Sunday, June 5, 2011

Health - At the Center of the Global E. Coli Scare, Hamburg Frets

Health - At the Center of the Global E. Coli Scare, Hamburg Frets

At the Center of the Global E. Coli Scare, Hamburg Frets

Posted: 04 Jun 2011 05:49 AM PDT

HAMBURG, Germany — It is a worrisome time in this wealthy port city, known for its 19th-century churches and busy canals, where more than 100 people have fallen ill since the outbreak of a potentially lethal form of E. coli, putting 20 patients in intensive care, including five pregnant women.

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Adding to the anxiety is the failure, so far, to identify the source of the infection.

“Very mysterious,” said Dr. Jörg F. Debatin, medical director at the University Medical Center, Hamburg-Eppendorf.

Hamburg is a proud and diverse city that has found itself at the center of global crises before: It struggled to counter its reputation as a breeding ground for Islamic extremism after it was revealed that some of the men who carried out the terrorist attacks on Sept. 11, 2001, lived, studied, worshiped and plotted here.

It has inched its way back, attracting tourists and young people who regularly fill its bars and restaurants and stroll its sprawling red light district, the largest in Europe.

This time, the scare is over a health crisis that appears to have emerged in or around the city.

Since the outbreak four weeks ago, 18 people have died and 1,730 have fallen ill, including 520 who have developed the most serious complications, known as hemolytic uremic syndrome, or H.U.S.

The Robert Koch Institute, Germany’s disease control agency, said the majority of the most serious infections have been reported within a short driving distance from the city: 97 here, 143 in Schleswig-Holstein, 82 in North Rhine-Westphalia and 51 in Lower Saxony.

In the United States, health officials said that the strain of E. coli involved in the outbreak was rare but not unknown. An unusual aspect of the outbreak is that the bacteria has incubated for as long as 12 days in the intestines of those infected before they became sick. Typically, E. coli infections take three days to turn into full-blown illness. The long incubation period makes it even more difficult for investigators to track the source of the outbreak.

On Friday, as panic continued to grip the streets here and across Europe, officials cautiously said the peak of the crisis might have passed.

The “situation seems to have calmed somewhat, as far as the number of new infections is concerned,” said Dr. Reinhard Brunkhorst, the president of the German Nephrology Society.

But experts said it was too soon to say if that was the case, adding that while they believed tomatoes, cucumbers and lettuce were the source of the bacteria, they were not sure. Researchers believe that because a high number of infections spread across a single region of one country, the bacteria probably entered the food chain after leaving farms, but before the produce was sold directly to consumers, said Jonathan Fletcher, a senior lecturer in microbiology at the University of Bradford in England.

“The distribution suggests this wasn’t at the point of origin because given the way food chains work these days that means it would have already spread more widely across Europe and possibly the world,” he said. “At the same time, this has already traveled far enough to suggest that not just one stall or supermarket was responsible.”

None of this speculation, though, did anything to calm a jittery public, especially in a nation where people are generally risk averse.

“I stopped eating salads as soon as I heard about the outbreak,” said Holger Schettler, a 68-year-old sailor visiting Hamburg. “I will not eat another bit of salad until they find the causes.” His wife nodded in agreement.

Tuti Fernanco, a waiter at Vesuvio Restaurant, which is near Hamburg’s main railway station, said: “I haven’t sold a green salad for days. Customers just ask for broccoli, or chips. No more salads. None. I am really surprised by the public reaction.”

Hlakan Dogan, manager of a döner kebab takeaway stand close to the central shopping mall, said he was experiencing the same thing. “Customers are very, very cautious now,” he said. “You can no longer automatically serve a salad with the kebab.”

Not surprisingly, vegetable vendors said their businesses were suffering.

At Hamburg’s fruit, vegetable and flower market, one of Europe’s largest, there were few customers and lots of angry and bewildered merchants watching their inventories spoil. The market was built in 1962, and, until recently, annual sales were running close to $3 billion.

Torsen Berens, the market manager, said he could not say precisely how much sales had fallen.

“All I can say is that it’s bad, very bad,” he said. “Let’s hope they find the source.”

Gardiner Harris contributed reporting from Washington.

Outbreak in Europe May Revive Stalled U.S. Effort to Tighten Rules on Food Safety

Posted: 03 Jun 2011 10:38 PM PDT

The deadly wave of food-borne illness in Europe, caused by a rare form of E. coli bacteria, could finally push the United States to take long-delayed steps to protect the food supply in this country from a similar group of toxic organisms.

Using a newly developed kit to check for pathogens.

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Food-safety advocates hope the federal government will act soon to ban the sale of ground beef if it contains any of six dangerous strains of E. coli that have increasingly been found to cause illness in the United States — a step that regulators have been considering for at least four years in the face of stiff industry opposition.

The outbreak in Europe could also bring more scrutiny of the produce industry. Investigators believe the outbreak was caused by contaminated vegetables, but they have not been able determine which type. So far, the authorities say, more than 1,700 people have been sickened, including 6 Americans, and at least 18 people have died.

For now, the focus in this country is on beef, since E. coli lives in the guts of cows.

In January, the United States Department of Agriculture drafted a much-anticipated proposal to regulate six forms of toxic E. coli in meat, in addition to the most common form, O157:H7, which is already regulated. But the proposal has been stalled at the federal Office of Management and Budget, which typically reviews proposed regulations, and officials could not say when it would be made public.

The details of the proposal have been kept secret until a final version is settled on, but there is wide expectation in the food industry and among food-safety advocates that it would either ban the sale of ground beef containing those strains or call for testing and other controls. Advocates for the rules fear that the White House, which had a representative at O.M.B. meetings on the issue, was seeking to dilute the measure or even kill it. But they say that the catastrophic European outbreak could now force the government’s hand.

“The horrific illnesses that are happening in Germany will make government and industry here have to pay attention,” said Bill Marler, a Seattle lawyer who specializes in food safety and who has petitioned the Agriculture Department to ban the pathogens from meat.

The form of E. coli in the European outbreak is not on the list made by the Agriculture Department because that strain has never been identified as a cause of illness in the United States. But food-safety experts said that because of its virulence, officials would almost certainly have to consider adding it at some point. David Goldman, an assistant U.S.D.A. administrator, said at a news conference on Friday said that he could not comment on the proposed rule.

“There are indeed a lot of complicated technical issues as well as many stakeholders,” he said. “We all intend to get this right.”

For many, the outbreak in Europe evokes memories of a 1993 outbreak in the United States that first brought toxic E. coli bacteria to widespread public attention. In that outbreak, four children died and hundreds became sick after eating hamburgers contaminated with the O157:H7 strain that were served at Jack in the Box restaurants.

David M. Theno, a food safety consultant who worked with Jack in the Box to help it respond to the 1993 outbreak, predicted that the German outbreak would force the U.S.D.A. to take action against a broader group of bacteria. “You can’t just ignore them and hope it doesn’t happen here,” Dr. Theno said.

In 1994, the Agriculture Department declared the sale of ground beef containing the O157 strain illegal, and the industry began establishing measures to keep it out of meat sold to the public. Since then, there have been numerous outbreaks and millions of pounds of ground beef have been recalled. The bacteria has also caused outbreaks tied to vegetables, including spinach and lettuce. Produce can become contaminated from exposure to cow manure in the fields or the water supply or during processing.

Over the years, other toxic strains of E. coli began to get the attention of public health officials. They eventually identified six that most frequently caused illness, and federal officials began studying whether the sale of meat containing these strains should also be banned.

As part of that effort, the Agriculture Department last fall issued standards for tests to rapidly screen food for the six strains.

Gardiner Harris contributed reporting from Washington.

Cultural Studies: Viagra: The Thrill That Was

Posted: 03 Jun 2011 04:34 PM PDT

IT isn’t often that an article in AARP’s magazine gets the attention of People, the London tabloids, The Huffington Post and the celebrity blogosphere. But so it was last year when Michael Douglas, upon turning 65, sat down for an interview with the mass-circulation periodical for the over-50 set, and in the process uttered a word heard round the world: “Viagra.”

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“Michael Douglas Takes Viagra” announced headlines in The New York Daily News and on sites like whyfame.com and hotfeeder.com, among others. “Michael Douglas Admits: I Have to Take Viagra” (The Daily Mail). “Michael Douglas: Thank Goodness for Viagra” (the Huffington Post).

And so on.

For the record, the exact quote was subtler (though the meaning seemed unmistakable), spoken during musings about his life with Catherine Zeta-Jones, the gorgeous (and quarter-century younger) actress he married in 2000: “God bless her that she likes older guys. And some wonderful enhancements have happened in the last few years — Viagra, Cialis — that can make us all feel younger.”

This was a man transformed, waxing poetic on the joys of fatherhood the second time around, that special feeling of knowing his was the “first face” his children see when they wake up and that sweet satisfaction from helping them get ready for school.

It could be argued that this new persona would never have existed but for the aforementioned little pill. At the very least, it seems to have played a role not only in fulfilling a marriage but also in the birth of the two children who turned the Hollywood playboy into a sentimental Mr. Mom.

With media images abounding these days of virile older men — Hugh Hefner, 85, and Crystal Harris, 25, announcing their engagement; 80-year-old Rupert Murdoch with his elementary-school-aged daughters; the 74-year-old Italian prime minister, Silvio Berlusconi, and that 18-year-old party girl — one has to wonder if Viagra has again worked its magic. (Do they or don’t they? Only their pharmacists know for sure.)

And now we have evidence that 54-year-old Osama bin Laden had what has been referred to as an “herbal version of Viagra” in his medicine chest at the compound where he was hiding out with multiple wives.

All of this raises the question of just what the far-reaching implications of Viagra (and similar drugs) are, beyond the specific medical achievement of providing a treatment, in the form of increased blood flow, for millions of men with erectile dysfunction.

More than any pill ever to be dispensed, Viagra has played to the yearnings of American culture: eternal youth, sexual prowess, not to mention the longing for an easy fix.

From the first announcement of the drug’s existence, fantasies went into overdrive; with the popping of a pill, lackluster marriages would be repaired. Or a generation of newly virile men would be on the make, hooking up with younger partners, maybe even getting a chance at righting any wrongs they had committed as fathers of young children years earlier. At the very least, everyone would be having great sex well into their twilight years.

It hasn’t worked out quite that way. Thirteen years after Viagra hit the market like a bolt of lightning (Dr. Jed Kaminetsky, a New York University urologist, said that at first he was so besieged with requests for prescriptions that he had to start seeing patients on weekends to keep up with the demand), we have not turned into a Viagra Nation.

Pfizer, the maker of Viagra, said that it has been prescribed to more than 35 million men worldwide. For many men, it has been a wonder drug, doctors like Dr. Kaminetsky agree.

But recently the market for Viagra-type drugs has stalled in the United States. Last year the total number of prescriptions for so-called ED drugs declined by 5 percent in the United States after growing just 1 percent annually the previous four years, according to IMS Health, a heath-care data and consulting firm. (Viagra prescriptions were off 7 percent; those for Levitra plummeted 18 percent.)

The drop seems all the more significant given that the population is aging, so there are surely more men who potentially need the drug.

There could be many reasons for the dip: effectiveness (it doesn’t work for everyone) or insurance payments, to name a few.

But another number is perhaps more telling: doctors widely observe that 40 to 50 percent of men who are given a first prescription do not end up refilling it. Perhaps the mentality is, as Dr. Kaminetsky suggested: “Having that blue pill is sort of like when they were kids but they walked around with a condom in their wallet: they may never have sex but they were ready.”

Abraham Morgentaler, the director of Men’s Health Boston and author of the book “The Viagra Myth,” said he was startled by the expectations that people initially poured into one little pill. It became, at least subconsciously, a panacea for all that was missing in their life. “Men look to these types of pills as a savior for other aspects of their lives where things are not going well,” he said.

But there’s only so much increased blood flow can do. Dr. Morgentaler cited two patients, one who stopped using Viagra shortly after he began and one who never used his prescription. The first man said that once he was able to perform again, he realized that the problems in his marriage went well beyond sex; soon after he began taking the drug, he and his wife separated. The second, a man in his 70s, said he and his wife realized the emotional connection was already there, so they decided not to use his prescription.

Neither has there been a boomlet of babies as a result of Viagra. In 2000, Ken Gronbach, a demographer, hailed the certain arrival of a “Viagra Generation,” a demographic of children who would never have been born but for the existence of the drug.

When a Child’s Anxieties Need Sorting

Posted: 03 Jun 2011 01:33 PM PDT

WHEN the 10-year-old son of Brooke Garber Neidich, a chairwoman at the Whitney Museum, was having difficulty in school, there was only one person who was able to give him a proper diagnosis: Dr. Harold Koplewicz.

When Debra G. Perelman, a daughter of the Revlon chairman Ronald O. Perelman, wanted to address her young daughter’s social anxiety, there was just one man she called: Dr. Harold Koplewicz.

And when the financier Marc Bell, was concerned about his twins’ mental health, he called (you guessed it) Dr. Harold Koplewicz.

“He basically saved my kids,” Mr. Bell said.

