Possible deal emerging in debt talks


WASHINGTON (AP) — The contours of a deal to avert the 'fiscal cliff' emerged Monday, with Democrats and Republicans agreeing to raise tax rates on family income over $450,000 a year, increase the estate tax rate and extend unemployment benefits for one year, officials familiar with the negotiations said.


But with a midnight deadline rapidly approaching, both sides were at an impasse over whether to put off automatic, across-the-board spending cuts set to take effect on Jan. 1, and if so, how to pay for that. Democrats want to put off the cuts for one year and offset the so-called sequester with unspecified revenue.


Officials emphasized that negotiations were continuing and the emerging deal was not yet final. President Barack Obama was to speak about the status of the negotiations from the White House early Monday afternoon.


The proposal in the works would raise the tax rates on family income over $450,000 to 39.6 percent, the same level as under former President Bill Clinton. Also, estates would be taxed at 40 percent after the first $5 million, up from 35 percent to 40 percent. Unemployment benefits would be extended for one year.


A Republican official familiar with the plans confirmed the details described to The Associated Press.


The officials requested anonymity in order to discuss the internal negotiations.


Urgent talks were continuing Monday afternoon between the White House and congressional Republicans, with longtime negotiating partners Vice President Joe Biden and Senate Republican leader Mitch McConnell at the helm.


An agreement on the proposed deal would also shield Medicare doctors from a 27 percent cut in fees and extend tax credits for research and development, as well as renewable energy.


The deal would also extend for five years a series of tax credits meant to lessen the financial burden on poorer and middle-class families, including one credit that helps people pay for college.


The deal would achieve about $600 billion in new revenue, the officials said.


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Canadian job creation seen sharply lower in December






OTTAWA (Reuters) – Canada‘s job market is expected to slow markedly in December to reflect the sluggish economy and employers’ fears about the U.S. fiscal crisis following outsized gains of over 50,000 jobs in two of the previous three months.


The median forecast in a Reuters poll is for the economy to add just 5,000 jobs in the month, with forecasts ranging from a loss of 20,000 positions to a gain of 21,000.






The forecast compares with employment growth of 59,600 in November, 1,800 in October and 52,100 in September.


The unemployment rate is seen ticking higher in the final month of the year to 7.3 percent from 7.2 percent.


Derek Holt, vice president of economics at Scotiabank, said he’s been surprised by the strength of job growth which he estimates to be the equivalent in the United States of about 1.5 million non-farm payroll jobs over the last three months.


“Here we are with the conundrum where we have zero growth in the Canadian economy, long predating the appearance of the greatest fiscal-cliff risks and yet we’re heaping on jobs like there’s no tomorrow,” Holt said.


Unlike the United States, Canada has long recovered all the jobs lost during the 2008-09 recession but the pace of hiring in 2012 was unsteady.


Benjamin Reitzes, economist at BMO Capital Markets, said if the 5,000-job forecast was accurate, it would put 2012 job growth at just 1.1 percent, “the weakest non-recession year since 1996.”


Canadian employers have faced uncertainty in one form or another during the recovery and are now fretting about the U.S. fiscal cliff, a set of tax hikes and spending cuts that will automatically take effect and could throw the United States into recession unless the White House and Congress reach an alternative agreement.


“For as long as Washington cannot agree on the new tax rules and spending focus, they’re not going to give business the confidence to go out and hire and engage in capital spending projects and that’s going to impede the pace of recovery until we get more clarity,” said Holt.


With the Canadian economy now expected to grow by far less in the fourth quarter than the Bank of Canada‘s projection of 2.5 percent, annualized, the blockbuster jobs growth of recent months looks suspect. The six-month trend shows more sustainable gains of about 21,000 a month.


The moderation means the Bank of Canada will be in no hurry to raise its benchmark interest rate, which it has held at 1.0 percent since September 2010.


Market players surveyed by Reuters in late November predicted the bank would resume hiking rates in the fourth quarter of 2013.


(Reporting by Louise Egan; Editing by Kenneth Barry)


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Can Samsung survive without Android?






