Tuesday, December 7, 2010

Health - Tracing the Spark of Creative Problem-Solving

Health - Tracing the Spark of Creative Problem-Solving

Tracing the Spark of Creative Problem-Solving

Posted: 06 Dec 2010 09:35 PM PST

The puzzles look easy, and mostly they are. Given three words — “trip,” “house” and “goal,” for example — find a fourth that will complete a compound word with each. A minute or so of mental trolling (housekeeper, goalkeeper, trip?) is all it usually takes.

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Craig Frazier

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The payoff of tackling a mental exercise: leaps of understanding that seem to come out of the blue, without the incremental drudgery of analysis.

But who wants to troll?

Let lightning strike. Let the clues suddenly coalesce in the brain — “field!” — as they do so often for young children solving a riddle. As they must have done, for that matter, in the minds of those early humans who outfoxed nature well before the advent of deduction, abstraction or SAT prep courses. Puzzle-solving is such an ancient, universal practice, scholars say, precisely because it depends on creative insight, on the primitive spark that ignited the first campfires.

And now, modern neuroscientists are beginning to tap its source.

In a just completed study, researchers at Northwestern University found that people were more likely to solve word puzzles with sudden insight when they were amused, having just seen a short comedy routine.

“What we think is happening,” said Mark Beeman, a neuroscientist who conducted the study with Karuna Subramaniam, a graduate student, “is that the humor, this positive mood, is lowering the brain’s threshold for detecting weaker or more remote connections” to solve puzzles.

This and other recent research suggest that the appeal of puzzles goes far deeper than the dopamine-reward rush of finding a solution. The very idea of doing a crossword or a Sudoku puzzle typically shifts the brain into an open, playful state that is itself a pleasing escape, captivating to people as different as Bill Clinton, a puzzle addict, and the famous amnesiac Henry Molaison, or H.M., whose damaged brain craved crosswords.

And that escape is all the more tantalizing for being incomplete. Unlike the cryptic social and professional mazes of real life, puzzles are reassuringly soluble; but like any serious problem, they require more than mere intellect to crack.

“It’s imagination, it’s inference, it’s guessing; and much of it is happening subconsciously,” said Marcel Danesi, a professor of anthropology at the University of Toronto and the author of “The Puzzle Instinct: The Meaning of Puzzles in Human Life.”

“It’s all about you, using your own mind, without any method or schema, to restore order from chaos,” Dr. Danesi said. “And once you have, you can sit back and say, ‘Hey, the rest of my life may be a disaster, but at least I have a solution.’ ”

For almost a century scientists have used puzzles to study what they call insight thinking, the leaps of understanding that seem to come out of the blue, without the incremental drudgery of analysis.

In one classic experiment, the German psychologist Karl Duncker presented people with a candle, a box of thumbtacks and the assignment of attaching the candle to a wall. About a quarter of the subjects in some studies thought to tack the box to the wall as a support — some immediately, and others after a few failed efforts to tack wax to drywall.

The creative leap may well be informed by subconscious cues. In another well-known experiment, psychologists challenged people to tie together two cords; the cords hung from the ceiling of a large room, too far apart to be grabbed at the same time.

A small percentage of people solved it without any help, by tying something like a pair of pliers to one cord and swinging it like a pendulum so that it could be caught while they held the other cord. In some experiments researchers gave hints to those who were stumped — for instance, by bumping into one of the strings so that it swung. Many of those who then solved the problem said they had no recollection of the hint, though it very likely registered subconsciously.

All along, researchers debated the definitions of insight and analysis, and some have doubted that the two are any more than sides of the same coin. Yet in an authoritative review of the research, the psychologists Jonathan W. Schooler and Joseph Melcher concluded that the abilities most strongly correlated with insight problem-solving “were not significantly correlated” with solving analytical problems.

Either way, creative problem-solving usually requires both analysis and sudden out-of-the-box insight.

“You really end up toggling between the two, but I think that they are truly different brain states,” said Adam Anderson, a psychologist at the University of Toronto.

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No Memory, but He Filled In the Blanks

Posted: 06 Dec 2010 09:17 PM PST

He did two crossword puzzles a day, sometimes more, working through the list of clues in strict order, as if to remember where he was.

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ADAPT H.M. has brain surgery to ease seizures.

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BINGO! Garth Sundem, author of “Brain Candy,” asks: Which winter doodle should go in the center box? (Click on the puzzle to see the answer.)

And, perhaps, what he was doing.

Henry Gustav Molaison — known through most of his life only as H.M., to protect his privacy — became the most studied patient in the history of brain science after 1953, when an experimental brain operation left him, at age 27, unable to form new memories.

Up until his death in a nursing home in 2008, Mr. Molaison cooperated in hundreds of studies, helping scientists identify and describe the brain structures critical to acquiring new information. He performed memory tests; he filled out questionnaires; he sat for brain scans and performed countless research tasks, each time as if for the first time.

In between it all he did puzzles, books upon books of them, a habit he’d picked up as a teenager. Near the end of his life he kept a crossword book and pen with him always, in a basket attached to his walker. His solving opened a window on the brain, and demonstrated puzzles’ power, and their limitations, in stretching a damaged mind.

“For someone with this profound amnesia, the question was: Why, of all the pastimes out there, would he find crosswords so reassuring?” said Dr. Brian Skotko, a clinical fellow in genetics at Children’s Hospital Boston. “Well, in a world that was buzzing by and not always so easy to understand, I think finding solutions gave him great satisfaction. He had those puzzle books nearby morning, afternoon and night, and he turned to them if nothing else was going on. It was his go-to activity.”

In a series of experiments, Dr. Skotko led a team from Duke University and M.I.T. who used crosswords to test Mr. Molaison’s language aptitude, as well as his capacity to learn new facts.

As expected, the puzzles stumped him badly if they drew on events that happened after 1953, the year that a surgeon removed two finger-shaped slivers of tissue from the brain to relieve severe, chronic seizures. Those slivers included a structure called the hippocampus, which scientists now know is critical for acquiring so-called declarative memories, those concerning people, places and facts. The Nixon presidency, the gulf war, the rise of Starbucks, the Internet bubble and its bursting — they all came and went without leaving any accessible trace on his memory.

Yet the researchers found that Mr. Molaison was a competent puzzle solver, compared with healthy people his own age, when allowed to draw on what he’d learned in the years before the operation. He knew about the 1929 stock market crash, the Great Depression and Pearl Harbor. His language skills, once acquired and uploaded from his then-intact hippocampi to higher areas in the cortex, were entirely independent, protected from surgical damage.

“We found that learned language is a robust dynamic,” Dr. Skotko said. “He often came up with answers to the clues that others did not.”

Mr. Molaison stunned researchers over the years by learning some new facts, said Suzanne Corkin, a professor in the department of brain and cognitive sciences at M.I.T. who worked with him in the last decades of his life. He knew that Archie Bunker called his son-in-law “Meathead,” on the 1970s show “All in the Family,” one of his favorites. He knew that Raymond Burr played a detective on TV. He knew about the moon landing, she said, perhaps because of his lifelong interest in rockets.

In particular, Dr. Corkin said, he seemed to be able to update pre-1953 memories.. To see whether his love for crosswords could help this process, Dr. Skotko, Dr. Corkin and others performed another study, this time testing Mr. Molaison’s ability to solve post-1953 clues that had pre-1953 answers. For instance: “Childhood disease successfully treated by Salk vaccine” (announced in 1955); and “_____Pact, military alliance of 7 European communist nations enacted to counter NATO” (also 1955).

After repeated trials on the same puzzles, the man who lost his memory learned to fill in the right answers. “We found that he could learn new semantic, factual information as long as he had something in his memory to anchor it to,” Dr. Skotko said.

Mr. Molaison, who grew up in Hartford, would certainly have known about polio: the city suffered through an epidemic during his childhood, said Dr. Corkin, a fellow Hartford native who, though younger, remembers it herself. “This would have been an emotional memory; he certainly would have know people who had polio, and maybe some who died of it,” she said. That emotion, she said, seemed to enhance his brain’s ability to update previous memories.

At least two processes may have been at work when H.M. learned new facts, Dr. Corkin argues. One is a weak signal from tissue around his hippocampus that survived the surgery; recent research shows that these surrounding areas are active in acquiring new facts.

But research also suggests that anytime the brain retrieves a stored memory, it updates and reshapes it. This process, called reconsolidation, occurs in higher cortical areas that were intact in Mr. Molaison’s brain. It does, however, apparently depend on the hippocampus to retain the updates. H.M., after he stopped practicing the study puzzles, soon forgot the post-1953 answers he had learned.

Not that he minded. In a 1992 interview, he admitted to Dr. Corkin that he did have trouble remembering things. “One thing I found out is that I fool around a lot with crossword puzzles,” he said. “And, well, it helps me, in a way.”

It helps you remember? Dr. Corkin asked.

It did, he said. And, he added, “You have fun while doing it, too.”

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Aspirin Helps in Reducing Cancer Deaths, a Study Finds

Posted: 06 Dec 2010 11:30 PM PST

Many Americans take aspirin to lower their risk of heart disease, but a new study suggests a remarkable added benefit, reporting that patients who took aspirin regularly for a period of several years were 21 percent less likely decades later to die of solid tumor cancers, including cancers of the stomach, esophagus and lung.

As part of the new study, published online Monday in the journal Lancet, researchers examined the cancer death rates of 25,570 patients who had participated in eight different randomized controlled trials of aspirin that ended up to 20 years earlier.

Participants who had been assigned to the aspirin arms of the studies were 20 percent less likely after 20 years to have died of solid tumor cancers than those who had been in the comparison group taking dummy pills during the clinical trials, and their risk of gastrointestinal cancer death was 35 percent lower. The risk of lung cancer death was 30 percent lower, the risk of colorectal cancer death was 40 percent lower and the risk of esophageal cancer death was 60 percent lower, the study reported.

The specific dose of aspirin taken did not seem to matter — most trials gave out low doses of 75 to 100 milligrams — but the participants in the longest lasting trials had the most drastic reductions in cancer death years later.

“This is important as a proof of principle that a single simple compound like aspirin can reduce the risk of cancer substantially,” said the study’s lead author, Dr. Peter M. Rothwell, professor of neurology at the University of Oxford. “There’s been a lot of work over the years showing that certain compounds can increase the risk of cancer, but it’s not been shown before that we can reduce the risk with something as simple as aspirin.”

But even as some experts hailed the new study as a breakthrough, others urged caution, warning people not to start a regimen of aspirin without first consulting a doctor about the potential risks, including gastrointestinal bleeding and bleeding in the brain (hemorrhagic strokes).

“Many people may wonder if they should start taking daily aspirin, but it would be premature to recommend people starting taking aspirin specifically to prevent cancer,” said Eric J. Jacobs, an epidemiologist with the American Cancer Society.

