Brain image study: Fructose may spur overeating


This is your brain on sugar — for real. Scientists have used imaging tests to show for the first time that fructose, a sugar that saturates the American diet, can trigger brain changes that may lead to overeating.


After drinking a fructose beverage, the brain doesn't register the feeling of being full as it does when simple glucose is consumed, researchers found.


It's a small study and does not prove that fructose or its relative, high-fructose corn syrup, can cause obesity, but experts say it adds evidence they may play a role. These sugars often are added to processed foods and beverages, and consumption has risen dramatically since the 1970s along with obesity. A third of U.S. children and teens and more than two-thirds of adults are obese or overweight.


All sugars are not equal — even though they contain the same amount of calories — because they are metabolized differently in the body. Table sugar is sucrose, which is half fructose, half glucose. High-fructose corn syrup is 55 percent fructose and 45 percent glucose. Some nutrition experts say this sweetener may pose special risks, but others and the industry reject that claim. And doctors say we eat too much sugar in all forms.


For the study, scientists used magnetic resonance imaging, or MRI, scans to track blood flow in the brain in 20 young, normal-weight people before and after they had drinks containing glucose or fructose in two sessions several weeks apart.


Scans showed that drinking glucose "turns off or suppresses the activity of areas of the brain that are critical for reward and desire for food," said one study leader, Yale University endocrinologist Dr. Robert Sherwin. With fructose, "we don't see those changes," he said. "As a result, the desire to eat continues — it isn't turned off."


What's convincing, said Dr. Jonathan Purnell, an endocrinologist at Oregon Health & Science University, is that the imaging results mirrored how hungry the people said they felt, as well as what earlier studies found in animals.


"It implies that fructose, at least with regards to promoting food intake and weight gain, is a bad actor compared to glucose," said Purnell. He wrote a commentary that appears with the federally funded study in Wednesday's Journal of the American Medical Association.


Researchers now are testing obese people to see if they react the same way to fructose and glucose as the normal-weight people in this study did.


What to do? Cook more at home and limit processed foods containing fructose and high-fructose corn syrup, Purnell suggested. "Try to avoid the sugar-sweetened beverages. It doesn't mean you can't ever have them," but control their size and how often they are consumed, he said.


A second study in the journal suggests that only severe obesity carries a high death risk — and that a few extra pounds might even provide a survival advantage. However, independent experts say the methods are too flawed to make those claims.


The study comes from a federal researcher who drew controversy in 2005 with a report that found thin and normal-weight people had a slightly higher risk of death than those who were overweight. Many experts criticized that work, saying the researcher — Katherine Flegal of the Centers for Disease Control and Prevention — painted a misleading picture by including smokers and people with health problems ranging from cancer to heart disease. Those people tend to weigh less and therefore make pudgy people look healthy by comparison.


Flegal's new analysis bolsters her original one, by assessing nearly 100 other studies covering almost 2.9 million people around the world. She again concludes that very obese people had the highest risk of death but that overweight people had a 6 percent lower mortality rate than thinner people. She also concludes that mildly obese people had a death risk similar to that of normal-weight people.


Critics again have focused on her methods. This time, she included people too thin to fit what some consider to be normal weight, which could have taken in people emaciated by cancer or other diseases, as well as smokers with elevated risks of heart disease and cancer.


"Some portion of those thin people are actually sick, and sick people tend to die sooner," said Donald Berry, a biostatistician at the University of Texas MD Anderson Cancer Center in Houston.


The problems created by the study's inclusion of smokers and people with pre-existing illness "cannot be ignored," said Susan Gapstur, vice president of epidemiology for the American Cancer Society.


A third critic, Dr. Walter Willett of the Harvard School of Public Health, was blunter: "This is an even greater pile of rubbish" than the 2005 study, he said. Willett and others have done research since the 2005 study that found higher death risks from being overweight or obese.


Flegal defended her work. She noted that she used standard categories for weight classes. She said statistical adjustments were made for smokers, who were included to give a more real-world sample. She also said study participants were not in hospitals or hospices, making it unlikely that large numbers of sick people skewed the results.