Samsung (005930) is the world’s top Android smartphone vendor by a staggering margin. Aside from LG (066570), which managed a small $ 20 million profit from its mobile division last quarter, no other global Android vendor can figure out how to make money selling Android phones. Meanwhile, Samsung posted a $ 6 billion profit on $ 47.6 billion in sales in the third quarter, thanks largely to record smartphone shipments and a massive marketing budget. Even as industry watchers turn sour on Apple, Samsung is seen steamrolling into 2013 and its stock is up nearly 50% on the year while Apple (AAPL) shares continue to fall from a record high hit in September. As unstoppable as Samsung appears right now, one key question remains: Is Samsung driving Android’s success or is Android driving Samsung’s success? Starting in 2013, we may finally begin to find out.


[More from BGR: Unreleased ‘BlackBerry X10′ QWERTY phone appears again in new photos]






Earlier this year, BGR wrote about Samsung’s effort to look beyond Android. Even with its own UI and application suite — and even with its own content services — Samsung will always rely on Google (GOOG) if it continues to base its devices on Google’s latest Android builds.


[More from BGR: RIM teases BlackBerry 10 launch with image of first BB10 smartphone]


This isn’t necessarily a bad thing, but it means Samsung will never truly control the end-to-end experience on its products. It also means Samsung will never truly own its smartphones and tablets. Instead, Samsung’s devices will deliver an experience that is an amalgamation of Google’s vision and its own.


But there are alternative options. One example is the path Amazon (AMZN) has taken. Amazon let Google do the grunt work and then took its open-source Android OS and built its own software and service layer on top. Kindle Fire users don’t sit around waiting for Android updates — many of them don’t even know they’re using an Android-powered tablet.


Samsung could do the same thing, but there is a great deal of prep work that would need to be done first. Amazon’s efforts were so successful (depending on your measure of success) because the company already had a massive ecosystem in place before it even launched its first device. Streaming movies and TV shows, eBooks, retail shopping and a stocked application store were all available on the Kindle Fire from day one.


Samsung doesn’t have this luxury. Yet.


Samsung could also take ownership of a new OS, and Tizen may or may not end up being that OS. Samsung is co-developing the new Linux-based mobile platform with Intel (INTC) and others, and a new rumor from Japan’s The Daily Yomiuri suggests Samsung plans to launch its first Tizen phone in 2013. “Samsung will probably begin selling the [Tizen] smartphones next year and they are likely to be released in Japan and other countries at around the same time,” the site’s sources claim.


This will be a slow process. If Samsung follows the same path it took with Bada, Samsung’s earlier Linux-based OS that was folded into the Tizen project, things will start out slow as Samsung launches regional devices that are restricted to a few Eastern markets. Testing the waters before dumping serious marketing dollars into the project isn’t a bad idea, especially considering the battle at the bottom of the smartphone OS food chain that will already be taking place in 2013.


But one thing is clear: Samsung is looking to broaden its strategy and move beyond a point where it relies entirely on another company for its smartphone software.


This article was originally published by BGR


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FDA approves 1st new tuberculosis drug in 40 years






WASHINGTON (AP) — The Food and Drug Administration says it has approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.


The agency approved J&J’s pill, Sirturo, for use with other older drugs to fight hard-to-treat tuberculosis.






Sirturo is the first medicine specifically designed for treating multi-drug-resistant tuberculosis. That’s an increasingly common form of the disease that cannot be treated with at least two of the four primary antibiotics used to treat tuberculosis.


The standard drugs used to fight the disease were developed in the 1950s and 1960s.


Roughly one-third of the world’s population is estimated to be infected with the bacteria causing tuberculosis.


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Biden, McConnell 'jump-start' stalled talks


Vice President Joe Biden looks on as President Barack Obama announces the nomination of Senator John Kerry as Secretary …Merry Cliffmas Eve? Vice President Joe Biden and Republican Senate Minority Leader Mitch McConnell on Monday pursued their behind-closed-doors efforts to avoid the “fiscal cliff” with just hours to halt painful automatic income tax hikes from biting into American paychecks.


McConnell announced on Sunday that he had reached out to Biden to help “jump-start” stalled negotiations with Democratic Senate Majority Leader Harry Reid. The two veteran Washington deal-makers spoke at 12:45 a.m. and 6:30 a.m., a McConnell aide said.


“The Leader and the VP continued their discussion late into the evening and will continue to work toward a solution,” McConnell spokesman Don Stewart told reporters by email on Monday, promising “more information as it becomes available.”


“We really are running out of time,” Reid said shortly after 11 a.m. as lawmakers began a highly unusual New Year’s Eve session. “There are a number of issues on which the two sides are still apart, but negotiations are continuing as I speak.”


