Well: The 'Monday Morning' Medical Screaming Match

I did not think I would ever see another “morbidity and mortality” conference in which senior doctors publicly attacked their younger colleagues for making medical errors. These types of heated meetings were commonplace when I was a medical student but have largely been abandoned.

Yet here they were again on “Monday Mornings,” a new medical drama on the TNT network, based on a novel by Dr. Sanjay Gupta, CNN’s chief medical correspondent and one of the executive producers of the show. Such screaming matches may make for good television, but it is useful to review why new strategies have emerged for dealing with medical mistakes.

So-called M&M conferences emerged in the early 20th century as a way for physicians to review cases that had either surprising outcomes or had somehow gone wrong. Although the format varied among institutions and departments, surgery M&Ms were especially known for their confrontations, as more experienced surgeons often browbeat younger doctors into admitting their errors and promising to never make them again.

Such conferences were generally closed door — that is, attended only by physicians. Errors were a private matter not to be shared with other hospital staff, let alone patients and families.

But in the late 1970s, a sociology graduate student named Charles L. Bosk gained access to the surgery department at the University of Chicago. His resultant 1979 book, “Forgive and Remember,” was one of the earliest public discussions of how the medical profession addressed its mistakes.

Dr. Bosk developed a helpful terminology. Technical and judgment errors by surgeons could be forgiven, but only if they were remembered and subsequently prevented by those who committed them. Normative errors, which called into question the moral character of the culprit, were unacceptable and potentially jeopardized careers.

Although Dr. Bosk’s book was more observational than proscriptive, his depiction of M&M conferences was disturbing. I remember attending a urology M&M as a medical student in which several senior physicians berated a very well-meaning and competent intern for a perceived mistake. The intern seemed to take it very well, but my fellow students and I were shaken by the event, asking how such hostility could be conducive to learning.

There were lots of angry accusations in the surgical M&Ms in the pilot episode of “Monday Mornings.” In one case, a senior doctor excoriated a colleague who had given Tylenol to a woman with hip pain who turned out to have cancer. “You allowed metastatic cancer to run amok for four months!” he screamed.

If this was what Dr. Bosk would have called a judgment error, the next case raised moral issues. A neurosurgeon had operated on a boy’s brain tumor without doing a complete family history, which would have revealed a disorder of blood clotting. The boy bled to death on the operating table. “The boy died,” announced the head surgeon, “because of a doctor’s arrogance.”

In one respect, it is good to see that the doctors in charge were so concerned. But as the study of medical errors expanded in the 1990s, researchers found that the likelihood of being blamed led physicians to conceal their errors. Meanwhile, although doctors who attended such conferences might indeed not make the exact same mistakes that had been discussed, it was far from clear that M&Ms were the best way to address the larger problem of medical errors, which, according to a 1999 study, killed close to 100,000 Americans annually.

Eventually, experts recommended a “systems approach” to medical errors, similar to what had been developed by the airline industry. The idea was to look at the root causes of errors and to devise systems to prevent them. Was there a way, for example, to ensure that the woman with the hip problem would return to medical care when the Tylenol did not help? Or could operations not be allowed to occur until a complete family history was in the chart? Increasingly, hospitals have put in systems, such as preoperative checklists and computer warnings, that successfully prevent medical errors.

Another key component of the systems approach is to reduce the emphasis on blame. Even the best doctors make mistakes. Impugning them publicly — or even privately — can make them clam up. But if errors are seen as resulting from inadequate systems, physicians and other health professionals should be more willing to speak up.

Of course, the systems approach is not perfect. Studies continue to show that physicians conceal their mistakes. And elaborate systems for preventing errors can at times interfere with getting things done in the hospital.

Finally, it is important not to entirely remove the issue of responsibility. Sad to say, there still are physicians who are careless and others who are arrogant. Even if today’s M&M conferences rarely involve screaming, supervising physicians need to let such colleagues know that these types of behaviors are unacceptable.


