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Updated: Monday Dec 31, 2012 | 11:45 AM EST
WASHINGTON (AP) — The Food and Drug Administration on Monday 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 older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.
Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.
Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.
The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.
"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."
Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.
Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.
Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.
"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."
The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.
Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.
WASHINGTON (Reuters) - Financial markets would be affected adversely if U.S. lawmakers fail to agree on a "fiscal cliff" deal before Tuesday, President Barack Obama said in an interview broadcast on Sunday, while urging Congress to act quickly to extend tax cuts for middle-class Americans.
Lawmakers are seeking a last-minute deal that would set aside $600 billion in tax increases and across-the-board government spending cuts that are set to start within days. If Congress does not make that happen, the first bill brought up in the new year would be to reduce taxes for middle-income families, Obama told NBC's "Meet the Press."
"Now I think that over the next 48 hours, my hope is that people recognize that, regardless of partisan differences, our top priority has to be to make sure that taxes on middle-class families do not go up. That would hurt our economy badly," Obama said in the interview taped on Saturday.
"We can get that done. Democrats and Republicans both say they don't want taxes to go up on middle-class families. That's something we all agree on. If we can get that done, that takes a big bite out of the 'fiscal cliff.' It avoids the worst outcomes," Obama added.
Low income tax rates first put in place under Republican former President George W. Bush are due to expire at the end of the day on Monday - the last day of 2012.
Obama said that failing to reach a deal would have a negative impact on financial markets.
"If people start seeing that on January 1st this problem still hasn't been solved, that we haven't seen the kind of deficit reduction that we could have had had the Republicans been willing to take the deal that I gave them ... then obviously that's going to have an adverse reaction in the markets," he said.
RARE SENATE SESSION ON SUNDAY
Obama met with congressional leaders at the White House on Friday and declared himself cautiously optimistic about the chances of an agreement, but he noted in the interview that nothing had materialized since then.
"I was modestly optimistic yesterday, but we don't yet see an agreement. And now the pressure's on Congress to produce," he said.
The Senate is scheduled to hold a rare Sunday session beginning at 1 p.m. EST (1800 GMT), but it was not clear whether the chamber would have fiscal-cliff legislation to act upon.
Obama sketched out what he believed to be the most likely scenarios the end the back-and-forth between both sides. Either the congressional leaders would come up with a deal, or Democrats in the Senate would bring a bill to the floor seeking an up-or-down vote to extend tax cuts for middle income earners.
"And if all else fails, if Republicans do in fact decide to block it, so that taxes on middle class families do in fact go up on January 1st, then we'll come back with a new Congress on January 4th and the first bill that will be introduced on the floor will be to cut taxes on middle class families," he said.
Obama chided Republicans for resisting his call for tax rates to go up for the top two percent of U.S. earners despite what he viewed as significant compromises on his part to cut spending and reform expensive social programs for the poor and elderly.
"They say that their biggest priority is making sure that we deal with the deficit in a serious way, but the way they're behaving is that their only priority is making sure that tax breaks for the wealthiest Americans are protected. That seems to be their only overriding, unifying theme," Obama said.
"The offers that I've made to them have been so fair that a lot of Democrats get mad at me. I mean I offered to make some significant changes to our entitlement programs in order to reduce the deficit," he said.
(Reporting by Jeff Mason; Editing by David Brunnstrom)
ARCHER’S POST, Kenya — Julius Lokinyi was one of the most notorious poachers in this part of Kenya, accused of single-handedly killing as many as 100 elephants and selling the tusks by the side of the road in the dead of night, pumping vast amounts of ivory into a shadowy global underground trade.
But after being hounded, shamed, browbeaten and finally persuaded by his elders, he recently made a remarkable transformation. Elephants, he has come to believe, are actually worth more alive than dead, because of the tourists they attract. So Mr. Lokinyi stopped poaching and joined a grass-roots squad of rangers — essentially a conservation militia — to protect the wildlife he once slaughtered.
Nowadays he gets up at dawn, slurps down a cup of sugary tea, tightens his combat boots and marches off with other villagers, some who had never picked up a gun before and are little more than volunteers, to fight poachers.
“We got to protect the elephants,” said Mr. Lokinyi, whose hooded eyes now glow with the zeal of a convert.