While Dr. Jacobs said the study design was valid, relatively few women were included in the trials, making it difficult to generalize the results to women.

“It’s hard to assess effects on mortality from just one study,” he said.

The findings do not come entirely as a surprise, Dr. Rothwell said, because aspirin has been found to slow or prevent the growth of tumor cell lines in the laboratory. Observational studies have reported that people who took aspirin were at lower risk for colorectal cancer recurrences, while other studies have pointed to similar reductions in cancers of the lung, stomach and esophagus.

“There have been hints of this before, but the quality of this study is the gold standard because it is based on randomized clinical trials,” said Dr. Alan A. Arslan, an assistant professor of obstetrics and gynecology and environmental medicine at New York University School of Medicine, who did an observational study several years ago reporting that women who had taken aspirin regularly had a lower risk of ovarian cancer. “Randomized controlled trials carry more weight.”

The strong results “add to the accumulating evidence that aspirin may be protective against various cancers,” Dr. Arslan said.

There are several ways in which aspirin may work to slow the development of cancers, experts say. Inflammation may play a role in cancer, and aspirin blocks the synthesis of prostaglandins, which are mediators of inflammation, and may affect early tumor promotion.

Aspirin may also induce the death of early cancer cells before they become aggressive, Dr. Arslan suggested.

The New Old Age: Assisted-Living Costs

Posted: 07 Dec 2010 09:05 AM PST

Recipes for Health: Spaghetti With Walnuts and Anchovies

Posted: 07 Dec 2010 08:45 AM PST

This is a pared-down version of a recipe that I came across in Nancy Jenkins’s informative book on Southern Italian food, “Cucina del Sole.” The dish is traditionally part of a meatless Christmas Eve dinner. If you can find freshly harvested walnuts, they’ll make this pasta even better.

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Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

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1/2 cup shelled walnuts (2 ounces)

1/4 cup extra virgin olive oil

3 garlic cloves, minced

4 anchovy fillets, coarsely chopped

3/4 pound spaghetti

1/4 cup minced flat-leaf parsley

freshly ground pepper

1/4 cup freshly grated pecorino (optional)

1. Begin heating a large pot of water over high heat. Meanwhile, lightly toast the walnuts on a baking sheet in a 375-degree oven for just a few minutes until fragrant, or in a pan over medium-high heat, stirring constantly. When the walnuts smell like they’re beginning to toast, remove them from the heat and transfer to a clean dish towel. Wrap them in the towel, and rub between your hands to remove some of the papery shells. Chop the nuts medium-fine, and set aside.

2. In a wide, heavy skillet or saucepan large enough to accommodate the cooked spaghetti, heat the oil over medium heat and add the garlic. Cook, stirring, until it begins to sizzle, and add the anchovies. Cook, mashing the anchovies with the back of your spoon or with a fork, for about 30 seconds until they begin to fall apart and melt into the oil. Add the walnuts, stir together for about a minute and remove from the heat.

3. When the water comes to a boil, salt generously and add the spaghetti. Cook al dente, following the timing recommendations on the package but checking about a minute before the indicated time. When the pasta is almost done, add 1/4 cup of the pasta water to the pan with the walnuts and anchovies, and reheat over medium heat.

4. When the pasta is ready, drain and toss with the walnut and anchovy mixture. Add the parsley, adjust salt if necessary and add pepper. Serve, passing the pecorino at the table.

Yield: Serves four.

Advance preparation: You can toast the walnuts well in advance, but the sauce can be done in the time it takes to boil the water and cook the pasta.

Nutritional information per serving: 530 calories; 23 grams fat; 3 grams saturated fat; 3 milligrams cholesterol; 66 grams carbohydrates; 3 grams dietary fiber; 156 milligrams sodium (does not include salt added during preparation); 14 grams protein

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

Doctor Faces Suits Over Cardiac Stents

Posted: 06 Dec 2010 03:18 AM PST

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, “which is the biggest day I remember hearing about,” an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore.

The Senate Finance Committee, which oversees Medicare, started investigating Dr. Midei in February after a series of articles in The Baltimore Sun said that Dr. Midei at St. Joseph Medical Center, in Towson, Md., had inserted stents in patients who did not need them, reaping high reimbursements from Medicare and private insurance.

The senators solicited 10,000 documents from Abbott and St. Joseph. Their report, provided in advance to The New York Times, concludes that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures.

The report also describes the close relationship between Dr. Midei and Abbott Labs, which paid consulting fees to the cardiologist after he left the hospital. “The serious allegations lodged against Dr. Midei regarding the medically unnecessary implantation of cardiac stents did not appear to deter Abbott’s interest in assisting him,” the report states.

The case has turned into a legal quagmire for Dr. Midei and St. Joseph, which have been sued by hundreds of patients who claim they received unnecessary implants. Some doctors say the case has revealed a level of inappropriate care that is more common than most patients know.

“What was going on in Baltimore is going on right now in every city in America,” said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”

Dr. Midei’s lawyer, Stephen L. Snyder, said that his client’s treatment of his patients was entirely appropriate and that Dr. Midei, who has recently practiced medicine at the Prince Salman Heart Center in Saudi Arabia, would be exonerated.

“This is all trumped up to hide the hospital’s criminal conduct,” said Mr. Snyder, who filed a $60 million lawsuit against St. Joseph on Dr. Midei’s behalf accusing the hospital of damaging Dr. Midei’s reputation by making false claims about his care. (The hospital responded that the assessments of Dr. Midei’s care were done by independent experts.)

Last month, St. Joseph agreed to pay a $22 million fine to settle charges that it paid illegal kickbacks to Dr. Midei’s medical practice, MidAtlantic Cardiovascular Associates, in exchange for patient referrals; the hospital did not admit wrongdoing. St. Joseph said in a statement Friday that it now conducts monthly random reviews of stent cases “to assure such a situation cannot occur again.”

As for Abbott Labs, a spokesman wrote in an e-mail that its affiliation with Dr. Midei ended early this year. “Dr. Midei has been a highly regarded physician in his field, with whom Abbott had consulted in the past,” said the spokesman, Jonathan Hamilton. “We have no further comment at this time.”

The case has had wide repercussions. Over the past year, St. Joseph has told hundreds of Dr. Midei’s patients that they did not need the expensive and potentially dangerous stents that the doctor inserted because their arteries were not as obstructed as he had claimed. Now, state health officials are investigating other local cardiologists who inserted a suspiciously high number of stents, which are tiny wire mesh devices inserted to prop open clogged arteries in the heart.

After reports about the Midei case and the wider state investigation, the number of stent procedures performed at St. Joseph and other area hospitals plunged, raising doubts about the appropriateness of much of the region’s cardiac care.

A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them. Dr. Christopher J. White, president-elect of the Society for Cardiovascular Angiography and Interventions, said that inappropriate stenting was a problem, but a rare one. The federal Medicare program spent $3.5 billion last year on stent procedures.

New Meningitis Vaccine Brings Hope of Taming a Ravaging Illness in Africa

Posted: 05 Dec 2010 12:40 PM PST

JOHANNESBURG — For over a century, epidemics of bacterial meningitis have swept across Africa, arriving with the dry harmattan winds to kill with terrifying speed. But on Monday, a drive starts to inoculate tens of millions of West Africans with a new vaccine in what scientists hope will be the beginning of the end of ravaging meningitis epidemics.

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Meningitis Belt

The aim is for these immunization campaigns to spread from Senegal in the west to Ethiopia in the east, bringing the disease under control and saving an estimated 150,000 lives by 2015 in a belt of 25 nations that girds the continent.

Hundreds of millions of dollars are still needed to accomplish that goal, public health officials say. But the meningitis vaccine itself is a milestone in developing inexpensive vaccines against neglected diseases that afflict poor countries, experts say.

More than a million cases of meningitis have been reported in Africa over the past two decades, and the vaccine works against the group A meningitis strain that causes more than 8 out of 10 cases on the continent. Moreover, it costs less than 50 cents a dose. In the United States, Novartis and Sanofi Pasteur market a single dose of meningitis vaccines against multiple strains of the disease for $80 to $100.

“Wow, that’s remarkable!” exclaimed Dr. Gregory A. Poland, head of vaccine research at the Mayo Clinic in Minnesota, when he heard how little the new vaccine would cost.

Bill Gates, whose foundation largely financed the endeavor, contrasted the undertaking with the development of vaccines for measles, smallpox and polio.

“All those things were created because rich people got sick,” he said in an interview. “This is the first vaccine that went through the whole process where there was no rich world market, and it had to be optimized at a very low price.”

The meningitis vaccine relies on a technology that was devised by researchers at the Food and Drug Administration and donated by the United States government at the cost of only token royalties. It is being manufactured by the Serum Institute of India, a major vaccine producer, and it was developed independently of the major American and European pharmaceutical companies.

“Doing this outside of big pharma and developing the vaccine explicitly for the developing world is very innovative,” said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt Medical School, who, like Dr. Poland, was not involved in developing the meningitis vaccine. “There’s nothing else like it.”

This model of vaccine development probably will not work to develop the first vaccines for complex diseases like AIDS and malaria, in which basic scientific breakthroughs are still necessary, experts said. But researchers are already working on efforts similar to the one for meningitis to produce inexpensive vaccines for cholera, pneumonia and rotavirus, a diarrheal disease.

The meningitis vaccination drives begin Monday in Burkina Faso and will get under way in Mali and Niger this month, but public health experts cautioned that the promise of the meningitis vaccine should not be oversold. It will not eradicate the disease because it is effective only against the group A strain most common in Africa.

“Almost certainly, you’ll see other serotypes start to infect people,” Dr. Poland said. But he said the vaccine, if used broadly, would solve the most pressing immediate problem: epidemics of the group A type.

The development of the vaccine was led by a team from Path, a nonprofit group in Seattle, and the World Health Organization. They coordinated contributions from nonprofit, public and for-profit parties. In June, after five years of clinical trials in West Africa and India, the World Health Organization approved the vaccine for use on a large scale.

“These product development efforts are very expensive,” said Doug Holtzman, deputy director of infectious diseases at the Bill and Melinda Gates Foundation. “This one is a bargain. For less than $100 million, a vaccine was developed from scratch and licensed, though the technological path had already been marked before.”

So far, donors and African countries have raised $95 million of the estimated $570 million cost of eliminating meningitis epidemics across Africa, W.H.O. officials say. But the global financial crisis has pinched foreign aid spending, leaving the remainder in doubt.

“I’m extremely worried,” Mr. Gates said. “You have one of the simplest, most effective interventions ever invented being limited by how much money you have, rather than country demand or regulatory problems.”

The push to find an effective new vaccine began after a meningitis epidemic in 1996 and 1997 infected more than a quarter million Africans, killed 25,000 and disabled 50,000. Richard Adegbola was a medical researcher in Gambia then and described hospitals overwhelmed with panicky patients.

