Mammography Devices Relisted
The FDA is making it easier for companies to get new digital mammography systems approved. The agency said it is reclassifying these devices, known as full field digital mammography systems, as medium-risk (class II) devices. When first approved by the agency in 2000, digital mammography systems were categorized as high risk (class III) because of their novelty. Since then, digital mammography has been validated in scientific studies involving tens of thousands of patients, the agency said. To win approval for a class III device, companies need to prove safety and effectiveness. Class II approval involves establishing that a device is substantially equivalent to one already on the market. Today, about 70% of the mammography units in use are digital and 70% of certified U.S. mammography centers have at least one digital unit, the FDA said.
Hospital Adverse Events Common
More than 13% of Medicare beneficiaries hospitalized in late 2008 experienced at least one adverse event causing lasting harm during their stays. Among them, 1.5% experienced an event that contributed to their deaths, according to a report from the Health and Human Services Office of the Inspector General. Another 13% of hospitalized beneficiaries experienced temporary harm, such as hypoglycemia, the report found. The combination of events cost Medicare an estimated $324 million in October 2008, the month the report covered, which means that such events could cost $4.4 billion a year. Physicians reviewing the data said that 44% of the adverse events, such as hospital-acquired infections, and temporary-harm events were clearly or probably preventable.
Medicare Reduces Bad Payments
Following a pledge to reduce waste, fraud, and abuse in Medicare, the Centers for Medicare and Medicaid Services said it has already reduced the error rate for claims since 2009 and is on track to cut it 50% by 2012. Improper payments don't necessarily represent fraud and abuse, the CMS said. Instead, most such errors stem from insufficient documentation and provision of medically unnecessary services. In 2009, the fee-for-service error rate was more than 12%, or an estimated $35.4 billion in improper claims, according to the report. In 2010, the rate has fallen to less than 11%, or an estimated $34.3 billion. The agency said it continues to work with providers across the country to help them eliminate errors.
Industry-Physician Ties Persist
Although most physicians continue to have financial relationships with industry, the percentage has declined significantly since 2004, according to a study led by Harvard Medical School researchers in Boston. They reported in the Archives of Internal Medicine that although fewer physicians are accepting gifts such as drug samples and food, most continue to do so. About 64% take drug samples, compared with 78% in 2004, and 71% accept free food and beverages, compared with 80% in 2004. However, the number of physicians accepting payments for consulting, speaking, or enrolling patients in clinical trials has fallen by half since 2004, according to the study. Only 18% of physicians said they accept reimbursements for meeting expenses, compared with 35% in 2004, and just 14% receive payments for professional services, compared with 28% in 2004. “These data clearly show that physician behavior, at least with respect to managing conflicts of interest, is mutable in a relatively short period,” the researchers concluded. “However, given that 83.8% of physicians have [physician-industry relationships], it is clear that industry still has substantial financial links with the nation's physicians.”
AMA Issues Social Media Policy