Barron H. Lerner, M.D., professor of medicine at New York University Langone Medical Center, is the author, most recently, of “One for the Road: Drunk Driving Since 1900.”
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Justice weighs action against Moody's










(Reuters) - The Justice Department and multiple states are discussing also suing Moody's Corp for defrauding investors, according to people familiar with the matter, but any such move will likely wait until a similar lawsuit against rival Standard and Poor's is tested in the courts.

Inquiries into Moody's are in the early stages, largely because state and federal authorities have dedicated more resources to the S&P lawsuit, said the sources, who were not authorized to speak publicly about enforcement discussions.

Moody's spokesman Michael Adler and Justice Department spokeswoman Adora Andy declined to comment for this story.

Moody's in the past has defended itself against similar allegations, including a 2011 congressional report that concluded the major ratings agencies manipulated ratings to drive business.

The firm previously said Moody's takes the quality of its ratings and the integrity of the ratings process very seriously. It also said the firm has protections in place to separate the commercial and analytical aspects of its business.

The U.S. Justice Department filed a $5 billion lawsuit against S&P late on Monday and accused it of an egregious scheme to defraud investors in the run-up to the financial crisis, fueled by a desire to gain more business.

Shares of McGraw Hill Cos Inc , which owns S&P, have fallen more than 25 percent since news of the lawsuits. Moody's shares have fallen about 15 percent, even though it was not named in any of this week's actions.

"Don't think Moody's is off the hook," said one law enforcement official.

Another rival, Fimalac SA's Fitch Ratings, is unlikely to face similar action, the sources said, since it is a much smaller player in the U.S. ratings industry. The firm also escaped the brunt of scrutiny from congressional investigators.

In a sign of just how high-stakes the battle is, S&P hired prominent defense attorney John Keker, who has represented everyone from cyclist Lance Armstrong to Enron's Andrew Fastow.

S&P said in a statement on Tuesday that the lawsuit is meritless and said it will vigorously defend itself.

A similar coordinated federal-state action against Moody's would follow lawsuits two states have already filed against the ratings firm. Connecticut, which led the states in this week's actions, sued Moody's and S&P in March 2010.

In January a state court in Hartford denied the last of the preliminary motions Moody's had filed to have the case thrown out. That case and the one against S&P are proceeding to trial in the second half of 2014.

Democratic Senator Richard Blumenthal of Connecticut, who as then-attorney general brought the cases against S&P and Moody's in 2010, said he found rampant abuse across the credit rating industry.

"The difference is one of degree and scale rather than essential modus operandi," Blumenthal said in an interview. "S&P is the largest and they did the most sizeable amount of ratings with the largest profits."

CASE THEORY

Those earlier cases and the more recent ones against S&P are based on a theory that the firms misled investors by stating that their ratings on mortgage products were objective and not influenced by conflicts of interest.

Instead, the lawsuits contend, the firms inflated ratings and understated risks as the housing bubble started to burst, driven by a desire to gain more business from the investment banks that issued mortgage securities.

Framing the cases in that manner steers clear of attacking individual ratings, which have largely been shielded under free speech protections. Instead, the focus is on proving false just one statement S&P made - that its ratings were objective.

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Quinn minimum wage hike could be tough sell

Chicago Tribune Springfield correspondent Ray Long analyzes Illinois Gov. Pat Quinn's State of the State speech, saying it was ambitious and much like one heard during a re-election campaign. (Posted on: Feb. 6, 2013.)









It won’t be easy for Democrat Gov. Pat Quinn to find enough lawmakers to vote for the minimum wage increase, what with business groups pronouncing it a “job killer.”


But the best news for Quinn is that key Democratic lawmakers already are lined up behind an idea that’s popular with a large number of low-income workers. Senate President John Cullerton and House Majority Leader Barbara Flynn Currie quickly embraced it. Cullerton flatly predicted, “We’ll be able to pass a minimum wage bill.”