Just who is this man, whom people from as far away as Dubai entrust with their children’s psyches; whose hourly rate can be as high as $1,000 (three to four times that of the average Manhattan therapist); and whose friends include the former New Jersey governor Jon S. Corzine and Secretary of State Hillary Rodham Clinton?

“I know that some people see him as a self-promoter, but I don’t see him that way,” said Dr. Alan Ravitz, a colleague. “Harold really wants to do something meaningful for children, which is kind of an amazing thing.”

Though Dr. Koplewicz admitted a knack for schmoozing (“I’m very good at fund-raising,” he said), his main mission in life, he contended, is to remove any stigma from mental illness among children and teenagers, make it merely something to be managed and overcome as it was with dyslexia or attention deficit disorder before it.

“People think of child psychiatry as playing with kids on the floor,” Dr. Koplewicz, 58, said recently at his office at the Child Mind Institute, his new children’s mental health care treatment center on Park Avenue and 56th Street. “We need to educate them and change the way they think about childhood psychiatric illnesses, so the shame goes away and it improves access to care.” According to the American Academy of Child and Adolescent Psychiatry, 15 million children in the United States suffer from some kind of psychiatric disorder, like bipolar disorder or schizophrenia, but about 80 percent never get help. And the illnesses tend to be discussed in hushed tones. “If your child has a rash, for instance, you can call up your friend to talk about a dermatologist, but it would be very rare to call up your friend and say my child has a mental health issue and could you recommend a doctor for me,” said Ms. Perelman, vice chairwoman of the Child Mind Institute.

That is precisely what the silver-haired, mustached Dr. Koplewicz (he eerily resembles the film critic Joel Siegel) is trying to change, with the help of his well-heeled supporters.

He traced his interest in the field to his own childhood. He was born in Crown Heights, Brooklyn, a son of Holocaust survivors. His father, who died last year, had been in multiple concentration camps, Dr. Koplewicz said, and was a participant in the Warsaw ghetto uprising.

“My father was very clear that what you carry in your head means everything,” said Dr. Koplewicz, who is married to Linda Sirow, an artist and art teacher at Dalton. They have three sons in their 20s and live on the Upper East Side. “He was very keen on my becoming a physician.”

At age 12, young Harold developed a bleeding disorder called idiopathic thrombocytopenic purpura. The doctors initially thought it was leukemia, and he had to take steroids. “I was so heavy at my bar mitzvah that no one recognized me,” he said with a rueful laugh.

He developed a close relationship with his doctors, some of whom he stayed in contact with through adulthood. One even helped him with his medical school applications. At the Albert Einstein School of Medicine he settled on pediatrics, but soon became bored with it: “The mothers were the ones you took care of,” he said. He found neurology and psychiatry much more interesting.

In 1996, Dr. Koplewicz became the chief of child and adolescent psychiatry at New York University Medical Center (now the N.Y.U. Langone Medical Center), and a year later founded the N.Y.U. Child Study Center, where he remained for 12 years. Over the course of his tenure he, along with Ms. Garber Neidich, who was chairwoman of the board (and now holds that position at Child Mind Institute), raised about $142 million for the N.Y.U. Child Center, he said.

And then matters became complicated.

In 2009, Dr. Koplewicz left N.Y.U. to start the Child Mind Institute, which has been operating since last November, but which officially opened May 3. The 24,000-square-foot office is equipped with video and computer equipment, a built-in TV studio and the latest in brain imaging technology. Its Web site, childmind.org, is edited by Caroline Miller, the former editor of New York magazine; there are 14 clinicians on staff.

According to Dr. Koplewicz, once he announced his resignation, N.Y.U. forbade him from entering his office and it pushed out professors who had said they wanted to join him at Child Mind Institute.

One of these was Dr. Ravitz, a former professor of child and adolescent mental health studies program at the university. “When I decided to come to the C.M.I., I was told by the Child Study Center that I could go into private practice and continue to teach, or could stay at the Child Study Center and continue to teach, but that if I went to C.M.I. I could not teach at N.Y.U.,” said Dr. Ravitz, the senior director of forensic psychiatry at Child Mind Institute. “I said I wished they would reconsider their decision, and they basically said, ‘Sorry, we can’t do it.’ ”

Twelve other N.Y.U. professors and the majority of the Child Study Center’s board of directors, which included not just Ms. Garber Neidich and her husband, Daniel, but also the Tribeca Film Festival founders Jane Rosenthal and Craig Hatkoff; Anne McNulty, managing partner of JBK Partners; and Claude Wasserstein, an ex-wife of the financier Bruce Wasserstein, also followed Dr. Koplewicz to the Child Mind Institute.

“Everybody who came with him took a chance — they had to start all over again,” Dr. Ravitz said. “It was scary. But I see Harold as an entirely decent, honorable, honest human being. The guy’s a force of nature.”

Christopher Rucas, a spokesman for N.Y.U. Langone Medical Center Center, declined to comment.

It would appear the institution has lost an expert networker. As vice dean of external affairs for the N.Y.U. Langone Medical Center, Dr. Koplewicz helped raise $509 million in the fiscal year 2007-8, he said. Last December, the Child Mind Institute gave an inaugural gala at Cipriani, raking in $5.5 million. Guests included Mr. Corzine, Dr. Ruth Westheimer, the Goldman Sachs president Gary Cohn, Robert De Niro, Grace Hightower and the billionaire J. Christopher Flowers.

Indeed, Dr. Koplewicz takes his fund-raising so seriously that he sees very few patients himself, which is how he explained his high rates (he will occasionally work pro bono, and other clinicians at the center offer sliding scales). Though the institute does not accept insurance, approximately 20 percent of patients receive financial aid or are charged fees as low as $50, according to the organization.

And thus far it has loyal support from former clients. Mr. Corzine met Dr. Koplewicz in the early 1990s, when Dr. Koplewicz treated Mr. Corzine’s children. Since that time, Mr. Corzine has given $6 million to the N.Y.U. Child Study Center, and $1 million to the Child Mind Institute, he said. “So many of the problems we see broadly in this world flow from the challenges that children’s mental health, as well as adult mental health, bring to bear,” Mr. Corzine said. “People want to support the center to help kids from inner cities who need treatment.”

Ms. Garber Neidich agreed. “Harold could make so much more money in private practice,” she said. “He does this because he believes in it.”

In Queens, New Mothers and Old Asian Custom

Posted: 04 Jun 2011 08:10 AM PDT

Katy Lu opened the front door of the two-story house near the Queens Botanical Garden. “Why don’t I show you the babies first?” she said in Mandarin Chinese, leading the way up a staircase and past a small kitchen where a rice cooker sat on a table.

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Annie Ling for The New York Times

SECLUDED Katy Lu runs a postpartum facility at a house in Queens.

A dozen bassinets lined the walls of the warm, low-lit nursery where two babies slept and a woman tended to a third at a changing table. Blankets in some of the empty bassinets suggested that other newborns would spend the night here as well.

Across the hall, an open door offered a view of a double room, with one woman sitting up in her bed and another lying under a blanket. The women, both new mothers, were there for the Chinese practice of postpartum confinement — called zuo yuezi, or, in Mandarin, sitting the month.

To Western ears, confinement sounds like something out of a Victorian novel, but in some traditional Asian cultures, women still spend the month after a baby’s birth in pampered seclusion. Typically, a woman’s relatives would care for her, but more recently, the practice has been outsourced to postpartum doulas and confinement centers, like the one Ms. Lu operates. In the United States, they cater to middle-class immigrant women separated from their families. Business is steady enough in New York City to support at least four postpartum centers, tucked away in the heavily Asian-immigrant neighborhoods of Flushing and Bayside, Queens.

The centers largely fly below the radar of English-language authorities — they advertise online or in Chinese-language publications. They make up such a niche market that city and state authorities did not know they even existed. Jeffrey Hammond, a spokesman for the state Health Department, said that as long as the centers were not offering medical services, they would not require a license. A spokeswoman for the city Health Department said that it had no information on the centers.

But they made a brief appearance in the news when, in March, officials in San Gabriel, Calif., shut down what they said was a home for women who had come to the United States to give birth so that the children would be American citizens — so-called anchor babies.

It’s unclear whether New York’s confinement centers cater to that market. Generally they practice a “don’t ask, don’t tell” policy regarding their clients’ origins. Both Ms. Lu’s center and the ones run by Annie Gao, another Flushing confinement entrepreneur, give a Beijing phone number on their Web sites. Ms. Gao, when pressed on what kind of clients her center drew — older or younger, local or tourist — said: “I’ve never noticed any tendency. When a woman comes to me, I only see a mother. It’s a mother and a baby, and that’s all that matters.” (She, like the other women interviewed, spoke in Mandarin Chinese.)

There are no hard numbers on how many women might be using the New York centers for so-called maternity tourism. And nationwide, “we really have no way of knowing,” said Jessica Vaughan, director of policy studies for the Center for Immigration Studies, a group that seeks tougher immigration laws. Government agencies and immigration advocacy groups said they did not track such numbers.

In New York, many of the local clients are new immigrants who may be unable to secure visas for their own mothers to come from China. Others feel a center would be able to oversee the process better. Through their own savings and money sent by relatives, the clients come up with the $1,500 to $3,000 cost for a month’s stay. One of the first major postpartum houses to open in New York belongs to Ms. Gao, a mother of three whose bubbly spirit is matched only by her ambition. Ms. Gao, who moved to New York 10 years ago, said she would occasionally offer a spare bedroom to a friend who had just delivered and oversee her confinement. Word of her services spread, and she began taking in women regularly in 2004.

Until last March, she had run the Flushing branch of her service, Angel Baby Care Center, out of her home. In April, Ms. Gao, 40, showed off a three-bedroom unit on an apartment-house floor for mothers and newborns.

“I think of it as relatives coming for an extended visit,” she said. Now, on a typical day, she drops her children off at school, buys groceries for her family and her centers, visits any mothers who are still in the hospital and then shuttles between her two centers, one in Flushing, the other in a house an hour’s drive away in Suffolk County that appears to accommodate about 10 beds.

As with many traditions, there is no formal set of rules for confinement, but the emphasis is on warmth. Women stay inside and avoid cold drafts, because their bones are believed to be weak in the aftermath of the birth, and too much cold air could lead to rheumatism or arthritis. Cold foods, believed to slow the shrinking of the uterus, are forbidden for the entire month, as are foods believed to cool the body’s energy flow, like cabbage and watermelon. The women eat foods tempered with additives like eucommia bark and wolfberry (also known as goji berry), believed to purge the uterus. Soup made of adzuki beans is often served as a dessert because the beans are believed to reduce swelling.

A proper confinement, Ms. Lu said, lasts 45 to 60 days, but centers in the United States generally keep it to 30. The most notorious rule of confinement — a ban on showering and washing hair for the month — is generally considered anachronistic given the availability of clean, hot water.

Jeany Lin, an immigrant from Fujian Province whose daughter is now 3, said a friend from church recommended Ms. Gao. Ms. Lin, 26, said that during her stay she ate five meals a day and that she was encouraged to rest as much as possible early on. She breastfed her baby, but otherwise the infant remained largely in the doulas’ care for the first two weeks. Her husband, a restaurant worker, visited daily. “During the third and fourth weeks I could get up and chat with the other moms, and sometimes the aunties would give us little lessons on baby care,” she said.

U.S. Calls Antibiotics Wrong Step on E. Coli

Posted: 03 Jun 2011 01:40 PM PDT

There are few things more frightening in the world of food safety than becoming infected with the kind of toxic strain of E. coli that has sickened more than 1,500 people in Germany and beyond, but public health officials in the United States caution that the bacteria is not as scary as some reports suggest.

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“Using terms like ‘mutant killer bacteria’ is irresponsible,” said Dr. Timothy Jones, the state epidemiologist in Tennessee. “Bacteria mutate all the time, even the ones we’re comfortable with. And having a strain that is virulent is not unusual.”

Of particular concern to officials in the United States have been reports that the European outbreak involves bacteria resistant to antibiotics — not because such reports suggest a particularly dangerous bug, but because they suggest that the Europeans are not looking in the right direction to fight the outbreak.

The accepted medical wisdom in the United States is that E. coli infections should not be treated with antibiotics at all, even if the strain is vulnerable to the drugs. And when a strain shows signs of resistance, treatment with the drugs is a particularly bad idea, said Dr. Phillip Tarr, a professor of pediatrics at Washington University.

“If you give antibiotics and the strain is resistant, then you give that bacteria a competitive advantage to the other bugs in your gut that are susceptible to the drugs, and so it’s an even better environment for the infection,” Dr. Tarr said.

While some news reports suggested that researchers in Germany were looking into the role of antibiotics in treating E.coli, on Friday doctors at the University Medical Center of Hamburg-Eppendorf, where many of the patients are being treated, confirmed that patients there were not being treated with antibiotics.

On both sides of the Atlantic, doctors agree: patients who suffer bloody diarrhea should be admitted to a hospital and isolated from others because their diarrhea can infect others — a surprisingly common mode of transmission. Toxic E. coli bacteria cause illness by releasing a toxin in the gut that is absorbed into the bloodstream and injures tiny blood vessels throughout the body. The body responds with clots that clog those vessels. The kidneys, replete with tiny blood vessels, are particularly vulnerable to such clogging and may slow or shut down entirely during a toxic attack, a life-threatening complication.

