FDA panel votes for more restrictions on Vicodin

WASHINGTONFederal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

The Food and Drug Administration's panel of drug safety specialists voted to subject hydrocodone drugs to the same restrictions as narcotics like oxycodone and morphine.




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Headlines: Vicodin may face tighter controls



The panel voted 19-10 in favor of the move, which is supported by the Drug Enforcement Agency. The FDA will weigh the vote in its decision-making process.

Hydrocodone is sold in combination pills like Vicodin, which mixes the drug with non-addictive painkillers like acetaminophen. The drug belongs to a family of drugs known as opioids, which include morphine, heroin, oxycodone, codeine and methadone.

Doctors prescribe the medicines to treat pain from injuries, surgery, arthritis and other ailments such as coughs.

Hydrocodone consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the Drug Enforcement Agency.

Panelists who voted for new restrictions said it would send a signal to doctors about the potential dangers of hydrocodone drugs.

"I don't think reclassification is a panacea for the opioid abuse problem in this country, but I think it's an important step to get doctors to rethink their prescribing practices," said Mary Ellen Olbrisch, a professor at Virginia Commonwealth University.

The DEA has asked the FDA to reclassify hydrocodone as a schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled. The Controlled Substances Act, passed in 1970, put hydrocodone combination drugs in the schedule III class, which is subject to fewer controls.

An April, 2012 Drug Enforcement Administration report showed that 42 tons of pure hydrocodone were prescribed across U.S. pharmacies in 2010, enough to give 24 5-milligram Vicodins to every person in the United States.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country.

Currently a prescription for hydrocodone-containing Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified patients could only receive a single 90-day prescription, similar to oxycodone. The drug could also not be prescribed by nurses and physician assistants.

Panelists who voted against the classification change said it would have unintended consequences, driving addicted patients to obtain the drugs illegally.

"If prescribing decreases, illicit opioid use will increase, with dire consequences," said Dr. John Mendelson, of St. Luke's Hospital in San Francisco. "I think this is a mistake and we will be back here with other problems."

Several physician and pharmacist groups also argued that new restrictions would burden medical professionals and disrupt patient care.

"Rescheduling the products to Schedule II would create significant hardships for all - leading to delayed access for vulnerable patients with legitimate chronic pain," said the National Community Pharmacists Association, in a statement.

The FDA is not required to follow the advice of its expert panelists, though their input is often critical in its decisions.

FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them.

"There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society," said Douglas Throckmorton, FDA's deputy director for regulatory programs.

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Apple Drops Manufacturer Using Underage Workers













Apple has stopped doing business with a Chinese manufacturer after a report said it had employed 74 underage workers. According to Apple's Supplier Responsibility Report, which was released by the company Thursday, Guangdong Real Faith Pingzhou Electronics was employing workers under the age of 16.


"Our auditors were dismayed to discover 74 cases of workers under age 16 — a core violation of our Code of Conduct. As a result, we terminated our business relationship with PZ," the company says in the report.


Apple has now lost its spot as the most valuable publicly traded company, one year after it first firmly overtook ExxonMobil. Even though it announced a record number of iPhone and iPad sales in its last quarter earnings, its stock price has fallen over 12 percent.


Apple says it is working hard to improve labor conditions at the factories of its Chinese contractors. It said it also discovered that one of the region's labor agencies had conspired with the manufacturer, providing children to them and helping forge age-verification documents. Apple said in its report that it alerted the provincial government, which fined the agency and suspended its business license.


Apple To Start Making Some Mac Computers in America in 2013


"The children were returned to their families, and PZ was required to pay expenses to facilitate their successful return," Apple says in the report.










In an interview with Bloomberg, Apple's Senior Vice President of Operations, Jeff Williams, said child labor was being used more than companies care to admit. "Most companies, they either don't report on it at all, or they say they look for it and found none, or they obscure the data in some way," Williams told Bloomberg. "If they're not finding it, they're not looking hard enough."


ABC News' Bill Weir visited the factory of Apple's Foxconn supplier last year and did not see any underage workers. "But while we looked hard for the kind of underage and maimed workers we've read so much about, we mostly found people who face their days through soul-crushing boredom and deep fatigue," Weir wrote about his visit.


PHOTOS: Inside Apple's Factories in China


In the 37-page Supplier Responsibility Progress Report, which can be viewed here, Apple said there had been a 72 percent increase in facility audits. According to the report, Apple achieved an average of 92 percent compliance with the goal, for now, of a maximum 60-hour work week.