“I support it. It’s very, very popular in Illinois,” Cullerton said. “There is overwhelming support in the electorate.”








The electorate is the target audience in Quinn’s State of the State speech as he ramps up for a 2014 re-election campaign. His office estimated 500,000 Illinoisans could benefit from the wage hike. That’s a huge number of potential supporters who might be easily persuaded to cast a vote for a politician that helped them put more money into their pockets, particularly one like Quinn whose margin of victory in both the 2010 primary and general elections were far from overwhelming.


Republicans, including potential rivals in 2014, refused to get behind the minimum wage hike. House Republican leader Tom Cross of Oswego charged Quinn’s priorities are askew when the “elephant in the room” is the state’s $96.8 billion pension debt — a worst-in-the-nation status that has sent the state’s credit rating into a tailspin.


The pension battle has Quinn locked in a protracted war with union workers who are fighting against any rollbacks in retirement benefits at the same time they are unable to come to terms with the administration on a labor contract.


But as Quinn revealed his minimum wage push to a joint session of the House and Senate, he sought to wrap his arms around the working class, saying Illinois must “honor the productivity of our workers.”


“Our businesses are only as good as the employees who drive their success,” Quinn said. “Nobody in Illinois should work 40 hours a week and live in poverty. That’s a principle as old as the Bible.”


Quinn said the state minimum wage — currently $8.25 an hour — should be bumped up over four years to “at least $10 an hour.”


But beyond the finances, Quinn may hope a populist pocketbook issue can boost his own low approval ratings as he prepares to fight potentially big-name Democratic challengers like Attorney General Lisa Madigan and Bill Daley, the former white House chief of staff and a high-profile heir to the Daley family legacy.


Quinn called for a minimum-wage hike during the 2010 governor’s race, while Republican challenger Sen. Bill Brady opposed it.


Following Quinn’s speech on Wednesday, Brady said he wanted to review Quinn’s plan when there details are rolled out.


Hinsdale Republican Sen. Kirk Dillard, who like Brady is eyeing Quinn’s job, said he does not support the minimum wage hike. “We need to create better jobs, not minimum wage jobs, for those who are trying to raise a family,” Dillard said.


The chief sponsor of the minimum wage increase is Sen. Kimberly Lightford, the Maywood Democrat on Cullerton’s leadership team. She has sought to negotiate with foes and backers of the legislation for eight months. She said she wants to roll out a bill in the next few weeks.


One controversial provision Lightford is working through is her desire to raise the minimum wage for restaurant waiters and waitresses, who get a fraction of $8.25 regular minimum wage and get subsidized by tips.


“Businesses should be able to pay them the full $8.25,” Lightford said. But with smaller restaurants in particular balking, Lightford said, finding a happy medium is “not an easy task.”


Still, she said the chance of passage in the Senate “looks good” because she has been priming colleagues about the issue over the last two years.


“It’s not new today, which is very helpful,” Lightford said.


In a town where a raised eyebrow or a snarl can result in major political ramifications, Lightford said she saw House Speaker Michael Madigan, D-Chicago, clapping when Quinn talked about raising the minimum wage.


“That was a good sign,” Lightford said.





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Segregationist U.S. Senator Thurmond’s biracial daughter dies






CHARLESTON, South Carolina (Reuters) – Essie Mae Washington-Williams, who in 2003 revealed she was the biracial daughter of segregationist U.S. Senator Strom Thurmond, died on Monday at age 87, her attorney said.


Washington-Williams, who had been in declining health in recent years, died of natural causes at a care home in Columbia, South Carolina, said lawyer Frank Wheaton.






Washington-Williams was born in 1925 to a black teenage girl who worked as a maid in Thurmond’s parents’ home when Thurmond was 22. She announced she was Thurmond’s daughter in 2003 after his death at age 100 that year, and the late senator’s family confirmed her claim.


Washington-Williams was a teacher in Los Angeles for three decades and was the mother of four. She moved to South Carolina about five years ago to be closer to a daughter who lived there, Wheaton said.