But the Americans point to studies that show that antibiotics increase the chances of kidney failure while doing little to shorten the duration of infection. Instead of antibiotics, the best treatment is intravenous fluids, which help to keep the kidneys functioning, Dr. Tarr said.

Most patients infected with toxic E. coli develop painful diarrhea, vomiting and fever within three days. The diarrhea becomes bloody one to three days later and usually resolves within a week of the onset of illness.

American officials were sympathetic to the challenges that European health authorities faced in tracing the source of the outbreak, since such investigations in the United States have been similarly long and confused. The foods involved in the outbreak — tomatoes, cucumbers and lettuce — are often eaten together, and their supply chains can be impossibly complicated to untangle. When a restaurant needs salad fixings, suppliers often mix vegetables from a variety of farms — making a trace to the source close to impossible.

But officials were skeptical that the strain responsible, believed to be E. coli 0104:H4, would prove to be unique.

“This bug has been seen before,” said Dr. Robert Tauxe, deputy director of the division of food-borne, bacterial and mycotic diseases at the Centers for Disease Control and Prevention in Atlanta. That the strain may have genetic material that makes it resistant to antibiotics, however, is intriguing, he said.

“Where has this organism been that it’s been exposed to so much antibiotics that it’s worth its while to be resistant?” Dr. Tauxe asked. The answer may influence a growing controversy in the United States over the widespread and routine use of antibiotics to fatten feed animals like pigs.

One clear lesson from the German outbreak is that contaminated food can come from anywhere, said Dr. Michael Osterholm, director of the Center for Infectious Disease Research at the University of Minnesota. “We often want to think that the foods from the developing world are risky,” Dr. Osterholm said. “Produce safety is a problem everywhere.”

Indeed, the German outbreak is likely to increase concerns over the safety of fresh vegetables, Dr. Tarr said. The United States has suffered multiple contamination scares over the past decade in tomatoes, lettuce and spinach.

“I can tell you how to make a hamburger safe, but I can’t tell you how to do that with a head of lettuce,” Dr. Tarr said. “And that’s important.”

A law passed by Congress last year gave the Food and Drug Administration new powers to mandate that companies undertake preventive measures to reduce the likelihood of such outbreaks, and the law called for increased inspections to ensure compliance. The agency requested additional financing to implement the new law, including hiring more inspectors next year. Republicans in the House have instead proposed cutting the agency’s budget.

Vital Signs: Awareness: Top 5 Don’ts for Doctors in Primary Care

Posted: 04 Jun 2011 12:40 AM PDT

Antibiotics for sore throats and CT scans for minor head injuries in children are among the most wasteful practices in primary care medicine, a national physicians’ group said last week. Among the others are electrocardiograms performed routinely on healthy adults and widespread prescribing of brand-name statins to reduce L.D.L., or “bad” cholesterol.

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The group issuing the report, the National Physicians Alliance, an organization of some 22,000 physicians, developed three separate “Top 5” lists for primary care doctors — internists, family doctors and pediatricians — that were essentially lists of medical “don’ts.” The lists were published online in The Archives of Internal Medicine.

The authors urged doctors not to perform bone-density scans on women younger than 65 and men younger than 70 who have no risk factors for osteoporosis. The researchers also urged physicians to forgo basic blood screening in healthy adults (though screening for cholesterol was recommended, as was diabetes screening in some cases).

“Doctors are inundated with ‘do this’ and ‘do that.’ We wanted to focus on what doctors should not do,” said Dr. Stephen Smith, professor emeritus of family medicine at the Warren Alpert Medical School at Brown University, who led the initiative. “We wanted to come up with the top things that primary care physicians can do that would enhance quality, but also reflect the idea of being good stewards of finite medical resources, save money and reduce harms and risks.”

Vital Signs: Screening: Saliva Test for Cytomegalovirus Proves Accurate

Posted: 04 Jun 2011 12:40 AM PDT

A new test offers a rapid, inexpensive and highly accurate method for screening newborns for cytomegalovirus, which can cause permanent hearing loss, researchers said on Wednesday.

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Though one in 150 babies are born infected with cytomegalovirus — known as CMV and part of the herpes virus family — current tests are not effective for widespread screening, the scientists said.

The new test does not require the culturing of blood samples; it employs saliva, easily obtained by swabbing the inside of a baby’s mouth.

Of 17,662 newborns screened, all 85 infants identified as infected with CMV by a blood culture test also were identified by the new test, researchers reported in a paper published in The New England Journal of Medicine. Another 17,327 newborns were screened with a different saliva test. It was slightly less accurate, detecting CMV in 74 of 76 infants identified by culturing.

Infected babies must be monitored and tested frequently for hearing loss so that support services can be provided if necessary, said Dr. Suresh B. Boppana, a professor of pediatrics at University of Alabama at Birmingham and one of the paper’s authors.

Vital Signs: Patterns: More People Praying About Health, Analysis Finds

Posted: 04 Jun 2011 12:40 AM PDT

More Americans are praying about their health, researchers have concluded.

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Scientists analyzed data on 30,080 adults ages 18 and older who took part in the National Health Interview Survey in 2002 and on 22,306 adults who participated in 2007.

Forty-nine percent of adults said in 2007 that they had prayed about their health during the previous year, up from 43 percent in 2002. In 1999, only 14 percent of survey participants said they had prayed about their health.

Among those least likely to pray were people who exercised on a regular basis; researchers speculated they may not have had any health concerns. Those with higher incomes were also less likely to pray.

According to the analysis, published in the May issue of the journal Psychology of Religion and Spirituality, the use of prayer has increased in recent years among adults of all ages. Women, black people, older and married individuals and those whose health status had changed — for better or worse — were more likely than others to pray. People with episodes of depression and dental pain also turned to prayer at high rates.

“We were surprised,” said Amy Wachholtz, director of health psychology at University of Massachusetts and co-author of the paper. “Our best guess is that it has to do with 9/11, but that’s an untested hypothesis. There doesn’t seem to be any other primary, overwhelming issue that would have so globally affected people.”

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Recipes for Health: Raspberry Crumble

Posted: 03 Jun 2011 12:00 AM PDT

I made this crumble because I had some less-than-delicious raspberries on hand — when you bake them in a crumble, the flavors deepen. Most of the sweetness is in the topping; the filling is somewhat tart.

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Each week this series will present recipes around a particular type of produce or a pantry item. This is food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and a pleasure to eat.

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2 quarts raspberries (you may use frozen)

3 tablespoons sugar, preferably raw organic sugar

2 teaspoons rose water

2 teaspoons cornstarch (if using frozen berries, increase to 1 tablespoon)

1 3/4 cups (7 ounces) crumble topping (recipe below)

1. In a large bowl, toss the raspberries with the sugar, rose water and cornstarch. Cover and let stand for 15 to 30 minutes. Meanwhile, preheat the oven to 350 degrees, and butter a 2-quart baking dish.

2. Transfer the fruit to the baking dish, making sure to scrape in all of the liquid from the bowl. Place in the oven for 15 minutes. Remove from the oven, and spread the crumble topping over the fruit in an even layer. Return to the oven for 15 to 20 minutes until the crumble is bubbling and nicely browned. Allow to stand for at least 15 minutes before serving.

Yield: Serves eight.

Advance preparation: You can bake the fruit without the crumble topping as instructed in Step 2, then allow it to sit for a few hours before you finish it with the crumble topping. You can keep the topping in an airtight container or freezer bag in the freezer for several weeks.

Nutritional information per serving: 222 calories; 4 grams saturated fat; 2 grams polyunsaturated fat; 2 grams monounsaturated fat; 16 milligrams cholesterol; 35 grams carbohydrates; 10 grams dietary fiber; 30 milligrams sodium (does not include salt to taste); 4 grams protein

Flaxseed and Oatmeal Crumble Topping

The newest of the grainy crumble toppings that I keep on hand in the freezer, this one has a particularly nutty flavor because of its toasted flaxseeds. Use certified gluten-free oats if you like.

1 1/4 cups rolled oats

1/4 cup rice flour

1/4 cup regular or (preferably) toasted flaxseeds, coarsely ground

1/3 cup unrefined turbinado sugar

1/2 teaspoon freshly grated nutmeg

1/8 teaspoon salt

3 ounces (6 tablespoons) cold unsalted butter, cut into 1/2-inch pieces

1. Preheat the oven to 350 degrees. Cover a baking sheet with parchment. Place the oats, rice flour, ground flaxseeds, sugar, salt and nutmeg in a food processor fitted with the steel blade. Pulse several times to combine. Add the butter, and pulse until it is evenly distributed throughout the grain mix. The mixture should have a crumbly consistency.

2. Spread the topping over the parchment-covered baking sheet in an even layer. Place in the oven, and bake 10 minutes. Rotate the pan, stir the mixture and bake another five to 10 minutes until nicely browned. Remove from the heat, and allow to cool. You can keep this in an airtight container or freezer bag in the freezer for several weeks.

Yield: 2 1/2 cups (10 ounces).

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

Business Briefing | MEDICINE: Drug Maker Withdraws Bid for Obesity Drug Approval

Posted: 03 Jun 2011 09:40 PM PDT

Orexigen Therapeutics, the maker of a weight-loss drug once seen as a potential blockbuster, said it was scrapping its bid for approval in the United States because of “unprecedented” demands by regulators on safety trials. Orexigen said that it would focus on developing the drug, Contrave, and another drug candidate, Empatic, in markets outside the United States until there was a clear pathway to approval in the United States. The Food and Drug Administration refused to approve Contrave in February because of concerns about its effects on the heart. Orexigen said the F.D.A. wanted it to conduct a study on Contrave’s heart side effects that is unprecedented and would generate much more information than necessary or feasible. As recently as 2010, Contrave was seen as a highly promising obesity drug. Stock in Orexigen, which is based in San Diego, fell $1.06, or 33 percent, to $2.12 a share.

Nutrition Plate Unveiled, Replacing Food Pyramid

Posted: 03 Jun 2011 09:01 PM PDT

The first lady, Michelle Obama, on Thursday relegated the government’s well-known food pyramid to the sands of history, unveiling a new, simpler image of a plate divided into basic food groups.

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The new design was revealed on Thursday morning.

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The food pyramid was updated in 2005.

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The 1992 food guide pyramid.

The new design, called MyPlate, was conceived as a crucial part of Mrs. Obama’s campaign against obesity, designed to remind consumers about the basics of a healthful diet.

The plate is split into four sections, for fruit, vegetables, grains and protein. A smaller circle sits beside it for dairy products.

Mrs. Obama, Agriculture Secretary Tom Vilsack and Dr. Regina M. Benjamin, the surgeon general, unveiled the new healthful eating icon at a news conference in Washington.

“This is a quick, simple reminder for all of us to be more mindful of the foods that we’re eating,” Mrs. Obama said. “We’re all bombarded with so many dietary messages that it’s hard to find time to sort through all this information, but we do have time to take a look at our kids’ plates.”

If the filled plate looks like the symbol, with lots of fruits and vegetables, she said, “then we’re good, it’s as simple as that.”

The Agriculture Department has created a Web site, ChooseMyPlate.com, that elaborates on the guidance reflected in the plate’s design. It includes tip sheets with recommendations like eating fish twice a week and avoiding high-fat, salty foods like salami and bologna.

Officials said they planned to use the plate in a campaign to communicate essential dietary guidelines to consumers, emphasizing one message at a time for the best effect.

The first part of the campaign will encourage people to make half their plate fruit and vegetables. Later phases will urge consumers to avoid oversize portions, enjoy their food but eat less of it and drink water instead of sugary drinks.

Nutritionists often criticized the food pyramid, which was first advanced in 1992, for being misleading or hard to understand. Some gave the plate cautious praise on Thursday.

“It’s better than the pyramid, but that’s not saying a lot,” said Marion Nestle, a professor of nutrition at New York University.

Dr. Nestle praised the plate for being generally easy to understand, but she said that labeling a large section of the plate “protein” was confusing and unnecessary, because grains and dairy products also are important sources of protein and most Americans get far more protein than they need.

But she said the emphasis on fruits and vegetables was a significant step.

“Americans aren’t used to eating this way, so this is a big change,” Dr. Nestle said.

The plate was created by the Agriculture Department with advice from the first lady’s anti-obesity team and federal health officials. The Agriculture Department said that it had conducted focus groups with about 4,500 people, including children, as it developed the plate.

The project, with the Web site and related educational materials, cost about $2 million. That money will also help pay for an educational campaign about the plate over the next year, officials said.

Urban Athlete: Hearts Beating Faster on High

Posted: 02 Jun 2011 10:48 PM PDT

THE morning after my date with Kenny, I could barely lift my arms to wash my hair. He had taken me to the High Line, where I spent an hour following his every command in front of total strangers.

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The High Line, that elevated stretch of urban idyll perfect for strolling with gelato or cozying up on chaise longues, is no stranger to first dates. But we did not blend into the scenery up there: we hit the High Line to hit our maximum heart rates.

