Dow surges 308 points on 'fiscal cliff' deal









NEW YORK — Investors poured back into the stock market on the first trading day of 2013 in a rally seen as a sigh of relief that President Obama and Congress were able to avert the so-called fiscal cliff and an immediate economic downturn.


The Dow Jones industrial average surged 308.41 points, or 2.4%, to 13,412.55 on Wednesday — the best one-day rise in more than a year. Wall Street followed rallies in European and Asian equities markets after Washington's last-minute fiscal deal late Tuesday.


The broader Standard & Poor's 500 index rose 36.23 points, or 2.5%, to 1,462.42. It was the S&P's best first-trading-day jump since 2009, according to Howard Silverblatt, senior index analyst for S&P Dow Jones Indices. The technology-heavy Nasdaq composite index gained 92.75 points, or 3.1%, to 3,112.26.





Though Washington may have averted an immediate downturn, political leaders put off stalemates over broad spending cuts in military and social programs to reduce the country's long-term deficit.


"They turned off the bomb," said Sean Kelly, head of equity trading at Knight Capital Group. "There's still danger in the whole thing, but as of right now there's no immediate danger."


Another fight over whether to raise the country's debt ceiling, or borrowing limit, could also rattle markets in coming weeks.


Doug Cote, chief investment strategist with ING Investment Management U.S., said the rally was one of "false relief" not based on the country's longer-term deficit problems, which remain an unresolved threat.


"There's relief that something got passed that was better than the worst-case scenario," he said.


andrew.tangel@latimes.com





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Ruling over bumper-car injury supports amusement park









SAN FRANCISCO — The California Supreme Court, protecting providers of risky recreational activities from lawsuits, decided Monday that bumper car riders may not sue amusement parks over injuries stemming from the inherent nature of the attraction.


The 6-1 decision may be cited to curb liability for a wide variety of activities — such as jet skiing, ice skating and even participating in a fitness class, lawyers in the case said.


"This is a victory for anyone who likes fun and risk activities," said Jeffrey M. Lenkov, an attorney for Great America, which won the case.








But Mark D. Rosenberg, who represented a woman injured in a bumper car at the Bay Area amusement park, said the decision was bad for consumers.


"Patrons are less safe today than they were yesterday," Rosenberg said.


The ruling came in a lawsuit by Smriti Nalwa, who fractured her wrist in 2005 while riding in a bumper car with her 9-year-old son and being involved in a head-on collision. Rosenberg said Great America had told ride operators not to allow head-on collisions, but failed to ask patrons to avoid them.


The court said Nalwa's injury was caused by a collision with another bumper car, a normal part of the ride. To reduce all risk of injury, the ride would have to be scrapped or completely reconfigured, the court said.


"A small degree of risk inevitably accompanies the thrill of speeding through curves and loops, defying gravity or, in bumper cars, engaging in the mock violence of low-speed collisions," Justice Kathryn Mickle Werdegar wrote for the majority. "Those who voluntarily join in these activities also voluntarily take on their minor inherent risks."


Monday's decision extended a legal doctrine that has limited liability for risky sports, such as football, to now include recreational activities.


"Where the doctrine applies to a recreational activity," Werdegar wrote, "operators, instructors and participants …owe other participants only the duty not to act so as to increase the risk of injury over that inherent in the activity."


Amusement parks will continue to be required to use the utmost care on thrill rides such as roller coasters, where riders surrender control to the operator. But on attractions where riders have some control, the parks can be held liable only if their conduct unreasonably raised the dangers.


"Low-speed collisions between the padded, independently operated cars are inherent in — are the whole point of — a bumper car ride," Werdegar wrote.


Parks that fail to provide routine safety measures such as seat belts, adequate bumpers and speed controls might be held liable for an injury, but operators should not be expected to restrict where a bumper car is bumped, the court said.


