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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BlackBerry's new phone is off to a good start in Britain and Canada

























































































BlackBerry Z10


The BlackBerry Z10 went on sale in Canada on Tuesday and sales are up more than 50% from previous BlackBerry phone launches.


(Frank Gunn, Associated Press / February 5, 2013)





































































The long-awaited BlackBerry Z10 won't be available in the U.S. until March, but it's already out in other countries and sales are hot, according to the maker.


BlackBerry's Z10 touch-screen smartphone has gotten off to a better start in Britain than any of its previous models, the company said.


To be precise, the Z10 is "selling almost three times better" than previous BlackBerry models have in their first week, according to a Bloomberg report that cites BlackBerry Chief Executive Thorsten Heins as the source.





The Z10 is also doing well in BlackBerry's homeland of Canada, with sales up more than 50% from previous BlackBerry phone launches, Heins said.


That's great news for BlackBerry, which is relying on the Z10 and its new Blackberry 10 operating system to remain relevant in the smartphone market.


But the Z10's big test will come next month when the Z10 makes its debut in the U.S. It will be carried by AT&T, Verizon Wireless and T-Mobile.


None of the companies have given release dates for the phone, but Verizon has said the phone will be available for $200 with a new contract.


salvador.rodriguez@latimes.com






















































































































































































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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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Chris Brown returns to court for probation issues


LOS ANGELES (AP) — With the woman he assaulted throwing him a kiss, Chris Brown walked into court Wednesday to face allegations he failed to complete his community labor sentence for Rihanna's 2009 beating.


A judge asked for more information and scheduled another hearing in two months.


Rihanna, the glamorous singer whose bruised face became a tabloid fixture after she was beaten by her then-boyfriend on the way to the Grammys, has been dating Brown again.


She arrived with the R&B star, his mother and two other women and blew him a kiss as he entered the courtroom. They left together after the short proceeding in which Superior Court Judge James Brandlin set the next hearing for April 5.


Brown's lawyer, Mark Geragos, said he was disturbed about the way the district attorney handled the matter and said he would be filing a motion opposing the prosecution's move to modify Brown's fulfillment of his community labor sentence.


Prosecutors, who said they could find no credible evidence that Brown had completed his community labor in his home state of Virginia, asked that he start all over and put in 180 days in Los Angeles County.


Prosecutors have suggested there was either sloppy record keeping or fraudulent reporting.


The judge noted during the brief court session that a prosecution filing did not request revocation of Brown's probation and he, therefore, would not revoke it.


A motion filed Tuesday also raised for the first time in Brown's felony assault case several incidents that prosecutors said demonstrate Brown has ongoing anger management issues.


The motion cited a Jan. 27 fight between Brown and fellow R&B star Frank Ocean, and a 2011 outburst in which Brown threw a chair through a window after he was asked about the Rihanna attack on "Good Morning America."


The filing represents a dramatic shift in the case against Brown, who was repeatedly praised by the judge overseeing his case for his completion of domestic violence courses and his community service work in his home state of Virginia.


That changed in September, when prosecutors raised concerns about Brown's community service after he logged 701 hours in seven months — an amount that had previously taken him more than two years to achieve.


Los Angeles investigators traveled to Richmond, Va., to investigate Brown's service, which was only described in broad strokes by Richmond Police Chief Bryan Norwood, who was overseeing the singer's community labor.


"This inquiry provided no credible, competent or verifiable evidence that defendant Brown performed his community labor as presented to this court," Deputy District Attorney Mary Murray wrote.


Brown's attorney Geragos blasted the court filing, saying the prosecutor ignored interviews "where sworn peace officers stated unequivocally that Mr. Brown was supervised and did all of the community service."


"I plan on asking for sanctions from the DA's office for filing a frivolous, scurrilous and frankly defamatory motion," he said Tuesday.


Brown's case was transferred to Brandlin after a recent shuffling of judicial assignments.


After pleading guilty to the Rihanna attack, Brown was given permission to serve 180 days of community labor in his home state of Virginia, but only as long as he performed manual labor such as graffiti removal and roadside cleanup.


Given problems with documentation and statements from some witnesses who contradict Brown's claims of work, prosecutors asked Brandlin to order Brown to repeat his service in Los Angeles.