Apple vowed last year to improve working conditions at its manufacturing facilities in China, vowing to work specifically on reducing working hours for Chinese workers. In March 2012, the Fair Labor Association released a report on the poor conditions at Apple's Foxconn supplier. The organization gave a long list of recommendations to Apple and Foxconn, and both Apple and Foxconn agreed to follow them.


In August, the FLA said that that Foxconn had completed 280 action items on time or ahead of schedule. By July 1, 2013, Foxconn has promised to reduce workers' hours to 49 hours per week and stabilize pay -- though the limit is rarely enforced because workers often want to work overtime and make ends meet.


Apple announced in December that it would begin to make some of its Mac computers in America in 2013.



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North Korea to target U.S. with nuclear, rocket tests


SEOUL (Reuters) - North Korea said on Thursday it would carry out further rocket launches and a nuclear test that would target the United States, dramatically stepping up its threats against a country it called its "sworn enemy".


The announcement by the country's top military body came a day after the U.N. Security Council agreed to a U.S.-backed resolution to censure and sanction North Korea for a rocket launch in December that breached U.N. rules.


North Korea is not believed to have the technology to deliver a nuclear warhead capable of hitting the continental United States, although its December launch showed it had the capacity to deliver a rocket that could travel 10,000 km (6,200 miles), potentially putting San Francisco in range, according to an intelligence assessment by South Korea.


"We are not disguising the fact that the various satellites and long-range rockets that we will fire and the high-level nuclear test we will carry out are targeted at the United States," North Korea's National Defence Commission said, according to state news agency KCNA.


North Korea is believed by South Korea and other observers to be "technically ready" for a third nuclear test, and the decision to go ahead rests with leader Kim Jong-un, who pressed ahead with the December rocket launch in defiance of the U.N. sanctions.


China, the one major diplomatic ally of the isolated and impoverished North, agreed to the U.S.-backed resolution and it also supported resolutions in 2006 and 2009 after Pyongyang's two earlier nuclear tests.


Thursday's statement by North Korea represents a huge challenge to Beijing as it undergoes a leadership transition, with Xi Jinping due to take office in March.


China's Foreign Ministry called for calm and restraint and a return to six-party talks, but effectively singled out North Korea, urging the "relevant party" not to take any steps that would raise tensions.


"We hope the relevant party can remain calm and act and speak in a cautious and prudent way and not take any steps which may further worsen the situation," ministry spokesman Hong Lei told reporters at a regular press briefing.


North Korea has rejected proposals to restart the talks aimed at reining in its nuclear capacity. The United States, China, Russia, Japan and the two Koreas are the six parties involved.


"After all these years and numerous rounds of six-party talks we can see that China's influence over North Korea is actually very limited. All China can do is try to persuade them not to carry out their threats," said Cai Jian, an expert on Korea at Fudan University in Shanghai.


Analysts said the North could test as early as February as South Korea prepares to install a new, untested president or that it could choose to stage a nuclear explosion to coincide with former ruler Kim Jong-il's Feb 16 birthday.


"North Korea will have felt betrayed by China for agreeing to the latest U.N. resolution and they might be targeting (China) as well (with this statement)," said Lee Seung-yeol, senior research fellow at Ewha Institute of Unification Studies in Seoul.


U.S. URGES NO TEST


Washington urged North Korea not to proceed with a third test just as the North's statement was published on Thursday.


"Whether North Korea tests or not is up to North Korea," Glyn Davies, the top U.S. envoy for North Korean diplomacy, said in the South Korean capital of Seoul.


"We hope they don't do it. We call on them not to do it," Davies said after a meeting with South Korean officials. "This is not a moment to increase tensions on the Korean peninsula."


The North was banned from developing missile and nuclear technology under sanctions dating from its 2006 and 2009 nuclear tests.


A South Korean military official said the concern now is that Pyongyang could undertake a third nuclear test using highly enriched uranium for the first time, opening a second path to a bomb.


North Korea's 2006 nuclear test using plutonium produced a puny yield equivalent to one kiloton of TNT - compared with 13-18 kilotons for the Hiroshima bomb - and U.S. intelligence estimates put the 2009 test's yield at roughly two kilotons


North Korea is estimated to have enough fissile material for about a dozen plutonium warheads, although estimates vary, and intelligence reports suggest that it has been enriching uranium to supplement that stock and give it a second path to the bomb.