Kenny is Kenny Wong, a 48-year-old former Marine and onetime backup dancer for a pop singer named Amber. He owns PeaceCore fitness studio in Chelsea, and I’m in what feels like the best shape of my life as I approach my 39th birthday because of the fitness classes he leads atop the High Line each week.

Kenny — I don’t know anyone who calls him Mr. Wong — knows that we create something of a spectacle up there. He brings business cards, fields questions from the curious and keeps us pushing our bodies. A pack of 5 to 10 of us run the High Line as if it were a track, dodging tourists and picnicking couples. We take the stairs — three sets — at least two at a time. We use the benches for push-ups. We kick the iron rails with the flat soles of our sneakers.

Unlike similar boot camps in Central Park or Prospect Park, where participants fit in among other exercisers, the High Line class puts us on display. Tourists take pictures (“those crazy New Yorkers!”), and camera crews have approached Kenny to see if we will pose for shots. A group of about 25 tourists once walked by as we were slogging through Kenny’s drills, and a few of them joined in.

“I told you guys to run,” Kenny recalled saying, and then everybody started clapping and shouting. “That was inspiring,” he said. Recently a tourist set up a tripod 20 feet from where I was lunging, but I didn’t miss a step.

That first date was miserable. An hour of push-ups, bear crawls, triceps dips, squat thrusts (shades of junior high), wall sits, burpees (the squat thrust’s more sadistic cousin) and lunges — all interrupted with intense running — left me with barely the energy to swipe my MetroCard for the ride home to Brooklyn.

Kenny makes it sound so simple. “We use our own body weight, Marine Corps-inspired drills,” he said. “We incorporate kickboxing, dance, yoga into the workout.”

The next morning in the shower I quivered with exhaustion and worried about what pain the day would bring. I was right to worry. The rest of my muscles caught up to my arms around midday, and by nighttime even sitting was painful.

But the High Line beckons, and I have kept my dates with Kenny each week. While on display between the windows above and the city streets below, I forget the pain and let my body take over. My energy surges, my lungs sear, my quads burn.

“All while watching the sun set,” Kenny said, adding, “Therefore, come the peace.”

PeaceCore classes run Monday through Friday at 6, 7 and 8 p.m.; $250 for 10 classes or $400 for 20; 437 West 16th Street, third floor, Chelsea; (917) 686-0610; peacecore-ny.com.

Brain Injuries Are Seen in New Scans of Veterans

Posted: 01 Jun 2011 10:28 PM PDT

A new study may help explain why some military personnel exposed to blasts have symptoms of brain injury even though their CT and M.R.I. scans look normal.

Using a highly sensitive type of magnetic resonance imaging, researchers studied 63 servicemen wounded by explosions in Iraq or Afghanistan and found evidence of brain injuries in some that were too subtle to be detected by standard scans. All the men already had a diagnosis of mild traumatic brain injury (synonymous with concussion), based on symptoms like having lost consciousness in the blast, having no memory of it or feeling dazed immediately afterward.

About 320,000 American troops have sustained traumatic brain injuries in Iraq and Afghanistan, most of them mild, according to a 2008 report by the RAND Corporation. The injuries are poorly understood, and sometimes produce lasting mental, physical and emotional problems.

“This sort of mild traumatic brain injury has been quite controversial,” said Dr. David L. Brody, an author of the new study and an assistant professor of neurology at Washington University in St. Louis. “Is it due to structural abnormalities in the brain, chemical dysregulation, psychological factors or all three? We show that at least in some there are structural abnormalities.”

The pattern of the damage differed from that found in head injuries not caused by blasts, and matched computer simulations predicting how explosions would affect the brain, Dr. Brody said. If the new findings hold up, he added, they may eventually influence the design of helmets to provide more protection against blasts.

But Dr. Brody and other researchers cautioned that the study was only “a small first step.” The study and an accompanying editorial were published online on Wednesday by The New England Journal of Medicine.

The special M.R.I. technique, known as diffusion tensor imaging, is also being studied to help improve the diagnosis of concussions. It can be performed by most M.R.I. machines and does not take longer or cost more than a standard M.R.I. The test measures the movement of water in nerve fibers in the brain; abnormal flow may indicate injury. Changes can be detected in bundles of thousands of axons, the fibers that carry signals.

Dr. Brody and others from Washington University collaborated with military researchers at the Landstuhl Regional Medical Center in Germany, to which troops injured in Iraq and Afghanistan are evacuated for treatment.

In 2008 and 2009, the researchers performed diffusion tensor imaging on 63 men who had recently sustained mild traumatic brain injuries from blasts; all but one had normal results on a standard M.R.I. For comparison, 21 control subjects were also scanned — men exposed to blasts recently but with no symptoms of concussion.

Eighteen of the 63 men with traumatic brain injury had abnormalities consistent with nerve injury in two or more brain regions, areas not usually damaged by other types of mild head injury. The researchers said that only 2 of 63 healthy subjects would be expected to have such abnormalities. Twenty other men with traumatic brain injury had abnormalities in one area, and 25 had none.

“A negative scan, even with these advanced methods, does not rule out traumatic brain injury,” Dr. Brody said.

Although the findings suggested that blasts may cause a specific pattern of brain injury, the researchers could not be sure, because their study subjects had experienced blows to the head in addition to blast exposure.

Dr. Allan H. Ropper, the executive vice chairman of neurology at Brigham and Women’s Hospital in Boston, who wrote the editorial, said in an interview, “It’s never been clear that a blast alone could cause brain damage without some kind of impact on the head, so it’s a very important finding that there may be a structural brain representation of a blast injury.”

Katherine Helmick, deputy director for traumatic brain injury at the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, said the Defense Department was eager for information that would “help us understand what blast is doing to the brain, and help us get what we really want in diagnosing traumatic brain injury, which is objective markers.”

The new study helps, but is by no means definitive, she said.

The researchers did not tell the study participants the results of their tests. “We were specifically directed by the Department of Defense not to do so,” Dr. Brody said. “Many of them were hoping we could give results to their care providers to document or validate their concerns. It was anguishing for us, because as a doctor I would like to be able to help them in any way I can. But it was not the protocol we agreed to.”

Nick Colgin, 26, an Army veteran with a brain injury from the war in Afghanistan, who was not involved in the study, said he would like very much to have one of the sensitive M.R.I. scans, to better understand his injury. After a blast in 2007, he developed problems with speech, balance, thinking and focusing his eyes. For a while, he could not write his own name. But nothing showed up on his M.R.I. He has improved gradually and is now attending the University of Wisconsin at Stevens Point, but he still has severe headaches.

Christine L. MacDonald, a research instructor in neurology at Washington University and another author of the study, said the scans were still a research tool and not ready for widespread use. Researchers are trying to perfect the technique as quickly as possible for use in the care of wounded service members, she said in an e-mail, adding, “I wish we could help them now, but we aren’t there yet.”

Report Finds Inequities in Payments for Medicare

Posted: 01 Jun 2011 10:28 PM PDT

WASHINGTON — Medicare uses inaccurate, unreliable data to pay doctors and hospitals, the National Academy of Sciences said Wednesday.

Although Medicare is a national program, it adjusts payments to health care providers to reflect regional differences in wages, rent and other costs.

But in a new report, a panel of experts from the academy’s Institute of Medicine said the payment formulas were deeply flawed.

The system of paying doctors has “fundamental conceptual problems,” and the method of paying hospitals is so unrealistic that almost 40 percent of them have been reclassified into higher-paying areas, the report said.

White House officials agreed to commission the study in March 2010 — in the last tense days of Congressional debate over President Obama’s health care overhaul — as a way to secure the votes of lawmakers from Iowa, Minnesota, Wisconsin and other states who believed their doctors and hospitals had long been shortchanged by Medicare. As a result of such underpayments, the lawmakers said, many parts of their states have difficulty recruiting doctors, nurses and other practitioners, and consumers often have difficulty finding specialists.

However, the new study says that geographic adjustments should be used to increase the accuracy of Medicare payments, not to address shortages of providers in some places.

The report criticizes the current arrangement under which Medicare distributes tens of billions of dollars based on regional variations in wages, rents and other costs in 441 hospital labor markets and 89 payment zones for doctors. Of the physician payment zones, 34 cover entire states.

The panel said Medicare should recognize a single set of 441 payment areas for doctors and hospitals alike.

As a result of such a change, the panel said, “higher-cost areas would be separated from lower-cost areas,” and payments to doctors in metropolitan areas would generally increase, while payments to doctors in some rural areas could be expected to decrease.

Michael D. Abrams, executive vice president of the Iowa Medical Society, said he was “a little surprised” and disappointed that the panel did not acknowledge that Medicare overemphasized the importance of geographic differences in office rents.

“You could argue that it costs more to deliver health care in rural America, in sparsely populated areas, than in densely populated areas,” Mr. Abrams said.

“Office space is a lot more expensive in Brooklyn, N.Y., than in Brooklyn, Iowa,” he said, but Medicare’s payment formula gives too much weight to such differences.

Mr. Abrams said he was concerned that the panel’s recommendations could “make things worse” for many doctors and patients in his state. The panel will analyze the impact of its recommendations in a report next spring.

By the end of this year, under the new health care law, the secretary of health and human services must send Congress a plan to revise the way Medicare adjusts payments to reflect regional differences in hospital wages.

Any such plan could have major economic and political implications. Wages account for about two-thirds of hospital costs, the panel said, and regional differences are substantial, with a registered nurse paid almost twice as much per hour in San Francisco as in Springfield, Mo.

Under the new health law, geographic adjustments may not increase total costs to Medicare, so that an increase in payments to one hospital or group of hospitals must generally be offset by decreases in payments to others.

Frank A. Sloan, a professor of economics at Duke University and chairman of the study panel, said Medicare needed to find a new source of data on commercial office rents. The current measure, based on rent for a two-bedroom apartment, does not accurately reflect the prices doctors face, he said.

Second Appellate Panel Hears Arguments on Health Care Law

Posted: 03 Jun 2011 05:56 AM PDT

CINCINNATI — A panel of federal appellate judges seemed eager on Wednesday to rule on whether it is constitutional for the Obama health care law to require that uninsured Americans buy medical coverage. But the judges must first decide whether the plaintiffs still have legal standing to sue, after one disclosed that she recently bought health insurance from her employer.

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The three judges from the United States Court of Appeals for the Sixth Circuit in Cincinnati heard arguments for 90 minutes on the second challenge to the health care law to reach an appellate hearing. Five lower-level district court judges have ruled on the merits of the challenges, with three upholding the law’s constitutionality and two striking down all or part of it.

The cases are vying for ultimate consideration by the Supreme Court, which is expected to decide whether President Obama’s signature domestic legislation exceeded the bounds of Congress’s constitutional authority to regulate interstate commerce.

One judge, James L. Graham, pressed that question on Wednesday with Neal K. Katyal, the acting United States solicitor general, who is defending the law for the Obama administration.

“Where, ultimately, is the limit on Congress’s power?” the judge asked.

Mr. Katyal responded that the government had never suggested that there were no limits.

“Where are they?” Judge Graham continued. “I want to find them.”

Mr. Katyal then argued that the law’s insurance mandate, which takes effect in 2014, does not so much require individuals to buy coverage as it does regulate the way they pay for health care they will inevitably consume. Without the mandate, Mr. Katyal said, the law’s requirement that insurers provide coverage to all applicants, regardless of their health status, would simply encourage people to buy insurance after they got sick.

“Congress is not regulating the failure to buy something, but the failure to secure financing,” Mr. Katyal said.

Wednesday’s hearing came in a challenge to the law filed by the Thomas More Law Center, a public interest law firm in Ann Arbor, Mich., that describes itself as “the Christian response to the A.C.L.U.” The center primarily takes cases involving Christian expression in the public square. Its health care lawsuit pointedly listed the defendant by his full name: Barack Hussein Obama.

Mr. Katyal began Wednesday’s hearing by arguing that the case should be dismissed because one of the plaintiffs, a Thomas More member named Jann DeMars, bought an insurance policy last October from her employer.

In the original lawsuit, filed in March 2010, Ms. DeMars argued that she was entitled to sue because she was uninsured and would have to make burdensome choices to afford a policy in 2014. Because she now has coverage, Mr. Katyal said, Ms. DeMars can no longer demonstrate any imminent injury, which is required to mount such a challenge.

The government arguably drew a less friendly panel on Wednesday than it did last month at the Court of Appeals for the Fourth Circuit in Richmond, Va., which heard the appeal of a ruling against the insurance mandate. The Fourth Circuit panel consisted of three judges appointed by Democratic presidents, including two by Mr. Obama himself.

The randomly selected Sixth Circuit panel includes two judges appointed by Republicans — Jeffrey S. Sutton, who was named by President George W. Bush, and Judge Graham, who was nominated by President Ronald Reagan to the Federal District Court in Ohio and is on temporary assignment to the appellate bench. The third judge, Boyce F. Martin Jr., was appointed by President Jimmy Carter, a Democrat.