"We still have to learn about obesity, including how best to measure it," Flegal's boss, CDC Director Dr. Thomas Frieden, said in a written statement. "However, it's clear that being obese is not healthy - it increases the risk of diabetes, heart disease, cancer, and many other health problems. Small, sustainable increases in physical activity and improvements in nutrition can lead to significant health improvements."


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Online:


Obesity info: http://www.cdc.gov/obesity/data/trends.html


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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP


Mike Stobbe can be followed at http://twitter.com/MikeStobbe


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Wall Street extends gains on "cliff" deal

NEW YORK (Reuters) - U.S. stocks jumped on the year's first day of trading, after Washington lawmakers cut a last-minute deal to avert automatic tax hikes that threatened to stunt economic growth.


With the gains, the S&P 500 was on target for its highest close since October 19.


The rally was broad-based, with nine stocks rising for every one falling on the New York Stock Exchange. All 10 S&P 500 industry sector indexes rose at least 1 percent, led by the S&P financial index <.gspf>, up 2.2 percent.


The S&P Information Technology index <.gspt> gained 2.1 percent. Among the strongest names in the sector was Hewlett-Packard , which climbed nearly 5 percent to $14.95. HP's gain followed a miserable 2012, when the stock fell nearly 45 percent.


On New Year's Day, while the U.S. stock market was closed, Congress passed a bill to raise taxes on wealthy individuals and families, and preserve certain benefits, while avoiding immediate austerity measures. The combination of mandatory tax hikes and reduced federal spending, which had been set to go into effect on January 1, had been known as the "fiscal cliff.


"We had three choices: We were going to be off the cliff, we were going to be on the cliff, or we were going to avoid the cliff, and we avoided it," said Brian Battle, director of trading at Performance Trust Capital Partners in Chicago.


"There's a relief rally, some progress because we raised revenue, but I think it's going to be short-lived because the relief rally today was created by politics, and the next cliff is going to be created by politics."


The vote avoided income-tax hikes for all U.S. households, but failed to resolve other political budget showdowns. Spending cuts of $109 billion in military and domestic programs were delayed for just two months, as another fight over the U.S. debt limit also looms then.


The market's surge was due to "the concrete news as opposed to a lack of specific news" that was common during the negotiations, said Stephen Carl, head of U.S. equity trading at The Williams Capital Group in New York.


U.S. stocks ended 2012 with the S&P 500 up 13.4 percent for the year, as investors largely shrugged off worries about the fiscal cliff. For the year, the Dow gained 7.3 percent and the Nasdaq jumped 15.9 percent.


The Dow Jones industrial average <.dji> gained 223.60 points, or 1.71 percent, to 13,327.74. The Standard & Poor's 500 Index <.spx> advanced 24.61 points, or 1.73 percent, to 1,450.80. The Nasdaq Composite Index <.ixic> climbed 66.87 points, or 2.21 percent, at 3,086.38.


Bank shares rose following news that U.S. regulators are close to securing another multibillion-dollar settlement with the largest banks to resolve allegations that they unlawfully cut corners when foreclosing on delinquent borrowers.


Bank of America Corp rose 3.4 percent to $11.99 and Wells Fargo shares added 2 percent to $34.87. JPMorgan Chase & Co shares rose 1.5 percent to $44.34.


Shares of Zipcar Inc jumped 48.4 percent to $12.23 after Avis Budget Group Inc said it would buy Zipcar for about $500 million in cash to compete with larger rivals Hertz and Enterprise Holdings Inc. Avis rose 4.5 percent to $20.72.


Shares of Apple rose 2.4 percent to $545, boosting technology stocks, following a report that the most valuable tech company has started testing a new iPhone and a new version of its iOS software. Apple stocks struggled in the final weeks of 2012 before a rally to end the year.


U.S. manufacturing expanded slightly in December after an unexpected November contraction, an Institute for Supply Management report showed on Wednesday.


A Commerce Department report showed U.S. construction spending fell in November for the first time in eight months, as an extended bout of weakness in the business sector outweighed modest growth in outlays on residential projects.


The stock market's reaction to both reports was muted.