According to estimates from the Institute for Science and International Security from late 2012, North Korea could have enough weapons grade uranium for 21-32 nuclear weapons by 2016 if it used one centrifuge at its Yongbyon nuclear plant to enrich uranium to weapons grade.


North Korea has not yet mastered the technology needed to make a nuclear warhead small enough for an intercontinental missile, most observers say, and needs to develop the capacity to shield any warhead from re-entry into the earth's atmosphere.


North Korea gave no time-frame for the coming test and often employs harsh rhetoric in response to U.N. and U.S. actions that it sees as hostile.


The bellicose statement on Thursday appeared to dent any remaining hopes that Kim Jong-un, believed to be 30 years old, would pursue a different path from his father, Kim Jong-il, who oversaw the country's military and nuclear programs.


The older Kim died in December 2011.


"The UNSC (Security Council) resolution masterminded by the U.S. has brought its hostile policy towards the Democratic Peoples Republic of Korea (North Korea) to its most dangerous stage," the commission was quoted as saying.


(Additional reporting by Christine Kim in SEOUL, Ben Blanchard and Sui-Lee Wee in Beijing; Writing by David Chance; Editing by Raju Gopalakrishnan and Ron Popeski)



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N.Korea threatens South over UN sanctions






SEOUL: North Korea on Friday threatened "physical counter-measures" against rival South Korea over a tightening of UN sanctions against Pyongyang following its recent rocket launch.

"If the South Korean puppet regime of traitors directly participates in the so-called UN 'sanctions', strong physical countermeasures would be taken," the North's Committee for Peaceful Reunification of Fatherland said.

The warning, carried by the official Korean Central News Agency, came a day after North Korea threatened to conduct its third nuclear test and boost its capacity for a military strike on the United States.

"Sanctions amount to a declaration of war against us," said the committee, which is the prime state body responsible for inter-Korean dialogue and exchange.

While Thursday's threat had firmly targeted the United States, the latest warning focused Pyongyang's anger on the capitalist South.

"As long as the South Korean puppet traitors' regime continues with it's anti-DPRK (North Korea) hostile policy, we will never sit down with them," it said.

- AFP/fa



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Microsoft: We're going to broaden Surface lineup



Microsoft Surface RT. The Surface Pro version goes on sale February 9. The CTO today reiterated that the lineup will grow.

Microsoft Surface RT. The Surface Pro version goes on sale February 9. The CTO today reiterated that the lineup will grow.



(Credit:
Brooke Crothers)


During Microsoft's second-quarter earnings conference call today, the company's chief financial officer reiterated that the lineup of Surface devices will expand.


After Microsoft reported reported earning today, Chief Financial Officer Peter Klein spoke about future Surface products -- though he was mum about specifics.


"We had limited distribution this quarter in our stores and we're excited about expanding that [distribution]," he said, responding to an analyst's question.


"We're going to expand geographically, we're going to expand the product lineup, we're going to expand retail distribution and capacity," he said, in comments about Surface. Microsoft has made similar comments in the past.



Klein repeated a number of times that Surface contributed to revenue. "Certainly this quarter it was a contributing factor to revenue growth in the Windows business," Klein said.


And he inserted some serious commentary inside an innocuous-sounding statement. "It highlights some interesting innovation that can happen...demonstrates the power of
Windows 8 when tightly integrated with hardware and software."


In short, in order for a product to be done right, one company must make both the hardware and software -- as Apple has done successfully.



Klein did not mention -- and wasn't asked about -- shipment numbers for Surface RT. Speculation has been all over the map, though most analysts believe the number is somewhere in the neighborhood of a million.


The CFO also repeated previous comments by other Microsoft executives regarding the demand for Windows 8 touch devices. "There's great demand for touch devices," he said, adding that supply cannot keep up with demand.


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Battery expert: "I would not fly in a Dreamliner"

(CBS News) WASHINGTON - Investigators say they still don't know what caused batteries to burn in two Boeing 787 Dreamliners, and until they figure that out and how to fix the problem, none of the planes will be allowed to fly.

More than any other plane, the Dreamliner relies on lithium ion batteries to help power its advanced electrical system. They're lighter and more powerful than older battery types, but they contain a highly flammable liquid electrolyte.