A hearing on a third constitutional challenge to the health care law is scheduled for next week in the 11th Circuit in Atlanta. The panel in that court includes Chief Judge Joel F. Dubina, who was appointed by the first President Bush; Judge Frank M. Hull, who was appointed by President Bill Clinton; and Judge Stanley Marcus, who also was named by Mr. Clinton, after being placed on the district court by Mr. Reagan.

All three district court opinions upholding the health care law were written by Democratic appointees, while both of the opinions against it came from Republican appointees.

In the Thomas More case, Judge George C. Steeh of Detroit, a Clinton appointee, accepted the government’s assertion that a choice to decline to obtain insurance could be defined as an active decision, subject to regulation by Congress like other commercial activities.

Supreme Court decisions have upheld Congress’s authority to regulate “activities” that have a substantial effect on interstate commerce. But the courts have never been asked to consider whether such activity can encompass a choice not to buy a commercial product.

Robert J. Muise, senior counsel for the Thomas More Legal Center, urged the judges on Wednesday to reject any effort to equate activity and inactivity.

“They’re mandating somebody to engage in commerce, so they’re effectively regulating inactivity,” Mr. Muise said. “This is where the line has to be drawn.”

U.S. Says New Indiana Law Improperly Limits Medicaid

Posted: 01 Jun 2011 10:20 PM PDT

WASHINGTON — The Obama administration prohibited the State of Indiana on Wednesday from carrying out a new state law that cuts off money for Planned Parenthood clinics providing health care to low-income women on Medicaid.   

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The state law penalized Planned Parenthood because some of its clinics also perform abortions.   

Dr. Donald M. Berwick, administrator of the federal Centers for Medicare and Medicaid Services, said the state law imposed impermissible restrictions on the freedom of Medicaid beneficiaries to choose health care providers. The freedom of choice, he said, is generally guaranteed by the federal Medicaid law.       

But state officials said Wednesday that they intended to continue enforcing the state law, which took effect on May 10, when it was signed by Gov. Mitch Daniels, a Republican.

In a letter to Indiana officials, Dr. Berwick said the state law “would eliminate the ability of Medicaid beneficiaries to receive services from specific providers for reasons not related to their qualifications to provide such services.”

For years, federal law has banned the use of Medicaid money to pay for abortion except in certain cases.

The Indiana law goes much further. It prohibits state agencies from entering contracts with or making grants to “any entity that performs abortions or maintains or operates a facility where abortions are performed.” It also terminates state contracts with such entities. The law does not apply to hospitals.

Planned Parenthood of Indiana provided services last year to 85,000 patients. Most received contraceptives or preventive health screenings, but 5,580 received abortions.

In a bulletin sent Wednesday to state officials around the country, Cindy Mann, the federal official who supervises Medicaid, said states could not exclude doctors, clinics or other providers from Medicaid “because they separately provide abortion services.”

After learning of the federal decision, Marcus J. Barlow, a spokesman for the Indiana Family and Social Services Administration, said: “For now, our lawyers advise us that we must continue to follow the law the Indiana General Assembly passed. We will seek guidance from the attorney general on how to proceed going forward.” 

Medicaid is financed jointly by the federal government and the states. When a state wants to modify its Medicaid program, it must amend its state Medicaid plan. The changes are subject to federal review and approval.

2 Studies Examine Syndrome of Fatigue

Posted: 31 May 2011 10:18 PM PDT

In a blow to patients with chronic fatigue syndrome, two new studies published on Tuesday raised serious doubts about earlier reports that the disabling disease is linked to infection with XMRV, a poorly understood retrovirus.

The new papers were posted online in the journal Science, which in October 2009 published the initial research linking XMRV to chronic fatigue syndrome. In an “editorial expression of concern” accompanying the two new studies, Bruce Alberts, editor in chief of the journal, declared that the earlier finding “is now seriously in question” and was most likely due to laboratory contamination.

Based on those earlier findings, some people with chronic fatigue syndrome tried to obtain access to antiretroviral drugs used to treat H.I.V., which had been shown in laboratory studies to inhibit the replication of XMRV.

But in one of the two new studies, researchers found no trace of XMRV or related viruses in the blood of 43 patients who had previously tested positive for XMRV. In the second study, scientists reported evidence that XMRV was likely a recombination of two mouse leukemia viruses created accidentally in laboratory experiments.

The new studies are the latest in a series of disappointments for people struggling with chronic fatigue syndrome. Other researchers have been unable to duplicate the original findings implicating XMRV, although none of their studies fully replicated the methods of the original research from the Cleveland Clinic, the National Cancer Institute and the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, Nev.

Dr. Vincent Racaniello, a microbiology professor at Columbia University, said in an interview that it now appeared unlikely that XMRV infection is a cause of chronic fatigue syndrome. But it also would be wrong to conclude that chronic fatigue syndrome is not an infectious disease, he added.

“These patients have a lot of signs of hyper-immune activation, with their immune systems firing almost constantly,” he said.

Dr. Jay Levy, a professor of medicine at the University of California, San Francisco, and the senior author of one of the new studies, said he nonetheless believed that many or most people with chronic fatigue syndrome are suffering from a disease initiated by one or more viruses.

Many of the disease’s symptoms are likely caused by the immune systems’ response to an infection, rather than to the pathogens themselves, he said.

“The immune system pours out its toxins to stop this agent, and then the immune system doesn’t calm down,” he said, adding that environmental toxins could also play a role in the illness.

Last week, the editors of Science asked the authors of the original research if they would retract their paper in view of the new findings about to be published. The senior author, Dr. Judy Mikovits, research director at the Whittemore Peterson Institute, responded that such a step was “premature” and that she knew of other investigators planning to publish research backing the original findings.

Some patients reacted angrily to the news that Science had asked for a retraction. “The patient community is shocked,” Rivka Solomon, a largely homebound Boston-area writer with chronic fatigue syndrome, said in an e-mail. “Most of us feel that the scientific inquiry necessary to bring this to conclusion has not yet been played out.”

Ms. Solomon recently organized small demonstrations in Washington, D.C., and San Francisco to focus attention on the small amount of financing the government has allocated to the disease in recent years. If the XMRV association does not pan out, she wrote, patients like her “worry that we will once again be abandoned.”

The government is supporting additional studies to determine whether XMRV plays any role in chronic fatigue syndrome at all. The retrovirus had also been linked to prostate cancer, an association also challenged by the research published on Tuesday.

U.S. Orders Review of Risks of Some Birth Control Pills

Posted: 31 May 2011 10:33 PM PDT

Bayer’s birth control pills will be reviewed by regulators after some studies suggested they may cause more blood clots than competing medicines.

Two recent reports in the British Medical Journal found a twofold to threefold greater risk of blood clots in women taking pills like Bayer’s Yaz, the Food and Drug Administration said Tuesday in a statement.

European regulators said last week that they were revising the products’ prescribing information to include the new safety findings.

While all birth control pills pose a risk of blood clots, the F.D.A. review focuses on the hormone drospirenone, found in Bayer’s Yaz, Yasmin, Beyaz and Safyral. The agency expects to have results later this summer of an 800,000-person study it commissioned to examine the risks.

In the meantime, regulators said doctors and patients should watch for symptoms of blood clots, including leg or chest pain.

The Yaz family of products generated $1.47 billion in sales last year for Bayer, or 3.3 percent of the company’s revenue.

“Patient safety is Bayer’s top priority,” the company said in an e-mail. “Bayer’s analysis of the overall body of available scientific evidence continues to support its current assessment about the safety of its oral contraceptives.”

Sales Tactics on Implants Raise Doubts

Posted: 31 May 2011 10:09 PM PDT

The message from cardiologists was loud and clear, according to a top executive at a heart device company. The doctors wanted implant makers to produce more clinical trials of devices to help them generate income from research fees.

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Biotronik, via Business Wire

The Justice Department is investigating Biotronik's sales practices.

To compete, “we must be able to ‘answer the bell,’ ” wrote Thomas V. Brown, an executive vice president at the American subsidiary of Biotronik, a small German firm that makes pacemakers and defibrillators.

Mr. Brown’s charge came in an e-mail last year to fellow Biotronik executives, one of scores of documents involving the company that offer a portrait of an implant industry where producers seek to influence the brand of device that patients receive long before a diagnosis.

The documents show, for example, that device makers recruit not only implant specialists as consultants but also general cardiologists who refer patients. Those cardiologists, called feeders in one of the documents, can benefit by enrolling the referred patients in a company-financed study that can pay a cardiologist up to $4,800 a patient.

A lawyer representing Biotronik, Christopher Myers, said Mr. Brown’s e-mail was sent around the same time that some Biotronik sales officials were asking the company to design “unscientific studies” to compete with producers offering sham studies “as a means of funneling money to doctors.” Mr. Myers said Biotronik executives like Mr. Brown had refused to do so and that the company’s studies were all scientifically sound.

In recent years, big makers of implants like heart devices and artificial joints, including Johnson & Johnson, Boston Scientific and St. Jude Medical, have settled Justice Department charges that they illegally promoted sales. The enforcement effort has sought to reduce the role of corporate influence over medicine through tactics like bogus or inflated consulting deals with doctors.

Since last year, the Justice Department has been investigating Biotronik’s sales and marketing practices. Biotronik and its consultants have not been accused of wrongdoing, and Mr. Myers said the company had abided by all federal regulations. Citing the Justice Department investigation, executives of the company’s American subsidiary, which is based in Lake Oswego, Ore., declined to be interviewed.

“The implication that our contractual partnership with expert cardiologists is simply to enhance sales is flatly wrong and unfair,” the company stated in a recent news release.

However, sales tactics, rather that scientific data, can determine which company’s device a patient gets because doctors have no independent source of information about which implants work best or last longest, several experts said.

“There is no reliable way to compare different devices on an independent basis,” said Dr. Alan H. Kadish, a cardiologist who is the president of Touro College in Manhattan.

The Biotronik documents, which discuss the company’s sales tactics and those of some competitors, were provided to The New York Times earlier this year by a former Biotronik employee involved in an employment dispute with the company. Biotronik said that last year it had fired the employee, Max Bennett, for inappropriate behavior; Mr. Bennett said that he had been fired after he complained to company executives about corporate wrongdoing.

The lawyer for Biotronik, Mr. Myers, described the records as providing a limited and misleading view of the company’s operations.

In the last few years, Biotronik’s share of the market has grown to about 5 percent from 1 percent, according to a recent report by Matthew J. Dodds, an industry analyst with Citi Investment. The company has attributed the increase to, among other things, products that it says are better and more reliable than those of competitors and to better service to doctors.

The documents, which include e-mails, sales reports and strategy documents, offer another possible contributing explanation: the company’s success in developing relationships with doctors who, in turn, can influence which brand of device a patient gets.

The company’s relationship with a general cardiologist in Tucson, Dr. Monty C. Morales, is the subject of several memos.

Well: How to Add Flaxseed to Your Diet

Posted: 03 Jun 2011 11:58 AM PDT

Well: The School Bully Is Sleepy

Posted: 02 Jun 2011 01:25 PM PDT

Well: Surgeons Who Burn the Midnight Oil

Posted: 03 Jun 2011 12:53 PM PDT

Well: Guide to a Gluten-Free Kitchen

Posted: 01 Jun 2011 01:12 PM PDT

Well: Eating Fat, Staying Lean

Posted: 31 May 2011 09:01 PM PDT

The New Old Age: Community Services

Posted: 03 Jun 2011 09:23 AM PDT

The New Old Age: Mean Girls in Nursing Homes

Posted: 31 May 2011 09:12 AM PDT

To Rest Easy, Forget the Sheep

Posted: 30 May 2011 09:40 PM PDT

Scientists know that many people inadvertently undermine their ability to fall asleep and stay asleep for a full night. Here are some frequent suggestions:

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1. Establish a regular sleep schedule and try to stick to it, even on weekends.

2. If you nap during the day, limit it to 20 or 30 minutes, preferably early in the afternoon.

3. Avoid alcohol in the evening, as it can disrupt sleep.

4. Don’t eat a big meal just before bedtime, but don’t go to bed hungry, either. Eat a light snack before bed, if needed, preferably one high in carbohydrates.

5. If you use medications that are stimulants, take them in the morning, or ask your doctor if you can switch to a nonstimulating alternative. If you use drugs that cause drowsiness, take them in the evening.

6. Get regular exercise during the day, but avoid vigorous exercise within three hours of bedtime.

7. If pressing thoughts interfere with falling asleep, write them down (keep a pad and pen next to the bed) and try to forget about them until morning.

8. If you are frequently awakened by a need to use the bathroom, cut down on how much you drink late in the day.

9. If you smoke, quit. Among other hazards, nicotine is a stimulant and can cause nightmares.

10. Avoid beverages and foods containing caffeine after 3 p.m. Even decaf versions have some caffeine, which can bother some people.

Op-Ed Contributors: Heavy in School, Burdened for Life

Posted: 03 Jun 2011 08:09 AM PDT

MUCH of the debate about the nation’s obesity epidemic has focused, not surprisingly, on food: labeling requirements, taxes on sugary beverages and snacks, junk food advertisements aimed at children and the nutritional quality of school lunches.

