Oct
30

Mammograms: For 1 life saved, 3 women overtreated

LONDON (AP) — Breast cancer screening for women over 50 saves lives, an independent panel in Britain has concluded, confirming findings in U.S. and other studies.But that screening comes with a cost: The review found that for every life saved, roughly three other women were overdiagnosed, meaning they were unnecessarily treated for a cancer that would never have threatened their lives.The expert panel...
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Dozens killed, millions without power in Sandy's wake

PITTSBURGH (AP) — The most devastating storm in decades to hit the country's most densely populated region upended man and nature as it rolled back the clock on 21st-century lives, cutting off modern communication and leaving millions without power Tuesday as thousands who fled their water-menaced homes wondered when — if — life would return to normal.A weakening Sandy, the hurricane turned fearsome...
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Oct
29

China wants to stop profiteering at temple sites

BEIJING (AP) — China is telling tourist-favored Buddhist temples: Don't let money be your mantra.Authorities announced a ban this week on temples selling shares to investors after leaders of several popular temples planned to pursue stock market listings for them as commercial entities. Even the Shaolin Temple of kung fu movie fame was once rumored to be planning a stock market debut — and critics...
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Apple software, retail chiefs out in overhaul

SAN FRANCISCO (Reuters) - Apple Inc CEO Tim Cook on Monday replaced the heads of its software and retail units in the company's biggest executive shake-up in a decade following embarrassing problems with its new mapping program and unpopular store-related decisions. Software chief Scott Forstall, who oversaw the launch of the flawed mapping software and much criticized Siri voice-enabled...
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China passes law to curb abuse of mental hospitals

BEIJING (AP) — China's legislature on Friday passed a long-awaited mental health law that aims to prevent people from being involuntarily held and unnecessarily treated in psychiatric facilities — abuses that have been used against government critics and triggered public outrage.The law standardizes mental health care services, requiring general hospitals to set up special outpatient clinics or provide...
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Superstorm Sandy slams into New Jersey coast

ATLANTIC CITY, N.J. (AP) — Superstorm Sandy slammed into the New Jersey coastline with 80 mph winds and hurled a record-breaking 13-foot surge of seawater at New York City on Monday, roaring ashore after washing away part of the Atlantic City boardwalk and putting the presidential campaign on hold.Just before its center reached land, the storm was stripped of hurricane status, but the distinction...
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Oct
28

UN says 22,000 displaced in latest Myanmar unrest

SITTWE, Myanmar (AP) — Victims of Myanmar's latest explosion of Muslim-Buddhist violence fled to already packed displacement camps along the country's western coast, with a top U.N. official saying the unrest has forced more than 22,000 people from their homes.State television reported the casualty toll has risen to 84 dead and 129 injured over the past week in nine townships in Rakhine state. The...
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SAP eyes "long" period of high sales growth: report

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FDA: Pharmacy tied to outbreak knew of bacteria

WASHINGTON (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."

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Sandy: East Coast braces for epic hurricane, ‘life-threatening’ storm surge

Waves crash into a pier in Nags Head, N.C., Oct. 27, 2012. (Gerry Broome/AP)


[UPDATED: 8:00 p.m. ET]


"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 280 miles southeast of Cape Hatteras, N.C., and 485 miles south of New York City early Sunday, carrying maximum sustained winds of 75 mph and moving northeast at 15 mph.


[Slideshow: Latest photos from Hurricane Sandy]


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 along the East River.


"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."


New Jersey Governor Chris Christie's message for residents was a bit more blunt. "Don't be stupid," Christie said Sunday afternoon, announcing the suspension of the state's transit system beginning at 12:01 a.m. Monday.


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. The New York Stock Exchange said its trading floor will be closed on Monday, too--the first such shutdown in 27 years, according to the Wall Street Journal.


[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 and southern New Jersey coastline 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."


(FEMA)


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 Virginia to Massachusetts. The hurricane-force winds extend 175 miles from the epicenter of the storm, while tropical storm-force winds extend 500 miles--or roughly 1,000 miles end to end, 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.


President Barack Obama received a briefing on the storm at Federal Emergency Management Agency headquarters in Washington on Sunday. "My main message to everybody involved is that we have to take this seriously," President Obama said. "[We will] respond big and respond fast."


[Also read: Big storm scrambles presidential race schedules]


"I can be as cynical as anyone," Christie said on Saturday, announcing a state of emergency. "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."


Meanwhile, emergency evacuations were being mulled by state officials in Connecticut, Massachusetts, Vermont, New Hampshire and even Maine.


In Virginia, Governor Bob McDonnell said 20,000 homes there had already reported power outages.


(Weather.com)


"This is not a coastal threat alone," said FEMA director Craig Fugate 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 in September 2011, forecasters noted, was four feet.


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