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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U.S. Official Faults F.A.A. for Missing 787 Battery Risk


The nation’s top transportation safety official said Thursday that the Federal Aviation Administration accepted test results from Boeing in 2007 that failed to properly assess the risks of smoke or fire leaking from the batteries on Boeing’s new 787 jets.  


Deborah Hersman, the chairwoman of the National Transportation Safety Board, told reporters that the problems seemed to have originated in the battery, when one of the eight cells had a short circuit and the fire spread to the rest of the cells. But she said that Boeing’s tests showed no indication that the new lithium-ion batteries on its 787 planes could erupt in flame and concluded they were likely to emit smoke less than once in every 10 million flight hours.


Once the planes were placed in service, though, the batteries overheated and emitted smoke twice last month, and caused one fire, after about 50,000 hours of commercial flights.


“The assumptions used to certify the batteries must be reconsidered,” Ms. Hersman said.


Late Thursday, the F.A.A. said it would allow Boeing to conduct test flights with its 787 to collect data on the batteries and the plane’s electrical system. The agency said the flights “will be an important part of our efforts to ensure the safety of passengers and return these aircraft to service.” It did not immediately specify the number of test flights or when they would begin.


Ms. Hersman, at her news conference, said that before the F.A.A. certified the batteries, Boeing’s tests found no evidence that a short circuit in one of the eight cells could spread to other cells.


But Ms. Hersman said the fire on a 787 parked at an airport in Boston on Jan. 7 started with a short-circuit in one cell and then spread to the other cells.


She said investigators have still not been able to tell what caused the short-circuit in that cell and led to a “thermal runaway,” overheating up to 500 degrees, that then cascaded to the rest of the cells.


Still, she said, “This investigation has demonstrated that a short-circuit in a single cell can propagate to adjacent cells and result in a fire.”


Battery experts said that the finding pinpointed one step Boeing could take to make the batteries safer: It could expand the size of the battery to create more physical separation between the cells. Ralph J. Brodd, a battery industry consultant in Henderson, Nev., said Boeing and its Japanese battery subcontractor, GS Yuasa, could make the design and manufacturing changes needed to do that fairly quickly.


But unless investigators can determine what caused the first cell to short-circuit, federal officials said, Boeing will also be required to make other changes to prevent any of the possible causes and to better contain or vent any overheated materials. And given the safety board’s findings about how poorly Boeing gauged the original safety risks, the F.A.A. is likely to take its time in assessing the validity of any new tests.


The 787 is the first commercial airplane to use large lithium-ion batteries for major flight functions. All 50 of Boeing’s 787s that were delivered to airlines have been grounded since mid-January, when a 787 made an emergency landing in Japan after the pilots smelled smoke in the cockpit. That incident occurred nine days after the Boston fire.


In searching for the cause of the fire on the plane in Boston, Ms. Hersman said the safety board was still looking at the battery’s charging mechanism and potential manufacturing defects or contamination, and whether the cells were not as isolated as they should have been.


Investigators have so far ruled out two possible reasons for the short-circuit — a mechanical or electrical shock from outside the battery.


“We have not yet identified what the cause of the short-circuit is,” she said. “We are looking at the design of the battery, at the manufacturing, and we are also looking at the cell charging. There are a lot of things we are still looking at.”


Boeing said in a statement Thursday that it viewed the safety board’s findings as narrowing the likely source of the problem to within the battery itself, as opposed to other components of the plane’s extensive new electric system. But company officials said they also recognized that it would take a combination of changes to restore confidence in the battery system.


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Obama names REI chief to lead the Interior Department

President Obama nominated REI business executive Sally Jewell to lead his second-term Interior Department.









WASHINGTON – President Obama on Wednesday nominated Sally Jewell, a former oil engineer and banker and current chief executive of a national outdoor retailer, to lead the Interior Department, making an unorthodox pick for his first woman nominee to his second-term Cabinet.


