Dozens sue pharmacy, but compensation uncertain


NASHVILLE, Tenn. (AP) — Dennis O'Brien rubs his head as he details ailments triggered by the fungal meningitis he developed after a series of steroid shots in his neck: nausea, vomiting, dizziness, drowsiness, blurred vision, exhaustion and trouble with his speech and attention.


He estimates the disease has cost him and his wife thousands of dollars in out-of-pocket expenses and her lost wages, including time spent on 6-hour round trip weekly visits to the hospital. They've filed a lawsuit seeking $4 million in damages from the Massachusetts pharmacy that supplied the steroid injections, but it could take years for them to get any money back and they may never get enough to cover their expenses. The same is true for dozens of others who have sued the New England Compounding Center.


"I don't have a life anymore. My life is a meningitis life," the 59-year-old former school teacher said, adding that he's grateful he survived.


His is one of at least 50 federal lawsuits in nine states that have been filed against NECC, and more are being filed in state courts every day. More than 500 people have gotten sick after receiving injections prepared by the pharmacy.


The lawsuits allege that NECC negligently produced a defective and dangerous product and seek millions to repay families for the death of spouses, physically painful recoveries, lost wages and mental and emotional suffering. Thirty-seven people have died in the outbreak.


"The truth is the chance of recovering damages from NECC is extremely low," said John Day, a Nashville attorney who represents several patients who have been sickened by fungal meningitis.


To streamline the process, attorneys on both sides are asking to have a single judge preside over the pretrial and discovery phases for all of the federal lawsuits.


This approach, called multidistrict litigation, would prevent inconsistent pretrial rulings and conserve resources of all parties. But unlike a class-action case, those lawsuits would eventually be returned to judges in their original district for trial, according to Brian Fitzpatrick, a law professor at Vanderbilt University Law School in Nashville.


Even with this approach, Fitzpatrick noted that federal litigation is very slow, and gathering all the evidence, records and depositions during the discovery phase could take months or years.


"Most of the time what happens is once they are consolidated for pretrial proceedings, there is a settlement, a global settlement between all the lawyers and the defendants before anything is shipped back for trial," he said.


A lawyer representing NECC, Frederick H. Fern, described the consolidation process as an important step.


"A Boston venue is probably the best scenario," Fern said in an email. "That's where the parties, witnesses and documents are located, and where the acts subject to these complaints occurred."


Complicating efforts to recover damages, attorneys for the patients said, NECC is a small private company that has now recalled all its products and laid off its workers. The company's pharmacy licenses have been surrendered, and it's unclear whether NECC had adequate liability insurance.


Fern said NECC has insurance, but they were still determining what the policy covers.


But Day says, "It's clear to me that at the end of the day, NECC is not going to have sufficient assets to compensate any of these people, not even 1 percent."


As a result, many attorneys are seeking compensation from other parties. Among the additional defendants named in lawsuits are NECC pharmacist and co-founder Barry Cadden; co-founder Greg Conigliaro; sister company Ameridose and its marketing and support arm, Medical Sales Management.


Founded in 2006 by Cadden and Conigliaro, Ameridose would eventually report annual revenue of $100 million. An NECC spokesman didn't respond to a request for the pharmacy's revenue.


While Federal Drug Administration regulators have also found contamination issues at Westborough, Mass.-based Ameridose, the FDA has said it has not connected Ameridose drugs to infection or illness.


Under tort law, a lawsuit has to prove a defendant has a potential liability, which in this case could be anyone involved in the medical procedure. However, any such suit could take years and ultimately may not be successful.


"I would not be surprised if doctors, hospitals, people that actually injected the drugs, the people that bought the drugs from the compounding company, many of those people will also be sued," said Fitzpatrick.


Plaintiffs' attorneys said they're considering that option but want more information on the relationships between the compounding pharmacy and the hundreds of hospitals and clinics that received its products.


Day, the attorney in Tennessee, said the clinics and doctors that purchase their drugs from compounding pharmacies or manufacturers could be held liable for negligence because they are in a better position to determine the safety of the medicine than the patients.


"Did they use due care in determining from whom to buy these drugs?" Day said.


Terry Dawes, a Michigan attorney who has filed at least 10 federal lawsuits in the case, said in traditional product liability cases, a pharmaceutical distributor could be liable.


"We are looking at any conceivable sources of recovery for our clients including pharmaceutical supply places that may have dealt with this company in the past," he said.


