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Federal grand jury investigating reports of fraud and abuse at Millennium drug-testing company

A federal grand jury in Boston is investigating allegations of health care fraud and employee intimidation against Millennium Laboratories of San Diego, Calif., a company that tests urine samples for the presence of pain medications. Millennium is one of a few companies in a relatively new industry of selling urine-testing services to pain clinics and doctors throughout the U.S. A growing number of health care providers rely on such services to test patients for painkillers before prescribing new drugs that can have potentially harmful interactions with painkillers the patient may already be taking. The services help health care providers monitor ... Read More

Fraudulent mislabeling of seafood products rampant, DNA testing finds

Genetic testing of hundreds of seafood samples found that one-third of the products were mislabeled as being something other than what the packaging said, according to the ocean conservation group Oceana. The group’s study, conducted to determine whether seafood packaging is “honestly labeled,” examined 1,215 seafood samples collected from nearly 674 retail stores in 21 states. DNA testing on the samples found that 33 percent of the products were mislabeled according to U.S. Food and Drug Administration (FDA) guidelines. According to Oceana, “Of the most commonly collected fish types, samples sold as snapper and tuna had the highest mislabeling rates … ... Read More

Vehicular heatstroke warning devices ineffective, NHTSA warns

Safety products designed to alert parents about children accidentally left in dangerously hot vehicles are unreliable, federal safety regulators said Monday. The National Highway Traffic Safety Administration (NHTSA) made the announcement amidst a push to raise awareness of auto safety concerns affecting children, including efforts aimed at preventing heatstroke death and injuries in children left in unattended vehicles. According to the agency, 527 children have died from heatstroke injuries they received by being locked in hot vehicles – about 38 deaths per year on average. Heatstroke is the leading non-crash, vehicle-related cause of death for children. NHTSA also warned that ... Read More

Congress considers accelerated approval process for experimental drugs

Drugs that target serious or life-threatening diseases may get a cheaper and faster ride to Food and Drug Administration (FDA) approval if a new proposal becomes law this year. The new plan would allow pharmaceutical companies testing experimental drugs to speed up clinical trials by either testing the medications for a shorter period of time or enrolling fewer patients. The proposal is designed to foster innovation by spurring jobs creation and bringing much-needed drugs to the market faster. This “accelerated approval” process for drugs was put into play in the early 1990s at the peak of the AIDS outbreak. “If ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More

Consumer group lobbies for stricter oversight of medical devices

Consumers Union (CU) is joining the fight to urge lawmakers to require stricter oversight of medical devices, especially since it says the current practice puts consumers, especially senior citizens, at risk for ongoing complications. CU is a nonprofit consumer watchdog that also publishes Consumer Reports magazine and ConsumerReports.org. The Food and Drug Administration (FDA) is charged with protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; and human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. Foods are regularly checked, and drugs must ... Read More

Woman nearly killed by bladder sling surgery lobbies for more oversight

Lena Keeton contracted a deadly flesh-eating bacteria following surgery in 2001 to implant a synthetic mesh bladder sling to treat her occasional incontinence, and has since endured 17 surgeries and ongoing medical problems as a result of the mesh. Now Keeton, who spits her time between Austin, Texas, and Miami Beach, Fla., was in Washington, D.C., last week lobbying federal officials to strengthen oversight of medical devices such as surgical mesh. The Food and Drug Administration (FDA) recently issued a warning to patients about complications with the mesh when used transvaginally to treat pelvic floor disorders, including incontinence and pelvic ... Read More

Major League Baseball’s new rules address concussion risk and recovery

Just as Brain Injury Awareness month comes to a close, new rules governing the safety of baseball players who receive concussions during play begin. Major League Baseball and its Players Union have adopted the new and improved rules to better address concussion and treat baseball players who suffer from this mild form of head injury, which left untreated or ignored, can transform into a permanent, debilitating injury. The rules, which go into effect this week, will require mandatory baseline neuropsychological and cognitive testing for all players who have received a blow to the head. The tests will help determine the ... Read More

Loved ones may recognize TBI symptoms in veterans before doctors

Traumatic brain injury is one of the most common types of injuries for American soldiers returning from the Iraq and Afghanistan wars, but the symptoms of TBI aren’t always obvious or easily recognizable. Sometimes called the “silent injury,” TBI often evades state-of-the-art medical imaging and diagnosis simply because it can be present even when there are no visible signs of damage to the brain. Moreover, given the vast complexities of the brain, TBI symptoms are not always the same in every person. So how do you know if the veteran in your life has TBI? Behavioral changes are the biggest ... Read More