From Tanzania to Cameroon, tens of thousands of elephants are being poached each year, more than at any time in decades, because of Asia’s soaring demand for ivory. Nothing seems to be stopping it, including deploying national armies, and the bullet-riddled carcasses keep stacking up. Scientists say that at this rate, African elephants could soon go the way of the wild American bison.
But in this stretch of northern Kenya, destitute villagers have seized upon an unconventional solution that, if replicated elsewhere, could be the key to saving thousands of elephants across Africa, conservationists say. In a growing number of communities here, people are so eager, even desperate, to protect their wildlife that civilians with no military experience are banding together, grabbing shotguns and G3 assault rifles and risking their lives to confront heavily armed poaching gangs.
It is essentially a militarized neighborhood watch, with loping, 6-foot-6 former herdsmen acting as the block captains, and the block being miles and miles of zebra-studded bush. These citizen-rangers are not doing this out of altruism or some undying love for pachyderms. They do it because in Kenya, perhaps more than just about anywhere else, wildlife means tourists, and tourists mean dollars — a lot of dollars.
It is not unusual here for a floppy-hatted visitor to drop $700 a night to sleep in a tent and absorb the sights, sounds and musky smells of wondrous game. Much of that money is contractually bound to go directly to impoverished local communities, which use it for everything from pumping water to college scholarships, giving them a clear financial stake in preserving wildlife. The safari business is a pillar of the Kenyan economy, generating more than a billion dollars a year and nearly 500,000 jobs: cooks, cleaners, bead-stringers, safari guides, bush pilots, even accountants to tally the proceeds.
Surprisingly, many jobs in the safari industry can pay as much as poaching. Though the ivory trade may seem lucrative, it is often like the Somali pirate business model, with the entry-level hijacker getting just a minuscule cut of the million-dollar ransoms. While a pound of ivory can fetch $1,000 on the streets of Beijing, Mr. Lokinyi, despite his lengthy poaching résumé, was broke, making it easier to lure him out of the business.
Villagers are also turning against poachers because the illegal wildlife trade fuels crime, corruption, instability and intercommunal fighting. Here in northern Kenya, poachers are diversifying into stealing livestock, printing counterfeit money and sometimes holding up tourists. Some are even buying assault rifles used in ethnic conflicts.
The conservation militias are often the only security forces around, so they have become de facto 911 squads, rushing off to all sorts of emergencies in areas too remote for the police to quickly gain access to and often getting into shootouts with poachers and bandits.
“This isn’t just about animals,” said Paul Elkan, a director at the Wildlife Conservation Society, who is trying to set up community ranger squads in South Sudan modeled on the Kenyan template. “It’s about security, conflict reconciliation, even nation building.”
The rangers tend to be hardened and uneducated, drawn from different ethnic groups and the surplus of unemployed youth. Gabriel Lesoipa was a goat herder; Joseph Lopeiyok, a cattle rustler; John Pameri won his coveted spot because he was fast — at the time he was selected, the first entry requirement was a grueling 11-mile race.
Many are considered warriors in their communities, experts in so-called bushcraft from years of grazing cattle and goats across the thorny savanna — and defending them against armed raiders. They can follow faint footprints across long, thirsty distances and instantly intuit when someone has trespassed on their land.
NASA has completed a 43,000 hour stress test — a record for ion thrusters — on a new rocket propulsion system that could extend future space travel to farther reaches of the solar system.
Developed by NASA’s Evolutionary Xenon Thruster Project, the 7-kilowatt ion thruster can burn 10-12 times longer than the conventional chemical thrusters used today. Though not practical for manned-spaceflight, the system could power exploratory rockets that reach outer planets and their moons.
[More from Mashable: NASA Unveils E-books on Hubble, Webb Space Telescopes]
To find out more, watch the video above and let us know your thoughts in the comments.
Photo courtesy of NASA
[More from Mashable: First ‘Alien Earth’ Will Be Found in 2013]
BONUS: 15 Twitter Accounts Every Space Lover Should Follow
Captain Williams is a NASA astronaut who recently completed the first triathlon in space.
Click here to view this gallery.
This story originally published on Mashable here.
Tech News Headlines – Yahoo! News
By Maggie Coughlan
12/30/2012 at 11:30 AM EST
The 28-year-old showed off her svelte figure in a tiny bikini as she splashed along the shores of Oahu, Hawaii on Saturday.