Ten years ago, seven fungal meningitis illnesses and deaths were linked to injectable steroid from a South Carolina compounding pharmacy. That resulted in fewer than a dozen lawsuits, a scale much smaller than the litigations mounting up against NECC.


Two companies that insured the South Carolina pharmacy and its operators tried unsuccessfully to deny payouts. An appellate court ruled against their argument that the pharmacy willfully violated state regulations by making multiple vials of the drug without specific prescriptions, but the opinion was unpublished and doesn't set a precedent for the current litigation.


The lawsuits represent a way for patients and their families recover expenses, but also to hold the pharmacy and others accountable for the incalculable emotional and physical toll of the disease.


A binder of snapshots shows what life is like in the O'Briens' rural Fentress County, Tenn., home: Dennis hooked up to an IV, Dennis in an antibiotics stupor, bruises on his body from injections and blood tests. He's had three spinal taps. His 11-day stay in the hospital cost over $100,000, which was covered by health insurance.


His wife said she sometimes quietly checks at night to see whether her husband of 35 years is still breathing.


"In my mind, I thought we were going to fight this and get over it. But we are not ever going to get over it," said Kaye O'Brien.


Marjorie Norwood, a 59-year-old grandmother of three who lives in Ethridge, Tenn., has spent just shy of two months total in the hospital in Nashville battling fungal meningitis after receiving a steroid injection in her back. She was allowed to come home for almost a week around Thanksgiving, but was readmitted after her symptoms worsened.


Family members are still dealing with much uncertainty about her recovery, but they have not filed a lawsuit, said their attorney Mark Chalos. He said Norwood will likely be sent to a rehabilitation facility after her second stay in the hospital rather than return home again.


Marjorie Norwood's husband, an autoworker, has taken time off work to care for her and they depend on his income and insurance.


"It doesn't just change her life, it changes everyone else's life around her because we care about her and want her to be happy and well and have everything that she needs," said her daughter, Melanie Norwood.


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Outgoing husband and wife reps at odds on fiscal cliff deal



Spinners and Winners


Husband-and-wife team Reps. Connie Mack, R-Fla., and Mary Bono Mack, R-Calif., got some bad news on November 6. Both lost their elections and are now leaving Congress at the same time. But they've got one foot out the door during one of the most controversial lame duck sessions in recent history. Neither is budging on their votes -- though they don't exactly see eye-to-eye on the ongoing fiscal cliff negotiations with the White House.


Bono Mack is more open to compromising on taxes than Mack is, joking that Spinners and Winners was trying to start a fight by bringing up the topic!


"I think if this is the best possible deal we can get, and for me I think that it is, I think we ought to go for it," Bono Mack said.


"She's for extending the tax cuts for the middle class, but we all know what that means—that means that what the bill actually is going to do is raise taxes on people who do make more than $250,000," Mack said. "A lot of us would say that that's raising taxes on small businesses, the very people that we rely on to go out and create jobs."


Bono Mack says she thinks President Obama and Speaker John Boehner, R-Ohio, will reach a deal that she will be able to support; Mack says if tax increases are part of the deal, it won't get his vote.


Bono Mack came to Congress in an unconventional way 14 years ago after her former husband, Rep. Sonny Bono, suddenly died. The brand new congresswoman found herself on the House Judiciary Committee in the midst of the Clinton impeachment hearings. She voted in favor of impeaching President Clinton at the time. Clinton is now one of the most respected political figures, but Bono Mack says she does not regret her decision, but says she thinks Republicans "overplayed their hand" at the time.


"It's not good to do it, it's not easy to do, it's not good for the American people, and if we should ever do it, it better be for very serious reasons, because it really tears us apart as a people," Mary said.


As for those incoming representatives, Mack has some advice: Build strong relationships with your fellow representatives, and don't get too attached to anything.


"If you ever question your permanency here, just look at your furniture," Connie said. "There's a bar code on the furniture in your office, and as quickly as they can move you in they can move you out."


To hear more from the Congressional couple, including their future plans, check out this week's Spinners and Winners.



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UN says 2 million Afghans at risk this winter


KABUL, Afghanistan (AP) — The United Nations and several humanitarian agencies are saying that more than 2 million Afghans are at risk from cold, disease and malnutrition this winter.


Wednesday's warning comes as an international appeal for funds to help Afghanistan — one of the world's poorest countries — has fallen drastically short of its goal.