The two sides were wrangling over how to extend massive tax cuts adopted in 2001 and 2003 and expiring at midnight. President Barack Obama campaigned on letting tax rates rise on income above $200,000 for individuals and $250,000 for households, but any final deal is expected to set the threshold considerably higher.


“I hope we can keep in mind – and I know we will – that our single most-important goal is to protect middle class families,” said Reid. “Whether or not we reach an agreement in the short time we have left, we’ll need cooperation on both sides to prevent taxes from going up tomorrow for every family in America.”



They were also battling over the estate tax paid on large inheritances. Republicans have fought to extend the current levels of what they call the “death tax” – exempting estates under $5 million and taxing transfers above that at 35%.  Absent a deal, the tax will hit estates above $1 million and impose a top tax rate of 55%.


The two sides were also struggling with the so-called sequester -- $1.2 trillion in automatic cuts to domestic and defense programs over ten years. Democrats suggested Sunday that they hoped to use some of the new tax revenues to postpone some proportion of those cuts. Republicans objected, saying that only new spending cuts could be used to offset the sequester.


And there was feuding over how to spare tens of million of Americans who otherwise would find themselves paying the Alternative Minimum Tax (AMT), and over how to prevent cuts in payments to doctors who treat Medicare patients.


Any deal would need to clear both the Democratic-led Senate and the Republican-held House of Representatives. Neither looked to be an easy effort.


And it was unlikely that the compromise would spare the country another bruising partisan battle over whether and how to raise the national debt limit. Republicans have signaled that they will hold the threat of a first-ever default as leverage to win more spending cuts from the Administration. President Barack Obama has signaled that he will not negotiate on the issue the way he did in 2011, when the partisan feuding over what had typically been a routine vote in the past led to the first-ever downgrade of America’s credit rating.



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List: No love for ‘fiscal cliff,’ ‘spoiler alert’






DETROIT (AP) — Spoiler alert: This story contains words and phrases that some people want to ban from the English language. “Spoiler alert” is among them. So are “kick the can down the road,” ”trending” and “bucket list.”


A dirty dozen have landed on the 38th annual List of Words to be Banished from the Queen’s English for Misuse, Overuse and General Uselessness. The nonbinding, tongue-in-cheek decree released Monday by northern Michigan’s Lake Superior State University is based on nominations submitted from the United States, Canada and beyond.






“Spoiler alert,” the seemingly thoughtful way to warn readers or viewers about looming references to a key plot point in a film or TV show, nevertheless passed its use-by date for many, including Joseph Foly, of Fremont, Calif. He argued in his submission the phrase is “used as an obnoxious way to show one has trivial information and is about to use it, no matter what.”


At the risk of further offense, here’s another spoiler alert: The phrase receiving the most nominations this year is “fiscal cliff,” banished because of its overuse by media outlets when describing across-the-board federal tax increases and spending cuts that economists say could harm the economy in the new year without congressional action.


“You can’t turn on the news without hearing this,” said Christopher Loiselle, of Midland, Mich., in his submission. “I’m equally worried about the River of Debt and Mountain of Despair.”


Other terms coming in for a literary lashing are “superfood,” ”guru,” ”job creators” and “double down.”


University spokesman Tom Pink said that in nearly four decades, the Sault Ste. Marie school has “banished” around 900 words or phrases, and somehow the whole idea has survived rapidly advancing technology and diminishing attention spans.


Nominations used to come by mail, then fax and via the school’s website, he said. Now most come through the university’s Facebook page. That’s fitting, since social media has helped accelerate the life cycle of certain words and phrases, such as this year’s entry “YOLO” — “you only live once.”


“The list surprises me in one way or another every year, and the same way every year: I’m always surprised how people still like it, love it,” he said.


Rounding out the list are “job creators/creation,” ”boneless wings” and “passion/passionate.” Those who nominated the last one say they are tired of hearing about a company’s “passion” as a substitute for providing a service or product for money.


Andrew Foyle, of Bristol, England, said it’s reached the point where “passion” is the only ingredient that keeps a chef from preparing “seared tuna” that tastes “like dust swept from a station platform.”


“Apparently, it’s insufficient to do it ably, with skill, commitment or finesse,” Foyle said. “Passionate, begone!”


As usual, the etymological exercise — or exorcise — only goes so far. Past lists haven’t eradicated “viral,” “amazing,” ”LOL” or “man cave” from everyday use.