“It was confusion and chaos,” said Mr. Adegbola, a microbiologist who now works at the Gates Foundation.

Bacterial meningitis is a highly contagious infection of the lining around the brain and spinal cord. People catch it by sharing eating utensils or cigarettes, by kissing, or by sneezing or coughing on each other.

The symptoms include fever, chills, headaches and a stiff neck. Within a day or two, it kills about one in 10 of the people who get it, even if they are swiftly treated with antibiotics. Up to a fifth of survivors suffer permanent disabilities, most commonly deafness, cerebral palsy, mental retardation and epilepsy.

Until the development of the new vaccine, public health officials had to rely on a far less effective polysaccharide vaccine that protected people only for two to three years and did not prevent transmission of the bacteria. As a result, it was used only to rein in an outbreak after it had occurred. Often, by the time supplies arrived, many people had already died.

In contrast, the new conjugate vaccine, which links the sugar in the vaccine with a protein, produces a more powerful immunity that experts hope will last 10 to 20 years. It also prevents transmission, helping protect people who have not been vaccinated and producing what is known as herd immunity. The plan is to vaccinate 300 million people across 25 nations, protecting about half a billion people from the disease, W.H.O. officials said.

Dr. F. Marc LaForce, who has led the effort, known as the Meningitis Vaccine Project, since its inception in 2001, said scientists still did not understand why the advent of the dry season brought meningitis.

“No one knows,” he said. “But if we are taking care of the problem without knowing exactly why it works, I don’t care. I’ll be satisfied. I want this disease to go away.”

Pfizer’s Chairman and Chief Retires Unexpectedly

Posted: 07 Dec 2010 08:47 AM PST

Jeffrey B. Kindler is retiring as chief executive and chairman of Pfizer, the world’s largest pharmaceutical firm, the company said on Sunday evening in an unexpected announcement.

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Jeffrey Kindler is leaving after four years as chief executive.

Ian C. Read, 57, Pfizer’s head of global biopharmaceutical operations, will take over as chief executive immediately. The board said in its statement that it would elect a new chairman at a meeting within two weeks.

Mr. Kindler, 55, ushered the company through a $68 billion purchase of Wyeth Pharmaceuticals last year, a period that included layoffs. The company also settled federal investigations in 2009 by making a $2.3 billion payment related to its off-label marketing of drugs.

That settlement included a $1.3 billion criminal fine for illegal marketing of the painkiller Bextra. It was the largest criminal fine and largest health care fraud case in United States history.

Pfizer faces a difficult business environment after the patent on Lipitor, the world’s top-selling drug, expires in November 2011. The cholesterol-fighting drug accounted for $11.4 billion of Pfizer’s $50 billion sales last year.

The timing did surprise several people who follow the company.

“The departure is sudden but I doubt there was one event per se that caused Kindler’s departure,” said Tim Anderson, a pharmaceutical analyst for Sanford C. Bernstein. He added that Pfizer stock might rise on the news because investors wanted to see some change at the company.

Barbara Ryan, an analyst at Deutsche Bank who follows major pharmaceutical companies, said Mr. Kindler did not appear to have been forced out.

“What I’ve heard is it was a mutual decision, and I think that’s probably true,” Ms. Ryan said on Sunday evening. “I think he’s done a lot of great things at Pfizer, and at the same time he hasn’t necessarily gotten broad support from all of Pfizer’s shareholders, which include external directors.”

But Erik Gordon, a pharmaceutical analyst and clinical assistant professor at the University of Michigan’s Ross School of Business, suggested that the board made such as sudden move because they were unhappy with Mr. Kindler.

“Pfizer needed an experienced pharma executive,” Mr. Gordon said Sunday. “It had better not be ‘business as usual’ because that’s not what boards who make unexpected C.E.O. changes are looking for.”

In the statement on Sunday, Mr. Kindler said he wanted to “recharge my batteries, spend some rare time with my family and prepare for the next challenge in my career.”

Mr. Kindler said the timing seemed to be right to step down now that the Pfizer and Wyeth operations have been combined for nearly a year.

Mr. Kindler joined Pfizer in 2002 as chief counsel after working at General Electric and McDonald’s. He succeeded Henry A. McKinnell Jr. as Pfizer’s chief in 2006.

Mr. Read, who was also named president of the company on Sunday, joined Pfizer in 1978 and has led worldwide pharmaceutical operations, which account for approximately 85 percent of Pfizer’s annual revenue. He was named corporate vice president in 2001. The company presidency is a newly created position.

Raymond F. Kerins Jr., Pfizer’s vice president for communications, who worked closely with Mr. Kindler, said that he was not being forced from office.

“The good news is we’ve got a guy with experience,” Mr. Kerins said. “Ian Read basically has been running 85 percent of the company anyway.”

Last year, Mr. Kindler also took an active role lobbying Congress and the White House over the health care overhaul. In March, he was named chairman of the industry trade group, Pharmaceutical Research and Manufacturers of America.

News Analysis: Arizona Medicaid Cuts Seen as a Sign of the Times

Posted: 04 Dec 2010 11:10 PM PST

With enrollments exploding, revenues shrinking and the low-hanging fruit plucked long ago, virtually every state has had to make painful cuts to its Medicaid program during the economic downturn.

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What distinguishes the reductions recently imposed in Arizona, where coverage was eliminated on Oct. 1 for certain transplants of the heart, liver, lung, pancreas and bone marrow, is the decision to stop paying for treatments urgently needed to ward off death.

The cuts in transplant coverage, which could deny organs to 100 adults currently on the transplant list, are testament to both the severity of fiscal pressures on the states and the particular bloodlessness of budget-cutting in Arizona.

“It’s a real sign of the times,” said Alan Weil, executive director of the National Academy for State Health Policy. “And I think this is a precursor to a much larger number of states having this discussion.”

Policy choices with such life-threatening implications are all the more striking given the partisan framing of the health debate.

Republicans have argued that the new health law will lead to rationing, warning even of “death panels.” Democrats have responded that care is already rationed, with 50 million people going largely without insurance, and that the law will bring greater equity.

The Arizona case, said Diane Rowland, director of the Kaiser Commission on Medicaid and the Uninsured, “is a classic example of making decisions based not on medical need but based on a budget.” And, she added, “it results, potentially, in denial of care to individuals in a life-or-death situation.”

The federal Centers for Medicare and Medicaid Services do not monitor which states use Medicaid money for transplants. But health experts said no other state had withdrawn coverage for patients pursuing transplants.

Arizona’s decision, by Gov. Jan Brewer, a Republican, and the Republican-controlled Legislature, was made after state officials assessed success and survival rates for a number of transplant procedures. National transplant groups call the figures misleading.

“It seems inappropriate that life-saving care has the potential to be withheld based solely on budgetary issues and the bureaucratic determination of relative benefits,” said Dr. Robert S. Gaston, president-elect of the American Society of Transplantation.

There is usually a long-term consequence to short-term cuts in safety-net programs like Medicaid, which insures low-income Americans and is financed by state and federal governments.

When payments to doctors are cut, fewer providers are willing to treat Medicaid patients. When eligibility levels are lowered, more people are left to seek charity care in emergency rooms. When optional benefits like dental services and prescription drugs are eliminated, conditions worsen until they require more expensive care.

But no other state in recent memory has made such a numbers-driven calculation pitting the potential loss of life against modest savings.

Jennifer Carusetta, the legislative liaison for Arizona’s Medicaid agency, said the transplant cuts would save a mere $800,000 in the current fiscal year, and only $1.4 million for a full year.

The cuts were imposed in an effort to close a $2.6 billion shortfall in the state’s $8.9 billion budget for this year.

The options available to states for cutting Medicaid have been limited because the federal stimulus package and the health care law have required them to maintain eligibility levels. That has left states to cut payments to providers and trim benefits not required by federal regulations.

Many states, including Arizona, have done both. A September report by the Kaiser Family Foundation found that 39 states cut provider payments and 20 cut optional benefits in their 2010 fiscal years, with similar numbers planning to do so in 2011.

Arizona reduced Medicaid payments to doctors by 5 percent last year and has frozen payments to hospitals and nursing homes for two years. All providers will undergo another 5 percent cut on April 1, Ms. Carusetta said.

This year, Arizona became the only state to eliminate its Children’s Health Insurance Program, which would have affected 47,000 children of working-class parents. Lawmakers reversed course before the effective date only after concluding that the state might run afoul of federal requirements and lose billions of dollars in matching money.

The state has also enacted a wide range of Medicaid cuts, eliminating coverage for emergency dental procedures, insulin pumps and orthotics. “We realize this has serious impacts on people,” Ms. Carusetta said. “Unfortunately, given the fiscal constraints facing our state, the Legislature has limited options at this point.”

State Cuts Put Officers on Front Lines of Mental Care

Posted: 04 Dec 2010 11:10 PM PST

PORTLAND, Me. — As community mental health systems fray under the strain of state budget cuts and a weak economy, law enforcement officers across the nation are increasingly having to step in to provide the emergency services that clinics have typically offered the mentally ill.

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Craig Dilger for The New York Times.

Jo Freedman, center, the mental health liaison for the city of Portland, Me., with a firefighter who saved a suicidal woman.

Police and sheriff’s departments that are already grappling with budget and manpower cuts say the situation is further straining their resources and forcing them to divert officers from their regular duties. It has also stoked fears among law enforcement officers of dangerous encounters between the police and people with severe mental illness.

“I worry that there’s going to be a tragedy,” said James Craig, chief of the Police Department here, where calls involving the mentally ill increased to 1,645 in 2009 from 1,424 in 2007. “I’m worried that an officer might lose his life dealing with a dangerous person, a person who really needs treatment.”

Improving the department’s handling of the mentally ill became one of Chief Craig’s biggest priorities last year after an officer was forced to dangle off the Casco Bay Bridge as he pulled a woman to safety during a suicide attempt. She was released from a hospital hours later and tried to jump off the bridge again.

The Portland department hired a full-time mental health coordinator in October.

In many ways, officers are better equipped than ever to handle calls involving the mentally ill. Hundreds of departments across the country, including in Portland, now offer Crisis Intervention Team training, which teaches officers to look for signs of mental illness and to work with doctors, nurses and therapists.

Despite increased awareness, many officers, mental health workers and advocates for the mentally ill say that with fewer hospital beds and reduced outpatient services — especially at centers that treat the uninsured — many patients’ family members and friends, and even bystanders, are turning to the police as the first choice for help when a crisis occurs. Many states are feeling the brunt of cuts that started years ago but have gotten worse because of the economy.

“A lot of people view calling the police as the only way to get loved ones any kind of treatment, because when the police come they have to do something,” said Laura Usher, the national Crisis Intervention Team coordinator for the National Alliance on Mental Illness. “But unfortunately that doesn’t necessarily always lead to appropriate treatment.”

