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According to recent examinations of treatment programs, most are rooted in outdated methods rather than newer approaches shown in scientific studies to be more effective in helping people achieve and maintain addiction-free lives.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.

Read More..

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.

Read More..

Postal Service Plans to End Saturday Delivery


Christopher Gregory/The New York Times


Patrick R. Donahoe, the postmaster general, announcing the planned service change.







WASHINGTON — Faced with billions of dollars in losses, the Postal Service announced on Wednesday that it would seek to stop Saturday delivery of letters, a sweeping change in mail delivery that immediately drew criticism from postal unions, some businesses and lawmakers.








Jim Wilson/The New York Times

Grinje Fernandez, a letter carrier for the Postal Service, delivered mail in San Francisco's Richmond District on Wednesday.






The post office said a five-day mail delivery schedule would begin in August and would shave about $2 billion a year from its losses, which were $15.9 billion last year. The Postal Service would continue to deliver packages six days a week, and post offices would still be open on Saturdays. Reducing Saturday delivery is in line with mail services in several other industrialized countries like Australia, Canada and Sweden, which deliver five days a week.


The move raised immediate legal questions on Capitol Hill, where some lawmakers claimed that the Postal Service could not change its delivery schedules without Congressional approval. The post office has made earlier attempts to change the law, only to meet with objections or delays in Congress. Now, seizing a moment when the post office believes the law no longer applies, it moved on its own to shut down Saturday letter delivery.


Whether it will succeed is difficult to predict. Many lawmakers view the Postal Service as the quintessential government service that touches constituents almost every day, and rigidly oppose any changes. Also, postal worker unions hold sway over some lawmakers who are influential in writing legislation that governs the agency.


Whether the post office is ultimately blocked by an act of Congress or it tries to move ahead with ending letter delivery on Saturdays, the announcement on Wednesday moves postal overhaul legislation — which had stalled for many months — up the Congressional agenda.


“Our financial condition is urgent,” said Patrick R. Donahoe, the postmaster general, at a news conference announcing the change. “This is too big of a cost savings for us to ignore.”


Mr. Donahoe said the move to end Saturday delivery was part of a long-term plan to return the agency to profitability. Since 2010, the agency has continued to close post offices, reduce hours at many small, rural offices and cut staff. It also announced plans to sharply reduce the number of its regional processing plants. Last month, the agency raised the price of a first-class stamp to 46 cents, the latest in a series of generally annual postage increases.


But post office officials say the cuts, rate increases and staff reductions are not enough to make up for the two reasons it is losing money. One is a requirement that it pay nearly $5.5 billion a year for health benefits to future retirees, a mandate imposed on no other government agency. Second, since 2007, first-class mail volume has declined by 37 percent as use of e-mail and online payment services has soared.


The agency said eliminating Saturday mail service represented a substantial cost savings because of fewer staff hours and less equipment needed to maintain the deliveries.  


The Postal Service also said the rise in online retail purchases and other e-commerce was contributing to its increase in that area and was why it would continue to deliver packages on Saturdays.


Since 1981, a Congressional mandate has required the Postal Service to deliver mail six days a week. But on Wednesday the agency argued that since the current stopgap budget measure for the entire government, known as a continuing resolution, did not contain language explicitly mandating six-day delivery, the agency could make the changes without Congressional approval.


But some members of Congress immediately questioned the Postal Service’s claim.


“The passage of the continuing resolution did not suspend that language, as they claim, but in fact extended it,” said Representative José E. Serrano, Democrat of New York and ranking member on the appropriations subcommittee on financial services and general government, which has jurisdiction over the post office. “Rather than use very dubious legal arguments to end Saturday delivery, the U.S.P.S. should work hand in hand with Congress to come up with a successful restructuring and reform package that allows them to become more efficient while maintaining vital services like Saturday delivery.”


This article has been revised to reflect the following correction:

Correction: February 6, 2013

An earlier version of this article misstated the news organization that first reported the Postal Service’s plans to end Saturday service. It was CBS News, not The Associated Press.



Read More..

Obama to Visit Israel in Spring





WASHINGTON — President Obama plans to travel to Israel this spring for the first time since taking office, as he and Prime Minister Benjamin Netanyahu try to move past the friction of the last four years now that both have won re-election.




By making Israel a stop on the first overseas trip of his new term, Mr. Obama hopes to demonstrate support for the Jewish state despite doubts among some of its backers. But the trip also seems designed to signal a desire to restart what has been a fraught relationship, and not to be seen as an ambitious effort to revive a stalled peace process.


“The start of the president’s second term and the formation of a new Israeli government offer the opportunity to reaffirm the deep and enduring bonds between the United States and Israel,” Jay Carney, the White House spokesman, said Tuesday, “and to discuss the way forward on a broad range of issues of mutual concern, including, of course, Iran and Syria.”


Mr. Carney said Mr. Obama would also travel to Jordan and the West Bank. The Israeli news media reported that Mr. Obama would arrive on March 20, but the White House would not discuss any dates for the trip.