The U.N. says that only 48 percent of $448 million requested to help 8.8 million Afghans was pledged by the end of November.


The aid agencies are preparing to help Afghans deal with harsh winter conditions, especially about 400,000 people who live in some of the most remote mountainous areas of northern and central Afghanistan.


Snow has already covered mountaintops and the first snow of the year was forecast to fall this week in the Afghan capital, Kabul.


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'Lincoln,' 'Les Mis,' 'Playbook' lead SAG awards


LOS ANGELES (AP) — Steven Spielberg's Civil War saga "Lincoln," the Victor Hugo musical adaptation "Les Miserables" and the lost-soul romance "Silver Linings Playbook" led the Screen Actors Guild Awards with four nominations each Wednesday.


All three films were nominated for overall performance by their casts. Also nominated for best ensemble cast were the Iran hostage-crisis thriller "Argo" and the British retiree adventure "The Best Exotic Marigold Hotel."


"Lincoln" also scored individual acting nominations for Daniel Day-Lewis in the title role as best actor, Sally Field for supporting actress as Mary Todd Lincoln and Tommy Lee Jones for supporting actor as abolitionist firebrand Thaddeus Stevens.


"Les Miserables" had nominations for Hugh Jackman for best actor as Hugo's long-suffering hero Jean Valjean and Anne Hathaway for supporting actress as a woman fallen into prostitution, plus a nomination for its stunt ensemble.


"Silver Linings Playbook" also had lead-acting nominations for Bradley Cooper and Jennifer Lawrence as troubled spirits who find a second chance at love and Robert De Niro for supporting actor as a football-obsessed dad.


Besides Lawrence, best-actress nominees are Jessica Chastain as a CIA analyst pursuing Osama bin Laden in "Zero Dark Thirty;" Marion Cotillard as a woman who finds romance after tragedy in "Rust and Bone;" Helen Mirren as Alfred Hitchcock's strong-willed wife in "Hitchcock;" and Naomi Watts as a woman caught in the devastation of a tsunami in "The Impossible."


Joining Cooper, Day-Lewis and Jackman in the best-actor field are John Hawkes as a polio victim aiming to lose his virginity in "The Sessions" and Denzel Washington as a boozy airline pilot in "Flight."


The SAG Awards will be presented Jan. 27. The guild nominations are one of Hollywood's first major announcements on the long road to the Feb. 24 Academy Awards, whose nominations will be released Jan. 10.


Nominations for the Golden Globes, the second-biggest film honors after the Oscars, come out Thursday.


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Online:


http://www.sagawards.org


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DA investigating Texas' troubled $3B cancer agency


AUSTIN, Texas (AP) — Turmoil surrounding an unprecedented $3 billion cancer-fighting effort in Texas worsened Tuesday when its executive director offered his resignation and the state's chief public corruption prosecutor announced an investigation into the beleaguered agency.


No specific criminal allegations are driving the latest probe into the Cancer Prevention and Research Institute of Texas, said Gregg Cox, director of the Travis County district attorney's public integrity unit. But his influential office opened a case only weeks after the embattled agency disclosed that an $11 million grant to a private company bypassed review.


That award is the latest trouble in a tumultuous year for CPRIT, which controls the nation's second-largest pot of cancer research dollars. Amid the mounting problems, the agency announced Tuesday that Executive Director Bill Gimson had submitted his letter of resignation.


"Unfortunately, I have also been placed in a situation where I feel I can no longer be effective," Gimson wrote in a letter dated Monday.


Gimson said the troubles have resulted in "wasted efforts expended in low value activities" at the agency, instead of a focused fight against cancer. Gimson offered to stay on until January, and the agency's board must still approve his request to step down.


His departure would complete a remarkable house-cleaning at CPRIT in a span of just eight months. It began in May, when Dr. Alfred Gilman resigned as chief science officer in protest over a different grant that the Nobel laureate wanted approved by a panel of scientists. He warned it would be "the bomb that destroys CPRIT."


Gilman was followed by Chief Commercialization Officer Jerry Cobbs, whose resignation in November came after an internal audit showed Cobbs included an $11 million proposal in a funding slate without a required outside review of the project's merits. The lucrative grant was given to Dallas-based Peloton Therapeutics, a biomedical startup.