Her 2006 memoir, “Dear Senator,” detailed her decades-long relationship with her father, the letters they wrote each other and the kindness he showed her personally, which she struggled to reconcile with his opposition to civil rights and his defense of racial segregation.


“She was very low-key and never wanted to rock the boat, I think that’s why she kept her secret until he died,” said William Stadiem, who co-wrote “Dear Senator.”


Stadiem said Thurmond had great affection for Washington-Williams‘ mother, Carrie Butler.


“The fact he stayed close to Essie for all those years, it would be so easy for him to say ‘get out of my life, you don’t exist,’ and he didn’t do that,” Stadiem said. “I think she reminded him of her mother.”


Washington-Williams as a young child went to live with her mother’s sister and her husband in Pennsylvania, and it was from him that she took the surname Washington. She adopted the name Williams from her marriage to attorney Julius Williams.


Thurmond began his career as a Democrat but switched to the Republican Party in 1964. In his lifetime, Thurmond said he was not racist but opposed what he saw as excessive federal intervention.


He staged the longest filibuster in U.S. history when he spoke for more than 24 hours against a 1957 civil rights bill that sought to fight the disenfranchisement of blacks in the South by giving new powers to federal prosecutors.


In 2004 a statue of Thurmond outside the South Carolina State House was altered to engrave the name Essie Mae with those of his other four children on the foundation stone.


(Reporting by Harriet McLeod; Writing by Alex Dobuzinskis; Editing by Xavier Briand)


Celebrity News Headlines – Yahoo! News





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Personal Health: Effective Addiction Treatment

Countless people addicted to drugs, alcohol or both have managed to get clean and stay clean with the help of organizations like Alcoholics Anonymous or the thousands of residential and outpatient clinics devoted to treating addiction.

But if you have failed one or more times to achieve lasting sobriety after rehab, perhaps after spending tens of thousands of dollars, you’re not alone. And chances are, it’s not your fault.

Of the 23.5 million teenagers and adults addicted to alcohol or drugs, only about 1 in 10 gets treatment, which too often fails to keep them drug-free. Many of these programs fail to use proven methods to deal with the factors that underlie addiction and set off relapse.

According to recent examinations of treatment programs, most are rooted in outdated methods rather than newer approaches shown in scientific studies to be more effective in helping people achieve and maintain addiction-free lives. People typically do more research when shopping for a new car than when seeking treatment for addiction.

A groundbreaking report published last year by the National Center on Addiction and Substance Abuse at Columbia University concluded that “the vast majority of people in need of addiction treatment do not receive anything that approximates evidence-based care.” The report added, “Only a small fraction of individuals receive interventions or treatment consistent with scientific knowledge about what works.”

The Columbia report found that most addiction treatment providers are not medical professionals and are not equipped with the knowledge, skills or credentials needed to provide the full range of evidence-based services, including medication and psychosocial therapy. The authors suggested that such insufficient care could be considered “a form of medical malpractice.”

The failings of many treatment programs — and the comprehensive therapies that have been scientifically validated but remain vastly underused — are described in an eye-opening new book, “Inside Rehab,” by Anne M. Fletcher, a science writer whose previous books include the highly acclaimed “Sober for Good.”

“There are exceptions, but of the many thousands of treatment programs out there, most use exactly the same kind of treatment you would have received in 1950, not modern scientific approaches,” A. Thomas McLellan, co-founder of the Treatment Research Institute in Philadelphia, told Ms. Fletcher.

Ms. Fletcher’s book, replete with the experiences of treated addicts, offers myriad suggestions to help patients find addiction treatments with the highest probability of success.

Often, Ms. Fletcher found, low-cost, publicly funded clinics have better-qualified therapists and better outcomes than the high-end residential centers typically used by celebrities like Britney Spears and Lindsay Lohan. Indeed, their revolving-door experiences with treatment helped prompt Ms. Fletcher’s exhaustive exploration in the first place.