“States across the country are cutting their mental health budgets, and people who are serviced by state mental health programs are the poorest, and they’re unable to get services any other way,” she added. “The community mental health system is broken.”

In Illinois, where mental health services were cut by $35 million this year — a $90 million cut was proposed — the state’s police departments are “essentially a 24-hour free service,” said Chief Robert T. Finney of the Champaign Police Department.

“We’re the people who get taxed with dealing with these people,” said Chief Finney, who is also vice president of the Illinois Association of Chiefs of Police. “Even if you arrest them and they’re released from your jail within hours, they’re back on your street doing the same thing.”

In Oklahoma, calls to the police involving mental illness have increased by 50 percent in the past year, said Stacey Puckett, executive director of the Oklahoma Association of Chiefs of Police. The state has cut about $17 million in mental health financing this year.

Ms. Puckett said officers were “traveling from one end of the state to the other and are out of their departments for 6, 8, 10 hours at a time.”

“It’s the bed shortage,” she said. “We just do not have enough beds for the numbers.”

Danny Ray of Ardmore, Okla., had to call the police in August after his 30-year-old son, who had been unable to get treatment, threatened him with a loaded gun.

“The police, if I had a problem right now, they are my only source of help,” said Mr. Ray, 57, whose son’s psychiatrist comes to town only once a month. Mr. Ray says he also finds it difficult to secure a bed for his son at the local hospital.

Rural areas are especially affected when mental health services are cut because officers must drive so far to admit mentally ill patients to hospitals.

Amanda Bittle, chief of the Police Department in Forest Park, Okla., an Oklahoma City suburb, started her career in a rural part of the state, and says it is often easier and less expensive for far-flung departments to encourage a mentally ill person to leave town than to drive the person to a hospital.

“It was cheaper for your department to buy a $59 bus ticket and send them as far away as you could,” Chief Bittle said. “I know that’s disturbing, but that’s the reality of what’s happening.”

The alternative, she said, is for a department to go “15 hours of no officer on the street, or an officer that’s paid overtime.”

“It’s sad,” she added, “but it comes down to those budgetary things.”

Patient Money: Treating Eating Disorders and Paying for It

Posted: 03 Dec 2010 10:30 PM PST

Notoriously difficult to treat, eating disorders may persist for years, wreaking havoc not just on the patient’s health and personal relationships but often on family finances, as well.

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Ruth Fremson/The New York Times

Dr. Evelyn Attia and Dr. Tim Walsh, who run the eating disorders research unit at the New York State Psychiatric Institute.

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Hospitalizations for problems caused by eating disorders grew 18 percent from 1999 to 2006, with the steepest rise among children under age 12 (up 119 percent), followed by adults ages 45 to 64 (up 48 percent) and men of all ages (up 37 percent), according to the federal Agency for Healthcare Research and Quality.

Care for these patients can be expensive. Many must be seen on a weekly basis by a team of specialists, including a psychiatrist, a physician and a nutritionist. A residential program costs $30,000 a month on average. And many patients require three or more months of treatment, often at a facility far from home. Even after leaving a specialized program, patients may need years of follow-up care.

Yet most insurers will not cover long-term treatment, and some routinely deny adequate coverage of eating disorders on the grounds that there is not enough evidence on how best to treat them, said Lynn S. Grefe, chief executive of the National Eating Disorders Association.

“Eating disorders pose a unique treatment challenge in comparison to other psychiatric illnesses,” said Dr. Evelyn Attia, director of the eating disorders research program at the New York State Psychiatric Institute. “They are not always easy to diagnose, and insurers are often not well informed about which treatments work."

Jeanne P.’s 19-year-old daughter has been battling anorexia for eight years and has tried 10 treatment programs. The family has “great health insurance,” said Ms. P, who asked that her full name not be used to protect her daughter’s privacy. Still, the best doctors are often not in the insurer’s network, she says she has found, and the family’s insurance has not always fully covered residential treatment programs.

The result?

“We have totally exhausted our retirement savings on her care,” said Ms. P.

If you suspect that a family member has an eating disorder or that you may have one, these steps may help you find treatment you can afford.

EARLY DIAGNOSIS No one knows exactly what causes eating disorders, though genetics and environmental triggers play large roles. Anorexia and bulimia tend to run in families, and obsessive dieters, athletes and performers have a higher-than-average risk for developing these conditions.

Whatever the cause, early intervention is critical.

“Eating disorders can become chronic and more difficult to treat over time,” Dr. Attia said.

If you suspect a problem, get a professional evaluation immediately. Call your physician or pediatrician, explain the symptoms and ask for a referral to an eating disorders specialist.

The Academy for Eating Disorders has an online tool that can help you locate doctors and therapists, as well as inpatient and outpatient treatment facilities in your area. Also try the National Eating Disorders Association help line (800-931-2237; 8:30 a.m. to 4:30 p.m. P.S.T.) for questions about treatment referrals and support groups and to learn more about eating disorders.

AT-HOME TREATMENT If it is your child who has received a diagnosis of anorexia or bulimia, you may want to consider family-based therapy, also called the Maudsley method.

Costs are minimal for this therapy because families do most of the monitoring themselves. Under the guidance of a trained therapist, the parent takes primary responsibility for helping a child get back to a healthy weight and normal eating habits. One recent study, published in the Archives of General Psychiatry, found that family-based therapy was more effective than individual therapy at helping children reach full remission from anorexia.

While this approach may be cost-effective compared to residential treatment, the emotional toll on families can be extreme. During the first phase of treatment, which can last a few months, the child needs supervision around the clock, tracking meals, snacks and exercise.

To learn more about how family-based therapy works and to find a trained therapist, go to the Maudsley Parents Web site at www.maudsleyparents.org. To find out how one family used this therapy to combat their daughter’s anorexia, take a look at Harriet Brown’s book, “Brave Girl Eating: A Family’s Struggle With Anorexia.”

INSURANCE COVERAGE If a high level of care is required — at, say, an inpatient treatment center — be prepared to take on your insurer. Learn as much as you can about your health policy and about the roadblocks you may encounter while trying to get coverage for specialized care.

The National Eating Disorders Association’s Web site has useful guidance on insurance issues in the Parent Toolkit section. It includes tips on how to explain to your insurer that the treatment your child requires is medically sound, how to manage an appeal and sample letters to send to reluctant insurers.

If your insurer balks at your requests for coverage, ask to be assigned a case manager, suggested Marcia Herrin, founder of the Dartmouth College Eating Disorders Prevention, Education and Treatment Program.

A case manager can often (though not always) help you get access to additional care. Insurers normally do not cover nutritional counseling, for example, but a case manager authorized six visits to a nutritionist for one of Dr. Herrin’s patients.

If the case manager cannot help you, you will have to take a route familiar to almost anyone who has tangled with an insurer. Get in touch with your employer’s human resources department, and ask them to go to bat on your behalf. If your employer and your insurer will not budge, make a formal appeal to your insurer. If your appeal is denied or not answered, contact your state’s insurance commissioner or even your representative in Congress.

Extreme though that may sound, it has been known to work. Susan M. was able to get her daughter’s lengthy residential treatment covered by enlisting the help of her senator’s office. An aide called the Department of Labor, and after several more steps, the insurer ultimately agreed to cover the treatment.

You might consider contacting a lawyer for advice on your rights and legal precedents in your state, as well.

FREE TREATMENT Some academic hospitals offer free treatment to individuals who meet specific criteria and are willing to participate in a research trial.

Patients who enroll in Dr. Attia’s program at the New York State Psychiatric Institute, for instance, do not pay a dime and can stay at the treatment center as long as they need to, but they must agree to answer surveys and stay in touch with the facility after they check out. All patients receive the best evidence-based treatment, and some may be involved in trials that assess physical activity or different psychotherapy approaches.

To find research programs, go to the Web sites of the National Eating Disorders Association and the Academy for Eating Disorders. Also, try ClinicalTrials.gov, which lists federally and privately supported research trials conducted worldwide.

FINANCIAL ASSISTANCE If you have limited resources, some treatment programs will provide financial assistance. Be sure to ask about it.

A few foundations also offer scholarships. Moonshadow’s Spirit, for instance, offers financial assistance to individuals who are seeking inpatient or partial hospitalization programs. The Kirsten Haglund Foundation and the Manna Scholarship Fund also offer grants to individuals in financial need.

Keep in mind that when aggressive intervention happens early, full recovery is possible. One notable study by researchers at the University of California, Los Angeles, found that 76 percent of anorexic adolescents had fully recovered from the disorder within 10 to 15 years of their initial hospitalizations.

Panel Votes to Expand Surgery for Less Obese

Posted: 03 Dec 2010 10:20 PM PST

A federal advisory panel Friday endorsed an expansion of the use of Allergan’s Lap-Band stomach-restricting device to patients who are less than severely obese.

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Allergan, via Associated Press

The Lap-Band stomach-restricting device.

The vote could pave the way to double the number of Americans who qualify for weight-loss surgery. And it could eventually lead to making other types of weight-loss surgery available to those who are not quite as heavy.

“I see this as the first step in the march toward changing the standard of care,” E. Francine Stokes McElveen, the consumer representative on the committee, said during the meeting in Gaithersburg, Md.

The advisory committee to the Food and Drug Administration voted 8 to 2 that the benefits of Lap-Band surgery exceeded the risks for patients in the lower range of obesity. It voted 8 to 2 that the device was safe, and 8 to 1, with one abstention, that the device was effective.

The F.D.A. usually agrees with its advisory committees, but it was not clear when a decision would be made.

Current guidelines say weight-loss surgery is appropriate for people who have failed to lose weight through diet and exercise and have a body mass index of 40 and above — or 35 and above if they have diabetes, hypertension or another severe health problem associated with diabetes.

Allergan wants to lower the threshold to a B.M.I. of 35 for people without health complications, and to 30 for people with health problems, which also would no longer have to be severe.

A person who is 5 feet, 5 inches with hypertension must weigh at least 210 pounds to qualify for surgery now. Under the proposal endorsed by the committee, that person would have to weigh only 180 pounds.

An Allergan executive said at the meeting that 27 million Americans had a B.M.I. between 30 and 35 and at least one associated health condition.

The panel’s endorsement coincided with the release of a new report by F.D.A. staff members on a diet pill, Contrave, that another panel plans to consider next week. The report said the drug seemed to be effective, but might pose potential cardiovascular risks.

Other new diet pills have been rejected by the F.D.A. in recent months, leaving few options for overweight Americans.

About one-third of American adults are obese, defined as a B.M.I. of 30 or more. A study published in the New England Journal of Medicine this week showed that women with a B.M.I. of 30 to 35 had a 44 percent higher risk of death than women of normal weight, which is a B.M.I. under 25.