U.S. officials defend handling of 787 mishaps
Boeing 787 probe turns to battery companies

Boeing plans to carry on with Dreamliner production

Federal investigators are examining the disassembled battery from the 787 that caught fire in Boston January 7, spewing molten electrolyte.

George Blomgren worked for Eveready, a batteries and flashlights company, for 40 years. He says lithium ion batteries are bundled together for the 787, and that increases the risk.

"These fires burn at very high temperatures, so they are just very dangerous fires," he said.


George Blomgren, a battery expert for Eveready

George Blomgren, a battery expert for Eveready


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CBS News

The Boston fire, and the burned-out battery on a Dreamliner in Japan, is not the first time lithium ion batteries have caused problems.

In 2011, a Chevy Volt lithium ion battery was damaged in a crash test. Three weeks later, it burst into flames. Chevrolet installed a number of fixes to prevent fires.

Safety features also were added to lithium ion batteries in some cell phones and laptops after 56 million were recalled for risk of overheating and exploding.

Boeing says lithium ion batteries "best met the performance and design objectives of the 787" and "Based on everything we know at this point, we have not changed our evaluation."

Blomgren considers the safety of lithium ion batteries on planes questionable.

"From what I know about incidents, I would not fly in a Dreamliner tomorrow. I just wouldn't feel that it was appropriate or safe," Blomgren said.

Many experts believe in the promise of lithium ion batteries, including for airlines, but they just aren't sure its safety has been perfected.

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Will Women Register for Selective Service?


Jan 24, 2013 5:53pm







ap women combat nt 130124 wblog Will Women Register for Selective Service?


Defense Secretary Leon Panetta today lifted the ban on women serving in combat positions, opening the door to more than 200,000  new military posts and raising a number of important questions, including: Will women eventually be eligible for the draft?


By law, all male U.S. citizens and permanent residents must register with the Selective Service System within 30 days of their 18th birthday. Registration puts those “male persons” on the list the government uses if ever the draft returns and conscription in the military is deemed necessary in a time of war.


As of a 1994 review, women were still exempt from registering because they did not serve in combat positions. Today’s change in Pentagon policy, however, could ultimately result in a change to the law.


But it will take more than just the stroke of the defense secretary’s pen for the Selective Service Act to include mention of women.


With any change to personnel policies, the Defense Department  is “required to provide an analysis of its impact on the Selective Service Act,” said a senior Pentagon official said on the condition of anonymity.  “So that will be part of the notification to Congress.”


But what comes next is  unclear.


“With regard to what will happen from there, I can’t say,” said the official.


Defense Secretary Leon Panetta later admitted to reporters that he, too, did not know the potential impact of the change to the Selective Service Act.


“That’s not our operation,” said Panetta.


Known for his use of colorful language, Panetta then said, “I don’t know who the hell controls Selective Service, if you want to know the truth.”


“But, you know,” Panetta added. “Whoever does, they’re going to have to exercise some judgment based on what we just did.”


The Selective Service System is a federal agency independent of the Department of Defense.



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North Korea to target U.S. with nuclear, rocket tests


SEOUL (Reuters) - North Korea said on Thursday it would carry out further rocket launches and a nuclear test that would target the United States, dramatically stepping up its threats against a country it called its "enemy".


The announcement by the country's top military body came a day after the United Nations Security Council agreed a U.S.-backed resolution to censure and sanction the country for a rocket launch in December that breached U.N. rules.


"We are not disguising the fact that the various satellites and long-range rockets that we will fire and the high-level nuclear test we will carry out are targeted at the United States," North Korea's National Defence Commission said, according to state news agency KCNA.


North Korea is believed by South Korea and other observers to be "technically ready" for a third nuclear test, and the decision to go ahead rests with leader Kim Jong-un who pressed ahead with the December rocket launch in defiance of the U.N. sanctions.


"Whether North Korea tests or not is up to North Korea," Glyn Davies, the top U.S. envoy for North Korean diplomacy, said in the South Korean capital of Seoul as KCNA released its statement.


"We hope they don't do it. We call on them not to do it," Davies said. "This is not a moment to increase tensions on the Korean peninsula."


The North was banned from developing missile and nuclear technology under sanctions dating from its 2006 and 2009 nuclear tests.


