Thursday, April 14, 2011

GAO: FDA Device Approval Process Endangers Patients

The AP reported, "Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters."  The "Government Accountability Office told Congress Wednesday that the approvals remain a serious issue for the government -- more than two years after the watchdog agency first cited the problem to the FDA." In response, Dr. William Maisel, deputy director for science in FDA's device center, said that the agency "will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012."

CQ reported that the GAO findings were based on an "analysis of 3,510 voluntary recalls from 2005 through 2009." The results were "discussed as part of a debate over whether the agency should update the so-called 510(k) process, which is the main procedure for approving medical devices. The process was intended to be an approval route for products similar to those already on the market; unlike another rarely-used and more stringent review for new products, known as the premarket approval (PMA) process, the 510(k) procedure does not require manufacturers to test devices in people before selling them in the United States."

Monday, April 11, 2011

CT Scans May Put Kids' Health at Risk

The South Florida Sun-Sentinel noted that according to a study in the journal Radiology, "children underwent five times more CT scans" during emergency department visits in "2008 than they did 13 years before -- and 90 percent of the exams were done in hospitals that do not specialize in pediatrics." Perhaps that is "not too surprising in an age in which computed tomography...has proven revolutionary in the diagnosis of all kinds of injuries and ailments." But, with these rewards "come significant risks, especially for children most susceptible to them, and the danger doesn't seem to be lighting much of a fire, for parents or the doctors they're trusting with their children's lives."

Monday, April 4, 2011

$1B Suit Against Facebook for Page Promoting Violence Against Israel, Jews

AFP reported, "Facebook and co-founder Mark Zuckerberg have been hit with a lawsuit seeking more than $1 billion in damages over a page on the social network which called for a 'Third Intifada' against Israel." Plaintiff Larry Klayman, a Jew and founder of political-based group Freedom Watch said Facebook "showed 'negligence' by not quickly responding to appeals to remove the page." Facebook "said the page was initially tolerated because it 'began as a call for peaceful protest' but direct calls for violence began appearing and the page was removed for violating Facebook's policies."

The Seattle Post Intelligencer reported the page, which was "was 'liked' by more than 350,000 users," featured "a call to kill Jews and talk of liberating Jerusalem through violence," according to the lawsuit. ZDNet reported the lawsuit alleges Facebook's delay in removing the page was "was an effort by Facebook and Zuckerberg to increase the social network's net worth based on viewership and use." The page was removed on Tuesday.