___


Follow Jeff Karoub on Twitter: http://twitter.com/jeffkaroub


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Suspected US drone kills 3 al-Qaida men in Yemen






SANAA, Yemen (AP) — Three al-Qaida militants were killed in a suspected U.S. drone strike in southern Yemen, Yemeni security officials said, the fourth such attack this week and a sign attacks from unmanned aircraft are on the upswing in the country.


The officials said the three men were hit as they were riding in a Land Cruiser in el-Manaseh village on the outskirts of Radda in Bayda province. Dozens of local al-Qaida-linked fighters protested the drone strikes after traditional Islamic Friday prayers.






Earlier this week another suspected U.S. drone strike killed two militants in Radda itself, Yemeni security officials say, and seven were killed in two other strikes in the southeastern province of Hadramawt. Four suspected drone strikes a week is uncommon in Yemen.


According to statistics gathered by the Long War Journal before Saturday’s attacks, the United States “is known to have carried out 41 airstrikes” this year against al-Qaida in the Arabian Peninsula (AQAP), as the group’s branch in Yemen is known. That makes for an average of around three to four strikes per month.


The Journal, a product of the Foundation for Defense of Democracies that was founded by former U.S. officials, says that since December 2009, the CIA and the US military’s Joint Special Operations Command are known to have conducted at least 54 air and missile strikes inside Yemen, excluding Saturday’s suspected attack.


AQAP overran entire towns and villages — including Radda — last year by taking advantage of a security lapse during nationwide protests that eventually ousted the country’s longtime ruler. Backed by the U.S. military, Yemen’s army was able to regain control of the southern region but al-Qaida militants continue to launch deadly attacks on security forces that have killed hundreds.


Also on Saturday, two gunmen on a motorbike shot and killed an intelligence officer in the southeast, security officials said. They said that the officer, Mutea Baqutian, was on his way to work in Mukalla, capital of Hadramawt province, when the men stopped his car, gunned him down, and fled.


The government has blamed al-Qaida militants for similar assassinations of several senior military and intelligence officials this year. The bullet-riddled body of Major al-Numeiry Abdo al-Oudi, deputy director of the security department of al-Qitten in Hadramawt, was found in the town’s suburbs last week. He had been kidnapped earlier in the month.


All officials spoke on condition of anonymity according to regulations.


Meanwhile, Maj. Gen. Ahmed Seif, who is commander of Yemen’s central military region, said the Defense Ministry has deployed an infantry brigade in the northeastern province of Marib to stop armed tribesmen who maintain cordial ties with al-Qaida from attacking oil pipelines and power generating stations, as well as to counter al-Qaida militants.


State TV meanwhile aired a meeting between President Abed Rabbo Mansour Hadi and eight Yemeni sailors who were rescued last week by forces of Somalia’s semiautonomous Puntland region after being held for nearly three years by Somali pirates.


The Puntland government says that its forces captured the hijacked Panama-flagged MV Iceberg 1 on Sunday after a siege that lasted two weeks. They freed the eight Yemeni sailors together with five Indians, two Pakistanis, four Ghanaians, two Sudanese and a Filipino. The ship was hijacked March 29, 2010.


Hadi congratulated the eight sailors for their safety and ordered the government to compensate them for their suffering.


Eqbal Yassin, a relative of one of the freed sailors, told The Associated Press that the hijackers had allowed some sailors to phone their relatives and convey the pirates’ demand for $ 5 million ransom. He said he was told by his relative that the hijackers killed a Yemeni sailor who tried to escape. He gave no further details.


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Microsoft Surface trampled at the bottom of the tablet pile this Christmas






While it does have drawbacks just like anything else, Microsoft’s (MSFT) Surface is a great slate for those looking for a fresh new take on the modern tablet. Unfortunately, it doesn’t look like very many people were looking for a fresh new take on the modern tablet this holiday season. In a recent note to investors, R.W. Baird analyst William Power recounted recent conversations had at retailers including Best Buy (BBY) and Staples (SPLS). While speaking with sales reps at the stores, Apple’s (AAPL) iPad was the most highly recommended tablet while Amazon’s (AMZN) Kindle Fire line and Samsung’s (005930) Galaxy Tab line were both recommended as alternatives. Microsoft’s Surface tablet, on the other hand, was not pushed by reps at either chain.