Mr. Netanyahu’s office said a visit by the president would be “an important opportunity to underscore the friendship and strong partnership between Israel and the United States.”


The relationship between the two leaders has been edgy for years over issues like Israel’s settlements in the West Bank and ways to stop Iran’s nuclear program.


While Mr. Obama won a clear victory in November, Mr. Netanyahu emerged from elections last month in a weakened state, winning enough seats to retain office but forced to recruit centrist lawmakers for a coalition that might temper his policies. He has until March 16 to present his new government.


Mr. Obama is not expected to unveil concrete proposals for bringing Israelis and Palestinians together during his visit or initiate a specific new peace process. But advisers hope that just by showing up and talking about these issues, Mr. Obama will show that he is not walking away from them.


Dennis Ross, a former Middle East adviser to Mr. Obama, attributed the trip to “a desire to connect with the Israeli public at a time when he can go and not have high expectations about having to produce something.”


The president “can create a new beginning with the same prime minister but with a new Israeli government,” Mr. Ross said.


Some peace advocates welcomed the trip but said it should go beyond atmospherics. “The key is, they’ve got to use this as a real substantive jumping off point for a serious diplomatic initiative,” said Jeremy Ben-Ami, the president of J Street, a Washington advocacy group. “This has to be more than a photo op to show that he cares.”


A former Israeli defense official said the trip’s announcement might have been timed to send a message to Israelis and even influence the composition of the next government amid talk of restarting the peace effort. The former official said a more centrist government would allow the sides more room to maneuver.


Also on the agenda this trip will be Iran and the continuing strife in Syria that threatens to descend into a wider regional conflict. Israel last week struck a convoy of antiaircraft weapons inside Syria that it feared was being moved to Hezbollah forces.


“The United States can put an end to the Iranian threat,” President Shimon Peres of Israel said in an address to Parliament on Tuesday, “and I believe that the president of the United States is determined to do it.”


While Mr. Obama visited Israel in 2008 as a candidate, he did not travel there during his first term, a fact that became fodder on the campaign trail last year. A television commercial from a group called the Emergency Committee for Israel said Mr. Obama had “traveled all over the Middle East but he hasn’t found time to visit our ally and friend, Israel.” Mitt Romney, the Republican presidential nominee, ran his own advertisement criticizing the president for not going to Israel.


Only four sitting presidents have visited Israel: Richard M. Nixon and Jimmy Carter each went once, George W. Bush twice, and Bill Clinton four times. Mr. Bush, considered one of the strongest friends Israel has had in the Oval Office, did not visit until 2008, near the end of his presidency.


Isabel Kershner contributed reporting from Jerusalem.



Read More..

Media Decoder Blog: Twitter Is Acquiring Bluefin Labs

Twitter confirmed on Tuesday that it was acquiring Bluefin Labs, a company that analyzes online chatter about TV shows and companies and sells its findings.

Twitter is paying nearly $100 million for Bluefin, according to a person with direct knowledge of the sale, making it the Web site’s biggest acquisition to date. The person insisted on anonymity because the terms of the deal were not disclosed publicly.

The deal suggests a new line of business for Twitter, which is under pressure to increase its revenue. Bluefin calls itself a social TV analytics company, one of many that have cropped up as Facebook and Twitter have created an instantaneous stream of commentary that helps inform television producers and distributors. Companies like CBS, which televised the Super Bowl on Sunday, pay Bluefin for information about what is being said about them online.

“We believe that Bluefin’s data science capabilities and social TV expertise will help us create innovative new ad products and consumer experiences in the exciting intersection of Twitter and TV,” the Twitter chief operating officer, Ali Rowghani, said in a blog post about the deal.

Bluefin’s backers have invested about $20 million in the company to date. The impending deal with Twitter was first reported on Monday afternoon by Business Insider.

Bluefin will remain a separate arm of Twitter. Bluefin’s office in Cambridge, Mass., will become an outpost for Twitter.

The acquisition comes six weeks after Twitter and Nielsen announced a partnership to provide a “Nielsen Twitter TV rating” for broadcasters and advertisers. Nielsen and one of its joint ventures, NM Incite, bought a smaller competitor of Bluefin’s, called SocialGuide, in November. The terms of that sale were not disclosed, but SocialGuide’s technology will be used in the Twitter TV rating service, expected to be available in the fall.

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.”

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.”

Read More..

Nanoparticles in Food Raise Concern by Advocacy Group


Nanomaterials, substances broken down by technology into molecule-size particles, are starting to enter the food chain through well-known food products and their packaging, but there is little acknowledgment by the companies using them, according to a new report from a nonprofit group that works to enhance corporate accountability.


Some companies may not even know whether nanomaterials are present in their products, the corporate accountability group As You Sow said.


Only 26 out of 2,500 companies, including PepsiCo, Whole Foods and the corporate parent of Pizza Hut and Taco Bell, responded to a survey from As You Sow about their use of nanomaterials.


“Only 14 said they don’t use nanomaterials, and of those only two had any policies on the use of nanomaterials,” said Andy Behar, chief executive of As You Sow. Various food companies have said they are interested in nanotechnology, which can help make products creamier without additional fat, intensify and improve flavors and brighten colors.