(Editing by Jan Paschal)



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Stampede at New Year’s Celebration Kills Dozens in Ivory Coast


Herve Sevi/Agence France-Presse — Getty Images


People injured in a stampede in Abidjan, Ivory Coast, were treated at the Cocody hospital on Tuesday.







At least 60 people were killed in Ivory Coast’s economic capital, Abidjan, as a New Year’s fireworks celebration turned into a deadly stampede early on Tuesday.




The crowd of thousands was leaving the sprawling stadium in the downtown Plateau neighborhood after the last fireworks had signaled the new year when panic struck. In the crush, dozens were trampled underfoot, officials in Abidjan said Tuesday.


Many were pushed into a small gully adjoining the Houphouët-Boigny stadium on the Boulevard de la République, in the heart of the city’s compact central business district, then crushed as the panicked crowd surged over them.


Children appeared to be among the injured and dead: the state television station, RTI, showed images of wounded children in one of the city’s hospitals, as well as pregnant women stretched on cots.


Ivorian officials Tuesday said that they were baffled as to what set off the stampede but that an investigation had been launched.


“The precise circumstances of this tragic occurrence are being looked into by the security services,” Ivory Coast’s interior minister, Hamed Bakayoko, said on RTI Tuesday. RTI showed rescue workers carrying bodies through the streets and ambulances lined up in the darkness.


Mr. Bakayoko told RTI that “the New Year’s Eve celebrations brought many onto the streets of Plateau. There were 50,000 people on the streets. They were going home, and there was a stampede.”


At the scene, witnesses said there were piles of abandoned shoes.


The head of the rescue services, Lt. Col. Issa Sakho, told an RTI reporter that the “flow of people created a great crush, and in the stampede there were people who were trampled, people who were suffocated.” More than 200 were wounded, officials said.


Careless police action could have incited the stampede, witnesses said. At the hospital in the city’s adjoining Cocody neighborhood, one of the wounded — a young man who declined to give his name — said that the police had tried to disperse the crowd as it was leaving the stadium. That action provoked a mass panic, the young man said, and the crowd surged forward.


The Ivorian police and security services, with a long record of brutality, are feared by the people of Abidjan, a sprawling city of some four million people. Arbitrary arrests, unpunished beatings, and impromptu traffic stops, often to extort money, are not uncommon in the city’s poorer neighborhoods.


The police and security forces were the principal instruments in a campaign of repression that lasted months in 2010-2011 by the deposed former president, Laurent Gbagbo, who was ousted by rebel fighters and French forces after he failed to give up office after his electoral defeat. Some 3,000 people were killed in the civil war precipitated by Mr. Gbagbo’s refusal.


The fireworks celebration, sponsored by the government of the country’s president, Alassane Ouattara, was the second since Mr. Gbagbo’s ouster. It was intended as another sign that Ivory Coast, with its surging economic growth rate and renewed foreign investment, has emerged from years of political crisis, repression and civil war.


Social, ethnic and political tensions remain acute, however, with some observers warning that Mr. Ouattara has done too little to resolve problems left over from the Gbagbo years.


Loucoumane Coulibaly contributed reporting.



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No surprise: YouTube, Angry Birds, Instagram and Facebook among 2012′s top apps









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Jessica Simpson & Jennifer Hudson Show Off Weight Loss in New Ad















01/01/2013 at 01:20 PM EST







Jennifer Hudson and Jessica Simpson


Courtesy of Weight Watchers


Jessica Simpson and Jennifer Hudson have a lot in common, specifically when it comes to balancing their careers with motherhood.

Now Simpson, 32, and Hudson, 31, have one more similarity to add to the list – they've both shed serious pounds thanks to Weight Watchers.

The spokeswomen for the weight loss company met when they shot their first joint advertisement – which will be available on PEOPLE.com on Wednesday – and discussed their lifelong struggles with their weight and body image.

Hudson says she figured she was "just born that way," while Simpson added that she was "always on some new life-stopping diet."

Simpson – who lost over 50 lbs. on the program – recently announced her pregnancy on Twitter.

But the mother to 7-month-old Maxwell Drew, "will not be following the [weight loss] program during the pregnancy while her weight and well-being are monitored by her obstetrician," Weight Watchers said in a statement.