The concern now is that Pyongyang, whose only major diplomatic ally, China, endorsed the latest U.N. resolution, could undertake a third nuclear test using highly enriched uranium for the first time, opening a second path to a bomb.


Its previous tests have been viewed as limited successes and used plutonium, of which the North has limited stocks.


North Korea gave no time-frame for the coming test and often employs harsh rhetoric in response to U.N. and U.S. actions.


Its long-range rockets are not seen as capable of reaching the United States mainland and it is not believed to have the technology to mount a nuclear warhead on a long-range missile.


"The UNSC (Security Council) resolution masterminded by the U.S. has brought its hostile policy towards the Democratic Peoples Republic of Korea (North Korea) to its most dangerous stage," the commission was quoted as saying.


(Writing by David Chance; Editing by Raju Gopalakrishnan)



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Taiwanese activists head for Japan-controlled isles






TOKYO: A boatload of Taiwanese activists protected by the island's coastguard was on Thursday heading for Japanese-held islands at the centre of a bitter international wrangle involving Tokyo, Beijing and Taipei.

The seven activists left port in Taiwan on a fishing vessel in the early hours and were expected to arrive in the area around the uninhabited islands about noon (0400 GMT), Taiwanese coastguard spokesman Shih Yi-che said.

A coastguard official in Japan said the vessel was "sailing towards the Senkakus".

The islands in the East China Sea, whose seabed is believed to harbour valuable mineral reserves, are known as Senkaku in Japanese and Diaoyu in Chinese. Both China and Taiwan claim them.

The group said it was on its way to plant a statue of a sea goddess believed by coastal communities in the region to have the power to protect seafarers, but it was not clear if the activists would attempt to land.

It also intended to "maintain sovereignty" against Japan's control, said Hsieh Mang-lin, the Taiwanese chairman of the Chinese Association for Protecting the Diaoyutais (Diaoyu Islands), in a short statement.

Japanese broadcaster NHK reported that Taipei had dispatched six patrol boats to "monitor" the ship, adding it was the same one that had entered waters off the islands in July.

Taiwan's coastguard denied it was an organised flotilla.

"Coastguard ships that patrol the area routinely will protect the boat," said spokesman Shih, who declined to give the number of official Taiwanese vessels in the area.

"The coastguard will protect our people's voluntary actions to defend the Diaoyu islands. Coastguard vessels will go wherever the fishing boat is... to defend our sovereignty and protect our fishing rights," a statement said.

In September, coastguard vessels from Japan and Taiwan duelled with water cannon after dozens of Taiwanese boats were escorted by patrol ships into the islands' waters.

Earlier, Japanese media reports had said there were Hong Kong activists on board the boat, but a spokesman for the southern Chinese territory's main Diaoyu protest group told AFP it was not involved.

Previous activist landings have resulted in the arrest and deportation of those setting foot on what Japan says has been its indisputable territory for more than a century.

The rocky island outposts have been the scene of a diplomatic tussle between Japan and China for months.

Japan's government nationalised three of them in September by taking them out of private Japanese ownership.

Since then, Beijing has repeatedly sent government ships into the waters. In December, a Chinese government plane flew over them, leading Japan to scramble fighter jets.

Earlier this month, both militaries had jets in the area and Japanese newspapers have reported that Tokyo is mulling allowing its pilots to fire warning shots.

While most commentators believe Asia's two largest economies will find some way to work around the problem, which has rattled relations for decades, some are warning that a mis-step could lead to armed confrontation.

- AFP/al



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Amazon's Kindle and Paperwhite available in Canada




The latest generation of Kindle and the Kindle Paperwhite are now available for sale in Canada, according to Amazon.


The company has started selling its e-readers on Amazon.ca, its Canadian site, today. The
Kindle costs 89 Canadian dollars ($88.98). The Paperwhite, which has a lighted, touch screen, starts at 139 Canadian dollars ($138.95) for the 3G version. The Paperwhite with both Wi-Fi and 3G costs 199 Canadian dollars ($198.97).


The devices, which started shipping in the U.S. in September and October, will also be available at over 1,000 retail locations in Canada, including Staples, The Source and Shoppers Drug Mart, according to Amazon.



Although it's been holding out on Canada, the company took the time to highlight the Canada Kindle Store's Canadian selections in its press release. The store has over 1.5 million Kindle book, including 50,000 French-language titles, and Canadian publishers and authors like Margaret Atwood, Alice Munro and Yann Martel.

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