Gimson chalked up Peloton's award to an honest mistake and has said that, to his knowledge, no one associated with CPRIT stood to benefit financially from the company receiving the taxpayer funds. That hasn't satisfied some members of the agency's governing board, who called last week for more assurances that no one personally profited.


Cox said he has been following the agency's problems and his office received a number of concerned phone calls. His department in Austin is charged with prosecuting crimes related to government officials; his most famous cases include winning a conviction against former U.S. House Majority Leader Tom DeLay in 2010 on money laundering charges.


"We have to gather the facts and figure what, if any, crime occurred so that (the investigation) can be focused more," Cox said.


Gimson's resignation letter was dated the same day the Texas attorney general's office also announced its investigation of the agency. Cox said his department would work cooperatively with state investigators, but he made clear the probes would be separate.


Peloton's award marks the second time this year that a lucrative taxpayer-funded grant authorized by CPRIT instigated backlash and raised questions about oversight. The first involved the $20 million grant to M.D. Anderson Cancer Center in Houston that Gilman described as a thin proposal that should have first been scrutinized by an outside panel of scientific peer-reviewers, even though none was required under the agency's rules.


Dozens of the nation's top scientists agreed. They resigned en masse from the agency's peer-review panels along with Gilman. Some accused the agency of "hucksterism" and charting a politically-driven path that was putting commercial product-development above science.


The latest shake-up at CPRIT caught Gilman's successor off-guard. Dr. Margaret Kripke, who was introduced to reporters Tuesday, acknowledged that she wasn't even sure who she would be answering to now that Gimson was stepping down. She said that although she wasn't with the agency when her predecessor announced his resignation, she was aware of the concerns and allegations.


"I don't think people would resign frivolously, so there must be some substance to those concerns," Kripke said.


Kripke also acknowledged the challenge of restocking the peer-review panels after the agency's credibility was so publicly smeared by some of the country's top scientists. She said she took the job because she felt the agency's mission and potential was too important to lose.


Only the National Institutes of Health doles out more cancer research dollars than CPRIT, which has awarded more than $700 million so far.


Gov. Rick Perry told reporters in Houston on Tuesday that he wasn't previously aware of the resignation but said Gimson's decision to step down was his own.


Joining the mounting criticism of CPRIT is the woman credited with brainstorming the idea for the agency in the first place. Cathy Bonner, who served under former Texas Gov. Ann Richards, teamed with cancer survivor Lance Armstrong in selling Texas voters in 2007 on a constitutional amendment to create an unprecedented state-run effort to finance a war on disease.


Now Bonner says politics have sullied an agency that she said was built to fund research, not subsidize private companies.


"There appears to be a cover-up going on," Bonner said.


Peloton has declined comment about its award and has referred questions to CPRIT. The agency has said the company wasn't aware that its application was never scrutinized by an outside panel, as required under agency rules.


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Follow Paul J. Weber on Twitter: www.twitter.com/pauljweber


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Defiant North Korea launches long-range rocket into orbit



United States officials confirm that North Korea appears to have carried out the successful launch of a long-range rocket.



The move comes as a surprise to the international community, which has consistently called on North Korea to abandon its efforts.



Less than 24 hours earlier, the North Koreans had indicated they were grappling with "technical uncertainties" that forced them to extend the launch window to Dec. 29.



The secretive regime insists its efforts are part of a peaceful space program intended to place a satellite into orbit. But the U.S. and key Asian allies believe it is a thinly disguised attempt to test an intercontinental ballistic missile aimed at furthering development of the technology needed to mount a nuclear warhead on a long-range rocket that could one day reach the U.S.



National Security Council spokesman Tom Vietor called the launch a "highly provocative act that threatens regional security."



In recent weeks even China, North Korean's only remaining ally, sent a high level delegation into Pyongyang to convey a message of constraint. Today, China expressed "regret" over the incident. In the past, China has supported North Korea's right to develop its space program.



"The action is yet another example of North Korea's pattern of irresponsible behavior," read the National Security Council statement. "The United States remains vigilant in the face of North Korean provocations and is fully committed to the security of allies in the region."



North American Aerospace Defense Command (NORAD) acknowledged the launch initiated at 9:49 a.m. local time and followed its intended trajectory, traveling south between Korea and Japan.



"At no time was the missile or the resultant debris a threat to North America," said NORAD.



Japan's emergency alert system – M-NET – recorded the rocket's flight path directly over Okinawa just after 10:00 a.m. Officials say they have located three points of debris: One in South Korea's Yellow Sea, a second location further down the country's west coast and the third point 180 miles north of the Philippines.