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Shannon Freshwater

But obesity affects not only health but also economic outcomes: overweight people have less success in the job market and make less money over the course of their careers than slimmer people. The problem is particularly acute for overweight women, because they are significantly less likely to complete college.

We arrived at this conclusion after examining data from a project that tracks more than 10,000 people who graduated from Wisconsin high schools in 1957. From career entry to retirement, overweight men experienced no barriers to getting hired and promoted. But heavier women worked in jobs that had lower earnings and social status and required less education than their thinner female peers.

At first glance this difference might appear to reflect bias on the part of employers, and male supervisors in particular. After all, studies find that employers tend to view overweight workers as less capable, less hard-working and lacking in self-control.

But the real reason was that overweight women were less likely to earn college degrees — regardless of their ability, professional goals or socioeconomic status. In other words, it didn’t matter how talented or ambitious they were, or how well they had done in high school. Nor did it matter whether their parents were rich or poor, well educated or high school dropouts.

Our study, published last year in the journal Social Forces, was the first to show that decreased education was the key mechanism that reduced the career achievement of overweight women — an impact that persisted even among those who lost weight later in life. We found no similar gap in educational attainment for overweight men.

Why doesn’t body size affect men’s attainment as much as women’s? One explanation is that overweight girls are more stigmatized and isolated in high school compared with overweight boys. Other studies have shown that body size is one of the primary ways Americans judge female — but not male — attractiveness. We also know that the social stigma associated with obesity is strongest during adolescence. So perhaps teachers and peers judge overweight girls more harshly. In addition, evidence suggests that, relative to overweight girls, overweight boys are more active in extracurricular activities, like sports, which may lead to stronger friendships and social ties. (Of course our study followed a particular group from career entry to retirement, and more study is needed to determine whether overweight girls finishing high school today face the same barriers, though these social factors suggest they do.)

That overweight women continue to trail men — including overweight men — in educational attainment in America is remarkable, given that women in general are outpacing men in college completion and in earning advanced degrees.

What does this mean for policy? Previous studies have shown that overweight adolescents feel stigmatized by their peers and their teachers, have fewer friends and often feel socially isolated. Teenagers who feel less connected to teachers, school and peers are less likely to graduate and go on to college. So policies to help overweight girls need to work on two levels: promoting healthful behaviors and shifting attitudes.

Obesity is occurring in children at younger and younger ages, so prevention needs to start as early as primary school. While early intervention has obvious potential health benefits, it is also critical from a career perspective. In addition, overweight girls should be encouraged to participate in college preparation courses and extracurricular activities. Health education that focuses on diet and exercise but does not stigmatize overweight teenagers is critical.

Teachers and principals need to be aggressive in limiting bullying and looking for signs of depression in overweight girls. Teenage girls, regardless of body size, struggle with self-esteem and are at higher risk of depression than boys, so expanding health education to include psychological as well as physical health could help all girls. Public health campaigns should reframe the problem of obesity from one of individual failure to one of public concern.

The economic harm to overweight women is more than a series of personal troubles; it may contribute to the rising disparities between rich and poor, and it is a drain on the human capital and economic productivity of our nation.

Christy M. Glass and Eric N. Reither are associate professors of sociology at Utah State University. Steven A. Haas is an assistant professor of sociology at Arizona State University.

Editorial: When States Punish Women

Posted: 03 Jun 2011 08:31 AM PDT

The Obama administration has rightly decided to reject a mean-spirited and dangerous Indiana law banning the use of Medicaid funds at Planned Parenthood clinics, which provide vital health services to low-income women.

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Barbara Kruger

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The law, signed by Gov. Mitch Daniels of Indiana in May, is just one effort by Republican-led state legislatures around the country to end public financing for Planned Parenthood — a goal the House Republicans failed to achieve in the budget deal in April. The organization is a favorite target because a small percentage of its work involves providing abortion care even though no government money is used for that purpose.

Governor Daniels and Republican lawmakers, by depriving Planned Parenthood of about $3 million in government funds, would punish thousands of low-income women on Medicaid, who stand to lose access to affordable contraception, life-saving breast and cervical cancer screenings, and testing and treatment for H.I.V. and other sexually transmitted diseases. Making it harder for women to obtain birth control is certainly a poor strategy for reducing the number of abortions.

On Wednesday, the administrator of the federal Centers for Medicare and Medicaid Services, Donald Berwick, said the Indiana law, which is already in effect, violates federal Medicaid law by imposing impermissible restrictions on the freedom of Medicaid beneficiaries to choose health care providers.

Although Mr. Berwick’s letter to Indiana officials did not say it explicitly, Indiana could lose millions of dollars in Medicaid financing unless it changes its law. In a bulletin to state officials around the country, the Medicaid office warned that states may not exclude doctors, clinics or other providers from Medicaid “because they separately provide abortion services.”

So far, Indiana isn’t budging. The issue will be taken up on Monday in federal court in Indiana where Planned Parenthood has filed a suit challenging the state’s action on statutory and constitutional grounds. The organization properly argues that it may not be penalized for engaging in constitutionally protected activities, like providing abortion services with its own money.

The Obama administration’s opposition to the Indiana law could help deter other states — including North Carolina, Texas, Wisconsin and Tennessee — from moving forward with similar measures to restrict payments to Planned Parenthood, either under Medicaid or Title X, the main federal family planning program. Kansas, for example, has enacted provisions to block Planned Parenthood from receiving any Title X money.

The measures against Planned Parenthood come amid further efforts to limit access to abortion. Just since April, six states — Indiana, Virginia, Nebraska, Idaho, Oklahoma and Kansas — have enacted laws banning insurance coverage of abortion in the health insurance exchanges created as part of federal health care reform, bringing the total to 14 states. Two states — Arizona and Texas — joined three others in making ultrasounds mandatory for women seeking to terminate pregnancies. Bills expected to be signed soon by Florida’s Republican governor, Rick Scott, contain both types of provisions.

Many of these fresh attacks on reproductive rights, not surprisingly, have come in states where the midterm elections left Republicans in charge of both chambers of the legislature and the governor’s mansion.

Drug Makers’ Feared Enemy Switches Sides, as Their Lawyer

Posted: 04 Jun 2011 12:30 PM PDT

Michael K. Loucks was arguably the nation’s most influential prosecutor of health care fraud.

He racked up numerous convictions and mega-settlements in nearly a quarter-century, using whistle-blowers and secret grand juries to pressure major pharmaceutical and health companies into ending illegal practices like kickbacks to doctors and misuse of blockbuster drugs.

Once described as a cross between a firebrand preacher and a charismatic litigator, Mr. Loucks burnished a reputation aptly captured in a Fortune magazine headline: “Why Do Drug Companies Fear This Man? Maybe because he’s declared all-out war on cheats in the drug industry.”

But a year and a half ago, Mr. Loucks, a Republican, left the United States attorney’s office in Boston after he was passed over for the top post and President Obama appointed a Democrat. Instead, Mr. Loucks joined Skadden, Arps last July, and has startled former allies by emerging in recent months as zealous a corporate defender as he was a prosecutor, complete with proposals seeking more lenient treatment for the medical companies he once vilified.

In a six-page memo last month to clients in his portfolio, which may include some of the very same corporations he prosecuted repeatedly, Mr. Loucks bemoaned strategies he had embraced.

“The government and the whistle-blower have an advantage,” he wrote, complaining that federal investigators were now using the law unfairly. “While prosecutors often assert the company has engaged in ‘serious’ misconduct, they keep the company in the dark, often for years, as to the specific allegations.”

Those who have known him are quick to recall that his crowning achievement was a $2.3 billion settlement against Pfizer that capped a four-year secret investigation.

“We’re all disappointed that he’s gone over to the dark side because it seemed that he was a good prosecutor,” said Shelley R. Slade, a whistle-blowers’ lawyer in Washington and a former senior counsel for health care fraud at the Justice Department.

“I looked upon it with sadness,” Patrick Burns, spokesman for the whistle-blower advocacy group Taxpayers Against Fraud, said of Mr. Loucks’ change. “He’s a good and honorable person. He did great work in the Boston office. He’s a good lawyer. It’s just too bad.”

Federal ethics rules prohibited Mr. Loucks from any dealings with the United States attorney’s office in Boston for a year after his resignation, and he can never be involved in cases he investigated directly. But he is not barred from representing clients he once prosecuted on other matters, and his law firm’s roster includes some of the biggest companies he once investigated, including Pfizer, Merck, Schering-Plough, Bristol-Myers Squibb and Medtronic.

He defends his newfound friendship with former foes, and notes that he’s still wearing cowboy boots native to his Oklahoma childhood even though he’s now working in the white-collar division of a prestigious law firm.

“While everyone calls it ‘the other side,’ I’m doing the same thing I’ve always done, which is zealously representing my clients,” he said.

And while he used to call some of those people’s actions “evil,” today he argues that drug and medical device companies are making strides in complying with federal billing, fraud and kickback laws. “They make products that have huge benefits to a number of people,” he said. Skadden, a 2,000-lawyer firm, has made several hires in recent years to amplify its health care practice.

In interviews and a lengthy e-mail exchange, Mr. Loucks said his views on the whistle-blower law had evolved.

The False Claims Act, with its triple damages, has been the government’s most powerful weapon against health care fraud since Congress in 1986 increased the rewards for whistle-blowers. Since then, taxpayers have recovered an estimated $28 billion from drug and medical companies.

As a federal prosecutor in Boston, Mr. Loucks created a health care fraud unit and used the law, as well as the tools of secrecy and surprise, to reap major awards. The unit’s victories are renowned, starting with an $875 million payment in 2001 by TAP Pharmaceuticals. Whistle-blowers shared $95 million in that case, alerting companies and informants to the stakes involved.

For years, Mr. Loucks has argued that whistle-blowers are paid far too much in health care fraud cases — bounties up to 30 percent, totaling $650 million in just the last two years, he said. These people would blow the whistle for much less money, he argued both inside the prosecutor’s office and more recently in a paper titled “the Great American Giveaway.” While that hostility toward what he considers the greed of some whistle-blowers is old news, Mr. Loucks’ views on unsealing their complaints are new.

In his May 12 memo to clients, Mr. Loucks urged some companies to press judges to unseal complaints more quickly. That way, he says, they can learn the scope of complaints sooner, identify witnesses and fight back harder.

“If Mike was still with the Justice Department, he could give you 10 reasons why this is a bad idea,” said Suzanne E. Durrell, a whistle-blowers’ lawyer in Boston who worked with Mr. Loucks for a decade when she was chief of the civil division for the United States attorney in Massachusetts.

Mr. Loucks says more openness would let companies clean up their own acts, even if it meant adverse publicity.

He points to new statistics that he says support his argument. The Justice Department reported to Congress that 885 False Claims Act cases involving health care fraud were pending under seal at the beginning of this year, with only about 200 prosecutors to juggle them. On average, a case was sealed for more than a year, and some much longer.

“That the government doesn’t have adequate resources to handle the cases is not a good cause to keep them under seal,” Mr. Loucks said in an interview, comparing it to a sports game where only one team is allowed to try to score. In these cases, that would now be his former team.

“I knew what I was doing on behalf of the government,” he said. “I don’t know if lawyers on the other side felt they were not able to adequately represent their clients while the case was under seal.”

Nicholas C. Theodorou, chairman of Foley Hoag’s business crimes defense group in Boston, said Mr. Loucks’ argument made sense from a corporate defense standpoint, and possibly would sit well with some federal judges who have questioned why cases remain under seal so long.

For his part, Mr. Loucks uses a baseball reference to explain his switching sides. Johnny Damon left his beloved Boston Red Sox in late 2005 to sign with “the evil empire, the New York Yankees,” Mr. Loucks said. Both teams won World Series with help from Mr. Damon.

Asked whether the “evil empire” analogy fit the Justice Department or Skadden, Mr. Loucks said, “One man’s evil empire is another’s home team.”

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Breaches Lead to Push to Protect Medical Data

Posted: 31 May 2011 04:36 AM PDT

Federal health officials call it the Wall of Shame. It’s a government Web page that lists nearly 300 hospitals, doctors and insurance companies that have reported significant breaches of medical privacy in the last couple of years.

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Associated Press

Kathleen Sebelius, secretary of health and human services.

Such lapses, frightening to consumers, could impede the Obama administration’s effort to shift the nation to electronic health care records.

“People need to be assured that their health records are secure and private,” Kathleen Sebelius, secretary of health and human services, said in an interview by phone. “I feel equally strongly that conversion to electronic health records may be one of the most transformative issues in the delivery of health care, lowering medical errors, reducing costs and helping to improve the quality of outcomes.”

So the administration is making new efforts to enforce existing rules about medical privacy and security. But some health care experts wonder if the current rules are enough or whether stronger laws are needed, for example making it a crime for someone to use information obtained improperly.

“The consequences of breaches matter,” conceded Dr. Farzad Mostashari, a former New York public hospitals official who recently became the Obama administration’s national coordinator for health information technology. “People say they are afraid that if their private information becomes known, they may not be able to get health insurance.”