The Lap-Band is an inflatable silicone ring that is placed around the upper part of the stomach. It restricts how much a person can eat and makes one feel full more quickly.

Allergan submitted a study to the F.D.A. in which 149 people in the new proposed weight range received the device. Those patients lost an average of about 18 percent of their weight after a year, an amount considered enough to have positive effects on their health.

But some committee members said the study was too small and too short, especially since people might have the band inside them for decades. Some wanted more evidence that the operation resolved diabetes or other health problems. Most panel members said the study included too few men, blacks and Hispanics.

Still, most of the committee, which included several bariatric surgeons, said that Allergan could do longer, larger studies after approval and there was enough evidence, including from other studies in the literature, that the band was safe and effective.

Two participants in Allergan’s study, whose transportation to the meeting was paid for by the company, testified that the surgery had changed their lives.

“I couldn’t walk up a flight of stairs or even take a shower without taking a rest,” said one of them, Brandi Jirka of Nashville, who did not specify how much weight she lost. “Now I can run and play with my children, I do yoga and can shop at regular stores in the mall. I’ve even been snorkeling while wearing a bikini.”

In her testimony, Diana Zuckerman of the National Research Center for Women and Families urged the committee to vote against approval, saying there was not enough long-term data. “We need that information before approval is expanded to include such a very large number of adults,” she said.

Some forms of weight-loss surgery, like gastric bypass, are considered medical procedures, not devices, so are not regulated by the F.D.A. But all types of bariatric surgery are covered by federal guidelines from 1991, 10 years before the Lap-Band was approved.

There are now efforts to revise those guidelines to lower the weight threshold. Some members of the committee said that the advent of minimally invasive surgery had made bariatric surgery much safer than it was in 1991. Some also said that B.M.I. was too crude a measure of how much a person needs surgery.

“The B.M.I. criterion is so seriously flawed,” said Dr. John G. Kral, professor of surgery and medicine at SUNY Downstate Medical Center in Brooklyn. “Removing this barrier of this idiotic number in itself would be an important step.”

Allergan, which is known mostly for Botox, hopes that expanding use of the Lap-Band to less obese adults — and also eventually to teenagers — will spur sales. Sales of its obesity products, mostly Lap-Band, fell 4 percent to $182.4 million in the first nine months of this year, a decline the company attributed to the weak economy. But obesity products make up only 5 percent of Allergan’s overall product sales.

Shares of Allergan rose 52 cents, to $68.80 in regular trading Friday. The shares rose 3 percent, to $70.89 in after-hours trading, following the panel’s vote.

New Jersey Closer to Sales of Medical Marijuana

Posted: 03 Dec 2010 10:48 PM PST

A standoff between Gov. Chris Christie of New Jersey and advocates for medical marijuana has ended in a compromise that could put marijuana on the market for seriously ill patients by next summer.

The new regulations, announced on Friday, would provide for six growing and distribution sites for medical marijuana in various parts of the state. The governor had wanted to limit the number of growers to two and distribution sites to four.

But among the states that allow it, New Jersey would become the only one to limit the amount of psychotropic chemical permitted in the marijuana.

While the Christie administration had pushed to require qualifying patients to exhaust all other treatments before receiving medical marijuana, the compromise applies that restriction to only three nonfatal conditions: seizures, glaucoma and intractable muscle spasms.

Mr. Christie hailed the compromise as “the best way to move forward on a responsible, medically based program that will avoid the significant fraud and criminal diversion that other states have experienced.”

Gov. Jon S. Corzine signed New Jersey’s medical marijuana law as he was leaving office in January, making New Jersey the 14th state to legalize the treatment. New York and Connecticut have not.

Since then, Mr. Christie, who was skeptical of the legalization, has been haggling with lawmakers and advocates over the particulars of how to carry out the law.

Advocates of medical marijuana complained on Friday that despite the compromise, the regulations continued to discourage access to the drug: by forbidding home cultivation or delivery, and by requiring doctors to be registered and to take a training course before they could certify patients for treatment.

Ken Wolski, a registered nurse and chief executive officer of the Coalition for Medical Marijuana New Jersey, complained that doctors also had to “attest that they’ve provided education for the patients on the lack of scientific consensus for the use of medical marijuana.”

“What kind of statement is that?” Mr. Wolski said. “The act found legitimate uses for marijuana therapy in a number of specified conditions.”

Patients with a number of conditions would have access to two ounces a month with a potency of 10 percent tetrahydrocannabinol, or THC, the psychotropic chemical. Mr. Wolski estimated that two ounces would be enough for half of all patients, and he said pharmacies in the Netherlands distributed potencies of 13 percent and 18 percent THC.

Pfizer Plans $75 Million Fund to Address Shareholder Suits

Posted: 03 Dec 2010 10:20 PM PST

Pfizer has agreed to set up a $75 million fund and to create a new compliance committee to settle shareholders’ lawsuits accusing the board and top officials of failing to stop illegal marketing of its drugs, according to a settlement agreement filed in United States District Court on Friday.

The company denied any wrongdoing as part of the preliminary settlement, which is subject to judicial review. A Pfizer spokesman said the fund and committee would advance the regulatory and ethics work it had already started in recent years amid a series of government investigations.

Mark Lebovitch, lead counsel for the institutional investors who brought the lawsuits, said it would be one of the largest derivative settlements ever and a good outcome for shareholders.

The suits were filed after Pfizer, the world’s largest pharmaceutical company, settled federal marketing investigations in September 2009. The company paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes. The total included the largest criminal fine in United States history, $1.3 billion, on a charge of illegal marketing of the painkiller Bextra, which was withdrawn from the market in 2005.

Last year’s case was Pfizer’s fourth settlement since 2002 over illegal marketing.

“The core question of the case was, Where was the board when this was going on?” Mr. Lebovitch said in an interview.

Pfizer brought in a powerhouse team in defense, including Robert B. Fiske Jr., the former United States attorney for the Southern District of New York, who had once employed the judge in the case, Jed S. Rakoff, as a federal prosecutor.

District Court Judge Rakoff will hold a preliminary hearing on the settlement on Monday and rule on it later.

About $22 million in lawyers’ fees for the plaintiffs, as well as expenses of up to $1.9 million, will be paid out of the $75 million fund, the court filing says. The remainder would finance the new committee for five years.

The Regulatory and Compliance Committee of the board would monitor legal, regulatory and marketing activities.

Ray Kerins, a Pfizer spokesman, said, “Pfizer’s directors and officers acted with integrity throughout this entire process, and we maintain strongly that plaintiffs’ case has no merit.”

The New Old Age: A Campus for Retirees

Posted: 03 Dec 2010 01:53 PM PST

Weight Watchers Upends Its Points System

Posted: 06 Dec 2010 03:40 PM PST

Their world had been rocked, and the questions came fast and furious: A 31-year-old teacher from Midtown Manhattan who had barely touched a banana in six years wanted to know if she could really consume them with impunity. A small-business owner from TriBeCa wondered whether she was being nudged to part with that second (or third) glass of wine. And a woman with silky brown hair, on her way out the door after a Weight Watchers meeting in the basement of a Park Avenue South office building, had a particularly urgent need.

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Fred R. Conrad/The New York Times

Lisa Shaub, leading a Weight Watchers meeting in Manhattan, explained a new food management system on Thursday morning.

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“I just have one question,” the woman said. “How much is a potato latke? I need to know for tonight.”

They and others had been searching for answers and grappling with their implications since Sunday, when Weight Watchers began unveiling its first major overhaul to its cultlike points system, prompting the 750,000 members who attend weekly meetings across the United States — and some one million online adherents — to rethink how they shop, cook and eat.

The new plan, company officials say, is based on scientific findings about how the body processes different foods. The biggest change: All fruits and most vegetables are point-free (or free of PointsPlus, as the new program is called). Processed foods, meanwhile, generally have higher point values, which roughly translates to: should be eaten less.

“If I lived in the Caribbean, maybe I’d be able to make goal,” said Susan J. Slotkis, 64, an interior designer at the Park Avenue South meeting on Wednesday. “The pineapple is great; all the fruits are fresh; you’re never tempted to drink juice.” In the new system, oranges are free, but eight ounces of orange juice cost three points.

When Weight Watchers introduced its points plan to Americans in 1997, it captivated a generation of women, propelling the company into a $1.4 billion empire. Weight Watchers points became a cultural touchstone: Restaurants like Applebee’s distributed special Weight Watchers menus; food companies like Healthy Choice listed points on their soup cans; and members bought Weight Watchers cookbooks, scales and points calculators. Members pay $12 to $15 a week to attend one of 20,000 weigh-ins and pep talks across the nation, or $65 to use the company’s Internet-monitoring program for three months.

Under the old points plan, all participants were given daily and weekly allowances of points, based on their particular bodies, and each food, from apples to pepperoni pizzas, was given a point value, based primarily on the number of calories it contained, with slight adjustments for fat (bad) and fiber (good).

“You could be holding an apple in one hand, which was two points, and you could be holding a 100-calorie snack pack of Oreos in the other hand, which was also two points,” David Kirchhoff, the president and chief executive of Weight Watchers International, said in a telephone interview.

Now, all of that has been upended. The new system allots points based on a complex formula that considers each item’s mix of protein, fiber, carbohydrates and fat. Making it more confusing, most people are now given more total allowed points — a kind of new math that requires recalculation of what had been ingrained.

Under the old system, for example, the average new member of Weight Watchers was allotted 22 daily points and an extra 35 weekly points. Now, the average new member is allotted 31 daily points and 49 weekly points. So while two potato latkes are now seven points instead of five, their portion of the total is about the same (too high). But a Burger King bacon double cheeseburger is still 12 points, making it slightly less objectionable under the new regime. And that little pack of Oreos? Up a point, to three.

“It’s a complete overhaul; it doesn’t get any bigger than this,” said Karen Miller-Kovach, the chief scientific officer for Weight Watchers International. “Fifteen years ago we said a calorie is a calorie is a calorie. If you ate 100 calories of butter or 100 calories of chicken, it was all the same. Now, we know that is not the case, in terms of how hard the body has to work to make that energy available. And even more important is that where that energy comes from affects feelings of hunger and fullness.”

Some people were drawn to the Weight Watchers point system by the idea that it seemed almost like an anti-diet: you could eat whatever you wanted, as long as you gauged the portion, counted the points and, if necessary, scrimped elsewhere. And while many members are lauding what one blogger described as a “Weight Watchers meets Michael Pollan,“ and celebrating the advent of the guilt-free fruit cup, others are pushing back.

“I don’t want to be forced to choose veggies. I do NOT like veggies or fruit,” one member wrote in an online discussion on the Weight Watchers Web site. “I feel like I am being forced to ‘diet,’ and that is what I DO NOT WANT.”