A South Korean military official confirmed that one of their three warships, equipped with the Aegis radar system, detected the launch. The first stage fell just below Byeonsanbando, southwest of the Korean peninsula, exactly where it was supposed to, according to the official.



Increased attention focused on North Korea in recent weeks as satellite images showed action at the Tongchang-ri launch site. But on Monday, a statement from the Korean Committee of Space Technology claimed that scientists and technicians "found a technical deficiency in the first-stage control engine module of the rocket carrying the satellite." Satellite images also revealed that a new third-stage booster was delivered to the launch pad on Saturday.



A key issue is how far the rocket traveled and whether it was able to successfully separate its second and third stage rockets. If so, the capacity to travel long distances would be greatly enhanced.



The type of rocket is believed to be the Taepodong 2 missile. The North Koreans refer to it as the Unha-3, which in Korean translates as "Galaxy-3." The same type of missile has been previously tested three times in 2006, 2009 and 2012. Each time, the rocket failed soon after launch. It is believed to have the capacity to travel a minimum of 3,400 miles. That puts it well within striking range of the western U.S.




The U.S. had mobilized four warships in the Asia-Pacific region to monitor the launch. The guided missile destroyers the USS John S. McCain, the USS Benfold and the USS Fitzgerald joined the guided missile cruiser the USS Shiloh to "reassure allies in the region" according to officials.



South Korea's president Lee Myung-bak called an emergency security meeting in response. The timing is particularly sensitive for this country which is still officially at war with North Korea.



In just one week, South Korea holds key elections and will choose a new president. North Korea's successful launch could potentially sway voters favoring either a harsher line or a return to the "Sunshine Policy" of past administrations.



Current ruling party candidate Park Geun-hye has indicated a willingness to hold talks with North Korea.



Her father, Park Chung-hee, served as the South Korean president for 16 years. He was the target of multiple assassination attempts by North Korea. One of those efforts killed his wife, Chung-hee's mother.



Park took over her mother's duties as first lady until her father was assassinated by the chief of security in 1979. She re-emerged in 1997 as an active politician and is the first female candidate to be seriously considered for president.



Her party, the Saenuridang, is a traditionally conservative group that adapts a somewhat stricter policy towards North Korea that her opponent, Moon Jae-in. As head of the Democratic United Party, he champions a more lenient approach to the South's belligerent neighbor.



In repeated breaking news announcements throughout the day North Korean state-run television celebrated the launch. "We are proud of the glorious success of our satellite technology," said the presenter. "This is a landmark achievement."



Dec. 17 marks the one year anniversary of the country's Dear Leader Kim Jong-il's death. Analysts believe his son and successor, Kim Jong-Un, is under pressure to show the world he is intent on continuing his father's "Military First" policy and demonstrate a show of strength.



While experts do not believe North Korea currently has the technology to mount a nuclear warhead, today's launch is a significant development for the closed country's new leader.

Also Read

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UN: Despite law, Afghan women still suffer abuse


KABUL, Afghanistan (AP) — Afghan women are frequent victims of abuse, despite some success by authorities in prosecuting rape cases, forced marriages and domestic violence under a 3-year-old law, according to a report issued Tuesday by the United Nations.


The report came out a day after gunmen shot and killed the head of the women's affairs department for eastern Laghman province. Afghan officials said Najia Sediqi, who took the job after her predecessor was killed in a bomb attack in July, was on her way to her office when she was shot dead.


Afghanistan enacted its Elimination of Violence Against Women law in August 2009. It criminalizes child marriage, selling and buying women to settle disputes, assault and more than a dozen other acts of violence and abuse against women.


The U.N. collected information from 22 of Afghanistan's 34 provinces during a 12-month period ending in September to find out how well the law was being implemented.


"Although prosecutors and courts were increasingly applying the law in a growing number of reported incidents, the overall use of the law remained low, indicating there is still a long way to go before women and girls in Afghanistan are fully protected from violence through the law," the report said.


Incidents of violence against women remain largely under-reported because of cultural restraints, social norms and religious beliefs, according to the report.


It was filled with anecdotal evidence of abuse.


A prosecutor in a district of northern Kunduz province told the U.N. researchers, "A woman by the name of Storay was strangled and killed by her husband because of domestic violence and giving birth to female children and not male children."