In the last two years, personal medical records of at least 7.8 million people have been improperly exposed, according to the government data. One particularly egregious case involved information about 1.7 million patients, staff members, contractors and suppliers of Bronx hospitals and clinics operated by the Health and Hospitals Corporation, the New York public health agency. Their electronic files were stolen from an unlocked van belonging to a record management company.

The affected patients got the disquieting news that their medical and personal information, like Social Security numbers, had been violated when their health care providers notified them under federal rules.

Showing just how lax security can be, the inspector general of the Department of Health and Human Services said two weeks ago that the agency had found dozens of vulnerabilities in systems to protect records of patients at seven large hospitals in New York, California, Illinois, Texas, Massachusetts, Georgia and Missouri. Auditors cited such problems as personal information that was not encrypted and was stored on computers that could be easily used by unauthorized users.

Auditing teams are now inspecting eight more hospitals, said Lori Pilcher, an assistant inspector general at Health and Human Services. The hospitals are not being identified to avoid alerting hackers, she said.

Another big breach was reported in March on the official Web site by Health Net, a California-based insurance company, which notified 1.9 million health plan members that records with their personal information were missing.

Health Net said I.B.M., which was managing its information system, told the insurer that the records could not be found.

“The health care industry is not as vigilant as they should be about protecting private information in a patient’s medical records,” said Representative Joe L. Barton, a Texas Republican who is co-chairman of the Bipartisan Privacy Caucus in the House.

Mr. Barton knows from personal experience. His own records after a heart attack, along with several thousand others from a research project at the National Institutes of Health, were “on a disk in a laptop in somebody’s trunk that disappeared,” he recalled. “I was stunned.”

The Obama administration has levied a string of stringent penalties for egregious violations of patient rights under the most commonly cited law, the Health Insurance Portability and Accountability Act, or HIPAA, of 1996. Health information is supposed to stay private under those rules, but research has shown that it is not that difficult to connect names and addresses to nominally anonymous data with Internet searches and computerized matchups.

Asked and Answered | Monica Coury: Under an Arizona Plan, Smokers and the Obese Would Pay Medicaid Fee

Posted: 30 May 2011 10:10 PM PDT

Arizona, like many other states, says it is no longer able to finance its Medicaid program adequately. As part of a plan to cut costs, the state has proposed imposing a $50 fee on childless adults on Medicaid who are either obese or who smoke. In Arizona, almost half of all Medicaid recipients smoke; while the number of obese people is unclear, about one in four Arizonans is overweight, according to the Centers for Disease Control and Prevention. The state’s plan must ultimately be approved by the federal government. Monica Coury, spokeswoman for Arizona’s Medicaid program, discusses.

Q. What is the current status of the state’s Medicaid program?

A. In Arizona, there has been an increase of 30 percent in the number of people on Medicaid and a 34 percent decrease in general fund revenue since 2007. We are one of just a few states that cover childless adults in Medicaid. We want to change the nature of eligibility for that program from an open-ended entitlement program to one that the state manages based on available funding, which means we can freeze the program and then open the program back up for enrollment should we come into additional funds. But that is just one of the things we are seeking to do. We also want to reform the payment system for Medicaid. Currently, Medicaid is structured such that we are a purchaser of ‘widgets,’ if you will. So, providers are incentivized to do more — since they get paid for quantity. There is no financial incentive for a provider to reduce the number of hospital admissions, for instance, because that drives down the bottom line. We want Medicaid to move away from that concept to one that supports and financially rewards health plans and providers for supporting quality.

Q. Why is it a good idea to charge people a fee for being overweight or for smoking?

A. The issue is this: we can’t keep complaining about the rising cost of health care and not drill down to what that means on the individual level. Maricopa County [where Phoenix is located] has started a program among its employees where smokers have to pay $450 more for health insurance than nonsmokers. They take a swab to detect nicotine. The bottom line is that there’s plenty of evidence and studies that show there is an undeniable link between smoking and obesity and health care costs.

Q. What has been the response from critics?

A. Some people have suggested it is discriminating against obese people. To me, it is a matter of fairness. We have an obligation to provide health care coverage to 1.35 million people. And we’ve got a budget crisis, so if there’s something you can do to help out — we’re just asking you to put a little more back into the system. What we want to test is whether making people pay is going to affect behavior. We think it will.

Q. How would disabled people be affected?

A. We’re not talking about the disabled, the elderly, pregnant women or children, and certainly there would be exceptions for certain conditions, like cancer. We are talking only about able-bodied people who have the capacity to manage their weight.

Q. How did you arrive at the amount of $50? Would that be sufficient to offset the fund’s costs?

A. We’ve talked about $50 once a year. We haven’t done the math, but it’s not about how much we would collect. It is totally about testing the efficacy of this strategy. Obesity is costing us billions in health care costs, so our thought is, Let’s test some of these strategies.

Medicare Plan for Payments Irks Hospitals

Posted: 31 May 2011 05:43 AM PDT

WASHINGTON — For the first time in its history, Medicare will soon track spending on millions of individual beneficiaries, reward hospitals that hold down costs and penalize those whose patients prove most expensive.

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The administration plans to establish “Medicare spending per beneficiary” as a new measure of hospital performance, just like the mortality rate for heart attack patients and the infection rate for surgery patients.

Hospitals could be held accountable not only for the cost of the care they provide, but also for the cost of services performed by doctors and other health care providers in the 90 days after a Medicare patient leaves the hospital.

This plan has drawn fire from hospitals, which say they have little control over services provided after a patient’s discharge — and, in many cases, do not even know about them. More generally, they are apprehensive about Medicare’s plans to reward and penalize hospitals based on untested measures of efficiency that include spending per beneficiary.

A major goal of the new health care law, often overlooked, is to improve “the quality and efficiency of health care” by linking payments to the performance of health care providers. The new Medicare initiative, known as value-based purchasing, will redistribute money among more than 3,100 hospitals.

Medicare will begin computing performance scores in July, for monetary rewards and penalties that start in October 2012.

The desire to reward hospitals for high-quality care is not new or controversial. The idea can be traced back to a bipartisan bill introduced in Congress in 2005, when Democrats and Republicans were still working together on health care. However, adding in “efficiency” is entirely new and controversial, as no consensus exists on how to define or measure the efficiency of health care providers.

The new health care law directs the secretary of health and human services to develop “efficiency measures, including measures of Medicare spending per beneficiary.” Obama administration officials will decide how to calculate spending per beneficiary and how to use it in paying hospitals.

Administration officials hope such efforts will slow the growth of Medicare without risking the political firestorm that burned Republicans who tried to remake the program this year.

In calculating Medicare spending per beneficiary, the administration said, it wants to count costs generated during a hospital stay, the three days before it and the 90 days afterward. This, it said, will encourage hospitals to coordinate care “in an efficient manner over an extended time period.”

If, for example, an 83-year-old woman is admitted to a hospital with a broken hip, she might have hip replacement surgery and then be released to a nursing home or a rehabilitation hospital. When she recovers, she might return to her own home, but still visit doctors and physical therapists or receive care from a home health agency. If she develops a serious infection, she might go back to the hospital within 90 days.

The new measure of Medicare spending per beneficiary would include all these costs, which — federal officials say — could be reduced by better coordination of care and communication among providers.

Here, in simplified form, is an example offered by federal officials to show how the rewards might work. If Medicare spends an average of $9,125 per beneficiary at a particular hospital and if the comparable figure for all hospitals nationwide is $12,467, the hospital would receive high marks — 9 points out of a possible 10 awarded for efficiency. This measure, combined with measures of quality, would be used to compute an overall performance score for the hospital. Based on this score, Medicare would pay a higher or lower percentage of each claim filed by the hospital.

Federal officials are still working out details, including how to distribute the money.

Charles N. Kahn III, president of the Federation of American Hospitals, which represents investor-owned companies, said he supported efforts to pay hospitals according to their performance. But he said the administration was “off track” in trying to hold hospitals accountable for what Medicare spends on patients two or three months after they leave the hospital.

“That’s unrealistic, beyond the pale,” Mr. Kahn said.

Since 2004, Medicare has provided financial incentives to hospitals to report on the quality of care, using widely accepted clinical measures.

Much of the information is posted on a government Web site (hospitalcompare.hhs.gov), but it has not been used as a basis for paying hospitals.

Popular Drug Stalls Ovarian Cancer, Studies Say

Posted: 04 Jun 2011 12:10 PM PDT

CHICAGO — A drug now used to prevent recurrences of breast cancer can also prevent it from occurring in the first place, providing a new option for women at high risk of getting the disease, researchers reported here on Saturday.

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Two drugs, tamoxifen and raloxifene, are already approved to prevent breast cancer but are rarely used for that purpose, in part because they can have serious side effects like uterine cancer and blood clots. The researchers said the new option, exemestane, does not have those side effects and might be more acceptable.

“There’s a very safe therapy that looks highly effective in preventing breast cancer,” Dr. Paul E. Goss, professor of medicine at Harvard and Massachusetts General Hospital, said at a news conference at the annual meeting of the American Society of Clinical Oncology. He was the lead investigator in the study, which is being presented at the conference and published online by the New England Journal of Medicine.

Two other studies presented at the conference show that the widely used cancer drug Avastin is effective in delaying the progression of ovarian cancer. But both studies so far have narrowly missed showing that the drug can prolong lives, the ultimate test of a cancer drug. That threatens to embroil the use of Avastin for ovarian cancer in a debate similar to the one surrounding its use in breast cancer.

Exemestane, also known by the brand name Aromasin, is one of a class of compounds known as aromatase inhibitors. These drugs have proven superior to tamoxifen in preventing recurrence of cancer after a breast tumor is surgically removed.

So researchers have long suspected that aromatase inhibitors would also reduce the risk of an initial occurrence of breast cancer, though this is the first big randomized study to demonstrate that.

The trial involved 4,560 post-menopausal women in the United States, Canada, France and Spain who were considered to be at a higher than normal risk of developing breast cancer either because of being over 60 or other factors. After a follow-up of about three years, 11 women getting the drug had developed invasive breast cancer compared with 32 of the women receiving a placebo. That is a reduction in risk of 65 percent.

About 94 women would have to be treated for three years to prevent one case of breast cancer, Dr. Goss said. That is less treatment than the 95 women who have to be treated for a longer time, five years, to prevent one cancer case with tamoxifen, he said. In the trial, exemestane side effects were acceptable, he said. But women who took exemestane had more hot flashes and arthritis than those who had the placebo. Still, whether exemestane will catch on where the other drugs have not remains to be seen.

One factor working against it is that aromatase inhibitors are now prescribed by oncologists. But for prevention, “They would have to be prescribed by gynecologists and family doctors,” said Dr. George W. Sledge Jr., a breast cancer specialist at Indiana University and the president of the oncology society. “These doctors are not comfortable with these drugs.”

Another factor is that the patent protection on the drug expired in April. Generic versions will mean much lower prices for women who decide to take it for the recommended five years.

But generic competition also means that Pfizer, which sells Aromasin, now has little incentive to seek regulatory approval for the drug for preventing breast cancer. Pfizer declined to comment on whether it would seek such approval. Pfizer helped pay for the study, and Dr. Goss has reported receiving honoraria from the company.

Regarding Avastin, the drug’s manufacturer, Roche, has filed for approval in Europe to market the drug as a treatment for ovarian cancer. But its American subsidiary, Genentech, is still in discussions with the Food and Drug Administration about whether there is enough evidence for an approval. One question is whether it will be necessary to show that the drug prolongs lives, said Dr. Sandra Horning, who runs cancer clinical trials for Genentech. The F.D.A. is now moving to revoke the approval of Avastin for use in treating breast cancer in part because the drug has not prolonged lives in clinical trials. The F.D.A. will hold a hearing on this issue this month.

One study presented here involved 484 women whose ovarian cancer had recurred after an initial drug treatment. All the women received two standard drugs, and half of them also received Avastin.

The median time that women lived before their cancer worsened was 12.4 months for those who got Avastin compared with 8.4 months for those who received only the two other drugs.

After two years, more women who received Avastin were alive, but the difference was not quite statistically significant. Too few women had died to draw conclusions.

“It really is not appropriate statistically to say we really know anything about overall survival here,” said Dr. Carol Aghajanian of the Memorial Sloan-Kettering Cancer Center, the lead investigator. The trial was sponsored by Genentech.

The other trial, partly paid for by Roche, involved adding Avastin to the standard drugs used as initial therapy. There were 178 deaths in the Avastin arm and 200 among those who got the standard drugs, a finding that narrowly missed statistical significance. However, in a subset of patients considered to be at higher risk of recurrence, there was a statistically significant improvement in survival.

Experts say that women with ovarian cancer tend to get many different treatments over time. Many women who did not receive Avastin in a trial might get it after the trial is over. That is one reason that Avastin is not prolonging lives even though it delays the time before tumors start growing again.

Avastin, also known as bevacizumab, is already widely used off label to treat recurrences of ovarian cancer, based on some smaller earlier trials. But some doctors said the new results might lead them to use the drug earlier in the course of the disease and for longer durations, providing insurers would pay. The drug costs about $88,000 a year, and more in some cases.