In an interview, Ms. Fletcher said she wanted to inform consumers “about science-based practices that should form the basis of addiction treatment” and explode some of the myths surrounding it.

One such myth is the belief that most addicts need to go to a rehab center.

“The truth is that most people recover (1) completely on their own, (2) by attending self-help groups, and/or (3) by seeing a counselor or therapist individually,” she wrote.

Contrary to the 30-day stint typical of inpatient rehab, “people with serious substance abuse disorders commonly require care for months or even years,” she wrote. “The short-term fix mentality partially explains why so many people go back to their old habits.”

Dr. Mark Willenbring, a former director of treatment and recovery research at the National Institute for Alcohol Abuse and Alcoholism, said in an interview, “You don’t treat a chronic illness for four weeks and then send the patient to a support group. People with a chronic form of addiction need multimodal treatment that is individualized and offered continuously or intermittently for as long as they need it.”

Dr. Willenbring now practices in St. Paul, where he is creating a clinic called Alltyr “to serve as a model to demonstrate what comprehensive 21st century treatment should look like.”

“While some people are helped by one intensive round of treatment, the majority of addicts continue to need services,” Dr. Willenbring said. He cited the case of a 43-year-old woman “who has been in and out of rehab 42 times” because she never got the full range of medical and support services she needed.

Dr. Willenbring is especially distressed about patients who are treated for opioid addiction, then relapse in part because they are not given maintenance therapy with the drug Suboxone.

“We have some pretty good drugs to help people with addiction problems, but doctors don’t know how to use them,” he said. “The 12-step community doesn’t want to use relapse-prevention medication because they view it as a crutch.”

Before committing to a treatment program, Ms. Fletcher urges prospective clients or their families to do their homework. The first step, she said, is to get an independent assessment of the need for treatment, as well as the kind of treatment needed, by an expert who is not affiliated with the program you are considering.

Check on the credentials of the program’s personnel, who should have “at least a master’s degree,” Ms. Fletcher said. If the therapist is a physician, he or she should be certified by the American Board of Addiction Medicine.

Does the facility’s approach to treatment fit with your beliefs and values? If a 12-step program like A.A. is not right for you, don’t choose it just because it’s the best known approach.

Meet with the therapist who will treat you and ask what your treatment plan will be. “It should be more than movies, lectures or three-hour classes three times a week,” Ms. Fletcher said. “You should be treated by a licensed addiction counselor who will see you one-on-one. Treatment should be individualized. One size does not fit all.”

Find out if you will receive therapy for any underlying condition, like depression, or a social problem that could sabotage recovery. The National Institute on Drug Abuse states in its Principles of Drug Addiction Treatment, “To be effective, treatment must address the individual’s drug abuse and any associated medical, psychological, social, vocational, and legal problems.”

Look for programs using research-validated techniques, like cognitive behavioral therapy, which helps addicts recognize what prompts them to use drugs or alcohol, and learn to redirect their thoughts and reactions away from the abused substance.

Other validated treatment methods include Community Reinforcement and Family Training, or Craft, an approach developed by Robert J. Meyers and described in his book, “Get Your Loved One Sober,” with co-author Brenda L. Wolfe. It helps addicts adopt a lifestyle more rewarding than one filled with drugs and alcohol.

This is the first of two articles on addiction treatment.

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Penny Pritzker a candidate for Commerce secretary













Penny Pritzker


Chicago businesswoman Penny Pritzker has been a prominent Barack Obama friend and supporter since his early days in politics and ran his 2008 campaign fundraising operation.
(Zbigniew Bzdak, Chicago Tribune / April 8, 2011)


























































Chicago businesswoman Penny Pritzker has emerged as a leading candidate to serve in the administration of President Obama, for whom she has long been a campaign supporter and top fund raiser.