Kate A. Mack, 28, a high school English teacher in Allentown, Pa., questioned the timing of the shift, between Thanksgiving and New Year’s, long a challenging time for the weight-conscious (a half-cup of reduced-calorie egg nog, for the record, used to be three points and now is four, but remember, the allowed total has changed, too).

Arizona Cuts Financing for Transplant Patients

Posted: 03 Dec 2010 05:22 AM PST

PHOENIX — Even physicians with decades of experience telling patients that their lives are nearing an end are having difficulty discussing a potentially fatal condition that has arisen in Arizona: Death by budget cut.

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Joshua Lott for The New York Times

Randy Shepherd, who needs a heart transplant, showed scars from an earlier operation. He hopes a decision is reversed.

Effective at the beginning of October, Arizona stopped financing certain transplant operations under the state’s version of Medicaid. Many doctors say the decision amounts to a death sentence for some low-income patients, who have little chance of survival without transplants and lack the hundreds of thousands of dollars needed to pay for them.

“The most difficult discussions are those that involve patients who had been on the donor list for a year or more and now we have to tell them they’re not on the list anymore,” said Dr. Rainer Gruessner, a transplant specialist at the University of Arizona College of Medicine. “The frustration is tremendous. It’s more than frustration.”

Organ transplants are already the subject of a web of regulations, which do not guarantee that everyone in need of a life-saving organ will receive one. But Arizona’s transplant specialists are alarmed that patients who were in line to receive transplants one day were, after the state’s budget cuts to its Medicaid program, ruled ineligible the next — unless they raised the money themselves.

Francisco Felix, 32, a father of four who has hepatitis C and is in need of a liver, received news a few weeks ago that a family friend was dying and wanted to donate her liver to him. But the budget cuts meant he no longer qualified for a state-financed transplant.

He was prepared anyway at Banner Good Samaritan Medical Center as his relatives scrambled to raise the needed $200,000. When the money did not come through, the liver went to someone else on the transplant list.

“I know times are tight and cuts are needed, but you can’t cut human lives,” said Mr. Felix’s wife, Flor. “You just can’t do that.”

Such high drama is unfolding regularly here as more and more of the roughly 100 people affected by the cuts are becoming known: the father of six who died before receiving a bone marrow transplant, the plumber in need of a new heart and the high school basketball coach who struggles to breathe during games at high altitudes as she awaits a lung transplant.

“I appreciate the need for budget restraints,” said Dr. Andrew M. Yeager, a University of Arizona professor who is director of the Blood and Marrow Transplantation Program at the Arizona Cancer Center. “But when one looks at a potentially lifesaving treatment, admittedly expensive, and we have data to support efficacy, cuts like this are shortsighted and sad.”

State Medicaid officials said they recommended discontinuing some transplants only after assessing the success rates for previous patients. Among the discontinued procedures are lung transplants, liver transplants for hepatitis C patients and some bone marrow and pancreas transplants, which altogether would save the state about $4.5 million a year.

“As an agency, we understand there have been difficult cuts and there will have to be more difficult cuts looking forward,” said Jennifer Carusetta, chief legislative liaison at the state Medicaid agency.

The issue has led to a fierce political battle, with Democrats condemning the reductions as “Brewercare,” after Gov. Jan Brewer.

“We made it very clear at the time of the vote that this was a death sentence,” said State Senator Leah Landrum Taylor, a Democrat. “This is not a luxury item. We’re not talking about cosmetic surgery.”

The Republican governor has in turn blamed “Obamacare,” meaning the federal health care overhaul, for the transplant cuts even though the Arizona vote came in March, before President Obama signed that bill into law.

But a top Republican, State Representative John Kavanagh, has already pledged to reconsider at least some of the state’s cuts for transplants when the Legislature reconvenes in January. Mr. Kavanagh, chairman of the Appropriations Committee, said he does not believe lawmakers had the full picture of the effect of the cuts on patients when they voted.

“It’s difficult to be linked to a situation where people’s lives are jeopardized and turned upside down,” he said in an interview. “Thankfully no one has died as a result of this, and I believe we have time to rectify this.”

Across the country, states have restricted benefits to their Medicaid programs, according to a 50-state survey published in September by the Kaiser Commission on Medicaid and the Uninsured. But none have gone as far as Arizona in eliminating some transplants, which are considered optional services under federal law.

Before the Legislature acted, Arizona’s Medicaid agency had provided an analysis to lawmakers of the transplants that were cut, which many health experts now say was seriously flawed. For instance, the state said that 13 of 14 patients under the state’s health system who received bone marrow transplants from nonrelatives over a two-year period died within six months.

But outside specialists said the success rates were considerably higher, particularly for leukemia patients in their first remission.

Opponents Take Aim at Limited Health Plans

Posted: 01 Dec 2010 11:20 PM PST

Maybe something isn’t always better than nothing.

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Joshua Roberts/Bloomberg News

Senator Jay Rockefeller criticized limited benefit policies at a hearing on Wednesday.

Or so went the argument offered by Senator John D. Rockefeller IV, the West Virginia Democrat, in a hearing on Wednesday about a controversial kind of health plan that seems destined to remain on the market for the next several years.

More than a million Americans enrolled in these plans think they have health insurance to protect them from financial catastrophe if they become seriously ill or hurt, Mr. Rockefeller said. “In fact, they don’t,” he said.

“It’s worse than nothing because of the false expectations and the false hope,” Mr. Rockefeller said.

He and other proponents of the new health care law are voicing concerns about the Obama administration’s recent decision to allow these plans, known as limited benefit or mini-med policies, to escape some of the legislation’s early requirements.

Taking the opposite view of Mr. Rockefeller, administration officials contended that coverage provided by these policies was better than nothing at all, and promised that more comprehensive plans would be available through state exchanges in 2014, when all plans will have to comply with the law.

Companies like McDonald’s, which was one of the first to seek a waiver from the new rules so it could continue offering plans that offer as little as $2,000 a year in benefits, say these plans are often the only affordable alternative for many of its part-time or low-income workers.

Critics, including Mr. Rockefeller, say people buying these policies often have no idea of how limited the coverage is. They say the employers and insurers, which include major companies like Aetna and Cigna, do not always make it clear to a worker that these policies will not protect them if they develop an expensive medical condition.

What is more, many of these plans are designed in such a way to pay less than the amount they say they will cover. While a policy might promise coverage up to $50,000 a year, for example, the fine print may actually limit what it will pay toward doctors’ visits at just $2,000 or a hospital stay at $250 a day. People who become seriously ill or hurt can end up with tens of thousands of dollars in unpaid medical bills.

“The language in these policies can be very confusing and lead people to believe they have insurance coverage or security if they experience illness or injury,” said Mark Rukavina, the director of the Access Project, a not-for-profit group in Boston that helps people who accumulate large sums of medical debt.

At the hearing, for example, Eugene Melville, a retail worker in California who bought a limited-benefit policy from Aetna, testified about his experience after learning he had oral cancer. While he said he understood that the policy was capped at $20,000 a year, he discovered that it paid only $2,000 for doctors’ visits and care provided outside a hospital.

Others claim to have been similarly surprised. “In no way did I expect the bill that arrived,” said Jessica Lynn Carroll, 30, a resident of San Jose, Calif., who also bought an Aetna policy. When she had to go to the emergency room because she lost feeling in one of her arms, she found her Aetna policy paid only $500 toward the bill. She ended up owing more than $16,000. “If I had known the insurance I had in the first place was absurd, I wouldn’t have purchased it,” said Ms. Carroll, who said the hospital has agreed to significantly reduce her bills.

At the hearing, McDonald’s insisted that its workers knew what they were paying for. “McDonald’s works hard to make sure that its employees understand the coverage limitations as well as the benefits provided by these plans,” testified Rich Floersch, an executive vice president at the company, who said about 90 percent of those enrolled never reached the limits.

Employees pay $11 a week, nearly $600 a year, for coverage that is capped at $2,000, Mr. Floersch said, and they can pay more for plans that limit benefits at $5,000 or $10,000 a year. McDonald’s also says it offers a more comprehensive — and more expensive — plan.

Aetna says its materials are clear. “We want people to know what they’re buying. We recognize that health insurance is complex and we have continually improved our member materials to make them clear so they are not surprised by the limited benefits in these plans,” the company said in a statement.

Cigna also defended the plans, saying they are a choice for people who cannot afford more comprehensive coverage. The company “is committed to helping our customers understand benefits plans before they purchase them,” Cigna said in a statement. “We work to educate our customers about how to best use their benefits after they enroll.”

But insurers also emphasize that customers should be sure to understand what they are buying. “Any consumer should know exactly what benefits their coverage provides before purchasing a policy,” said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans, a trade association. Even policies that provide as much as $1 million in coverage may limit the amount they will pay for specific services.

The federal waivers are only good for a year, and regulators say they plan to ask the plans for more information so they can decide how to handle these policies. Administration officials also say they plan to make sure the insurers are clear that the policies do not meet the requirements of the federal law

“We are working to bring unprecedented transparency to the insurance market, and improve the quality of health insurance, while helping to ensure that people can keep the coverage they have,” said Steve Larsen, director of the Office of Oversight in the Health and Human Services’ Office of Consumer Information and Insurance Oversight. “As part of this effort, we will be requiring insurance companies that offer mini-med plans to tell consumers in plain language that their plan has limited coverage.”

Still, some consumer advocates say individuals may sometimes be better off if they have no insurance at all. If they are uninsured, they may qualify for deeply discounted or even free charity care from the hospital, which they might not get if they had some kind of coverage. “For some people, frankly, they may be better off with no coverage if this is the alternative,” Mr. Rukavina said.

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Recipes for Health: Pasta With Fresh Herbs, Lemon and Peas

Posted: 07 Dec 2010 09:30 AM PST

If you don’t grow your own herbs, I suggest that you buy a bunch of parsley along with basil or chives to keep on hand in your refrigerator. The herbs will keep for a week if properly stored.

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Produce departments often use misters, a practice that drives me crazy because leafy greens don’t keep well once wet. So when you get home, spin the herbs in salad spinner if they’re wet, wrap them in a paper towel and then bag them.

1/2 cup finely chopped fresh herbs, such as parsley, basil, tarragon, mint and chives

Zest of 1 organic lemon, finely chopped

1 garlic clove, finely minced

2 tablespoons fresh lemon juice

3 tablespoons extra virgin olive oil

Salt to taste

3/4 pound pasta, any type

1 cup frozen peas, thawed

1/4 cup freshly grated Parmesan or pecorino

1. Bring a large pot of water to a boil. Meanwhile, in a large bowl or pasta bowl, combine the herbs, lemon zest, garlic, lemon juice and olive oil.

2. When the water comes to a boil, salt generously and add the pasta. Follow the cooking instructions on the package, but check the pasta a minute before the indicated time. A few minutes before the pasta is done, add the peas to the water. When the pasta is just about al dente, remove a half cup of the cooking water and add to the bowl with the herbs. Drain the pasta and peas, toss with the herb mixture and the cheese, and serve.