The president and CEO of Recreational Equipment Inc., Jewell has no government and little public policy experience, and has spent her career far from Washington. But her resume has elements that appealed to both of the two feuding interests that consume much of the debate at the department that controls public lands: the oil and gas extraction industries seeking access to public lands, as well as environmentalists seeking to preserve them.


Jewell, 56, started her career as a petroleum engineer working in the oil fields of Oklahoma and Colorado for Mobil Oil Corp. She then moved to the corporate banking industry, and joined the REI board in 1996,  becoming chief operating officer four years later.








PHOTOS: President Obama’s past


She has been credited with expanding the Washington state-based retailer's Internet operations and contributing the membership cooperative’s resources to environmental stewardship. Jewell, an avid outdoorswoman, serves on the board of the National Parks Conservation Assn. as well as the Board of Regents of the University of Washington.


In announcing his choice, Obama cast her as someone who would seek a balance between protection and economic development of public lands. 


“She knows the link between conservation and good jobs,” Obama said in remarks at the White House. “She knows that there’s no contradiction between being good stewards of the land and our economic progress, that in fact, those two things need to go hand-in-hand. She’s shown that a company with more than $1 billion in sales can do the right thing for our planet.”


In fact, little is known about Jewell’s policy positions. And while environmental groups largely praised her nomination, Republicans and some Democrats withheld judgment.


“The livelihoods of Americans living and working in the West rely on maintaining a real balance between conservation and economic opportunity,” said Sen. Lisa Murkowski (R-Alaska), the ranking member of the Senate committee on energy and national resources.  “I look forward to hearing about the qualifications Ms. Jewell has that make her a suitable candidate to run such an important agency, and how she plans to restore balance to the Interior Department.”


PHOTOS: President Obama’s second inauguration


If confirmed, Jewell will replace Ken Salazar, who served in the post throughout the president’s first term and led a period of expansion of oil and gas drilling on public lands. Salazar plans to return to Colorado. Obama on Wednesday praised the former senator as a close friend and trusted advisor.


Salazar, he said, had “ushered in a new era of conservation of our land, our water and our wildlife.”


“He’s opened more public land and water for safe and responsible energy production – not just gas and oil, but also wind and solar – creating thousands of new jobs and nearly doubling our use of renewable energy in this country,” Obama said. 


Jewell is the first woman to be named to lead a Cabinet-level department in the second term. After naming a few white men to top jobs, Obama said the next round of nominees would include more women and be more racially diverse.


Follow Politics Now on Twitter and Facebook


Kathleen.hennessey@latimes.com


Twitter: @khennessey





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Microsoft Teases Future Surface Pro Accessories With Extra Battery Power



Days before Surface Pro’s release date, Microsoft is already teasing the types of accessories we’ll see for the device.


In a Reddit AMA hosted on Wednesday, members of the Surface Team responded to user questions, and suggested that a Surface Pro cover that would double as an extra battery pack is in the works. Good thing, too, since we found that the Surface Pro could barely get around four hours of normal usage.


Naturally, that’s a major concern for people considering buying the computer — Reddit members brought it up on multiple occasions. Asked about the new connectors at the bottom of the Surface Pro on either side of the cover port, a Microsoft rep said, “At launch we talked about the ‘accessory spine’ and hinted at future peripherals that can click in and do more. Those connectors look like can carry more current than the pogo pins, don’t they?”


The cryptic answer was fleshed out in another response. A redditor specifically asked if Microsoft plans to make a thicker keyboard with an extra battery pack.


“That would require extending the design of the accessory spine to include some way to transfer higher current between the peripheral and the main battery. Which we did,” a Surface Team member replied.


Considering that Microsoft already has released two covers for Surface Pro and Surface RT, along with a Surface-branded Wedge Touch Mouse, it’s not hard to imagine the company expanding its Surface accessory lineup. It’s a natural next step as the company continues to focus on its hardware division, which has traditionally offered accessories like mice and keyboards.