A senior administration official cautioned that no announcement is imminent and that Obama has made no decision. But Pritzker is under consideration to serve as Commerce secretary or perhaps in another senior position involving relations between Obama and business leaders, according to officials close to the process who spoke anonymously to comment on internal deliberations.


Pritzker is a member of the Chicago family behind the Hyatt Hotels Corp. She has been a prominent Obama friend and supporter since his early days in politics and ran his 2008 campaign fundraising operation.


 She is founder and CEO of PSP Capital Partners and the Pritzker Realty Group, as well as chair of the Artemis Real Estate Partners. She is also a member of the Chicago Board of Education and has had two White House appointments, serving on the President’s Council on Jobs and Competitiveness and the President’s Economic Recovery Advisory Board.


Forbes’ annual list of the world’s billionaires last March put Pritzker at No. 719 and said her hotels and investments were worth $1.8 billion.





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Judge: PTSD experts not needed in triple-murder trial









A Cook County judge today denied an effort by a defendant in a triple murder case in Hoffman Estates to have a trio of experts testify that he was suffering from post-traumatic stress disorder when the slayings occurred.

Judge Ellen Mandeltort said the three experts would not add to an understanding of D’Andre Howard’s claims of self-defense and that their testimony would amount to speculation about Howard’s state of mind on the night of the murders.


The ruling paves the way for Howard’s trial later this year on murder and related charges in the slayings of Laura Engelhardt, 18, her father, Alan Engelhardt, 57, and her grandmother, Marlene Gacek, 73, in 2009. He faces charges of murder, attempted murder and kidnapping, prosecutors said.








In her ruling, Mandeltort said Howard is not relying on mental illness as a defense and that any testimony about his abuse as a child could be understood by a jury without a detailed explanation from experts.


“The defendant will rely on self-defense, not insanity,” said Mandeltort. “His prior abuse is not a concept beyond the comprehension of the trier of fact.” 


Howard has been in custody since April 2009 after police discovered Laura Engelhardt, 18, and the bodies of Alan Engelhardt, 57, and Marlene Gacek, 73, in their home in the 1000 block of North Bluebonnet Lane. Howard is charged with using a butcher knife to kill them following an argument with Amanda Engelhardt, his girlfriend and mother of his child, prosecutors said. Amanda Engelhardt, the daughter of Alan and Shelly Engelhardt, was not injured but witnessed the killings, authorities said.


Shelly Engelhardt, the mother of Laura and Amanda, also was stabbed but recovered and is expected to testify at the trial. 


Assistant public defenders Deana Binstock and Georgeena Carson were trying to show that Howard was suffering from post-traumatic stress disorder because of childhood abuse and felt threatened by family members. Binstock said the ruling was a setback for the defense.


“It impacts our defense strategy,” said Binstock. “PTSD is a significant component of self-defense.”


Mandeltort also pressed Binstock for a trial date, noting that that case will be four years old in April. Binstock asked for another continuance, which was scheduled for March 11.


Binstock and Carson took over the case a year ago after Howard’s original attorney, assistant public defender Jim Mullenix, retired.


“I will try this case when I’m ready,” said Binstock after the hearing. “It would be a disservice to D’Andre not to. I’m anxious to go to trial, too.”





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Smooth-singing Josh Groban offers edgier sound on new album






LOS ANGELES (Reuters) – After selling more than 22 million albums in the United States and becoming a staple in the classical music field, singer Josh Groban is embracing an edgier sound for his latest record, “All That Echoes,” out on Tuesday.


Groban, 31, put together a collection of covers and original songs for the album, including a rendition of one of his personal favorites, “Falling Slowly” from the movie and stage musical “Once.”






Under the guidance of veteran producer Rob Cavallo, the Warner Bros. Records chairman who has worked with rockers like Green Day, Goo Goo Dolls and Paramore, Groban showcases his usual smooth vocals against a more energetic, live-concert sound.


“It’s not about walking out of your lane and scaring people. It’s about slightly expanding what your lane is and allowing all of that to be part of your world,” Groban said in an interview with Reuters.