Yield: Serves four.

Advance preparation: The herbs can be chopped several hours ahead, but don’t combine the ingredients until you’ve put the water on for the pasta.

Nutritional information per serving: 460 calories; 13 grams fat; 2 grams saturated fat; 4 milligrams cholesterol; 70 grams carbohydrates; 4 grams dietary fiber; 123 milligrams sodium (does not include salt added during preparation); 15 grams protein

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

Recipes for Health: Quick and Easy Pastas

Posted: 06 Dec 2010 08:02 AM PST

Years ago, I stayed with an Italian friend in Bologna who worked long hours at his job. By the time he got home, he was hungry, so he’d start water boiling and cast about his tiny kitchen to see what he could use for dinner.

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Then, to my fascination, he’d whip up a delicious pasta sauce from almost nothing: a few anchovies and some walnuts, or a can of tuna and another of beans. Yesterday’s bread became today’s bread crumbs, browned in olive oil with garlic and tossed with spaghetti, olives, capers and jarred tomato purée.

Important to any home kitchen, I realized, is a varied pantry, a place where you can always pull together the essentials for a meal. These days, my pantry is more than just a cupboard. In the freezer, I keep peas and edamame, as well as nuts of all kinds and bread crumbs. In the refrigerator, I always have feta, goat cheese, Parmesan and often pecorino or another hard cheese. Lemons are helpful, too, as is flat-leaf parsley.

These ingredients are particularly useful for pasta. As you’ll see this week, the sauces made with them take no more time than it takes to heat the pasta water.

Pasta With Roasted Red Peppers and Goat Cheese

I try to keep a jar of roasted peppers handy at all times. They’re useful for panini, pizzas and especially pastas like this one. Spanish piquillo peppers are particularly sweet, but bell peppers will do as well. If you have basil, it’s delicious in this dish — but not required.

2 tablespoons extra virgin olive oil

2 garlic cloves, minced

1 cup thinly sliced roasted sweet red peppers

Salt and freshly ground pepper

4 large basil leaves, cut in slivers (chiffonade) (optional)

3 ounces goat cheese, crumbled

3/4 pound pasta, any shape

1. Bring a large pot of water to a boil. Meanwhile, heat the olive oil over medium heat in a large, heavy skillet. Add the garlic. Cook, stirring, until fragrant, about 30 seconds. Add the sliced roasted peppers, and stir together for about a minute until well infused with the oil and garlic. Season with salt and pepper, and stir in the basil (if using) and goat cheese. Remove from the heat.

2. When the water comes to a boil, salt generously and add the pasta. Cook until al dente — firm to the bite — following the recommendations on the package. Ladle about 1/2 cup of the pasta cooking water into the frying pan, and stir well so that the goat cheese begins to melt. Drain the pasta, and toss immediately with the pepper mixture in the pan. Serve.

Yield: Serves four.

Advance preparation: You can make this through Step 1 several hours before you wish to serve it. Add the basil and cheese only when you reheat it.

Nutritional information per serving: 478 calories; 16 grams fat; 6 grams saturated fat; 22 milligrams cholesterol; 65 grams carbohydrates; 2 grams dietary fiber; 110 milligrams sodium (does not include salt added during preparation); 17 grams protein

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

Recipes for Health: Turkey and Mizuna Salad

Posted: 02 Dec 2010 12:30 AM PST

This dish has bright, mildly spicy Asian flavors and lots of crunch. Mizuna is a Japanese mustard green that’s high in folic acid, vitamin A, carotenoids and vitamin C. If you can’t find it, substitute arugula.

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Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

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For the salad:

2 cups mizuna or arugula

3 cups shredded or diced cooked turkey

Salt and freshly ground pepper

1 serrano chili, seeded if desired and chopped (optional)

1 bunch scallions, white part and green, thinly sliced

1 small cucumber, seeded, diced and peeled if waxy; or 1/2 long European cucumber, diced

1/4 cup chopped cilantro

1 small red bell pepper, cut in thin strips

2 tablespoons coarsely chopped walnuts

2 broccoli crowns, cut or broken into small florets, steamed four to five minutes, refreshed with cold water and drained on paper towels (optional)

For the dressing:

2 tablespoons fresh lime juice

1 tablespoon seasoned rice wine vinegar

1 garlic clove, minced or put through a press

2 teaspoons finely minced fresh ginger

1 tablespoon soy sauce

2 tablespoons dark Chinese sesame oil or walnut oil

2 tablespoons canola or peanut oil

1/3 cup low-fat buttermilk or plain nonfat yogurt

1 tablespoon turkey stock or water, for thinning out if using yogurt

1. Line a platter or large bowl with the mizuna or arugula.

2. Season the turkey with salt and pepper, and combine in a large bowl with the chili, scallions, cucumber, cilantro, red pepper and walnuts

3. Combine the ingredients for the dressing, and mix well. Toss with the turkey mixture. Arrange on top of the mizuna or arugula and serve.

Yield: Serves six.

Advance preparation: You can prepare and combine the salad ingredients several hours before tossing with the dressing. Keep in the refrigerator.

Nutritional information per serving: 293 calories; 17 grams fat; 3 grams saturated fat; 54 milligrams cholesterol; 10 grams carbohydrates; 4 grams dietary fiber; 242 milligrams sodium (does not include salt added during preparation); 24 grams protein

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

Congress Approves Child Nutrition Bill

Posted: 02 Dec 2010 11:30 PM PST

WASHINGTON — Congress gave final approval on Thursday to a child nutrition bill that expands the school lunch program and sets new standards to improve the quality of school meals, with more fruits and vegetables.

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Michelle Obama lobbied for the bill as a way to combat obesity and hunger. About half of the $4.5 billion cost is financed by a cut in food stamps starting in several years.

Mrs. Obama said she was thrilled by passage of what she described as a groundbreaking piece of legislation.

By a vote of 264 to 157, the House on Thursday passed the bill, which was approved in the Senate by unanimous consent in August. It goes now to President Obama, who intends to sign it.

On the final roll call, 247 Democrats and 17 Republicans voted for the bill. Four Democrats and 153 Republicans voted no.

Some liberal House Democrats and advocates for the poor railed against the bill in September, saying it was wrong to pay for the expansion of child nutrition programs by cutting money for food stamps, now known as the Supplemental Nutrition Assistance Program.

Democrats put aside their disagreements on Thursday, after concluding that it was better to take what they could get than to gamble on their chances in the next Congress when Republicans will control the House. Mr. Obama tamped down concern by telling Democrats he would work with them to find other ways to pay for the bill, before the cuts in food stamps take effect.

“The president will do everything he can to restore these unconscionable cuts,” said Representative Barbara Lee, Democrat of California and chairwoman of the Congressional Black Caucus.

Democrats and a few Republicans praised Mrs. Obama. “She has been an incredible champion for our children, particularly in the areas of nutrition and obesity,” said Representative Jim McGovern, Democrat of Massachusetts.

Mr. McGovern, who is co-chairman of the House Hunger Caucus, said: “Hunger and obesity are two sides of the same coin. Highly processed, empty-calorie foods are less expensive than fresh nutritious foods.”

School meal programs have a major impact on the nation’s health, and supporters of the bill said it could reduce the prevalence of obesity among children. The lunch program feeds more than 31 million children a day.

Representative Rosa DeLauro, Democrat of Connecticut, said, “The bill sets national nutrition standards that will finally get all of the junk food infiltrating our classrooms and our cafeterias out the door.”

But Representative Paul Broun, Republican of Georgia and a physician, said: “This bill is not about child nutrition. It’s not about healthy kids. It’s about an expansion of the federal government, more and more control from Washington, borrowing more money and putting our children in greater debt. The federal government has no business setting nutritional standards and telling families what they should and should not eat.”

The bill gives the secretary of agriculture authority to establish nutrition standards for foods sold in schools during the school day, including items in vending machines. The standards would require schools to serve more fruits and vegetables, whole grains and low-fat dairy products.

And for the first time in more than three decades, the bill would increase federal reimbursement for school lunches beyond inflation — to help cover the cost of higher-quality meals. It would also allow more than 100,000 children on Medicaid to qualify automatically for free school meals.

One of the most contentious provisions of the bill regulates prices for lunches served to children with family incomes over 185 percent of the poverty level (more than $40,793 a year for a family of four).

“This provision would require some schools to raise their lunch prices,” the Congressional Budget Office said.

Representative John Kline, Republican of Minnesota, said this provision was tantamount to a tax increase on middle-class families. The National Governors Association and local school officials objected to it as a new federal mandate.

But Margo G. Wootan, director of nutrition policy at the Center for Science in the Public Interest, a research and advocacy group, said: “The price of paid lunches needs to go up. Schools are not charging enough to cover the cost. As a result, money intended to provide healthy food to low-income kids is being diverted to subsidize food for higher-income children.”

School districts that comply with the new standards can receive an additional federal payment of 6 cents for each lunch served. The National School Boards Association, representing local board members, said “the actual increased cost of compliance” was at least twice that amount.

The bill was written mainly by Senator Blanche Lincoln, Democrat of Arkansas and chairwoman of the Senate Agriculture Committee, who lost her bid for re-election.

The bill rounds out the tenure of Speaker Nancy Pelosi, Democrat of California. When she took the gavel in January 2007, she was surrounded by the children of House members, and she called the House to order in the name of “all America’s children.”

Remaking a School Lunch

Posted: 03 Dec 2010 12:40 AM PST

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How the nutrition bill would change a meal.

BEFORE

Fried chicken patty

White roll

Canned green beans

Whole milk

Package of snack cakes (from vending machine)

AFTER

Barbecued chicken patty

Whole grain roll

Locally grown carrots

1 percent milk

Sliced apples

Source: Center for Science in the Public Interest

Tests for H.I.V. Reach a Record

Posted: 02 Dec 2010 09:51 AM PST

The number of American adults tested for H.I.V., the virus that causes AIDS, reached a record high in 2009, the Centers for Disease Control and Prevention said Tuesday.

Nonetheless, about 55 percent of all adults — and about 28 percent of all people who are at higher risk for getting infected — have still never been tested.

Starting in 2006, the disease centers began urging doctors to order H.I.V. tests as part of routine blood work for all patients. Success has been modest; the percentage of all adults who have ever had a test rose only to 45 percent after years of holding steady at 40 percent.

Almost one-third of people who learn they are infected find out only when they fall seriously ill, the disease centers said, meaning they have presumably infected others during that time and have also missed the opportunity to get treatment.

F.D.A. Panel Rejects Expanded Use of Prostate Drug

Posted: 02 Dec 2010 11:30 PM PST

The question before the Food and Drug Administration advisory committee on Tuesday was path-breaking: Would it recommend that the labels of two drugs be changed to say that they can reduce a man’s risk of getting prostate cancer?