The singer and son Bronx (with Pete Wentz) joined pregnant big sister Jessica, her fiancé Eric Johnson and 7-month-old niece Maxwell Drew for a Hawaiian holiday.
Ashlee – who recently split from Boardwalk Empire actor Vincent Piazza after a year and a half of dating – smiled as she held hands with Bronx, 4.
This holiday season has been all about family for the Simpson clan. Tina Simpson – who filed for divorce from husband of 34 years, Joe Simpson, in October – also joined the girls in Hawaii.
NAIROBI, Kenya (AP) — The director of the Pumwani Maternity Hospital, located in a hardscrabble neighborhood of downtown Nairobi, freely acknowledges what he's accused of: detaining mothers who can't pay their bills. Lazarus Omondi says it's the only way he can keep his medical center running.
Two mothers who live in a mud-wall and tin-roof slum a short walk from the maternity hospital, which is affiliated with the Nairobi City Council, told The Associated Press that Pumwani wouldn't let them leave after delivering their babies. The bills the mothers couldn't afford were $60 and $160. Guards would beat mothers with sticks who tried to leave without paying, one of the women said.
Now, a New York-based group has filed a lawsuit on the women's behalf in hopes of forcing Pumwani to stop the practice, a practice Omondi is candid about.
"We hold you and squeeze you until we get what we can get. We must be self-sufficient," Omondi said in an interview in his hospital office. "The hospital must get money to pay electricity, to pay water. We must pay our doctors and our workers."
"They stay there until they pay. They must pay," he said of the 350 mothers who give birth each week on average. "If you don't pay the hospital will collapse."
The Center for Reproductive Rights, which filed the suit this month in the High Court of Kenya, says detaining women for not paying is illegal. Pumwani is associated with the Nairobi City Council, one reason it might be able to get away with such practices, and the patients are among Nairobi's poorest with hardly anyone to stand up for them.
Maimouna Awuor was an impoverished mother of four when she was to give birth to her fifth in October 2010. Like many who live in Nairobi's slums, Awuor performs odd jobs in the hopes of earning enough money to feed her kids that day. Awuor, who is named in the lawsuit, says she had saved $12 and hoped to go to a lower-cost clinic but was turned away and sent to Pumwani. After giving birth, she couldn't pay the $60 bill, and was held with what she believes was about 60 other women and their infants.
"We were sleeping three to a bed, sometimes four," she said. "They abuse you, they call you names," she said of the hospital staff.
She said saw some women tried to flee but they were beaten by the guards and turned back. While her husband worked at a faraway refugee camp, Awuor's 9-year-old daughter took care of her siblings. A friend helped feed them, she said, while the children stayed in the family's 50-square-foot shack, where rent is $18 a month. She says she was released after 20 days after Nairobi's mayor paid her bill. Politicians in Kenya in general are expected to give out money and get a budget to do so.
A second mother named in the lawsuit, Margaret Anyoso, says she was locked up in Pumwani for six days in 2010 because she could not pay her $160 bill. Her pregnancy was complicated by a punctured bladder and heavy bleeding.
"I did not see my child until the sixth day after the surgery. The hospital staff were keeping her away from me and it was only when I caused a scene that they brought her to me," said Anyoso, a vegetable seller and a single mother with five children who makes $5 on a good day.
Anyoso said she didn't have clothes for her child so she wrapped her in a blood-stained blouse. She was released after relatives paid the bill.
One woman says she was detained for nine months and was released only after going on a hunger strike. The Center for Reproductive Rights says other hospitals also detain non-paying patients.
Judy Okal, the acting Africa director for the Center for Reproductive Rights, said her group filed the lawsuit so all Kenyan women, regardless of socio-economic status, are able to receive health care without fear of imprisonment. The hospital, the attorney general, the City Council of Nairobi and two government ministries are named in the suit.
___
Associated Press reporter Tom Odula contributed to this report.
NEW YORK (Reuters) - Stocks fell on Friday, putting the S&P 500 on track for a fifth straight decline, as President Barack Obama and top congressional leaders were to make a last-ditch attempt to steer the United States away from driving off the "fiscal cliff."
Obama and lawmakers will meet at the White House Friday afternoon for talks before a New Year's deadline to keep large tax hikes and spending cuts from taking effect and threatening the economy with recession.