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Clinton receiving blood thinners to dissolve clot


WASHINGTON (AP) — Secretary of State Hillary Rodham Clinton continues to recover in a New York hospital where she's being treated for a blood clot in her head.


Her doctors say blood thinners are being used to dissolve the clot and they are confident she will make a full recovery. Clinton didn't suffer a stroke or neurological damage from the clot that formed after she suffered a concussion during a fainting spell at her home in early December, doctors said in a statement Monday.


Clinton, 65, was admitted to New York-Presbyterian Hospital on Sunday when the clot turned up on a follow-up exam on the concussion, Clinton spokesman Phillipe Reines said. The clot is located in the vein in the space between the brain and the skull behind the right ear. She will be released once the medication dose for the blood thinners has been established, the doctors said.


In their statement, Dr. Lisa Bardack of the Mount Kisco Medical Group and Dr. Gigi El-Bayoumi of George Washington University said Clinton was making excellent progress and was in good spirits.


Clinton's complication "certainly isn't the most common thing to happen after a concussion" and is one of the few types of blood clots in the skull or head that are treated with blood thinners, said Dr. Larry Goldstein, a neurologist who is director of Duke University's stroke center. He is not involved in Clinton's care.


The area where Clinton's clot developed is "a drainage channel, the equivalent of a big vein inside the skull. It's how the blood gets back to the heart," Goldstein said.


Blood thinners usually are enough to treat the clot and it should have no long-term consequences if her doctors are saying she has suffered no neurological damage from it, Goldstein said.


Clinton returned to the U.S. from a trip to Europe, then fell ill with a stomach virus in early December that left her severely dehydrated and forced her to cancel a trip to North Africa and the Middle East. Until then, she had canceled only two scheduled overseas trips, one to Europe after breaking her elbow in June 2009 and one to Asia after the February 2010 earthquake in Haiti.


Her condition worsened when she fainted, fell and suffered a concussion while at home alone in mid-December as she recovered from the virus.


This isn't the first time Clinton has suffered a blood clot. In 1998, midway through her husband's second term as president, Clinton was in New York fundraising for the midterm elections when a swollen right foot led her doctor to diagnose a clot in her knee requiring immediate treatment.


Clinton had planned to step down as secretary of state at the beginning of President Barack Obama's second term. Whether she will return to work before she resigns remains a question.


Democrats are privately if not publicly speculating: How might her illness affect a decision about running for president in 2016?


After decades in politics, Clinton says she plans to spend the next year resting. She has long insisted she had no intention of mounting a second campaign for the White House four years from now. But the door is not entirely closed, and she would almost certainly emerge as the Democrat to beat if she decided to give in to calls by Democratic fans and run again.


Her age — and thereby health — would probably be a factor under consideration, given that Clinton would be 69 when sworn in, if she were elected in 2016. That might become even more of an issue in the early jockeying for 2016 if what started as a bad stomach bug becomes a prolonged, public bout with more serious infirmity.


Not that Democrats are willing to talk openly about the political implications of a long illness, choosing to keep any discussions about her condition behind closed doors. Publicly, Democrats reject the notion that a blood clot could hinder her political prospects.


"Some of those concerns could be borderline sexist," said Basil Smikle, a Democratic strategist who worked for Clinton when she was a senator. "Dick Cheney had significant heart problems when he was vice president, and people joked about it. He took the time he needed to get better, and it wasn't a problem."


It isn't uncommon for presidential candidates' health — and age — to be an issue. Both in 2000 and 2008, Sen. John McCain, R-Ariz., had to rebut concerns he was too old to be commander in chief or that his skin cancer could resurface.


Beyond talk of future politics, Clinton's three-week absence from the State Department has raised eyebrows among some conservative commentators who questioned the seriousness of her ailment after she canceled planned Dec. 20 testimony before Congress on the deadly attack on the U.S. diplomatic mission in Benghazi, Libya.


Clinton had been due to discuss with lawmakers a scathing report she had commissioned on the attack. It found serious failures of leadership and management in two State Department bureaus were to blame for insufficient security at the facility. Clinton took responsibility for the incident before the report was released, but she was not blamed. Four officials cited in the report have either resigned or been reassigned.