The Reddit AMA also covered issues like Surface Pro’s lack of storage space and whether the company plans to release a 3G or 4G Surface. The latter answer was a roundabout “no.” As for storage space, the Surface Team’s Marc DesCamp said, once again, that you can extend storage through the USB 3.0 port and microSDX card slot. He also mentioned that initial reports of available storage space (23GB for the 64GB model, and 83GB for the 128GB model) are conservative; you actually get around 6 to 7GB more than that.


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Kiefer Sutherland named Hasty Pudding Man of the Year






LOS ANGELES (TheWrap.com) – Kiefer Sutherland has gained his share of accolades throughout his acting career, but none quite like this.


The “24″ star has been named 2013′s Man of the Year by Harvard University‘s Hasty Pudding Theatricals student society, succeeding “The Muppets” actor Jason Segel, who received the honors last year.






Sutherland will be feted with a roast on Friday at Harvard’s Farkas Hall, where he will receive his ceremonial Pudding Pot. If Hasty Pudding tradition is any indication, Sutherland will also dress at least partially in women’s clothes at some point during the event. Which is presumably a rare event for the actor.


“Inception” actress Marion Cotillard, who was named 2013′s Woman of the Year by the theatrical society, was honored at a January 13 ceremony, during which she led a parade through the streets of Cambridge, Mass.


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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Media Decoder Blog: Cable TV Revenue Help Spur Time Warner Profit

2:14 p.m. | Updated The cable television business helped propel Time Warner to a 51-percent increase in net income and offset weakness in magazine publishing and movies in the three months that ended Dec. 31.

The media company said Wednesday that an increase in advertising revenue and subscription fees paid by cable and satellite companies to carry channels like TNT and TBS helped lift net income in the fourth quarter to $1.17 billion, or $1.21 a share, up from $773 million, or 76 cents a share, in the same three-month period last year. Revenues remained flat at $8.2 billion.

The results underscore the widening gap between the fast-growing cable television business and the more challenged magazine publishing industry and, to a lesser degree, the movie businesses.

Time Warner also said on Wednesday that its board had approved $4 billion in stock buybacks and that it would raise its quarterly dividend by 11 percent to 28.75 cents per share.

Jeffrey L. Bewkes, Time Warner’s chairman and chief executive, called the cable television business the “core of the company.” He praised the premium cable channel HBO, pointing to the interest fueled by returning series like “Game of Thrones” and “True Blood” and new original series like “Girls.” HBO added domestic subscribers in the quarter, the company reported.

At the same time, Time Inc., the nation’s largest magazine publisher, readied for layoffs of 6 percent of its global work force, cutbacks that it announced last week. Time Warner estimated the reductions would cost an estimated $60 million in restructuring charges, which will be reported in the first quarter of 2013.

Revenue at the company’s television networks, which include TNT, TBS, and CNN, rose 5 percent to $3.67 billion in the quarter. Subscription and advertising revenues at Time Warner’s suite of cable channels grew 7 percent and 3 percent, respectively, in the quarter, compared with last year. An increase in the number of National Basketball Association games on Turner channels, as well as coverage of the presidential election on CNN, led to higher ratings.

Mr. Bewkes said that, even with the boon from election coverage, CNN’s ratings disappointed. He praised the recent choice of Jeff Zucker, a former chief executive of NBC Universal, to lead CNN. “I’m optimistic that with the new leadership we’ve announced, CNN will once again fulfill the promise of its iconic brand,” he said on a conference call with analysts.

Revenue at the Warner Brothers studio fell 4 percent in the quarter to $3.7 billion, due largely to a tough comparison with 2011, which included the home entertainment release of the popular “Harry Potter and the Deathly Hallows: Part 2.” The performance of “Argo” and “The Hobbit: An Unexpected Journey” lifted Warner Brothers’ performance in the quarter and contributed to a 29 percent increase in operating income to $522 million.