If the drugs were approved for that purpose, they would be only the second class of cancer-prevention drugs on the market — the first being drugs like tamoxifen that block estrogen and reduce the risk of breast cancer.

But the answer was a resounding no. There was too much uncertainty about long-term consequences, the committee said, especially if the drugs would be used by hundreds of thousands of healthy people.

The drugs are dutasteride, made by GlaxoSmithKline and sold as Avodart, and finasteride, a generic made by Merck and sold as Proscar. Both are already on the market to shrink the prostate, alleviating a harmless but uncomfortable condition that results in frequent urination in older men.

GlaxoSmithKline was seeking permission to add cancer risk reduction to its drug’s label, and to market dutasteride as a drug to reduce prostate cancer risk. Merck was not seeking a cancer risk reduction indication but attended the meeting at the request of the F.D.A.

The data before the committee included results from two large studies of the drugs. GlaxoSmithKline’s study involved 8,000 men at risk for prostate cancer because their PSA tests had found elevations of that blood protein. The men also had had prostate biopsies, but at the start of the study none had received a diagnosis of prostate cancer.

The finasteride study, sponsored by the National Cancer Institute, included 18,800 healthy men over age 55 who were randomly assigned to take the drug or a placebo.

Both studies found the drugs reduced the overall prostate cancer risk by about 25 percent.

But both studies also found small increases in the incidence of higher-grade, riskier cancers, in men taking the drugs as compared with placebos.

The companies and independent researchers had explanations for that. They said that the drugs reduced the size of a man’s prostate, making it easier to find lethal cancers on biopsies.

“You take something the size of an apricot and shrink it to the size of an almond,” Dr. Anne Phillips, a Glaxo SmithKline vice president, said in an interview before the F.D.A. meeting.

If a man’s prostate is smaller, a doctor who randomly sticks a needle into the prostate is more likely to strike a tumor if it is present. So, the analysis went, instead of increasing a man’s risk of getting a dangerous tumor, the drugs increased the chances that such tumors, if they were present, would be found.

Finasteride investigators published detailed analyses also reaching that conclusion.

“I think there is no question that this drug enhances the detection of high-grade disease,” Dr. Howard Parnes of the National Cancer Institute said about finasteride in an interview before the meeting.

But committee members were not convinced. Was it really safe for men to take the drugs for decades?

“I wouldn’t do it,” said Dr. Patrick J. Loehrer, a committee member from Indiana University, explaining his no vote on finasteride.

And they were worried that the drugs might be misused or misunderstood in the general population, with direct-to-consumer advertising and general practitioners who might not fully appreciate how to use them.

Dr. Richard Pazdur, head of oncology at the F.D.A., told the committee that what they were being asked to decide was very different from their usual charge. Ordinarily, the committee votes on whether cancer drugs should be approved for sick patients who have few alternatives.

In this case, Dr. Pazdur said, the drugs were already approved for a different indication. The question was what would happen if they were marketed to reduce prostate cancer risk.

“Hundreds of thousands of people will be exposed to these drugs,” Dr. Pazdur said. “This is not an oncology drug that is going to be prescribed by a select group of medical oncologists.”

Dr. Ian Thompson, a urologist at The University of Texas Health Science Center at San Antonio, who led the cancer institute’s study of finasteride, was deeply disappointed in the decision.

“The bar is so high I am not sure we will see chemoprevention in my lifetime,” Dr. Thompson said.

Yet the need is great, he said. One in six men will receive a diagnosis of prostate cancer, Dr. Thompson noted.

“It was somehow felt that that was O.K.,” he said. “I personally feel that that is not acceptable. A man at risk of prostate cancer may at least be informed that he could reduce his risk.”

Obesity Surgery May Become Option for Many More

Posted: 02 Dec 2010 07:47 AM PST

Weight-loss surgery, once a last resort for extremely overweight people, may soon become an option for those who are less heavy.

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Rashida Brown of Jamaica Plain, Mass., wanted gastric banding surgery but her body mass index was below federal guidelines.

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Less Fat, More Surgery

An advisory committee to the Food and Drug Administration will consider on Friday a request by Allergan, the pharmaceutical company, to significantly lower how obese someone must be to qualify for surgery using the company’s Lap-Band device, which restricts intake to the stomach.

On Wednesday, the F.D.A. acknowledged that a new study by the company showed that people in the proposed range of obesity who had the band experienced “statistically significant decreases in all measures of weight loss.”

If the agency approves the change, the number of Americans eligible for the Lap-Band operation could easily double, ensuring more sales for Allergan and probably more insurance coverage for such operations. But the proposed change, sought at a time when the obesity epidemic in the United States seems intractable, still leaves some people uneasy, in part because of side effects and failure rates. In addition, long-term weight reduction is hard to maintain.

“You’re talking about millions and millions of people who would meet these criteria,” said Dr. George Blackburn, associate director of the division of nutrition at Harvard Medical School. “Let’s make sure by the most rigorous research that this is safe and effective.”

A new generation of diet pills has failed to gain federal approval, limiting options for overweight Americans, and Allergan and other companies are betting that surgery will become more of a frontline option rather than a last resort.

“It would be kind of ironic if people have access to surgery and not medical therapies, where they can go from Weight Watchers to surgery and have nothing in-between,” said Dr. Louis J. Aronne, an obesity expert at Weill Cornell Medical College. “But it appears it may be the way it will be in the near future.”

Doctors have already started to operate on extremely heavy teenagers, not just adults. And some experts are recasting weight-loss procedures, known as bariatric surgery, as metabolic surgery, saying that it might be justified to treat diabetes, even in people who are barely obese or not obese. Gastric banding involves placing an inflatable silicone ring around the upper part of the stomach, which limits food consumption and makes one feel full faster.

Current guidelines say weight loss surgery is appropriate for people who have failed to lose weight through diet and exercise and have a body mass index, or B.M.I., of 40 and above, or 35 and above if a person has at least one serious health problem, like diabetes or high blood pressure, that is tied to obesity. Allergan wants to lower the threshold for the Lap-Band to a B.M.I. of 35 with no associated health problems and to 30 with such problems.

For instance, a person who is 5 feet 6 inches and has diabetes would have to weigh 216 pounds to qualify now. Under the proposed lower threshold, that person could weigh 30 pounds less, or 186 pounds.

Federal statistics suggest that nearly 20 percent of the adult population has a B.M.I. between 30 and 35, more than double the population above 35. Probably half or more of the people between 30 and 35 have some associated health condition.

Bariatric surgeons and some obesity experts say that surgery has proven to be the only way many people can lose a lot of weight and keep it off, and some cite a Swedish study suggesting that it prolonged lives. And, they say, the operations have become safer since the obesity thresholds were first set in 1991 in a meeting organized by the National Institutes of Health.

“The whole risk-benefit ratio is completely different than it was back then,” said Dr. Marc Bessler, chief of the division of minimally invasive and bariatric surgery at Columbia.

Banding is a less radical operation than the main alternative, the gastric bypass. It is also reversible and costs less — from $12,000 to more than $20,000, compared with $20,000 to more than $30,000 for a bypass. But banding also leads to a weight loss of about 20 percent on average, less than that of bypass.

Bypass has been the preferred operation in the United States, though Allergan executives said on a recent call with investors that banding now has about 50 percent market share. Within the banding market, Allergan’s Lap-Band has about 70 percent market share, according to the company, with the rest belonging to the Realize Band sold by Ethicon Endo-Surgery, a division of Johnson & Johnson. Allergan’s band was approved in 2001.

To win approval of the lower threshold, Allergan sponsored a study in which 149 of these less obese people had the band implanted. About 80 percent of the participants achieved the goal of losing at least 30 percent of their excess weight, meaning the amount by which they were overweight, after one year. About 70 percent of patients experienced a side effect, like vomiting or pain. The F.D.A. indicated on Wednesday that it had questions about how meaningful the weight loss was and whether the results of the study would be applicable to people other than the white women who made up a large portion of the participants.

Some doctors are dropping the band, in part because some older studies suggest that up to a third of patients eventually have the band removed because of side effects or ineffective weight loss. While about one in 1,000 patients die within 30 days of surgery, a survey of members of the bariatric surgery society suggested that deaths occurring later are under-reported.

“Before they start putting the Lap-Band on patients who are 50 pounds overweight, the public has to be made aware of how dangerous this is,” said Stephanie Quatinetz, a New York lawyer whose daughter, Rebecca, died at age 27 in August 2009, two months after getting Lap-Band surgery.

Scans Could Aid Diagnosis of Brain Trauma in Living

Posted: 01 Dec 2010 11:30 PM PST

In a finding that could eventually lead to ways to identify and perhaps treat athletes who have chronic traumatic encephalopathy, Boston-based researchers announced on Wednesday that a new imaging technique found chemical changes in the brains of living athletes with a history of head trauma.

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C.T.E., whose diagnosis in more than a dozen deceased N.F.L. players and one collegian has helped lift the dangers of sports concussions to national prominence, can be confirmed only through a specialized examination of brain tissue after death. As such, the question of whether a particular living athlete who is showing symptoms of the disease — anger control, memory loss and more — has C.T.E. has remained only gnawing speculation.

At the Radiological Society of North America’s annual meeting in Chicago, Dr. Alexander Lin of Brigham and Women’s Hospital in Boston described how magnetic resonance spectroscopy scans identified biomarkers in five athletes showing signs of C.T.E. The subjects were three retired N.F.L. players, one boxer and one wrestler; their scans were compared with those of nonathletes of the same age and relative lifestyle.

“We measured the brain chemistry of men with a broad history of brain trauma and found these changes that indicate something biochemically abnormal,” Lin said. “We don’t know whether they have C.T.E. We don’t know at this point if these living changes are related.”

One of the study’s co-authors, Dr. Robert Stern of the Boston University Center for the Study of Traumatic Encephalopathy, expressed similar caution that these preliminary results not be over-interpreted, particularly given the public’s growing understanding of C.T.E. and its effects.

It remains unknown whether brain trauma caused the chemical changes, Stern said, something that further studies could help determine. Stern said that potential treatments would be best pursued through the identification of living people with the disease.

“This is a first step in a long process,” Stern said. “This is an initial study with a very small sample that shows us that the technology may be of use in C.T.E. diagnosis. It does not, however, suggest that we are close to being able to use the technology in the near future.”

Any proven method to diagnose C.T.E. in a living person could have major economic effects on the N.F.L. Retired players with cognitive problems still cannot prove their condition was caused by football, which has limited their ability to obtain benefits either through the league’s disability plan, state worker’s compensation or lawsuits.

Given California’s unique worker’s compensation system, which allow players who played one game in the state to file claims years after their retirement, proof that cognitive decline was related to their N.F.L. career could lead to teams’ owing millions of dollars for medical treatment (including institutional care) for each retiree.

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