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"Fiscal cliff" moves to House, timing and outcome uncertain


WASHINGTON (Reuters) - Washington's last-minute scramble to step back from a recession-inducing "fiscal cliff" shifted to the Republican-controlled House of Representatives on Tuesday after the Senate approved a bipartisan deal to avoid steep tax hikes and spending cuts.


In a rare late-night show of unity, the Senate voted 89 to 8 to raise some taxes on the wealthy while keeping income taxes low on more moderate income voters.


The bill's prospects were less certain in the House, where a vote had not yet been scheduled. Many conservative Republicans have rejected tax increases on any Americans, no matter how wealthy. Some liberal Democrats were also upset with a complex deal that they thought gave away too much.


Lingering uncertainty over U.S. tax and spending policy has unnerved investors and depressed business activity for months, and lawmakers had hoped to reach a deal before Tuesday, when a broad range of automatic tax increases and spending cuts would begin to punch a $600 billion hole in the economy.


Financial markets have avoided a steep plunge on the assumption that Washington would ultimately avoid pushing the country off the fiscal cliff into a recession.


With financial markets closed for the New Year's Day holiday, lawmakers have one more day to close the deal.


"My district cannot afford to wait a few days and have the stock market go down 300 points tomorrow if we don't get together and do something," Representative Steve Cohen, a Democrat from Tennessee, said on the House floor.


The bill passed by the Senate at around 2 a.m. would raise income taxes on families earning more than $450,000 per year. Low temporary rates that have been in place for less affluent taxpayers for the past decade would be made permanent, along with a range of targeted tax breaks put in place by President Barack Obama in the depths of the 2009 recession.


However, workers would see up to $2,000 more taken out of their paychecks as a temporary payroll tax cut was set to expire.


The bill would also delay an across-the-board 8 percent spending cut to domestic and military programs for two months, and extend jobless benefits for 2 million people who otherwise would see them run out.


Obama in a statement on Monday urged the House to vote. "There's more work to do to reduce our deficits, and I'm willing to do it," he said.


Republicans had hoped to include significant spending cuts in the deal to narrow trillion-dollar budget deficits. Conservatives were already looking forward to the next battle over the debt ceiling, in late February, to extract deficit reduction measures from the Democratic president.


Vice President Joe Biden, who was instrumental in pushing through the Senate measure, was scheduled to address a closed-door meeting of House Democrats. Their support likely will be needed to pass the bill.


Republican members were to meet to discuss "a path forward," a senior aide said.


The meeting could help Republicans leaders decide when to begin consideration of the White House-backed measure. A vote could come later in the day, but was not yet scheduled.


The conservative Club for Growth urged a "no" vote on the Senate measure, saying it would be on its "congressional scorecard" used to challenge members of Congress.


Liberal groups also have urged Democrats to reject the deal.


Richard Trumka, head of the AFL-CIO labor union, wrote on Twitter that the deal does not raise taxes enough on the wealthy and "sets the stage for more hostage taking" by Republicans in future budget confrontations.


Republican Representative Tom Cole said his House colleagues should pass the Senate bill rather than try to change it.


"We ought to take this deal right now, and we'll live to fight another day," Cole said on MSNBC. "Putting to bed this thing before the markets (open on Wednesday) is really a pretty important thing to do."


(Writing by Andy Sullivan; Editing by Fred Barbash and Vicki Allen)



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Dr. Rita Levi-Montalcini, a Revolutionary in the Study of the Brain, Dies at 103


Fabio Campana/European Pressphoto Agency


Dr. Rita Levi-Montalcini in 2007. She discovered chemical tools the body uses to direct cell growth and build nerve networks.







Dr. Rita Levi-Montalcini, a Nobel Prize-winning neurologist who discovered critical chemical tools that the body uses to direct cell growth and build nerve networks, opening the way for the study of how those processes can go wrong in diseases like dementia and cancer, died on Sunday at her home in Rome. She was 103.




Her death was announced by Mayor Gianni Alemanno of Rome.


“I don’t use these words easily, but her work revolutionized the study of neural development, from how we think about it to how we intervene,” said Dr. Gerald D. Fishbach, a neuroscientist and professor emeritus at Columbia.