The justices noted that the state inspected the Great America rides annually, and the maintenance and safety staff checked on the bumper cars the day Nalwa broke her wrist. The ride was functioning normally.


Reports showed that bumper car riders at the park suffered 55 injuries — including bruises, cuts, scrapes and strains — in 2004 and 2005, but Nalwa's injury was the only fracture. Nalwa said her wrist snapped when she tried to brace herself by putting her hand on the dashboard.


Rosenberg said the injury stemmed from the head-on collision. He said the company had configured bumper rides in other parks to avoid such collisions and made the Santa Clara ride uni-directional after the lawsuit was filed.


Justice Joyce L. Kennard dissented, complaining that the decision would saddle trial judges "with the unenviable task of determining the risks of harm that are inherent in a particular recreational activity."


"Whether the plaintiff knowingly assumed the risk of injury no longer matters," Kennard said.


maura.dolan@latimes.com





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9 Apps to Fast-Track Your New Years’ Resolutions






Whether your goal in 2013 is to lose five pounds, manage your finances, or spend more time with friends and family, there are a growing number of apps that fall into the self-help category and can assist you in accomplishing these resolutions.


At Mashable we’ve tested a lot of them out, but we’re still always hearing about new ones. There are a ton of fitness and health apps to chose from, but you might be pleasantly surprised to know they’re not all about weight loss. A device and app called Tinke monitors your stress levels and how deeply you’re breathing. An app called Fig will remind you to drink more water, skip fried foods and take breaks at work to keep you feeling good. Arianna Huffington also released an app called, “GPS for the Soul” that focuses on wellbeing.






[More from Mashable: Time Machine App Transports You Back to 2012]


Other apps can help you organize your social life, make new friends or save money for a vacation.


We’ve compiled a list of apps that can help you accomplish all sorts of goals this year. Check it out and let us know if we missed any that you plan on using in 2013.


[More from Mashable: It’s Easy to Save Videos From Facebook Poke Permanently]


OurGroceries


If you’re trying to eat out less and cook at home more often, make sure you always have a current grocery list at your fingertips. Mashable wrote about several grocery list apps this year. The standout seems to be OurGroceries for Android and iOS. If you have roommates or a significant other, everyone can download the app and sync lists. That way if you’re making a quick after-work trip to the grocery store you’ll not only be able to see the items you added, but also see what they’ve added, too.


Click here to view this gallery.


Photo courtesy of iStockphoto, hocus-focus


This story originally published on Mashable here.


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Playboy Hugh Hefner marries his 'runaway bride'


LOS ANGELES (AP) — Hugh Hefner's celebrating the new year as a married man once again.


The 86-year-old Playboy magazine founder exchanged vows with his "runaway bride," Crystal Harris, at a private Playboy Mansion ceremony on New Year's Eve. Harris, a 26-year-old "Playmate of the Month" in 2009, broke off a previous engagement to Hefner just before they were to be married in 2011.


Playboy said on Tuesday that the couple celebrated at a New Year's Eve party at the mansion with guests that included comic Jon Lovitz, Gene Simmons of KISS and baseball star Evan Longoria.


The bride wore a strapless gown in soft pink, Hefner a black tux. Hefner's been married twice before but lived the single life between 1959 and 1989.


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Study Suggests Lower Mortality Risk for Overweight People





A century ago, Elsie Scheel was the perfect woman. So said a 1912 article in The New York Times about how Miss Scheel, 24, was chosen by the “medical examiner of the 400 ‘co-eds’ ” at Cornell University as a woman “whose very presence bespeaks perfect health.”




Miss Scheel, however, was hardly model-thin. At 5-foot-7 and 171 pounds, she would, by today’s medical standards, be clearly overweight. (Her body mass index was 27; 25 to 29.9 is overweight.)


But a new report suggests that Miss Scheel may have been onto something. The report on nearly three million people found that those whose B.M.I. ranked them as overweight had less risk of dying than people of normal weight. And while obese people had a greater mortality risk over all, those at the lowest obesity level (B.M.I. of 30 to 34.9) were not more likely to die than normal-weight people.