[More from BGR: Purported photo of new BlackBerry phone with QWERTY keyboard leaks]






From Power’s note, as picked up by Barron’s:


[More from BGR: Sprint salesman refuses to sell iPhone to customer, says his ‘fingers are too fat’ to use it]



Microsoft’s Surface, which Best Buy just recently started carrying, was not recommended to us by reps without us asking about it specifically. When asked about sales to date, reps noted that the device was new and indicated that early demand has been modest relative to the iPad and Kindle Fire. We would also note that the device was in stock at every store we contacted […] We contacted Staples stores in an effort to further gauge Microsoft Surface sales, though our impression from speaking with reps was tablets are not a major seller at Staples. Tellingly, Staples doesn’t currently carry the iPad. When pressed for details, Staples reps indicated that Surface volumes have been modest to date. Most reps told us that the primary appeal to Surface buyers is the ability to run Microsoft Office. Consistent with our Best Buy checks, the Surface was also in stock at all Staples stores we contacted. Outside of the Surface, the Google Nexus 10 was cited as another strong tablet option.



Further supporting the idea that Microsoft’s debut tablet wasn’t a big seller this holiday season, Twitter user A.X. Ian did a quick analysis of tweets discussing new tablets during a 24-hour period around Christmas Eve.


Based on his data, 1,795 people tweeted about getting a new iPad during that time span while 250 tweeted about their new Kindle Fires, 100 mentioned their new Nexus 10 tablets and just 36 tweets were posted by users who had received a new Surface.


This article was originally published by BGR


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Hot spots draw believers, but not doomsday






As the sun rose from time zone to time zone across the world on Friday, there was still no sign of the world’s end — but that didn’t stop those convinced that a 5,125-year Mayan calendar predicts the apocalypse from gathering at some of the world’s purported survival hot spots.


Many of the esoterically inclined expected a new age of consciousness — others wanted a party. But, in some places said to offer salvation from the end, fewer people showed up than officials had predicted — much to the disappointment of vendors hoping to sell souvenirs.






Here are some key places being marked by the fascination over doomsday rumors:


MEXICO


In an area of Mexico that was once the ancient Mayan heartland, spiritualists gathered in the darkness before dawn on Friday to prepare white clothes, drums, conch shells and incense. They believed the sunrise would herald the birth of a new and better age as a vast cycle in the Mayan calendar comes to an end.


Many people who came to Yucatan for the occasion were already calling it “a new sun” and “a new era.”


FRANCE


According to one rumor, a rocky mountain in the French Pyrenees will be the sole place on Earth to escape destruction. A giant UFO and aliens are said to be waiting under the mountain, ready to burst through and spirit those nearby to safety. But there is bad news for those seeking salvation: French gendarmes, some on horseback, blocked outsiders from reaching the Bugarach peak and its village of some 200 people.


Eric Freysselinard, head of local government, said the security forces had “partially stopped the new age enthusiasts as well as curious people from coming to the area.”


Meanwhile, some Bugarach residents dressed up like aliens, with tinfoil costumes and funnels and fake antenna on their heads, strolling around their village Friday to make light of the rumored UFO prophecy.


RUSSIA


Doomsday rumors have prompted some people across Russia to stock up on candles, water, canned foods and other non-perishable foods. The apocalypse has proven a good business, with some shops selling survival aid packages that include soap and vodka.


In Moscow, salvation has also been promised in the underground bunker for the former Soviet dictator Josef Stalin — with a 50 percent refund if nothing happens. An underground stay was originally priced at 50,000 rubles ($ 1,625) but dropped to 15,000 ($ 490) a week ahead of the feared end.


The bunker, located 65 meters (210 feet) below ground, was designed to withstand a nuclear attack. Now home to a small museum, it has an independent electricity supply, water and food — but no more room, because the museum has already sold out all 1,000 tickets.


BRITAIN


Hundreds of people have converged on Stonehenge for an “End of the World” party that coincides with the Winter Solstice.


Arthur Uther Pendragon, Britain’s best-known druid, said he was anticipating a much larger crowd than usual at Stonehenge this year. But he doesn’t agree that the world is ending, noting that he and fellow druids believe that things happen in cycles.


“We’re looking at it more as a new beginning than an end,” he said. “We’re looking at new hope.”


Meanwhile, end-of-days parties will be held across London on Friday. One event billed as a “last supper club” is offering a three-course meal served inside an “ark.”