Brown spent one-third of the hours he logged in Virginia working night shifts at a day care center in rural Virginia where his mother once served as director and where the singer spent time as a child.


A detective who checked on Brown's work nine times at the Tappahannock Children's Center found the singer, his mother and a bodyguard at the center on each visit.


The records said Brown waxed floors or performed general cleaning at the center.


A professional floor cleaner contracted to work at the daycare center told investigators he had been cleaning the floors during the months Brown reported working at the facility.


"Claims that the defendant cleaned, stripped and waxed floors at that location have been credibly contradicted," prosecutors said in the filing.


Brown's mother, Joyce Hawkins, no longer had a formal role at the day care center but had her own set of keys and coordinated her son's work at the facility, prosecutors said.


Murray stated in her filing that Norwood's report on Brown's service was "at best sloppy documentation and at worst fraudulent reporting."


Richmond police spokesman Gene Lepley declined to discuss the allegations.


"We believe it would inappropriate to comment on a matter that's before the court," Lepley said.


According to the motion, officials with Virginia's probation office told investigators that Brown's arrangement to be supervised by Norwood was "extremely unusual" and had not been approved by the agency. No one from Virginia's probation department oversaw Brown's hours, prosecutors said.


The motion noted that the only records the department has to indicate Brown was supervised were officers' overtime sheets. Five of 21 days that officers logged overtime for Brown were spent providing security for the singer's concerts.


The allegations are the latest pre-Grammy controversy for Brown, who was arrested shortly after the 2009 ceremony for his attack on Rihanna. He has since returned to the awards show by performing and winning an award in 2011 for his album "F.A.M.E."


Brown and Ocean are competing against one other for the Best Urban Contemporary Album category at Sunday's Grammys.


___


AP writers Anthony McCartney and Ryan Pearson contributed to this report.


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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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Crimes against tourists are latest blow to Mexico tourism




























































































Police say five masked and armed men broke into a bungalow and raped six Spanish tourists.






























































Despite past assurances that tourists are safe in their country, Mexican tourism officials are again faced with trying to explain away another report of crime against foreign visitors.


The latest incident took place in the resort town of Acapulco, where six Spanish tourists on vacation were raped Sunday by masked gunmen.


Unlike many crimes involving drug violence in the country's interior states, the rapes took place near the beach, where the tourists were renting bungalows near four-star hotels.



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    Photos: The fastest roller coaster and other record-setting thrill rides






































  • Ships of doom: Some of history's worst shipwrecks





    Photos: Ships of doom: Some of history's worst shipwrecks






































  • TSA finds weapons in the strangest places





    Photos: TSA finds weapons in the strangest places


















  • Mexico's secretary of tourism issued a statement expressing sympathy for the tourists and said local authorities would investigate the crime.


    Crime tied to drug violence has reduced the number of tourists from the U.S. to Mexico in recent years but Mexican tourism officials have responded by targeting travelers from countries such as Russia, Brazil, Peru and Colombia.


    Despite the violence, Mexico predicts it will host 24.7 million foreign visitors in 2012, surpassing last year's record of 23.4 million.


    But the latest crime report will only make it harder for Mexico to shrug off the incidents of crime in tourist towns as isolated and rare, experts say.


    "It doesn't matter if Mexico is safe or not because the perception is they are not," said Carl Winston, director of the school of hospitality and tourism at San Diego State University.


    But some travel agents say they have not seen a drop off in tourists from the U.S. booking trips to Mexico.


    Coastline Travel Advisors in Garden Grove is in the process of booking a group of 30 people to visit Loreto in Baja California.


    "We haven't had anyone afraid to visit Mexico or ask if it is safe," said Kate Malczynski, a spokeswoman for the company. "Our agents know what is best and what areas are safe."


    ALSO:


    Mexico tourism grows thanks to non-U.S. visitors


    Texas warns students on spring break to avoid Mexico


    22 Carnival Splendor cruise ship passengers robbed in Mexico


    Follow Hugo Martin on Twitter at @hugomartin



    Read More..

    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.





    Read More..

    Disney working on standalone 'Star Wars' films


    LOS ANGELES (AP) — Disney is mining The Force for even more new films.


    Walt Disney Co. CEO Bob Iger says screenwriters Larry Kasdan and Simon Kinberg are working on standalone "Star Wars" movies that aren't part of the planned new trilogy.