The report, although not the first to suggest this relationship between B.M.I. and mortality, is by far the largest and most carefully done, analyzing nearly 100 studies, experts said.


But don’t scrap those New Year’s weight-loss resolutions and start gorging on fried Belgian waffles or triple cheeseburgers.


Experts not involved in the research said it suggested that overweight people need not panic unless they have other indicators of poor health and that depending on where fat is in the body, it might be protective or even nutritional for older or sicker people. But over all, piling on pounds and becoming more than slightly obese remains dangerous.


“We wouldn’t want people to think, ‘Well, I can take a pass and gain more weight,’ ” said Dr. George Blackburn, associate director of Harvard Medical School’s nutrition division.


Rather, he and others said, the report, in The Journal of the American Medical Association, suggests that B.M.I., a ratio of height to weight, should not be the only indicator of healthy weight.


“Body mass index is an imperfect measure of the risk of mortality,” and factors like blood pressure, cholesterol and blood sugar must be considered, said Dr. Samuel Klein, director of the Center for Human Nutrition at Washington University School of Medicine in St. Louis.


Dr. Steven Heymsfield, executive director of the Pennington Biomedical Research Center in Louisiana, who wrote an editorial accompanying the study, said that for overweight people, if indicators like cholesterol “are in the abnormal range, then that weight is affecting you,” but that if indicators are normal, there’s no reason to “go on a crash diet.”


Experts also said the data suggested that the definition of “normal” B.M.I., 18.5 to 24.9, should be revised, excluding its lowest weights, which might be too thin.


The study did show that the two highest obesity categories (B.M.I. of 35 and up) are at high risk. “Once you have higher obesity, the fat’s in the fire,” Dr. Blackburn said.


But experts also suggested that concepts of fat be refined.


“Fat per se is not as bad as we thought,” said Dr. Kamyar Kalantar-Zadeh, professor of medicine and public health at the University of California, Irvine.


“What is bad is a type of fat that is inside your belly,” he said. “Non-belly fat, underneath your skin in your thigh and your butt area — these are not necessarily bad.”


He added that, to a point, extra fat is accompanied by extra muscle, which can be healthy.


Still, it is possible that overweight or somewhat obese people are less likely to die because they, or their doctors, have identified other conditions associated with weight gain, like high cholesterol or diabetes.


“You’re more likely to be in your doctor’s office and more likely to be treated,” said Dr. Robert Eckel, a past president of the American Heart Association and a professor at University of Colorado.


Some experts said fat could be protective in some cases, although that is unproven and debated. The study did find that people 65 and over had no greater mortality risk even at high obesity.


“There’s something about extra body fat when you’re older that is providing some reserve,” Dr. Eckel said.


And studies on specific illnesses, like heart and kidney disease, have found an “obesity paradox,” that heavier patients are less likely to die.


Still, death is not everything. Even if “being overweight doesn’t increase your risk of dying,” Dr. Klein said, it “does increase your risk of having diabetes” or other conditions.


Ultimately, said the study’s lead author, Katherine Flegal, a senior scientist at the Centers for Disease Control and Prevention, “the best weight might depend on the situation you’re in.”


Take the perfect woman, Elsie Scheel, in whose “physical makeup there is not a single defect,” the Times article said.


This woman who “has never been ill and doesn’t know what fear is” loved sports and didn’t consume candy, coffee or tea. But she also ate only three meals every two days, and loved beefsteak.


Maybe such seeming contradictions made sense against the societal inconsistencies of that time. After all, her post-college plans involved tilling her father’s farm, but “if she were a man, she would study mechanical engineering.”


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Optimistic stock investors reaped rewards worldwide in 2012









Wall Street closed out the year with a surge in the final trading session, betting on a last-minute resolution of the so-called fiscal cliff.