Along with covers including a rendition of Stevie Wonder’s “I Believe (When I Fall in Love It Will Be Forever),” Groban also wrote original songs, which he said emerged from frustration.


“It was the frustration of hearing songs that were maybe written for me after a little bit of success, going ‘Ahh, is that really what you think I do?’ Yes, I know the other thing was kind of cheesy, but that’s really cheesy,’” the singer said.


“All That Echoes” features original songs such as “Below the Line,” which draws in Latin jazz beats and sweeping ballads such as “Brave” and “False Alarms,” where Groban showcases his powerful voice.


ACTING CHOPS


Groban first found the spotlight in 1999, when he was asked to fill in for ailing Italian tenor Andrea Bocelli at a rehearsal with Canadian singer Celine Dion.


Groban went on to land a short role on TV show “Ally McBeal” in 2001 and released his debut self-titled solo album later that year.


Five studio albums later, Groban has cemented himself at the top of the list of pop-vocal performers. His 2007 holiday record “Noel” became the best-selling U.S. album of the year.


Los Angeles native Groban has also taken small acting roles in TV comedy “The Office, movie “Crazy Stupid Love” and will make a cameo appearance on an upcoming episode of “CSI: NY.”


If he had his dream gig, Groban said he would be fronting rock band Queen for a day. But in the more foreseeable future, he hoped to become a regular face in theater.


“There are only so many albums I’m going to want to make before I decide to go and follow that dream for a minute or longer than a minute,” the singer said.


“I think that there will come a time very soon, hopefully in the next two or three years, where I’ll take out a big chunk of time and dedicate it to theater and do some of that.”


For now, the singer will hit the road in support of his new album, heading to Australia in April before returning to Los Angeles to perform three dates at the Hollywood Bowl in July.


(Reporting By Lindsay Claiborn, writing by Piya Sinha-Roy; Editing by Cynthia Osterman)


Music News Headlines – Yahoo! News





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Well: Warning Too Late for Some Babies

Six weeks after Jack Mahoney was born prematurely on Feb. 3, 2011, the neonatal staff at WakeMed Hospital in Raleigh, N.C., noticed that his heart rate slowed slightly when he ate. They figured he was having difficulty feeding, and they added a thickener to help.

When Jack was discharged, his parents were given the thickener, SimplyThick, to mix into his formula. Two weeks later, Jack was back in the hospital, with a swollen belly and in inconsolable pain. By then, most of his small intestine had stopped working. He died soon after, at 66 days old.

A month later, the Food and Drug Administration issued a caution that SimplyThick should not be fed to premature infants because it may cause necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue.


Catherine Saint Louis speaks about using SimplyThick in premature infants.



Experts do not know how the product may be linked to the condition, but Jack is not the only child to die after receiving SimplyThick. An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.

Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.

SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.

John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.

However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”

Since 2001, SimplyThick has been widely used by adults with swallowing difficulties. A liquid thickened to about the consistency of honey allows the drinker more time to close his airway and prevent aspiration.

Doctors in newborn intensive care units often ask non-physician colleagues like speech pathologists to determine whether an infant has a swallowing problem. And those auxiliary feeding specialists often recommended SimplyThick for neonates with swallowing troubles or acid reflux.

The thickener became popular because it was easy to mix, could be used with breast milk, and maintained its consistency, unlike alternatives like rice cereal.

“It was word of mouth, then neonatologists got used to using it. It became adopted,” said Dr. Steven Abrams, a neonatologist at Texas Children’s Hospital in Houston. “At any given time, several babies in our nursery — and in any neonatal unit — would be on it.”

But in early 2011, Dr. Benson Silverman, the director of the F.D.A.’s infant formula section, was alerted to an online forum where doctors had reported 15 cases of NEC among infants given SimplyThick. The agency issued its first warning about its use in babies that May. “We can only do something with the information we are provided with,” he said. “If information is not provided, how would we know?”

