China wants to stop profiteering at temple sites
Labels: World
In San Francisco, tech investor leads a political makeover
Labels: Technology
Publisher: New Khaled Hosseini novel out May 21
Labels: Lifestyle
FDA: Pharmacy tied to outbreak knew of bacteria
Labels: Health
Northeast hunkers down ahead of hurricane
Labels: Business
UN says 22,000 displaced in Myanmar unrest
Labels: World
SAP eyes "long" period of high sales growth: report
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Broadway takes few chances with superstorm coming
Labels: LifestyleNEW YORK (AP) — Broadway is taking the threat of the mammoth storm seriously, with many theater owners canceling Sunday evening shows long before a drop of rain fell in Times Square.
Sundays are big days for Broadway. Many shows have both a matinee and evening performance. But forecasts called for rain late Sunday or early Monday and subway service is to be halted, so many Sunday evening performances were scrubbed, including "Mama Mia!" ''Mary Poppins," ''The Lion King" and "Newsies."
The megahit "The Book of Mormon" vowed to keep its 7 p.m. curtain time.
Off-Broadway shows including "Stomp," ''Bad Jews" and "Golden Child" were also canceled.
Other shows had no evening show scheduled, including "Cyrano de Bergerac," ''Chaplin," ''Enemy of the People," ''Once," ''Jersey Boys" and "Nice Work If You Can Get It."
FDA: Pharmacy tied to outbreak knew of bacteria
Labels: HealthWASHINGTON (AP) — Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors.
In a preliminary report on conditions at the pharmacy, the Food and Drug Administration said Friday that even when the contamination at New England Compounding Center exceeded the company's own safety levels, there is no evidence that staffers investigated or corrected the problem. The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year.
The report comes from an FDA inspection of the Framingham, Mass.-based company earlier this month after steroid injections made by the company were tied to an outbreak of fungal meningitis. FDA officials confirmed last week that the black fungus found in the company's vials was the same fungus that has sickened 338 people across the U.S., causing 25 deaths.
The New England Compounding Center's lawyer said Friday the pharmacy "will review this report and will continue our cooperation with the FDA."
Compounding pharmacies like NECC traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They have traditionally been overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.
The FDA report provides new details about NECC's conditions, which were first reported by state officials earlier this week. The drug at the center of the investigation is made without preservative, so it's very important that it be made under highly sterile conditions. Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility.
But FDA inspectors noted that workers at the pharmacy turned off the clean room's air conditioning every night. FDA regulators said that could interfere with the conditions needed to prevent bacterial growth.
Inspectors also say they found a host of potential contaminants in or around the pharmacy's clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.
Additionally, inspectors found "greenish yellow discoloration" inside an autoclave, a piece of equipment used to sterilize vials and stoppers. In another supposedly sterile room inspectors found a "dark, hair-like discoloration" along the wall. Elsewhere FDA staff said that dust from a nearby recycling facility appeared to be drifting into the pharmacy's rooftop air-conditioning system.
The FDA on Friday declined to characterize the severity of the problems at NECC, or to speculate on how they may have led to contamination of the products made by the pharmacy. FDA emphasized that the report is based on "initial observations" and that the agency's investigation is ongoing.
The agency also provided new details about the pharmacy's handling of the steroids it recalled last month. The company recalled three lots of steroids made since May that totaled 17,676 single-dose vials of medicine — roughly equivalent to 20 gallons. The shots are mainly used to treat back pain.
According to the agency's report, the pharmacy began shipping vials from the August lot to customers on Aug. 17. That was nearly two weeks before the pharmacy received test results from an outside laboratory confirming the sterility of the drug. When FDA scientists went back and tested the same lot this month, they found contamination in 50 vials.
Outside experts said the report paints a picture of a dysfunctional operation.
"The entire pharmacy was an incubator of bacteria and fungus," said Sarah Sellers, a former FDA officer who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. She now consults for drug manufacturers. "The pharmacy knew this through monitoring results, and chose to do nothing."
Sandy: East Coast braces for epic hurricane, ‘life-threatening’ storm surge
Labels: BusinessWaves crash into a pier in Nags Head, N.C., Oct. 27, 2012. (Gerry Broome/AP)
"Superstorm." "The Perfect Storm." "Frankenstorm."
Whatever you want to call it, the East Coast is bracing for Hurricane Sandy, a "rare hybrid storm" that is expected to bring a life-threatening storm surge to the mid-Atlantic coast, Long Island Sound and New York harbor, forecasters say, with winds expected to be at or near hurricane force when it makes landfall sometime on Monday.
According to the National Hurricane Center, the Category 1 hurricane was centered about 260 miles southeast of Cape Hatteras, N.C., and 395 miles south of New York City early Sunday, carrying maximum sustained winds of 75 mph and moving northeast at 10 mph.
New York Mayor Michael Bloomberg ordered the immediate, mandatory evacuation for low-lying coastal areas, including Coney Island, the Rockaways, Brighton Beach, Red Hook and some parts of lower Manhattan.
"If you don't evacuate, you're not just putting your own life at risk," Mayor Bloomberg said at a news conference Sunday. "You're endangering first responders who may have to rescue you."
Earlier, New York Governor Andrew Cuomo announced the suspension of all MTA service--including subways, buses, Long Island Railroad and Metro North--beginning at 7 p.m. Sunday. New York City Public Schools will be closed on Monday, the mayor said.
[Related: Superstorm could impact 60 million]
Sandy is expected to continue on a parallel path along the mid-Atlantic coast later Sunday before making a sharp turn toward the northwest on Monday--with the Jersey Shore and New York City in its projected path.
But the path is not necessarily the problem.
"Don't get fixated on a particular track," the Associated Press said. "Wherever it hits, the rare behemoth storm inexorably gathering in the eastern U.S. will afflict a third of the country with sheets of rain, high winds and heavy snow."
(Weather.com)
A tropical storm warning has been issued between Cape Fear to Duck, N.C., while hurricane watches and high-wind warnings are in effect from the Carolinas to New England. The hurricane-force winds extend 175 miles from the epicenter of the storm, while tropical storm-force winds extend 520 miles--making Sandy one of the biggest storms to ever hit the East Coast.
"We're looking at impact of greater than 50 to 60 million people," Louis Uccellini, head of environmental prediction for the National Oceanic and Atmospheric Administration, told the Associated Press.
"The size of this alone, affecting a heavily populated area, is going to be history making," Jeff Masters wrote on the Weather Underground blog.
[Also read: Big storm scrambles presidential race schedules]
New Jersey Governor Chris Christie declared a state of emergency, ordering a shutdown of the state's casinos.
"I can be as cynical as anyone," Christie said on Saturday. "But when the storm comes, if it's as bad as they're predicting, you're going to wish you weren't as cynical as you otherwise might have been."
Similar emergency evacuations were being mulled by state officials in Connecticut, Massachusetts, Vermont, New Hampshire and even Maine.
"This is not a coastal threat alone," said Craig Fugate, director of the Federal Emergency Management Agency, said during a media briefing early Sunday. "This is a very large area."
Forecasters also fear the combination of storm surge, high tide and heavy rain--between 3 and 12 inches in some areas--could be life-threatening for coastal residents.
According to the National Hurricane Center summary, coastal water levels could rise anywhere between 1 and 12 feet from North Carolina to Cape Cod, depending on the timing of the "peak surge." A surge of 6 to 11 feet is forecast for Long Island Sound and Raritan Bay, including New York Harbor.
The storm surge in New York Harbor during Hurricane Irene, forecasters noted, was four feet.
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