St. Jude Promoted Medical Device Without Approval, FDA Says

Friday Briefing

May 18, 2012 |

Panel examines whether anthrax vaccine should be tested on children. The Presidential Commission for the Study of Bioethical Issues is expected to decide by the end of the year whether pediatric studies are warranted on the vaccine and other treatments being stockpiled in case of a bioterror attack. The reason for such research is that, “We can’t just assume that what we have for adults works for children,” Health and Human Services Secretary Kathleen Sebelius told the panel Thursday. Still, testing medications in children requires extra safeguards. If a child won’t receive a direct medical benefit, federal regulations say studies are allowed only if risks are minimal and testing adults can’t provide the answers. The Associated Press

Louisiana watchdog group urges federal government to take over state air quality oversight. The Louisiana Bucket Brigade, an environmental group that focuses on industrial emissions, says the state Department of Environmental Quality has done such a poor job of enforcing air quality laws that the U.S. Environmental Protection Agency should take over the role. A leader of the watchdog group said the Louisiana agency’s inspectors routinely arrive hours after an accident and don’t do extended monitoring of the air in areas directly downwind. “That’s why they can say there is no impact,” she said, adding that the agency’s philosophy is “based on a culture of protecting industry.” The agency disputed the claims. The Times-Picayune

Study finds that workplace safety inspections reduce injuries without hurting profits. Researchers came to those conclusions after looking at data on 409 California businesses randomly inspected by state regulators and 409 similar job sites that weren’t inspected. The researchers found that in high-hazard industries, inspections reduced injury claims 9.4 percent and cut workers’ compensation costs 26 percent in the four years after inspection. “We found that workplace inspections worked pretty much the way they are supposed to. They improved safety, and they did not cost firms enough that we could detect it,” said lead researcher Michael Toffel of Harvard Business School. HealthDay

Boston area manufacturer pays $600,000 in safety fines after explosion. Bostik Inc., a Middleton, Mass.,-based adhesives company, agreed to make the payment and improve its safety practices to settle 50 violations cited by the U.S. Occupational Safety and Health Administration. The agency investigated after a March, 2011 explosion at the plant that hurt four workers and rocked the surrounding community. The blast occurred when a valve was left open, releasing flammable acetone vapors. OSHA originally proposed $917,000 in fines. “This resolution speeds corrective action that might otherwise have been delayed through lengthy litigation,” said a Labor Department official. OSHA, The Salem News

Workplace safety regulators seek $212,000 in fines against Texas aluminum plant. The U.S. Occupational Safety and Health Administration charged Western Extrusions Corp.’s plant in Carrollton, Texas with 15 violations, including two willful violations, the agency’s most serious charges. “This company has a history of failing to implement effective safety measures … to prevent employees from coming in contact with moving machine parts during servicing and setup,” an OSHA official said in a news release. The company said the issues have been resolved and there have been no injuries. It has 15 business day to contest or otherwise respond to OSHA’s charges. OSHA, CBS

Recalls and warnings: shellfish from South Korea, imodium caplets, Circulon cookware sold at Costco, Ferrari 458 Italia and California models, Porter Athletic climbing ropes, First Fitness trampolines, Saffron Road lamb koftis

Compiled by Stuart Silverstein

Thursday Briefing

May 17, 2012 |

Researchers find equivalent brain injuries in athletes and combat veterans. Scientists have concluded that roadside bomb explosions hurt the brain in ways strikingly similar to the jolts suffered in football or boxing. The researchers also discovered the possible mechanism by which explosions damage brain tissue and trigger a disease called chronic traumatic encephalopathy, or CTE. ...

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