Their small size allows nanoparticles to go places in the body where larger particles cannot and enter cells. They have been found in the blood stream after ingestion and inhalation, and while research on their health effects is limited, studies have shown them to have deleterious effects on mice and cells.


“We’re not taking a no nano position,” Mr. Behar said. “We’re saying just show it’s safe before you put these things into food or food packaging.”


He noted that the European Union requires labeling of foods containing nanomaterials and that the European Food Safety Authority has published guidance for assessing nanomaterials in food and animal feed.


Last April, the Food and Drug Administration issued an unusually emphatic statement on nanomaterials, saying it did not have enough data to determine the safety of nanomaterials in food.


The Environmental Protection Agency is evaluating various nanoparticles used in consumer products, like sunscreens.


As You Sow tested 10 varieties of powdered doughnuts for the presence of nanoparticles. With the help of an independent lab, it found that Hostess Donettes and Dunkin’ Donuts Powdered Cake Donuts tested positive for the presence of titanium dioxide materials of less than 10 nanometers. Titanium dioxide is used to brighten white substances. The nano variety is under investigation by the E.P.A.


Michelle King, a spokeswoman for Dunkin’ Donuts, said the company was working with its supplier to validate As You Sow’s findings. Hostess Brands went out of business during the test and closed its factories.


Read More..

Europol Investigation Shows Fixing Is Suspected in 680 Soccer Matches


Robin Van Lonkhuijsen/Agence France-Presse — Getty Images


Rob Wainwright, the director of Europol, at a press conference in The Hague on Monday.







Soccer is known throughout much of the world as the beautiful game. But the sport’s ugliest side — the scourge of match-fixing — will not soon go away.




With the 2014 World Cup in Brazil drawing closer, a European police intelligence agency said Monday that its 19-month investigation, code-named Operation Veto, revealed widespread occurrences of match-fixing in recent years, with 680 games globally deemed suspicious. The list of match types is staggering: some 150 international matches, mostly in Africa, Asia and Latin America; roughly 380 games in Europe, covering World Cup and European championship qualifiers as well as two Champions League games; and games that run the gamut from lower-division semiprofessional matches to contests in top domestic leagues.


But officials at the news conference at The Hague repeatedly sidestepped questions from reporters on how many of the actual 680 matches cited had been previously reported, and, in some instances, previously prosecuted, and how many of them represented new information.


Nor would the officials identify any of the teams and individuals newly linked to match-fixing, citing the need to guard the confidentiality of police procedures.


Still, one new tantalizing detail did emerge: the revelation that one of the suspicious matches uncovered was a game in the Champions League — the most prestigious annual soccer tournament in the world — and that it was played in England in the last three or four years.


Even as the news conference continued, fans immediately took to social media to speculate on the match in question and, indeed, on which English team might have been involved. Manchester United, Manchester City, Arsenal, Chelsea, Liverpool and Tottenham are the only English teams that have participated in the Champions League during the time frame cited by officials. All six are iconic teams in England’s Premier League, which is by far the world’s most popular soccer league and has an unparalleled global following.


And while the absence of details left it unclear as to whether investigators believed an English team was culpable in fixing a Champions League game, or whether it was an opposing team from another country that had come to England for the match, the fact that match-fixing was now being linked to the country that represents the biggest international stage in soccer left many in the sport apprehensive.


“It would be naïve and complacent of those in the U.K. to think such a criminal conspiracy does not involve the English game and all the football in Europe,” Rob Wainwright, the director of the police intelligence agency, known as Europol, told reporters.


Most of the investigation’s focus, however, was elsewhere. Europol described a wide-ranging network of fixing that struck at the sport’s core. Nearly $11 million in profits and nearly $3 million in bribes were discovered during the investigation, which uncovered “match-fixing activity on a scale we have not seen before,” Wainwright said.


“This is a sad day for European football,” he added.


Fixers typically seek to dictate a game’s result by corrupting the players or the on-field officials, and the Europol officials said Monday that roughly 425 people were under suspicion because of the investigation, with 50 people having been arrested. The scope of the investigation covered games from roughly 2008 to 2011.


An organized crime syndicate based in Asia is believed to be the driving force behind the fixing activity, which stretches across at least 15 countries, Europol officials said. Individual bribes were, in some instances, higher than $136,000, and fixers would place bets on the tainted matches through bookmakers in Asia.


Various matches in Africa, Asia and South and Central America were identified as suspicious, and Declan Hill, a Canadian journalist and the author of “The Fix: Soccer and Organized Crime,” said his reporting on the subject — which was included in Europol’s investigation — had not previously indicated such widespread fixing among national teams.


David Jolly contributed reporting from The Hague.



Read More..

TIMESCAST: Super Bowl Ads Recall Days Gone By

February 4, 2013

TimesCast Media+Tech: The successes and failures of this year’s Super Bowl ads. | Ang Lee on the technology behind “Life of Pi.” | An interactive project encourages action against human trafficking.

Read More..