The market may have jumped the gun, but investors' hopefulness fit the pattern of 2012: It was a year of solid stock price gains worldwide, as various predictions of Armageddon fell flat.


That has reinforced many market pros' conventional cautious optimism as the new year begins. Bears can still find plenty to be dour about, but the bulls have called it right in three of the last four years since the 2008 financial-system crash.





On Monday, the Dow Jones industrial average jumped 166 points, or 1.3%, to end the year at 13,104. Stocks rallied late in the session as rumors spread that Congress would approve a deal to limit the tax increases and spending cuts otherwise set to kick in Tuesday.


But after the closing bell, a deal to avert the fiscal cliff appeared uncertain — raising fears of a blistering market sell-off Wednesday.


Still, investors who had expected a sustained slump in stocks in 2012 found themselves left behind as most world markets posted double-digit percentage gains, underpinned by a resilient U.S. economy and by central banks' efforts to keep interest rates at rock bottom.


Wall Street optimism about 2013 remains rooted in expectations that the U.S. economy will continue to expand, albeit slowly, and with it corporate earnings.


"Absent a complete failure from Washington, growth should remain positive," said Russ Koesterich, global chief investment strategist at money management giant BlackRock Inc. in New York.


That bet paid off in 2012: The Standard & Poor's 500 index, a popular benchmark for many Americans' retirement accounts, rose 1.7% to 1,426 on Monday and was up 13.4% for the year.


That was the biggest advance since the index rose 23.4% in 2009. Stocks' gains last year also beat returns on most kinds of bonds and on low-yielding short-term cash accounts.


The S&P index now has rebounded 111% from its decade low in March 2009, restoring most of the wealth lost by investors in the Great Recession — if they held on.


In Europe, the Stoxx index of 600 big-name shares rose 14.4% for the year, also the biggest rally since 2009. Japan's main market index soared 22.9%. Most so-called emerging markets also were up sharply, including those in India, Mexico and Turkey.


The 30-stock Dow index was a relative laggard, rising 7.3% for the year. It was hurt by weakness in major energy stocks as crude oil prices fell and by a collapse of shares of troubled tech giant Hewlett-Packard Co.


Markets worldwide had rallied in the first few months of 2012, then dived in spring as doubts multiplied about the global economy.


Europe, gripped for a third year by its government-debt crisis, was the epicenter of those fears: Many investors expected the Eurozone to finally break up under its debt strains, consigning Greece, Spain, Portugal and perhaps other nations to economic death spirals.


But the doomsday predictions were thwarted by the European Central Bank. In late July, ECB President Mario Draghi shocked markets by declaring that the central bank would do whatever was necessary to preserve the Eurozone. "And believe me, it will be enough," Draghi said.


The ECB followed that pledge with a commitment to buy unlimited sums of Eurozone governments' bonds, if necessary, to pull down countries' borrowing costs — similar to the U.S. Federal Reserve's ongoing program of buying Treasury debt.


The ECB's move sparked a sharp rally in the euro that buoyed confidence in European stocks as well, despite deep recessions in the Continent's hardest-hit economies.


The U.S. economy, meanwhile, confounded expectations that it would slide back into recession. The economy grew at a 3.1% annualized rate in the third quarter after slowing to a 1.3% rate in the second quarter. Growth was supported in part by the housing market's continuing rebound.


"Housing got us into this mess. Now it's one of the sectors to get us out," said Sam Stovall, chief investment strategist at S&P Capital IQ in New York.


Housing-related stocks were some of the year's biggest winners, with builder PulteGroup Inc. up 188%, appliance maker Whirlpool Corp. rising 114% and paint producer Sherwin-Williams Co. up 72%.


Worldwide, investors' confidence also benefited as worries dissipated about a war between Israel and Iran. And late in the year, hopes rose that China's slowing economy would avoid a so-called hard landing — which could have put it in a recession — and instead would help drive global growth in the new year. The Shanghai stock market rocketed nearly 15% in December alone.