“It creates sort of a conundrum,” said Dr. Robert A. Burger of the Fox Chase Cancer Center in Philadelphia, who was an investigator in a different trial of Avastin presented last year. “And a lot of it is based on the cost of treatment.”

Rosalyn S. Yalow, Nobel Medical Physicist, Dies at 89

Posted: 03 Jun 2011 01:50 PM PDT

Rosalyn S. Yalow, a medical physicist who persisted in entering a field largely reserved for men to become only the second woman to earn a Nobel Prize in Medicine, died on Monday in the Bronx, where she had lived most of her life. She was 89.

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Rosalyn S. Yalow and Sol Berson in Pittsburgh with a check they won from the Universtiy of Pittsburgh.

Her son, Benjamin Yalow, confirmed her death.

Dr. Yalow, a product of New York City schools and the daughter of parents who never finished high school, graduated magna cum laude from Hunter College in New York at the age of 19 and was the college’s first physics major. Yet she struggled to be accepted for graduate studies. In one instance, a skeptical Midwestern university wrote: “She is from New York. She is Jewish. She is a woman.”

Undeterred, she went on to carve out a renowned career in medical research, largely at a Bronx veterans hospital, and in the 1950s became a co-discoverer of the radioimmunoassay, an extremely sensitive way to measure insulin and other hormones in the blood. The technique invigorated the field of endrocrinology, making possible major advances in diabetes research and in diagnosing and treating hormonal problems related to growth, thyroid function and fertility.

The test is used, for example, to prevent mental retardation in babies with underactive thyroid glands. No symptoms are present until a baby is more than 3 months old, too late to prevent brain damage. But a few drops of blood from a pinprick on the newborn’s heel can be analyzed with radioimmunoassay to identify babies at risk.

The technique “brought a revolution in biological and medical research,” the Karolinska Institute in Sweden said in awarding Dr. Yalow the Nobel Prize in Physiology or Medicine in 1977.

“We are witnessing the birth of a new era of endocrinology, one that started with Yalow,” the institute said.

Dr. Yalow developed radioimmunoassay with her longtime collaborator, Dr. Solomon A. Berson. Their work challenged what was then accepted wisdom about the immune system; skeptical medical journals initially refused to publish their findings unless they were modified.

Dr. Berson died in 1972, before Dr. Yalow was honored with the Nobel. The institute does not make awards posthumously. Dr. Yalow was the second woman to win the Nobel Prize in Physiology or Medicine. The first, in 1947, was Gerty Theresa Cori, an American born in Prague. Dr. Yalow shared her Nobel with two other scientists for unrelated research. (Eight more women have won the medicine prize since then.)

Rosalyn Sussman was born in the South Bronx on July 19, 1921. Her father, Simon Sussman, who had moved from the Lower East Side of Manhattan to the Bronx, was a wholesaler of packaging materials; her mother, the former Clara Zipper, who was born in Germany, was a homemaker.

Dr. Yalow told interviewers that she had known from the time she was 8 years old that she wanted to be a scientist in an era when women were all but prohibited from science careers. She loved the logic of science and its ability to explain the natural world, she said.

At Walton High School in the Bronx, she wrote, a “great” teacher had excited her interest in chemistry. (She was one of two Walton graduates, both women, to earn a Nobel in medicine, the other being Gertrude Elion, in 1988. Walton was closed in 2008 as a failing school.) Her interests gravitated to physics after she read Eve Curie’s 1937 biography of her mother, Marie Curie, a two-time Nobel laureate for her research on radioactivity.

Nuclear physics “was the most exciting field in the world,” Dr. Yalow wrote in her official Nobel autobiography. “It seemed as if every major experiment brought a Nobel Prize.”

She went on to Hunter College, becoming its first physics major and graduating with high honors at only 19. After she applied to Purdue University for a graduate assistantship to study physics, the university wrote back to her professor: “She is from New York. She is Jewish. She is a woman. If you can guarantee her a job afterward, we’ll give her an assistantship.”

No guarantee was possible, and the rejection hurt, Dr. Yalow told an interviewer. “They told me that as a woman, I’d never get into graduate school in physics,” she said, “so they got me a job as a secretary at the College of Physicians and Surgeons and promised that, if I were a good girl, I would take courses there.” The college is part of Columbia University.

World War II and the draft were creating academic opportunities for women; to her delight, Dr. Yalow was awarded a teaching assistantship at the College of Engineering at the University of Illinois. She tore up her steno books and headed to Champaign-Urbana, becoming the first woman to join the engineering school’s faculty in 24 years.

Gina Kolata and Daniel E. Slotnik contributed reporting.

Viral Outbreaks in Dogs Yield Clues on Origins of Hepatitis C

Posted: 30 May 2011 10:29 PM PDT

Hepatitis C is, in some ways, a high-profile disease. Worldwide, an estimated 200 million people are infected with the virus. Some of them will suffer cirrhosis, liver cancer and even death. Celebrities like Steven Tyler of Aerosmith and “American Idol” have spoken publicly of their infections. 

But mysteries still shroud the disease. Typically spread through drug injections, blood transfusions and sexual contact, hepatitis C can quietly cause liver damage for 20 years or more before victims become aware that they are ill. “Worldwide, it’s causing devastation,” said Brian Edlin, an epidemiologist at SUNY Downstate Medical Center in Brooklyn.

Its origins are even more puzzling. Hepatitis C is a distinct disease from hepatitis A and B; it belongs to an entirely different virus family that includes diseases like West Nile fever and yellow fever. Scientists have searched for years for related viruses in animals to figure out how it evolved into a human disease.

“Identifying the species reservoir of hepatitis C — one of the most common and deadly of all human viruses — has been something of a holy grail in studies of viral evolution,” said Eddie Holmes, a virologist at Penn State University.

Now scientists have gotten an important clue, finding a close relative in an unexpected host: dogs.

The discovery, published in Proceedings of the National Academy of Sciences, “represents a major step forward,” said Dr. Holmes, who was not involved in the research.

The finding came as a surprise to all the scientists involved. Researchers at Pfizer were investigating virus outbreaks in dogs in shelters across the United States. They swabbed the noses of dogs sick with respiratory diseases and searched for viruses. In some cases they could not isolate a known virus, so they sent samples to the Center for Infection and Immunity at Columbia University, where researchers specialize in finding new viruses.

The Columbia center found that six of nine dogs in one outbreak and three of five in another shared the same unknown virus. Nasal swabs from 60 healthy dogs showed no sign of it.

Amit Kapoor, a Columbia virologist, compared the genetic material of the new virus to known ones. His analysis revealed it was closely related to the hepatitis C virus (HCV for short). “I was not expecting anything like HCV,” Dr. Kapoor said. Like many other researchers, he assumed that it had evolved from a primate virus, because chimpanzees can be experimentally infected with hepatitis C.

But as Dr. Kapoor and Peter Simmonds of the University of Edinburgh analyzed more genetic data, the link continued to hold. Dr. Kapoor and his colleagues have called the new virus canine hepacivirus, or CHV for short.

The Columbia researchers collaborated with hepatitis C experts at Rockefeller University in New York to compare the two viruses. Canine hepacivirus infects the airways of dogs and is present at low levels in the liver.

Based on the genetic similarity of the two viruses, the scientists estimate that they share a common ancestor that lived 500 to 1,000 years ago. “It’s really quite rough,” said W. Ian Lipkin, the director of the Center for Infection and Immunity and an author of the journal article. “This is not something that happened recently, but it didn’t happen hundreds of thousands of years ago.”

The researchers see three possibilities for the origin of the viruses. The least likely is that dogs acquired hepatitis C from humans. Another possibility is that dogs and humans both acquired the virus from an unknown animal. This is the sort of evolution that gave rise to the 2004 outbreak of SARS. At first scientists found the virus in the catlike palm civet of Southeast Asia. But later research revealed that the virus actually started out in bats and then spread to palm civets and humans.

A third possibility — one favored by Dr. Kapoor — is that the virus started in dogs, and then evolved into a liver-infecting disease in humans.

“The evidence we have favors an origin in dogs,” Dr. Kapoor said.

To test these alternatives, Dr. Kapoor and his colleagues plan to search for hepatitis C-like viruses in dogs from other countries, as well as in foxes and other species of carnivorous mammals.

Even before that mystery is resolved, however, researchers expect to see some benefits from the discovery of canine hepacivirus. In the current issue of the journal Nature, Dr. Edlin argues that much more needs to be done to fight the hepatitis C epidemic. Along with better surveillance, he sees a need for research into antiviral drugs as well as vaccines. (Currently there is no commercially available hepatitis C vaccine.) Researchers may now be able to study CHV in dogs to get insights into hepatitis C in humans.

“I’m sure this will be helpful,” Dr. Edlin said.

Recipes for Health: Granola Bars With Chocolate

Posted: 01 Jun 2011 11:50 PM PDT

Most granola bars are too sweet for my taste, so I wasn’t much of a fan until I made these. They’re inspired by a recipe from “Good to the Grain,” by Kim Boyce, but I’ve cut down on the honey and added chocolate.

Recipes for Health

Each week this series will present recipes around a particular type of produce or a pantry item. This is food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and a pleasure to eat.

Related

3 tablespoons unsalted butter or canola oil, plus additional for the pan and for your hands

2 cups mixed flaked grain cereal or rolled oats

1/2 cup flaxseed meal

1/2 teaspoon cinnamon

1/4 teaspoon salt (optional)

1/3 cup honey or agave syrup

2 tablespoons brown sugar

1 teaspoon vanilla

1/2 cup chopped bittersweet chocolate or chocolate chips

1. Preheat the oven to 300 degrees. Generously butter or oil a 9-by-9-inch metal or glass baking pan.

2. Melt the butter over medium heat in a wide saucepan. Add the flaked grains or oats. Stir over medium heat until the grains are lightly toasted, taking care not to let them burn. Stir until they are beginning to smell toasty and have slightly darkened, six to seven minutes. Remove from the heat, and transfer to a bowl. Add the flaxseed meal, the cinnamon and the salt. Wipe the pan clean.

3. Combine the honey, vanilla and brown sugar in the pan in which you toasted the oats. Bring to a boil over medium heat. Boil five minutes. Pour over the oat mixture, and stir until it is evenly distributed over the mixture. Allow to cool for five minutes, then stir in the chocolate pieces.

4. Scrape into the pan, and spread evenly. Place in the oven for 20 minutes. Do not allow to brown or the bars will be hard instead of chewy. Remove from the heat, and allow to cool. Cut into 16 to 20 pieces, and store in an airtight container.

Yield: Fifteen to 20 pieces.

Advance preparation: The bars will keep for a few weeks in an airtight container.

Nutritional information per serving (15 pieces): 131 calories; 3 grams saturated fat; 1 gram polyunsaturated fat; 2 grams monounsaturated fat; 6 milligrams cholesterol; 19 grams carbohydrates; 2 grams dietary fiber; 23 milligrams sodium (does not include salt to taste); 2 grams protein

Nutritional information per serving (20 pieces): 98 calories; 2 grams saturated fat; 1 gram polyunsaturated fat; 1 gram monounsaturated fat; 14 grams carbohydrates; 2 grams dietary fiber; 17 milligrams sodium; 2 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

Recipes for Health: Flax and Mixed Grains Granola

Posted: 01 Jun 2011 12:10 AM PDT

I use toasted flaxseeds for this nutty, not-too-sweet granola. Because the seeds are already toasted, it’s important to bake the mixture at a low temperature so they don’t burn.

Recipes for Health

Each week this series will present recipes around a particular type of produce or a pantry item. This is food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and a pleasure to eat.

Related

5 cups flaked or rolled oats, or a mixture of flaked or rolled oats and other grains, such as rye and wheat

1 cup oat bran

1 cup coarsely ground toasted flaxseeds

1 cup chopped nuts (I recommend almonds and pecans)

1/2 to 1 teaspoon freshly grated nutmeg (to taste)

2 to 3 teaspoons ground cinnamon (to taste)

1/2 teaspoon salt (optional)

1/3 cup canola oil

1/2 cup mild honey, like clover honey, or agave syrup

1 tablespoon vanilla

1 to 2 cups raisins (optional)

1. Preheat the oven to 300 degrees. Line two baking sheets with parchment. Toss together all of the dry ingredients except the raisins in a very large bowl. Combine the oil, honey and vanilla in a saucepan or measuring cup. Warm over low heat, or heat at 50 percent power in a microwave. Do not let the mixture come to a simmer. Stir into the dry ingredients. Stir to coat evenly.

2. Spread the granola mixture on the sheet pans, and bake for 45 minutes to 1 hour until golden, stirring every 10 to 15 minutes and switching the pans from lower to middle racks. Remove from the heat, stir in the raisins if using, and allow to cool on the pans. Store in well sealed jars, bags or containers.

Yield: About 2 1/2 quarts.

Advance preparation: This granola will keep well for several weeks in the freezer.

Nutritional information per 1/2 cup serving: 217 calories; 1 gram saturated fat; 3 grams polyunsaturated fat; 6 grams monounsaturated fat; 0 milligrams cholesterol; 27 grams carbohydrates; 5 grams dietary fiber; 1 milligram sodium (does not include salt to taste); 6 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

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