Scientists had virtually no idea how embryo cells built a latticework of intricate connections to other cells when Dr. Levi-Montalcini began studying chicken embryos in the bedroom of her house in Turin, Italy, during World War II. After years of obsessive study, much of it at Washington University in St. Louis with Dr. Viktor Hamburger, she found a protein that, when released by cells, attracted nerve growth from nearby developing cells.


In the early 1950s, she and Dr. Stanley Cohen, a biochemist also at Washington University, isolated and described the chemical, known as nerve growth factor — and in the process altered the study of cell growth and development. Scientists soon realized that the protein gave them a new way to study and understand disorders of neural growth, like cancer, or of degeneration, like Alzheimer’s disease, and to potentially develop therapies.


In the years after the discovery, Dr. Levi-Montalcini, Dr. Cohen and others described a large family of such growth-promoting agents, each of which worked to regulate the growth of specific cells. One, called epidermal growth factor and discovered by Dr. Cohen, plays a central role in breast cancer; in part by studying its behavior, scientists developed drugs to combat the abnormal growth.


In 1986, Dr. Levi-Montalcini and Dr. Cohen shared the Nobel Prize in Physiology or Medicine for their work.


Dr. Cohen, now an emeritus professor at Vanderbilt University, said Dr. Levi-Montalcini possessed a rare combination of intuition and passion, as well as biological knowledge. “She had this feeling for what was happening biologically,” he said. “She was an intuitive observer, and she saw that something was making these nerve connections grow and was determined to find out what it was.”


One of four children, Rita Levi-Montalcini was born in Turin on April 22, 1909, to Adamo Levi, an engineer, and Adele Montalcini, a painter, both Italian Jews who traced their roots to the Roman Empire. In keeping with the Victorian customs of the time, Mr. Levi discouraged his three daughters from entering college, fearing that it would interfere with their lives as wives and mothers.


It was not a future that Rita wanted. She had decided to become a doctor and told her father so. “He listened, looking at me with that serious and penetrating gaze of his that caused me such trepidation,” she wrote in her autobiography, “In Praise of Imperfection” (1988). He also agreed to support her.


She graduated summa cum laude from the University of Turin medical school in 1936. Two years later, Mussolini issued a manifesto barring non-Aryan Italians from having professional careers. She began her research anyway, setting up a small laboratory in her home to study chick embryos, inspired by the work of Dr. Hamburger, a prominent researcher in St. Louis who also worked with the embryos.


During World War II, the family fled Turin for the countryside, and in 1943 the invasion by Germany forced them to Florence. The family returned at the close of the war, in 1945, and Dr. Hamburger soon invited Dr. Levi-Montalcini to work for a year in his lab at Washington University.


She stayed on, becoming an associate professor in 1956 and a full professor in 1958. In 1962, she helped establish the Institute of Cell Biology in Rome and became its first director. She retired from Washington University in 1977, becoming a guest professor and splitting her time between Rome and St. Louis.


Italy honored her in 2001 by making her a senator for life.


An elegant presence, confident and passionate, she was a sought-after speaker until late in life. “At 100, I have a mind that is superior — thanks to experience — than when I was 20,” she said in 2009.


She never married and had no children. In addition to her autobiography, she was the author or co-author of dozens of research studies and received numerous professional awards, including the National Medal of Science.


“It is imperfection — not perfection — that is the end result of the program written into that formidably complex engine that is the human brain,” Dr. Levi-Montalcini wrote in her autobiography, “and of the influences exerted upon us by the environment and whoever takes care of us during the long years of our physical, psychological and intellectual development.”


This article has been revised to reflect the following correction:

Correction: December 30, 2012

An earlier version of this obituary misstated the year Mussolini issued a manifesto barring non-Aryan Italians from having professional careers. It was 1938, not 1936.



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Kim Kardashian: From Divorce Drama to Baby Mama in 5 Clicks





Follow her odyssey from her messy split with Kris Humphries to her great expectation with Kanye West








Credit: Prahl/Winslow/Splash News Online



Updated: Monday Dec 31, 2012 | 11:45 AM EST




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FDA approves 1st new tuberculosis drug in 40 years


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.


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