Emerging markets such as China could be a big lure for global investors in 2013, some experts said. Many governments in those markets have more leeway than developed economies to bolster growth with fiscal stimulus measures and with lower interest rates, said Jack Ablin, chief investment officer at BMO Private Bank in Chicago.


By contrast, Ablin worries that U.S. economic growth and corporate earnings growth will be much slower than many investors are anticipating in the new year.


Whatever the ultimate workout of the fiscal cliff, Ablin said, "We are going to see taxes go up incrementally and spending go down incrementally," weighing on the economy.


Market pessimists believe that stock markets since 2009 have been driven largely by cheap credit supplied by central banks, particularly the Federal Reserve. Critics say the Fed's latest decision to ramp up purchases of Treasury bonds, aimed at pumping more money into the economy, smacks of desperation.


Fed Chairman Ben S. Bernanke, however, has insisted that the Fed still has plenty of tools left to help the U.S. recovery gain speed. Wall Street, by and large, believes Bernanke.


"If they can print money," Stovall said, "are the central banks ever really out of bullets?"


business@latimes.com





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Hillary Clinton expected to make full recovery from blood clot









WASHINGTON – The blood clot that led to Secretary of State Hillary Rodham Clinton’s hospitalization on Sunday is lodged in a vein behind her right ear, her doctors disclosed in a statement late Monday.


The doctors said the clot, called a right transverse sinus venous thrombosis, was discovered on Sunday when Clinton underwent an MRI as a “routine follow-up” to the treatment she has been receiving for a concussion. The vein runs between the brain and skull.


Drs. Lisa Bardack with the Mt. Kisco Medical Group and Gigi El-Bayoumi at The George Washington University Hospital said in their statement that the clot is being treated with blood thinners. They didn’t predict when she would be able to leave New York-Presbyterian Hospital, saying that she would be released “once the medication dose has been established.”





They said the clot didn’t result in a stroke or any neurological damage.


The doctors said that “in all other aspects of her recovery, the secretary is making excellent progress, and we are confident she will make a full recovery.” They described Clinton as being “in good spirits, engaging with her doctors, her family and her staff.”


Clinton suffered a concussion 2 1/2 weeks ago after she fell while she was battling a flu virus. She has made no public appearances since then and was forced to miss congressional hearings exploring the terrorist attack in September in Libya that killed four Americans.


With Clinton releasing only bare-bones information about her condition, most medical speculation has focused on the possibility that the clot formed in her leg while she was resting in bed trying to recover.


Clots in the leg are not uncommon and pose risks largely because they can travel into the lungs, potentially causing severe distress or even death. Clots in the head are rarer.


Clinton is in the final few weeks of her service as secretary of state. President Obama has chosen Sen. John Kerry (D-Mass.) to succeed her.


Follow Politics Now on Twitter and Facebook


paul.richter@latimes.com





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Ban on demanding Facebook passwords among new 2013 state laws






CHICAGO (Reuters) – Employers in California and Illinois will be prohibited from demanding access to workers’ password-protected social networking accounts and teachers in Oregon will be required to report suspected student bullies thanks to new laws taking effect in 2013.


In all, more than 400 measures were enacted at the state level during 2012 and will become law in the new year, according to the National Conference of State Legislatures (NCSL).






Some of the statutes, which deal with everything from consumer protection to gun control and healthcare, take effect at the stroke of midnight. Others will not kick in until later in the year.


The raft of measures includes a new abortion restriction in New Hampshire, public-employee pension reform in California and Alabama, same-sex marriage in Maryland, and a requirement that private insurers in Alaska cover autism in kids and young adults, NCSL said.


In New Hampshire, a rarely used form of late-term abortion will become illegal except to save the life of the mother – and even then only if two doctors from separate hospitals certify the procedure is medically necessary.