    Iger told CNBC on Tuesday that the standalone movies will be based on "great 'Star Wars' characters that are not part of the overall saga." The films would be released during the six-year period of the new trilogy, starting in 2015 with "Star Wars: Episode VII."


    Disney confirmed last month that "Star Trek" director J.J. Abrams will direct the seventh installment of the "Star Wars" saga.


    Disney bought "Star Wars" maker Lucasfilm last year for more than $4 billion.


    The "Star Wars" prequel trilogy was released from 1999 to 2005.


    Read More..

    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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    State seeks back taxes from small-business shareholders









    SACRAMENTO — For almost two decades, California has provided a hefty tax break for residents owning shares of small businesses that keep most of their workers and assets in the state.


    Not anymore. A court has thrown out the incentive, and now, to the frustration and anger of about 2,000 taxpayers, the state tax collector wants the money back, plus interest.


    The Franchise Tax Board is going after four years' worth of these tax breaks. It recalculated the back taxes of people who benefited and mailed out a holiday surprise.





    "It's a surreal situation," said Brian Overstreet of Healdsburg in the Sonoma County wine country. He said investors learned they owed taxes only in late December when the board sent out letters telling them the so-called qualified small-business capital gains tax incentive had been deemed unconstitutional.


    "California is not a banana republic," said one critic, state Sen. Ted Lieu (D-Torrance). "California government should not punish innocent, law-abiding taxpayers retroactively just because it may have the power to do so."


    Lieu says the state's move is questionable. In a strongly worded letter to the board, he called a staff decision to ask for the back taxes "an incredibly dangerous precedent" that could discourage businesses from locating in California.


    Lieu is demanding that the board reverse its decision. He buttresses his argument by citing a number of U.S. Supreme Court decisions as a legal basis for a reversal.


    The board says it's owed about $120 million in taxes plus accrued interest for earnings from Californians who sold stock in such small companies from 2008 through 2011.


    In contention is a 1993 state law, which created the tax break for investors in companies with gross assets of less than $50 million. The law cut the tax rate on capital gains — profits made on stock sales — in half, to 4.5% from 9%.


    But to ensure the tax break would boost the California economy, lawmakers mandated that at least 80% of the companies' payroll costs and assets had to be located in the Golden State.


    And that's how the statute fell afoul of the U.S. Constitution — 19 years after it became law. In August, a state appeals court, ruling on a lawsuit brought by an investor whose stock holdings didn't meet the 80%-in-California test, invalidated the law because it interfered with interstate commerce: granting a special benefit to stockholders in California small businesses that investors in similar out-of-state companies couldn't get.


    Tax officials argue that the court's finding gave them no choice but to demand retroactive taxes.


    "If the statute is invalid, it can't be enforced," said board spokeswoman Denise Azimi. "To cure discrimination we have to treat all taxpayers alike."


    The only way to keep the tax break and still satisfy the court would be to drop the requirement that the small-business investment be primarily in California, making the incentive available to all investors, regardless of a company's location, she said.


    Such a change can be done only by the state Legislature's passing a new version of the 1993 law, the board's attorneys insist.


    That's the plan being put together by California Business Defense, a just-organized group, backed by the Bay Area Council, an alliance of large, high-tech companies from the San Francisco-Silicon Valley region.


    "A lot of people are just waking up to the fact that this is happening," Overstreet said. "We want to recraft the issue and hand it back to the FTB to do what they do, which is to enforce the law."


    So far, Overstreet and the business group have gained support from a couple of lawmakers. Assemblyman Bob Wieckowski (D-Fremont) has submitted draft legislation aimed at preserving the tax break to the Legislature's attorneys that could be introduced as a bill this month.


    For his part, Lieu argues that the Franchise Tax Board could fix the problem without passage of new legislation.


    "The FTB staff is wrong, wrong, wrong to say this issue requires action by the Legislature," he said. "The FTB staff is misleading the public."


    The board, which comprises the state controller, the director of the Department of Finance and the chairman of the state Board of Equalization, has the authority to grant the tax break to all investors, Lieu asserted. It should reverse its demand for retroactive taxes, which Lieu says violates the due process requirement of the U.S. Constitution.


    "It's wrong to sock it to these taxpayers," he said, "after they relied on the law the way it was written."


    marc.lifsher@latimes.com





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