SERBIA


Some Serbs are saying to forget that sacred mountain in the French Pyrenees. The place to be Friday is Mount Rtanj, a pyramid-shaped peak in Serbia already drawing cultists.


According to legend, the mountain once swallowed an evil sorcerer who will be released on doomsday in a ball of fire that will hit the mountain top. The inside of the mountain will then open up, becoming a safe place to hide as the sorcerer goes on to destroy the rest of the world. In the meantime, some old coal mine shafts have been opened up as safe rooms.


On Friday a New Age group called “The Spirit of Rtanj” was holding a conference there. Participants, however, said they expect not the end of time but the start of a new time cycle. Locals turned out to sell brandy and herbs.


“There will be no tragedy, no doomsday,” said resident Dalibor Jovic. “It was supposed to happen at 12:12 and I think that time has passed. So, we can now go on with our lives and be happy to be alive.”


TURKEY


A small Turkish village known for its wines, Sirince, has also been touted as the only place after Bugarach that would escape the world’s end. But on Friday journalists and security officials outnumbered cultists. This outcome disappointed local business people who had prepared a range of doomsday products to sell, including a specially labeled Doomsday wine and Turkish delight candy whose “best before” date was Dec. 21, 2012. One restaurant prepared a special “last meal” menu that included a “heaven kebab” and “forbidden fruit dessert.”


ITALY


Another spot said to be spared: Cisternino, a beautiful small town in southern Italy in an area of trulli, traditional dry stone huts with conical roofs. The notion that Cisternino could be a safe haven at world’s end derives from an Indian guru, Babaji, who said “Cisternino will become an island” at world’s end. His followers built a community in Cisternino centered on an ashram built in 1979. Hotel bookings are up this weekend.


Mayor Donato Baccaro told the AP that the beauty of the place has inspired many foreigners to live there. “This confirms that this place has a special energy,” he said.


CHINA


A fringe Christian group has been spreading rumors about the world’s impending end, prompting Chinese authorities to detain more than 500 people this week and seize leaflets, video discs, books and other material.


Those detained are reported to be members of the group Almighty God, also called Eastern Lightning, which preaches that Jesus has reappeared as a woman in central China. Authorities in the province of Qinghai say they are waging a “severe crackdown” on the group, accusing it of attacking the Communist Party and the government.


U.S.


Dozens of Michigan schools canceled classes for thousands of students to cool off rumored threats of violence and problems related to doomsday. The fears were exacerbated by the recent shooting at a Connecticut elementary school, which “changed all of us,” the school system in Genesee County said. “Canceling school is the right thing to do.”


___


Associated Press writers Florent Bajrami in Bugarach, France; Mansur Mirovalev in Moscow; Peppino Ciraci in Cisternino, Italy; Suzan Fraser in Ankara, Turkey; Paisley Dodds in London; and Dejan Mladenovic in Mount Rtanj, Serbia, contributed to this report.


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Year in Review: Meningitis Outbreak Still a Challenge






As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here’s what’s happened with the fungal meningitis outbreak since we published our first report.


The fungal meningitis outbreak that made headlines in the fall was “unprecedented,” in the words of the of the clinicians at the eye of the storm.






What’s more, “we’re not out of the woods yet,” said Tom Chiller, MD, deputy director of the CDC’s mycotic diseases branch.


The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.


It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.


“The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing,” Kauffman told MedPage Today. “The huge morbidity and, for some, mortality, is enormous.”




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The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called “compounding pharmacies.”


And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.


The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.


The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: “We’re still in the middle of this thing.”


Compounding Out of Bounds


The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.


That was problematic in itself: The company was licensed as a compounding pharmacy, meaning in principle it was allowed only to make up small quantities of specialized drugs, after getting a prescription from a doctor for an individual patient.


Instead, it was acting more like a large-scale drug manufacturer, and had been for some years, according to Massachusetts officials, which should have placed it under the FDA’s authority.


The manufacturing scale played a key role in what ensued: more than 13,000 people were exposed to the drug when they got injections – mainly into the spine – to control chronic pain.


They were also exposed to a fungal contaminant in the steroid vials, later found to be a black mold called Exserohilum rostratum, which only rarely causes human disease.


Oddly, the index case for the outbreak, reported to health authorities on Sept. 18, was a 56-year-old man in Nashville who had a case of meningitis apparently associated with the fungus Aspergillus fumigatus.


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