John Lynch, the state’s outgoing Democratic governor, had vetoed the measure, saying it would threaten the lives of women in rural areas. But the state’s Republican-controlled legislature later overrode him.


In California and Illinois, laws that take effect at 12:01 a.m. local time will make it illegal for bosses to request social networking passwords or non-public online account information from their employees or job applicants.


Michigan’s Republican Governor Rick Snyder signed a similar measure into law earlier this month that took effect immediately. The Michigan law also penalizes educational institutions for dismissing or failing to admit a student who does not provide passwords and other account information used to access private internet and email accounts, including social networks like Facebook and Twitter.


But workers and job seekers in all three states will still need to be careful what they post online: Employers may continue to use publicly available social networking information. So inappropriate pictures, tweets and other social media indiscretions can still come back to haunt them.


Gun violence – in places where it’s all too common, such as Chicago, and in places where it’s unexpected, such as Sandy Hook Elementary School in Newtown, Connecticut – was big news in 2012. But only a handful of new state firearms laws are set to take effect in 2013.


In Michigan, the definition of a “pistol” under the law will now include any firearm less than 26 inches in length. The new definition encompasses some rifles with folding stocks and will make the weapons subject to the same restrictions as pistols.


In Illinois, certain guns currently regulated by state law, including paintball guns, will be excluded from the definition of a firearm and participants in military re-enactments will be exempt from some weapons laws.


Another big story in 2012 was the effort by lawmakers in a number of cash-strapped states to put their public employee pension funds on a sounder financial footing.


In California and Alabama, reforms designed to begin to address the unfunded liabilities of those retirement systems will take effect in 2013.


Among the other new laws on the books in 2013:


* In California, prison workers and peace officers will now be prohibited from having sex with inmates and prisoners in transport.


* In Illinois, sex offenders will be prohibited from distributing candy on Halloween, or playing Santa or the Easter Bunny.


* In Oregon, employers won’t be allowed to advertise a job vacancy if they won’t consider applicants who are currently out of work.


* In Kentucky, residents will be prohibited from releasing feral or wild hogs back into the wild and Illinois will ban the possession and sale of shark fins.


* And in Florida, the term “motor vehicle” will no longer apply to the specialized all-terrain vehicles with over-sized tires known as “swamp buggies” that are popular in some parts of the state.


(Reporting by James B. Kelleher; Editing by Greg McCune and Nick Zieminski)


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Armstrong better, Green Day to resume tour in 2013


LOS ANGELES (AP) — Green Day is going back on the road.


The Grammy-winning punk band announced new tour dates Monday.


The band canceled the rest of its 2012 club schedule and postponed the start of a 2013 arena tour after singer-guitarist Billie Joe Armstrong's substance abuse problems emerged publicly in September when he had a profane meltdown on the stage of the iHeartRadio Music Festival in Las Vegas. The band's rep announced later that Armstrong was headed to treatment for substance abuse.


"I just want to thank you all for the love and support you've shown for the past few months," Armstrong told fans in a statement Monday. "Believe me, it hasn't gone unnoticed and I'm eternally grateful to have such an amazing set of friends and family. I'm getting better every day. So now, without further ado, the show must go on."


The tour is scheduled to begin March 28 at the Allstate Arena in the Chicago area. Tickets for postponed shows will be honored on the new dates, and refunds will be available for canceled shows.


"We want to thank everyone for hanging in with us for the last few months," the band said. "We are very excited to hit the road and see all of you again, though we regret having to cancel more shows."


The band released their most recent album, "Tre," on Dec. 11, more than a month ahead of schedule.


___


Online:


http://www.greenday.com/


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F.D.A. Approves Sirturo, a New Tuberculosis Drug





The Food and Drug Administration announced on Monday that it had approved a new treatment for multidrug-resistant tuberculosis that can be used as an alternative when other drugs fail.