Last week, Time Warner announced that Kevin Tsujihara, currently the head of the studio’s home entertainment division, would succeed Barry M. Meyer as chief executive of Warner Brothers. “I chose him because he’s got the greatest breadth of experience across Warner’s businesses,” Mr. Bewkes said on Wednesday.

Time Inc., the publisher of People, Sports Illustrated and InStyle, represents a small part of Time Warner’s overall business, but nevertheless continued to weigh on the company’s overall results. Revenues at Time Inc. declined 7 percent to $967 million, while advertising revenues fell 4 percent, or $24 million. Subscription revenues remained flat.

For the full fiscal year, which also ended Dec. 31, Time Warner reported net income of $3 billion, or $3.09 per share, compared with $2.9 billion, or $2.71 per share in 2011. In the full fiscal year, revenues decreased 1 percent to $28.7 billion.

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L.A. Archdiocese considering $200-million fund-raising campaign









In the midst of renewed public outrage over its handling of the priest molestation cases, the Los Angeles Archdiocese is considering a $200-million fund-raising campaign.


The archdiocese has hired a New York company, Guidance in Giving, to study the feasibility of a capital campaign that would shore up the church’s finances.


The archdiocese is $80 million in debt, according to a recent church financial report. In 2007, the archdiocese agreed to a record $600-million settlement with more than 500 alleged victims of priest abuse.








The consultants conducting the six-month study are interviewing every pastor in the archdiocese, as well as lay leaders.


A spokesman for the church said initial feedback has been “very positive.” The funds used would “be put into various endowments earmarked to support the pastoral priorities of the archdiocese, as well as for the general repair and upkeep of our parish churches and schools,” spokesman Tod Tamberg said in a statement.


The campaign would be the archdiocese’s first in 60 years. During the Truman administration, the church raised $3.5 million for new schools in just three weeks. At the time of that 1949 drive, there were about 650,000 Catholics in the archdiocese. Now there are more than 5 million, according to church figures.


The church has not announced the possibility of a campaign to the faithful, but Tamberg acknowledged it in response to questions from The Times on Tuesday.
Last week, Archbishop Jose Gomez publicly rebuked his predecessor, Cardinal Roger M. Mahony, and a high-ranking bishop, Thomas J. Curry, for their handling of molestation claims in the 1980 and 1990s. Files made public last month showed Mahony and Curry working to conceal priests’ sex abuse of children from the police.


At the same time he condemned their actions, the church posted 12,000 pages of priest personnel files on its website that revealed many more instances where officials covered up for abusers. Gomez, who got his undergraduate degree in accounting, assembled a special committee last year to evaluate the possibility of a large-scale campaign, according to the church financial report.


The archdiocese is still paying back a $175-million loan it received to pay victims in the civil settlement. “The archbishop considers stewardship of the church’s financial resources and sound fiscal planning to be a vital dimension of the new evangelization,” church auditors wrote in a recent report.





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Finally, a Mophie Juice Pack for Your iPhone 5











The iPhone 5 finally has its own Mophie juice pack battery case to call its own, the Juice Pack Helium. The 1,500 mAh battery-toting case boosts your iPhone 5′s battery life by 80 percent, and is 13 percent thinner than Mophie’s previous iPhone juice packs.


We’ve been waiting for this since the iPhone came out. Mophie’s juice pack iPhone cases are lifesaver at conferences or all-day events where you’re constantly checking, reading, tapping and typing on your phone. They also excel at protecting your handset while supplying additional battery power to extend your phone’s life. We love Mophie cases because they’re tougher than an organic chemistry final and sleeker than a lot of cases out there. The juice pack charges via micro USB, and when your encased iPhone is plugged in, both are charged. A standby switch keeps the juice pack off until you decide you need the extra power.


The Mophie Juice Pack Helium for iPhone 5 is $80. Available in two hues, “dark metallic” begins shipping Feb. 14, and “silver metallic” ships early March.






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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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