A married 15-year-old girl from western Heart province said, "My husband and my father-in-law beat me without any reason several times. The repeated mistreatment had forced me to complain, but (it was) all in vain as the prosecutor overlooked my petition and warned me to either withdraw the complaint or face imprisonment."


A 10-year-old third grader from eastern Baghlan province was quoted in the report as saying, "My uncle intends to marry me with his son for my property that I inherited from my late father, but I don't want a husband. Rather I want to pursue my education and live with my mother."


Widespread discrimination and women's fears of social stigma or threats to their lives discourage them from seeking to prosecute their offenders.


"We are calling on the Afghan authorities to take, of course, much greater steps to both facilitate reporting of incidents of violence against women and actually open investigations and take on prosecutions," Georgette Gagnon, human rights director for the U.N. in Afghanistan, told reporters at a news conference in the Afghan capital, Kabul.


A rising number of incidents of violence against women are being reported, and courts are issuing more convictions based on the law, but they represent only a fraction of the problem.


The Afghanistan Independent Human Rights commission recorded more than 4,000 cases of violence against women from March 21 to October 21, but most were not reported to police. In contrast, during the 12-month period that the U.N. reviewed, police and prosecutors in the provinces recorded only 470 incidents.


Indictments were filed in 163 of the cases, or about 35 percent, the report said. Only 72 of the indictments were based on violations of the Elimination of Violence Against Women law. But of those, more than 70 percent resulted in convictions, the report said.


"While advances in using the law are welcome, progress in addressing violence against women will be limited until the law is applied more widely," Gagnon said.


Though Afghan girls and women continue to suffer, there are signs that views on women's rights could be slowly changing, at least in the capital.


In July, dozens of women — and men — took to the streets of Kabul to protest the public killing of an Afghan woman accused of adultery. A video of her gruesome, execution-style killing showed the woman being shot multiple times in Parwan province, north of the Afghan capital, as people stood nearby, smiling and cheering.


The protesters marched from the Afghan Ministry of Women's Affairs to a traffic circle near a U.N. compound, and some shouted, "Death to those who did this act!"


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BlackBerry Messenger 7 adds free Wi-Fi voice calling, split-screen multitasking and more






Research in Motion (RIMM) updated its BlackBerry Messenger to version 7 on Monday, adding a new key feature called “BBM Voice” that “will allow customers to make free voice calls to their BBM contacts around the world over a Wi-Fi connection.” BBM 7 also introduces multitasking with split-screen, which allows users to BBM, check email, or use other apps while on a BBM Voice call; new compatibility with Bluetooth headsets and accessories, 16 new emoticons; direct BBM Update Notification that provides in-app alerts when new versions of an app are available and an easier way to synchronize BBM profiles; Groups; and Contacts with BBIDs for simpler backup and restores. BBM 7 is available as a free update for all BlackBerry smartphones running BlackBerry 6 OS or higher. Users on BlackBerry OS 5 will get BBM Voice “early next year.”


“BBM began as a convenient and effective business messaging tool, and today it is an essential part of daily communications for customers around the world,” said T.A. McCann, RIM’s Vice President of BBM and Social Communities. ”Now, with BBM version 7, customers have a new option: they can text and talk with their BBM contacts near and far, for free.”






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Luke Bryan cleans up at ACAs with 9 awards


Luke Bryan didn't want the American Country Awards to end.


He cleaned up during the fan-voted show, earning nine awards, including artist and album of the year. His smash hit "I Don't Want This Night To End" was named single and music video of the year.


Miranda Lambert took home the second most guitar trophies with three. Jason Aldean was named touring artist of the year. Carrie Underwood won female artist of the year, and a tearful Lauren Alaina won new artist of the year.


Bryan, Aldean, Keith Urban, Lady Antebellum and Trace Adkins with Lynyrd Skynrd were among the high-energy performances.


The third annual ACAs were held at Mandalay Bay in Las Vegas Monday night.


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Online: http://www.theACAs.com


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Follow http://www.twitter.com/AP_Country for the latest country music news from The Associated Press.


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New tests could hamper food outbreak detection


WASHINGTON (AP) — It's about to get faster and easier to diagnose food poisoning, but that progress for individual patients comes with a downside: It could hurt the nation's ability to spot and solve dangerous outbreaks.