The drug, to be called Sirturo, was discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, and is the first in a new class of drugs that aims to treat the drug-resistant strain of the disease.


Tuberculosis is a highly infectious disease that is transmitted through the air and usually affects the lungs but can also affect other parts of the body, including the brain and kidneys. It is considered one of the world’s most serious public health threats. Although rare in the United States, multidrug-resistant tuberculosis is a growing problem elsewhere in the world, especially in poorer countries. About 12 million people worldwide had tuberculosis in 2011, according to Johnson & Johnson, and about 630,000 had multidrug-resistant TB.


A study in September in The Lancet found that almost 44 percent of patients with tuberculosis in countries like Russia, Peru and Thailand showed resistance to at least one second-line drug, or a medicine used after another drug had already failed.


Treating drug-resistant tuberculosis can take years and can cost 200 times as much as treating the ordinary form of the disease


“This is quite a milestone in the story of therapy for TB,” Dr. Paul Stoffels, the chief scientific officer at Johnson & Johnson, said in an interview. He said the approval was the first time in 40 years that the agency had approved a drug that attacked tuberculosis in a different way from the current treatments on the market. Sirturo works by inhibiting an enzyme needed by the tuberculosis bacteria to replicate and spread throughout the body.


Sirturo, also known as bedaquiline, would be used on top of the standard treatment, which is a combination of several drugs. Patients with drug-resistant tuberculosis often must be treated for 18 to 24 months.


Even as it announced the approval, however, the F.D.A. also issued some words of caution.


“Multidrug-resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” Edward Cox, director of the office of antimicrobial products in the F.D.A.’s center for drug evaluation and research, said in a statement. “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.”


The consumer advocacy group Public Citizen opposed approval in a letter to the F.D.A. in mid-December, saying that the results of a limited clinical trial showed that patients using bedaquiline were five times as likely to die than those on the standard drug regimen to treat the disease.


“Given that bedaquiline belongs to an entirely new class of drugs, it is entirely feasible that death in some cases was due to some unmeasured toxicity of the drug,” the letter said.


Sirturo carries a so-called black box warning for patients and health care professionals that the drug can affect the heart’s electrical activity, which could lead to an abnormal and potentially fatal heart rhythm. The warning also notes deaths in patients treated with Sirturo. Nine patients who received Sirturo died compared with two patients who received a placebo. Five of the deaths in the Sirturo group and all of the deaths in the placebo arm seemed to be related to tuberculosis, but no consistent reason for the deaths in the remaining Sirturo-treated patients could be identified.


Doctors Without Borders and the Bill and Melinda Gates Foundation, both active in the fight against tuberculosis and other global diseases, applauded the F.D.A.’s decision.


Jan Gheuens, interim director of the TB Program for the Gates Foundation, called it a “long-awaited event” and said the fight against TB had not benefited from new drugs in the way H.I.V. had. Beyond the benefits of the drug itself, he said the quick approval process could be a model for other drugs sorely needed in the developing world.


He also suggested, however, that more trials should be conducted to get a better understanding of the side effects that led to the black box warning.


The F.D.A. approved bedaquiline under an accelerated program that allows the agency to conditionally approve drugs that are viewed as filling unmet medical needs with less than the usual evidence that they work. The drug’s approval was based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen, but it did not measure whether in the end patients actually fared better on bedaquiline. Johnson & Johnson will conduct larger clinical trials to investigate whether the drug performs as predicted.


In a statement responding to Public Citizen’s letter, a spokeswoman for Johnson & Johnson said the company was committed to supporting appropriate use of Sirturo and would “work to ensure Sirturo is used only where treatment alternatives are not available.”


Dr. Stoffels said the hope was that other new tuberculosis drugs would also be approved that, when used in combination with bedaquiline, could shorten and simplify the current standard of treatment. “That is still a long time away,” he acknowledged, but “this is a first step in a new regimen for TB.”


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