Investors' pessimism about achieving anything more than a stop-gap deal by the deadline showed in the benchmark S&P index's 1.6 percent decline this week. The broad index was on pace for its worst weekly performance since the U.S. elections.
With time running short, members of Congress may attempt to pass a retroactive fix on tax rises and spending cuts soon after the automatic fiscal policies come into effect on January 1.
"It doesn't matter which side wins, but at this point nobody wants to play a game where there aren't rules," said Joe Costigan, director of equity research at Bryn Mawr Trust in Bryn Mawr, Pennsylvania.
"So everybody is talking about what the prospects are for changes in the rules, but at the end of the day nothing is happening."
Highlighting Wall Street's sensitivity to developments in Washington, stocks took a dive of more than 1 percent on Thursday after Senate Majority Leader Harry Reid warned a deal was unlikely before the deadline. But later the index rebounded after the House of Representatives said it hold an unusual Sunday session to work on a fiscal solution.
With many market participants away for the holiday-shortened week, volume is expected to remain light, which could exacerbate market swings.
The Dow Jones industrial average <.dji> dropped 90.70 points, or 0.69 percent, to 13,005.61. The Standard & Poor's 500 Index <.spx> lost 9.74 points, or 0.69 percent, to 1,408.36. The Nasdaq Composite Index <.ixic> fell 16.25 points, or 0.54 percent, to 2,969.66.
Market breadth was skewed to the negative, with declining stocks outnumbering gainers on the NYSE by 2,044 to 690, while on the Nasdaq, decliners outnumbered advancers 1,466 to 707.
Positive economic data failed to alter the market's downtrend.
The National Association of Realtors said contracts to buy previously owned U.S. homes rose in November to their highest level in 2-1/2 years, while a report from the Institute for Supply Management-Chicago showed business activity in the U.S. Midwest expanded in December.
Barnes & Noble Inc
MagicJack Vocaltec Ltd
Aeterna Zentaris Inc U.S.-listed shares surged 18.4 percent to $2.57 after the company said it had reached an agreement with the U.S. Food and Drug Administration on a special protocol assessment by the FDA for phase 3 registration trial in endometrial cancer with AEZS-108 treatment.
(Reporting by Chuck Mikolajczak; Editing by Kenneth Barry)
President Jacob Zuma, left, said in a speech that the idea of having a pet was part of “white culture” and that people should focus on family welfare, the newspaper The Star reported Thursday. The president’s office sought to clarify the remarks, saying that he was encouraging “the previously oppressed African majority” to uphold its own culture. It also suggested the way in which the comments were reported, rather than the comments themselves, was divisive.
During his speech on Wednesday to a crowd in KwaZulu-Natal, Mr. Zuma’s home province, the president said that people who loved dogs more than people had a “lack of humanity” and that some people were trying in vain to “emulate whiteness,” The Star reported. In a statement, the South African presidency said that Mr. Zuma was trying to “decolonize the African mind post-liberation” and enable people to take pride in their heritage and not feel pressure to adopt customs of minority cultures. Animals can be cared for, was the message, but not at the expense of people.
Apple’s (AAPL) share of the global tablet market is in decline now that low-cost Android slates are proliferating, but the iPad still appears to be the most used tablet by a huge margin. Ad firm Chitika regularly monitors tablet traffic in the United States and Canada and in its latest report, Apple’s iPad was responsible for almost 90% of all tablet traffic across the company’s massive network.
[More from BGR: Samsung looks to address its biggest weakness in 2013]
Using a sample of tens of millions of impressions served to tablets between December 8th and December 14th this year, Chitika determined that various iPad models collectively accounted for 87% of tablet traffic in North America. That figure is down a point from the prior month but still represents a commanding lead in the space.
[More from BGR: New purported BlackBerry Z10 specs emerge: 1.5GHz processor, 2GB RAM, 8MP camera]
The next closest device line, Amazon’s (AMZN) Kindle Fire tablet family, had a 4.25% share of tablet traffic during that period, up from 3.57% in November. Samsung’s (005930) Galaxy tablets made up 2.65% of traffic, up from 2.36%, and Google’s (GOOG) Nexus 7 and Nexus 10 tablets combined to account for 1.06% of tablet traffic in early December.
“Despite these gains by some of the bigger players in the tablet marketplace, there has been a negligible impact to Apple’s dominant usage share,” Chitika wrote in a post on its blog.
This article was originally published by BGR
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