Next-generation tests that promise to shave a few days off the time needed to tell whether E. coli, salmonella or other foodborne bacteria caused a patient's illness could reach medical laboratories as early as next year. That could allow doctors to treat sometimes deadly diseases much more quickly — an exciting development.


The problem: These new tests can't detect crucial differences between different subtypes of bacteria, as current tests can. And that fingerprint is what states and the federal government use to match sick people to a contaminated food. The older tests might be replaced by the new, more efficient ones.


"It's like a forensics lab. If somebody says a shot was fired, without the bullet you don't know where it came from," explained E. coli expert Dr. Phillip Tarr of Washington University School of Medicine in St. Louis.


The federal Centers for Disease Control and Prevention warns that losing the ability to literally take a germ's fingerprint could hamper efforts to keep food safe, and the agency is searching for solutions. According to CDC estimates, 1 in 6 Americans gets sick from foodborne illnesses each year, and 3,000 die.


"These improved tests for diagnosing patients could have the unintended consequence of reducing our ability to detect and investigate outbreaks, ultimately causing more people to become sick," said Dr. John Besser of the CDC.


That means outbreaks like the salmonella illnesses linked this fall to a variety of Trader Joe's peanut butter might not be identified that quickly — or at all.


It all comes down to what's called a bacterial culture — whether labs grow a sample of a patient's bacteria in an old-fashioned petri dish, or skip that step because the new tests don't require it.


Here's the way it works now: Someone with serious diarrhea visits the doctor, who gets a stool sample and sends it to a private testing laboratory. The lab cultures the sample, growing larger batches of any lurking bacteria to identify what's there. If disease-causing germs such as E. coli O157 or salmonella are found, they may be sent on to a public health laboratory for more sophisticated analysis to uncover their unique DNA patterns — their fingerprints.


Those fingerprints are posted to a national database, called PulseNet, that the CDC and state health officials use to look for food poisoning trends.


There are lots of garden-variety cases of salmonella every year, from runny eggs to a picnic lunch that sat out too long. But if a few people in, say, Baltimore have salmonella with the same molecular signature as some sick people in Cleveland, it's time to investigate, because scientists might be able narrow the outbreak to a particular food or company.


But culture-based testing takes time — as long as two to four days after the sample reaches the lab, which makes for a long wait if you're a sick patient.


What's in the pipeline? Tests that could detect many kinds of germs simultaneously instead of hunting one at a time — and within hours of reaching the lab — without first having to grow a culture. Those tests are expected to be approved as early as next year.


This isn't just a science debate, said Shari Shea, food safety director at the Association of Public Health Laboratories.


If you were the patient, "you'd want to know how you got sick," she said.


PulseNet has greatly improved the ability of regulators and the food industry to solve those mysteries since it was launched in the mid-1990s, helping to spot major outbreaks in ground beef, spinach, eggs and cantaloupe in recent years. Just this fall, PulseNet matched 42 different salmonella illnesses in 20 different states that were eventually traced to a variety of Trader Joe's peanut butter.


Food and Drug Administration officials who visited the plant where the peanut butter was made found salmonella contamination all over the facility, with several of the plant samples matching the fingerprint of the salmonella that made people sick. A New Mexico-based company, Sunland Inc., recalled hundreds of products that were shipped to large retailers all over the country, including Target, Safeway and other large grocery chains.


The source of those illnesses probably would have remained a mystery without the national database, since there weren't very many illnesses in any individual state.


To ensure that kind of crucial detective work isn't lost, the CDC is asking the medical community to send samples to labs to be cultured even when they perform a new, non-culture test.


But it's not clear who would pay for that extra step. Private labs only can perform the tests that a doctor orders, noted Dr. Jay M. Lieberman of Quest Diagnostics, one of the country's largest testing labs.


A few first-generation non-culture tests are already available. When private labs in Wisconsin use them, they frequently ship leftover samples to the state lab, which grows the bacteria itself. But as more private labs switch over after the next-generation rapid tests arrive, the Wisconsin State Laboratory of Hygiene will be hard-pressed to keep up with that extra work before it can do its main job — fingerprinting the bugs, said deputy director Dr. Dave Warshauer.


Stay tuned: Research is beginning to look for solutions that one day might allow rapid and in-depth looks at food poisoning causes in the same test.


"As molecular techniques evolve, you may be able to get the information you want from non-culture techniques," Lieberman said.


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Follow Mary Clare Jalonick on Twitter at http://twitter.com/mcjalonick


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