Most infants who took SimplyThick did not fall ill, and NEC is not uncommon in premature infants. But most who develop NEC do so while still in the hospital. Some premature infants given SimplyThick developed NEC later than usual, a few after they went home, a pattern the F.D.A. found unusually worrisome.

Even now it is not known how the thickener might have contributed to the infant deaths. One possibility is that xanthan gum itself is not suitable for the fragile digestive systems of newborns. The intestines of premature babies are “much more likely to have bacterial overgrowth” than adults’, said Dr. Jeffrey Pietz, the chief of newborn medicine at Children’s Hospital Central California in Madera.

“You try not to put anything in a baby’s intestine that’s not natural.” If you do, he added, “you’ve got to have a good reason.”

A second possibility is that batches of the thickener were contaminated with harmful bacteria. In late May 2011, the F.D.A. inspected the plants that make SimplyThick and found violations at one in Stone Mountain, Ga., including a failure to “thermally process” the product to destroy bacteria of a “public health significance.”

The company, Thermo Pac, voluntarily withdrew certain batches. But it appears some children may have ingested potentially contaminated batches.

The parents of Jaden Santos, a preemie who died of NEC while on SimplyThick, still have unused packets of recalled lots, according to their lawyer, Joe Taraska.

The authors of the F.D.A. report theorized that the infants’ intestinal membranes could have been damaged by bacteria breaking down the xanthan gum into too many toxic byproducts.

Dr. Qing Yang, a neonatologist at Wake Forest University, is a co-author of a case series in the Journal of Perinatology about three premature infants who took SimplyThick, developed NEC and were treated. The paper speculates that NEC was “most likely caused by the stimulation of the immature gut by xanthan gum.”

Dr. Yang said she only belatedly realized “there’s a lack of data” on xanthan gum’s use in preemies. “The lesson I learned is not to be totally dependent on the speech pathologist.”

Julie Mueller’s daughter Addison was born full-term and given SimplyThick after a swallow test showed she was at risk of choking. It was recommended by a speech pathologist at the hospital.

Less than a month later, Addison was dead with multiple holes in her small intestine. “It was a nightmare,” said Ms. Mueller, who has filed a lawsuit against SimplyThick. “I was astounded how a hospital and manufacturer was gearing this toward newborns when they never had to prove it would be safe for them. Basically we just did a research trial for the manufacturer.”

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Deficit hits 5-year low, but cuts drag economy









WASHINGTON -- The federal deficit will drop to less than $1 trillion for the first time in five years, but massive spending cuts that have improved the budget outlook are also slowing the economy, according to a report released Tuesday by the Congressional Budget office.


The nonpartisan arbiter of federal budgets said the combination of new tax revenue from the "fiscal cliff" deal as well as looming cuts that kick in March 1 will push the deficit down to $845 billion for fiscal 2013. Deficits have topped $1 trillion in recent years.


The projections will fuel the coming budget debates, which started Tuesday as President Obama was calling on Congress to steer around the coming budget cuts.





The budget office said the cuts will contribute to an economy that lags in 2013. The unemployment rate likely will remain above 7.5% through the year. It predicted that the gross domestic product will be well below its potential, growing by just 1.4%, more than half a percentage point slower than would happen if the spending cuts were averted.


At the same time, the nation's debt load is expected to fluctuate but ultimately rise to record levels this decade, largely because of increased spending on healthcare and the federal safety net for older Americans with the aging of the baby boom population.


Additionally, the outlook shows how difficult it will be for House Republicans to accomplish their goal of balancing the budget in 10 years with potentially deep austerity measures.


Even though revenue is rising and spending is decreasing, the overall budget outlook remains stark. By the end of the decade, public debt is set to rise to 77% of GDP, a decade of highs on par with debt levels in World War II.


"The projected path of the federal budget remains a significant concern," the CBO wrote.


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Lisa.mascaro@latimes.com


Twitter: @LisaMascaroinDC





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